Drugs approved in 2013

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Drugs approved in 2013

In 2013, the Food and Drug Administration approved 27 new molecular entities (i.e., drugs) for human use. Because of their indications, it is unlikely that four will be used in pregnancy or lactation, so they are not discussed here. The four agents are ospemifene (Osphena), an estrogen agonist/antagonist used for severe dyspareunia; [223Ra]radium dichloride (Xofigo), for late-stage metastatic prostate cancer; conjugated estrogens/bazedoxifene (Duavee) for hot flashes associated with menopause and to prevent osteoporosis; and flutemetamol F-18 injection (Vizamyl), a radioactive diagnostic agent to aid in the evaluation of Alzheimer’s disease and dementia.

There are two other drugs that are unlikely to be used in pregnancy: macitentan (Opsumit) and riociguat (Adempas). These drugs are oral vasodilators indicated for the treatment of pulmonary hypertension. Both are teratogenic in rats and rabbits, but there are no reports of their use in human pregnancy. For female patients of reproductive potential, they are only available through restricted programs. Pregnancy must be excluded before starting therapy, monthly during treatment, and for 1 month after treatment is stopped.

The remaining 21 agents can be classified into the following categories: anticonvulsant (1), antidepressant (1), antidiabetics (2), antineoplastics (7), antihyperlipidemic (1), anti-infectives (4), diagnostics (2), immunologic (1), and respiratory (2). It is important to note that, except for two drugs (fluticasone in a combination product and dimethyl fumarate), there is no reported human pregnancy experience for these agents. Moreover, all probably cross the placenta to the embryo and/or the fetus, at least in some part of pregnancy.

Eslicarbazepine (Aptiom) is indicated as adjunctive treatment of partial-onset seizures. Developmental toxicity was observed in three animals: teratogenicity (mice), embryolethality (rats), and fetal growth restriction (rabbits). The no-effect dose was not found in two species, and was less than the human dose based on body surface area in the third. If a pregnant woman is taking this drug, she should be encouraged to enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 888-233-2334.

Vortioxetine (Brintellix) is indicated for the treatment of major depressive disorder. The drug was not teratogenic in animals but did cause developmental delays in one species. Although the antidepressant mechanism is not fully understood, it appears to be related to the inhibition of the reuptake of serotonin (5-hydroxytryptamine). If so, vortioxetine would be closely related to the drugs in the selective serotonin reuptake inhibitor (SSRI) class: citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), and vilazodone (Viibryd). The relationship could be important because the use of SSRIs or serotonin norepinephrine reuptake inhibitors (SNRIs) close to birth is related to significant toxicity in the newborn.

There are two new antidiabetic agents for the treatment of type 2 diabetes. Alogliptin (Nesina), a dipeptidyl peptidase–4 inhibitor, is in the same pharmacologic class as linagliptin (Tradjenta), saxagliptin (Onglyza), and sitagliptin (Januvia). Canagliflozin (Invokana) is a sodium-glucose cotransporter 2 inhibitor, the first drug in this class to be approved. The animal data for alogliptin suggest low risk, whereas canagliflozin caused renal toxicity in rats at exposures corresponding to the late second and third trimester in humans. Insulin remains the treatment of choice for pregnant diabetics because tight control of glucose levels is beneficial for the mother, embryo-fetus, and newborn.

The seven new antineoplastic agents are ado-trastuzumab emtansine (Kadcyla) for HER2-positive breast cancer; afatinib (Gilotrif) for non–small cell lung cancer; dabrafenib (Tafinlar) for unresectable or metastatic melanoma; ibrutinib (Imbruvica) for mantle cell lymphoma or chronic lymphocytic leukemia; obinutuzumab (Gazyva) for chronic lymphocytic leukemia; pomalidomide (Pomalyst) for multiple myeloma; and trametinib (Mekinist) for unresectable or metastatic melanoma. Only pomalidomide is contraindicated in pregnancy. Although obinutuzumab did not cause teratogenicity in monkeys, its use in the latter portion of pregnancy resulted in newborn depletion of B cells that took up to 6 months after birth to restore. Moreover, it is used in combination with chlorambucil, a known teratogen. The animal data suggest risk in the other five agents. Nevertheless, the maternal condition should determine whether any of these antineoplastics are used in a pregnant woman.

Mipomersen sodium (Kynamro) is given subcutaneously once a week as an adjunct to lipid-lowering medications. The drug caused embryo toxicity in one of three animal species.

Among the four anti-infectives are two oral agents for the treatment of chronic hepatitis C virus infection: simeprevir (Olysio) and sofosbuvir (Sovaldi). Because both agents are recommended to be combined with peginterferon alfa and ribavirin, they are classified as contraindicated in pregnancy. However, when used alone, the animal data suggest that sofosbuvir was low risk, whereas simeprevir might have higher risk.

 

 

Luliconazole (Luzu), an azole antifungal, is a cream used for the treatment of tinea pedis, tinea cruris, and tinea corporis. Systemic absorption is minimal. The animal data suggest low risk, but there are no human pregnancy reports. Nevertheless, topical use is probably compatible in pregnancy, as are the other topical azole antifungals in this pharmacologic class: clotrimazole (Lotrimin), econazole (Spectazole), ketoconazole (Kuric), miconazole (Micatin), oxiconazole (Oxistat), sertaconazole (Ertaczo), and sulconazole (Exelderm).

Dolutegravir (Tivicay) is an HIV-1 integrase strand transfer inhibitor given in combination with other antiretroviral drugs. The animal data suggest low risk. If indicated, the drug should not be withheld because of pregnancy.

Gadoterate meglumine (Dotarem), a gadolinium-based contrast agent, is indicated to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity. No developmental toxicity was observed in pregnant animals. Closely related diagnostic agents are gadobenate dimeglumine (MultiHance), gadodiamide (Omniscan), gadofosveset (Ablavar), gadopentetate dimeglumine (Magnevist), gadoteridol (Prohance), and gadoversetamide (OptiMARK). Although the animal data for these agents show risk, no harm has been reported in human pregnancies. However, the available human data are very limited, and the risk magnitude for embryo-fetal harm remains unknown.

Technetium (99mTc) tilmanocept (Lymphoseek) is a radioactive diagnostic agent used in patients with breast cancer or melanoma. The active ingredient is technetium (99mTc). Animal reproduction studies have not been conducted. 99mTc is probably compatible in pregnancy (see Drugs in Pregnancy and Lactation, 10th ed.; Philadelphia: Lippincott, Williams and Wilkins, 2014:1317-8; to be released in August), but the risk of the tilmanocept moiety is unknown.

The immunologic agent dimethyl fumarate (Tecfidera) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. The drug caused developmental toxicity (embryolethality, impaired growth, and birth defects) in animals during all portions of pregnancy. In clinical trials, there were 38 exposed pregnancies with the following outcomes: 22 live births, 3 spontaneous abortions, 9 elective abortions, 3 ongoing pregnancies, and 1 lost to follow-up (CNS Drugs 2014;28:89-94). A pregnancy registry has been established, and patients should be encouraged to enroll by calling 800-456-2255.

Two new respiratory combination products were approved in 2013, both for chronic obstructive pulmonary disease: fluticasone/vilanterol (Breo Ellipta) and umeclidinium/vilanterol (Anoro Ellipta). Inhaled fluticasone, a corticosteroid, is compatible in pregnancy (see Drugs in Pregnancy and Lactation, 9th ed.; Philadelphia: Lippincott, Williams and Wilkins; 2011:599-601). Vilanterol is a long-acting beta2-adrenergic agonist that is probably compatible in pregnancy. The absolute bioavailability of inhaled fluticasone and vilanterol in nonpregnant adults was about 15% and 27%, respectively. The animal data for the combination or when given individually suggest low risk in pregnancy. Umeclidinium is a long-acting anticholinergic. It also is absorbed from the lung, but the amount was not specified by the manufacturer. The animal data for umeclidinium suggest low risk.

There are no reports of the above drugs being used during breastfeeding, but excretion into breast milk should be expected. The effect of these exposures on a nursing infant is unknown. However, if a mother is taking one of these drugs and breastfeeding, her infant should be monitored for adverse effects, especially those that are the most common (typically listed on the first page of the package insert) in patients taking the drug. Close monitoring is particularly important during the first 2 postpartum months. A 2003 study found that most adverse reactions in nursing infants occurred within that time period (Clin. Pediatr. 2003;42:325-40).

Mr. Briggs is a pharmacist clinical specialist at the outpatient clinics of Memorial Care Center for Women at Miller Children’s Hospital in Long Beach, Calif.; clinical professor of pharmacy at the University of California, San Francisco; and adjunct professor of pharmacy at the University of Southern California, Los Angeles, and Washington State University, Spokane. He also is coauthor of "Drugs in Pregnancy and Lactation," and coeditor of "Diseases, Complications, and Drug Therapy in Obstetrics." He had no other relevant financial disclosures. Contact him at [email protected].

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In 2013, the Food and Drug Administration approved 27 new molecular entities (i.e., drugs) for human use. Because of their indications, it is unlikely that four will be used in pregnancy or lactation, so they are not discussed here. The four agents are ospemifene (Osphena), an estrogen agonist/antagonist used for severe dyspareunia; [223Ra]radium dichloride (Xofigo), for late-stage metastatic prostate cancer; conjugated estrogens/bazedoxifene (Duavee) for hot flashes associated with menopause and to prevent osteoporosis; and flutemetamol F-18 injection (Vizamyl), a radioactive diagnostic agent to aid in the evaluation of Alzheimer’s disease and dementia.

There are two other drugs that are unlikely to be used in pregnancy: macitentan (Opsumit) and riociguat (Adempas). These drugs are oral vasodilators indicated for the treatment of pulmonary hypertension. Both are teratogenic in rats and rabbits, but there are no reports of their use in human pregnancy. For female patients of reproductive potential, they are only available through restricted programs. Pregnancy must be excluded before starting therapy, monthly during treatment, and for 1 month after treatment is stopped.

The remaining 21 agents can be classified into the following categories: anticonvulsant (1), antidepressant (1), antidiabetics (2), antineoplastics (7), antihyperlipidemic (1), anti-infectives (4), diagnostics (2), immunologic (1), and respiratory (2). It is important to note that, except for two drugs (fluticasone in a combination product and dimethyl fumarate), there is no reported human pregnancy experience for these agents. Moreover, all probably cross the placenta to the embryo and/or the fetus, at least in some part of pregnancy.

Eslicarbazepine (Aptiom) is indicated as adjunctive treatment of partial-onset seizures. Developmental toxicity was observed in three animals: teratogenicity (mice), embryolethality (rats), and fetal growth restriction (rabbits). The no-effect dose was not found in two species, and was less than the human dose based on body surface area in the third. If a pregnant woman is taking this drug, she should be encouraged to enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 888-233-2334.

Vortioxetine (Brintellix) is indicated for the treatment of major depressive disorder. The drug was not teratogenic in animals but did cause developmental delays in one species. Although the antidepressant mechanism is not fully understood, it appears to be related to the inhibition of the reuptake of serotonin (5-hydroxytryptamine). If so, vortioxetine would be closely related to the drugs in the selective serotonin reuptake inhibitor (SSRI) class: citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), and vilazodone (Viibryd). The relationship could be important because the use of SSRIs or serotonin norepinephrine reuptake inhibitors (SNRIs) close to birth is related to significant toxicity in the newborn.

There are two new antidiabetic agents for the treatment of type 2 diabetes. Alogliptin (Nesina), a dipeptidyl peptidase–4 inhibitor, is in the same pharmacologic class as linagliptin (Tradjenta), saxagliptin (Onglyza), and sitagliptin (Januvia). Canagliflozin (Invokana) is a sodium-glucose cotransporter 2 inhibitor, the first drug in this class to be approved. The animal data for alogliptin suggest low risk, whereas canagliflozin caused renal toxicity in rats at exposures corresponding to the late second and third trimester in humans. Insulin remains the treatment of choice for pregnant diabetics because tight control of glucose levels is beneficial for the mother, embryo-fetus, and newborn.

The seven new antineoplastic agents are ado-trastuzumab emtansine (Kadcyla) for HER2-positive breast cancer; afatinib (Gilotrif) for non–small cell lung cancer; dabrafenib (Tafinlar) for unresectable or metastatic melanoma; ibrutinib (Imbruvica) for mantle cell lymphoma or chronic lymphocytic leukemia; obinutuzumab (Gazyva) for chronic lymphocytic leukemia; pomalidomide (Pomalyst) for multiple myeloma; and trametinib (Mekinist) for unresectable or metastatic melanoma. Only pomalidomide is contraindicated in pregnancy. Although obinutuzumab did not cause teratogenicity in monkeys, its use in the latter portion of pregnancy resulted in newborn depletion of B cells that took up to 6 months after birth to restore. Moreover, it is used in combination with chlorambucil, a known teratogen. The animal data suggest risk in the other five agents. Nevertheless, the maternal condition should determine whether any of these antineoplastics are used in a pregnant woman.

Mipomersen sodium (Kynamro) is given subcutaneously once a week as an adjunct to lipid-lowering medications. The drug caused embryo toxicity in one of three animal species.

Among the four anti-infectives are two oral agents for the treatment of chronic hepatitis C virus infection: simeprevir (Olysio) and sofosbuvir (Sovaldi). Because both agents are recommended to be combined with peginterferon alfa and ribavirin, they are classified as contraindicated in pregnancy. However, when used alone, the animal data suggest that sofosbuvir was low risk, whereas simeprevir might have higher risk.

 

 

Luliconazole (Luzu), an azole antifungal, is a cream used for the treatment of tinea pedis, tinea cruris, and tinea corporis. Systemic absorption is minimal. The animal data suggest low risk, but there are no human pregnancy reports. Nevertheless, topical use is probably compatible in pregnancy, as are the other topical azole antifungals in this pharmacologic class: clotrimazole (Lotrimin), econazole (Spectazole), ketoconazole (Kuric), miconazole (Micatin), oxiconazole (Oxistat), sertaconazole (Ertaczo), and sulconazole (Exelderm).

Dolutegravir (Tivicay) is an HIV-1 integrase strand transfer inhibitor given in combination with other antiretroviral drugs. The animal data suggest low risk. If indicated, the drug should not be withheld because of pregnancy.

Gadoterate meglumine (Dotarem), a gadolinium-based contrast agent, is indicated to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity. No developmental toxicity was observed in pregnant animals. Closely related diagnostic agents are gadobenate dimeglumine (MultiHance), gadodiamide (Omniscan), gadofosveset (Ablavar), gadopentetate dimeglumine (Magnevist), gadoteridol (Prohance), and gadoversetamide (OptiMARK). Although the animal data for these agents show risk, no harm has been reported in human pregnancies. However, the available human data are very limited, and the risk magnitude for embryo-fetal harm remains unknown.

Technetium (99mTc) tilmanocept (Lymphoseek) is a radioactive diagnostic agent used in patients with breast cancer or melanoma. The active ingredient is technetium (99mTc). Animal reproduction studies have not been conducted. 99mTc is probably compatible in pregnancy (see Drugs in Pregnancy and Lactation, 10th ed.; Philadelphia: Lippincott, Williams and Wilkins, 2014:1317-8; to be released in August), but the risk of the tilmanocept moiety is unknown.

The immunologic agent dimethyl fumarate (Tecfidera) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. The drug caused developmental toxicity (embryolethality, impaired growth, and birth defects) in animals during all portions of pregnancy. In clinical trials, there were 38 exposed pregnancies with the following outcomes: 22 live births, 3 spontaneous abortions, 9 elective abortions, 3 ongoing pregnancies, and 1 lost to follow-up (CNS Drugs 2014;28:89-94). A pregnancy registry has been established, and patients should be encouraged to enroll by calling 800-456-2255.

Two new respiratory combination products were approved in 2013, both for chronic obstructive pulmonary disease: fluticasone/vilanterol (Breo Ellipta) and umeclidinium/vilanterol (Anoro Ellipta). Inhaled fluticasone, a corticosteroid, is compatible in pregnancy (see Drugs in Pregnancy and Lactation, 9th ed.; Philadelphia: Lippincott, Williams and Wilkins; 2011:599-601). Vilanterol is a long-acting beta2-adrenergic agonist that is probably compatible in pregnancy. The absolute bioavailability of inhaled fluticasone and vilanterol in nonpregnant adults was about 15% and 27%, respectively. The animal data for the combination or when given individually suggest low risk in pregnancy. Umeclidinium is a long-acting anticholinergic. It also is absorbed from the lung, but the amount was not specified by the manufacturer. The animal data for umeclidinium suggest low risk.

There are no reports of the above drugs being used during breastfeeding, but excretion into breast milk should be expected. The effect of these exposures on a nursing infant is unknown. However, if a mother is taking one of these drugs and breastfeeding, her infant should be monitored for adverse effects, especially those that are the most common (typically listed on the first page of the package insert) in patients taking the drug. Close monitoring is particularly important during the first 2 postpartum months. A 2003 study found that most adverse reactions in nursing infants occurred within that time period (Clin. Pediatr. 2003;42:325-40).

Mr. Briggs is a pharmacist clinical specialist at the outpatient clinics of Memorial Care Center for Women at Miller Children’s Hospital in Long Beach, Calif.; clinical professor of pharmacy at the University of California, San Francisco; and adjunct professor of pharmacy at the University of Southern California, Los Angeles, and Washington State University, Spokane. He also is coauthor of "Drugs in Pregnancy and Lactation," and coeditor of "Diseases, Complications, and Drug Therapy in Obstetrics." He had no other relevant financial disclosures. Contact him at [email protected].

In 2013, the Food and Drug Administration approved 27 new molecular entities (i.e., drugs) for human use. Because of their indications, it is unlikely that four will be used in pregnancy or lactation, so they are not discussed here. The four agents are ospemifene (Osphena), an estrogen agonist/antagonist used for severe dyspareunia; [223Ra]radium dichloride (Xofigo), for late-stage metastatic prostate cancer; conjugated estrogens/bazedoxifene (Duavee) for hot flashes associated with menopause and to prevent osteoporosis; and flutemetamol F-18 injection (Vizamyl), a radioactive diagnostic agent to aid in the evaluation of Alzheimer’s disease and dementia.

There are two other drugs that are unlikely to be used in pregnancy: macitentan (Opsumit) and riociguat (Adempas). These drugs are oral vasodilators indicated for the treatment of pulmonary hypertension. Both are teratogenic in rats and rabbits, but there are no reports of their use in human pregnancy. For female patients of reproductive potential, they are only available through restricted programs. Pregnancy must be excluded before starting therapy, monthly during treatment, and for 1 month after treatment is stopped.

The remaining 21 agents can be classified into the following categories: anticonvulsant (1), antidepressant (1), antidiabetics (2), antineoplastics (7), antihyperlipidemic (1), anti-infectives (4), diagnostics (2), immunologic (1), and respiratory (2). It is important to note that, except for two drugs (fluticasone in a combination product and dimethyl fumarate), there is no reported human pregnancy experience for these agents. Moreover, all probably cross the placenta to the embryo and/or the fetus, at least in some part of pregnancy.

Eslicarbazepine (Aptiom) is indicated as adjunctive treatment of partial-onset seizures. Developmental toxicity was observed in three animals: teratogenicity (mice), embryolethality (rats), and fetal growth restriction (rabbits). The no-effect dose was not found in two species, and was less than the human dose based on body surface area in the third. If a pregnant woman is taking this drug, she should be encouraged to enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 888-233-2334.

Vortioxetine (Brintellix) is indicated for the treatment of major depressive disorder. The drug was not teratogenic in animals but did cause developmental delays in one species. Although the antidepressant mechanism is not fully understood, it appears to be related to the inhibition of the reuptake of serotonin (5-hydroxytryptamine). If so, vortioxetine would be closely related to the drugs in the selective serotonin reuptake inhibitor (SSRI) class: citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), and vilazodone (Viibryd). The relationship could be important because the use of SSRIs or serotonin norepinephrine reuptake inhibitors (SNRIs) close to birth is related to significant toxicity in the newborn.

There are two new antidiabetic agents for the treatment of type 2 diabetes. Alogliptin (Nesina), a dipeptidyl peptidase–4 inhibitor, is in the same pharmacologic class as linagliptin (Tradjenta), saxagliptin (Onglyza), and sitagliptin (Januvia). Canagliflozin (Invokana) is a sodium-glucose cotransporter 2 inhibitor, the first drug in this class to be approved. The animal data for alogliptin suggest low risk, whereas canagliflozin caused renal toxicity in rats at exposures corresponding to the late second and third trimester in humans. Insulin remains the treatment of choice for pregnant diabetics because tight control of glucose levels is beneficial for the mother, embryo-fetus, and newborn.

The seven new antineoplastic agents are ado-trastuzumab emtansine (Kadcyla) for HER2-positive breast cancer; afatinib (Gilotrif) for non–small cell lung cancer; dabrafenib (Tafinlar) for unresectable or metastatic melanoma; ibrutinib (Imbruvica) for mantle cell lymphoma or chronic lymphocytic leukemia; obinutuzumab (Gazyva) for chronic lymphocytic leukemia; pomalidomide (Pomalyst) for multiple myeloma; and trametinib (Mekinist) for unresectable or metastatic melanoma. Only pomalidomide is contraindicated in pregnancy. Although obinutuzumab did not cause teratogenicity in monkeys, its use in the latter portion of pregnancy resulted in newborn depletion of B cells that took up to 6 months after birth to restore. Moreover, it is used in combination with chlorambucil, a known teratogen. The animal data suggest risk in the other five agents. Nevertheless, the maternal condition should determine whether any of these antineoplastics are used in a pregnant woman.

Mipomersen sodium (Kynamro) is given subcutaneously once a week as an adjunct to lipid-lowering medications. The drug caused embryo toxicity in one of three animal species.

Among the four anti-infectives are two oral agents for the treatment of chronic hepatitis C virus infection: simeprevir (Olysio) and sofosbuvir (Sovaldi). Because both agents are recommended to be combined with peginterferon alfa and ribavirin, they are classified as contraindicated in pregnancy. However, when used alone, the animal data suggest that sofosbuvir was low risk, whereas simeprevir might have higher risk.

 

 

Luliconazole (Luzu), an azole antifungal, is a cream used for the treatment of tinea pedis, tinea cruris, and tinea corporis. Systemic absorption is minimal. The animal data suggest low risk, but there are no human pregnancy reports. Nevertheless, topical use is probably compatible in pregnancy, as are the other topical azole antifungals in this pharmacologic class: clotrimazole (Lotrimin), econazole (Spectazole), ketoconazole (Kuric), miconazole (Micatin), oxiconazole (Oxistat), sertaconazole (Ertaczo), and sulconazole (Exelderm).

Dolutegravir (Tivicay) is an HIV-1 integrase strand transfer inhibitor given in combination with other antiretroviral drugs. The animal data suggest low risk. If indicated, the drug should not be withheld because of pregnancy.

Gadoterate meglumine (Dotarem), a gadolinium-based contrast agent, is indicated to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity. No developmental toxicity was observed in pregnant animals. Closely related diagnostic agents are gadobenate dimeglumine (MultiHance), gadodiamide (Omniscan), gadofosveset (Ablavar), gadopentetate dimeglumine (Magnevist), gadoteridol (Prohance), and gadoversetamide (OptiMARK). Although the animal data for these agents show risk, no harm has been reported in human pregnancies. However, the available human data are very limited, and the risk magnitude for embryo-fetal harm remains unknown.

Technetium (99mTc) tilmanocept (Lymphoseek) is a radioactive diagnostic agent used in patients with breast cancer or melanoma. The active ingredient is technetium (99mTc). Animal reproduction studies have not been conducted. 99mTc is probably compatible in pregnancy (see Drugs in Pregnancy and Lactation, 10th ed.; Philadelphia: Lippincott, Williams and Wilkins, 2014:1317-8; to be released in August), but the risk of the tilmanocept moiety is unknown.

The immunologic agent dimethyl fumarate (Tecfidera) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. The drug caused developmental toxicity (embryolethality, impaired growth, and birth defects) in animals during all portions of pregnancy. In clinical trials, there were 38 exposed pregnancies with the following outcomes: 22 live births, 3 spontaneous abortions, 9 elective abortions, 3 ongoing pregnancies, and 1 lost to follow-up (CNS Drugs 2014;28:89-94). A pregnancy registry has been established, and patients should be encouraged to enroll by calling 800-456-2255.

Two new respiratory combination products were approved in 2013, both for chronic obstructive pulmonary disease: fluticasone/vilanterol (Breo Ellipta) and umeclidinium/vilanterol (Anoro Ellipta). Inhaled fluticasone, a corticosteroid, is compatible in pregnancy (see Drugs in Pregnancy and Lactation, 9th ed.; Philadelphia: Lippincott, Williams and Wilkins; 2011:599-601). Vilanterol is a long-acting beta2-adrenergic agonist that is probably compatible in pregnancy. The absolute bioavailability of inhaled fluticasone and vilanterol in nonpregnant adults was about 15% and 27%, respectively. The animal data for the combination or when given individually suggest low risk in pregnancy. Umeclidinium is a long-acting anticholinergic. It also is absorbed from the lung, but the amount was not specified by the manufacturer. The animal data for umeclidinium suggest low risk.

There are no reports of the above drugs being used during breastfeeding, but excretion into breast milk should be expected. The effect of these exposures on a nursing infant is unknown. However, if a mother is taking one of these drugs and breastfeeding, her infant should be monitored for adverse effects, especially those that are the most common (typically listed on the first page of the package insert) in patients taking the drug. Close monitoring is particularly important during the first 2 postpartum months. A 2003 study found that most adverse reactions in nursing infants occurred within that time period (Clin. Pediatr. 2003;42:325-40).

Mr. Briggs is a pharmacist clinical specialist at the outpatient clinics of Memorial Care Center for Women at Miller Children’s Hospital in Long Beach, Calif.; clinical professor of pharmacy at the University of California, San Francisco; and adjunct professor of pharmacy at the University of Southern California, Los Angeles, and Washington State University, Spokane. He also is coauthor of "Drugs in Pregnancy and Lactation," and coeditor of "Diseases, Complications, and Drug Therapy in Obstetrics." He had no other relevant financial disclosures. Contact him at [email protected].

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A fatal ‘never event’

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A fatal ‘never event’

DB was a 22-year-old man who was brought to the hospital after he was found down in the street by police. Witnesses confirmed that DB was a pedestrian involved in a hit-and-run accident with a motor vehicle.

Upon initial assessment at the hospital, DB was awake and alert. Imaging confirmed several rib fractures, a broken right humerus, and two burst fractures of the thoracic spine. In addition, DB had evidence of a pulmonary contusion and a pneumothorax. DB went to the operating room for his spinal injuries and was subsequently admitted by Dr. Hospitalist 1 to the trauma intensive care unit. DB remained intubated and sedated. Dr. Hospitalist 1 documented that DB was at high risk for venous thromboembolism (VTE) and DB received bilateral intermittent pneumatic compression (IPC) of his legs and subcutaneous unfractionated heparin (UFH), 5,000 units every 8 hours, for VTE prophylaxis.

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The complaint alleged that the physicians caring for DB failed to apply appropriate VTE prophylaxis commensurate with his high risk.

Over the next week, DB underwent open reduction and internal fixation of his right humerus fracture, along with an additional neurosurgical procedure to further stabilize his spine. DB made progress with respect to his pneumothorax and his chest tubes were eventually discontinued. DB was extubated on hospital day 5. On hospital day 7, DB was transferred out of the trauma ICU. For unclear reasons, DB’s prophylactic UFH was discontinued at the time of transfer. DB continued to wear bilateral IPC devices on his legs while he was in bed.

DB began physical therapy, but he had significant pain control issues. On hospital day 11, Dr. Hospitalist 2 restarted UFH, 5,000 units every 8 hours, for VTE prophylaxis. Two days later, DB was noted to have asymmetric edema of his right lower extremity and Dr. Hospitalist 3 obtained a vascular ultrasound. DB was diagnosed with an acute right femoral deep vein thrombosis. Dr. Hospitalist 3 ordered intravenous UFH 80 units/kg bolus followed by an intravenous infusion at 18 units/kg per hour.

The following morning (hospital day 14), the activated partial thromboplastin time was noted to be 82 seconds (1.5-2.5 thromboplastin time control). At approximately 10 a.m. that same day, DB collapsed while he was up to the commode. A code blue was called, but DB did not respond to resuscitation and was pronounced dead at 10:45 a.m. Autopsy confirmed the cause of death as a large saddle pulmonary embolism.

Complaint

DB’s mother was a flight attendant and very familiar with the concept of VTE and VTE prevention. According to her research on the internet, pulmonary embolism (PE) was a "never event" for hospitals and she immediately sought DB’s medical records to ascertain whether appropriate VTE prophylaxis had occurred. Once she discovered that DB had his prophylactic UFH discontinued for 4 days (12 doses of heparin missed), she contacted an attorney and a complaint was filed.

The complaint alleged that the physicians caring for DB failed to apply appropriate VTE prophylaxis commensurate with his high risk, and their collective failure in this regard was the proximate cause for his acute deep vein thrombosis and fatal PE.

Scientific principles

Trauma patients are considered to be at high risk for the development of VTE and some form of prophylaxis is universally recommended. Low-dose UFH given subcutaneously has been shown in multiple studies to safely and effectively decrease the incidence of VTE in high-risk groups. For those patients deemed to be at prohibitive risk for bleeding, nonpharmacologic methods of prevention are recommended. IPC prevents venous thrombosis by enhancing blood flow in the deep veins of the legs, thereby preventing venous stasis. IPC also reduces plasminogen activator inhibitor-1 (PAI-1), thereby increasing endogenous fibrinolytic activity.

Despite appropriate prophylaxis, acute VTE can still occur. Full-dose anticoagulant therapy is indicated for patients with symptomatic VTE, and anticoagulation is usually achieved initially with intravenous UFH or weight-adjusted doses of subcutaneous low-molecular-weight heparin. A 2010 meta-analysis of 13 prospective cohort studies and 56 randomized clinical trials demonstrated that the rate of recurrent fatal VTE following the appropriate initiation of full-dose anticoagulant therapy was just 0.4% (Ann. Intern. Med.2010;152:578-89).

Complaint rebuttal and discussion

The defense argued that the approach to VTE prophylaxis in a patient such as DB was a matter of clinical judgment and that, regardless of the strategy applied, acute events can and do occur. The defense highlighted the fact that DB was persistently anemic following his ICU transfer and that the physicians were concerned about possible hemorrhage. The defense also pointed out that DB continued to receive mechanical prophylaxis, which was appropriate.

 

 

In addition, the defense explained that DB had his acute DVT diagnosed immediately and he received appropriate full-dose anticoagulation prior to his death; DB therefore had less than a 0.4% chance of dying from VTE, according to the literature. Defense experts opined that, since DB went on to succumb to fatal PE despite adequate therapy, he was somehow different than those who typically respond to treatment and/or VTE prevention. In other words, the defense experts opined that DB would have developed and ultimately died from VTE regardless of what the physicians did or didn’t do in this case.

Conclusion

At the time of DB’s transition of care from the ICU to the regular nursing floor, there was no chart documentation to support the notion that his physicians were concerned about hemorrhage. It is more likely than not that DB had his subcutaneous UFH discontinued for several days by mistake.

Whether DB would still have suffered an acute DVT (along with a fatal PE) had the UFH prophylaxis not been interrupted is unknown. Sadly, DB defied the odds when he did not respond to treatment following the diagnosis of his acute DVT. At the end of the day, the plaintiffs were unable to find an expert to rebut the opinions of the defense in this case and, as a result, the case was dismissed without prejudice.

Dr. Michota is director of academic affairs in the hospital medicine department at the Cleveland Clinic and medical editor of Hospitalist News. He has been involved in peer review both within and outside the legal system.

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DB was a 22-year-old man who was brought to the hospital after he was found down in the street by police. Witnesses confirmed that DB was a pedestrian involved in a hit-and-run accident with a motor vehicle.

Upon initial assessment at the hospital, DB was awake and alert. Imaging confirmed several rib fractures, a broken right humerus, and two burst fractures of the thoracic spine. In addition, DB had evidence of a pulmonary contusion and a pneumothorax. DB went to the operating room for his spinal injuries and was subsequently admitted by Dr. Hospitalist 1 to the trauma intensive care unit. DB remained intubated and sedated. Dr. Hospitalist 1 documented that DB was at high risk for venous thromboembolism (VTE) and DB received bilateral intermittent pneumatic compression (IPC) of his legs and subcutaneous unfractionated heparin (UFH), 5,000 units every 8 hours, for VTE prophylaxis.

©LeeAnnWhite/thinkstockphotos.com
The complaint alleged that the physicians caring for DB failed to apply appropriate VTE prophylaxis commensurate with his high risk.

Over the next week, DB underwent open reduction and internal fixation of his right humerus fracture, along with an additional neurosurgical procedure to further stabilize his spine. DB made progress with respect to his pneumothorax and his chest tubes were eventually discontinued. DB was extubated on hospital day 5. On hospital day 7, DB was transferred out of the trauma ICU. For unclear reasons, DB’s prophylactic UFH was discontinued at the time of transfer. DB continued to wear bilateral IPC devices on his legs while he was in bed.

DB began physical therapy, but he had significant pain control issues. On hospital day 11, Dr. Hospitalist 2 restarted UFH, 5,000 units every 8 hours, for VTE prophylaxis. Two days later, DB was noted to have asymmetric edema of his right lower extremity and Dr. Hospitalist 3 obtained a vascular ultrasound. DB was diagnosed with an acute right femoral deep vein thrombosis. Dr. Hospitalist 3 ordered intravenous UFH 80 units/kg bolus followed by an intravenous infusion at 18 units/kg per hour.

The following morning (hospital day 14), the activated partial thromboplastin time was noted to be 82 seconds (1.5-2.5 thromboplastin time control). At approximately 10 a.m. that same day, DB collapsed while he was up to the commode. A code blue was called, but DB did not respond to resuscitation and was pronounced dead at 10:45 a.m. Autopsy confirmed the cause of death as a large saddle pulmonary embolism.

Complaint

DB’s mother was a flight attendant and very familiar with the concept of VTE and VTE prevention. According to her research on the internet, pulmonary embolism (PE) was a "never event" for hospitals and she immediately sought DB’s medical records to ascertain whether appropriate VTE prophylaxis had occurred. Once she discovered that DB had his prophylactic UFH discontinued for 4 days (12 doses of heparin missed), she contacted an attorney and a complaint was filed.

The complaint alleged that the physicians caring for DB failed to apply appropriate VTE prophylaxis commensurate with his high risk, and their collective failure in this regard was the proximate cause for his acute deep vein thrombosis and fatal PE.

Scientific principles

Trauma patients are considered to be at high risk for the development of VTE and some form of prophylaxis is universally recommended. Low-dose UFH given subcutaneously has been shown in multiple studies to safely and effectively decrease the incidence of VTE in high-risk groups. For those patients deemed to be at prohibitive risk for bleeding, nonpharmacologic methods of prevention are recommended. IPC prevents venous thrombosis by enhancing blood flow in the deep veins of the legs, thereby preventing venous stasis. IPC also reduces plasminogen activator inhibitor-1 (PAI-1), thereby increasing endogenous fibrinolytic activity.

Despite appropriate prophylaxis, acute VTE can still occur. Full-dose anticoagulant therapy is indicated for patients with symptomatic VTE, and anticoagulation is usually achieved initially with intravenous UFH or weight-adjusted doses of subcutaneous low-molecular-weight heparin. A 2010 meta-analysis of 13 prospective cohort studies and 56 randomized clinical trials demonstrated that the rate of recurrent fatal VTE following the appropriate initiation of full-dose anticoagulant therapy was just 0.4% (Ann. Intern. Med.2010;152:578-89).

Complaint rebuttal and discussion

The defense argued that the approach to VTE prophylaxis in a patient such as DB was a matter of clinical judgment and that, regardless of the strategy applied, acute events can and do occur. The defense highlighted the fact that DB was persistently anemic following his ICU transfer and that the physicians were concerned about possible hemorrhage. The defense also pointed out that DB continued to receive mechanical prophylaxis, which was appropriate.

 

 

In addition, the defense explained that DB had his acute DVT diagnosed immediately and he received appropriate full-dose anticoagulation prior to his death; DB therefore had less than a 0.4% chance of dying from VTE, according to the literature. Defense experts opined that, since DB went on to succumb to fatal PE despite adequate therapy, he was somehow different than those who typically respond to treatment and/or VTE prevention. In other words, the defense experts opined that DB would have developed and ultimately died from VTE regardless of what the physicians did or didn’t do in this case.

Conclusion

At the time of DB’s transition of care from the ICU to the regular nursing floor, there was no chart documentation to support the notion that his physicians were concerned about hemorrhage. It is more likely than not that DB had his subcutaneous UFH discontinued for several days by mistake.

Whether DB would still have suffered an acute DVT (along with a fatal PE) had the UFH prophylaxis not been interrupted is unknown. Sadly, DB defied the odds when he did not respond to treatment following the diagnosis of his acute DVT. At the end of the day, the plaintiffs were unable to find an expert to rebut the opinions of the defense in this case and, as a result, the case was dismissed without prejudice.

Dr. Michota is director of academic affairs in the hospital medicine department at the Cleveland Clinic and medical editor of Hospitalist News. He has been involved in peer review both within and outside the legal system.

DB was a 22-year-old man who was brought to the hospital after he was found down in the street by police. Witnesses confirmed that DB was a pedestrian involved in a hit-and-run accident with a motor vehicle.

Upon initial assessment at the hospital, DB was awake and alert. Imaging confirmed several rib fractures, a broken right humerus, and two burst fractures of the thoracic spine. In addition, DB had evidence of a pulmonary contusion and a pneumothorax. DB went to the operating room for his spinal injuries and was subsequently admitted by Dr. Hospitalist 1 to the trauma intensive care unit. DB remained intubated and sedated. Dr. Hospitalist 1 documented that DB was at high risk for venous thromboembolism (VTE) and DB received bilateral intermittent pneumatic compression (IPC) of his legs and subcutaneous unfractionated heparin (UFH), 5,000 units every 8 hours, for VTE prophylaxis.

©LeeAnnWhite/thinkstockphotos.com
The complaint alleged that the physicians caring for DB failed to apply appropriate VTE prophylaxis commensurate with his high risk.

Over the next week, DB underwent open reduction and internal fixation of his right humerus fracture, along with an additional neurosurgical procedure to further stabilize his spine. DB made progress with respect to his pneumothorax and his chest tubes were eventually discontinued. DB was extubated on hospital day 5. On hospital day 7, DB was transferred out of the trauma ICU. For unclear reasons, DB’s prophylactic UFH was discontinued at the time of transfer. DB continued to wear bilateral IPC devices on his legs while he was in bed.

DB began physical therapy, but he had significant pain control issues. On hospital day 11, Dr. Hospitalist 2 restarted UFH, 5,000 units every 8 hours, for VTE prophylaxis. Two days later, DB was noted to have asymmetric edema of his right lower extremity and Dr. Hospitalist 3 obtained a vascular ultrasound. DB was diagnosed with an acute right femoral deep vein thrombosis. Dr. Hospitalist 3 ordered intravenous UFH 80 units/kg bolus followed by an intravenous infusion at 18 units/kg per hour.

The following morning (hospital day 14), the activated partial thromboplastin time was noted to be 82 seconds (1.5-2.5 thromboplastin time control). At approximately 10 a.m. that same day, DB collapsed while he was up to the commode. A code blue was called, but DB did not respond to resuscitation and was pronounced dead at 10:45 a.m. Autopsy confirmed the cause of death as a large saddle pulmonary embolism.

Complaint

DB’s mother was a flight attendant and very familiar with the concept of VTE and VTE prevention. According to her research on the internet, pulmonary embolism (PE) was a "never event" for hospitals and she immediately sought DB’s medical records to ascertain whether appropriate VTE prophylaxis had occurred. Once she discovered that DB had his prophylactic UFH discontinued for 4 days (12 doses of heparin missed), she contacted an attorney and a complaint was filed.

The complaint alleged that the physicians caring for DB failed to apply appropriate VTE prophylaxis commensurate with his high risk, and their collective failure in this regard was the proximate cause for his acute deep vein thrombosis and fatal PE.

Scientific principles

Trauma patients are considered to be at high risk for the development of VTE and some form of prophylaxis is universally recommended. Low-dose UFH given subcutaneously has been shown in multiple studies to safely and effectively decrease the incidence of VTE in high-risk groups. For those patients deemed to be at prohibitive risk for bleeding, nonpharmacologic methods of prevention are recommended. IPC prevents venous thrombosis by enhancing blood flow in the deep veins of the legs, thereby preventing venous stasis. IPC also reduces plasminogen activator inhibitor-1 (PAI-1), thereby increasing endogenous fibrinolytic activity.

Despite appropriate prophylaxis, acute VTE can still occur. Full-dose anticoagulant therapy is indicated for patients with symptomatic VTE, and anticoagulation is usually achieved initially with intravenous UFH or weight-adjusted doses of subcutaneous low-molecular-weight heparin. A 2010 meta-analysis of 13 prospective cohort studies and 56 randomized clinical trials demonstrated that the rate of recurrent fatal VTE following the appropriate initiation of full-dose anticoagulant therapy was just 0.4% (Ann. Intern. Med.2010;152:578-89).

Complaint rebuttal and discussion

The defense argued that the approach to VTE prophylaxis in a patient such as DB was a matter of clinical judgment and that, regardless of the strategy applied, acute events can and do occur. The defense highlighted the fact that DB was persistently anemic following his ICU transfer and that the physicians were concerned about possible hemorrhage. The defense also pointed out that DB continued to receive mechanical prophylaxis, which was appropriate.

 

 

In addition, the defense explained that DB had his acute DVT diagnosed immediately and he received appropriate full-dose anticoagulation prior to his death; DB therefore had less than a 0.4% chance of dying from VTE, according to the literature. Defense experts opined that, since DB went on to succumb to fatal PE despite adequate therapy, he was somehow different than those who typically respond to treatment and/or VTE prevention. In other words, the defense experts opined that DB would have developed and ultimately died from VTE regardless of what the physicians did or didn’t do in this case.

Conclusion

At the time of DB’s transition of care from the ICU to the regular nursing floor, there was no chart documentation to support the notion that his physicians were concerned about hemorrhage. It is more likely than not that DB had his subcutaneous UFH discontinued for several days by mistake.

Whether DB would still have suffered an acute DVT (along with a fatal PE) had the UFH prophylaxis not been interrupted is unknown. Sadly, DB defied the odds when he did not respond to treatment following the diagnosis of his acute DVT. At the end of the day, the plaintiffs were unable to find an expert to rebut the opinions of the defense in this case and, as a result, the case was dismissed without prejudice.

Dr. Michota is director of academic affairs in the hospital medicine department at the Cleveland Clinic and medical editor of Hospitalist News. He has been involved in peer review both within and outside the legal system.

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The springtime eruptions

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The spectrum of idiopathic ultraviolet-induced dermatoses includes the most severe variant, polymorphous light eruption (PMLE), in which erythematous papules, papulovesicles, and plaques form from a delayed type IV hypersensitivity reaction to the sun. Its milder cousins, benign summer light eruption and juvenile springtime eruption, are milder, more transient variants.

Patients may experience sudden-onset, pruritic, sometimes painful papules and papulovesicles or cheilitis within 30 minutes to several hours of exposure to UV light in areas normally covered in the winter months. The rash subsides over 1-7 days (or sooner with effective topical steroid administration and strict sun avoidance) and without scarring. Occasionally, patients experience systemic flulike symptoms after sun exposure. Triggers can be UVA, UVB, or UVC. However, because most cases appear in the spring, describing these variants as benign summer light eruption is something of a misnomer.

These seasonal rashes are often underrecognized in skin of color patients, particularly those with Fitzpatrick skin types III-VI, because many practitioners assume a protective role of melanin (Photochem. Photobiol. Sci. 2013;12:65-77). A study by Kerr and Lim identified 280 patients with photodermatoses; 135 (48%) were African American, 110 (40%) were white, and 35 (12%) were other ethnicities. They noted a significantly higher proportion of African Americans with PMLE, compared with whites (J. Am. Acad. Dermatol. 2007;57:638-43). Also, Native Americans have a hereditary form of PMLE with autosomal dominant inheritance that can involve the face and is most common in patients with Fitzpatrick skin types III-VI.

For sun-sensitive patients, and especially skin of color patients, diagnosis and treatment include ruling out other photosensitive diseases such as systemic lupus, and then counseling about the importance of sun avoidance and the use of sunscreens, which include both UVA and UVB protection. Prophylactic phototherapy or photochemotherapy at the beginning of spring for several weeks may prevent flare-ups throughout the summer. PUVA (psoralen and UVA) therapy, as well as UVB phototherapy, have been successful at preventing flares in several studies. Topical steroids, antihistamines, and oral prednisone are mainstays of treatment for severe flares, alone or in combination with phototherapy. For severe cases, or those recalcitrant to first-line treatment, antimalarials, azathioprine, and thalidomide have been used with variable efficacy.

Particularly at this time of year, I always ask patients with photo-distributed rashes about their ethnicities. One can never assume ethnicity, culture, skin type, background, or even photosensitivity based on skin color alone. I have been surprised by the many patients with dark skin who may have Native American origins who present with photosensitive rashes, or the many patients with hereditary photosensitive rashes with fair skin. Our beautiful, multicultural society makes it harder to define or categorize dermatoses by skin type alone, based on the definitions we have set for skin type in our literature today.

Dr. Talakoub and Dr. Wesley are co-contributors to a monthly Aesthetic Dermatology column in Skin & Allergy News. Dr. Talakoub is in private practice at McLean (Va.) Dermatology Center. Dr. Wesley practices dermatology in Beverly Hills, Calif.

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The spectrum of idiopathic ultraviolet-induced dermatoses includes the most severe variant, polymorphous light eruption (PMLE), in which erythematous papules, papulovesicles, and plaques form from a delayed type IV hypersensitivity reaction to the sun. Its milder cousins, benign summer light eruption and juvenile springtime eruption, are milder, more transient variants.

Patients may experience sudden-onset, pruritic, sometimes painful papules and papulovesicles or cheilitis within 30 minutes to several hours of exposure to UV light in areas normally covered in the winter months. The rash subsides over 1-7 days (or sooner with effective topical steroid administration and strict sun avoidance) and without scarring. Occasionally, patients experience systemic flulike symptoms after sun exposure. Triggers can be UVA, UVB, or UVC. However, because most cases appear in the spring, describing these variants as benign summer light eruption is something of a misnomer.

These seasonal rashes are often underrecognized in skin of color patients, particularly those with Fitzpatrick skin types III-VI, because many practitioners assume a protective role of melanin (Photochem. Photobiol. Sci. 2013;12:65-77). A study by Kerr and Lim identified 280 patients with photodermatoses; 135 (48%) were African American, 110 (40%) were white, and 35 (12%) were other ethnicities. They noted a significantly higher proportion of African Americans with PMLE, compared with whites (J. Am. Acad. Dermatol. 2007;57:638-43). Also, Native Americans have a hereditary form of PMLE with autosomal dominant inheritance that can involve the face and is most common in patients with Fitzpatrick skin types III-VI.

For sun-sensitive patients, and especially skin of color patients, diagnosis and treatment include ruling out other photosensitive diseases such as systemic lupus, and then counseling about the importance of sun avoidance and the use of sunscreens, which include both UVA and UVB protection. Prophylactic phototherapy or photochemotherapy at the beginning of spring for several weeks may prevent flare-ups throughout the summer. PUVA (psoralen and UVA) therapy, as well as UVB phototherapy, have been successful at preventing flares in several studies. Topical steroids, antihistamines, and oral prednisone are mainstays of treatment for severe flares, alone or in combination with phototherapy. For severe cases, or those recalcitrant to first-line treatment, antimalarials, azathioprine, and thalidomide have been used with variable efficacy.

Particularly at this time of year, I always ask patients with photo-distributed rashes about their ethnicities. One can never assume ethnicity, culture, skin type, background, or even photosensitivity based on skin color alone. I have been surprised by the many patients with dark skin who may have Native American origins who present with photosensitive rashes, or the many patients with hereditary photosensitive rashes with fair skin. Our beautiful, multicultural society makes it harder to define or categorize dermatoses by skin type alone, based on the definitions we have set for skin type in our literature today.

Dr. Talakoub and Dr. Wesley are co-contributors to a monthly Aesthetic Dermatology column in Skin & Allergy News. Dr. Talakoub is in private practice at McLean (Va.) Dermatology Center. Dr. Wesley practices dermatology in Beverly Hills, Calif.

The spectrum of idiopathic ultraviolet-induced dermatoses includes the most severe variant, polymorphous light eruption (PMLE), in which erythematous papules, papulovesicles, and plaques form from a delayed type IV hypersensitivity reaction to the sun. Its milder cousins, benign summer light eruption and juvenile springtime eruption, are milder, more transient variants.

Patients may experience sudden-onset, pruritic, sometimes painful papules and papulovesicles or cheilitis within 30 minutes to several hours of exposure to UV light in areas normally covered in the winter months. The rash subsides over 1-7 days (or sooner with effective topical steroid administration and strict sun avoidance) and without scarring. Occasionally, patients experience systemic flulike symptoms after sun exposure. Triggers can be UVA, UVB, or UVC. However, because most cases appear in the spring, describing these variants as benign summer light eruption is something of a misnomer.

These seasonal rashes are often underrecognized in skin of color patients, particularly those with Fitzpatrick skin types III-VI, because many practitioners assume a protective role of melanin (Photochem. Photobiol. Sci. 2013;12:65-77). A study by Kerr and Lim identified 280 patients with photodermatoses; 135 (48%) were African American, 110 (40%) were white, and 35 (12%) were other ethnicities. They noted a significantly higher proportion of African Americans with PMLE, compared with whites (J. Am. Acad. Dermatol. 2007;57:638-43). Also, Native Americans have a hereditary form of PMLE with autosomal dominant inheritance that can involve the face and is most common in patients with Fitzpatrick skin types III-VI.

For sun-sensitive patients, and especially skin of color patients, diagnosis and treatment include ruling out other photosensitive diseases such as systemic lupus, and then counseling about the importance of sun avoidance and the use of sunscreens, which include both UVA and UVB protection. Prophylactic phototherapy or photochemotherapy at the beginning of spring for several weeks may prevent flare-ups throughout the summer. PUVA (psoralen and UVA) therapy, as well as UVB phototherapy, have been successful at preventing flares in several studies. Topical steroids, antihistamines, and oral prednisone are mainstays of treatment for severe flares, alone or in combination with phototherapy. For severe cases, or those recalcitrant to first-line treatment, antimalarials, azathioprine, and thalidomide have been used with variable efficacy.

Particularly at this time of year, I always ask patients with photo-distributed rashes about their ethnicities. One can never assume ethnicity, culture, skin type, background, or even photosensitivity based on skin color alone. I have been surprised by the many patients with dark skin who may have Native American origins who present with photosensitive rashes, or the many patients with hereditary photosensitive rashes with fair skin. Our beautiful, multicultural society makes it harder to define or categorize dermatoses by skin type alone, based on the definitions we have set for skin type in our literature today.

Dr. Talakoub and Dr. Wesley are co-contributors to a monthly Aesthetic Dermatology column in Skin & Allergy News. Dr. Talakoub is in private practice at McLean (Va.) Dermatology Center. Dr. Wesley practices dermatology in Beverly Hills, Calif.

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Reference apps bring the evidence to you

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There are at least two ways to consider the meaning of evidence-based apps. One is a category of apps that have clinical trial evidence showing that they are useful, a topic we cover regularly in this column.

Another category, though, is apps that take existing evidence-based guidelines or already-vetted medical information and deliver that to you in a more efficient, convenient package.

Courtesy of the Wound, Ostomy and Continence Nurses Society
Is the WOCN's app worth the $60 price?

One of the latest examples of the latter is the new Evidence-Based Wound Care Guidelines and Fecal Ostomy Best Practice app, sold by the Wound, Ostomy and Continence Nurses Society (WOCN) for iPhones, iPads, or iPod Touch devices. Is it worth the $60 price?

It would cost you at least $160 to buy print copies from the WOCN of the five guidelines included in the app, on management of patients with pressure ulcers, lower-extremity arterial disease (LEAD), lower-extremity neuropathic disease (LEND), lower-extremity venous disease (LEVD), and fecal ostomy.

Or, you could spend a fair amount of time finding and printing the equivalent guidelines in the archives of medical journals or online. The Agency for Healthcare Research and Quality (AHRQ) provides detailed summaries of most of these guidelines on its website, including the major recommendations in each guideline and ratings of the evidence behind those recommendations. You can find the AHRQ pages on management of pressure ulcers, LEND, LEVD, and fecal ostomy, for example. They’re free, but it’s a time-consuming process that leaves you with bulky printouts.

Alternatively, the WOCN offers a free, 12-page, quick-reference guide for management of lower-extremity venous, arterial, or neuropathic wounds that you can download and print for free or, alternatively, consult without printing.

Courtesy of the Wound, Ostomy and Continence Nurses Society
The WOCN offers a free, 12-page, quick-reference guide for management of lower-extremity venous, arterial, or neuropathic wounds.

All in all, that’s a lot of dead trees to carry around if you want to consult these guidelines while treating patients, unless you have a bulky desktop computer handy. Compare that with the convenience of pulling out your smartphone or tablet to consult the literature on best practices at the bedside, and you can see why knowledge-delivering apps have caught physicians’ imaginations.

How can you know that an app is delivering credible information? The easiest way is to choose an app from a credible organization, such as the Cancer.Net app for patients with cancer, from the American Society of Clinical Oncology. Apps that have been vetted by the likes of the Cleveland Clinic, Mayo Clinic, or Veterans Affairs Healthcare System, for example, typically have been assessed with some quality-control measures. Every app has its flaws, however, so it’s usually worth searching for reviews online to gauge the strengths and weaknesses of various apps, especially when there is more than one available on a particular topic.

For-profit companies have developed some of the most popular evidence-driven apps for physicians. UpToDate claims that its physicians, authors, and editors synthesize the available medical evidence so the app can provide recommendations in primary care, ob.gyn., pediatrics, general surgery, emergency medicine, internal medicine, and all of the internal medicine subspecialties, among others. An individual subscription costs $499/year.

Epocrates offers a free app that provides medication information and lets you look up drug interactions and more, with additional services for a fee. Other apps do the same – Lexicomp is one subscription-based app that allows a 30-day free trial.

How to choose? Again, reviews may be helpful. The physician-run site iMedicalApps compared several medical drug reference apps in a 2010 review, but in app development time, that already seems light-years ago.

Courtesy of the Wound, Ostomy and Continence Nurses Society
For-profit companies have developed some of the most popular evidence-driven apps for physicians.

If you don’t recognize a company as a credible player in delivering mobile medical information, you can take several steps to assess the app’s trustworthiness. When you look at the app’s description online or in your mobile device’s app store, often the description is short and doesn’t list the reference information that the app relies on, though that’s often included in the app itself.

You’ll find reviews and ratings in the app description, but take these with a grain of salt. These can be anonymous, reflect anecdotal experiences, and may be planted by the developer of the app to make it look good.

Click on the tab for the developer in the app description, and if you don’t recognize the name, make sure there’s a link to a website or at least an e-mail address so you can assess whether the developer has health care expertise.

 

 

It’s also worth clicking on the Updates or Version History tab to see if it’s been updated, because good-quality apps usually get frequent updates, typically at least every 6 months, several app consultants said in interviews.

Are you already using evidence-delivering apps? Which are your favorites? Let us know, and we may highlight them in a future column.

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There are at least two ways to consider the meaning of evidence-based apps. One is a category of apps that have clinical trial evidence showing that they are useful, a topic we cover regularly in this column.

Another category, though, is apps that take existing evidence-based guidelines or already-vetted medical information and deliver that to you in a more efficient, convenient package.

Courtesy of the Wound, Ostomy and Continence Nurses Society
Is the WOCN's app worth the $60 price?

One of the latest examples of the latter is the new Evidence-Based Wound Care Guidelines and Fecal Ostomy Best Practice app, sold by the Wound, Ostomy and Continence Nurses Society (WOCN) for iPhones, iPads, or iPod Touch devices. Is it worth the $60 price?

It would cost you at least $160 to buy print copies from the WOCN of the five guidelines included in the app, on management of patients with pressure ulcers, lower-extremity arterial disease (LEAD), lower-extremity neuropathic disease (LEND), lower-extremity venous disease (LEVD), and fecal ostomy.

Or, you could spend a fair amount of time finding and printing the equivalent guidelines in the archives of medical journals or online. The Agency for Healthcare Research and Quality (AHRQ) provides detailed summaries of most of these guidelines on its website, including the major recommendations in each guideline and ratings of the evidence behind those recommendations. You can find the AHRQ pages on management of pressure ulcers, LEND, LEVD, and fecal ostomy, for example. They’re free, but it’s a time-consuming process that leaves you with bulky printouts.

Alternatively, the WOCN offers a free, 12-page, quick-reference guide for management of lower-extremity venous, arterial, or neuropathic wounds that you can download and print for free or, alternatively, consult without printing.

Courtesy of the Wound, Ostomy and Continence Nurses Society
The WOCN offers a free, 12-page, quick-reference guide for management of lower-extremity venous, arterial, or neuropathic wounds.

All in all, that’s a lot of dead trees to carry around if you want to consult these guidelines while treating patients, unless you have a bulky desktop computer handy. Compare that with the convenience of pulling out your smartphone or tablet to consult the literature on best practices at the bedside, and you can see why knowledge-delivering apps have caught physicians’ imaginations.

How can you know that an app is delivering credible information? The easiest way is to choose an app from a credible organization, such as the Cancer.Net app for patients with cancer, from the American Society of Clinical Oncology. Apps that have been vetted by the likes of the Cleveland Clinic, Mayo Clinic, or Veterans Affairs Healthcare System, for example, typically have been assessed with some quality-control measures. Every app has its flaws, however, so it’s usually worth searching for reviews online to gauge the strengths and weaknesses of various apps, especially when there is more than one available on a particular topic.

For-profit companies have developed some of the most popular evidence-driven apps for physicians. UpToDate claims that its physicians, authors, and editors synthesize the available medical evidence so the app can provide recommendations in primary care, ob.gyn., pediatrics, general surgery, emergency medicine, internal medicine, and all of the internal medicine subspecialties, among others. An individual subscription costs $499/year.

Epocrates offers a free app that provides medication information and lets you look up drug interactions and more, with additional services for a fee. Other apps do the same – Lexicomp is one subscription-based app that allows a 30-day free trial.

How to choose? Again, reviews may be helpful. The physician-run site iMedicalApps compared several medical drug reference apps in a 2010 review, but in app development time, that already seems light-years ago.

Courtesy of the Wound, Ostomy and Continence Nurses Society
For-profit companies have developed some of the most popular evidence-driven apps for physicians.

If you don’t recognize a company as a credible player in delivering mobile medical information, you can take several steps to assess the app’s trustworthiness. When you look at the app’s description online or in your mobile device’s app store, often the description is short and doesn’t list the reference information that the app relies on, though that’s often included in the app itself.

You’ll find reviews and ratings in the app description, but take these with a grain of salt. These can be anonymous, reflect anecdotal experiences, and may be planted by the developer of the app to make it look good.

Click on the tab for the developer in the app description, and if you don’t recognize the name, make sure there’s a link to a website or at least an e-mail address so you can assess whether the developer has health care expertise.

 

 

It’s also worth clicking on the Updates or Version History tab to see if it’s been updated, because good-quality apps usually get frequent updates, typically at least every 6 months, several app consultants said in interviews.

Are you already using evidence-delivering apps? Which are your favorites? Let us know, and we may highlight them in a future column.

[email protected]

On Twitter @sherryboschert

There are at least two ways to consider the meaning of evidence-based apps. One is a category of apps that have clinical trial evidence showing that they are useful, a topic we cover regularly in this column.

Another category, though, is apps that take existing evidence-based guidelines or already-vetted medical information and deliver that to you in a more efficient, convenient package.

Courtesy of the Wound, Ostomy and Continence Nurses Society
Is the WOCN's app worth the $60 price?

One of the latest examples of the latter is the new Evidence-Based Wound Care Guidelines and Fecal Ostomy Best Practice app, sold by the Wound, Ostomy and Continence Nurses Society (WOCN) for iPhones, iPads, or iPod Touch devices. Is it worth the $60 price?

It would cost you at least $160 to buy print copies from the WOCN of the five guidelines included in the app, on management of patients with pressure ulcers, lower-extremity arterial disease (LEAD), lower-extremity neuropathic disease (LEND), lower-extremity venous disease (LEVD), and fecal ostomy.

Or, you could spend a fair amount of time finding and printing the equivalent guidelines in the archives of medical journals or online. The Agency for Healthcare Research and Quality (AHRQ) provides detailed summaries of most of these guidelines on its website, including the major recommendations in each guideline and ratings of the evidence behind those recommendations. You can find the AHRQ pages on management of pressure ulcers, LEND, LEVD, and fecal ostomy, for example. They’re free, but it’s a time-consuming process that leaves you with bulky printouts.

Alternatively, the WOCN offers a free, 12-page, quick-reference guide for management of lower-extremity venous, arterial, or neuropathic wounds that you can download and print for free or, alternatively, consult without printing.

Courtesy of the Wound, Ostomy and Continence Nurses Society
The WOCN offers a free, 12-page, quick-reference guide for management of lower-extremity venous, arterial, or neuropathic wounds.

All in all, that’s a lot of dead trees to carry around if you want to consult these guidelines while treating patients, unless you have a bulky desktop computer handy. Compare that with the convenience of pulling out your smartphone or tablet to consult the literature on best practices at the bedside, and you can see why knowledge-delivering apps have caught physicians’ imaginations.

How can you know that an app is delivering credible information? The easiest way is to choose an app from a credible organization, such as the Cancer.Net app for patients with cancer, from the American Society of Clinical Oncology. Apps that have been vetted by the likes of the Cleveland Clinic, Mayo Clinic, or Veterans Affairs Healthcare System, for example, typically have been assessed with some quality-control measures. Every app has its flaws, however, so it’s usually worth searching for reviews online to gauge the strengths and weaknesses of various apps, especially when there is more than one available on a particular topic.

For-profit companies have developed some of the most popular evidence-driven apps for physicians. UpToDate claims that its physicians, authors, and editors synthesize the available medical evidence so the app can provide recommendations in primary care, ob.gyn., pediatrics, general surgery, emergency medicine, internal medicine, and all of the internal medicine subspecialties, among others. An individual subscription costs $499/year.

Epocrates offers a free app that provides medication information and lets you look up drug interactions and more, with additional services for a fee. Other apps do the same – Lexicomp is one subscription-based app that allows a 30-day free trial.

How to choose? Again, reviews may be helpful. The physician-run site iMedicalApps compared several medical drug reference apps in a 2010 review, but in app development time, that already seems light-years ago.

Courtesy of the Wound, Ostomy and Continence Nurses Society
For-profit companies have developed some of the most popular evidence-driven apps for physicians.

If you don’t recognize a company as a credible player in delivering mobile medical information, you can take several steps to assess the app’s trustworthiness. When you look at the app’s description online or in your mobile device’s app store, often the description is short and doesn’t list the reference information that the app relies on, though that’s often included in the app itself.

You’ll find reviews and ratings in the app description, but take these with a grain of salt. These can be anonymous, reflect anecdotal experiences, and may be planted by the developer of the app to make it look good.

Click on the tab for the developer in the app description, and if you don’t recognize the name, make sure there’s a link to a website or at least an e-mail address so you can assess whether the developer has health care expertise.

 

 

It’s also worth clicking on the Updates or Version History tab to see if it’s been updated, because good-quality apps usually get frequent updates, typically at least every 6 months, several app consultants said in interviews.

Are you already using evidence-delivering apps? Which are your favorites? Let us know, and we may highlight them in a future column.

[email protected]

On Twitter @sherryboschert

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Rupa Marya, M.D.: Living both dreams

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Dr. Rupa Marya is a typical academic hospitalist for about half the year, managing acutely ill patients and teaching residents at the University of California, San Francisco, Medical Center. But the rest of the time, she’s traveling the world and writing music with her alternative rock band, Rupa & the April Fishes.

Dr. Marya has been a hospitalist at UCSF since she finished her residency there in 2007. Her focus has been on examining health and disease patterns based on social determinants, and communicating with patients about end-of-life care decisions. She also works at a free clinic in San Francisco’s Mission district, the Clinica Martin Baro, where UCSF medical students and faculty provide low-cost primary care to low-income and undocumented patients.

Denis Beaumont
Rupa & The April Fishes

Over the last 7 years, Dr. Marya and her bandmates (Aaron Kierbel, Safa Shokrai, Misha Khalikulov, and Mario Alberto Silva) have recorded four albums that draw on different genres and languages. The lyrics, whether in French, Spanish, or English, have a romantic sound but tackle thorny social issues ranging from the struggles of immigrants to the government’s practice of rendition. Listen to their music here.

In an interview with Hospitalist News, Dr. Marya explains how she is able to juggle two challenging careers and get the best out of both worlds.

Question: When did you decide to seriously pursue both music and medicine as careers?

Dr. Marya: Throughout my education, I was equally drawn to science and the humanities. I developed these interests in a parallel fashion throughout college, where I studied molecular biology and political theater. I didn’t clearly see a path until I was in my intern year of my medicine residency at UCSF. I spoke with my program directors about my belief that I would be a better physician if I could find a way to balance my work as an artist and that my art would thrive if I could find a way to maintain my development as a physician. They have supported my exploration ever since, and after residency, I came on as a faculty member with this schedule that is divided between my time working on music and my time at the hospital.

Question: How do you juggle the demands of working in the hospital and also touring and recording with your band?

Dr. Marya: I work 4-6 months a year in the hospital and the rest of my time with the band. We have been touring 5-6 months a year for the past 7 years. I could not do this without the full support of the division of hospitalist medicine at UCSF. The leadership and culture of our division is incredible in creating a place in which physicians are encouraged to manifest their full potential and to bring that experience to the table with who they are as physicians and educators. Bob Wachter, our division chief, was my residency director and now continues as a mentor and leader of our division. If every hospital had a leader like him, we’d have a more inspired health care system.

The lifestyle of being a hospitalist works in perfect balance for me. I love managing the acuity of illness, having the opportunity to teach, and getting the unique lens into social situations that hospital medicine gives. Being with patients at times of important transitions as well as learning about the determinants of social and physical disease are inspiring to my work as an artist and thinker.

Question: How do you think music affects the way you treat patients?

Dr. Rupa Marya

Dr. Marya: Music teaches me how to listen. I feel the deeper I get into my practice of music, the better listener I am. There’s a flexibility to my mind that I also attribute to my work in art that helps me in more challenging clinical problems. When I come back to the hospital from the road, I feel refreshed and excited, each time.

There are times when I say, whether on stage looking out at an audience or leaving the room after a profound exchange with a family, "I can’t believe this is my life!" I feel grateful to all the people who have helped me, taught me, and shown me the way – patients, mentors, managers, agents, audience members, sound crew, backstage helpers, my band, and my family.

Question: You write your own music. Do you ever get song ideas from your interactions with patients?

Dr. Marya: I believe at the root, my music is inspired by the transitory nature of life and the demand I feel to celebrate that life in us when it is here. Every contact I have with someone’s true experience, stripped of pretense and raw in front of me, is inspiration. Being at the transition of life and death – sometimes in a person’s home, sometimes in the hospital, sometimes on the side of the road – that highlights this intensely special moment of being alive right now and being in the presence of another being. To be witnessed and to witness. To accompany someone in their journey. These things are what inspire and fuel my art.

 

 

Question: What’s next for you and your band?

Dr. Marya: Indianapolis. A tour of Europe this summer. I will be speaking and the band will be performing this year at TEDMED. I am currently recording an album of string quartet versions of my songs arranged by brilliant composer Mark Orton, together with Todd Sickafoose and Quartet San Francisco. We are trying to build a better model for sustainability for artists, which is truly difficult in an age in which people believe in some way that music should be free. We hope to be touring Asia, Central America, and Australia before next summer.

Question: What advice do you have for young physicians who have an outside interest they want to continue?

Dr. Marya: Discover and make space for your bliss – it will cost you something, but do not be afraid of that cost because your bliss is what will make you a truly incredible clinician. Whatever will bring you bliss will be of utmost importance to your patients because your joy and balance will radiate to them in the time they most need it. It will also bring you the patience to see how you can best accompany them in their need. Do not be afraid to articulate your unique path and to seek support along the way.

Surprisingly, I have found more wholehearted support for my work in medicine than in the music industry, which is far more conservative than the culture in medicine. Do not believe the naysayers. And never be afraid to articulate your truth, no matter how contradictory it may seem. It will help everyone around you to be more courageous and through that, we can develop a system of more humane and intact health care as visionary caregivers.

Take us to your leader. Nominate a hospitalist whose work inspires you. E-mail suggestions to [email protected]. Read previous columns at ehospitalistnews.com.

[email protected]

On Twitter @maryellenny

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Dr. Rupa Marya is a typical academic hospitalist for about half the year, managing acutely ill patients and teaching residents at the University of California, San Francisco, Medical Center. But the rest of the time, she’s traveling the world and writing music with her alternative rock band, Rupa & the April Fishes.

Dr. Marya has been a hospitalist at UCSF since she finished her residency there in 2007. Her focus has been on examining health and disease patterns based on social determinants, and communicating with patients about end-of-life care decisions. She also works at a free clinic in San Francisco’s Mission district, the Clinica Martin Baro, where UCSF medical students and faculty provide low-cost primary care to low-income and undocumented patients.

Denis Beaumont
Rupa & The April Fishes

Over the last 7 years, Dr. Marya and her bandmates (Aaron Kierbel, Safa Shokrai, Misha Khalikulov, and Mario Alberto Silva) have recorded four albums that draw on different genres and languages. The lyrics, whether in French, Spanish, or English, have a romantic sound but tackle thorny social issues ranging from the struggles of immigrants to the government’s practice of rendition. Listen to their music here.

In an interview with Hospitalist News, Dr. Marya explains how she is able to juggle two challenging careers and get the best out of both worlds.

Question: When did you decide to seriously pursue both music and medicine as careers?

Dr. Marya: Throughout my education, I was equally drawn to science and the humanities. I developed these interests in a parallel fashion throughout college, where I studied molecular biology and political theater. I didn’t clearly see a path until I was in my intern year of my medicine residency at UCSF. I spoke with my program directors about my belief that I would be a better physician if I could find a way to balance my work as an artist and that my art would thrive if I could find a way to maintain my development as a physician. They have supported my exploration ever since, and after residency, I came on as a faculty member with this schedule that is divided between my time working on music and my time at the hospital.

Question: How do you juggle the demands of working in the hospital and also touring and recording with your band?

Dr. Marya: I work 4-6 months a year in the hospital and the rest of my time with the band. We have been touring 5-6 months a year for the past 7 years. I could not do this without the full support of the division of hospitalist medicine at UCSF. The leadership and culture of our division is incredible in creating a place in which physicians are encouraged to manifest their full potential and to bring that experience to the table with who they are as physicians and educators. Bob Wachter, our division chief, was my residency director and now continues as a mentor and leader of our division. If every hospital had a leader like him, we’d have a more inspired health care system.

The lifestyle of being a hospitalist works in perfect balance for me. I love managing the acuity of illness, having the opportunity to teach, and getting the unique lens into social situations that hospital medicine gives. Being with patients at times of important transitions as well as learning about the determinants of social and physical disease are inspiring to my work as an artist and thinker.

Question: How do you think music affects the way you treat patients?

Dr. Rupa Marya

Dr. Marya: Music teaches me how to listen. I feel the deeper I get into my practice of music, the better listener I am. There’s a flexibility to my mind that I also attribute to my work in art that helps me in more challenging clinical problems. When I come back to the hospital from the road, I feel refreshed and excited, each time.

There are times when I say, whether on stage looking out at an audience or leaving the room after a profound exchange with a family, "I can’t believe this is my life!" I feel grateful to all the people who have helped me, taught me, and shown me the way – patients, mentors, managers, agents, audience members, sound crew, backstage helpers, my band, and my family.

Question: You write your own music. Do you ever get song ideas from your interactions with patients?

Dr. Marya: I believe at the root, my music is inspired by the transitory nature of life and the demand I feel to celebrate that life in us when it is here. Every contact I have with someone’s true experience, stripped of pretense and raw in front of me, is inspiration. Being at the transition of life and death – sometimes in a person’s home, sometimes in the hospital, sometimes on the side of the road – that highlights this intensely special moment of being alive right now and being in the presence of another being. To be witnessed and to witness. To accompany someone in their journey. These things are what inspire and fuel my art.

 

 

Question: What’s next for you and your band?

Dr. Marya: Indianapolis. A tour of Europe this summer. I will be speaking and the band will be performing this year at TEDMED. I am currently recording an album of string quartet versions of my songs arranged by brilliant composer Mark Orton, together with Todd Sickafoose and Quartet San Francisco. We are trying to build a better model for sustainability for artists, which is truly difficult in an age in which people believe in some way that music should be free. We hope to be touring Asia, Central America, and Australia before next summer.

Question: What advice do you have for young physicians who have an outside interest they want to continue?

Dr. Marya: Discover and make space for your bliss – it will cost you something, but do not be afraid of that cost because your bliss is what will make you a truly incredible clinician. Whatever will bring you bliss will be of utmost importance to your patients because your joy and balance will radiate to them in the time they most need it. It will also bring you the patience to see how you can best accompany them in their need. Do not be afraid to articulate your unique path and to seek support along the way.

Surprisingly, I have found more wholehearted support for my work in medicine than in the music industry, which is far more conservative than the culture in medicine. Do not believe the naysayers. And never be afraid to articulate your truth, no matter how contradictory it may seem. It will help everyone around you to be more courageous and through that, we can develop a system of more humane and intact health care as visionary caregivers.

Take us to your leader. Nominate a hospitalist whose work inspires you. E-mail suggestions to [email protected]. Read previous columns at ehospitalistnews.com.

[email protected]

On Twitter @maryellenny

Dr. Rupa Marya is a typical academic hospitalist for about half the year, managing acutely ill patients and teaching residents at the University of California, San Francisco, Medical Center. But the rest of the time, she’s traveling the world and writing music with her alternative rock band, Rupa & the April Fishes.

Dr. Marya has been a hospitalist at UCSF since she finished her residency there in 2007. Her focus has been on examining health and disease patterns based on social determinants, and communicating with patients about end-of-life care decisions. She also works at a free clinic in San Francisco’s Mission district, the Clinica Martin Baro, where UCSF medical students and faculty provide low-cost primary care to low-income and undocumented patients.

Denis Beaumont
Rupa & The April Fishes

Over the last 7 years, Dr. Marya and her bandmates (Aaron Kierbel, Safa Shokrai, Misha Khalikulov, and Mario Alberto Silva) have recorded four albums that draw on different genres and languages. The lyrics, whether in French, Spanish, or English, have a romantic sound but tackle thorny social issues ranging from the struggles of immigrants to the government’s practice of rendition. Listen to their music here.

In an interview with Hospitalist News, Dr. Marya explains how she is able to juggle two challenging careers and get the best out of both worlds.

Question: When did you decide to seriously pursue both music and medicine as careers?

Dr. Marya: Throughout my education, I was equally drawn to science and the humanities. I developed these interests in a parallel fashion throughout college, where I studied molecular biology and political theater. I didn’t clearly see a path until I was in my intern year of my medicine residency at UCSF. I spoke with my program directors about my belief that I would be a better physician if I could find a way to balance my work as an artist and that my art would thrive if I could find a way to maintain my development as a physician. They have supported my exploration ever since, and after residency, I came on as a faculty member with this schedule that is divided between my time working on music and my time at the hospital.

Question: How do you juggle the demands of working in the hospital and also touring and recording with your band?

Dr. Marya: I work 4-6 months a year in the hospital and the rest of my time with the band. We have been touring 5-6 months a year for the past 7 years. I could not do this without the full support of the division of hospitalist medicine at UCSF. The leadership and culture of our division is incredible in creating a place in which physicians are encouraged to manifest their full potential and to bring that experience to the table with who they are as physicians and educators. Bob Wachter, our division chief, was my residency director and now continues as a mentor and leader of our division. If every hospital had a leader like him, we’d have a more inspired health care system.

The lifestyle of being a hospitalist works in perfect balance for me. I love managing the acuity of illness, having the opportunity to teach, and getting the unique lens into social situations that hospital medicine gives. Being with patients at times of important transitions as well as learning about the determinants of social and physical disease are inspiring to my work as an artist and thinker.

Question: How do you think music affects the way you treat patients?

Dr. Rupa Marya

Dr. Marya: Music teaches me how to listen. I feel the deeper I get into my practice of music, the better listener I am. There’s a flexibility to my mind that I also attribute to my work in art that helps me in more challenging clinical problems. When I come back to the hospital from the road, I feel refreshed and excited, each time.

There are times when I say, whether on stage looking out at an audience or leaving the room after a profound exchange with a family, "I can’t believe this is my life!" I feel grateful to all the people who have helped me, taught me, and shown me the way – patients, mentors, managers, agents, audience members, sound crew, backstage helpers, my band, and my family.

Question: You write your own music. Do you ever get song ideas from your interactions with patients?

Dr. Marya: I believe at the root, my music is inspired by the transitory nature of life and the demand I feel to celebrate that life in us when it is here. Every contact I have with someone’s true experience, stripped of pretense and raw in front of me, is inspiration. Being at the transition of life and death – sometimes in a person’s home, sometimes in the hospital, sometimes on the side of the road – that highlights this intensely special moment of being alive right now and being in the presence of another being. To be witnessed and to witness. To accompany someone in their journey. These things are what inspire and fuel my art.

 

 

Question: What’s next for you and your band?

Dr. Marya: Indianapolis. A tour of Europe this summer. I will be speaking and the band will be performing this year at TEDMED. I am currently recording an album of string quartet versions of my songs arranged by brilliant composer Mark Orton, together with Todd Sickafoose and Quartet San Francisco. We are trying to build a better model for sustainability for artists, which is truly difficult in an age in which people believe in some way that music should be free. We hope to be touring Asia, Central America, and Australia before next summer.

Question: What advice do you have for young physicians who have an outside interest they want to continue?

Dr. Marya: Discover and make space for your bliss – it will cost you something, but do not be afraid of that cost because your bliss is what will make you a truly incredible clinician. Whatever will bring you bliss will be of utmost importance to your patients because your joy and balance will radiate to them in the time they most need it. It will also bring you the patience to see how you can best accompany them in their need. Do not be afraid to articulate your unique path and to seek support along the way.

Surprisingly, I have found more wholehearted support for my work in medicine than in the music industry, which is far more conservative than the culture in medicine. Do not believe the naysayers. And never be afraid to articulate your truth, no matter how contradictory it may seem. It will help everyone around you to be more courageous and through that, we can develop a system of more humane and intact health care as visionary caregivers.

Take us to your leader. Nominate a hospitalist whose work inspires you. E-mail suggestions to [email protected]. Read previous columns at ehospitalistnews.com.

[email protected]

On Twitter @maryellenny

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Up in the air

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I find it scary to travel without my kids, even just to a meeting. I’m not sure what I fear more: that something is going to happen to me (like what, I’ll freeze to death in a conference room?) or that something will happen to one of them (with someone else driving them to school, they really will finally strangle each other). The person I should really be worried about is the sitter left to watch five kids all week! I’ll be relieved if when we get back she still has all her nose rings.

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I never have any concerns that my kids will listen to their babysitter. Me, too...    

Learning curveball

Have you ever kept doing something you knew was stupid, even after the thing everyone told you was going to happen happened? If you’ve ever had a hangover -- twice -- then are you really surprised that a resurgence of vaccine-preventable disease hasn’t done a thing to improve vaccination rates? People don’t make unwise choices accidentally; they work really hard at it.

If you’re like me, then ever since 1998 you’ve been saying, “Just wait until vaccine-preventable diseases make a comeback. Then those vaccine deniers will come to their senses.” Remember how innocent we were back in 1998? Just in case you had some lingering glimmer of hope for humanity, researchers from Seattle Children’s presented new findings at the Pediatric Academic Societies’ meeting earlier this month regarding a whooping cough outbreak in Washington State in 2011.
 
A team led by Dr. Elizabeth Wolf compared local pertussis vaccination rates before and during the outbreak, presuming that when people realized that their own babies were threatened by a deadly disease, they would, you know, respond. As it turns out, they did respond, either by denying that there was a threat or by ignoring that there was anything to do about it. I suppose these data don’t bode well for vaccine acceptance or, for that matter, for other problems where science points to an obvious solution that some people don’t want to accept, like gun safety and global warming. It’s enough to make me court a hangover -- my 23rd.

Well rounded

Have you gotten caught up in this fad for “life-hacking,” trying to save time and effort with tricks like using paper clips to organize electrical cables, painting look-alike house keys with colored nail polish, or not having five children? Now a study suggests a new way for pediatricians and parents to simplify: Don’t treat moderate to severe positional plagiocephaly with skull-molding helmets. I know, it’s not as cool as using a sawed-off water bottle to seal your unused chocolate chips, but it’ll save a lot more money, and you’re less likely to need stitches.

A group of Dutch researchers randomized 84 otherwise normal 5- to 6-month-old infants with moderate to severe positional plagiocephaly to 6 months of helmet therapy vs. 6 months of, well, not wearing helmets. (There’s just no feasible way to double-blind a helmet study.) End points involved careful measurements of the skull at 24 months of age as well as secondary findings like ear deviation, facial asymmetry, and whether parents argued over where they were going to find $2,500 for the helmet.

In the end, helmets made no difference whatsoever in outcomes. Helmet makers were swift to point out that the study excluded premature infants younger than 36 weeks and those with dysmorphic features or torticollis. It’s too early to gauge whether this study will actually lead providers and parents to turn to skull molding helmets less often, but think about it: With each helmet not prescribed, we’ll be able to save enough money to paint 10,000 previously indistinguishable keys with nail polish!

Short changed

Have you ever noticed that in every monster movie there’s that one scene where a cop, faced with a scaly creature roughly the size of the Staples Center, unloads the magazine of a handgun at it and then stares in terror to see that the beast is unfazed or, even worse, annoyed? When the American Academy of Pediatrics announced that its latest child health priority is poverty, some of us thought of the new AAP President James Perrin in the role of that ambitious but outgunned officer. (Full disclosure: I’ve met Dr. Perrin and, at the time, he was wearing neither dark blue nor a sidearm.)

For those who wonder why the AAP would take on a leviathan like poverty, there is a new study in the Proceedings of the National Academy of Sciences comparing African American children from severely underprivileged and privileged backgrounds. The investigators found a difference much deeper than whether family members used SAT words around the dinner table or, for that matter, could afford dinner. They discovered that destitution actually shortens children’s telomeres, leading to poorer health and a reduced life expectancy at the genetic level. These findings might lend us some perspective when our kids don’t get accepted to the first choice colleges.

These results make me want to go home at the end of this trip and hug my children, assuming we all survive. I already got them presents, and I even picked up something for the sitter. I hope she loves her new nose ring!

 

 


David L. Hill, M.D., FAAP is the author of Dad to Dad: Parenting Like a Pro (AAP Publishing, 2012). He is also vice president of Cape Fear Pediatrics in Wilmington, N.C., and  adjunct assistant professor of pediatrics at the University of North Carolina at Chapel Hill. He serves as Program Director for the AAP Council on Communications and Media and as an executive committee member of the North Carolina Pediatric Society. He has recorded commentaries for NPR's All Things Considered and provided content for various print, television, and Internet outlets.

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I find it scary to travel without my kids, even just to a meeting. I’m not sure what I fear more: that something is going to happen to me (like what, I’ll freeze to death in a conference room?) or that something will happen to one of them (with someone else driving them to school, they really will finally strangle each other). The person I should really be worried about is the sitter left to watch five kids all week! I’ll be relieved if when we get back she still has all her nose rings.

iStock
I never have any concerns that my kids will listen to their babysitter. Me, too...    

Learning curveball

Have you ever kept doing something you knew was stupid, even after the thing everyone told you was going to happen happened? If you’ve ever had a hangover -- twice -- then are you really surprised that a resurgence of vaccine-preventable disease hasn’t done a thing to improve vaccination rates? People don’t make unwise choices accidentally; they work really hard at it.

If you’re like me, then ever since 1998 you’ve been saying, “Just wait until vaccine-preventable diseases make a comeback. Then those vaccine deniers will come to their senses.” Remember how innocent we were back in 1998? Just in case you had some lingering glimmer of hope for humanity, researchers from Seattle Children’s presented new findings at the Pediatric Academic Societies’ meeting earlier this month regarding a whooping cough outbreak in Washington State in 2011.
 
A team led by Dr. Elizabeth Wolf compared local pertussis vaccination rates before and during the outbreak, presuming that when people realized that their own babies were threatened by a deadly disease, they would, you know, respond. As it turns out, they did respond, either by denying that there was a threat or by ignoring that there was anything to do about it. I suppose these data don’t bode well for vaccine acceptance or, for that matter, for other problems where science points to an obvious solution that some people don’t want to accept, like gun safety and global warming. It’s enough to make me court a hangover -- my 23rd.

Well rounded

Have you gotten caught up in this fad for “life-hacking,” trying to save time and effort with tricks like using paper clips to organize electrical cables, painting look-alike house keys with colored nail polish, or not having five children? Now a study suggests a new way for pediatricians and parents to simplify: Don’t treat moderate to severe positional plagiocephaly with skull-molding helmets. I know, it’s not as cool as using a sawed-off water bottle to seal your unused chocolate chips, but it’ll save a lot more money, and you’re less likely to need stitches.

A group of Dutch researchers randomized 84 otherwise normal 5- to 6-month-old infants with moderate to severe positional plagiocephaly to 6 months of helmet therapy vs. 6 months of, well, not wearing helmets. (There’s just no feasible way to double-blind a helmet study.) End points involved careful measurements of the skull at 24 months of age as well as secondary findings like ear deviation, facial asymmetry, and whether parents argued over where they were going to find $2,500 for the helmet.

In the end, helmets made no difference whatsoever in outcomes. Helmet makers were swift to point out that the study excluded premature infants younger than 36 weeks and those with dysmorphic features or torticollis. It’s too early to gauge whether this study will actually lead providers and parents to turn to skull molding helmets less often, but think about it: With each helmet not prescribed, we’ll be able to save enough money to paint 10,000 previously indistinguishable keys with nail polish!

Short changed

Have you ever noticed that in every monster movie there’s that one scene where a cop, faced with a scaly creature roughly the size of the Staples Center, unloads the magazine of a handgun at it and then stares in terror to see that the beast is unfazed or, even worse, annoyed? When the American Academy of Pediatrics announced that its latest child health priority is poverty, some of us thought of the new AAP President James Perrin in the role of that ambitious but outgunned officer. (Full disclosure: I’ve met Dr. Perrin and, at the time, he was wearing neither dark blue nor a sidearm.)

For those who wonder why the AAP would take on a leviathan like poverty, there is a new study in the Proceedings of the National Academy of Sciences comparing African American children from severely underprivileged and privileged backgrounds. The investigators found a difference much deeper than whether family members used SAT words around the dinner table or, for that matter, could afford dinner. They discovered that destitution actually shortens children’s telomeres, leading to poorer health and a reduced life expectancy at the genetic level. These findings might lend us some perspective when our kids don’t get accepted to the first choice colleges.

These results make me want to go home at the end of this trip and hug my children, assuming we all survive. I already got them presents, and I even picked up something for the sitter. I hope she loves her new nose ring!

 

 


David L. Hill, M.D., FAAP is the author of Dad to Dad: Parenting Like a Pro (AAP Publishing, 2012). He is also vice president of Cape Fear Pediatrics in Wilmington, N.C., and  adjunct assistant professor of pediatrics at the University of North Carolina at Chapel Hill. He serves as Program Director for the AAP Council on Communications and Media and as an executive committee member of the North Carolina Pediatric Society. He has recorded commentaries for NPR's All Things Considered and provided content for various print, television, and Internet outlets.

I find it scary to travel without my kids, even just to a meeting. I’m not sure what I fear more: that something is going to happen to me (like what, I’ll freeze to death in a conference room?) or that something will happen to one of them (with someone else driving them to school, they really will finally strangle each other). The person I should really be worried about is the sitter left to watch five kids all week! I’ll be relieved if when we get back she still has all her nose rings.

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I never have any concerns that my kids will listen to their babysitter. Me, too...    

Learning curveball

Have you ever kept doing something you knew was stupid, even after the thing everyone told you was going to happen happened? If you’ve ever had a hangover -- twice -- then are you really surprised that a resurgence of vaccine-preventable disease hasn’t done a thing to improve vaccination rates? People don’t make unwise choices accidentally; they work really hard at it.

If you’re like me, then ever since 1998 you’ve been saying, “Just wait until vaccine-preventable diseases make a comeback. Then those vaccine deniers will come to their senses.” Remember how innocent we were back in 1998? Just in case you had some lingering glimmer of hope for humanity, researchers from Seattle Children’s presented new findings at the Pediatric Academic Societies’ meeting earlier this month regarding a whooping cough outbreak in Washington State in 2011.
 
A team led by Dr. Elizabeth Wolf compared local pertussis vaccination rates before and during the outbreak, presuming that when people realized that their own babies were threatened by a deadly disease, they would, you know, respond. As it turns out, they did respond, either by denying that there was a threat or by ignoring that there was anything to do about it. I suppose these data don’t bode well for vaccine acceptance or, for that matter, for other problems where science points to an obvious solution that some people don’t want to accept, like gun safety and global warming. It’s enough to make me court a hangover -- my 23rd.

Well rounded

Have you gotten caught up in this fad for “life-hacking,” trying to save time and effort with tricks like using paper clips to organize electrical cables, painting look-alike house keys with colored nail polish, or not having five children? Now a study suggests a new way for pediatricians and parents to simplify: Don’t treat moderate to severe positional plagiocephaly with skull-molding helmets. I know, it’s not as cool as using a sawed-off water bottle to seal your unused chocolate chips, but it’ll save a lot more money, and you’re less likely to need stitches.

A group of Dutch researchers randomized 84 otherwise normal 5- to 6-month-old infants with moderate to severe positional plagiocephaly to 6 months of helmet therapy vs. 6 months of, well, not wearing helmets. (There’s just no feasible way to double-blind a helmet study.) End points involved careful measurements of the skull at 24 months of age as well as secondary findings like ear deviation, facial asymmetry, and whether parents argued over where they were going to find $2,500 for the helmet.

In the end, helmets made no difference whatsoever in outcomes. Helmet makers were swift to point out that the study excluded premature infants younger than 36 weeks and those with dysmorphic features or torticollis. It’s too early to gauge whether this study will actually lead providers and parents to turn to skull molding helmets less often, but think about it: With each helmet not prescribed, we’ll be able to save enough money to paint 10,000 previously indistinguishable keys with nail polish!

Short changed

Have you ever noticed that in every monster movie there’s that one scene where a cop, faced with a scaly creature roughly the size of the Staples Center, unloads the magazine of a handgun at it and then stares in terror to see that the beast is unfazed or, even worse, annoyed? When the American Academy of Pediatrics announced that its latest child health priority is poverty, some of us thought of the new AAP President James Perrin in the role of that ambitious but outgunned officer. (Full disclosure: I’ve met Dr. Perrin and, at the time, he was wearing neither dark blue nor a sidearm.)

For those who wonder why the AAP would take on a leviathan like poverty, there is a new study in the Proceedings of the National Academy of Sciences comparing African American children from severely underprivileged and privileged backgrounds. The investigators found a difference much deeper than whether family members used SAT words around the dinner table or, for that matter, could afford dinner. They discovered that destitution actually shortens children’s telomeres, leading to poorer health and a reduced life expectancy at the genetic level. These findings might lend us some perspective when our kids don’t get accepted to the first choice colleges.

These results make me want to go home at the end of this trip and hug my children, assuming we all survive. I already got them presents, and I even picked up something for the sitter. I hope she loves her new nose ring!

 

 


David L. Hill, M.D., FAAP is the author of Dad to Dad: Parenting Like a Pro (AAP Publishing, 2012). He is also vice president of Cape Fear Pediatrics in Wilmington, N.C., and  adjunct assistant professor of pediatrics at the University of North Carolina at Chapel Hill. He serves as Program Director for the AAP Council on Communications and Media and as an executive committee member of the North Carolina Pediatric Society. He has recorded commentaries for NPR's All Things Considered and provided content for various print, television, and Internet outlets.

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TAVR quickly penetrates to low-risk patients

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TAVR quickly penetrates to low-risk patients

Have too many low-risk U.S. patients undergone transcatheter aortic-valve replacement since the procedure became available in October 2012 to U.S. patients who are also judged eligible for surgical aortic-valve replacement?

Furthermore, regardless of the answer, are the tools currently available to cardiologists and cardiac surgeons to estimate a patient’s risk for undergoing aortic-valve surgery too limited and flawed to even allow clinicians to reasonably judge who is at high risk for surgical valve replacement and who isn’t?

And finally, have the benefits of transcatheter aortic valve replacement (TAVR) as an alternative to surgery become so compelling that patients, cardiologists, and surgeons are all now willing to ignore the possible downside that still remains to TAVR and the risk-level ground rules that the field set up just a few years ago?

Courtesy Dr. Edwin P. Ewing, Jr., Centers for Disease Control and Prevention
Do the benefits of transcatheter aortic-valve replacement outweigh the risks?

Answering the third question is probably the easiest, and the answer seems to be yes, at least based on U.S. use of TAVR since the first valve system came onto the U.S. market for inoperable patients in November 2011, as well as on what happened in the latest big TAVR trial. Last November, researchers published a report on the first 7,710 U.S. TAVR patients, while results from the latest big trial, the CoreValve pivotal trial, came out in March.

A key finding in the JAMA report last November on nearly 8,000 TAVR recipients, most of whom were operable patients once this indication received U.S. approval in 2012, was that the median Predicted Risk of Operative Mortality score by the formula crafted by the Society of Thoracic Surgeons (the STS PROM score) was 7%, and a quarter of all U.S. patients had a score of 5% or less. Those risk levels are quite low relative to the levels in the first TAVR pivotal trial, the PARTNER I trial, and relative to how TAVR developers viewed the role for this technology when it first entered the U.S. market a couple of years ago.

In the first U.S. pivotal trial for TAVR in patients judged operable, a head-to-head comparison of TAVR and surgical aortic valve replacement (SAVR), all enrolled patients had to have an STS PROM score of at least 10%, and the average score of enrolled patients was 11.8%. Labeling for the first U.S. approved TAVR system was for patients with an STS PROM score of at least 8%. The follow-up trial designed to test a second-generation TAVR device, PARTNER II, launched about 3 years ago and not scheduled to finish until the end of 2015, specifically targeted "intermediate-risk" patients with aortic stenosis, those with an STS PROM of 4%-8%. Even this next-generation-device trial, PARTNER II, wasn’t designed to target patients with risk levels of less than 4%, yet patients of that very sort have already received treatment with the first-generation device based on the registry results.

It’s not just the registry that shows a shift toward lower-risk patients. The CoreValve pivotal trial that pitted a different TAVR system head to head against SAVR showed more of the same. The trial was designed to enroll operable patients with a predicted 30-day mortality risk after SAVR of at least 15%, though the study left it up to clinicians to decide how to measure risk and gave them free rein to use parameters in addition to the STS PROM score. The result was that the average STS PROM score of enrolled patients in the CoreValve trial was 7%, and roughly 10% of enrolled patients had a score of less than 4%. The temptation to use TAVR on lower-risk patients seems to have been inescapable, happening in both the CoreValve trial as well as in the registry’s Sapien experience.

Of course, the CoreValve results also showed significant survival benefit from TAVR using the CoreValve system, a game-changing result.

Part of what has been going on with risk assessment is that in the CoreValve study as well as in routine practice, clinicians have been fudging their use of the STS PROM score when sizing up patients for TAVR. I asked several interventional cardiologists about this at the ACC meeting in March, and their answers were all variants of what Dr. James Hermiller told me: "It’s frailty that often gets a patient to TAVR, and frailty is hard to quantify. Frailty can exist even when the STS score is not high." And even though labeling for the first-generation TAVR system that all 7,710 of the first U.S. patients received specified an STS PROM score of at least 8%, Dr. David Holmes told me that for Medicare reimbursement, all that’s needed is for two cardiac surgeons to sign off on saying that the patient’s status warrants TAVR. "That’s what carries the day," he said.

 

 

Data from the new CoreValve study underscore how limited the STS PROM score is right now. The average score of the patients enrolled in the surgical arm of this study was 7.5%, which means that 7.5 % of the patients who underwent SAVR were predicted by the scoring system to die during the first 30 days after surgery. But the actual rate was 4.5%, "substantially lower," said the CoreValve report. STS PROM scoring resulted in a substantial overcall on predicted risk.

When TAVR was first introduced, experts had two caveats about its potential to completely replace SAVR. The first was uncertainty about the long-term durability (think 10 or more years) of TAVR. The second was uncertainty about the short- and intermediate-term safety and efficacy of TAVR, especially for the patients for whom conventional SAVR was a reasonable option.

Doubts about short- and intermediate-term efficacy arose with the first-generation TAVR device, Sapien, because of the issue of paravalvular leak and the inability of TAVR to surpass SAVR outcomes in the PARTNER I results, but those doubts have now been mostly swept away from by the CoreValve results, which established CoreValve as superior to SAVR and made it the current standard for essentially all patients who need their aortic valve replaced. Even if paravalvular leak is still an issue for some patients, patients treated with CoreValve, TAVR overall did significantly better after 1 year than SAVR in the CoreValve trial, which means that TAVR was best regardless of whether paravalvular leak was an issue for some patients. And this was in patients who represented a wide range of STS PROM risk, with close to 10% of enrolled patients having a score of less than 4%. A subanalysis showed that the low-risk patients derived as much benefit from CoreValve TAVR, compared with SAVR, as did higher-risk patients.

The long-term durability question still remains for now, but the substantial mortality benefit in the CoreValve trial seen after 1 year probably trumps that.

Researchers designed the TAVR trials to methodically progress through a spectrum of patient risk levels. As recently as a year ago, several experts told me that no way in the near future could TAVR be an option for low-risk patients with STS PROM scores of less than 4%. But that is not how it has worked out. Patients, cardiac surgeons, and cardiologists embraced TAVR way faster and tighter than anyone expected just a few years ago.

[email protected]

On Twitter @mitchelzoler

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Have too many low-risk U.S. patients undergone transcatheter aortic-valve replacement since the procedure became available in October 2012 to U.S. patients who are also judged eligible for surgical aortic-valve replacement?

Furthermore, regardless of the answer, are the tools currently available to cardiologists and cardiac surgeons to estimate a patient’s risk for undergoing aortic-valve surgery too limited and flawed to even allow clinicians to reasonably judge who is at high risk for surgical valve replacement and who isn’t?

And finally, have the benefits of transcatheter aortic valve replacement (TAVR) as an alternative to surgery become so compelling that patients, cardiologists, and surgeons are all now willing to ignore the possible downside that still remains to TAVR and the risk-level ground rules that the field set up just a few years ago?

Courtesy Dr. Edwin P. Ewing, Jr., Centers for Disease Control and Prevention
Do the benefits of transcatheter aortic-valve replacement outweigh the risks?

Answering the third question is probably the easiest, and the answer seems to be yes, at least based on U.S. use of TAVR since the first valve system came onto the U.S. market for inoperable patients in November 2011, as well as on what happened in the latest big TAVR trial. Last November, researchers published a report on the first 7,710 U.S. TAVR patients, while results from the latest big trial, the CoreValve pivotal trial, came out in March.

A key finding in the JAMA report last November on nearly 8,000 TAVR recipients, most of whom were operable patients once this indication received U.S. approval in 2012, was that the median Predicted Risk of Operative Mortality score by the formula crafted by the Society of Thoracic Surgeons (the STS PROM score) was 7%, and a quarter of all U.S. patients had a score of 5% or less. Those risk levels are quite low relative to the levels in the first TAVR pivotal trial, the PARTNER I trial, and relative to how TAVR developers viewed the role for this technology when it first entered the U.S. market a couple of years ago.

In the first U.S. pivotal trial for TAVR in patients judged operable, a head-to-head comparison of TAVR and surgical aortic valve replacement (SAVR), all enrolled patients had to have an STS PROM score of at least 10%, and the average score of enrolled patients was 11.8%. Labeling for the first U.S. approved TAVR system was for patients with an STS PROM score of at least 8%. The follow-up trial designed to test a second-generation TAVR device, PARTNER II, launched about 3 years ago and not scheduled to finish until the end of 2015, specifically targeted "intermediate-risk" patients with aortic stenosis, those with an STS PROM of 4%-8%. Even this next-generation-device trial, PARTNER II, wasn’t designed to target patients with risk levels of less than 4%, yet patients of that very sort have already received treatment with the first-generation device based on the registry results.

It’s not just the registry that shows a shift toward lower-risk patients. The CoreValve pivotal trial that pitted a different TAVR system head to head against SAVR showed more of the same. The trial was designed to enroll operable patients with a predicted 30-day mortality risk after SAVR of at least 15%, though the study left it up to clinicians to decide how to measure risk and gave them free rein to use parameters in addition to the STS PROM score. The result was that the average STS PROM score of enrolled patients in the CoreValve trial was 7%, and roughly 10% of enrolled patients had a score of less than 4%. The temptation to use TAVR on lower-risk patients seems to have been inescapable, happening in both the CoreValve trial as well as in the registry’s Sapien experience.

Of course, the CoreValve results also showed significant survival benefit from TAVR using the CoreValve system, a game-changing result.

Part of what has been going on with risk assessment is that in the CoreValve study as well as in routine practice, clinicians have been fudging their use of the STS PROM score when sizing up patients for TAVR. I asked several interventional cardiologists about this at the ACC meeting in March, and their answers were all variants of what Dr. James Hermiller told me: "It’s frailty that often gets a patient to TAVR, and frailty is hard to quantify. Frailty can exist even when the STS score is not high." And even though labeling for the first-generation TAVR system that all 7,710 of the first U.S. patients received specified an STS PROM score of at least 8%, Dr. David Holmes told me that for Medicare reimbursement, all that’s needed is for two cardiac surgeons to sign off on saying that the patient’s status warrants TAVR. "That’s what carries the day," he said.

 

 

Data from the new CoreValve study underscore how limited the STS PROM score is right now. The average score of the patients enrolled in the surgical arm of this study was 7.5%, which means that 7.5 % of the patients who underwent SAVR were predicted by the scoring system to die during the first 30 days after surgery. But the actual rate was 4.5%, "substantially lower," said the CoreValve report. STS PROM scoring resulted in a substantial overcall on predicted risk.

When TAVR was first introduced, experts had two caveats about its potential to completely replace SAVR. The first was uncertainty about the long-term durability (think 10 or more years) of TAVR. The second was uncertainty about the short- and intermediate-term safety and efficacy of TAVR, especially for the patients for whom conventional SAVR was a reasonable option.

Doubts about short- and intermediate-term efficacy arose with the first-generation TAVR device, Sapien, because of the issue of paravalvular leak and the inability of TAVR to surpass SAVR outcomes in the PARTNER I results, but those doubts have now been mostly swept away from by the CoreValve results, which established CoreValve as superior to SAVR and made it the current standard for essentially all patients who need their aortic valve replaced. Even if paravalvular leak is still an issue for some patients, patients treated with CoreValve, TAVR overall did significantly better after 1 year than SAVR in the CoreValve trial, which means that TAVR was best regardless of whether paravalvular leak was an issue for some patients. And this was in patients who represented a wide range of STS PROM risk, with close to 10% of enrolled patients having a score of less than 4%. A subanalysis showed that the low-risk patients derived as much benefit from CoreValve TAVR, compared with SAVR, as did higher-risk patients.

The long-term durability question still remains for now, but the substantial mortality benefit in the CoreValve trial seen after 1 year probably trumps that.

Researchers designed the TAVR trials to methodically progress through a spectrum of patient risk levels. As recently as a year ago, several experts told me that no way in the near future could TAVR be an option for low-risk patients with STS PROM scores of less than 4%. But that is not how it has worked out. Patients, cardiac surgeons, and cardiologists embraced TAVR way faster and tighter than anyone expected just a few years ago.

[email protected]

On Twitter @mitchelzoler

Have too many low-risk U.S. patients undergone transcatheter aortic-valve replacement since the procedure became available in October 2012 to U.S. patients who are also judged eligible for surgical aortic-valve replacement?

Furthermore, regardless of the answer, are the tools currently available to cardiologists and cardiac surgeons to estimate a patient’s risk for undergoing aortic-valve surgery too limited and flawed to even allow clinicians to reasonably judge who is at high risk for surgical valve replacement and who isn’t?

And finally, have the benefits of transcatheter aortic valve replacement (TAVR) as an alternative to surgery become so compelling that patients, cardiologists, and surgeons are all now willing to ignore the possible downside that still remains to TAVR and the risk-level ground rules that the field set up just a few years ago?

Courtesy Dr. Edwin P. Ewing, Jr., Centers for Disease Control and Prevention
Do the benefits of transcatheter aortic-valve replacement outweigh the risks?

Answering the third question is probably the easiest, and the answer seems to be yes, at least based on U.S. use of TAVR since the first valve system came onto the U.S. market for inoperable patients in November 2011, as well as on what happened in the latest big TAVR trial. Last November, researchers published a report on the first 7,710 U.S. TAVR patients, while results from the latest big trial, the CoreValve pivotal trial, came out in March.

A key finding in the JAMA report last November on nearly 8,000 TAVR recipients, most of whom were operable patients once this indication received U.S. approval in 2012, was that the median Predicted Risk of Operative Mortality score by the formula crafted by the Society of Thoracic Surgeons (the STS PROM score) was 7%, and a quarter of all U.S. patients had a score of 5% or less. Those risk levels are quite low relative to the levels in the first TAVR pivotal trial, the PARTNER I trial, and relative to how TAVR developers viewed the role for this technology when it first entered the U.S. market a couple of years ago.

In the first U.S. pivotal trial for TAVR in patients judged operable, a head-to-head comparison of TAVR and surgical aortic valve replacement (SAVR), all enrolled patients had to have an STS PROM score of at least 10%, and the average score of enrolled patients was 11.8%. Labeling for the first U.S. approved TAVR system was for patients with an STS PROM score of at least 8%. The follow-up trial designed to test a second-generation TAVR device, PARTNER II, launched about 3 years ago and not scheduled to finish until the end of 2015, specifically targeted "intermediate-risk" patients with aortic stenosis, those with an STS PROM of 4%-8%. Even this next-generation-device trial, PARTNER II, wasn’t designed to target patients with risk levels of less than 4%, yet patients of that very sort have already received treatment with the first-generation device based on the registry results.

It’s not just the registry that shows a shift toward lower-risk patients. The CoreValve pivotal trial that pitted a different TAVR system head to head against SAVR showed more of the same. The trial was designed to enroll operable patients with a predicted 30-day mortality risk after SAVR of at least 15%, though the study left it up to clinicians to decide how to measure risk and gave them free rein to use parameters in addition to the STS PROM score. The result was that the average STS PROM score of enrolled patients in the CoreValve trial was 7%, and roughly 10% of enrolled patients had a score of less than 4%. The temptation to use TAVR on lower-risk patients seems to have been inescapable, happening in both the CoreValve trial as well as in the registry’s Sapien experience.

Of course, the CoreValve results also showed significant survival benefit from TAVR using the CoreValve system, a game-changing result.

Part of what has been going on with risk assessment is that in the CoreValve study as well as in routine practice, clinicians have been fudging their use of the STS PROM score when sizing up patients for TAVR. I asked several interventional cardiologists about this at the ACC meeting in March, and their answers were all variants of what Dr. James Hermiller told me: "It’s frailty that often gets a patient to TAVR, and frailty is hard to quantify. Frailty can exist even when the STS score is not high." And even though labeling for the first-generation TAVR system that all 7,710 of the first U.S. patients received specified an STS PROM score of at least 8%, Dr. David Holmes told me that for Medicare reimbursement, all that’s needed is for two cardiac surgeons to sign off on saying that the patient’s status warrants TAVR. "That’s what carries the day," he said.

 

 

Data from the new CoreValve study underscore how limited the STS PROM score is right now. The average score of the patients enrolled in the surgical arm of this study was 7.5%, which means that 7.5 % of the patients who underwent SAVR were predicted by the scoring system to die during the first 30 days after surgery. But the actual rate was 4.5%, "substantially lower," said the CoreValve report. STS PROM scoring resulted in a substantial overcall on predicted risk.

When TAVR was first introduced, experts had two caveats about its potential to completely replace SAVR. The first was uncertainty about the long-term durability (think 10 or more years) of TAVR. The second was uncertainty about the short- and intermediate-term safety and efficacy of TAVR, especially for the patients for whom conventional SAVR was a reasonable option.

Doubts about short- and intermediate-term efficacy arose with the first-generation TAVR device, Sapien, because of the issue of paravalvular leak and the inability of TAVR to surpass SAVR outcomes in the PARTNER I results, but those doubts have now been mostly swept away from by the CoreValve results, which established CoreValve as superior to SAVR and made it the current standard for essentially all patients who need their aortic valve replaced. Even if paravalvular leak is still an issue for some patients, patients treated with CoreValve, TAVR overall did significantly better after 1 year than SAVR in the CoreValve trial, which means that TAVR was best regardless of whether paravalvular leak was an issue for some patients. And this was in patients who represented a wide range of STS PROM risk, with close to 10% of enrolled patients having a score of less than 4%. A subanalysis showed that the low-risk patients derived as much benefit from CoreValve TAVR, compared with SAVR, as did higher-risk patients.

The long-term durability question still remains for now, but the substantial mortality benefit in the CoreValve trial seen after 1 year probably trumps that.

Researchers designed the TAVR trials to methodically progress through a spectrum of patient risk levels. As recently as a year ago, several experts told me that no way in the near future could TAVR be an option for low-risk patients with STS PROM scores of less than 4%. But that is not how it has worked out. Patients, cardiac surgeons, and cardiologists embraced TAVR way faster and tighter than anyone expected just a few years ago.

[email protected]

On Twitter @mitchelzoler

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Mobile health validation efforts in infancy

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Hardly a day goes by anymore without an announcement of a new mobile health app, but there are precious few data to show which apps are useful in clinical or financial terms. Lots of people would like to change that, but how?

Three experts offered ideas in a recent opinion article in the Journal of the American Medical Association, and some partnerships between academia and industry may be laying the groundwork for greater validation of new mobile health (mHealth) tools.

Courtesy of UCSF
A new partnership between UCSF and Samsung Electronics aims to validate and commercialize promising digital tools for health care.

Of the more than 40,000 health, fitness, and medical apps on the market, reviews "have largely focused on personal impressions, rather than evidence-based, unbiased assessments of clinical performance and data security," Adam C. Powell, Ph.D., Dr. Adam B. Landman, and Dr. David W. Bates wrote in their article, "In Search of a Few Good Apps" (JAMA 2014;311:1851-2).

The Office of the National Coordinator for Health Information Technology (ONC) could play a greater role supporting development of mHealth app guidelines and, eventually, commission non-profit or for-profit entities to certify apps, as it does now for electronic health records, they suggested.

Dr. Powell is a Boston-based consultant. Dr. Landman, an emergency medicine specialist, is chief medical information officer for health information innovation and integration at Brigham and Women’s Hospital, Boston. Dr. Bates is chief of general internal medicine and the chief quality officer at Brigham and Women’s. Dr. Landman and Dr. Bates are both at Harvard Medical School in Boston.

The National Institutes of Health mHealth Training Institute is educating an interdisciplinary group of researchers about the potential of mHealth and the need to evaluate these new tools. "If this effort is coupled with increased funding for mHealth research, it may help galvanize a larger body of evidence to inform mHealth app development and certification," the authors wrote.

Meanwhile, a new partnership between the University of California, San Francisco (UCSF), and Samsung Electronics aims to validate and commercialize promising digital tools for health care, including apps, in a Digital Health Innovation Lab. A few other universities recently entered into similar partnerships with industry.

Both UCSF and Samsung are making a "significant investment" to fund the lab but are not ready to release financial details, Dr. Michael Blum said in an interview.

The partnership initially will focus on preventive health, said Dr. Blum, who will direct the lab to be located at UCSF’s Mission Bay campus. "There is no better way to treat disease than by avoiding it in the first place. [Moe than] 70% of our health care dollars are spent on avoidable disease," said Dr. Blum, a cardiologist who has been leading UCSF’s relatively new Center for Digital Health Innovation.

Dr. Michael Blum

UCSF already has begun testing medical apps in clinical trials, such as a smoking cessation app, and will pursue clinical testing of tools including health sensors, wearable computing, and cloud-based analytics.

"There are many sites designing medical apps but very few are rigorously validated," Dr. Blum said. "We believe that validation is critical to the success of these apps and products. It is important for health care providers to know that they can trust the data and information which will lead to more consistent use and, hopefully, better outcomes for the users."

In Michigan, the William Davidson Foundation in January 2014 awarded $3 million to the Henry Ford Health System to create the William Davidson Center for Entrepreneurs in Digital Health. The center hopes to attract corporate partners and others to create, clinically validate, and commercialize digital health tools and to create a curriculum integrating health care, digital technologies, and entrepreneurship, according to a statement released by the Henry Ford Innovation Institute.

At the University of Colorado, Denver, the Center for Information Technology Innovation recently launched a Digital Health Consortium to bring its business school faculty together with entrepreneurs, health care providers, researchers, educators, and others to develop and clinically validate the next generation of digital health tools. The Center is funded by its members, which include the university and more than 30 Colorado information technology business leaders.

As each of these initiatives and others like them report results from their validation efforts, we’ll bring you the latest news on medical apps. Watch this space.

[email protected]

On Twitter @sherryboschert

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Hardly a day goes by anymore without an announcement of a new mobile health app, but there are precious few data to show which apps are useful in clinical or financial terms. Lots of people would like to change that, but how?

Three experts offered ideas in a recent opinion article in the Journal of the American Medical Association, and some partnerships between academia and industry may be laying the groundwork for greater validation of new mobile health (mHealth) tools.

Courtesy of UCSF
A new partnership between UCSF and Samsung Electronics aims to validate and commercialize promising digital tools for health care.

Of the more than 40,000 health, fitness, and medical apps on the market, reviews "have largely focused on personal impressions, rather than evidence-based, unbiased assessments of clinical performance and data security," Adam C. Powell, Ph.D., Dr. Adam B. Landman, and Dr. David W. Bates wrote in their article, "In Search of a Few Good Apps" (JAMA 2014;311:1851-2).

The Office of the National Coordinator for Health Information Technology (ONC) could play a greater role supporting development of mHealth app guidelines and, eventually, commission non-profit or for-profit entities to certify apps, as it does now for electronic health records, they suggested.

Dr. Powell is a Boston-based consultant. Dr. Landman, an emergency medicine specialist, is chief medical information officer for health information innovation and integration at Brigham and Women’s Hospital, Boston. Dr. Bates is chief of general internal medicine and the chief quality officer at Brigham and Women’s. Dr. Landman and Dr. Bates are both at Harvard Medical School in Boston.

The National Institutes of Health mHealth Training Institute is educating an interdisciplinary group of researchers about the potential of mHealth and the need to evaluate these new tools. "If this effort is coupled with increased funding for mHealth research, it may help galvanize a larger body of evidence to inform mHealth app development and certification," the authors wrote.

Meanwhile, a new partnership between the University of California, San Francisco (UCSF), and Samsung Electronics aims to validate and commercialize promising digital tools for health care, including apps, in a Digital Health Innovation Lab. A few other universities recently entered into similar partnerships with industry.

Both UCSF and Samsung are making a "significant investment" to fund the lab but are not ready to release financial details, Dr. Michael Blum said in an interview.

The partnership initially will focus on preventive health, said Dr. Blum, who will direct the lab to be located at UCSF’s Mission Bay campus. "There is no better way to treat disease than by avoiding it in the first place. [Moe than] 70% of our health care dollars are spent on avoidable disease," said Dr. Blum, a cardiologist who has been leading UCSF’s relatively new Center for Digital Health Innovation.

Dr. Michael Blum

UCSF already has begun testing medical apps in clinical trials, such as a smoking cessation app, and will pursue clinical testing of tools including health sensors, wearable computing, and cloud-based analytics.

"There are many sites designing medical apps but very few are rigorously validated," Dr. Blum said. "We believe that validation is critical to the success of these apps and products. It is important for health care providers to know that they can trust the data and information which will lead to more consistent use and, hopefully, better outcomes for the users."

In Michigan, the William Davidson Foundation in January 2014 awarded $3 million to the Henry Ford Health System to create the William Davidson Center for Entrepreneurs in Digital Health. The center hopes to attract corporate partners and others to create, clinically validate, and commercialize digital health tools and to create a curriculum integrating health care, digital technologies, and entrepreneurship, according to a statement released by the Henry Ford Innovation Institute.

At the University of Colorado, Denver, the Center for Information Technology Innovation recently launched a Digital Health Consortium to bring its business school faculty together with entrepreneurs, health care providers, researchers, educators, and others to develop and clinically validate the next generation of digital health tools. The Center is funded by its members, which include the university and more than 30 Colorado information technology business leaders.

As each of these initiatives and others like them report results from their validation efforts, we’ll bring you the latest news on medical apps. Watch this space.

[email protected]

On Twitter @sherryboschert

Hardly a day goes by anymore without an announcement of a new mobile health app, but there are precious few data to show which apps are useful in clinical or financial terms. Lots of people would like to change that, but how?

Three experts offered ideas in a recent opinion article in the Journal of the American Medical Association, and some partnerships between academia and industry may be laying the groundwork for greater validation of new mobile health (mHealth) tools.

Courtesy of UCSF
A new partnership between UCSF and Samsung Electronics aims to validate and commercialize promising digital tools for health care.

Of the more than 40,000 health, fitness, and medical apps on the market, reviews "have largely focused on personal impressions, rather than evidence-based, unbiased assessments of clinical performance and data security," Adam C. Powell, Ph.D., Dr. Adam B. Landman, and Dr. David W. Bates wrote in their article, "In Search of a Few Good Apps" (JAMA 2014;311:1851-2).

The Office of the National Coordinator for Health Information Technology (ONC) could play a greater role supporting development of mHealth app guidelines and, eventually, commission non-profit or for-profit entities to certify apps, as it does now for electronic health records, they suggested.

Dr. Powell is a Boston-based consultant. Dr. Landman, an emergency medicine specialist, is chief medical information officer for health information innovation and integration at Brigham and Women’s Hospital, Boston. Dr. Bates is chief of general internal medicine and the chief quality officer at Brigham and Women’s. Dr. Landman and Dr. Bates are both at Harvard Medical School in Boston.

The National Institutes of Health mHealth Training Institute is educating an interdisciplinary group of researchers about the potential of mHealth and the need to evaluate these new tools. "If this effort is coupled with increased funding for mHealth research, it may help galvanize a larger body of evidence to inform mHealth app development and certification," the authors wrote.

Meanwhile, a new partnership between the University of California, San Francisco (UCSF), and Samsung Electronics aims to validate and commercialize promising digital tools for health care, including apps, in a Digital Health Innovation Lab. A few other universities recently entered into similar partnerships with industry.

Both UCSF and Samsung are making a "significant investment" to fund the lab but are not ready to release financial details, Dr. Michael Blum said in an interview.

The partnership initially will focus on preventive health, said Dr. Blum, who will direct the lab to be located at UCSF’s Mission Bay campus. "There is no better way to treat disease than by avoiding it in the first place. [Moe than] 70% of our health care dollars are spent on avoidable disease," said Dr. Blum, a cardiologist who has been leading UCSF’s relatively new Center for Digital Health Innovation.

Dr. Michael Blum

UCSF already has begun testing medical apps in clinical trials, such as a smoking cessation app, and will pursue clinical testing of tools including health sensors, wearable computing, and cloud-based analytics.

"There are many sites designing medical apps but very few are rigorously validated," Dr. Blum said. "We believe that validation is critical to the success of these apps and products. It is important for health care providers to know that they can trust the data and information which will lead to more consistent use and, hopefully, better outcomes for the users."

In Michigan, the William Davidson Foundation in January 2014 awarded $3 million to the Henry Ford Health System to create the William Davidson Center for Entrepreneurs in Digital Health. The center hopes to attract corporate partners and others to create, clinically validate, and commercialize digital health tools and to create a curriculum integrating health care, digital technologies, and entrepreneurship, according to a statement released by the Henry Ford Innovation Institute.

At the University of Colorado, Denver, the Center for Information Technology Innovation recently launched a Digital Health Consortium to bring its business school faculty together with entrepreneurs, health care providers, researchers, educators, and others to develop and clinically validate the next generation of digital health tools. The Center is funded by its members, which include the university and more than 30 Colorado information technology business leaders.

As each of these initiatives and others like them report results from their validation efforts, we’ll bring you the latest news on medical apps. Watch this space.

[email protected]

On Twitter @sherryboschert

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RealSelf

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If you have patients who express interest in cosmetic procedures, and especially if you are a cosmetic dermatologist or a plastic surgeon, you might want to familiarize yourself with RealSelf.com. Founded in 2006, RealSelf is an online community for learning and sharing information about cosmetic surgery, dermatology, dentistry, and other elective treatments. In 2013, the site had 36 million unique visitors, and it is expected to grow.

Why might RealSelf be relevant for you? Simply put, it’s another channel to market you and your practice. It works by allowing physicians to answer users’ questions about cosmetic procedures ranging from rhinoplasty and liposuction to tattoo removal and Botox. Over time, your participation can lead to new consultations at your practice.

To ensure credibility, physicians must be board-certified in order to join RealSelf’s physician community. There is an element of game mechanics: The more active the physician, the more exposure his or her profile and practice receives. Similarly, paid subscriptions lead to more exposure than free subscriptions (more on this later.) Although this model does not appeal to some physicians, many of them do like the platform, and see it as a way to build a reputation as an expert and to market their practices.

Unlike doctor review sites that focus on the physician, RealSelf focuses on the procedure. For each procedure, users will find actual patient reviews and before and after photos, as well as Q&A’s with board-certified physicians. Users will also find licensed physicians in their area as well as the average cost for the procedure. RealSelf believes that patients value transparency, and including prices creates transparency.

Since most patients genuinely want to help other patients make informed medical decisions, the reviews tend to be thoughtful and thorough, and many of them contain multiple before-and-after photos. As a physician perusing the patient reviews, you’ll start to notice that most of them are reasonable. For example, customer satisfaction with laser treatment for melasma was 51%, whereas satisfaction for laser treatment for rosacea was 80%.

Patients and prospective patients are flocking to the site because it allows them to share their experiences, interact with other patients, and gain access to physician experts in the field. Many patients have difficulty making decisions about cosmetic procedures; RealSelf aims to alleviate their fears and help them "make confident health and beauty decisions." If a prospective patient wants to see a video of tattoo removal or Botox injections, he or she can. If a patient wants to ask physicians their opinions, he or she can. According to RealSelf, physicians have answered over 500,000 questions on the site.

Of course, all this isn’t free for physicians. RealSelf is a business. They have a tiered membership – free, pro, and spotlight. To obtain free membership, you simply visit the site and follow the prompts to "claim your profile." Once your profile is completed, you will have access to a "doctor advisor" who can help you "optimize your visibility on the site." Both "pro" and "spotlight" offer additional benefits, such as integrating patient reviews on your practice website, promotions on Facebook and Twitter, extended directory listings, and exposure in your local area. RealSelf does not discuss costs of membership until you have claimed your profile.

Only you can determine if RealSelf is beneficial to you and your practice. If, for example, you’re not looking for new patients, then you might find it unnecessary. But at the very least, you’ll know what RealSelf is the next time a fellow cosmetic physician brings it up at a conference. And it’s never a bad idea to be familiar with current social technologies that may affect your livelihood.

If you’ve used RealSelf, let us know what you think. For more information, visit RealSelf.com.

Disclaimer: I have no financial interest in RealSelf and am not an active member.

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @Dermdoc on Twitter.

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If you have patients who express interest in cosmetic procedures, and especially if you are a cosmetic dermatologist or a plastic surgeon, you might want to familiarize yourself with RealSelf.com. Founded in 2006, RealSelf is an online community for learning and sharing information about cosmetic surgery, dermatology, dentistry, and other elective treatments. In 2013, the site had 36 million unique visitors, and it is expected to grow.

Why might RealSelf be relevant for you? Simply put, it’s another channel to market you and your practice. It works by allowing physicians to answer users’ questions about cosmetic procedures ranging from rhinoplasty and liposuction to tattoo removal and Botox. Over time, your participation can lead to new consultations at your practice.

To ensure credibility, physicians must be board-certified in order to join RealSelf’s physician community. There is an element of game mechanics: The more active the physician, the more exposure his or her profile and practice receives. Similarly, paid subscriptions lead to more exposure than free subscriptions (more on this later.) Although this model does not appeal to some physicians, many of them do like the platform, and see it as a way to build a reputation as an expert and to market their practices.

Unlike doctor review sites that focus on the physician, RealSelf focuses on the procedure. For each procedure, users will find actual patient reviews and before and after photos, as well as Q&A’s with board-certified physicians. Users will also find licensed physicians in their area as well as the average cost for the procedure. RealSelf believes that patients value transparency, and including prices creates transparency.

Since most patients genuinely want to help other patients make informed medical decisions, the reviews tend to be thoughtful and thorough, and many of them contain multiple before-and-after photos. As a physician perusing the patient reviews, you’ll start to notice that most of them are reasonable. For example, customer satisfaction with laser treatment for melasma was 51%, whereas satisfaction for laser treatment for rosacea was 80%.

Patients and prospective patients are flocking to the site because it allows them to share their experiences, interact with other patients, and gain access to physician experts in the field. Many patients have difficulty making decisions about cosmetic procedures; RealSelf aims to alleviate their fears and help them "make confident health and beauty decisions." If a prospective patient wants to see a video of tattoo removal or Botox injections, he or she can. If a patient wants to ask physicians their opinions, he or she can. According to RealSelf, physicians have answered over 500,000 questions on the site.

Of course, all this isn’t free for physicians. RealSelf is a business. They have a tiered membership – free, pro, and spotlight. To obtain free membership, you simply visit the site and follow the prompts to "claim your profile." Once your profile is completed, you will have access to a "doctor advisor" who can help you "optimize your visibility on the site." Both "pro" and "spotlight" offer additional benefits, such as integrating patient reviews on your practice website, promotions on Facebook and Twitter, extended directory listings, and exposure in your local area. RealSelf does not discuss costs of membership until you have claimed your profile.

Only you can determine if RealSelf is beneficial to you and your practice. If, for example, you’re not looking for new patients, then you might find it unnecessary. But at the very least, you’ll know what RealSelf is the next time a fellow cosmetic physician brings it up at a conference. And it’s never a bad idea to be familiar with current social technologies that may affect your livelihood.

If you’ve used RealSelf, let us know what you think. For more information, visit RealSelf.com.

Disclaimer: I have no financial interest in RealSelf and am not an active member.

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @Dermdoc on Twitter.

If you have patients who express interest in cosmetic procedures, and especially if you are a cosmetic dermatologist or a plastic surgeon, you might want to familiarize yourself with RealSelf.com. Founded in 2006, RealSelf is an online community for learning and sharing information about cosmetic surgery, dermatology, dentistry, and other elective treatments. In 2013, the site had 36 million unique visitors, and it is expected to grow.

Why might RealSelf be relevant for you? Simply put, it’s another channel to market you and your practice. It works by allowing physicians to answer users’ questions about cosmetic procedures ranging from rhinoplasty and liposuction to tattoo removal and Botox. Over time, your participation can lead to new consultations at your practice.

To ensure credibility, physicians must be board-certified in order to join RealSelf’s physician community. There is an element of game mechanics: The more active the physician, the more exposure his or her profile and practice receives. Similarly, paid subscriptions lead to more exposure than free subscriptions (more on this later.) Although this model does not appeal to some physicians, many of them do like the platform, and see it as a way to build a reputation as an expert and to market their practices.

Unlike doctor review sites that focus on the physician, RealSelf focuses on the procedure. For each procedure, users will find actual patient reviews and before and after photos, as well as Q&A’s with board-certified physicians. Users will also find licensed physicians in their area as well as the average cost for the procedure. RealSelf believes that patients value transparency, and including prices creates transparency.

Since most patients genuinely want to help other patients make informed medical decisions, the reviews tend to be thoughtful and thorough, and many of them contain multiple before-and-after photos. As a physician perusing the patient reviews, you’ll start to notice that most of them are reasonable. For example, customer satisfaction with laser treatment for melasma was 51%, whereas satisfaction for laser treatment for rosacea was 80%.

Patients and prospective patients are flocking to the site because it allows them to share their experiences, interact with other patients, and gain access to physician experts in the field. Many patients have difficulty making decisions about cosmetic procedures; RealSelf aims to alleviate their fears and help them "make confident health and beauty decisions." If a prospective patient wants to see a video of tattoo removal or Botox injections, he or she can. If a patient wants to ask physicians their opinions, he or she can. According to RealSelf, physicians have answered over 500,000 questions on the site.

Of course, all this isn’t free for physicians. RealSelf is a business. They have a tiered membership – free, pro, and spotlight. To obtain free membership, you simply visit the site and follow the prompts to "claim your profile." Once your profile is completed, you will have access to a "doctor advisor" who can help you "optimize your visibility on the site." Both "pro" and "spotlight" offer additional benefits, such as integrating patient reviews on your practice website, promotions on Facebook and Twitter, extended directory listings, and exposure in your local area. RealSelf does not discuss costs of membership until you have claimed your profile.

Only you can determine if RealSelf is beneficial to you and your practice. If, for example, you’re not looking for new patients, then you might find it unnecessary. But at the very least, you’ll know what RealSelf is the next time a fellow cosmetic physician brings it up at a conference. And it’s never a bad idea to be familiar with current social technologies that may affect your livelihood.

If you’ve used RealSelf, let us know what you think. For more information, visit RealSelf.com.

Disclaimer: I have no financial interest in RealSelf and am not an active member.

Dr. Benabio is a partner physician in the department of dermatology of the Southern California Permanente Group in San Diego and a volunteer clinical assistant professor at the University of California, San Diego. Dr. Benabio is @Dermdoc on Twitter.

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Law & Medicine: Antitrust issues in health care, part 2

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Question: On antitrust, the U.S. courts have made the following statements, except:

A. To agree to prices is to fix them.

B. There is no learned profession exception to the antitrust laws.

C. To fix maximum price may amount to a fix of minimum price.

D. A group boycott of chiropractors violates the Sherman Act.

E. Tying arrangement in the health care industry is per se illegal.

Answer: E (see Jefferson Parish Hospital below). In the second part of the 20th century, the U.S. Supreme Court and other appellate courts began issuing a number of landmark opinions regarding health care economics and antitrust. Group boycotts were a major target, as was price fixing. This article briefly reviews a few of these decisions to impart a sense of how the judicial system views free market competition in health care.

In AMA v. United States (317 U.S. 519 [1943]), the issue was whether the medical profession’s leading organization, the American Medical Association, could be allowed to expel its salaried doctors or those who associated professionally with salaried doctors. Those who were denied AMA membership were naturally less able to compete (hospital privileges, consultations, etc.).

The U.S. Supreme Court held that such a group boycott of all salaried doctors was illegal because of its anticompetitive purpose, even if it allegedly promoted professional competence and public welfare.

Wilk v. AMA (895 F.2d 352 [1990]) was the culmination of a number of lawsuits surrounding the AMA and chiropractic. In 1963, the AMA had formed a Committee on Quackery aimed at eliminating chiropractic as a profession. The AMA Code of Ethics, Principle 3, opined that it was unethical for a physician to associate professionally with chiropractors. In 1976, Dr. Wilk and four other licensed chiropractors filed suit against the AMA, and a jury trial found that the purpose of the boycott was to eliminate substantial competition without corresponding procompetitive benefits.

The U.S. Court of Appeals for the Seventh Circuit subsequently affirmed the lower court’s finding that the AMA violated Section 1 of the Sherman Act in its illegal boycott of chiropractors, although the court did not answer the question as to whether chiropractic theory was in fact scientific. The court inquired into whether there was a genuine reasonable concern for the use of the scientific method in the doctor-patient relationship, and whether that concern was the dominating, motivating factor in the boycott, and if so, whether it could have been satisfied without restraining competition.

The court found that the AMA’s motive for the boycott was anticompetitive, believing that concern for patient care could be expressed, for example, through public-education campaigns. Although the AMA had formally removed Principle 3 in 1980, it nonetheless appealed this adverse decision to the U.S. Supreme Court on three separate occasions, but the latter declined to hear the case.

In Goldfarb v. Virginia State Bar (421 U.S. 773 [1975]), the Virginia State Bar enforced an "advisory" minimum fee schedule for legal services. The U.S. Supreme Court found that this was an agreement to fix prices, holding, "This is not merely a case of an agreement that may be inferred from an exchange of price information ... for here a naked agreement was clearly shown, and the effect on prices is plain."

The court rejected the defendant’s argument that the practice of law was not a trade or commerce intended to be under Sherman Act scrutiny, declaring there was to be no "learned profession" exemption.

However, it noted that special considerations might apply, holding that "It would be unrealistic to view the practice of professions as interchangeable with other business activities, and automatically to apply to the professions antitrust concepts, which originated in other areas. The public service aspect, and other features of the professions, may require that a particular practice, which could properly be viewed as a violation of the Sherman Act in another context, be treated differently."

Following Goldfarb, there remains no doubt that professional services – legal, medical, and other services – are all to be governed by the antitrust laws.

A flurry of health care–related antitrust cases, including Patrick v. Burget (to be discussed in part 3), reached the courts in the 1980s. In Arizona v. Maricopa County Medical Society (457 U.S. 332 [1982]), the county medical society set maximum allowable fees that member physicians could charge their patients, presumably to guard against price gouging. However, the U.S. Supreme Court, using the tough illegal per se standard, characterized the agreement as price fixing, despite it being for maximum rather than minimum fees.

 

 

The court ruled, "Maximum and minimum price fixing may have different consequences in many situations. But schemes to fix maximum prices, by substituting perhaps the erroneous judgment of a seller for the forces of the competitive market, may severely intrude upon the ability of buyers to compete and survive in that market. ... Maximum prices may be fixed too low ... may channel distribution through a few large or specifically advantaged dealers. ... Moreover, if the actual price charged under a maximum price scheme is nearly always the fixed maximum price, which is increasingly likely as the maximum price approaches the actual cost of the dealer, the scheme tends to acquire all the attributes of an arrangement fixing minimum prices."

At issue in Jefferson Parish Hospital District No. 2 v. Hyde (466 U.S. 2 [1984]) was an exclusive contract between a group of four anesthesiologists and Jefferson Parish Hospital in the New Orleans area. Dr. Hyde was an independent board-certified anesthesiologist who was denied medical staff privileges at the hospital because of this exclusive contract. The exclusive arrangement in effect required patients at the hospital to use the services of the four anesthesiologists and none others, raising the issue of unlawful "tying," where a seller requires a customer to purchase one product or service as a condition of being allowed to purchase another.

In a rare unanimous decision, the U.S. Supreme Court, while agreeing that the contract was a tying arrangement, nonetheless rejected the argument that it was per se illegal or that it unreasonably restrained competition among anesthesiologists. The court reasoned that the hospital’s 30% share of the market did not amount to sufficient market power in the provision of hospital services in the Jefferson Parish area. Pointing out that every patient undergoing surgery needed anesthesia, the court found no evidence that any patient received unnecessary services, and it noted that the tying arrangement that was generally employed in the health care industry improved patient care and promoted hospital efficiency.

Tying arrangements in health care are frequently analyzed under a rule of reason standard instead of the strict per se standard, and the favorable decision in this specific case depended heavily on the hospitals’ relatively small market power.

Finally, consider a case on insurance reimbursement and a group boycott against a third-party payer. In Federal Trade Commission v. Indiana Federation of Dentists (476 U.S. 447 [1986]), dental health insurers in Indiana attempted to contain the cost of dental treatment by limiting payments to the least expensive yet adequate treatment suitable to the needs of the patient. The insurers required the submission of x-rays by treating dentists for review of their insurance claims.

Viewing such review of diagnostic and treatment decisions as a threat to their professional independence and economic well-being, members of the Indiana Dental Association and later the Indiana Federation of Dentists agreed collectively to refuse to submit the requested x-rays. These concerted activities resulted in the denial of information that dental customers had requested and had a right to know, and forced them to choose between acquiring the information in a more costly manner or forgoing it altogether.

The lower court had ruled in favor of the dentists, but the U.S. Supreme Court reversed. It agreed that in the absence of concerted behavior, an individual dentist would have been subject to market forces of competition, creating incentives for him or her to comply with the requests of patients’ third-party insurers. But the conduct of the federation was tantamount to a group boycott, which unreasonably restrained trade. The court noted that while this was not price fixing as such, no elaborate industry analysis was required to demonstrate the anticompetitive character of such an agreement.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, "Medical Malpractice: Understanding the Law, Managing the Risk", and his 2012 Halsbury treatise, "Medical Negligence and Professional Misconduct." For additional information, readers may contact the author at [email protected].

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Question: On antitrust, the U.S. courts have made the following statements, except:

A. To agree to prices is to fix them.

B. There is no learned profession exception to the antitrust laws.

C. To fix maximum price may amount to a fix of minimum price.

D. A group boycott of chiropractors violates the Sherman Act.

E. Tying arrangement in the health care industry is per se illegal.

Answer: E (see Jefferson Parish Hospital below). In the second part of the 20th century, the U.S. Supreme Court and other appellate courts began issuing a number of landmark opinions regarding health care economics and antitrust. Group boycotts were a major target, as was price fixing. This article briefly reviews a few of these decisions to impart a sense of how the judicial system views free market competition in health care.

In AMA v. United States (317 U.S. 519 [1943]), the issue was whether the medical profession’s leading organization, the American Medical Association, could be allowed to expel its salaried doctors or those who associated professionally with salaried doctors. Those who were denied AMA membership were naturally less able to compete (hospital privileges, consultations, etc.).

The U.S. Supreme Court held that such a group boycott of all salaried doctors was illegal because of its anticompetitive purpose, even if it allegedly promoted professional competence and public welfare.

Wilk v. AMA (895 F.2d 352 [1990]) was the culmination of a number of lawsuits surrounding the AMA and chiropractic. In 1963, the AMA had formed a Committee on Quackery aimed at eliminating chiropractic as a profession. The AMA Code of Ethics, Principle 3, opined that it was unethical for a physician to associate professionally with chiropractors. In 1976, Dr. Wilk and four other licensed chiropractors filed suit against the AMA, and a jury trial found that the purpose of the boycott was to eliminate substantial competition without corresponding procompetitive benefits.

The U.S. Court of Appeals for the Seventh Circuit subsequently affirmed the lower court’s finding that the AMA violated Section 1 of the Sherman Act in its illegal boycott of chiropractors, although the court did not answer the question as to whether chiropractic theory was in fact scientific. The court inquired into whether there was a genuine reasonable concern for the use of the scientific method in the doctor-patient relationship, and whether that concern was the dominating, motivating factor in the boycott, and if so, whether it could have been satisfied without restraining competition.

The court found that the AMA’s motive for the boycott was anticompetitive, believing that concern for patient care could be expressed, for example, through public-education campaigns. Although the AMA had formally removed Principle 3 in 1980, it nonetheless appealed this adverse decision to the U.S. Supreme Court on three separate occasions, but the latter declined to hear the case.

In Goldfarb v. Virginia State Bar (421 U.S. 773 [1975]), the Virginia State Bar enforced an "advisory" minimum fee schedule for legal services. The U.S. Supreme Court found that this was an agreement to fix prices, holding, "This is not merely a case of an agreement that may be inferred from an exchange of price information ... for here a naked agreement was clearly shown, and the effect on prices is plain."

The court rejected the defendant’s argument that the practice of law was not a trade or commerce intended to be under Sherman Act scrutiny, declaring there was to be no "learned profession" exemption.

However, it noted that special considerations might apply, holding that "It would be unrealistic to view the practice of professions as interchangeable with other business activities, and automatically to apply to the professions antitrust concepts, which originated in other areas. The public service aspect, and other features of the professions, may require that a particular practice, which could properly be viewed as a violation of the Sherman Act in another context, be treated differently."

Following Goldfarb, there remains no doubt that professional services – legal, medical, and other services – are all to be governed by the antitrust laws.

A flurry of health care–related antitrust cases, including Patrick v. Burget (to be discussed in part 3), reached the courts in the 1980s. In Arizona v. Maricopa County Medical Society (457 U.S. 332 [1982]), the county medical society set maximum allowable fees that member physicians could charge their patients, presumably to guard against price gouging. However, the U.S. Supreme Court, using the tough illegal per se standard, characterized the agreement as price fixing, despite it being for maximum rather than minimum fees.

 

 

The court ruled, "Maximum and minimum price fixing may have different consequences in many situations. But schemes to fix maximum prices, by substituting perhaps the erroneous judgment of a seller for the forces of the competitive market, may severely intrude upon the ability of buyers to compete and survive in that market. ... Maximum prices may be fixed too low ... may channel distribution through a few large or specifically advantaged dealers. ... Moreover, if the actual price charged under a maximum price scheme is nearly always the fixed maximum price, which is increasingly likely as the maximum price approaches the actual cost of the dealer, the scheme tends to acquire all the attributes of an arrangement fixing minimum prices."

At issue in Jefferson Parish Hospital District No. 2 v. Hyde (466 U.S. 2 [1984]) was an exclusive contract between a group of four anesthesiologists and Jefferson Parish Hospital in the New Orleans area. Dr. Hyde was an independent board-certified anesthesiologist who was denied medical staff privileges at the hospital because of this exclusive contract. The exclusive arrangement in effect required patients at the hospital to use the services of the four anesthesiologists and none others, raising the issue of unlawful "tying," where a seller requires a customer to purchase one product or service as a condition of being allowed to purchase another.

In a rare unanimous decision, the U.S. Supreme Court, while agreeing that the contract was a tying arrangement, nonetheless rejected the argument that it was per se illegal or that it unreasonably restrained competition among anesthesiologists. The court reasoned that the hospital’s 30% share of the market did not amount to sufficient market power in the provision of hospital services in the Jefferson Parish area. Pointing out that every patient undergoing surgery needed anesthesia, the court found no evidence that any patient received unnecessary services, and it noted that the tying arrangement that was generally employed in the health care industry improved patient care and promoted hospital efficiency.

Tying arrangements in health care are frequently analyzed under a rule of reason standard instead of the strict per se standard, and the favorable decision in this specific case depended heavily on the hospitals’ relatively small market power.

Finally, consider a case on insurance reimbursement and a group boycott against a third-party payer. In Federal Trade Commission v. Indiana Federation of Dentists (476 U.S. 447 [1986]), dental health insurers in Indiana attempted to contain the cost of dental treatment by limiting payments to the least expensive yet adequate treatment suitable to the needs of the patient. The insurers required the submission of x-rays by treating dentists for review of their insurance claims.

Viewing such review of diagnostic and treatment decisions as a threat to their professional independence and economic well-being, members of the Indiana Dental Association and later the Indiana Federation of Dentists agreed collectively to refuse to submit the requested x-rays. These concerted activities resulted in the denial of information that dental customers had requested and had a right to know, and forced them to choose between acquiring the information in a more costly manner or forgoing it altogether.

The lower court had ruled in favor of the dentists, but the U.S. Supreme Court reversed. It agreed that in the absence of concerted behavior, an individual dentist would have been subject to market forces of competition, creating incentives for him or her to comply with the requests of patients’ third-party insurers. But the conduct of the federation was tantamount to a group boycott, which unreasonably restrained trade. The court noted that while this was not price fixing as such, no elaborate industry analysis was required to demonstrate the anticompetitive character of such an agreement.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, "Medical Malpractice: Understanding the Law, Managing the Risk", and his 2012 Halsbury treatise, "Medical Negligence and Professional Misconduct." For additional information, readers may contact the author at [email protected].

Question: On antitrust, the U.S. courts have made the following statements, except:

A. To agree to prices is to fix them.

B. There is no learned profession exception to the antitrust laws.

C. To fix maximum price may amount to a fix of minimum price.

D. A group boycott of chiropractors violates the Sherman Act.

E. Tying arrangement in the health care industry is per se illegal.

Answer: E (see Jefferson Parish Hospital below). In the second part of the 20th century, the U.S. Supreme Court and other appellate courts began issuing a number of landmark opinions regarding health care economics and antitrust. Group boycotts were a major target, as was price fixing. This article briefly reviews a few of these decisions to impart a sense of how the judicial system views free market competition in health care.

In AMA v. United States (317 U.S. 519 [1943]), the issue was whether the medical profession’s leading organization, the American Medical Association, could be allowed to expel its salaried doctors or those who associated professionally with salaried doctors. Those who were denied AMA membership were naturally less able to compete (hospital privileges, consultations, etc.).

The U.S. Supreme Court held that such a group boycott of all salaried doctors was illegal because of its anticompetitive purpose, even if it allegedly promoted professional competence and public welfare.

Wilk v. AMA (895 F.2d 352 [1990]) was the culmination of a number of lawsuits surrounding the AMA and chiropractic. In 1963, the AMA had formed a Committee on Quackery aimed at eliminating chiropractic as a profession. The AMA Code of Ethics, Principle 3, opined that it was unethical for a physician to associate professionally with chiropractors. In 1976, Dr. Wilk and four other licensed chiropractors filed suit against the AMA, and a jury trial found that the purpose of the boycott was to eliminate substantial competition without corresponding procompetitive benefits.

The U.S. Court of Appeals for the Seventh Circuit subsequently affirmed the lower court’s finding that the AMA violated Section 1 of the Sherman Act in its illegal boycott of chiropractors, although the court did not answer the question as to whether chiropractic theory was in fact scientific. The court inquired into whether there was a genuine reasonable concern for the use of the scientific method in the doctor-patient relationship, and whether that concern was the dominating, motivating factor in the boycott, and if so, whether it could have been satisfied without restraining competition.

The court found that the AMA’s motive for the boycott was anticompetitive, believing that concern for patient care could be expressed, for example, through public-education campaigns. Although the AMA had formally removed Principle 3 in 1980, it nonetheless appealed this adverse decision to the U.S. Supreme Court on three separate occasions, but the latter declined to hear the case.

In Goldfarb v. Virginia State Bar (421 U.S. 773 [1975]), the Virginia State Bar enforced an "advisory" minimum fee schedule for legal services. The U.S. Supreme Court found that this was an agreement to fix prices, holding, "This is not merely a case of an agreement that may be inferred from an exchange of price information ... for here a naked agreement was clearly shown, and the effect on prices is plain."

The court rejected the defendant’s argument that the practice of law was not a trade or commerce intended to be under Sherman Act scrutiny, declaring there was to be no "learned profession" exemption.

However, it noted that special considerations might apply, holding that "It would be unrealistic to view the practice of professions as interchangeable with other business activities, and automatically to apply to the professions antitrust concepts, which originated in other areas. The public service aspect, and other features of the professions, may require that a particular practice, which could properly be viewed as a violation of the Sherman Act in another context, be treated differently."

Following Goldfarb, there remains no doubt that professional services – legal, medical, and other services – are all to be governed by the antitrust laws.

A flurry of health care–related antitrust cases, including Patrick v. Burget (to be discussed in part 3), reached the courts in the 1980s. In Arizona v. Maricopa County Medical Society (457 U.S. 332 [1982]), the county medical society set maximum allowable fees that member physicians could charge their patients, presumably to guard against price gouging. However, the U.S. Supreme Court, using the tough illegal per se standard, characterized the agreement as price fixing, despite it being for maximum rather than minimum fees.

 

 

The court ruled, "Maximum and minimum price fixing may have different consequences in many situations. But schemes to fix maximum prices, by substituting perhaps the erroneous judgment of a seller for the forces of the competitive market, may severely intrude upon the ability of buyers to compete and survive in that market. ... Maximum prices may be fixed too low ... may channel distribution through a few large or specifically advantaged dealers. ... Moreover, if the actual price charged under a maximum price scheme is nearly always the fixed maximum price, which is increasingly likely as the maximum price approaches the actual cost of the dealer, the scheme tends to acquire all the attributes of an arrangement fixing minimum prices."

At issue in Jefferson Parish Hospital District No. 2 v. Hyde (466 U.S. 2 [1984]) was an exclusive contract between a group of four anesthesiologists and Jefferson Parish Hospital in the New Orleans area. Dr. Hyde was an independent board-certified anesthesiologist who was denied medical staff privileges at the hospital because of this exclusive contract. The exclusive arrangement in effect required patients at the hospital to use the services of the four anesthesiologists and none others, raising the issue of unlawful "tying," where a seller requires a customer to purchase one product or service as a condition of being allowed to purchase another.

In a rare unanimous decision, the U.S. Supreme Court, while agreeing that the contract was a tying arrangement, nonetheless rejected the argument that it was per se illegal or that it unreasonably restrained competition among anesthesiologists. The court reasoned that the hospital’s 30% share of the market did not amount to sufficient market power in the provision of hospital services in the Jefferson Parish area. Pointing out that every patient undergoing surgery needed anesthesia, the court found no evidence that any patient received unnecessary services, and it noted that the tying arrangement that was generally employed in the health care industry improved patient care and promoted hospital efficiency.

Tying arrangements in health care are frequently analyzed under a rule of reason standard instead of the strict per se standard, and the favorable decision in this specific case depended heavily on the hospitals’ relatively small market power.

Finally, consider a case on insurance reimbursement and a group boycott against a third-party payer. In Federal Trade Commission v. Indiana Federation of Dentists (476 U.S. 447 [1986]), dental health insurers in Indiana attempted to contain the cost of dental treatment by limiting payments to the least expensive yet adequate treatment suitable to the needs of the patient. The insurers required the submission of x-rays by treating dentists for review of their insurance claims.

Viewing such review of diagnostic and treatment decisions as a threat to their professional independence and economic well-being, members of the Indiana Dental Association and later the Indiana Federation of Dentists agreed collectively to refuse to submit the requested x-rays. These concerted activities resulted in the denial of information that dental customers had requested and had a right to know, and forced them to choose between acquiring the information in a more costly manner or forgoing it altogether.

The lower court had ruled in favor of the dentists, but the U.S. Supreme Court reversed. It agreed that in the absence of concerted behavior, an individual dentist would have been subject to market forces of competition, creating incentives for him or her to comply with the requests of patients’ third-party insurers. But the conduct of the federation was tantamount to a group boycott, which unreasonably restrained trade. The court noted that while this was not price fixing as such, no elaborate industry analysis was required to demonstrate the anticompetitive character of such an agreement.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, "Medical Malpractice: Understanding the Law, Managing the Risk", and his 2012 Halsbury treatise, "Medical Negligence and Professional Misconduct." For additional information, readers may contact the author at [email protected].

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