Diffuse large B-cell lymphoma

A study of lymphoma patients receiving R-CHOP chemotherapy showed that use of the antiviral drug entecavir resulted in a lower incidence of hepatitis B virus (HBV)-related hepatitis and HBV reactivation, when compared with the drug lamivudine.

HBV reactivation is a well-documented complication of chemotherapy that can result in life-threatening liver failure, as well as delays in chemotherapy or

premature termination of treatment.

However, researchers have not identified an optimal approach to prevent HBV reactivation.

So He Huang, MD, of the Sun Yat-sen University Cancer Center in Guangzhou, China, and colleagues set out to do that. They reported their findings in JAMA alongside a related editorial.

The team enrolled 121 patients with untreated diffuse large B-cell lymphoma who were receiving chemotherapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) and were seropositive for the hepatitis B surface antigen.

Patients were randomized to receive entecavir (n=61) or lamivudine (n=60). They began taking these drugs 1 week before the initiation of R-CHOP and continued until 6 months after they completed chemotherapy.

The study was conducted from February 2008 through December 2012 at 10 medical centers in China. This trial was a substudy of a parent study designed to compare a 3-week R-CHOP regimen with a 2-week R-CHOP regimen.

Results showed that, compared to the lamivudine group, patients in the entecavir group had significantly lower rates of hepatitis (8.2% vs 23.3%, P=0.02), HBV-related hepatitis (0% vs 13.3%, P=0.003), HBV reactivation (6.6% vs 30%, P=0.001), delayed hepatitis B (0% vs 8.3%, P=0.03), and chemotherapy disruption (1.6% vs 18.3%, P=0.002).

The rate of treatment-related adverse events was not significantly different between the groups. Such events occurred in 24.6% of patients in the entecavir group and 30.0% of patients in the lamivudine group (P=0.50).

The researchers noted that entecavir is more expensive than lamivudine, so additional studies are needed to determine whether all patients who are seropositive for the hepatitis B surface antigen and are receiving rituximab-based immunosuppressive therapy should be given entecavir.

Additional studies could also help pinpoint which patients will benefit most from entecavir prophylaxis. However, if these findings are replicated, they support the use of entecavir in these patients.

Diffuse large B-cell lymphoma

A study of lymphoma patients receiving R-CHOP chemotherapy showed that use of the antiviral drug entecavir resulted in a lower incidence of hepatitis B virus (HBV)-related hepatitis and HBV reactivation, when compared with the drug lamivudine.

HBV reactivation is a well-documented complication of chemotherapy that can result in life-threatening liver failure, as well as delays in chemotherapy or

premature termination of treatment.

However, researchers have not identified an optimal approach to prevent HBV reactivation.

So He Huang, MD, of the Sun Yat-sen University Cancer Center in Guangzhou, China, and colleagues set out to do that. They reported their findings in JAMA alongside a related editorial.

The team enrolled 121 patients with untreated diffuse large B-cell lymphoma who were receiving chemotherapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) and were seropositive for the hepatitis B surface antigen.

Patients were randomized to receive entecavir (n=61) or lamivudine (n=60). They began taking these drugs 1 week before the initiation of R-CHOP and continued until 6 months after they completed chemotherapy.

The study was conducted from February 2008 through December 2012 at 10 medical centers in China. This trial was a substudy of a parent study designed to compare a 3-week R-CHOP regimen with a 2-week R-CHOP regimen.

Results showed that, compared to the lamivudine group, patients in the entecavir group had significantly lower rates of hepatitis (8.2% vs 23.3%, P=0.02), HBV-related hepatitis (0% vs 13.3%, P=0.003), HBV reactivation (6.6% vs 30%, P=0.001), delayed hepatitis B (0% vs 8.3%, P=0.03), and chemotherapy disruption (1.6% vs 18.3%, P=0.002).

The rate of treatment-related adverse events was not significantly different between the groups. Such events occurred in 24.6% of patients in the entecavir group and 30.0% of patients in the lamivudine group (P=0.50).

The researchers noted that entecavir is more expensive than lamivudine, so additional studies are needed to determine whether all patients who are seropositive for the hepatitis B surface antigen and are receiving rituximab-based immunosuppressive therapy should be given entecavir.

Additional studies could also help pinpoint which patients will benefit most from entecavir prophylaxis. However, if these findings are replicated, they support the use of entecavir in these patients.

Diffuse large B-cell lymphoma

A study of lymphoma patients receiving R-CHOP chemotherapy showed that use of the antiviral drug entecavir resulted in a lower incidence of hepatitis B virus (HBV)-related hepatitis and HBV reactivation, when compared with the drug lamivudine.

HBV reactivation is a well-documented complication of chemotherapy that can result in life-threatening liver failure, as well as delays in chemotherapy or

premature termination of treatment.

However, researchers have not identified an optimal approach to prevent HBV reactivation.

So He Huang, MD, of the Sun Yat-sen University Cancer Center in Guangzhou, China, and colleagues set out to do that. They reported their findings in JAMA alongside a related editorial.

The team enrolled 121 patients with untreated diffuse large B-cell lymphoma who were receiving chemotherapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) and were seropositive for the hepatitis B surface antigen.

Patients were randomized to receive entecavir (n=61) or lamivudine (n=60). They began taking these drugs 1 week before the initiation of R-CHOP and continued until 6 months after they completed chemotherapy.

The study was conducted from February 2008 through December 2012 at 10 medical centers in China. This trial was a substudy of a parent study designed to compare a 3-week R-CHOP regimen with a 2-week R-CHOP regimen.

Results showed that, compared to the lamivudine group, patients in the entecavir group had significantly lower rates of hepatitis (8.2% vs 23.3%, P=0.02), HBV-related hepatitis (0% vs 13.3%, P=0.003), HBV reactivation (6.6% vs 30%, P=0.001), delayed hepatitis B (0% vs 8.3%, P=0.03), and chemotherapy disruption (1.6% vs 18.3%, P=0.002).

The rate of treatment-related adverse events was not significantly different between the groups. Such events occurred in 24.6% of patients in the entecavir group and 30.0% of patients in the lamivudine group (P=0.50).

The researchers noted that entecavir is more expensive than lamivudine, so additional studies are needed to determine whether all patients who are seropositive for the hepatitis B surface antigen and are receiving rituximab-based immunosuppressive therapy should be given entecavir.

Additional studies could also help pinpoint which patients will benefit most from entecavir prophylaxis. However, if these findings are replicated, they support the use of entecavir in these patients.

Since 1979, obstetric and other health care providers who treat pregnant or potentially pregnant and breastfeeding women have relied heavily on the Food and Drug Administration’s pregnancy labeling categories for pharmaceuticals – the familiar A, B, C, D, X. However, as early as 1997, a public hearing was held that challenged the value of these labels as typically used in clinical practice by both providers and patients.

Now, 17 years later, in December 2014, the FDA has released the “Pregnancy and Lactation Labeling Rule” (also known as PLLR or final rule). In brief, the revised label will require that:

• Contact information be prominently listed for a pregnancy exposure registry for the drug, when one is available.

• Narrative sections be presented that include a risk summary, clinical considerations, and the supporting data.

• A lactation subsection be included that provides information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.

• A subsection on females and males of reproductive potential be included, when necessary, with information about the need for pregnancy testing, contraception recommendations, and information about infertility as it relates to the drug.

The labeling changes go into effect on June 30, 2015. Prescription drugs and biologic products submitted for FDA review after that date will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.

Why are these changes needed, and what impact will they likely have for clinical practice?

First a bit of history – the pregnancy label A, B, C, D, X categories were initially introduced in the 1970s, following the recognition that thalidomide was a human teratogen. The intention was to help the clinician deal in a more standardized way with the increasing amount of experimental animal data and human reports generated for drugs that might be used by women of reproductive potential.

However, the letter categories, and their accompanying standard text statements, were frequently misinterpreted in oversimplistic and inaccurate ways (Birth Defects Res. Part A 2007,79:627-30). Clinicians and patients often believe that risk increases as you move across the letter categories; for example, that a category C drug is worse than a category B drug for a given patient.

Clinicians and patients also commonly think that drugs in the same category have the same level of risk, or that there is a similar quantity and quality of information to support that risk category. Frequently cited examples of misinterpretation include those drugs assigned a category X, for example, label text indicating that the drug is “contraindicated in women who are or may become pregnant.” In reality, in some cases, the X category has been applied to drugs with known human teratogenic potential (such as isotretinoin or thalidomide). However, in other cases, the X has been assigned to drugs for which there were no or very limited human data indicating risk (such as ribavirin or leflunomide) or for which the treatment for the underlying condition would not be necessary or advisable in pregnancy (such as statins or some weight loss drugs).

There is no differentiation made in the category X label for varying risks specifically related to dose and timing of exposure in gestation. In each of these situations where there are no clear-cut human data, inadvertent exposure to the drug in an unplanned pregnancy can easily lead to the misunderstanding that the drug is known to cause birth defects in humans.

The immediate impact of the PLLR label revision will be to require narrative sections that describe the actual data, provide a summary of risks, and also present clinical considerations that may include the risk of undertreatment or no treatment with the drug. The new format is intended to provide the clinician (and the patient) with more comprehensive information on which to base decisions.

The downside of the label revision is that clinicians will have to learn to interpret more comprehensive information and deal with the unknowns, which are many.

The other major impact of the label revision will be to highlight the clear lack of sufficient human data for most drugs currently marketed in the United States. A recent review of drugs (both prescription and over the counter) approved by the FDA between 2000 and 2010 found that 73.3% had no human data available that was relevant to pregnancy safety (Am. J. Med. Genet. C. Semin. Med. Genet. 157C:175-82).

In the short term, the learning curve for label writers and the end users of such labels will be steep. However, clinicians and patients can contribute to the compilation of data for most drugs by more proactively engaging in pregnancy and lactation safety studies. Information about the existence of any pregnancy registries in drug labeling has been recommended in the past, but will now be required. Acting on that information by enrolling patients in these studies can ensure that labels can more quickly be populated with evidence-based data that can better inform patient care.

Dr. Chambers is a professor of pediatrics and director of clinical research at Rady Children’s Hospital, and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is director of MotherToBaby California, a past president of the Organization of Teratology Information Specialists, and past president of the Teratology Society. She has no relevant financial disclosures. To comment, e-mail her at obnews@frontlinemedcom.com.

Since 1979, obstetric and other health care providers who treat pregnant or potentially pregnant and breastfeeding women have relied heavily on the Food and Drug Administration’s pregnancy labeling categories for pharmaceuticals – the familiar A, B, C, D, X. However, as early as 1997, a public hearing was held that challenged the value of these labels as typically used in clinical practice by both providers and patients.

Now, 17 years later, in December 2014, the FDA has released the “Pregnancy and Lactation Labeling Rule” (also known as PLLR or final rule). In brief, the revised label will require that:

• Contact information be prominently listed for a pregnancy exposure registry for the drug, when one is available.

• Narrative sections be presented that include a risk summary, clinical considerations, and the supporting data.

• A lactation subsection be included that provides information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.

• A subsection on females and males of reproductive potential be included, when necessary, with information about the need for pregnancy testing, contraception recommendations, and information about infertility as it relates to the drug.

The labeling changes go into effect on June 30, 2015. Prescription drugs and biologic products submitted for FDA review after that date will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.

Why are these changes needed, and what impact will they likely have for clinical practice?

First a bit of history – the pregnancy label A, B, C, D, X categories were initially introduced in the 1970s, following the recognition that thalidomide was a human teratogen. The intention was to help the clinician deal in a more standardized way with the increasing amount of experimental animal data and human reports generated for drugs that might be used by women of reproductive potential.

However, the letter categories, and their accompanying standard text statements, were frequently misinterpreted in oversimplistic and inaccurate ways (Birth Defects Res. Part A 2007,79:627-30). Clinicians and patients often believe that risk increases as you move across the letter categories; for example, that a category C drug is worse than a category B drug for a given patient.

Clinicians and patients also commonly think that drugs in the same category have the same level of risk, or that there is a similar quantity and quality of information to support that risk category. Frequently cited examples of misinterpretation include those drugs assigned a category X, for example, label text indicating that the drug is “contraindicated in women who are or may become pregnant.” In reality, in some cases, the X category has been applied to drugs with known human teratogenic potential (such as isotretinoin or thalidomide). However, in other cases, the X has been assigned to drugs for which there were no or very limited human data indicating risk (such as ribavirin or leflunomide) or for which the treatment for the underlying condition would not be necessary or advisable in pregnancy (such as statins or some weight loss drugs).

There is no differentiation made in the category X label for varying risks specifically related to dose and timing of exposure in gestation. In each of these situations where there are no clear-cut human data, inadvertent exposure to the drug in an unplanned pregnancy can easily lead to the misunderstanding that the drug is known to cause birth defects in humans.

The immediate impact of the PLLR label revision will be to require narrative sections that describe the actual data, provide a summary of risks, and also present clinical considerations that may include the risk of undertreatment or no treatment with the drug. The new format is intended to provide the clinician (and the patient) with more comprehensive information on which to base decisions.

The downside of the label revision is that clinicians will have to learn to interpret more comprehensive information and deal with the unknowns, which are many.

The other major impact of the label revision will be to highlight the clear lack of sufficient human data for most drugs currently marketed in the United States. A recent review of drugs (both prescription and over the counter) approved by the FDA between 2000 and 2010 found that 73.3% had no human data available that was relevant to pregnancy safety (Am. J. Med. Genet. C. Semin. Med. Genet. 157C:175-82).

In the short term, the learning curve for label writers and the end users of such labels will be steep. However, clinicians and patients can contribute to the compilation of data for most drugs by more proactively engaging in pregnancy and lactation safety studies. Information about the existence of any pregnancy registries in drug labeling has been recommended in the past, but will now be required. Acting on that information by enrolling patients in these studies can ensure that labels can more quickly be populated with evidence-based data that can better inform patient care.

Dr. Chambers is a professor of pediatrics and director of clinical research at Rady Children’s Hospital, and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is director of MotherToBaby California, a past president of the Organization of Teratology Information Specialists, and past president of the Teratology Society. She has no relevant financial disclosures. To comment, e-mail her at obnews@frontlinemedcom.com.

Since 1979, obstetric and other health care providers who treat pregnant or potentially pregnant and breastfeeding women have relied heavily on the Food and Drug Administration’s pregnancy labeling categories for pharmaceuticals – the familiar A, B, C, D, X. However, as early as 1997, a public hearing was held that challenged the value of these labels as typically used in clinical practice by both providers and patients.

Now, 17 years later, in December 2014, the FDA has released the “Pregnancy and Lactation Labeling Rule” (also known as PLLR or final rule). In brief, the revised label will require that:

• Contact information be prominently listed for a pregnancy exposure registry for the drug, when one is available.

• Narrative sections be presented that include a risk summary, clinical considerations, and the supporting data.

• A lactation subsection be included that provides information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.

• A subsection on females and males of reproductive potential be included, when necessary, with information about the need for pregnancy testing, contraception recommendations, and information about infertility as it relates to the drug.

The labeling changes go into effect on June 30, 2015. Prescription drugs and biologic products submitted for FDA review after that date will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.

Why are these changes needed, and what impact will they likely have for clinical practice?

First a bit of history – the pregnancy label A, B, C, D, X categories were initially introduced in the 1970s, following the recognition that thalidomide was a human teratogen. The intention was to help the clinician deal in a more standardized way with the increasing amount of experimental animal data and human reports generated for drugs that might be used by women of reproductive potential.

However, the letter categories, and their accompanying standard text statements, were frequently misinterpreted in oversimplistic and inaccurate ways (Birth Defects Res. Part A 2007,79:627-30). Clinicians and patients often believe that risk increases as you move across the letter categories; for example, that a category C drug is worse than a category B drug for a given patient.

Clinicians and patients also commonly think that drugs in the same category have the same level of risk, or that there is a similar quantity and quality of information to support that risk category. Frequently cited examples of misinterpretation include those drugs assigned a category X, for example, label text indicating that the drug is “contraindicated in women who are or may become pregnant.” In reality, in some cases, the X category has been applied to drugs with known human teratogenic potential (such as isotretinoin or thalidomide). However, in other cases, the X has been assigned to drugs for which there were no or very limited human data indicating risk (such as ribavirin or leflunomide) or for which the treatment for the underlying condition would not be necessary or advisable in pregnancy (such as statins or some weight loss drugs).

There is no differentiation made in the category X label for varying risks specifically related to dose and timing of exposure in gestation. In each of these situations where there are no clear-cut human data, inadvertent exposure to the drug in an unplanned pregnancy can easily lead to the misunderstanding that the drug is known to cause birth defects in humans.

The immediate impact of the PLLR label revision will be to require narrative sections that describe the actual data, provide a summary of risks, and also present clinical considerations that may include the risk of undertreatment or no treatment with the drug. The new format is intended to provide the clinician (and the patient) with more comprehensive information on which to base decisions.

The downside of the label revision is that clinicians will have to learn to interpret more comprehensive information and deal with the unknowns, which are many.

The other major impact of the label revision will be to highlight the clear lack of sufficient human data for most drugs currently marketed in the United States. A recent review of drugs (both prescription and over the counter) approved by the FDA between 2000 and 2010 found that 73.3% had no human data available that was relevant to pregnancy safety (Am. J. Med. Genet. C. Semin. Med. Genet. 157C:175-82).

In the short term, the learning curve for label writers and the end users of such labels will be steep. However, clinicians and patients can contribute to the compilation of data for most drugs by more proactively engaging in pregnancy and lactation safety studies. Information about the existence of any pregnancy registries in drug labeling has been recommended in the past, but will now be required. Acting on that information by enrolling patients in these studies can ensure that labels can more quickly be populated with evidence-based data that can better inform patient care.

Dr. Chambers is a professor of pediatrics and director of clinical research at Rady Children’s Hospital, and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is director of MotherToBaby California, a past president of the Organization of Teratology Information Specialists, and past president of the Teratology Society. She has no relevant financial disclosures. To comment, e-mail her at obnews@frontlinemedcom.com.

According to the last Gallup poll, most Americans still favor the death penalty. Nevertheless, over the years, the number of capital-eligible defendants has been gradually whittled down because of challenges over the execution of juveniles, the intellectually disabled, and for defendants guilty of crimes other than murder. The latest challenge came up again in December, when lawyers for Texas death row inmate Scott Panetti sought a reprievealleging that he was incompetent to understand the reason for his execution.

Scott Panetti had a longstanding history of schizoaffective disorder dating back to the age of 20 years and had been hospitalized for treatment of his hallucinations and delusions at least 14 times. He once was convinced that the devil had possessed his home and had buried several valuables next to the house to “cleanse” it. His wife sought emergency intervention once when he threatened to kill her. In 1992, dressed in camouflage, he broke into the home of his estranged wife’s parents and killed them in front of her. He took his wife and young daughter hostage overnight but eventually surrendered to police.

At trial he wanted to represent himself, so the court ordered an evaluation of his competence to waive counsel. He was found competent and proceeded to present his own insanity defense to a jury. By the time of trial, he had been off medication for 2 months, and his behavior during the hearing was later described as bizarre and confusing at best. He came to court dressed in a cowboy suit, referred to himself as his alter-ego “Sarge,” and attempted to subpoena the Pope. He was convicted, in part, because jurors feared his behavior enough that they wanted to ensure he would never be released. He was sentenced to death.

Panetti received appointed counsel for his appeal after he was found incompetent to waive representation. His execution date was set in 2003, but the defense filed a motion alleging that he was incompetent to be put to death. The motion was accompanied by supporting documentation from a psychologist that Panetti did not understand the reasons for his punishment. The court appointed two experts who disagreed, stating that Panetti knew that he was about to be put to death and that he had the ability to understand the reason for the execution. They also implied that Panetti’s bizarre behavior in court was a calculated plan to present himself as insane.

Without a hearing, the court found Panetti competent. Panetti appealed to the Supreme Court, stating that under an earlier Supreme Court case, Ford v. Wainwright, he had a right to have a hearing on the competency issue, which would allow him to challenge the state’s experts and to present contrary medical evidence. The question at appeal was not whether execution of the mentally ill per se was cruel and unusual, but what standard should be applied to determine competency, and whether Texas followed the proper procedure to determine it.

Under Ford v. Wainwright, the bar was set extremely low. In order to be competent for execution, a defendant had only to know that he was being put to death, and that the death sentence was a punishment for a crime he had committed. This was a standard that required no more than intellectual or factual knowledge. Panetti was found competent to be executed because he could recite these facts. However, he disagreed with the facts: He believed that he was being executed by the state to prevent him from preaching the gospel. The Court of Appeals held that delusions alone would not necessarily mean that someone was incompetent. In 2007, the Supreme Court held in Panetti v. Quartermanthat competency requires a prisoner to have a rational as well as a factual understanding of the execution.

The American Psychiatric Association, the American Psychological Association, and the National Alliance on Mental Illness all joined to file an amicus brief on the case. In the brief, all the organizations agreed that “a prisoner is not competent to be executed if he ‘has a mental disorder or disability that significantly impairs his or her capacity to understand the nature and purpose of the punishment, or to appreciate the reason for its imposition in the prisoner’s own case.’ ” In other words, punishment is futile if the person in question doesn’t have the ability to understand that he is being punished.

The case was sent back for a formal hearing, and Panetti was again found competent. This time, the Supreme Court refused to hear his appeal. An execution date was set for Dec. 3 but was stayed 7 hours before he was to be put to death. Another competency assessment is probably on the horizon, given that 7 years have passed since the last one. The outcome this time will probably be the same, since Panetti reportedly has been on no medications for most of the last 20 years, and he has not been diagnosed with a psychotic illness in the prison system by any of the 14 mental health staff who have evaluated him.

Of course, none of this litigation to date settles the question of whether our judiciary should be executing anyone, with or without a mental illness. But until that question is settled, psychiatry will struggle along with the courts to decide exactly how ill is too ill to die.

Dr. Hanson is a forensic psychiatrist and coauthor of “Shrink Rap: Three Psychiatrists Explain Their Work.” The opinions expressed are those of the author only, and do not represent those of any of Dr. Hanson’s employers or consultees, including the Maryland Department of Health and Mental Hygiene or the Maryland Division of Correction.

According to the last Gallup poll, most Americans still favor the death penalty. Nevertheless, over the years, the number of capital-eligible defendants has been gradually whittled down because of challenges over the execution of juveniles, the intellectually disabled, and for defendants guilty of crimes other than murder. The latest challenge came up again in December, when lawyers for Texas death row inmate Scott Panetti sought a reprievealleging that he was incompetent to understand the reason for his execution.

Scott Panetti had a longstanding history of schizoaffective disorder dating back to the age of 20 years and had been hospitalized for treatment of his hallucinations and delusions at least 14 times. He once was convinced that the devil had possessed his home and had buried several valuables next to the house to “cleanse” it. His wife sought emergency intervention once when he threatened to kill her. In 1992, dressed in camouflage, he broke into the home of his estranged wife’s parents and killed them in front of her. He took his wife and young daughter hostage overnight but eventually surrendered to police.

At trial he wanted to represent himself, so the court ordered an evaluation of his competence to waive counsel. He was found competent and proceeded to present his own insanity defense to a jury. By the time of trial, he had been off medication for 2 months, and his behavior during the hearing was later described as bizarre and confusing at best. He came to court dressed in a cowboy suit, referred to himself as his alter-ego “Sarge,” and attempted to subpoena the Pope. He was convicted, in part, because jurors feared his behavior enough that they wanted to ensure he would never be released. He was sentenced to death.

Panetti received appointed counsel for his appeal after he was found incompetent to waive representation. His execution date was set in 2003, but the defense filed a motion alleging that he was incompetent to be put to death. The motion was accompanied by supporting documentation from a psychologist that Panetti did not understand the reasons for his punishment. The court appointed two experts who disagreed, stating that Panetti knew that he was about to be put to death and that he had the ability to understand the reason for the execution. They also implied that Panetti’s bizarre behavior in court was a calculated plan to present himself as insane.

Without a hearing, the court found Panetti competent. Panetti appealed to the Supreme Court, stating that under an earlier Supreme Court case, Ford v. Wainwright, he had a right to have a hearing on the competency issue, which would allow him to challenge the state’s experts and to present contrary medical evidence. The question at appeal was not whether execution of the mentally ill per se was cruel and unusual, but what standard should be applied to determine competency, and whether Texas followed the proper procedure to determine it.

Under Ford v. Wainwright, the bar was set extremely low. In order to be competent for execution, a defendant had only to know that he was being put to death, and that the death sentence was a punishment for a crime he had committed. This was a standard that required no more than intellectual or factual knowledge. Panetti was found competent to be executed because he could recite these facts. However, he disagreed with the facts: He believed that he was being executed by the state to prevent him from preaching the gospel. The Court of Appeals held that delusions alone would not necessarily mean that someone was incompetent. In 2007, the Supreme Court held in Panetti v. Quartermanthat competency requires a prisoner to have a rational as well as a factual understanding of the execution.

The American Psychiatric Association, the American Psychological Association, and the National Alliance on Mental Illness all joined to file an amicus brief on the case. In the brief, all the organizations agreed that “a prisoner is not competent to be executed if he ‘has a mental disorder or disability that significantly impairs his or her capacity to understand the nature and purpose of the punishment, or to appreciate the reason for its imposition in the prisoner’s own case.’ ” In other words, punishment is futile if the person in question doesn’t have the ability to understand that he is being punished.

The case was sent back for a formal hearing, and Panetti was again found competent. This time, the Supreme Court refused to hear his appeal. An execution date was set for Dec. 3 but was stayed 7 hours before he was to be put to death. Another competency assessment is probably on the horizon, given that 7 years have passed since the last one. The outcome this time will probably be the same, since Panetti reportedly has been on no medications for most of the last 20 years, and he has not been diagnosed with a psychotic illness in the prison system by any of the 14 mental health staff who have evaluated him.

Of course, none of this litigation to date settles the question of whether our judiciary should be executing anyone, with or without a mental illness. But until that question is settled, psychiatry will struggle along with the courts to decide exactly how ill is too ill to die.

Dr. Hanson is a forensic psychiatrist and coauthor of “Shrink Rap: Three Psychiatrists Explain Their Work.” The opinions expressed are those of the author only, and do not represent those of any of Dr. Hanson’s employers or consultees, including the Maryland Department of Health and Mental Hygiene or the Maryland Division of Correction.

According to the last Gallup poll, most Americans still favor the death penalty. Nevertheless, over the years, the number of capital-eligible defendants has been gradually whittled down because of challenges over the execution of juveniles, the intellectually disabled, and for defendants guilty of crimes other than murder. The latest challenge came up again in December, when lawyers for Texas death row inmate Scott Panetti sought a reprievealleging that he was incompetent to understand the reason for his execution.

Scott Panetti had a longstanding history of schizoaffective disorder dating back to the age of 20 years and had been hospitalized for treatment of his hallucinations and delusions at least 14 times. He once was convinced that the devil had possessed his home and had buried several valuables next to the house to “cleanse” it. His wife sought emergency intervention once when he threatened to kill her. In 1992, dressed in camouflage, he broke into the home of his estranged wife’s parents and killed them in front of her. He took his wife and young daughter hostage overnight but eventually surrendered to police.

At trial he wanted to represent himself, so the court ordered an evaluation of his competence to waive counsel. He was found competent and proceeded to present his own insanity defense to a jury. By the time of trial, he had been off medication for 2 months, and his behavior during the hearing was later described as bizarre and confusing at best. He came to court dressed in a cowboy suit, referred to himself as his alter-ego “Sarge,” and attempted to subpoena the Pope. He was convicted, in part, because jurors feared his behavior enough that they wanted to ensure he would never be released. He was sentenced to death.

Panetti received appointed counsel for his appeal after he was found incompetent to waive representation. His execution date was set in 2003, but the defense filed a motion alleging that he was incompetent to be put to death. The motion was accompanied by supporting documentation from a psychologist that Panetti did not understand the reasons for his punishment. The court appointed two experts who disagreed, stating that Panetti knew that he was about to be put to death and that he had the ability to understand the reason for the execution. They also implied that Panetti’s bizarre behavior in court was a calculated plan to present himself as insane.

Without a hearing, the court found Panetti competent. Panetti appealed to the Supreme Court, stating that under an earlier Supreme Court case, Ford v. Wainwright, he had a right to have a hearing on the competency issue, which would allow him to challenge the state’s experts and to present contrary medical evidence. The question at appeal was not whether execution of the mentally ill per se was cruel and unusual, but what standard should be applied to determine competency, and whether Texas followed the proper procedure to determine it.

Under Ford v. Wainwright, the bar was set extremely low. In order to be competent for execution, a defendant had only to know that he was being put to death, and that the death sentence was a punishment for a crime he had committed. This was a standard that required no more than intellectual or factual knowledge. Panetti was found competent to be executed because he could recite these facts. However, he disagreed with the facts: He believed that he was being executed by the state to prevent him from preaching the gospel. The Court of Appeals held that delusions alone would not necessarily mean that someone was incompetent. In 2007, the Supreme Court held in Panetti v. Quartermanthat competency requires a prisoner to have a rational as well as a factual understanding of the execution.

The American Psychiatric Association, the American Psychological Association, and the National Alliance on Mental Illness all joined to file an amicus brief on the case. In the brief, all the organizations agreed that “a prisoner is not competent to be executed if he ‘has a mental disorder or disability that significantly impairs his or her capacity to understand the nature and purpose of the punishment, or to appreciate the reason for its imposition in the prisoner’s own case.’ ” In other words, punishment is futile if the person in question doesn’t have the ability to understand that he is being punished.

The case was sent back for a formal hearing, and Panetti was again found competent. This time, the Supreme Court refused to hear his appeal. An execution date was set for Dec. 3 but was stayed 7 hours before he was to be put to death. Another competency assessment is probably on the horizon, given that 7 years have passed since the last one. The outcome this time will probably be the same, since Panetti reportedly has been on no medications for most of the last 20 years, and he has not been diagnosed with a psychotic illness in the prison system by any of the 14 mental health staff who have evaluated him.

Of course, none of this litigation to date settles the question of whether our judiciary should be executing anyone, with or without a mental illness. But until that question is settled, psychiatry will struggle along with the courts to decide exactly how ill is too ill to die.

Dr. Hanson is a forensic psychiatrist and coauthor of “Shrink Rap: Three Psychiatrists Explain Their Work.” The opinions expressed are those of the author only, and do not represent those of any of Dr. Hanson’s employers or consultees, including the Maryland Department of Health and Mental Hygiene or the Maryland Division of Correction.

Introduction

Both the medical and lay press have directed a lot of attention lately to the treatment of children and adolescents with antipsychotic medications. The literature is clear that the number of children taking this class of medications has risen sharply since their release (Arch. Gen. Psychiatry 2006;63:679-85). What is much less clear is the degree to which this increase represents a reasonable intervention for patients in significant need versus an overuse when other strategies are more appropriate.

Case Summary

Cody is a 6-year-old boy who lives with his younger sister and single mother. The family struggles financially, and the father, who has never had much contact with his son, is currently incarcerated. Since he was a toddler, Cody has been prone to high levels of aggressive behavior and frequent, intense angry outbursts. He was asked to leave his preschool due to his behavior and now is commonly disruptive at school. His pediatrician diagnosed him with attention-deficit/hyperactivity disorder a year ago and began a trial of a psychostimulant, which made him even more irritable, and was discontinued. Cody and his mother now present with concerns that there is “something more” affecting his behavior. The pediatrician now considers whether or not treatment with an antipsychotic medication is reasonable at this point.

Discussion

The above clinical scenario represents a critical and often antagonizing moment in treatment for both the family and the treating physician, yet it is hardly uncommon. The situation often is made more complicated by the fact that what is often the first plan of action, namely referral or consultation with a child psychiatrist, can be very difficult to access.

The American Academy of Child and Adolescent Psychiatry has published online guidelines for the use of antipsychotic medication in youth (http://bit.ly/1eat7e9). Key recommendations and points from this 27-page document and 19 recommendations include the following:

• Patients being considered for treatment with an antipsychotic medication should receive a “meticulous diagnostic assessment” with any medication prescribed being part of a “multidisciplinary” treatment plan (Recommendation 1).

• Prescribers should “regularly check the current literature” regarding the scientific evidence for antipsychotic medication use (Recommendation 2).

• Antipsychotic medications are considered first-line medication treatment for bipolar disorder, schizophrenia, tics/Tourette’s, and autism. (Recommendation 2).

• Antipsychotic medications are not first-line treatment for several other diagnoses and behaviors, including disruptive behavior disorders such as ADHD, aggression, eating disorders, and post-traumatic stress disorder (PTSD). Their use should be considered only after other pharmacologic and nonpharmacologic interventions have failed (Recommendation 2).

• Antipsychotic medications are not advised for preschool-aged patients. (Recommendation 2).

• Dosing should be as low as possible and not exceed the maximum recommended dose for adults (Recommendation 4).

• Simultaneous treatment with multiple antipsychotic medications is not recommended (Recommendation 8).

• Patients should receive regular metabolic monitoring, including lab work, both before and during treatment (Recommendations 11-13).

These are rigorous guidelines that challenge even those who regularly assess and treat children with serious psychiatric disorders. The clinical and legal implications of prescribing antipsychotic medications without adhering to these guidelines will, and probably should, give many physicians pause. Further, the specific point about the need for a thorough psychiatric evaluation underlies the commonly heard recommendation that this class of medicines generally should be avoided by primary care physicians. At the same time, many pediatricians are acutely aware of how dire the clinical situation often is for these families. At this point, it can easily begin to feel very much like a “no-win” situation.

Here are some thoughts that may be useful to consider in these moments:

• Remember that many non-MD mental health professionals can offer a lot of help. Although they can’t do the prescribing themselves, referral to a psychologist or another type of therapist can be useful in getting information about a patient’s diagnosis and the degree to which nonpharmacologic options have been exhausted. If the patient is already seeing a therapist, it is certainly worthwhile to seek their advice as to whether or not antipsychotic medications are now reasonable to consider.

• Look for opportunities to talk “curbside” to a child psychiatrist. Most of us are keenly aware of how inadequate access is to child psychiatry and want to help. Indeed, many states now have specific brief consultation programs in place.

• Get the lab work. A recent study in Pediatrics reported that a baseline glucose was obtained in only 11% of youth receiving antipsychotic medication treatment (Pediatrics 2014;134:e1308-14). In addition to providing important information, this step signals to everyone involved that the decision to use these medications is not something to be taken lightly.

Case follow-up

Cody’s pediatrician decides to get a diagnostic evaluation from a psychologist, who confirms the ADHD diagnosis without associated conditions such as bipolar disorder. The psychologist recommends a course of therapy to build regulatory skills for Cody and provide the mother with some parent behavioral guidance about how to best manage Cody’s challenges and encourage health-promoting behaviors such as physical activity, reading, and a regular sleep routine. The pediatrician decides to try a second line ADHD medication, guanfacine, and the school also begins to institute an incentive plan to reinforce positive behavior. In combination, these efforts significantly reduce the level of aggression and dysregulated behavior.

Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Dr. Rettew said he has no relevant financial disclosures. Follow him on Twitter @pedipsych.

Introduction

Both the medical and lay press have directed a lot of attention lately to the treatment of children and adolescents with antipsychotic medications. The literature is clear that the number of children taking this class of medications has risen sharply since their release (Arch. Gen. Psychiatry 2006;63:679-85). What is much less clear is the degree to which this increase represents a reasonable intervention for patients in significant need versus an overuse when other strategies are more appropriate.

Case Summary

Cody is a 6-year-old boy who lives with his younger sister and single mother. The family struggles financially, and the father, who has never had much contact with his son, is currently incarcerated. Since he was a toddler, Cody has been prone to high levels of aggressive behavior and frequent, intense angry outbursts. He was asked to leave his preschool due to his behavior and now is commonly disruptive at school. His pediatrician diagnosed him with attention-deficit/hyperactivity disorder a year ago and began a trial of a psychostimulant, which made him even more irritable, and was discontinued. Cody and his mother now present with concerns that there is “something more” affecting his behavior. The pediatrician now considers whether or not treatment with an antipsychotic medication is reasonable at this point.

Discussion

The above clinical scenario represents a critical and often antagonizing moment in treatment for both the family and the treating physician, yet it is hardly uncommon. The situation often is made more complicated by the fact that what is often the first plan of action, namely referral or consultation with a child psychiatrist, can be very difficult to access.

The American Academy of Child and Adolescent Psychiatry has published online guidelines for the use of antipsychotic medication in youth (http://bit.ly/1eat7e9). Key recommendations and points from this 27-page document and 19 recommendations include the following:

• Patients being considered for treatment with an antipsychotic medication should receive a “meticulous diagnostic assessment” with any medication prescribed being part of a “multidisciplinary” treatment plan (Recommendation 1).

• Prescribers should “regularly check the current literature” regarding the scientific evidence for antipsychotic medication use (Recommendation 2).

• Antipsychotic medications are considered first-line medication treatment for bipolar disorder, schizophrenia, tics/Tourette’s, and autism. (Recommendation 2).

• Antipsychotic medications are not first-line treatment for several other diagnoses and behaviors, including disruptive behavior disorders such as ADHD, aggression, eating disorders, and post-traumatic stress disorder (PTSD). Their use should be considered only after other pharmacologic and nonpharmacologic interventions have failed (Recommendation 2).

• Antipsychotic medications are not advised for preschool-aged patients. (Recommendation 2).

• Dosing should be as low as possible and not exceed the maximum recommended dose for adults (Recommendation 4).

• Simultaneous treatment with multiple antipsychotic medications is not recommended (Recommendation 8).

• Patients should receive regular metabolic monitoring, including lab work, both before and during treatment (Recommendations 11-13).

These are rigorous guidelines that challenge even those who regularly assess and treat children with serious psychiatric disorders. The clinical and legal implications of prescribing antipsychotic medications without adhering to these guidelines will, and probably should, give many physicians pause. Further, the specific point about the need for a thorough psychiatric evaluation underlies the commonly heard recommendation that this class of medicines generally should be avoided by primary care physicians. At the same time, many pediatricians are acutely aware of how dire the clinical situation often is for these families. At this point, it can easily begin to feel very much like a “no-win” situation.

Here are some thoughts that may be useful to consider in these moments:

• Remember that many non-MD mental health professionals can offer a lot of help. Although they can’t do the prescribing themselves, referral to a psychologist or another type of therapist can be useful in getting information about a patient’s diagnosis and the degree to which nonpharmacologic options have been exhausted. If the patient is already seeing a therapist, it is certainly worthwhile to seek their advice as to whether or not antipsychotic medications are now reasonable to consider.

• Look for opportunities to talk “curbside” to a child psychiatrist. Most of us are keenly aware of how inadequate access is to child psychiatry and want to help. Indeed, many states now have specific brief consultation programs in place.

• Get the lab work. A recent study in Pediatrics reported that a baseline glucose was obtained in only 11% of youth receiving antipsychotic medication treatment (Pediatrics 2014;134:e1308-14). In addition to providing important information, this step signals to everyone involved that the decision to use these medications is not something to be taken lightly.

Case follow-up

Cody’s pediatrician decides to get a diagnostic evaluation from a psychologist, who confirms the ADHD diagnosis without associated conditions such as bipolar disorder. The psychologist recommends a course of therapy to build regulatory skills for Cody and provide the mother with some parent behavioral guidance about how to best manage Cody’s challenges and encourage health-promoting behaviors such as physical activity, reading, and a regular sleep routine. The pediatrician decides to try a second line ADHD medication, guanfacine, and the school also begins to institute an incentive plan to reinforce positive behavior. In combination, these efforts significantly reduce the level of aggression and dysregulated behavior.

Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Dr. Rettew said he has no relevant financial disclosures. Follow him on Twitter @pedipsych.

Introduction

Both the medical and lay press have directed a lot of attention lately to the treatment of children and adolescents with antipsychotic medications. The literature is clear that the number of children taking this class of medications has risen sharply since their release (Arch. Gen. Psychiatry 2006;63:679-85). What is much less clear is the degree to which this increase represents a reasonable intervention for patients in significant need versus an overuse when other strategies are more appropriate.

Case Summary

Cody is a 6-year-old boy who lives with his younger sister and single mother. The family struggles financially, and the father, who has never had much contact with his son, is currently incarcerated. Since he was a toddler, Cody has been prone to high levels of aggressive behavior and frequent, intense angry outbursts. He was asked to leave his preschool due to his behavior and now is commonly disruptive at school. His pediatrician diagnosed him with attention-deficit/hyperactivity disorder a year ago and began a trial of a psychostimulant, which made him even more irritable, and was discontinued. Cody and his mother now present with concerns that there is “something more” affecting his behavior. The pediatrician now considers whether or not treatment with an antipsychotic medication is reasonable at this point.

Discussion

The above clinical scenario represents a critical and often antagonizing moment in treatment for both the family and the treating physician, yet it is hardly uncommon. The situation often is made more complicated by the fact that what is often the first plan of action, namely referral or consultation with a child psychiatrist, can be very difficult to access.

The American Academy of Child and Adolescent Psychiatry has published online guidelines for the use of antipsychotic medication in youth (http://bit.ly/1eat7e9). Key recommendations and points from this 27-page document and 19 recommendations include the following:

• Patients being considered for treatment with an antipsychotic medication should receive a “meticulous diagnostic assessment” with any medication prescribed being part of a “multidisciplinary” treatment plan (Recommendation 1).

• Prescribers should “regularly check the current literature” regarding the scientific evidence for antipsychotic medication use (Recommendation 2).

• Antipsychotic medications are considered first-line medication treatment for bipolar disorder, schizophrenia, tics/Tourette’s, and autism. (Recommendation 2).

• Antipsychotic medications are not first-line treatment for several other diagnoses and behaviors, including disruptive behavior disorders such as ADHD, aggression, eating disorders, and post-traumatic stress disorder (PTSD). Their use should be considered only after other pharmacologic and nonpharmacologic interventions have failed (Recommendation 2).

• Antipsychotic medications are not advised for preschool-aged patients. (Recommendation 2).

• Dosing should be as low as possible and not exceed the maximum recommended dose for adults (Recommendation 4).

• Simultaneous treatment with multiple antipsychotic medications is not recommended (Recommendation 8).

• Patients should receive regular metabolic monitoring, including lab work, both before and during treatment (Recommendations 11-13).

These are rigorous guidelines that challenge even those who regularly assess and treat children with serious psychiatric disorders. The clinical and legal implications of prescribing antipsychotic medications without adhering to these guidelines will, and probably should, give many physicians pause. Further, the specific point about the need for a thorough psychiatric evaluation underlies the commonly heard recommendation that this class of medicines generally should be avoided by primary care physicians. At the same time, many pediatricians are acutely aware of how dire the clinical situation often is for these families. At this point, it can easily begin to feel very much like a “no-win” situation.

Here are some thoughts that may be useful to consider in these moments:

• Remember that many non-MD mental health professionals can offer a lot of help. Although they can’t do the prescribing themselves, referral to a psychologist or another type of therapist can be useful in getting information about a patient’s diagnosis and the degree to which nonpharmacologic options have been exhausted. If the patient is already seeing a therapist, it is certainly worthwhile to seek their advice as to whether or not antipsychotic medications are now reasonable to consider.

• Look for opportunities to talk “curbside” to a child psychiatrist. Most of us are keenly aware of how inadequate access is to child psychiatry and want to help. Indeed, many states now have specific brief consultation programs in place.

• Get the lab work. A recent study in Pediatrics reported that a baseline glucose was obtained in only 11% of youth receiving antipsychotic medication treatment (Pediatrics 2014;134:e1308-14). In addition to providing important information, this step signals to everyone involved that the decision to use these medications is not something to be taken lightly.

Case follow-up

Cody’s pediatrician decides to get a diagnostic evaluation from a psychologist, who confirms the ADHD diagnosis without associated conditions such as bipolar disorder. The psychologist recommends a course of therapy to build regulatory skills for Cody and provide the mother with some parent behavioral guidance about how to best manage Cody’s challenges and encourage health-promoting behaviors such as physical activity, reading, and a regular sleep routine. The pediatrician decides to try a second line ADHD medication, guanfacine, and the school also begins to institute an incentive plan to reinforce positive behavior. In combination, these efforts significantly reduce the level of aggression and dysregulated behavior.

Dr. Rettew is an associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Dr. Rettew said he has no relevant financial disclosures. Follow him on Twitter @pedipsych.

The recent rise of specialty hospitalists, particularly in the surgery and oncology fields, has benefitted hospitals and patients alike. Consider the growing ranks of oncology hospitalists, a small but quickly expanding HM specialty that has applied hospitalist principles to inpatient cancer and end-of-life care.

One such program at M.D. Anderson Cancer Center in Houston has attracted nine hospital-based physicians, four advanced-practice nurses, and two pharmacists since its launch in 2006. More doctors and nurse practitioners are being recruited, and the group is piloting an observation unit geared toward symptom management for an average of five oncology patients per day.

Although most inpatients cared for M.D. Anderson hospitalists are being treated for cancer, many have general medical needs, such as managing diabetes or high blood pressure, explains hospitalist Maria-Claudia Campagna, MD, FHM, assistant professor in the division of internal medicine at MD Anderson. Other patients, including those who don't yet have a confirmed cancer diagnosis, and family members of cancer patients may also be seen by the hospitalists. MD Anderson also has an established palliative-care service.

Increasingly, hospitals have employed specialty hospitalist teams, staffed by general oncologists or internal medicine hospitalists skilled at complex cancer care to care for inpatients with cancer, and the trend shows no signs of slowing.

Likewise, the practice of employing surgical hospitalists in non-trauma centers is gaining steam. Some non-trauma hospitals have reported improved patient outcomes and greater  efficiency with surgical hospitalists.

A retrospective review of emergency surgical operations performed over five years at Sutter Medical Center, in Sacramento, Calif., found that an acute-care surgery model resulted in fewer overall complications, shorter lengths of stay, and lower hospital costs.

This approach by Surgical Affiliates Management Group, Inc. of Sacramento—the group contracted to perform the surgeries at SMC—combines elements of trauma, critical care, emergency surgical medicine, and elective general surgery, and it could be applied to emergency general surgeries at other hospitals that lack a trauma service without jeopardizing quality of care, the authors state.

Visit our website for more information on specialty hospitalist programs.

The recent rise of specialty hospitalists, particularly in the surgery and oncology fields, has benefitted hospitals and patients alike. Consider the growing ranks of oncology hospitalists, a small but quickly expanding HM specialty that has applied hospitalist principles to inpatient cancer and end-of-life care.

One such program at M.D. Anderson Cancer Center in Houston has attracted nine hospital-based physicians, four advanced-practice nurses, and two pharmacists since its launch in 2006. More doctors and nurse practitioners are being recruited, and the group is piloting an observation unit geared toward symptom management for an average of five oncology patients per day.

Although most inpatients cared for M.D. Anderson hospitalists are being treated for cancer, many have general medical needs, such as managing diabetes or high blood pressure, explains hospitalist Maria-Claudia Campagna, MD, FHM, assistant professor in the division of internal medicine at MD Anderson. Other patients, including those who don't yet have a confirmed cancer diagnosis, and family members of cancer patients may also be seen by the hospitalists. MD Anderson also has an established palliative-care service.

Increasingly, hospitals have employed specialty hospitalist teams, staffed by general oncologists or internal medicine hospitalists skilled at complex cancer care to care for inpatients with cancer, and the trend shows no signs of slowing.

Likewise, the practice of employing surgical hospitalists in non-trauma centers is gaining steam. Some non-trauma hospitals have reported improved patient outcomes and greater  efficiency with surgical hospitalists.

A retrospective review of emergency surgical operations performed over five years at Sutter Medical Center, in Sacramento, Calif., found that an acute-care surgery model resulted in fewer overall complications, shorter lengths of stay, and lower hospital costs.

This approach by Surgical Affiliates Management Group, Inc. of Sacramento—the group contracted to perform the surgeries at SMC—combines elements of trauma, critical care, emergency surgical medicine, and elective general surgery, and it could be applied to emergency general surgeries at other hospitals that lack a trauma service without jeopardizing quality of care, the authors state.

Visit our website for more information on specialty hospitalist programs.

The recent rise of specialty hospitalists, particularly in the surgery and oncology fields, has benefitted hospitals and patients alike. Consider the growing ranks of oncology hospitalists, a small but quickly expanding HM specialty that has applied hospitalist principles to inpatient cancer and end-of-life care.

One such program at M.D. Anderson Cancer Center in Houston has attracted nine hospital-based physicians, four advanced-practice nurses, and two pharmacists since its launch in 2006. More doctors and nurse practitioners are being recruited, and the group is piloting an observation unit geared toward symptom management for an average of five oncology patients per day.

Although most inpatients cared for M.D. Anderson hospitalists are being treated for cancer, many have general medical needs, such as managing diabetes or high blood pressure, explains hospitalist Maria-Claudia Campagna, MD, FHM, assistant professor in the division of internal medicine at MD Anderson. Other patients, including those who don't yet have a confirmed cancer diagnosis, and family members of cancer patients may also be seen by the hospitalists. MD Anderson also has an established palliative-care service.

Increasingly, hospitals have employed specialty hospitalist teams, staffed by general oncologists or internal medicine hospitalists skilled at complex cancer care to care for inpatients with cancer, and the trend shows no signs of slowing.

Likewise, the practice of employing surgical hospitalists in non-trauma centers is gaining steam. Some non-trauma hospitals have reported improved patient outcomes and greater  efficiency with surgical hospitalists.

A retrospective review of emergency surgical operations performed over five years at Sutter Medical Center, in Sacramento, Calif., found that an acute-care surgery model resulted in fewer overall complications, shorter lengths of stay, and lower hospital costs.

This approach by Surgical Affiliates Management Group, Inc. of Sacramento—the group contracted to perform the surgeries at SMC—combines elements of trauma, critical care, emergency surgical medicine, and elective general surgery, and it could be applied to emergency general surgeries at other hospitals that lack a trauma service without jeopardizing quality of care, the authors state.

Visit our website for more information on specialty hospitalist programs.

Sound Physicians' recent acquisition of Cogent Healthcare creates the largest hospitalist management group in the country, which may or may not be a good thing, one hospitalist expert notes.

The deal, which closed last month, creates a company with more than 1,750 hospitalists in 180 hospitals nationwide. Reuters estimated the sale price at more than $375 million.

"We certainly don't care so much about biggest," says Robert Bessler, MD, chief executive officer of Sound Physicians, which will be the merged firms' name moving forward. "We're focused on trying to be the practice of choice for docs and provider of choice for hospitals—and really focus on performance as a business model to drive results."

John Nelson, MD, MHM, a principal in Nelson Flores Hospital Medicine Consultants and regular columnist for The Hospitalist, says he believes the impact of the merger will vary by market.

"Hospitalists in competing groups could benefit, for example, by being seen as a more attractive alternative for candidates in the market to join a practice, and large companies may be able to invest in innovation that might benefit all of us," Dr. Nelson says in an email. "But for others, it may seem to make things worse, for example, by influencing the local market toward lower compensation or higher workload. It will be very market-dependent."

Dr. Bessler says he believes the merger "creates incredible synergy." For example, Cogent has The Intensivist Group, which operates full-service intensivist programs, and it can now potentially expand to hospitals where Sound hospitalists work.

Conversely, Sound’s post-acute-care program can be expanded to hospitals where Cogent has a presence.

Dr. Bessler understands that being the largest group can be seen as a good or a bad thing by industry watchers. "I think it leads to further innovation," he says. "It pools resources to do better things for hospital medicine, for hospitals, for patients, and for docs. And the reality is that even on a combined basis, we have less than 5% of the market. It's a massive market."

Visit our website for more information on mergers in hospital medicine.

Sound Physicians' recent acquisition of Cogent Healthcare creates the largest hospitalist management group in the country, which may or may not be a good thing, one hospitalist expert notes.

The deal, which closed last month, creates a company with more than 1,750 hospitalists in 180 hospitals nationwide. Reuters estimated the sale price at more than $375 million.

"We certainly don't care so much about biggest," says Robert Bessler, MD, chief executive officer of Sound Physicians, which will be the merged firms' name moving forward. "We're focused on trying to be the practice of choice for docs and provider of choice for hospitals—and really focus on performance as a business model to drive results."

John Nelson, MD, MHM, a principal in Nelson Flores Hospital Medicine Consultants and regular columnist for The Hospitalist, says he believes the impact of the merger will vary by market.

"Hospitalists in competing groups could benefit, for example, by being seen as a more attractive alternative for candidates in the market to join a practice, and large companies may be able to invest in innovation that might benefit all of us," Dr. Nelson says in an email. "But for others, it may seem to make things worse, for example, by influencing the local market toward lower compensation or higher workload. It will be very market-dependent."

Dr. Bessler says he believes the merger "creates incredible synergy." For example, Cogent has The Intensivist Group, which operates full-service intensivist programs, and it can now potentially expand to hospitals where Sound hospitalists work.

Conversely, Sound’s post-acute-care program can be expanded to hospitals where Cogent has a presence.

Dr. Bessler understands that being the largest group can be seen as a good or a bad thing by industry watchers. "I think it leads to further innovation," he says. "It pools resources to do better things for hospital medicine, for hospitals, for patients, and for docs. And the reality is that even on a combined basis, we have less than 5% of the market. It's a massive market."

Visit our website for more information on mergers in hospital medicine.

Sound Physicians' recent acquisition of Cogent Healthcare creates the largest hospitalist management group in the country, which may or may not be a good thing, one hospitalist expert notes.

The deal, which closed last month, creates a company with more than 1,750 hospitalists in 180 hospitals nationwide. Reuters estimated the sale price at more than $375 million.

"We certainly don't care so much about biggest," says Robert Bessler, MD, chief executive officer of Sound Physicians, which will be the merged firms' name moving forward. "We're focused on trying to be the practice of choice for docs and provider of choice for hospitals—and really focus on performance as a business model to drive results."

John Nelson, MD, MHM, a principal in Nelson Flores Hospital Medicine Consultants and regular columnist for The Hospitalist, says he believes the impact of the merger will vary by market.

"Hospitalists in competing groups could benefit, for example, by being seen as a more attractive alternative for candidates in the market to join a practice, and large companies may be able to invest in innovation that might benefit all of us," Dr. Nelson says in an email. "But for others, it may seem to make things worse, for example, by influencing the local market toward lower compensation or higher workload. It will be very market-dependent."

Dr. Bessler says he believes the merger "creates incredible synergy." For example, Cogent has The Intensivist Group, which operates full-service intensivist programs, and it can now potentially expand to hospitals where Sound hospitalists work.

Conversely, Sound’s post-acute-care program can be expanded to hospitals where Cogent has a presence.

Dr. Bessler understands that being the largest group can be seen as a good or a bad thing by industry watchers. "I think it leads to further innovation," he says. "It pools resources to do better things for hospital medicine, for hospitals, for patients, and for docs. And the reality is that even on a combined basis, we have less than 5% of the market. It's a massive market."

Visit our website for more information on mergers in hospital medicine.

While typing this column, I could not recall the last time I saw a patient with “tennis elbow” (lateral epicondylitis) from actual tennis. Lateral epicondylitis peaks between the ages of 30 and 65 years and affects about 1.3% of this group – the vast majority of whom, I am quite suddenly convinced, do not play tennis. Pain is worse with wrist extension and typically affects the dominant hand. The most likely etiology is repeated microtrauma.

The examination is straightforward and about 90% will recover by 1 year without a surgical procedure. The unhappy customers who darken our doorways with worsening or nonimproving symptoms are the ones who make us wonder if we gave them effective conservative measures to begin with.

So what conservative measures are effective?

Sims and colleagues published a meta-analysis evaluating nonsurgical treatments for lateral epicondylitis. The review involved 58 studies (Hand 2014.9:419-46).

The investigators concluded that steroid injections provide relief only for the short term. The authors suggest that this may related to lateral epicondylitis being caused by repeated microtrauma rather than inflammation (perhaps this is why NSAIDs are not always beneficial either). Botulinum A, which works by paralyzing the extensor muscles, thereby allowing them to heal, is comparable to steroids. But patients may not love the experience of extensor muscle paralysis. Prolotherapy, injection of osmotics or irritants to promote inflammation in the target tissue, is also comparable to steroids. Platelet-rich plasma or autologous blood injections have uncertain relative benefit compared to steroids. Bracing with a counterforce brace (i.e., “tennis elbow strap”) or wrist extension splint, physical therapy, and shock wave therapy do not lessen pain or improve function in a dependable way.

This review leaves primary care clinicians who are uncomfortable injecting steroids into the arm with not much in the way of clearly effective evidence-based therapies. Personally, I ask my Ortho Hand colleagues to help me with the injection part. But only when patients fail to respond to what I give them.

So if this is a self-limited disease that gets better in 12-18 months, should we just be offering nothing more than activity modification? Patients will not accept this. My read on the data Sims collected is that there weren’t any quality studies comparing the elbow strap to offering nothing and patients tended to improve with it – although admittedly not clearly more than other therapies such as strengthening exercises. So for now, I will continue to recommend: 1) the elbow strap; 2) home exercises, and 3) lots and lots of reassurance. It’s all I got to give.

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

While typing this column, I could not recall the last time I saw a patient with “tennis elbow” (lateral epicondylitis) from actual tennis. Lateral epicondylitis peaks between the ages of 30 and 65 years and affects about 1.3% of this group – the vast majority of whom, I am quite suddenly convinced, do not play tennis. Pain is worse with wrist extension and typically affects the dominant hand. The most likely etiology is repeated microtrauma.

The examination is straightforward and about 90% will recover by 1 year without a surgical procedure. The unhappy customers who darken our doorways with worsening or nonimproving symptoms are the ones who make us wonder if we gave them effective conservative measures to begin with.

So what conservative measures are effective?

Sims and colleagues published a meta-analysis evaluating nonsurgical treatments for lateral epicondylitis. The review involved 58 studies (Hand 2014.9:419-46).

The investigators concluded that steroid injections provide relief only for the short term. The authors suggest that this may related to lateral epicondylitis being caused by repeated microtrauma rather than inflammation (perhaps this is why NSAIDs are not always beneficial either). Botulinum A, which works by paralyzing the extensor muscles, thereby allowing them to heal, is comparable to steroids. But patients may not love the experience of extensor muscle paralysis. Prolotherapy, injection of osmotics or irritants to promote inflammation in the target tissue, is also comparable to steroids. Platelet-rich plasma or autologous blood injections have uncertain relative benefit compared to steroids. Bracing with a counterforce brace (i.e., “tennis elbow strap”) or wrist extension splint, physical therapy, and shock wave therapy do not lessen pain or improve function in a dependable way.

This review leaves primary care clinicians who are uncomfortable injecting steroids into the arm with not much in the way of clearly effective evidence-based therapies. Personally, I ask my Ortho Hand colleagues to help me with the injection part. But only when patients fail to respond to what I give them.

So if this is a self-limited disease that gets better in 12-18 months, should we just be offering nothing more than activity modification? Patients will not accept this. My read on the data Sims collected is that there weren’t any quality studies comparing the elbow strap to offering nothing and patients tended to improve with it – although admittedly not clearly more than other therapies such as strengthening exercises. So for now, I will continue to recommend: 1) the elbow strap; 2) home exercises, and 3) lots and lots of reassurance. It’s all I got to give.

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

While typing this column, I could not recall the last time I saw a patient with “tennis elbow” (lateral epicondylitis) from actual tennis. Lateral epicondylitis peaks between the ages of 30 and 65 years and affects about 1.3% of this group – the vast majority of whom, I am quite suddenly convinced, do not play tennis. Pain is worse with wrist extension and typically affects the dominant hand. The most likely etiology is repeated microtrauma.

The examination is straightforward and about 90% will recover by 1 year without a surgical procedure. The unhappy customers who darken our doorways with worsening or nonimproving symptoms are the ones who make us wonder if we gave them effective conservative measures to begin with.

So what conservative measures are effective?

Sims and colleagues published a meta-analysis evaluating nonsurgical treatments for lateral epicondylitis. The review involved 58 studies (Hand 2014.9:419-46).

The investigators concluded that steroid injections provide relief only for the short term. The authors suggest that this may related to lateral epicondylitis being caused by repeated microtrauma rather than inflammation (perhaps this is why NSAIDs are not always beneficial either). Botulinum A, which works by paralyzing the extensor muscles, thereby allowing them to heal, is comparable to steroids. But patients may not love the experience of extensor muscle paralysis. Prolotherapy, injection of osmotics or irritants to promote inflammation in the target tissue, is also comparable to steroids. Platelet-rich plasma or autologous blood injections have uncertain relative benefit compared to steroids. Bracing with a counterforce brace (i.e., “tennis elbow strap”) or wrist extension splint, physical therapy, and shock wave therapy do not lessen pain or improve function in a dependable way.

This review leaves primary care clinicians who are uncomfortable injecting steroids into the arm with not much in the way of clearly effective evidence-based therapies. Personally, I ask my Ortho Hand colleagues to help me with the injection part. But only when patients fail to respond to what I give them.

So if this is a self-limited disease that gets better in 12-18 months, should we just be offering nothing more than activity modification? Patients will not accept this. My read on the data Sims collected is that there weren’t any quality studies comparing the elbow strap to offering nothing and patients tended to improve with it – although admittedly not clearly more than other therapies such as strengthening exercises. So for now, I will continue to recommend: 1) the elbow strap; 2) home exercises, and 3) lots and lots of reassurance. It’s all I got to give.

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

SAN FRANCISCO – Adding vosaroxin to cytarabine chemotherapy increased overall survival in first relapsed or refractory acute myeloid leukemia in the phase III VALOR study.

The difference in this primary endpoint, however, failed to achieve statistically significance (median 7.5 months vs. 6.1 months; P = .06), lead study author Dr. Farhad Ravandi reported at the annual meeting of the American Society of Hematology.

More patients receiving vosaroxin (Qinprezo) and cytarabine than cytarabine alone achieved complete remission (CR) (30.1% vs. 16.3%; P < .0001).

The benefit was significant across all subgroups (age at least 60 years, refractory disease, early and late relapse), except in those aged younger than 60 years, he said.

Vosaroxin is an investigational, first-in-class anticancer quinolone derivative that was granted fast track designation by the Food and Drug Administration in 2011 for the potential treatment of relapsed or refractory acute myeloid leukemia (AML) in combination with cytarabine.

Despite missing its primary endpoint, Dr. Ravandi argued during a press briefing that VALOR was a positive trial and that the survival benefit with combination vosaroxin was “highly significant.” He described relapsed/refractory AML as the equivalent of metastatic cancer, with patients presenting with disease “all over their body, right from day 1.”

“In solid tumors, we are excited about a 1- or 2-month survival improvement and I don’t see why we shouldn’t be excited in AML as well,” said Dr. Ravandi of the University of Texas M.D. Anderson Cancer Center in Houston.

He suggested that the bar has been set high in AML because about 40% of patients are cured and that great leaps forward remain rare. “We should not discount the small steps forward in treating our patients and providing better treatment options,” he said.

Press briefing moderator Dr. David Steensma of the Dana-Farber Cancer Institute, Boston, agreed that change is often incremental in AML but countered that the magnitude of benefit wasn’t great.

“AML is a really difficult population, no question about it, but there’s also no question that seven and a half months is pretty crummy and we need to do better than that,” Dr. Steensma said.

VALOR randomly assigned 711 adult patients from 124 sites in 15 countries to IV cytarabine 1 g/m² on days 1-5 plus placebo or IV vosaroxin 90 mg/m² on days 1 and 4 for induction and 70 mg/m² for subsequent cycles. Patients had AML refractory to initial induction therapy or were in first relapse, defined as relapse within 90 days to 24 months after first CR or CR with incomplete platelet recovery.

In all, 30.1% of patients in the vosaroxin group and 29% in the placebo group underwent allogeneic stem cell transplantation (ASCT). In those younger than 60 years, rates were 46.2% and 45.4%.

When stratified by age, there was a significant overall survival benefit with the vosaroxin combination for patients aged 60 years and older, who accounted for two-thirds of the study population (median 7.1 months vs. 5.0 months; hazard ratio, 0.75; P = .003), Dr. Ravandi said.

There was no survival advantage in patients younger than 60 years (median 9.1 months vs. 7.9 months; HR, 1.08, P = .60).

In a preplanned analysis censored for ASCT, median overall survival was significantly better in patients receiving the vosaroxin combination versus cytarabine alone (6.7 months vs. 5.3 months; HR, 0.83; P = .02).

“The benefit may be underestimated by the high rate of [ASCT], particularly in the younger patients,” Dr. Ravandi concluded during the formal presentation of the late-breaking abstract. “These data support the use of vosaroxin in combination with cytarabine as a new standard for salvage therapy in older patients with relapsed or refractory AML.”

During the discussion following the presentation, session comoderator Dr. Jonathan Friedberg of the University of Rochester Medical Center in Rochester, N.Y., asked, “How do you reconcile the observation that the patients you wanted to get to transplant got there, and yet you’re blaming the transplant for poor outcomes?”

Dr. Ravandi responded that transplantation is an issue in all AML studies and that a much larger study would have been needed to show a survival difference regardless of transplant status.

Treatment-related adverse events were more common in patients on vosaroxin and were mostly infection related. Stomatitis was identified as a dose-limiting toxicity in previous studies and occurred at any grade in 49% of vosaroxin patients and 19% of controls and at grade 3/4 in 15% and 3%.

Other notable grade 3/4 events were febrile neutropenia (47% vs. 33%) and thrombocytopenia (24% vs. 25%). This increase in toxicity did not translate into worse all-cause mortality at either 30 or 60 days, Dr. Ravandi said.

Sunesis Pharmaceuticals funded the study. Dr. Ravandi and several coauthors reported financial ties with Sunesis. Dr Steensma reported financial ties with several companies. Dr. Friedberg reported no disclosures.

pwendling@frontlinemedcom.com

SAN FRANCISCO – Adding vosaroxin to cytarabine chemotherapy increased overall survival in first relapsed or refractory acute myeloid leukemia in the phase III VALOR study.

The difference in this primary endpoint, however, failed to achieve statistically significance (median 7.5 months vs. 6.1 months; P = .06), lead study author Dr. Farhad Ravandi reported at the annual meeting of the American Society of Hematology.

More patients receiving vosaroxin (Qinprezo) and cytarabine than cytarabine alone achieved complete remission (CR) (30.1% vs. 16.3%; P < .0001).

The benefit was significant across all subgroups (age at least 60 years, refractory disease, early and late relapse), except in those aged younger than 60 years, he said.

Vosaroxin is an investigational, first-in-class anticancer quinolone derivative that was granted fast track designation by the Food and Drug Administration in 2011 for the potential treatment of relapsed or refractory acute myeloid leukemia (AML) in combination with cytarabine.

Despite missing its primary endpoint, Dr. Ravandi argued during a press briefing that VALOR was a positive trial and that the survival benefit with combination vosaroxin was “highly significant.” He described relapsed/refractory AML as the equivalent of metastatic cancer, with patients presenting with disease “all over their body, right from day 1.”

“In solid tumors, we are excited about a 1- or 2-month survival improvement and I don’t see why we shouldn’t be excited in AML as well,” said Dr. Ravandi of the University of Texas M.D. Anderson Cancer Center in Houston.

He suggested that the bar has been set high in AML because about 40% of patients are cured and that great leaps forward remain rare. “We should not discount the small steps forward in treating our patients and providing better treatment options,” he said.

Press briefing moderator Dr. David Steensma of the Dana-Farber Cancer Institute, Boston, agreed that change is often incremental in AML but countered that the magnitude of benefit wasn’t great.

“AML is a really difficult population, no question about it, but there’s also no question that seven and a half months is pretty crummy and we need to do better than that,” Dr. Steensma said.

VALOR randomly assigned 711 adult patients from 124 sites in 15 countries to IV cytarabine 1 g/m² on days 1-5 plus placebo or IV vosaroxin 90 mg/m² on days 1 and 4 for induction and 70 mg/m² for subsequent cycles. Patients had AML refractory to initial induction therapy or were in first relapse, defined as relapse within 90 days to 24 months after first CR or CR with incomplete platelet recovery.

In all, 30.1% of patients in the vosaroxin group and 29% in the placebo group underwent allogeneic stem cell transplantation (ASCT). In those younger than 60 years, rates were 46.2% and 45.4%.

When stratified by age, there was a significant overall survival benefit with the vosaroxin combination for patients aged 60 years and older, who accounted for two-thirds of the study population (median 7.1 months vs. 5.0 months; hazard ratio, 0.75; P = .003), Dr. Ravandi said.

There was no survival advantage in patients younger than 60 years (median 9.1 months vs. 7.9 months; HR, 1.08, P = .60).

In a preplanned analysis censored for ASCT, median overall survival was significantly better in patients receiving the vosaroxin combination versus cytarabine alone (6.7 months vs. 5.3 months; HR, 0.83; P = .02).

“The benefit may be underestimated by the high rate of [ASCT], particularly in the younger patients,” Dr. Ravandi concluded during the formal presentation of the late-breaking abstract. “These data support the use of vosaroxin in combination with cytarabine as a new standard for salvage therapy in older patients with relapsed or refractory AML.”

During the discussion following the presentation, session comoderator Dr. Jonathan Friedberg of the University of Rochester Medical Center in Rochester, N.Y., asked, “How do you reconcile the observation that the patients you wanted to get to transplant got there, and yet you’re blaming the transplant for poor outcomes?”

Dr. Ravandi responded that transplantation is an issue in all AML studies and that a much larger study would have been needed to show a survival difference regardless of transplant status.

Treatment-related adverse events were more common in patients on vosaroxin and were mostly infection related. Stomatitis was identified as a dose-limiting toxicity in previous studies and occurred at any grade in 49% of vosaroxin patients and 19% of controls and at grade 3/4 in 15% and 3%.

Other notable grade 3/4 events were febrile neutropenia (47% vs. 33%) and thrombocytopenia (24% vs. 25%). This increase in toxicity did not translate into worse all-cause mortality at either 30 or 60 days, Dr. Ravandi said.

Sunesis Pharmaceuticals funded the study. Dr. Ravandi and several coauthors reported financial ties with Sunesis. Dr Steensma reported financial ties with several companies. Dr. Friedberg reported no disclosures.

pwendling@frontlinemedcom.com

SAN FRANCISCO – Adding vosaroxin to cytarabine chemotherapy increased overall survival in first relapsed or refractory acute myeloid leukemia in the phase III VALOR study.

The difference in this primary endpoint, however, failed to achieve statistically significance (median 7.5 months vs. 6.1 months; P = .06), lead study author Dr. Farhad Ravandi reported at the annual meeting of the American Society of Hematology.

More patients receiving vosaroxin (Qinprezo) and cytarabine than cytarabine alone achieved complete remission (CR) (30.1% vs. 16.3%; P < .0001).

The benefit was significant across all subgroups (age at least 60 years, refractory disease, early and late relapse), except in those aged younger than 60 years, he said.

Vosaroxin is an investigational, first-in-class anticancer quinolone derivative that was granted fast track designation by the Food and Drug Administration in 2011 for the potential treatment of relapsed or refractory acute myeloid leukemia (AML) in combination with cytarabine.

Despite missing its primary endpoint, Dr. Ravandi argued during a press briefing that VALOR was a positive trial and that the survival benefit with combination vosaroxin was “highly significant.” He described relapsed/refractory AML as the equivalent of metastatic cancer, with patients presenting with disease “all over their body, right from day 1.”

“In solid tumors, we are excited about a 1- or 2-month survival improvement and I don’t see why we shouldn’t be excited in AML as well,” said Dr. Ravandi of the University of Texas M.D. Anderson Cancer Center in Houston.

He suggested that the bar has been set high in AML because about 40% of patients are cured and that great leaps forward remain rare. “We should not discount the small steps forward in treating our patients and providing better treatment options,” he said.

Press briefing moderator Dr. David Steensma of the Dana-Farber Cancer Institute, Boston, agreed that change is often incremental in AML but countered that the magnitude of benefit wasn’t great.

“AML is a really difficult population, no question about it, but there’s also no question that seven and a half months is pretty crummy and we need to do better than that,” Dr. Steensma said.

VALOR randomly assigned 711 adult patients from 124 sites in 15 countries to IV cytarabine 1 g/m² on days 1-5 plus placebo or IV vosaroxin 90 mg/m² on days 1 and 4 for induction and 70 mg/m² for subsequent cycles. Patients had AML refractory to initial induction therapy or were in first relapse, defined as relapse within 90 days to 24 months after first CR or CR with incomplete platelet recovery.

In all, 30.1% of patients in the vosaroxin group and 29% in the placebo group underwent allogeneic stem cell transplantation (ASCT). In those younger than 60 years, rates were 46.2% and 45.4%.

When stratified by age, there was a significant overall survival benefit with the vosaroxin combination for patients aged 60 years and older, who accounted for two-thirds of the study population (median 7.1 months vs. 5.0 months; hazard ratio, 0.75; P = .003), Dr. Ravandi said.

There was no survival advantage in patients younger than 60 years (median 9.1 months vs. 7.9 months; HR, 1.08, P = .60).

In a preplanned analysis censored for ASCT, median overall survival was significantly better in patients receiving the vosaroxin combination versus cytarabine alone (6.7 months vs. 5.3 months; HR, 0.83; P = .02).

“The benefit may be underestimated by the high rate of [ASCT], particularly in the younger patients,” Dr. Ravandi concluded during the formal presentation of the late-breaking abstract. “These data support the use of vosaroxin in combination with cytarabine as a new standard for salvage therapy in older patients with relapsed or refractory AML.”

During the discussion following the presentation, session comoderator Dr. Jonathan Friedberg of the University of Rochester Medical Center in Rochester, N.Y., asked, “How do you reconcile the observation that the patients you wanted to get to transplant got there, and yet you’re blaming the transplant for poor outcomes?”

Dr. Ravandi responded that transplantation is an issue in all AML studies and that a much larger study would have been needed to show a survival difference regardless of transplant status.

Treatment-related adverse events were more common in patients on vosaroxin and were mostly infection related. Stomatitis was identified as a dose-limiting toxicity in previous studies and occurred at any grade in 49% of vosaroxin patients and 19% of controls and at grade 3/4 in 15% and 3%.

Other notable grade 3/4 events were febrile neutropenia (47% vs. 33%) and thrombocytopenia (24% vs. 25%). This increase in toxicity did not translate into worse all-cause mortality at either 30 or 60 days, Dr. Ravandi said.

Sunesis Pharmaceuticals funded the study. Dr. Ravandi and several coauthors reported financial ties with Sunesis. Dr Steensma reported financial ties with several companies. Dr. Friedberg reported no disclosures.

pwendling@frontlinemedcom.com

Sutures, hemoclips, and electrocautery are the primary means of achieving hemostasis during gynecologic surgery. When these are inadequate or infeasible, topical hemostatic agents can be employed. Use of these agents has increased by 10%-21% since 2000, yet studies evaluating their use in gynecologic surgery are limited (J. Surg. Res. 2014;186:458-66).

Oxidized regenerated cellulose

Oxidized regenerated cellulose (Surgicel) is made from dissolved oxidized cellulose woven into a dry gauze sheet (J. Urol. 2006;176:2367-74). It is applied directly to tissue, creating a scaffold for platelet aggregation and decreasing tissue pH, further activating the clotting cascade (Surg. Infect. (Larchmt.) 2003;4:255-62). It is absorbed in 14 days, but can persist for 1 year.

Oxidized regenerated cellulose (ORC) is easily passed through laparoscopic trocars. One study found ORC efficacious in controlling tubal hemorrhage during laparoscopic sterilization (Int. J. Gynaecol. Obstet. 2003;82:221-2). It has also been shown to have bactericidal activity (Surg. Infect. (Larchmt.) 2003; 4:255-62) and prevent development of peritoneal adhesions (Acta. Chir. Scand. 1978;144:375-8).

Microfibrillar collagen

Microfibrillar collagen (Avitene) is made from bovine collagen in a powder or sponge sheet, and acts as a scaffold for platelet aggregation. It is applied directly to tissue and is absorbed in 3 months. One study found microfibrillar collagen (MC) use during cold knife conization resulted in nonsignificant reduction in operative time and similar hemostatic results compared to Sturmdorf suture (Obstet. Gynecol. 1978;51:118-22). MC also has been used to treat bleeding following uterine perforation and during laparoscopic hysterectomy.

Gelatins

Gelatins (Gelfoam, Surgifoam) are made of porcine collagen in a powder or foam (J. Urol. 2006;176:2367-74). It is applied directly to tissue, acting as a sponge to absorb blood. Pressure for several minutes is necessary for optimal hemostasis. Some surgeons moisten gelatins with topical thrombin prior to use, though no trials exist evaluating the efficacy of this maneuver.

Gelatin is absorbed in 4-6 weeks (J. Urol. 2006;176:2367-74) and can be passed through laparoscopic trocars. No studies have evaluated gelatins in gynecologic surgery so its applications are extrapolated from vascular and urologic surgery (J. Urol. 2006;176:2367-74).

Microporous polysaccharide spheres

Microporous polysaccharide spheres (Arista) form a polysaccharide powder made from potato starch. It absorbs water, concentrating platelets and other proteins to accelerate clot formation. It is applied to a dry surgical field and followed with gentle pressure. MPS is absorbed in 48 hours. No studies specifically evaluate the use of MPS in gynecologic surgery.

Topical thrombins

Thrombin (Thrombin-JMI, Evithrom, Recothrom) is derived from bovine, human, or recombinant sources. It converts fibrinogen to fibrin and activates factor XIII, platelets, and smooth muscle constriction (Biologics 2008;2:593-9). Thrombin is a spray or syringe, and is often used with gelatin foam (Thrombi-Gel) or matrix (FloSeal) (Biologics 2008;2:593-9). FloSeal use has been reported during ovarian cystectomy (J. Minim. Invasive. Gynecol. 2009;16:153-6), hysterotomy repair (J. Obstet. Gynaecol. 2012;32:34-5). During myomectomy, it was associated with decreased blood loss, transfusions, and shorter length of stay (Fertil. Steril. 2009;92:356-60).

Fibrin sealants

Fibrin sealants (Tisseel, TachoSil) are made of thrombin and concentrated fibrinogen from human plasma. They must be mixed prior to application and act by forming a fibrin clot. Tisseel can reduce hemorrhage after loop electrosurgical excision procedure (Gynecol. Obstet. Invest. 2012;74:1-5) and decreases operative time, time to hemostasis, and blood loss during laparoscopic myomectomy (Surg. Endosc. 2012;26:2046-53). Case reports describe the use of fibrin sealants in the management of obstetrical hemorrhage and hysterotomy repair.

Cost and complications

Hemostatic agents vary significantly in cost, but no comparative cost analyses exist. One study found that commercial insurance was associated with topical hemostatic agent use during gynecologic surgery (J. Surg. Res. 2014;186:458-66).

Use of ORC has been associated with postoperative abscess and imitation of abscess without true infection, and MC and gelatins can also increase infection risk. The dry hemostatic agents have been associated with thromboembolism. The complications of thrombins and fibrins are related to immune responses or transmission of pathogens. Recombinant thrombin is believed to be the safest option (J. Am. Coll. Surg. 2007;205:256-65). Floseal has been reported to cause diffuse pelvic inflammation and postoperative small bowel obstruction. Because of possible complications, it is important to use only the needed amount of product, and to dictate use in the operative note.

Despite widespread use of topical hemostatic agents in gynecologic surgery, studies are limited and these agents should be recommended only as adjuncts to conventional methods of achieving hemostasis.

Topical hemostatic agents are recommended for surgical fields that are less amenable to electrocautery, including denuded areas on peritoneal surfaces, and around important heat-sensitive structures such as nerves. The dry matrix agents (ORC, MC, gelatin, and MPS) are most useful in slowly bleeding areas or in patients with a bleeding diathesis. Thrombin and fibrin can be useful in situations when more significant bleeding is encountered. Complications arising from topical hemostatic agents are few.

Given current limited studies, the choice of product continues to depend on patient characteristics and surgeon preference.

Dr. Wysham is currently a fellow in the department of gynecologic oncology at the University of North Carolina at Chapel Hill. Dr. Roque is a fellow in the gynecologic oncology program at UNC-Chapel Hill. Dr. Soper is a professor of gynecologic oncology at UNC-Chapel Hill.

Sutures, hemoclips, and electrocautery are the primary means of achieving hemostasis during gynecologic surgery. When these are inadequate or infeasible, topical hemostatic agents can be employed. Use of these agents has increased by 10%-21% since 2000, yet studies evaluating their use in gynecologic surgery are limited (J. Surg. Res. 2014;186:458-66).

Oxidized regenerated cellulose

Oxidized regenerated cellulose (Surgicel) is made from dissolved oxidized cellulose woven into a dry gauze sheet (J. Urol. 2006;176:2367-74). It is applied directly to tissue, creating a scaffold for platelet aggregation and decreasing tissue pH, further activating the clotting cascade (Surg. Infect. (Larchmt.) 2003;4:255-62). It is absorbed in 14 days, but can persist for 1 year.

Oxidized regenerated cellulose (ORC) is easily passed through laparoscopic trocars. One study found ORC efficacious in controlling tubal hemorrhage during laparoscopic sterilization (Int. J. Gynaecol. Obstet. 2003;82:221-2). It has also been shown to have bactericidal activity (Surg. Infect. (Larchmt.) 2003; 4:255-62) and prevent development of peritoneal adhesions (Acta. Chir. Scand. 1978;144:375-8).

Microfibrillar collagen

Microfibrillar collagen (Avitene) is made from bovine collagen in a powder or sponge sheet, and acts as a scaffold for platelet aggregation. It is applied directly to tissue and is absorbed in 3 months. One study found microfibrillar collagen (MC) use during cold knife conization resulted in nonsignificant reduction in operative time and similar hemostatic results compared to Sturmdorf suture (Obstet. Gynecol. 1978;51:118-22). MC also has been used to treat bleeding following uterine perforation and during laparoscopic hysterectomy.

Gelatins

Gelatins (Gelfoam, Surgifoam) are made of porcine collagen in a powder or foam (J. Urol. 2006;176:2367-74). It is applied directly to tissue, acting as a sponge to absorb blood. Pressure for several minutes is necessary for optimal hemostasis. Some surgeons moisten gelatins with topical thrombin prior to use, though no trials exist evaluating the efficacy of this maneuver.

Gelatin is absorbed in 4-6 weeks (J. Urol. 2006;176:2367-74) and can be passed through laparoscopic trocars. No studies have evaluated gelatins in gynecologic surgery so its applications are extrapolated from vascular and urologic surgery (J. Urol. 2006;176:2367-74).

Microporous polysaccharide spheres

Microporous polysaccharide spheres (Arista) form a polysaccharide powder made from potato starch. It absorbs water, concentrating platelets and other proteins to accelerate clot formation. It is applied to a dry surgical field and followed with gentle pressure. MPS is absorbed in 48 hours. No studies specifically evaluate the use of MPS in gynecologic surgery.

Topical thrombins

Thrombin (Thrombin-JMI, Evithrom, Recothrom) is derived from bovine, human, or recombinant sources. It converts fibrinogen to fibrin and activates factor XIII, platelets, and smooth muscle constriction (Biologics 2008;2:593-9). Thrombin is a spray or syringe, and is often used with gelatin foam (Thrombi-Gel) or matrix (FloSeal) (Biologics 2008;2:593-9). FloSeal use has been reported during ovarian cystectomy (J. Minim. Invasive. Gynecol. 2009;16:153-6), hysterotomy repair (J. Obstet. Gynaecol. 2012;32:34-5). During myomectomy, it was associated with decreased blood loss, transfusions, and shorter length of stay (Fertil. Steril. 2009;92:356-60).

Fibrin sealants

Fibrin sealants (Tisseel, TachoSil) are made of thrombin and concentrated fibrinogen from human plasma. They must be mixed prior to application and act by forming a fibrin clot. Tisseel can reduce hemorrhage after loop electrosurgical excision procedure (Gynecol. Obstet. Invest. 2012;74:1-5) and decreases operative time, time to hemostasis, and blood loss during laparoscopic myomectomy (Surg. Endosc. 2012;26:2046-53). Case reports describe the use of fibrin sealants in the management of obstetrical hemorrhage and hysterotomy repair.

Cost and complications

Hemostatic agents vary significantly in cost, but no comparative cost analyses exist. One study found that commercial insurance was associated with topical hemostatic agent use during gynecologic surgery (J. Surg. Res. 2014;186:458-66).

Use of ORC has been associated with postoperative abscess and imitation of abscess without true infection, and MC and gelatins can also increase infection risk. The dry hemostatic agents have been associated with thromboembolism. The complications of thrombins and fibrins are related to immune responses or transmission of pathogens. Recombinant thrombin is believed to be the safest option (J. Am. Coll. Surg. 2007;205:256-65). Floseal has been reported to cause diffuse pelvic inflammation and postoperative small bowel obstruction. Because of possible complications, it is important to use only the needed amount of product, and to dictate use in the operative note.

Despite widespread use of topical hemostatic agents in gynecologic surgery, studies are limited and these agents should be recommended only as adjuncts to conventional methods of achieving hemostasis.

Topical hemostatic agents are recommended for surgical fields that are less amenable to electrocautery, including denuded areas on peritoneal surfaces, and around important heat-sensitive structures such as nerves. The dry matrix agents (ORC, MC, gelatin, and MPS) are most useful in slowly bleeding areas or in patients with a bleeding diathesis. Thrombin and fibrin can be useful in situations when more significant bleeding is encountered. Complications arising from topical hemostatic agents are few.

Given current limited studies, the choice of product continues to depend on patient characteristics and surgeon preference.

Dr. Wysham is currently a fellow in the department of gynecologic oncology at the University of North Carolina at Chapel Hill. Dr. Roque is a fellow in the gynecologic oncology program at UNC-Chapel Hill. Dr. Soper is a professor of gynecologic oncology at UNC-Chapel Hill.

Sutures, hemoclips, and electrocautery are the primary means of achieving hemostasis during gynecologic surgery. When these are inadequate or infeasible, topical hemostatic agents can be employed. Use of these agents has increased by 10%-21% since 2000, yet studies evaluating their use in gynecologic surgery are limited (J. Surg. Res. 2014;186:458-66).

Oxidized regenerated cellulose

Oxidized regenerated cellulose (Surgicel) is made from dissolved oxidized cellulose woven into a dry gauze sheet (J. Urol. 2006;176:2367-74). It is applied directly to tissue, creating a scaffold for platelet aggregation and decreasing tissue pH, further activating the clotting cascade (Surg. Infect. (Larchmt.) 2003;4:255-62). It is absorbed in 14 days, but can persist for 1 year.

Oxidized regenerated cellulose (ORC) is easily passed through laparoscopic trocars. One study found ORC efficacious in controlling tubal hemorrhage during laparoscopic sterilization (Int. J. Gynaecol. Obstet. 2003;82:221-2). It has also been shown to have bactericidal activity (Surg. Infect. (Larchmt.) 2003; 4:255-62) and prevent development of peritoneal adhesions (Acta. Chir. Scand. 1978;144:375-8).

Microfibrillar collagen

Microfibrillar collagen (Avitene) is made from bovine collagen in a powder or sponge sheet, and acts as a scaffold for platelet aggregation. It is applied directly to tissue and is absorbed in 3 months. One study found microfibrillar collagen (MC) use during cold knife conization resulted in nonsignificant reduction in operative time and similar hemostatic results compared to Sturmdorf suture (Obstet. Gynecol. 1978;51:118-22). MC also has been used to treat bleeding following uterine perforation and during laparoscopic hysterectomy.

Gelatins

Gelatins (Gelfoam, Surgifoam) are made of porcine collagen in a powder or foam (J. Urol. 2006;176:2367-74). It is applied directly to tissue, acting as a sponge to absorb blood. Pressure for several minutes is necessary for optimal hemostasis. Some surgeons moisten gelatins with topical thrombin prior to use, though no trials exist evaluating the efficacy of this maneuver.

Gelatin is absorbed in 4-6 weeks (J. Urol. 2006;176:2367-74) and can be passed through laparoscopic trocars. No studies have evaluated gelatins in gynecologic surgery so its applications are extrapolated from vascular and urologic surgery (J. Urol. 2006;176:2367-74).

Microporous polysaccharide spheres

Microporous polysaccharide spheres (Arista) form a polysaccharide powder made from potato starch. It absorbs water, concentrating platelets and other proteins to accelerate clot formation. It is applied to a dry surgical field and followed with gentle pressure. MPS is absorbed in 48 hours. No studies specifically evaluate the use of MPS in gynecologic surgery.

Topical thrombins

Thrombin (Thrombin-JMI, Evithrom, Recothrom) is derived from bovine, human, or recombinant sources. It converts fibrinogen to fibrin and activates factor XIII, platelets, and smooth muscle constriction (Biologics 2008;2:593-9). Thrombin is a spray or syringe, and is often used with gelatin foam (Thrombi-Gel) or matrix (FloSeal) (Biologics 2008;2:593-9). FloSeal use has been reported during ovarian cystectomy (J. Minim. Invasive. Gynecol. 2009;16:153-6), hysterotomy repair (J. Obstet. Gynaecol. 2012;32:34-5). During myomectomy, it was associated with decreased blood loss, transfusions, and shorter length of stay (Fertil. Steril. 2009;92:356-60).

Fibrin sealants

Fibrin sealants (Tisseel, TachoSil) are made of thrombin and concentrated fibrinogen from human plasma. They must be mixed prior to application and act by forming a fibrin clot. Tisseel can reduce hemorrhage after loop electrosurgical excision procedure (Gynecol. Obstet. Invest. 2012;74:1-5) and decreases operative time, time to hemostasis, and blood loss during laparoscopic myomectomy (Surg. Endosc. 2012;26:2046-53). Case reports describe the use of fibrin sealants in the management of obstetrical hemorrhage and hysterotomy repair.

Cost and complications

Hemostatic agents vary significantly in cost, but no comparative cost analyses exist. One study found that commercial insurance was associated with topical hemostatic agent use during gynecologic surgery (J. Surg. Res. 2014;186:458-66).

Use of ORC has been associated with postoperative abscess and imitation of abscess without true infection, and MC and gelatins can also increase infection risk. The dry hemostatic agents have been associated with thromboembolism. The complications of thrombins and fibrins are related to immune responses or transmission of pathogens. Recombinant thrombin is believed to be the safest option (J. Am. Coll. Surg. 2007;205:256-65). Floseal has been reported to cause diffuse pelvic inflammation and postoperative small bowel obstruction. Because of possible complications, it is important to use only the needed amount of product, and to dictate use in the operative note.

Despite widespread use of topical hemostatic agents in gynecologic surgery, studies are limited and these agents should be recommended only as adjuncts to conventional methods of achieving hemostasis.

Topical hemostatic agents are recommended for surgical fields that are less amenable to electrocautery, including denuded areas on peritoneal surfaces, and around important heat-sensitive structures such as nerves. The dry matrix agents (ORC, MC, gelatin, and MPS) are most useful in slowly bleeding areas or in patients with a bleeding diathesis. Thrombin and fibrin can be useful in situations when more significant bleeding is encountered. Complications arising from topical hemostatic agents are few.

Given current limited studies, the choice of product continues to depend on patient characteristics and surgeon preference.

Dr. Wysham is currently a fellow in the department of gynecologic oncology at the University of North Carolina at Chapel Hill. Dr. Roque is a fellow in the gynecologic oncology program at UNC-Chapel Hill. Dr. Soper is a professor of gynecologic oncology at UNC-Chapel Hill.

He has aged a year since President Obama nominated him for U.S. Surgeon General in November 2013, but on Monday Boston hospitalist Vivek Murthy, MD, was confirmed as the highest physician in America.

According to multiple sources, Dr. Murthy’s outspoken support for stricter gun laws and belief that guns are a public health issue delayed his confirmation due to opposition from the National Rifle Association (NRA), which in a letter to Senate leadership in February said Dr. Murthy’s confirmation would be a “prescription for disaster for America’s gun owners.”

Despite this, Senate Democrats approved his four-year appointment in a 51-43 vote that cut along party lines. In his confirmation hearing in February, Dr. Murthy said he does not “intend to use the surgeon general’s office as a bully pulpit for gun control.”

Dr. Murthy, 37, earned his medical and business degrees from Yale and for the last decade has worked as both an internist and a hospitalist at Brigham and Women’s Hospital in Boston. He is the youngest Surgeon General ever, and the first of Indian-American descent.

"On behalf of America's 44,000 hospitalists, I congratulate Dr. Murthy, a fellow hospitalist and one of our SHM members, on his historic appointment to U.S. Surgeon General," says Society of Hospital Medicine President Burke Kealey, MD, SFHM. "Being America’s doctor requires many of the same traits required of hospitalists: leadership, sharp clinical skills, and the ability to engage with patients. And, like hospitalists in thousands of hospitals across the country, I am confident Dr. Murthy will become an agent of change to improve delivery of care in our country."

In 2008, Dr. Murthy founded Doctors for Obama, a non-profit, grassroots organization of 16,000 physicians and medical students dedicated to transforming the healthcare system. After the election, he changed the name of the organization to Doctors for America. He also started the software company TrialNetworks in 2007 to aid in drug development, and, in 1995, he started an HIV and AIDS education non-profit in India called VISIONS Worldwide.

In a statement from the White House Monday, President Obama applauded the Senate for Dr. Murthy’s confirmation, saying: “Vivek’s confirmation makes us better positioned to save lives around the world and protect the American people here at home.”

Dr. Murthy replaces acting Surgeon General Boris Lushniak, who took over when Regina Benjamin resigned in July 2013. The surgeon general is the U.S.’ top spokesperson on all matters of public health and oversees the 6,700 members of the U.S. Public Health Service Commissioned Corps.

Kelly April Tyrrell is a freelance writer in Madison, Wis.

 Information for this report was published online at cnn.com and usatoday.com.

He has aged a year since President Obama nominated him for U.S. Surgeon General in November 2013, but on Monday Boston hospitalist Vivek Murthy, MD, was confirmed as the highest physician in America.

According to multiple sources, Dr. Murthy’s outspoken support for stricter gun laws and belief that guns are a public health issue delayed his confirmation due to opposition from the National Rifle Association (NRA), which in a letter to Senate leadership in February said Dr. Murthy’s confirmation would be a “prescription for disaster for America’s gun owners.”

Despite this, Senate Democrats approved his four-year appointment in a 51-43 vote that cut along party lines. In his confirmation hearing in February, Dr. Murthy said he does not “intend to use the surgeon general’s office as a bully pulpit for gun control.”

Dr. Murthy, 37, earned his medical and business degrees from Yale and for the last decade has worked as both an internist and a hospitalist at Brigham and Women’s Hospital in Boston. He is the youngest Surgeon General ever, and the first of Indian-American descent.

"On behalf of America's 44,000 hospitalists, I congratulate Dr. Murthy, a fellow hospitalist and one of our SHM members, on his historic appointment to U.S. Surgeon General," says Society of Hospital Medicine President Burke Kealey, MD, SFHM. "Being America’s doctor requires many of the same traits required of hospitalists: leadership, sharp clinical skills, and the ability to engage with patients. And, like hospitalists in thousands of hospitals across the country, I am confident Dr. Murthy will become an agent of change to improve delivery of care in our country."

In 2008, Dr. Murthy founded Doctors for Obama, a non-profit, grassroots organization of 16,000 physicians and medical students dedicated to transforming the healthcare system. After the election, he changed the name of the organization to Doctors for America. He also started the software company TrialNetworks in 2007 to aid in drug development, and, in 1995, he started an HIV and AIDS education non-profit in India called VISIONS Worldwide.

In a statement from the White House Monday, President Obama applauded the Senate for Dr. Murthy’s confirmation, saying: “Vivek’s confirmation makes us better positioned to save lives around the world and protect the American people here at home.”

Dr. Murthy replaces acting Surgeon General Boris Lushniak, who took over when Regina Benjamin resigned in July 2013. The surgeon general is the U.S.’ top spokesperson on all matters of public health and oversees the 6,700 members of the U.S. Public Health Service Commissioned Corps.

Kelly April Tyrrell is a freelance writer in Madison, Wis.

 Information for this report was published online at cnn.com and usatoday.com.

He has aged a year since President Obama nominated him for U.S. Surgeon General in November 2013, but on Monday Boston hospitalist Vivek Murthy, MD, was confirmed as the highest physician in America.

According to multiple sources, Dr. Murthy’s outspoken support for stricter gun laws and belief that guns are a public health issue delayed his confirmation due to opposition from the National Rifle Association (NRA), which in a letter to Senate leadership in February said Dr. Murthy’s confirmation would be a “prescription for disaster for America’s gun owners.”

Despite this, Senate Democrats approved his four-year appointment in a 51-43 vote that cut along party lines. In his confirmation hearing in February, Dr. Murthy said he does not “intend to use the surgeon general’s office as a bully pulpit for gun control.”

Dr. Murthy, 37, earned his medical and business degrees from Yale and for the last decade has worked as both an internist and a hospitalist at Brigham and Women’s Hospital in Boston. He is the youngest Surgeon General ever, and the first of Indian-American descent.

"On behalf of America's 44,000 hospitalists, I congratulate Dr. Murthy, a fellow hospitalist and one of our SHM members, on his historic appointment to U.S. Surgeon General," says Society of Hospital Medicine President Burke Kealey, MD, SFHM. "Being America’s doctor requires many of the same traits required of hospitalists: leadership, sharp clinical skills, and the ability to engage with patients. And, like hospitalists in thousands of hospitals across the country, I am confident Dr. Murthy will become an agent of change to improve delivery of care in our country."

In 2008, Dr. Murthy founded Doctors for Obama, a non-profit, grassroots organization of 16,000 physicians and medical students dedicated to transforming the healthcare system. After the election, he changed the name of the organization to Doctors for America. He also started the software company TrialNetworks in 2007 to aid in drug development, and, in 1995, he started an HIV and AIDS education non-profit in India called VISIONS Worldwide.

In a statement from the White House Monday, President Obama applauded the Senate for Dr. Murthy’s confirmation, saying: “Vivek’s confirmation makes us better positioned to save lives around the world and protect the American people here at home.”

Dr. Murthy replaces acting Surgeon General Boris Lushniak, who took over when Regina Benjamin resigned in July 2013. The surgeon general is the U.S.’ top spokesperson on all matters of public health and oversees the 6,700 members of the U.S. Public Health Service Commissioned Corps.

Kelly April Tyrrell is a freelance writer in Madison, Wis.

 Information for this report was published online at cnn.com and usatoday.com.