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Feds extend ACA enrollment deadline for some
Consumers who have had difficulty enrolling in a health insurance plan through healthcare.gov or through federal call centers will be given extra time to sign up beyond the March 31 open enrollment deadline, according to the Obama administration.
The leeway applies only to those trying to enroll through the federal health insurance exchange, which operates in 27 states. Several other states, including Maryland, Minnesota, and Nevada, also have offered relief to consumers having trouble signing up through those states’ exchanges.
"We are experiencing a surge in demand and are making sure that we will be ready to help consumers who may be in line by the deadline to complete enrollment – either online or over the phone," said Aaron Albright, a spokesman for the Health and Human Services (HHS) department.
The agency has not yet issued guidance on how to get help finishing up the enrollment process or how long the extension would last.
For everyone else, open enrollment ends March 31.
"Like clockwork, another day, another delay," House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) said in a statement. He also noted that HHS Secretary Kathleen Sebelius told the committee in December that there would be no more delays, and that "2 weeks ago an HHS official insisted that the administration did not have ‘statutory authority’ to extend the enrollment period for this year; yet here we are."
Rep. Dave Camp (R-Mich.) and Rep. Kevin Brady (R-Tex.) said in a statement that they are going to press the administration on just how many individuals have paid for their insurance coverage so far – information that HHS says it does not have.
"We have recently obtained information that suggests your most recent testimony before the Ways and Means Committee was at best evasive and perhaps misleading," they wrote in a letter to Ms. Sebelius. They note that the committee has obtained evidence that insurers are indeed submitting payment data to the Centers for Medicare and Medicaid Services.
On Twitter @aliciaault
Consumers who have had difficulty enrolling in a health insurance plan through healthcare.gov or through federal call centers will be given extra time to sign up beyond the March 31 open enrollment deadline, according to the Obama administration.
The leeway applies only to those trying to enroll through the federal health insurance exchange, which operates in 27 states. Several other states, including Maryland, Minnesota, and Nevada, also have offered relief to consumers having trouble signing up through those states’ exchanges.
"We are experiencing a surge in demand and are making sure that we will be ready to help consumers who may be in line by the deadline to complete enrollment – either online or over the phone," said Aaron Albright, a spokesman for the Health and Human Services (HHS) department.
The agency has not yet issued guidance on how to get help finishing up the enrollment process or how long the extension would last.
For everyone else, open enrollment ends March 31.
"Like clockwork, another day, another delay," House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) said in a statement. He also noted that HHS Secretary Kathleen Sebelius told the committee in December that there would be no more delays, and that "2 weeks ago an HHS official insisted that the administration did not have ‘statutory authority’ to extend the enrollment period for this year; yet here we are."
Rep. Dave Camp (R-Mich.) and Rep. Kevin Brady (R-Tex.) said in a statement that they are going to press the administration on just how many individuals have paid for their insurance coverage so far – information that HHS says it does not have.
"We have recently obtained information that suggests your most recent testimony before the Ways and Means Committee was at best evasive and perhaps misleading," they wrote in a letter to Ms. Sebelius. They note that the committee has obtained evidence that insurers are indeed submitting payment data to the Centers for Medicare and Medicaid Services.
On Twitter @aliciaault
Consumers who have had difficulty enrolling in a health insurance plan through healthcare.gov or through federal call centers will be given extra time to sign up beyond the March 31 open enrollment deadline, according to the Obama administration.
The leeway applies only to those trying to enroll through the federal health insurance exchange, which operates in 27 states. Several other states, including Maryland, Minnesota, and Nevada, also have offered relief to consumers having trouble signing up through those states’ exchanges.
"We are experiencing a surge in demand and are making sure that we will be ready to help consumers who may be in line by the deadline to complete enrollment – either online or over the phone," said Aaron Albright, a spokesman for the Health and Human Services (HHS) department.
The agency has not yet issued guidance on how to get help finishing up the enrollment process or how long the extension would last.
For everyone else, open enrollment ends March 31.
"Like clockwork, another day, another delay," House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) said in a statement. He also noted that HHS Secretary Kathleen Sebelius told the committee in December that there would be no more delays, and that "2 weeks ago an HHS official insisted that the administration did not have ‘statutory authority’ to extend the enrollment period for this year; yet here we are."
Rep. Dave Camp (R-Mich.) and Rep. Kevin Brady (R-Tex.) said in a statement that they are going to press the administration on just how many individuals have paid for their insurance coverage so far – information that HHS says it does not have.
"We have recently obtained information that suggests your most recent testimony before the Ways and Means Committee was at best evasive and perhaps misleading," they wrote in a letter to Ms. Sebelius. They note that the committee has obtained evidence that insurers are indeed submitting payment data to the Centers for Medicare and Medicaid Services.
On Twitter @aliciaault
The Downside of Truth
At a recent surgical Morbidity and Mortality Conference, we discussed a tragic case of an elderly gentleman who had been explored for a gastric outlet obstruction. He was found to have a widely metastatic malignancy of unknown primary that was clearly unresectable. Biopsies were taken, a bypass was performed to alleviate the obstruction, and the patient was closed. The surgeon subsequently discussed the findings with the patient and his family. They were understandably upset after getting the news, but plans were made for follow-up and possible treatment when the final pathology was back. During several days in the hospital, the patient seemed to be in good spirits and was seen regularly, encouraging his family not to worry. However, on the day of discharge, the patient went home and committed suicide.
This case raised a series of important questions at the Morbidity and Mortality (M&M) Conference. Had the patient shown signs of depression? Should he have been evaluated by psychiatry? Did the surgical team miss any signs of his impending actions? In the tradition of M&M Conferences, the discussion focused on the question, "What would you have done differently?"
One issue repeatedly raised in the discussions at conference given the patient’s response was whether he should have been told his diagnosis. Such a consideration is a radical idea today when no physician would argue against telling a patient a diagnosis of cancer. But this consensus of full disclosure is relatively new in the medical profession. In 1961, 88% of physicians surveyed at Michael Reese Hospital in Chicago stated that their general policy was not to disclose a cancer diagnosis to the patient (JAMA 1961;175:1120-8). Certainly, this view among physicians has changed dramatically in recent decades. By 1979, the same survey at the same hospital revealed that 98% of physicians said that they tell patients that when the diagnosis is cancer (JAMA 1979;241:897-900).
In the medical profession, a diagnosis is no longer seen as information that can be withheld from a patient. The idea of respecting the patient as a person means that the patient must have the information necessary to make decisions about his or her future.
In this context, the recent New York Times article entitled "When Doctors Need to Lie" (Feb. 22, 2014) is provocative. Dr. Sandeep Jauhar suggests that sometimes there are situations in which doctors need to exercise a form of paternalism and lie to patients for their own benefit. Dr. Jauhar described a case in which he informed the family of a young patient of the true diagnosis, but only gradually and gently told the young man of his true condition.
Informing the elderly gentleman of his diagnosis may well have triggered his suicide. If the patient had not known that he had unresectable cancer, he could well still be alive. Nevertheless, no one at the M&M conference thought that lying about the diagnosis could be justified. Knowing the diagnosis is the fundamental basis for a patient to project a future existence. The ability to make the best medical and nonmedical decisions is dependent on having valid information. Without truthful information, the decisions made are uninformed and no better than guesses. It is not the physician’s role to guess the reaction of a patient to a diagnosis or project a future circumstance that may result from the patient learning the truth.
While the outcome of the transmission of knowledge to the patient may at times be unfortunate, the ethical implications of not telling patients the truth are potentially even more unfortunate. How can a surgeon establish a relationship of trust while also lying to a patient or withholding important information? Even though the choice made by this particular patient was tragic, to have lied to him is contrary to the physician’s role. Truth is the basis of trust, and trust in turn must be the basis of the relationship between doctor and patient.
Dr. Angelos is an ACS Fellow; the Linda Kohler Anderson Professor of Surgery and Surgical Ethics; chief, endocrine surgery; and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.
At a recent surgical Morbidity and Mortality Conference, we discussed a tragic case of an elderly gentleman who had been explored for a gastric outlet obstruction. He was found to have a widely metastatic malignancy of unknown primary that was clearly unresectable. Biopsies were taken, a bypass was performed to alleviate the obstruction, and the patient was closed. The surgeon subsequently discussed the findings with the patient and his family. They were understandably upset after getting the news, but plans were made for follow-up and possible treatment when the final pathology was back. During several days in the hospital, the patient seemed to be in good spirits and was seen regularly, encouraging his family not to worry. However, on the day of discharge, the patient went home and committed suicide.
This case raised a series of important questions at the Morbidity and Mortality (M&M) Conference. Had the patient shown signs of depression? Should he have been evaluated by psychiatry? Did the surgical team miss any signs of his impending actions? In the tradition of M&M Conferences, the discussion focused on the question, "What would you have done differently?"
One issue repeatedly raised in the discussions at conference given the patient’s response was whether he should have been told his diagnosis. Such a consideration is a radical idea today when no physician would argue against telling a patient a diagnosis of cancer. But this consensus of full disclosure is relatively new in the medical profession. In 1961, 88% of physicians surveyed at Michael Reese Hospital in Chicago stated that their general policy was not to disclose a cancer diagnosis to the patient (JAMA 1961;175:1120-8). Certainly, this view among physicians has changed dramatically in recent decades. By 1979, the same survey at the same hospital revealed that 98% of physicians said that they tell patients that when the diagnosis is cancer (JAMA 1979;241:897-900).
In the medical profession, a diagnosis is no longer seen as information that can be withheld from a patient. The idea of respecting the patient as a person means that the patient must have the information necessary to make decisions about his or her future.
In this context, the recent New York Times article entitled "When Doctors Need to Lie" (Feb. 22, 2014) is provocative. Dr. Sandeep Jauhar suggests that sometimes there are situations in which doctors need to exercise a form of paternalism and lie to patients for their own benefit. Dr. Jauhar described a case in which he informed the family of a young patient of the true diagnosis, but only gradually and gently told the young man of his true condition.
Informing the elderly gentleman of his diagnosis may well have triggered his suicide. If the patient had not known that he had unresectable cancer, he could well still be alive. Nevertheless, no one at the M&M conference thought that lying about the diagnosis could be justified. Knowing the diagnosis is the fundamental basis for a patient to project a future existence. The ability to make the best medical and nonmedical decisions is dependent on having valid information. Without truthful information, the decisions made are uninformed and no better than guesses. It is not the physician’s role to guess the reaction of a patient to a diagnosis or project a future circumstance that may result from the patient learning the truth.
While the outcome of the transmission of knowledge to the patient may at times be unfortunate, the ethical implications of not telling patients the truth are potentially even more unfortunate. How can a surgeon establish a relationship of trust while also lying to a patient or withholding important information? Even though the choice made by this particular patient was tragic, to have lied to him is contrary to the physician’s role. Truth is the basis of trust, and trust in turn must be the basis of the relationship between doctor and patient.
Dr. Angelos is an ACS Fellow; the Linda Kohler Anderson Professor of Surgery and Surgical Ethics; chief, endocrine surgery; and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.
At a recent surgical Morbidity and Mortality Conference, we discussed a tragic case of an elderly gentleman who had been explored for a gastric outlet obstruction. He was found to have a widely metastatic malignancy of unknown primary that was clearly unresectable. Biopsies were taken, a bypass was performed to alleviate the obstruction, and the patient was closed. The surgeon subsequently discussed the findings with the patient and his family. They were understandably upset after getting the news, but plans were made for follow-up and possible treatment when the final pathology was back. During several days in the hospital, the patient seemed to be in good spirits and was seen regularly, encouraging his family not to worry. However, on the day of discharge, the patient went home and committed suicide.
This case raised a series of important questions at the Morbidity and Mortality (M&M) Conference. Had the patient shown signs of depression? Should he have been evaluated by psychiatry? Did the surgical team miss any signs of his impending actions? In the tradition of M&M Conferences, the discussion focused on the question, "What would you have done differently?"
One issue repeatedly raised in the discussions at conference given the patient’s response was whether he should have been told his diagnosis. Such a consideration is a radical idea today when no physician would argue against telling a patient a diagnosis of cancer. But this consensus of full disclosure is relatively new in the medical profession. In 1961, 88% of physicians surveyed at Michael Reese Hospital in Chicago stated that their general policy was not to disclose a cancer diagnosis to the patient (JAMA 1961;175:1120-8). Certainly, this view among physicians has changed dramatically in recent decades. By 1979, the same survey at the same hospital revealed that 98% of physicians said that they tell patients that when the diagnosis is cancer (JAMA 1979;241:897-900).
In the medical profession, a diagnosis is no longer seen as information that can be withheld from a patient. The idea of respecting the patient as a person means that the patient must have the information necessary to make decisions about his or her future.
In this context, the recent New York Times article entitled "When Doctors Need to Lie" (Feb. 22, 2014) is provocative. Dr. Sandeep Jauhar suggests that sometimes there are situations in which doctors need to exercise a form of paternalism and lie to patients for their own benefit. Dr. Jauhar described a case in which he informed the family of a young patient of the true diagnosis, but only gradually and gently told the young man of his true condition.
Informing the elderly gentleman of his diagnosis may well have triggered his suicide. If the patient had not known that he had unresectable cancer, he could well still be alive. Nevertheless, no one at the M&M conference thought that lying about the diagnosis could be justified. Knowing the diagnosis is the fundamental basis for a patient to project a future existence. The ability to make the best medical and nonmedical decisions is dependent on having valid information. Without truthful information, the decisions made are uninformed and no better than guesses. It is not the physician’s role to guess the reaction of a patient to a diagnosis or project a future circumstance that may result from the patient learning the truth.
While the outcome of the transmission of knowledge to the patient may at times be unfortunate, the ethical implications of not telling patients the truth are potentially even more unfortunate. How can a surgeon establish a relationship of trust while also lying to a patient or withholding important information? Even though the choice made by this particular patient was tragic, to have lied to him is contrary to the physician’s role. Truth is the basis of trust, and trust in turn must be the basis of the relationship between doctor and patient.
Dr. Angelos is an ACS Fellow; the Linda Kohler Anderson Professor of Surgery and Surgical Ethics; chief, endocrine surgery; and associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago.
Small PNETs may still harbor malignant potential
PHOENIX, ARIZ. – Even small pancreatic neuroendocrine tumors have the potential for malignancy and need excision or close monitoring, investigators caution.
A retrospective cohort study following outcomes for patients with nonfunctional pancreatic neuroendocrine tumors (PNETs) 2 cm in diameter or less found that in an unadjusted analysis stratified by surgery type, those who did not have surgery had significantly worse overall survival 5 years after diagnosis, although there were no significant survival differences among all surgery types, reported Dr. Lauren Gratian of Duke University, Durham, N.C.
PNETs 2 cm in size or smaller are increasing in incidence in the United States, Dr. Gratian said at the annual Society of Surgical Oncology Cancer Symposium. "This is important, because their malignant potential is uncertain, and optimal surgical management remains unclear."
She pointed to National Comprehensive Cancer Network (NCCN) guidelines, which say that nonfunctional PNETs 2 cm or smaller are candidates for either enucleation or partial pancreatic resection, and that in certain cases, observation may be considered. Specifically, tumors smaller than 1 cm that were discovered incidentally may be candidates for observation, with the decision based on estimated surgical risk, site of the tumor, and patient comorbidities.
To get a better handle on the incidence of nonfunctional PNETs over time, discern their malignant potential, and see what factors are associated with survival, the investigators drew from the American College of Surgeons’ National Cancer Data Base (NCDB) for records on patients diagnosed from 1998 through 2011 with nonfunctional PNETs that met the criteria. Patients with functional PNETs, carcinoids, and/or exocrine tumors were excluded.
Of the 1,854 patients identified, 487 with more than 1 malignant primary, unknown surgical status, or surgery/pancreatectomy not otherwise specified were excluded, leaving a survival cohort of 1,367. Of this group, 368 (27%) had no surgery, 586 (43%) had a partial pancreatic resection, 324 (24%) had a pancreatoduodenectomy (Whipple procedure) with or without a partial gastrectomy, and 89 (6%) underwent total pancreatectomy.
The researchers found that the incidence of small nonfunctional PNETs as a percentage of all PNETs increased significantly over time, from 7% in 1998 to 20% in 2010.
When they grouped tumors by size (5 mm or smaller, more than 5 mm up to 1 cm, and more than 1 cm up to 2 cm), they found that there were no differences in tumor propensity for either distant metastases (11%, 9%, and 13%, respectively) or regional lymph node involvement (34%, 21%, and 29%).
Patients with distant metastases were significantly more likely to have had no surgery (P less than .001), and patients with partial pancreatic sections were significantly more likely than those who had undergone Whipple or total procedures to have positive surgical margins (P = .009).
An unadjusted analysis of 5-year overall survival by surgery type showed no significant differences among patients treated with the various procedures, but significantly worse outcomes for patients who had no surgery vs. any surgery (P less than .01).
There were no significant differences in survival between patients who had some regional lymph nodes examined compared with those who had no nodal dissection.
In a proportional hazards analysis adjusted for demographic and clinical features, factors significantly associated with overall survival were older age at diagnosis, which was associated with a higher risk of death (hazard ratio, 1.04; 95% confidence interval, 1.02-1.06); later year of diagnosis, associated with a lower risk (HR, 0.85; 95% CI, 0.77-0.94); and Whipple procedure, which was associated with an increased risk for death vs. partial pancreatectomy (HR, 1.88; 95% CI, 1.13-3.11).
Dr. Gratian noted that the study was limited by the inclusion of only malignant tumors in the database; potential coding errors; missing data on grade and stage of diseases; and the lack of information on variables such as disease recurrence, mitotic rates, or the Ki67 proliferative index.
The funding source for the study was not disclosed. Dr. Gratian and her coauthors reported having no financial disclosures.
PHOENIX, ARIZ. – Even small pancreatic neuroendocrine tumors have the potential for malignancy and need excision or close monitoring, investigators caution.
A retrospective cohort study following outcomes for patients with nonfunctional pancreatic neuroendocrine tumors (PNETs) 2 cm in diameter or less found that in an unadjusted analysis stratified by surgery type, those who did not have surgery had significantly worse overall survival 5 years after diagnosis, although there were no significant survival differences among all surgery types, reported Dr. Lauren Gratian of Duke University, Durham, N.C.
PNETs 2 cm in size or smaller are increasing in incidence in the United States, Dr. Gratian said at the annual Society of Surgical Oncology Cancer Symposium. "This is important, because their malignant potential is uncertain, and optimal surgical management remains unclear."
She pointed to National Comprehensive Cancer Network (NCCN) guidelines, which say that nonfunctional PNETs 2 cm or smaller are candidates for either enucleation or partial pancreatic resection, and that in certain cases, observation may be considered. Specifically, tumors smaller than 1 cm that were discovered incidentally may be candidates for observation, with the decision based on estimated surgical risk, site of the tumor, and patient comorbidities.
To get a better handle on the incidence of nonfunctional PNETs over time, discern their malignant potential, and see what factors are associated with survival, the investigators drew from the American College of Surgeons’ National Cancer Data Base (NCDB) for records on patients diagnosed from 1998 through 2011 with nonfunctional PNETs that met the criteria. Patients with functional PNETs, carcinoids, and/or exocrine tumors were excluded.
Of the 1,854 patients identified, 487 with more than 1 malignant primary, unknown surgical status, or surgery/pancreatectomy not otherwise specified were excluded, leaving a survival cohort of 1,367. Of this group, 368 (27%) had no surgery, 586 (43%) had a partial pancreatic resection, 324 (24%) had a pancreatoduodenectomy (Whipple procedure) with or without a partial gastrectomy, and 89 (6%) underwent total pancreatectomy.
The researchers found that the incidence of small nonfunctional PNETs as a percentage of all PNETs increased significantly over time, from 7% in 1998 to 20% in 2010.
When they grouped tumors by size (5 mm or smaller, more than 5 mm up to 1 cm, and more than 1 cm up to 2 cm), they found that there were no differences in tumor propensity for either distant metastases (11%, 9%, and 13%, respectively) or regional lymph node involvement (34%, 21%, and 29%).
Patients with distant metastases were significantly more likely to have had no surgery (P less than .001), and patients with partial pancreatic sections were significantly more likely than those who had undergone Whipple or total procedures to have positive surgical margins (P = .009).
An unadjusted analysis of 5-year overall survival by surgery type showed no significant differences among patients treated with the various procedures, but significantly worse outcomes for patients who had no surgery vs. any surgery (P less than .01).
There were no significant differences in survival between patients who had some regional lymph nodes examined compared with those who had no nodal dissection.
In a proportional hazards analysis adjusted for demographic and clinical features, factors significantly associated with overall survival were older age at diagnosis, which was associated with a higher risk of death (hazard ratio, 1.04; 95% confidence interval, 1.02-1.06); later year of diagnosis, associated with a lower risk (HR, 0.85; 95% CI, 0.77-0.94); and Whipple procedure, which was associated with an increased risk for death vs. partial pancreatectomy (HR, 1.88; 95% CI, 1.13-3.11).
Dr. Gratian noted that the study was limited by the inclusion of only malignant tumors in the database; potential coding errors; missing data on grade and stage of diseases; and the lack of information on variables such as disease recurrence, mitotic rates, or the Ki67 proliferative index.
The funding source for the study was not disclosed. Dr. Gratian and her coauthors reported having no financial disclosures.
PHOENIX, ARIZ. – Even small pancreatic neuroendocrine tumors have the potential for malignancy and need excision or close monitoring, investigators caution.
A retrospective cohort study following outcomes for patients with nonfunctional pancreatic neuroendocrine tumors (PNETs) 2 cm in diameter or less found that in an unadjusted analysis stratified by surgery type, those who did not have surgery had significantly worse overall survival 5 years after diagnosis, although there were no significant survival differences among all surgery types, reported Dr. Lauren Gratian of Duke University, Durham, N.C.
PNETs 2 cm in size or smaller are increasing in incidence in the United States, Dr. Gratian said at the annual Society of Surgical Oncology Cancer Symposium. "This is important, because their malignant potential is uncertain, and optimal surgical management remains unclear."
She pointed to National Comprehensive Cancer Network (NCCN) guidelines, which say that nonfunctional PNETs 2 cm or smaller are candidates for either enucleation or partial pancreatic resection, and that in certain cases, observation may be considered. Specifically, tumors smaller than 1 cm that were discovered incidentally may be candidates for observation, with the decision based on estimated surgical risk, site of the tumor, and patient comorbidities.
To get a better handle on the incidence of nonfunctional PNETs over time, discern their malignant potential, and see what factors are associated with survival, the investigators drew from the American College of Surgeons’ National Cancer Data Base (NCDB) for records on patients diagnosed from 1998 through 2011 with nonfunctional PNETs that met the criteria. Patients with functional PNETs, carcinoids, and/or exocrine tumors were excluded.
Of the 1,854 patients identified, 487 with more than 1 malignant primary, unknown surgical status, or surgery/pancreatectomy not otherwise specified were excluded, leaving a survival cohort of 1,367. Of this group, 368 (27%) had no surgery, 586 (43%) had a partial pancreatic resection, 324 (24%) had a pancreatoduodenectomy (Whipple procedure) with or without a partial gastrectomy, and 89 (6%) underwent total pancreatectomy.
The researchers found that the incidence of small nonfunctional PNETs as a percentage of all PNETs increased significantly over time, from 7% in 1998 to 20% in 2010.
When they grouped tumors by size (5 mm or smaller, more than 5 mm up to 1 cm, and more than 1 cm up to 2 cm), they found that there were no differences in tumor propensity for either distant metastases (11%, 9%, and 13%, respectively) or regional lymph node involvement (34%, 21%, and 29%).
Patients with distant metastases were significantly more likely to have had no surgery (P less than .001), and patients with partial pancreatic sections were significantly more likely than those who had undergone Whipple or total procedures to have positive surgical margins (P = .009).
An unadjusted analysis of 5-year overall survival by surgery type showed no significant differences among patients treated with the various procedures, but significantly worse outcomes for patients who had no surgery vs. any surgery (P less than .01).
There were no significant differences in survival between patients who had some regional lymph nodes examined compared with those who had no nodal dissection.
In a proportional hazards analysis adjusted for demographic and clinical features, factors significantly associated with overall survival were older age at diagnosis, which was associated with a higher risk of death (hazard ratio, 1.04; 95% confidence interval, 1.02-1.06); later year of diagnosis, associated with a lower risk (HR, 0.85; 95% CI, 0.77-0.94); and Whipple procedure, which was associated with an increased risk for death vs. partial pancreatectomy (HR, 1.88; 95% CI, 1.13-3.11).
Dr. Gratian noted that the study was limited by the inclusion of only malignant tumors in the database; potential coding errors; missing data on grade and stage of diseases; and the lack of information on variables such as disease recurrence, mitotic rates, or the Ki67 proliferative index.
The funding source for the study was not disclosed. Dr. Gratian and her coauthors reported having no financial disclosures.
AT SSO 2014
Major finding: Among patients with pancreatic neuroendocrine tumors 2 cm or smaller, 5-year overall survival was significantly worse for patients treated with observation alone than for those who had any type of surgery (P less than .01).
Data source: A retrospective database cohort study of 1,367 patients from 1998 through 2011 with nonfunctional PNETs.
Disclosures: The funding source for the study was not disclosed. Dr. Gratian and her coauthors reported having no financial disclosures.
Outcomes linked to distance from liver transplant center
Eligible patients who live farther away from a liver transplant center are less likely to be put on a waiting list, less likely to receive a transplant, and more likely to die within 5 years than are those who live closer, according to a report published online March 25 in JAMA.
These findings have broad implications beyond those for liver transplantation alone. "As complex, expensive medical technology evolves, certain services may be offered only at a limited number of sites" – an approach that may be more efficient but that increases the distance between patients and the centers at which they can receive care. "Our study is the first to demonstrate the adverse consequences of centralization of specialized care at a limited number of sites," said Dr. David S. Goldberg of the division of gastroenterology, Hospital of the University of Pennsylvania, Philadelphia, and his associates.
The researchers assessed the medical records of 50,637 patients who were active users of Veterans Affairs outpatient care and had decompensated cirrhosis or hepatocellular carcinoma; of these, 2,895 were wait-listed for liver transplantation during 2003 and 2012. Liver transplantation is offered at only five VA transplant centers, which are located in Houston; Nashville, Tenn.; Pittsburgh; Portland, Ore.; and Richmond, Va.
Patients who lived farther away from these five centers and from non-VA transplant centers were significantly less likely to be wait-listed than were those who lived closer. For example, 66% of veterans who lived within 100 miles of a liver transplant center were wait-listed, compared with less than 51% of those who resided farther away.
Once patients were on the list, they were significantly less likely to receive a liver transplant if they resided far from a transplant center. For example, 70.4% of patients who lived within 100 miles of a transplant center received a transplant, compared with only 58.8% of those who lived 101-200 miles away, 57.3% of those who lived 201-300 miles away, and 53.5% of those who lived 301-500 miles away.
Overall survival also decreased as distance from a liver transplant center increased. For example, a wait-listed patient living 25 miles from a transplant center had a 62.9% probability of survival 5 years from the first hepatic decompensation event, while one who lived 100 miles from a transplant center had a 59.8% probability of surviving 5 years from the first hepatic decompensation event, Dr. Goldberg and his associates wrote (JAMA 2014;311:1234-43).
Several health services including proton-beam therapy, bariatric surgery, and treatment for complex or rare cancers currently are offered at a limited number of sites or are preferentially reimbursed by insurers if they are treated at designated "centers of excellence." The results of this study demonstrate that such centralized care may have the unintended consequence of excluding patients who live farther from these centers from treatment, the investigators added.
This study was supported in part by the U.S. Health Resources and Services Administration. No financial conflicts of interest were reported.
Eligible patients who live farther away from a liver transplant center are less likely to be put on a waiting list, less likely to receive a transplant, and more likely to die within 5 years than are those who live closer, according to a report published online March 25 in JAMA.
These findings have broad implications beyond those for liver transplantation alone. "As complex, expensive medical technology evolves, certain services may be offered only at a limited number of sites" – an approach that may be more efficient but that increases the distance between patients and the centers at which they can receive care. "Our study is the first to demonstrate the adverse consequences of centralization of specialized care at a limited number of sites," said Dr. David S. Goldberg of the division of gastroenterology, Hospital of the University of Pennsylvania, Philadelphia, and his associates.
The researchers assessed the medical records of 50,637 patients who were active users of Veterans Affairs outpatient care and had decompensated cirrhosis or hepatocellular carcinoma; of these, 2,895 were wait-listed for liver transplantation during 2003 and 2012. Liver transplantation is offered at only five VA transplant centers, which are located in Houston; Nashville, Tenn.; Pittsburgh; Portland, Ore.; and Richmond, Va.
Patients who lived farther away from these five centers and from non-VA transplant centers were significantly less likely to be wait-listed than were those who lived closer. For example, 66% of veterans who lived within 100 miles of a liver transplant center were wait-listed, compared with less than 51% of those who resided farther away.
Once patients were on the list, they were significantly less likely to receive a liver transplant if they resided far from a transplant center. For example, 70.4% of patients who lived within 100 miles of a transplant center received a transplant, compared with only 58.8% of those who lived 101-200 miles away, 57.3% of those who lived 201-300 miles away, and 53.5% of those who lived 301-500 miles away.
Overall survival also decreased as distance from a liver transplant center increased. For example, a wait-listed patient living 25 miles from a transplant center had a 62.9% probability of survival 5 years from the first hepatic decompensation event, while one who lived 100 miles from a transplant center had a 59.8% probability of surviving 5 years from the first hepatic decompensation event, Dr. Goldberg and his associates wrote (JAMA 2014;311:1234-43).
Several health services including proton-beam therapy, bariatric surgery, and treatment for complex or rare cancers currently are offered at a limited number of sites or are preferentially reimbursed by insurers if they are treated at designated "centers of excellence." The results of this study demonstrate that such centralized care may have the unintended consequence of excluding patients who live farther from these centers from treatment, the investigators added.
This study was supported in part by the U.S. Health Resources and Services Administration. No financial conflicts of interest were reported.
Eligible patients who live farther away from a liver transplant center are less likely to be put on a waiting list, less likely to receive a transplant, and more likely to die within 5 years than are those who live closer, according to a report published online March 25 in JAMA.
These findings have broad implications beyond those for liver transplantation alone. "As complex, expensive medical technology evolves, certain services may be offered only at a limited number of sites" – an approach that may be more efficient but that increases the distance between patients and the centers at which they can receive care. "Our study is the first to demonstrate the adverse consequences of centralization of specialized care at a limited number of sites," said Dr. David S. Goldberg of the division of gastroenterology, Hospital of the University of Pennsylvania, Philadelphia, and his associates.
The researchers assessed the medical records of 50,637 patients who were active users of Veterans Affairs outpatient care and had decompensated cirrhosis or hepatocellular carcinoma; of these, 2,895 were wait-listed for liver transplantation during 2003 and 2012. Liver transplantation is offered at only five VA transplant centers, which are located in Houston; Nashville, Tenn.; Pittsburgh; Portland, Ore.; and Richmond, Va.
Patients who lived farther away from these five centers and from non-VA transplant centers were significantly less likely to be wait-listed than were those who lived closer. For example, 66% of veterans who lived within 100 miles of a liver transplant center were wait-listed, compared with less than 51% of those who resided farther away.
Once patients were on the list, they were significantly less likely to receive a liver transplant if they resided far from a transplant center. For example, 70.4% of patients who lived within 100 miles of a transplant center received a transplant, compared with only 58.8% of those who lived 101-200 miles away, 57.3% of those who lived 201-300 miles away, and 53.5% of those who lived 301-500 miles away.
Overall survival also decreased as distance from a liver transplant center increased. For example, a wait-listed patient living 25 miles from a transplant center had a 62.9% probability of survival 5 years from the first hepatic decompensation event, while one who lived 100 miles from a transplant center had a 59.8% probability of surviving 5 years from the first hepatic decompensation event, Dr. Goldberg and his associates wrote (JAMA 2014;311:1234-43).
Several health services including proton-beam therapy, bariatric surgery, and treatment for complex or rare cancers currently are offered at a limited number of sites or are preferentially reimbursed by insurers if they are treated at designated "centers of excellence." The results of this study demonstrate that such centralized care may have the unintended consequence of excluding patients who live farther from these centers from treatment, the investigators added.
This study was supported in part by the U.S. Health Resources and Services Administration. No financial conflicts of interest were reported.
From JAMA
Major finding: Living more than 100 miles from a VA transplant center means that veterans in liver failure are less likely to survive to transplant: A wait-listed veteran living 25 miles from a VATC would have a 62.9% 5-year adjusted probability of survival from first hepatic decompensation event, compared with a 59.8% 5-year adjusted probability of survival for a veteran living 100 miles from a VATC.
Data source: A retrospective analysis of the medical records of 50,637 VA patients eligible for liver transplantation in 2003-2012.
Disclosures: This study was supported in part by the U.S. Health Resources and Services Administration. No financial conflicts of interest were reported.
Bariatric surgery reduces uterine cancer risk
TAMPA – Women who undergo bariatric surgery to lose weight are about 70% less likely to develop uterine cancer than are obese women who do not undergo such surgery, according to findings from a large retrospective cohort study.
The risk reduction was even greater (81%) among those who maintained their weight loss after surgery. The findings suggest that obesity may be a modifiable risk factor for uterine cancer, reported Dr. Kristy Kay Ward of the Moores Cancer Center at the University of California, San Diego.
Of more than 7.4 million inpatient admissions among women aged 18 years or older who were registered in the University Health System Consortium dataset from Jan. 1, 2009, to June 1, 2013, 103,797 had a history of bariatric surgery, and 44,345 had a diagnosis of uterine malignancy. The overall rate of uterine malignancy was 599/100,000 patients among those without a history of bariatric surgery, and which was 2.8 times higher among obese vs. nonobese patients within this group (1,409 vs. 496 per 100,000).
The overall rate of uterine cancer among those with a history of bariatric surgery was 408/100,000, but the rate was 2.5 times higher among those with persistent obesity after surgery, compared with those who maintained weight loss after surgery (682/100,000 vs. 270/100,000), Dr. Ward said at the annual meeting of the Society of Gynecologic Oncology.
Compared with obese women without a history of bariatric surgery, the relative risk of uterine cancer was 0.29 for women with prior bariatric surgery, 0.19 for women with normal weight after surgery, and 0.48 for women who remained obese after surgery, so the overall risk reduction with surgery was 70%, the maximum risk reduction (for those with normal weight after surgery) was 81%, and the lowest reduction in risk (for those who had surgery but remained obese) was 52%, Dr. Ward said.
Though limited by the retrospective nature of the study and the fact that the data didn’t differentiate between types of bariatric surgery, the findings are notable, because about 50,000 women were diagnosed with uterine cancer in 2013, making it the most common cancer affecting female reproductive organs. Furthermore, endometrial cancer, which accounts for 95% of uterine cancers, is associated with obesity in about 50% of cases, she explained.
In fact, obese women are two- to fourfold more likely to develop endometrial cancer than are women of normal weight, she said.
The current findings suggest that "a history of bariatric surgery is associated with substantial and clinically significantly reduced risk of uterine malignancy," she said, adding: "Our previous work, in agreement with the findings of others, had indicated that the risk of uterine malignancy increases linearly with BMI [body mass index]. Along with the findings of the current study, this supports that obesity may be a modifiable risk factor related to the development of endometrial cancer."
The mechanism for the link between bariatric surgery and reduced uterine cancer risk remains unclear, but fat loss likely plays a role, as adiposity is known to increase endogenous estrogen circulation. The bariatric surgery itself may also "somehow be influencing the immune system and decreasing inflammation," thereby contributing to decreased cancer risk, Dr. Ward noted.
The findings suggest that weight reduction measures, including bariatric surgery in appropriate candidates, are vitally important in obese women, she said.
"Screening of patients, counseling patients about the dangers of obesity, and appropriate referral for bariatric surgery may have great impact on the overall health of this population," she concluded, adding that future research should examine the benefits of bariatric surgery for the reduction of cancer, including endometrial cancer.
Dr. Ward reported having no disclosures.
TAMPA – Women who undergo bariatric surgery to lose weight are about 70% less likely to develop uterine cancer than are obese women who do not undergo such surgery, according to findings from a large retrospective cohort study.
The risk reduction was even greater (81%) among those who maintained their weight loss after surgery. The findings suggest that obesity may be a modifiable risk factor for uterine cancer, reported Dr. Kristy Kay Ward of the Moores Cancer Center at the University of California, San Diego.
Of more than 7.4 million inpatient admissions among women aged 18 years or older who were registered in the University Health System Consortium dataset from Jan. 1, 2009, to June 1, 2013, 103,797 had a history of bariatric surgery, and 44,345 had a diagnosis of uterine malignancy. The overall rate of uterine malignancy was 599/100,000 patients among those without a history of bariatric surgery, and which was 2.8 times higher among obese vs. nonobese patients within this group (1,409 vs. 496 per 100,000).
The overall rate of uterine cancer among those with a history of bariatric surgery was 408/100,000, but the rate was 2.5 times higher among those with persistent obesity after surgery, compared with those who maintained weight loss after surgery (682/100,000 vs. 270/100,000), Dr. Ward said at the annual meeting of the Society of Gynecologic Oncology.
Compared with obese women without a history of bariatric surgery, the relative risk of uterine cancer was 0.29 for women with prior bariatric surgery, 0.19 for women with normal weight after surgery, and 0.48 for women who remained obese after surgery, so the overall risk reduction with surgery was 70%, the maximum risk reduction (for those with normal weight after surgery) was 81%, and the lowest reduction in risk (for those who had surgery but remained obese) was 52%, Dr. Ward said.
Though limited by the retrospective nature of the study and the fact that the data didn’t differentiate between types of bariatric surgery, the findings are notable, because about 50,000 women were diagnosed with uterine cancer in 2013, making it the most common cancer affecting female reproductive organs. Furthermore, endometrial cancer, which accounts for 95% of uterine cancers, is associated with obesity in about 50% of cases, she explained.
In fact, obese women are two- to fourfold more likely to develop endometrial cancer than are women of normal weight, she said.
The current findings suggest that "a history of bariatric surgery is associated with substantial and clinically significantly reduced risk of uterine malignancy," she said, adding: "Our previous work, in agreement with the findings of others, had indicated that the risk of uterine malignancy increases linearly with BMI [body mass index]. Along with the findings of the current study, this supports that obesity may be a modifiable risk factor related to the development of endometrial cancer."
The mechanism for the link between bariatric surgery and reduced uterine cancer risk remains unclear, but fat loss likely plays a role, as adiposity is known to increase endogenous estrogen circulation. The bariatric surgery itself may also "somehow be influencing the immune system and decreasing inflammation," thereby contributing to decreased cancer risk, Dr. Ward noted.
The findings suggest that weight reduction measures, including bariatric surgery in appropriate candidates, are vitally important in obese women, she said.
"Screening of patients, counseling patients about the dangers of obesity, and appropriate referral for bariatric surgery may have great impact on the overall health of this population," she concluded, adding that future research should examine the benefits of bariatric surgery for the reduction of cancer, including endometrial cancer.
Dr. Ward reported having no disclosures.
TAMPA – Women who undergo bariatric surgery to lose weight are about 70% less likely to develop uterine cancer than are obese women who do not undergo such surgery, according to findings from a large retrospective cohort study.
The risk reduction was even greater (81%) among those who maintained their weight loss after surgery. The findings suggest that obesity may be a modifiable risk factor for uterine cancer, reported Dr. Kristy Kay Ward of the Moores Cancer Center at the University of California, San Diego.
Of more than 7.4 million inpatient admissions among women aged 18 years or older who were registered in the University Health System Consortium dataset from Jan. 1, 2009, to June 1, 2013, 103,797 had a history of bariatric surgery, and 44,345 had a diagnosis of uterine malignancy. The overall rate of uterine malignancy was 599/100,000 patients among those without a history of bariatric surgery, and which was 2.8 times higher among obese vs. nonobese patients within this group (1,409 vs. 496 per 100,000).
The overall rate of uterine cancer among those with a history of bariatric surgery was 408/100,000, but the rate was 2.5 times higher among those with persistent obesity after surgery, compared with those who maintained weight loss after surgery (682/100,000 vs. 270/100,000), Dr. Ward said at the annual meeting of the Society of Gynecologic Oncology.
Compared with obese women without a history of bariatric surgery, the relative risk of uterine cancer was 0.29 for women with prior bariatric surgery, 0.19 for women with normal weight after surgery, and 0.48 for women who remained obese after surgery, so the overall risk reduction with surgery was 70%, the maximum risk reduction (for those with normal weight after surgery) was 81%, and the lowest reduction in risk (for those who had surgery but remained obese) was 52%, Dr. Ward said.
Though limited by the retrospective nature of the study and the fact that the data didn’t differentiate between types of bariatric surgery, the findings are notable, because about 50,000 women were diagnosed with uterine cancer in 2013, making it the most common cancer affecting female reproductive organs. Furthermore, endometrial cancer, which accounts for 95% of uterine cancers, is associated with obesity in about 50% of cases, she explained.
In fact, obese women are two- to fourfold more likely to develop endometrial cancer than are women of normal weight, she said.
The current findings suggest that "a history of bariatric surgery is associated with substantial and clinically significantly reduced risk of uterine malignancy," she said, adding: "Our previous work, in agreement with the findings of others, had indicated that the risk of uterine malignancy increases linearly with BMI [body mass index]. Along with the findings of the current study, this supports that obesity may be a modifiable risk factor related to the development of endometrial cancer."
The mechanism for the link between bariatric surgery and reduced uterine cancer risk remains unclear, but fat loss likely plays a role, as adiposity is known to increase endogenous estrogen circulation. The bariatric surgery itself may also "somehow be influencing the immune system and decreasing inflammation," thereby contributing to decreased cancer risk, Dr. Ward noted.
The findings suggest that weight reduction measures, including bariatric surgery in appropriate candidates, are vitally important in obese women, she said.
"Screening of patients, counseling patients about the dangers of obesity, and appropriate referral for bariatric surgery may have great impact on the overall health of this population," she concluded, adding that future research should examine the benefits of bariatric surgery for the reduction of cancer, including endometrial cancer.
Dr. Ward reported having no disclosures.
AT THE ANNUAL MEETING ON WOMEN’S CANCER
Major finding: Bariatric surgery was associated with a 70% reduction in risk of uterine cancer.
Data source: A retrospective cohort study involving more than 7.4 million inpatient admissions.
Disclosures: Dr. Ward reported having no disclosures.
VIDEO: The DecisionDx-Melanoma test can predict metastasis of sentinel node-negative melanomas
DENVER – A 134-patient study of patients with stage I, II, or III cutaneous melanoma found that the DecisionDx-Melanoma test was useful for identifying a high-risk group of patients with negative sentinel lymph node biopsy results.
In a video interview, Dr. Pedram Gerami of the department of dermatology and director of melanoma research at the Northwestern University Skin Cancer Institute, Chicago, explains the best uses for the test and its patient management advantages.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @naseemmiller
DENVER – A 134-patient study of patients with stage I, II, or III cutaneous melanoma found that the DecisionDx-Melanoma test was useful for identifying a high-risk group of patients with negative sentinel lymph node biopsy results.
In a video interview, Dr. Pedram Gerami of the department of dermatology and director of melanoma research at the Northwestern University Skin Cancer Institute, Chicago, explains the best uses for the test and its patient management advantages.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @naseemmiller
DENVER – A 134-patient study of patients with stage I, II, or III cutaneous melanoma found that the DecisionDx-Melanoma test was useful for identifying a high-risk group of patients with negative sentinel lymph node biopsy results.
In a video interview, Dr. Pedram Gerami of the department of dermatology and director of melanoma research at the Northwestern University Skin Cancer Institute, Chicago, explains the best uses for the test and its patient management advantages.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @naseemmiller
AT THE AAD ANNUAL MEETING
Gene test predicts metastasis of sentinel node-negative melanomas
DENVER – A gene expression profile test was an independent predictor of metastasis of primary cutaneous melanomas in patients with negative sentinel lymph node biopsies.
The DecisionDx-Melanoma test is useful for identifying a high-risk group of patients with negative sentinel lymph node biopsy results, said Dr. Pedram Gerami of the department of dermatology and director of melanoma research at the Northwestern University, Chicago, Skin Cancer Institute. The test "is an independent predictor of metastasis and death, and significantly improves upon sentinel lymph node biopsy for staging melanoma patients."
The results of the DecisionDx-Melanoma test, a noninvasive 31-gene expression profile (GEP) test, were compared with the results of sentinel lymph node biopsy (SLNB) in 134 patients who had stage I, II, or III cutaneous melanoma and underwent a documented sentinel lymph node procedure. Of the 134 patients, 28 had positive sentinel lymph nodes and 91 had positive (class 2, high risk) GEP results.
Metastases developed over a subsequent 5-year period in 18 of the 28 patients with positive SLNB and in 62 of the 91 patients with positive GEP results. Metastases developed in 51 of the 106 patients with negative SLNB and in 7 of 43 patients with negative (class 1, low risk) GEP results.
While the positive predictive value of the two tests were comparable, the ability of GEP to predict negative outcomes was significantly better than that of SLNB (P less than .0001), Dr. Gerami reported at the annual meeting of the American Academy of Dermatology.
The rate of 5-year metastasis-free survival (MFS) was 55% for 106 patients with negative SLNB, compared to 37% for 28 patients with positive SLNB (P = .003). The GEP test results showed improved prognostic accuracy in these same patients with an MFS of 87% for the 43 patients with negative GEP (class 1, low risk) results and of 31% for the 91 patients with positive GEP (class 2, high risk) results (P less than .0001).
Differences in overall survival (OS) paralleled the MFS rates, with SLNB-negative patients having a 5-year OS of 67% and SLNB-positive patients having a 5-year OS of 55% (P = .024). OS for negative GEP (class 1, low risk) patients was 92% and for positive GEP (high risk, class 2) was 49% (P less than .0001).
Use of the GEP test also was analyzed in combination with SLNB status. As expected, the 20% of patients (n = 27) who had high-risk results for both tests (GEP class 2 and SLNB-positive findings) had lower survival rates (MFS, 34%; OS, 53%). Similarly, the 31% of patients (n = 42) who had low-risk results for both tests (GEP class 1 and SLNB-negative findings) had higher survival rates (MFS, 82%; OS, 92%).
Importantly, the MFS was 31% and the OS was 49% at 5 years in the 64 patients who had SLNB-negative results but class 2 GEP test results, Dr. Gerami said. Cox multivariate analysis comparing the GEP test to SLNB showed the GEP test to be the only independent and highly significant prognostic factor in this analysis (P less than .000003).
Dr. Gerami has been a consultant to Castle Biosciences. The DecisionDx-Melanoma test is a product of Castle Biosciences, the sponsor of the study. More information about the test can be found at www.skinmelanoma.com.
On Twitter @maryjodales
DENVER – A gene expression profile test was an independent predictor of metastasis of primary cutaneous melanomas in patients with negative sentinel lymph node biopsies.
The DecisionDx-Melanoma test is useful for identifying a high-risk group of patients with negative sentinel lymph node biopsy results, said Dr. Pedram Gerami of the department of dermatology and director of melanoma research at the Northwestern University, Chicago, Skin Cancer Institute. The test "is an independent predictor of metastasis and death, and significantly improves upon sentinel lymph node biopsy for staging melanoma patients."
The results of the DecisionDx-Melanoma test, a noninvasive 31-gene expression profile (GEP) test, were compared with the results of sentinel lymph node biopsy (SLNB) in 134 patients who had stage I, II, or III cutaneous melanoma and underwent a documented sentinel lymph node procedure. Of the 134 patients, 28 had positive sentinel lymph nodes and 91 had positive (class 2, high risk) GEP results.
Metastases developed over a subsequent 5-year period in 18 of the 28 patients with positive SLNB and in 62 of the 91 patients with positive GEP results. Metastases developed in 51 of the 106 patients with negative SLNB and in 7 of 43 patients with negative (class 1, low risk) GEP results.
While the positive predictive value of the two tests were comparable, the ability of GEP to predict negative outcomes was significantly better than that of SLNB (P less than .0001), Dr. Gerami reported at the annual meeting of the American Academy of Dermatology.
The rate of 5-year metastasis-free survival (MFS) was 55% for 106 patients with negative SLNB, compared to 37% for 28 patients with positive SLNB (P = .003). The GEP test results showed improved prognostic accuracy in these same patients with an MFS of 87% for the 43 patients with negative GEP (class 1, low risk) results and of 31% for the 91 patients with positive GEP (class 2, high risk) results (P less than .0001).
Differences in overall survival (OS) paralleled the MFS rates, with SLNB-negative patients having a 5-year OS of 67% and SLNB-positive patients having a 5-year OS of 55% (P = .024). OS for negative GEP (class 1, low risk) patients was 92% and for positive GEP (high risk, class 2) was 49% (P less than .0001).
Use of the GEP test also was analyzed in combination with SLNB status. As expected, the 20% of patients (n = 27) who had high-risk results for both tests (GEP class 2 and SLNB-positive findings) had lower survival rates (MFS, 34%; OS, 53%). Similarly, the 31% of patients (n = 42) who had low-risk results for both tests (GEP class 1 and SLNB-negative findings) had higher survival rates (MFS, 82%; OS, 92%).
Importantly, the MFS was 31% and the OS was 49% at 5 years in the 64 patients who had SLNB-negative results but class 2 GEP test results, Dr. Gerami said. Cox multivariate analysis comparing the GEP test to SLNB showed the GEP test to be the only independent and highly significant prognostic factor in this analysis (P less than .000003).
Dr. Gerami has been a consultant to Castle Biosciences. The DecisionDx-Melanoma test is a product of Castle Biosciences, the sponsor of the study. More information about the test can be found at www.skinmelanoma.com.
On Twitter @maryjodales
DENVER – A gene expression profile test was an independent predictor of metastasis of primary cutaneous melanomas in patients with negative sentinel lymph node biopsies.
The DecisionDx-Melanoma test is useful for identifying a high-risk group of patients with negative sentinel lymph node biopsy results, said Dr. Pedram Gerami of the department of dermatology and director of melanoma research at the Northwestern University, Chicago, Skin Cancer Institute. The test "is an independent predictor of metastasis and death, and significantly improves upon sentinel lymph node biopsy for staging melanoma patients."
The results of the DecisionDx-Melanoma test, a noninvasive 31-gene expression profile (GEP) test, were compared with the results of sentinel lymph node biopsy (SLNB) in 134 patients who had stage I, II, or III cutaneous melanoma and underwent a documented sentinel lymph node procedure. Of the 134 patients, 28 had positive sentinel lymph nodes and 91 had positive (class 2, high risk) GEP results.
Metastases developed over a subsequent 5-year period in 18 of the 28 patients with positive SLNB and in 62 of the 91 patients with positive GEP results. Metastases developed in 51 of the 106 patients with negative SLNB and in 7 of 43 patients with negative (class 1, low risk) GEP results.
While the positive predictive value of the two tests were comparable, the ability of GEP to predict negative outcomes was significantly better than that of SLNB (P less than .0001), Dr. Gerami reported at the annual meeting of the American Academy of Dermatology.
The rate of 5-year metastasis-free survival (MFS) was 55% for 106 patients with negative SLNB, compared to 37% for 28 patients with positive SLNB (P = .003). The GEP test results showed improved prognostic accuracy in these same patients with an MFS of 87% for the 43 patients with negative GEP (class 1, low risk) results and of 31% for the 91 patients with positive GEP (class 2, high risk) results (P less than .0001).
Differences in overall survival (OS) paralleled the MFS rates, with SLNB-negative patients having a 5-year OS of 67% and SLNB-positive patients having a 5-year OS of 55% (P = .024). OS for negative GEP (class 1, low risk) patients was 92% and for positive GEP (high risk, class 2) was 49% (P less than .0001).
Use of the GEP test also was analyzed in combination with SLNB status. As expected, the 20% of patients (n = 27) who had high-risk results for both tests (GEP class 2 and SLNB-positive findings) had lower survival rates (MFS, 34%; OS, 53%). Similarly, the 31% of patients (n = 42) who had low-risk results for both tests (GEP class 1 and SLNB-negative findings) had higher survival rates (MFS, 82%; OS, 92%).
Importantly, the MFS was 31% and the OS was 49% at 5 years in the 64 patients who had SLNB-negative results but class 2 GEP test results, Dr. Gerami said. Cox multivariate analysis comparing the GEP test to SLNB showed the GEP test to be the only independent and highly significant prognostic factor in this analysis (P less than .000003).
Dr. Gerami has been a consultant to Castle Biosciences. The DecisionDx-Melanoma test is a product of Castle Biosciences, the sponsor of the study. More information about the test can be found at www.skinmelanoma.com.
On Twitter @maryjodales
AT THE AAD ANNUAL MEETING
Major finding: Metastasis-free survival was 31% and overall survival was 49% at 5 years in the 64 patients who had negative sentinel node lymph biopsy results and high-risk, class 2 gene expression profile test results.
Data source: A study of 134 patients who had stage I, II, or III cutaneous melanoma and underwent a documented sentinel lymph node procedure.
Disclosures: Dr. Gerami has been a consultant to Castle Biosciences. The DecisionDx-Melanoma test is a product of Castle Biosciences, the study sponsor.
Contraception challenge could have broad impact on medicine
Should a company be required to provide employees with health insurance coverage for contraception if the owner says it is a violation of his or her religious beliefs?
That’s one issue the Supreme Court will consider when it hears oral arguments March 25 in cases filed by Hobby Lobby Stores and Conestoga Wood Specialties Corp.
Each company objects to the Affordable Care Act’s requirement that insurance plans (with some exceptions) provide coverage of family planning counseling and any Food and Drug Administration–approved contraceptive method, as well as follow-up counseling and management, all at no cost to employees.
If the court rules in favor of the companies, millions of women potentially could lose their health care coverage for contraception.
More chillingly, such a ruling could lead to interference in the physician-patient relationship. Further, if for-profit employers are allowed to deny coverage of contraception based on religion, might they eventually seek to drop coverage for vaccination, psychiatric care, transfusions, and other medical procedures from their health plans?
"It would be a dangerous precedent," Dr. Hal C. Lawrence III, executive vice president and chief executive officer of the American Congress of Obstetricians and Gynecologists (ACOG), said in a briefing with reporters.
Tom Goldstein, a partner with law firm Goldstein & Russell and the publisher of SCOTUSblog, agreed.
"The legal principle invoked by the plaintiffs has some potentially startling implications for what one might claim as a religious liberty," he said at a briefing sponsored by the Kaiser Family Foundation. A ruling in their favor could result in "more expansive, more troubling claims," including denial of coverage for other medical procedures and, potentially, discrimination based on race, ethnicity, gender, or sexual orientation – all in the name of religious freedom.
Not all insurance plans must provide contraception coverage under the ACA. Health plans that existed before 2010 and have not substantially changed since are "grandfathered" and don’t have to provide coverage. Plans offered by nonprofit religious organizations are exempt. Nonprofit, religiously affiliated employers also are accommodated. If these employers object to providing coverage on religious grounds, they must notify their insurer. The employer can elect not to pay for that benefit, but the insurer has to reimburse the worker for contraception.
There are no exemptions for plans offered by secular employers, which face a $100 per day per enrollee penalty if they do not provide coverage. Hobby Lobby could face fines of up to $475 million a year, and Conestoga could be looking at $35 million a year in penalties, according to Laurie Sobel, a senior policy analyst with the Kaiser Family Foundation.
The contraception requirement has triggered at least 93 lawsuits. Some object to providing any contraception coverage, while others focus in on emergency contraception. The Hobby Lobby and Conestoga cases are the first to make it to the Supreme Court.
Religious objections
The family that owns Hobby Lobby, a chain with 500 stores and 13,000 employees, says it objects to covering Plan B, Ella, or IUDs because doing so violates its religious beliefs and First Amendment rights.
The Hahn family, which owns the 950-employee Conestoga Wood Specialties, says that it objects to covering Plan B or Ella for the same reasons.
Both object to covering family planning counseling as well.
The companies argue that the Religious Freedom Restoration Act of 1993 gives them the right to deny coverage. The task before their attorneys is to convince Supreme Court justices that a corporation can have religious beliefs and that expressing those beliefs is covered by the First Amendment.
Their arguments are supported by 59 amicus (friend of the court) briefs filed by religious groups and related parties.
The court has not upheld anything like that before, according to Marci A. Hamilton, the Paul R. Verkuil Chair in Public Law at the Benjamin N. Cardozo School of Law at Yeshiva University in New York. Religious beliefs are usually strictly protected, but religious conduct, which has the potential to harm people, can be governed, Ms. Hamilton said at the Kaiser briefing.
Contraception and public health
The government is arguing that it has a compelling interest to require contraception coverage and family planning because it helps prevent unintended pregnancy and thus improves the health of women and children.
This argument is supported in 23 amicus briefs filed by groups including physician organizations such as ACOG, the American Academy of Pediatrics, the Association of Reproductive Health Professionals, the California Medical Association, the Massachusetts Medical Society, and the Society for Maternal-Fetal Medicine, among others.
"The value of family planning, including contraception, has been clearly demonstrated for decades," said Dr. Lawrence of ACOG. It gives women the ability to prevent unintended pregnancy and to time and space pregnancies, and it helps to reduce fetal and maternal morbidity and mortality, he said.
Dr. Lawrence noted that Hobby Lobby and Conestoga were characterizing emergency contraception as abortion methods. "The best scientific evidence shows that emergency contraception works by inhibiting ovulation," he said. "This is contraception, not abortion."
Doctor-patient relationship
If the court upholds the companies’ objection to counseling, that also could open the door to a wide range of restrictions on what physicians can talk to their patients about.
"Your employer would be telling your doctor what you can and can’t talk about," said Adam Sonfield, a senior public policy associate with the Guttmacher Institute. "That would be a clear violation of the rights of the patient ... and could even be considered malpractice."
Dr. Lawrence said that "to not be able to educate patients about their bodies is anathema to women’s health care."
Decisions about a woman’s needs and her health should be between her and her doctor and "should not include input from a woman’s boss," he added.
That sentiment was echoed by ACOG and other medical groups in their brief. They said that "important, private medical decisions should be made by a patient in consultation with her health care provider. There is no role for a woman’s employer in these decisions."
Predictions on ruling?
The Supreme Court could make its ruling any time between March 25 and the end of its current term in late June. Legal experts at the Kaiser Family Foundation and National Health Law Program said they did not expect a ruling in favor of the plaintiffs, Hobby Lobby and Conestoga Wood.
Should the court support the companies’ arguments, however, many state laws require contraceptive equity, said Susan Berke Fogel, director of Reproductive Health at the National Health Law Program.
Mr. Sonfeld of the Guttmacher Institute also noted that 28 states require employers to cover the full range of FDA-approved contraceptives.
On Twitter @aliciaault
Should a company be required to provide employees with health insurance coverage for contraception if the owner says it is a violation of his or her religious beliefs?
That’s one issue the Supreme Court will consider when it hears oral arguments March 25 in cases filed by Hobby Lobby Stores and Conestoga Wood Specialties Corp.
Each company objects to the Affordable Care Act’s requirement that insurance plans (with some exceptions) provide coverage of family planning counseling and any Food and Drug Administration–approved contraceptive method, as well as follow-up counseling and management, all at no cost to employees.
If the court rules in favor of the companies, millions of women potentially could lose their health care coverage for contraception.
More chillingly, such a ruling could lead to interference in the physician-patient relationship. Further, if for-profit employers are allowed to deny coverage of contraception based on religion, might they eventually seek to drop coverage for vaccination, psychiatric care, transfusions, and other medical procedures from their health plans?
"It would be a dangerous precedent," Dr. Hal C. Lawrence III, executive vice president and chief executive officer of the American Congress of Obstetricians and Gynecologists (ACOG), said in a briefing with reporters.
Tom Goldstein, a partner with law firm Goldstein & Russell and the publisher of SCOTUSblog, agreed.
"The legal principle invoked by the plaintiffs has some potentially startling implications for what one might claim as a religious liberty," he said at a briefing sponsored by the Kaiser Family Foundation. A ruling in their favor could result in "more expansive, more troubling claims," including denial of coverage for other medical procedures and, potentially, discrimination based on race, ethnicity, gender, or sexual orientation – all in the name of religious freedom.
Not all insurance plans must provide contraception coverage under the ACA. Health plans that existed before 2010 and have not substantially changed since are "grandfathered" and don’t have to provide coverage. Plans offered by nonprofit religious organizations are exempt. Nonprofit, religiously affiliated employers also are accommodated. If these employers object to providing coverage on religious grounds, they must notify their insurer. The employer can elect not to pay for that benefit, but the insurer has to reimburse the worker for contraception.
There are no exemptions for plans offered by secular employers, which face a $100 per day per enrollee penalty if they do not provide coverage. Hobby Lobby could face fines of up to $475 million a year, and Conestoga could be looking at $35 million a year in penalties, according to Laurie Sobel, a senior policy analyst with the Kaiser Family Foundation.
The contraception requirement has triggered at least 93 lawsuits. Some object to providing any contraception coverage, while others focus in on emergency contraception. The Hobby Lobby and Conestoga cases are the first to make it to the Supreme Court.
Religious objections
The family that owns Hobby Lobby, a chain with 500 stores and 13,000 employees, says it objects to covering Plan B, Ella, or IUDs because doing so violates its religious beliefs and First Amendment rights.
The Hahn family, which owns the 950-employee Conestoga Wood Specialties, says that it objects to covering Plan B or Ella for the same reasons.
Both object to covering family planning counseling as well.
The companies argue that the Religious Freedom Restoration Act of 1993 gives them the right to deny coverage. The task before their attorneys is to convince Supreme Court justices that a corporation can have religious beliefs and that expressing those beliefs is covered by the First Amendment.
Their arguments are supported by 59 amicus (friend of the court) briefs filed by religious groups and related parties.
The court has not upheld anything like that before, according to Marci A. Hamilton, the Paul R. Verkuil Chair in Public Law at the Benjamin N. Cardozo School of Law at Yeshiva University in New York. Religious beliefs are usually strictly protected, but religious conduct, which has the potential to harm people, can be governed, Ms. Hamilton said at the Kaiser briefing.
Contraception and public health
The government is arguing that it has a compelling interest to require contraception coverage and family planning because it helps prevent unintended pregnancy and thus improves the health of women and children.
This argument is supported in 23 amicus briefs filed by groups including physician organizations such as ACOG, the American Academy of Pediatrics, the Association of Reproductive Health Professionals, the California Medical Association, the Massachusetts Medical Society, and the Society for Maternal-Fetal Medicine, among others.
"The value of family planning, including contraception, has been clearly demonstrated for decades," said Dr. Lawrence of ACOG. It gives women the ability to prevent unintended pregnancy and to time and space pregnancies, and it helps to reduce fetal and maternal morbidity and mortality, he said.
Dr. Lawrence noted that Hobby Lobby and Conestoga were characterizing emergency contraception as abortion methods. "The best scientific evidence shows that emergency contraception works by inhibiting ovulation," he said. "This is contraception, not abortion."
Doctor-patient relationship
If the court upholds the companies’ objection to counseling, that also could open the door to a wide range of restrictions on what physicians can talk to their patients about.
"Your employer would be telling your doctor what you can and can’t talk about," said Adam Sonfield, a senior public policy associate with the Guttmacher Institute. "That would be a clear violation of the rights of the patient ... and could even be considered malpractice."
Dr. Lawrence said that "to not be able to educate patients about their bodies is anathema to women’s health care."
Decisions about a woman’s needs and her health should be between her and her doctor and "should not include input from a woman’s boss," he added.
That sentiment was echoed by ACOG and other medical groups in their brief. They said that "important, private medical decisions should be made by a patient in consultation with her health care provider. There is no role for a woman’s employer in these decisions."
Predictions on ruling?
The Supreme Court could make its ruling any time between March 25 and the end of its current term in late June. Legal experts at the Kaiser Family Foundation and National Health Law Program said they did not expect a ruling in favor of the plaintiffs, Hobby Lobby and Conestoga Wood.
Should the court support the companies’ arguments, however, many state laws require contraceptive equity, said Susan Berke Fogel, director of Reproductive Health at the National Health Law Program.
Mr. Sonfeld of the Guttmacher Institute also noted that 28 states require employers to cover the full range of FDA-approved contraceptives.
On Twitter @aliciaault
Should a company be required to provide employees with health insurance coverage for contraception if the owner says it is a violation of his or her religious beliefs?
That’s one issue the Supreme Court will consider when it hears oral arguments March 25 in cases filed by Hobby Lobby Stores and Conestoga Wood Specialties Corp.
Each company objects to the Affordable Care Act’s requirement that insurance plans (with some exceptions) provide coverage of family planning counseling and any Food and Drug Administration–approved contraceptive method, as well as follow-up counseling and management, all at no cost to employees.
If the court rules in favor of the companies, millions of women potentially could lose their health care coverage for contraception.
More chillingly, such a ruling could lead to interference in the physician-patient relationship. Further, if for-profit employers are allowed to deny coverage of contraception based on religion, might they eventually seek to drop coverage for vaccination, psychiatric care, transfusions, and other medical procedures from their health plans?
"It would be a dangerous precedent," Dr. Hal C. Lawrence III, executive vice president and chief executive officer of the American Congress of Obstetricians and Gynecologists (ACOG), said in a briefing with reporters.
Tom Goldstein, a partner with law firm Goldstein & Russell and the publisher of SCOTUSblog, agreed.
"The legal principle invoked by the plaintiffs has some potentially startling implications for what one might claim as a religious liberty," he said at a briefing sponsored by the Kaiser Family Foundation. A ruling in their favor could result in "more expansive, more troubling claims," including denial of coverage for other medical procedures and, potentially, discrimination based on race, ethnicity, gender, or sexual orientation – all in the name of religious freedom.
Not all insurance plans must provide contraception coverage under the ACA. Health plans that existed before 2010 and have not substantially changed since are "grandfathered" and don’t have to provide coverage. Plans offered by nonprofit religious organizations are exempt. Nonprofit, religiously affiliated employers also are accommodated. If these employers object to providing coverage on religious grounds, they must notify their insurer. The employer can elect not to pay for that benefit, but the insurer has to reimburse the worker for contraception.
There are no exemptions for plans offered by secular employers, which face a $100 per day per enrollee penalty if they do not provide coverage. Hobby Lobby could face fines of up to $475 million a year, and Conestoga could be looking at $35 million a year in penalties, according to Laurie Sobel, a senior policy analyst with the Kaiser Family Foundation.
The contraception requirement has triggered at least 93 lawsuits. Some object to providing any contraception coverage, while others focus in on emergency contraception. The Hobby Lobby and Conestoga cases are the first to make it to the Supreme Court.
Religious objections
The family that owns Hobby Lobby, a chain with 500 stores and 13,000 employees, says it objects to covering Plan B, Ella, or IUDs because doing so violates its religious beliefs and First Amendment rights.
The Hahn family, which owns the 950-employee Conestoga Wood Specialties, says that it objects to covering Plan B or Ella for the same reasons.
Both object to covering family planning counseling as well.
The companies argue that the Religious Freedom Restoration Act of 1993 gives them the right to deny coverage. The task before their attorneys is to convince Supreme Court justices that a corporation can have religious beliefs and that expressing those beliefs is covered by the First Amendment.
Their arguments are supported by 59 amicus (friend of the court) briefs filed by religious groups and related parties.
The court has not upheld anything like that before, according to Marci A. Hamilton, the Paul R. Verkuil Chair in Public Law at the Benjamin N. Cardozo School of Law at Yeshiva University in New York. Religious beliefs are usually strictly protected, but religious conduct, which has the potential to harm people, can be governed, Ms. Hamilton said at the Kaiser briefing.
Contraception and public health
The government is arguing that it has a compelling interest to require contraception coverage and family planning because it helps prevent unintended pregnancy and thus improves the health of women and children.
This argument is supported in 23 amicus briefs filed by groups including physician organizations such as ACOG, the American Academy of Pediatrics, the Association of Reproductive Health Professionals, the California Medical Association, the Massachusetts Medical Society, and the Society for Maternal-Fetal Medicine, among others.
"The value of family planning, including contraception, has been clearly demonstrated for decades," said Dr. Lawrence of ACOG. It gives women the ability to prevent unintended pregnancy and to time and space pregnancies, and it helps to reduce fetal and maternal morbidity and mortality, he said.
Dr. Lawrence noted that Hobby Lobby and Conestoga were characterizing emergency contraception as abortion methods. "The best scientific evidence shows that emergency contraception works by inhibiting ovulation," he said. "This is contraception, not abortion."
Doctor-patient relationship
If the court upholds the companies’ objection to counseling, that also could open the door to a wide range of restrictions on what physicians can talk to their patients about.
"Your employer would be telling your doctor what you can and can’t talk about," said Adam Sonfield, a senior public policy associate with the Guttmacher Institute. "That would be a clear violation of the rights of the patient ... and could even be considered malpractice."
Dr. Lawrence said that "to not be able to educate patients about their bodies is anathema to women’s health care."
Decisions about a woman’s needs and her health should be between her and her doctor and "should not include input from a woman’s boss," he added.
That sentiment was echoed by ACOG and other medical groups in their brief. They said that "important, private medical decisions should be made by a patient in consultation with her health care provider. There is no role for a woman’s employer in these decisions."
Predictions on ruling?
The Supreme Court could make its ruling any time between March 25 and the end of its current term in late June. Legal experts at the Kaiser Family Foundation and National Health Law Program said they did not expect a ruling in favor of the plaintiffs, Hobby Lobby and Conestoga Wood.
Should the court support the companies’ arguments, however, many state laws require contraceptive equity, said Susan Berke Fogel, director of Reproductive Health at the National Health Law Program.
Mr. Sonfeld of the Guttmacher Institute also noted that 28 states require employers to cover the full range of FDA-approved contraceptives.
On Twitter @aliciaault
Blood test predicts Merkel cell carcinoma metastases
DENVER – A newly-available test based on the results of a simple blood draw has proved useful for detecting early recurrences of Merkel cell carcinomas in those patients who produce antibodies to the Merkel polyomavirus oncoprotein at initial diagnosis.
Known as AMERK, the test can be used at diagnosis to determine which patients have the oncoprotein antibodies and performed at routine followups as an indicator of recurrence in asymptomatic, antibody-positive patients.
The test already has been shown to alert clinicians to the presence of surgically manageable metastases that would have otherwise gone undetected until symptoms prompted a tomographic scan, Dr. Astrid Blom reported at the annual meeting of the American Academy of Dermatology. She presented two cases of surgically operable metastatic Merkel cell tumors, one metastatic to the kidney and the other to the pancreas; both were detected via increasing titers of oncoprotein antibodies in otherwise asymptomatic patients.
Nearly 40% of Merkel cell carcinomas recur. Performing a predictive blood test at routine followups can be a reassuring measure in those patients with negative findings. It also can be an early indicator of metastasis in otherwise asymptomatic patients who made oncoprotein antibodies at diagnosis and were successfully treated for Merkel call carcinoma, she said.
Merkel cell polyomavirus drives about 80% of the approximately 2,000 Merkel cell carcinomas that are diagnosed each year. About half of affected patients produce oncoprotein antibodies to the polyomavirus, which are detectable at diagnosis. The AMERK test is useful only for followup of those patients with oncoprotein antibodies. Patients who lack initially detectable levels of oncoprotein antibodies at diagnosis do not later produce antibodies should their disease recur, reported Dr. Blom of the University of Washington, Seattle, where the test was developed and is performed.
The clinical utility of AMERK, a 75-step assay that takes nearly 2 days to perform, was verified using 1,342 samples from 104 controls and 519 patients from around the world, with data correlating to 3,018 status updates. The data analysis was limited to the 217 patients with adequate follow-up data.
A simple blood draw was collected and sent for analysis at the University of Washington, Seattle. Oncoprotein antibodies were detected in 52% of 217 patients with incident cases of Merkel cell carcinoma and in 2% of 530 control subjects. The antibody titers in controls were barely detectable, however, unlike the levels seen in the patients. The sensitivity of the test was 82%, and the specificity was 98%; the negative predictive value was 99%, and the positive predictive value was 78%.
Levels decrease by 90% or more over the course of the year after successful surgical treatment of Merkel cell carcinomas. When the cancers recur, at least a 10-fold increase in oncoprotein antibody titers are noted.
Support for the development of the AMERK test came from the National Institutes of Health, the National Cancer Institute, and the American Cancer Society and from private donors and patients.
RESOURCES:
Information about the test is available online at http://www.merkelcell.org/sero/
A video that discusses the antibody test can be viewed here.
Dr. Kelly Paulsen, et.al. published the scientific paper that first described the test (Cancer Res. 70(21): 8388-97).
How to order the Merkel virus serology test
Physicians and staff based outside of the University of Washington system should contact their local laboratory where the patient will have their blood sample collected to initiate the process.
The local laboratory "send out test coordinator" should contact the UW Reference Laboratory Services Call Center at 206-685-6066. UW Reference Laboratory Services will set up an account for the ordering physician or clinic; collect the required billing and reporting information; and provide requirements for sample collection, processing and shipping from the local laboratory. Once this one-time administrative process is complete, patient samples can be collected routinely from that facility for the Merkel antibody test (name of test is "AMERK").
On Twitter @maryjodales
DENVER – A newly-available test based on the results of a simple blood draw has proved useful for detecting early recurrences of Merkel cell carcinomas in those patients who produce antibodies to the Merkel polyomavirus oncoprotein at initial diagnosis.
Known as AMERK, the test can be used at diagnosis to determine which patients have the oncoprotein antibodies and performed at routine followups as an indicator of recurrence in asymptomatic, antibody-positive patients.
The test already has been shown to alert clinicians to the presence of surgically manageable metastases that would have otherwise gone undetected until symptoms prompted a tomographic scan, Dr. Astrid Blom reported at the annual meeting of the American Academy of Dermatology. She presented two cases of surgically operable metastatic Merkel cell tumors, one metastatic to the kidney and the other to the pancreas; both were detected via increasing titers of oncoprotein antibodies in otherwise asymptomatic patients.
Nearly 40% of Merkel cell carcinomas recur. Performing a predictive blood test at routine followups can be a reassuring measure in those patients with negative findings. It also can be an early indicator of metastasis in otherwise asymptomatic patients who made oncoprotein antibodies at diagnosis and were successfully treated for Merkel call carcinoma, she said.
Merkel cell polyomavirus drives about 80% of the approximately 2,000 Merkel cell carcinomas that are diagnosed each year. About half of affected patients produce oncoprotein antibodies to the polyomavirus, which are detectable at diagnosis. The AMERK test is useful only for followup of those patients with oncoprotein antibodies. Patients who lack initially detectable levels of oncoprotein antibodies at diagnosis do not later produce antibodies should their disease recur, reported Dr. Blom of the University of Washington, Seattle, where the test was developed and is performed.
The clinical utility of AMERK, a 75-step assay that takes nearly 2 days to perform, was verified using 1,342 samples from 104 controls and 519 patients from around the world, with data correlating to 3,018 status updates. The data analysis was limited to the 217 patients with adequate follow-up data.
A simple blood draw was collected and sent for analysis at the University of Washington, Seattle. Oncoprotein antibodies were detected in 52% of 217 patients with incident cases of Merkel cell carcinoma and in 2% of 530 control subjects. The antibody titers in controls were barely detectable, however, unlike the levels seen in the patients. The sensitivity of the test was 82%, and the specificity was 98%; the negative predictive value was 99%, and the positive predictive value was 78%.
Levels decrease by 90% or more over the course of the year after successful surgical treatment of Merkel cell carcinomas. When the cancers recur, at least a 10-fold increase in oncoprotein antibody titers are noted.
Support for the development of the AMERK test came from the National Institutes of Health, the National Cancer Institute, and the American Cancer Society and from private donors and patients.
RESOURCES:
Information about the test is available online at http://www.merkelcell.org/sero/
A video that discusses the antibody test can be viewed here.
Dr. Kelly Paulsen, et.al. published the scientific paper that first described the test (Cancer Res. 70(21): 8388-97).
How to order the Merkel virus serology test
Physicians and staff based outside of the University of Washington system should contact their local laboratory where the patient will have their blood sample collected to initiate the process.
The local laboratory "send out test coordinator" should contact the UW Reference Laboratory Services Call Center at 206-685-6066. UW Reference Laboratory Services will set up an account for the ordering physician or clinic; collect the required billing and reporting information; and provide requirements for sample collection, processing and shipping from the local laboratory. Once this one-time administrative process is complete, patient samples can be collected routinely from that facility for the Merkel antibody test (name of test is "AMERK").
On Twitter @maryjodales
DENVER – A newly-available test based on the results of a simple blood draw has proved useful for detecting early recurrences of Merkel cell carcinomas in those patients who produce antibodies to the Merkel polyomavirus oncoprotein at initial diagnosis.
Known as AMERK, the test can be used at diagnosis to determine which patients have the oncoprotein antibodies and performed at routine followups as an indicator of recurrence in asymptomatic, antibody-positive patients.
The test already has been shown to alert clinicians to the presence of surgically manageable metastases that would have otherwise gone undetected until symptoms prompted a tomographic scan, Dr. Astrid Blom reported at the annual meeting of the American Academy of Dermatology. She presented two cases of surgically operable metastatic Merkel cell tumors, one metastatic to the kidney and the other to the pancreas; both were detected via increasing titers of oncoprotein antibodies in otherwise asymptomatic patients.
Nearly 40% of Merkel cell carcinomas recur. Performing a predictive blood test at routine followups can be a reassuring measure in those patients with negative findings. It also can be an early indicator of metastasis in otherwise asymptomatic patients who made oncoprotein antibodies at diagnosis and were successfully treated for Merkel call carcinoma, she said.
Merkel cell polyomavirus drives about 80% of the approximately 2,000 Merkel cell carcinomas that are diagnosed each year. About half of affected patients produce oncoprotein antibodies to the polyomavirus, which are detectable at diagnosis. The AMERK test is useful only for followup of those patients with oncoprotein antibodies. Patients who lack initially detectable levels of oncoprotein antibodies at diagnosis do not later produce antibodies should their disease recur, reported Dr. Blom of the University of Washington, Seattle, where the test was developed and is performed.
The clinical utility of AMERK, a 75-step assay that takes nearly 2 days to perform, was verified using 1,342 samples from 104 controls and 519 patients from around the world, with data correlating to 3,018 status updates. The data analysis was limited to the 217 patients with adequate follow-up data.
A simple blood draw was collected and sent for analysis at the University of Washington, Seattle. Oncoprotein antibodies were detected in 52% of 217 patients with incident cases of Merkel cell carcinoma and in 2% of 530 control subjects. The antibody titers in controls were barely detectable, however, unlike the levels seen in the patients. The sensitivity of the test was 82%, and the specificity was 98%; the negative predictive value was 99%, and the positive predictive value was 78%.
Levels decrease by 90% or more over the course of the year after successful surgical treatment of Merkel cell carcinomas. When the cancers recur, at least a 10-fold increase in oncoprotein antibody titers are noted.
Support for the development of the AMERK test came from the National Institutes of Health, the National Cancer Institute, and the American Cancer Society and from private donors and patients.
RESOURCES:
Information about the test is available online at http://www.merkelcell.org/sero/
A video that discusses the antibody test can be viewed here.
Dr. Kelly Paulsen, et.al. published the scientific paper that first described the test (Cancer Res. 70(21): 8388-97).
How to order the Merkel virus serology test
Physicians and staff based outside of the University of Washington system should contact their local laboratory where the patient will have their blood sample collected to initiate the process.
The local laboratory "send out test coordinator" should contact the UW Reference Laboratory Services Call Center at 206-685-6066. UW Reference Laboratory Services will set up an account for the ordering physician or clinic; collect the required billing and reporting information; and provide requirements for sample collection, processing and shipping from the local laboratory. Once this one-time administrative process is complete, patient samples can be collected routinely from that facility for the Merkel antibody test (name of test is "AMERK").
On Twitter @maryjodales
AT THE AAD ANNUAL MEETING
Major finding: Two cases of surgically operable, metastatic Merkel cell tumors, one metastatic to the kidney and the other to the pancreas, were detected via increasing serum titers of oncoprotein antibodies as part of the followup of otherwise asymptomatic patients.
Data source: Followup study of the 52% of 217 patients who had incident cases of Merkel cell carcinoma and had positive titers for oncoprotein antibodies.
Disclosures: Support for the development of the AMERK test came from the National Institutes of Health, the National Cancer Institute, the American Cancer Society, and from private donors and patients.
DNR orders and medical futility
Question: A 71-year-old woman with heart disease and breast cancer was hospitalized for uncontrolled diabetes and a hip fracture. There, she suffered two grand mal seizures that could not be controlled with anticonvulsants, and the patient lapsed into coma. Her daughter became the surrogate decision maker, and she made it clear that her mother always said she wanted everything done.
After several weeks, the physicians decided that further care would be futile. The chair of the ethics committee took the view that the family’s opinion was not relevant, because cardiopulmonary resuscitation (CPR) was not a genuine therapeutic option and would be "medically contraindicated, inhumane, and unethical." Accordingly, the attending physician entered a do-not-resuscitate (DNR) order despite strong protest from the daughter. The patient died shortly thereafter without receiving CPR.
In this actual case where the daughter filed a negligence lawsuit against the hospital, which of the following statements is incorrect?
A. The defendant’s expert relied upon the position paper of the American Thoracic Society, which states that life support "can be limited without the consent of patient or surrogate when the intervention is judged to be futile."
B. Futile intervention may be defined as treatment that would be highly unlikely to result in a meaningful survival of the patient.
C. The jury found that if competent, the patient would have wanted CPR and would have wanted ventilation until death.
D. The jury found such treatment would be futile.
E. The jury entered a verdict of negligence.
Answer: E. The above narrative is based on Gilgunn v. Massachusetts General Hospital (verdict issued April 21, 1995) and adapted from an article by the prominent ethicist Alexander M. Capron.1 All of the options listed were evident at trial, except that it was a defense verdict, i.e., no negligence. The case remains the best-known litigated example of medical futility. In earlier cases such as Wanglie2 and Baby K,3 the courts had avoided addressing the issue directly.
Gilgunn supports the notion that futility of CPR can trump a patient’s family insistence on having such intervention. But being a trial court verdict, it lacks the precedential authority that an appellate decision would confer.
The verdict also was not without its critics. As Mr. Capron wrote:
"But to allow Mrs. Gilgunn’s physicians to impose this view, however widely held, on their patient is the equivalent of allowing them to abandon the patient. We still need means ... to reach a social consensus on whether health professionals should have authority to decide, among the interventions patients (or surrogates) will accept, which will actually be provided and which they may withhold based upon their evaluation of the worth of the outcome. When we come to adopt such policies, we would do well to ponder long and hard before adopting a utilitarian measure that affords the waning lives of the most vulnerable in our society less protection from unilateral decisions by powerful professionals."1
In 1999, the District of Columbia Court of Appeals agreed with a trial court’s order to issue a DNR order for a neglected 2-year-old child who was born prematurely with serious medical problems and virtually nonexistent cognition, but who could still experience pain.4 The biological mother and putative father appealed, but the Court of Appeals affirmed. The court held, among other things, that the standard of proof required for issuance of a DNR order is clear and convincing evidence, and the applicable standard is the best interests of the child test rather than a substituted judgment standard. However, this case pitted the biological parents against a court-appointed guardian, rather than the medical providers.
The American Medical Association’s current Code of Ethics urges that when neither a patient nor surrogate is able or available to make a decision regarding CPR, an attending physician contemplating a DNR order should consult another physician or a hospital ethics committee if one is available.5 If the physician determines that a request for resuscitation would not be medically effective, "the physician should seek to resolve the conflict through a fair decision-making process, when time permits." In an earlier version,6 the AMA stated: "CPR may be withheld if, in the judgment of the treating physician, an attempt to resuscitate the patient would be futile."
DNR orders are at the heart of the futility conundrum, especially because CPR is a highly invasive, low-success procedure (notable exceptions exist, however). Medical futility denotes treatment that cannot confer an overall benefit on the whole person even if it can restore some physiologic variable.7 The Latin word "futilis" means leaky, and in Greek mythology, the daughters of Danaus were condemned in the underworld to draw water in leaky sieves, conveying the full meaning of futility.
The debate is over whether an intervention, however hopeless and ineffective, can ever be characterized as completely futile. Moreover, without absolute certainty, will this suffice to override a patient’s insistence on having that treatment?
Others have countered that absoluteness is an unrealistic standard, and that inhumane suffering and costs are relevant factors to ponder. The AMA has clearly stated that "physicians are not ethically obligated to deliver care that, in their best professional judgment, will not have a reasonable chance of benefiting their patients," and "patients should not be given treatments simply because they demand them."8
One legal consequence of discontinuing medical treatment that ends with a patient’s demise is the specter of criminal prosecution, although charges of homicide are unlikely to prevail.
In a landmark California case, Barber v. Superior Court of Los Angeles County,9 the court recognized that "a physician is authorized under the standards of medical practice to discontinue a form of therapy which in his medical judgment is useless. ... If the treating physicians have determined that continued use of a respirator is useless, then they may decide to discontinue it without fear of civil or criminal liability."
In Kansas v. Naramore,10 the state appeals court reversed and entered a verdict of acquittal despite a jury finding Dr. Naramore guilty over his provision of palliative treatment. The court noted that the burden of proof to establish the criminal guilt of a physician for acts arising out of providing medical treatment is higher than that necessary to find medical malpractice or to impose medical licensure discipline. It held that "with no direct evidence of criminal intent, it is highly disturbing that testimony by such an impressive array of apparently objective medical experts, who found the defendant’s actions to be not only noncriminal, but medically appropriate, can be dismissed as ‘unbelievable’ and not even capable of generating reasonable doubt."
Notwithstanding widely accepted ethical notions of medical futility, there are state and federal statutes touching on DNR orders that warrant careful attention.
For example, New York Public Health Law Section 2962, paragraph 1, states: "Every person admitted to a hospital shall be presumed to consent to the administration of cardiopulmonary resuscitation in the event of cardiac or respiratory arrest, unless there is consent to the issuance of an order not to resuscitate as provided in this article." This raises the question as to whether it is ever legally permissible to enter a unilateral DNR order against the wishes of the patient.
On the other hand, Hawaii Revised Statutes 327E-13(d) notes: "This chapter shall not authorize or require a health care provider or institution to provide health care contrary to generally accepted health care standards." This has been interpreted as allowing the prevailing standard of care to serve as the yardstick of propriety.
Finally, the federal "antidumping" law governing emergency treatment in hospitals, widely known as EMTALA (Emergency Medical Treatment & Labor Act), requires all emergency departments to provide treatment necessary to prevent the material deterioration of the individual’s condition. This would always include the use of CPR unless specifically rejected by the patient or surrogate, because the law does not contain a "standard of care" or futility exception.
References
1. Capron, A.M., Abandoning a Waning Life. Hastings Center Report 1995;25:24-6.
2. In re the conservatorship of Helga M. Wanglie, No. PX-91-283, District Probate Division, 4th Judicial District of the County of Hennepin, State of Minnesota.
3. In the Matter of Baby "K", 16 F.3d F. Supp. 590 (E.D. VA 1993). WL 38674 (4th Cir. 1994).
4. In re K.I., 735 A.2d 448 (D.C. Ct. App. 1999).
5. Code of Ethics of the AMA, section 2.22, 2012-2013 edition.
7. Ann. Int. Med. 1990;112:949-54.
8. Code of Ethics of the AMA, section 2.035, 2012-2013 edition.
9. Barber v. Superior Court of Los Angeles County, 147 Cal. App. 3d 1006 (1983).
10. Kansas v. Naramore, 965 P.2d 211 (Kan. 1998).
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].
Question: A 71-year-old woman with heart disease and breast cancer was hospitalized for uncontrolled diabetes and a hip fracture. There, she suffered two grand mal seizures that could not be controlled with anticonvulsants, and the patient lapsed into coma. Her daughter became the surrogate decision maker, and she made it clear that her mother always said she wanted everything done.
After several weeks, the physicians decided that further care would be futile. The chair of the ethics committee took the view that the family’s opinion was not relevant, because cardiopulmonary resuscitation (CPR) was not a genuine therapeutic option and would be "medically contraindicated, inhumane, and unethical." Accordingly, the attending physician entered a do-not-resuscitate (DNR) order despite strong protest from the daughter. The patient died shortly thereafter without receiving CPR.
In this actual case where the daughter filed a negligence lawsuit against the hospital, which of the following statements is incorrect?
A. The defendant’s expert relied upon the position paper of the American Thoracic Society, which states that life support "can be limited without the consent of patient or surrogate when the intervention is judged to be futile."
B. Futile intervention may be defined as treatment that would be highly unlikely to result in a meaningful survival of the patient.
C. The jury found that if competent, the patient would have wanted CPR and would have wanted ventilation until death.
D. The jury found such treatment would be futile.
E. The jury entered a verdict of negligence.
Answer: E. The above narrative is based on Gilgunn v. Massachusetts General Hospital (verdict issued April 21, 1995) and adapted from an article by the prominent ethicist Alexander M. Capron.1 All of the options listed were evident at trial, except that it was a defense verdict, i.e., no negligence. The case remains the best-known litigated example of medical futility. In earlier cases such as Wanglie2 and Baby K,3 the courts had avoided addressing the issue directly.
Gilgunn supports the notion that futility of CPR can trump a patient’s family insistence on having such intervention. But being a trial court verdict, it lacks the precedential authority that an appellate decision would confer.
The verdict also was not without its critics. As Mr. Capron wrote:
"But to allow Mrs. Gilgunn’s physicians to impose this view, however widely held, on their patient is the equivalent of allowing them to abandon the patient. We still need means ... to reach a social consensus on whether health professionals should have authority to decide, among the interventions patients (or surrogates) will accept, which will actually be provided and which they may withhold based upon their evaluation of the worth of the outcome. When we come to adopt such policies, we would do well to ponder long and hard before adopting a utilitarian measure that affords the waning lives of the most vulnerable in our society less protection from unilateral decisions by powerful professionals."1
In 1999, the District of Columbia Court of Appeals agreed with a trial court’s order to issue a DNR order for a neglected 2-year-old child who was born prematurely with serious medical problems and virtually nonexistent cognition, but who could still experience pain.4 The biological mother and putative father appealed, but the Court of Appeals affirmed. The court held, among other things, that the standard of proof required for issuance of a DNR order is clear and convincing evidence, and the applicable standard is the best interests of the child test rather than a substituted judgment standard. However, this case pitted the biological parents against a court-appointed guardian, rather than the medical providers.
The American Medical Association’s current Code of Ethics urges that when neither a patient nor surrogate is able or available to make a decision regarding CPR, an attending physician contemplating a DNR order should consult another physician or a hospital ethics committee if one is available.5 If the physician determines that a request for resuscitation would not be medically effective, "the physician should seek to resolve the conflict through a fair decision-making process, when time permits." In an earlier version,6 the AMA stated: "CPR may be withheld if, in the judgment of the treating physician, an attempt to resuscitate the patient would be futile."
DNR orders are at the heart of the futility conundrum, especially because CPR is a highly invasive, low-success procedure (notable exceptions exist, however). Medical futility denotes treatment that cannot confer an overall benefit on the whole person even if it can restore some physiologic variable.7 The Latin word "futilis" means leaky, and in Greek mythology, the daughters of Danaus were condemned in the underworld to draw water in leaky sieves, conveying the full meaning of futility.
The debate is over whether an intervention, however hopeless and ineffective, can ever be characterized as completely futile. Moreover, without absolute certainty, will this suffice to override a patient’s insistence on having that treatment?
Others have countered that absoluteness is an unrealistic standard, and that inhumane suffering and costs are relevant factors to ponder. The AMA has clearly stated that "physicians are not ethically obligated to deliver care that, in their best professional judgment, will not have a reasonable chance of benefiting their patients," and "patients should not be given treatments simply because they demand them."8
One legal consequence of discontinuing medical treatment that ends with a patient’s demise is the specter of criminal prosecution, although charges of homicide are unlikely to prevail.
In a landmark California case, Barber v. Superior Court of Los Angeles County,9 the court recognized that "a physician is authorized under the standards of medical practice to discontinue a form of therapy which in his medical judgment is useless. ... If the treating physicians have determined that continued use of a respirator is useless, then they may decide to discontinue it without fear of civil or criminal liability."
In Kansas v. Naramore,10 the state appeals court reversed and entered a verdict of acquittal despite a jury finding Dr. Naramore guilty over his provision of palliative treatment. The court noted that the burden of proof to establish the criminal guilt of a physician for acts arising out of providing medical treatment is higher than that necessary to find medical malpractice or to impose medical licensure discipline. It held that "with no direct evidence of criminal intent, it is highly disturbing that testimony by such an impressive array of apparently objective medical experts, who found the defendant’s actions to be not only noncriminal, but medically appropriate, can be dismissed as ‘unbelievable’ and not even capable of generating reasonable doubt."
Notwithstanding widely accepted ethical notions of medical futility, there are state and federal statutes touching on DNR orders that warrant careful attention.
For example, New York Public Health Law Section 2962, paragraph 1, states: "Every person admitted to a hospital shall be presumed to consent to the administration of cardiopulmonary resuscitation in the event of cardiac or respiratory arrest, unless there is consent to the issuance of an order not to resuscitate as provided in this article." This raises the question as to whether it is ever legally permissible to enter a unilateral DNR order against the wishes of the patient.
On the other hand, Hawaii Revised Statutes 327E-13(d) notes: "This chapter shall not authorize or require a health care provider or institution to provide health care contrary to generally accepted health care standards." This has been interpreted as allowing the prevailing standard of care to serve as the yardstick of propriety.
Finally, the federal "antidumping" law governing emergency treatment in hospitals, widely known as EMTALA (Emergency Medical Treatment & Labor Act), requires all emergency departments to provide treatment necessary to prevent the material deterioration of the individual’s condition. This would always include the use of CPR unless specifically rejected by the patient or surrogate, because the law does not contain a "standard of care" or futility exception.
References
1. Capron, A.M., Abandoning a Waning Life. Hastings Center Report 1995;25:24-6.
2. In re the conservatorship of Helga M. Wanglie, No. PX-91-283, District Probate Division, 4th Judicial District of the County of Hennepin, State of Minnesota.
3. In the Matter of Baby "K", 16 F.3d F. Supp. 590 (E.D. VA 1993). WL 38674 (4th Cir. 1994).
4. In re K.I., 735 A.2d 448 (D.C. Ct. App. 1999).
5. Code of Ethics of the AMA, section 2.22, 2012-2013 edition.
7. Ann. Int. Med. 1990;112:949-54.
8. Code of Ethics of the AMA, section 2.035, 2012-2013 edition.
9. Barber v. Superior Court of Los Angeles County, 147 Cal. App. 3d 1006 (1983).
10. Kansas v. Naramore, 965 P.2d 211 (Kan. 1998).
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].
Question: A 71-year-old woman with heart disease and breast cancer was hospitalized for uncontrolled diabetes and a hip fracture. There, she suffered two grand mal seizures that could not be controlled with anticonvulsants, and the patient lapsed into coma. Her daughter became the surrogate decision maker, and she made it clear that her mother always said she wanted everything done.
After several weeks, the physicians decided that further care would be futile. The chair of the ethics committee took the view that the family’s opinion was not relevant, because cardiopulmonary resuscitation (CPR) was not a genuine therapeutic option and would be "medically contraindicated, inhumane, and unethical." Accordingly, the attending physician entered a do-not-resuscitate (DNR) order despite strong protest from the daughter. The patient died shortly thereafter without receiving CPR.
In this actual case where the daughter filed a negligence lawsuit against the hospital, which of the following statements is incorrect?
A. The defendant’s expert relied upon the position paper of the American Thoracic Society, which states that life support "can be limited without the consent of patient or surrogate when the intervention is judged to be futile."
B. Futile intervention may be defined as treatment that would be highly unlikely to result in a meaningful survival of the patient.
C. The jury found that if competent, the patient would have wanted CPR and would have wanted ventilation until death.
D. The jury found such treatment would be futile.
E. The jury entered a verdict of negligence.
Answer: E. The above narrative is based on Gilgunn v. Massachusetts General Hospital (verdict issued April 21, 1995) and adapted from an article by the prominent ethicist Alexander M. Capron.1 All of the options listed were evident at trial, except that it was a defense verdict, i.e., no negligence. The case remains the best-known litigated example of medical futility. In earlier cases such as Wanglie2 and Baby K,3 the courts had avoided addressing the issue directly.
Gilgunn supports the notion that futility of CPR can trump a patient’s family insistence on having such intervention. But being a trial court verdict, it lacks the precedential authority that an appellate decision would confer.
The verdict also was not without its critics. As Mr. Capron wrote:
"But to allow Mrs. Gilgunn’s physicians to impose this view, however widely held, on their patient is the equivalent of allowing them to abandon the patient. We still need means ... to reach a social consensus on whether health professionals should have authority to decide, among the interventions patients (or surrogates) will accept, which will actually be provided and which they may withhold based upon their evaluation of the worth of the outcome. When we come to adopt such policies, we would do well to ponder long and hard before adopting a utilitarian measure that affords the waning lives of the most vulnerable in our society less protection from unilateral decisions by powerful professionals."1
In 1999, the District of Columbia Court of Appeals agreed with a trial court’s order to issue a DNR order for a neglected 2-year-old child who was born prematurely with serious medical problems and virtually nonexistent cognition, but who could still experience pain.4 The biological mother and putative father appealed, but the Court of Appeals affirmed. The court held, among other things, that the standard of proof required for issuance of a DNR order is clear and convincing evidence, and the applicable standard is the best interests of the child test rather than a substituted judgment standard. However, this case pitted the biological parents against a court-appointed guardian, rather than the medical providers.
The American Medical Association’s current Code of Ethics urges that when neither a patient nor surrogate is able or available to make a decision regarding CPR, an attending physician contemplating a DNR order should consult another physician or a hospital ethics committee if one is available.5 If the physician determines that a request for resuscitation would not be medically effective, "the physician should seek to resolve the conflict through a fair decision-making process, when time permits." In an earlier version,6 the AMA stated: "CPR may be withheld if, in the judgment of the treating physician, an attempt to resuscitate the patient would be futile."
DNR orders are at the heart of the futility conundrum, especially because CPR is a highly invasive, low-success procedure (notable exceptions exist, however). Medical futility denotes treatment that cannot confer an overall benefit on the whole person even if it can restore some physiologic variable.7 The Latin word "futilis" means leaky, and in Greek mythology, the daughters of Danaus were condemned in the underworld to draw water in leaky sieves, conveying the full meaning of futility.
The debate is over whether an intervention, however hopeless and ineffective, can ever be characterized as completely futile. Moreover, without absolute certainty, will this suffice to override a patient’s insistence on having that treatment?
Others have countered that absoluteness is an unrealistic standard, and that inhumane suffering and costs are relevant factors to ponder. The AMA has clearly stated that "physicians are not ethically obligated to deliver care that, in their best professional judgment, will not have a reasonable chance of benefiting their patients," and "patients should not be given treatments simply because they demand them."8
One legal consequence of discontinuing medical treatment that ends with a patient’s demise is the specter of criminal prosecution, although charges of homicide are unlikely to prevail.
In a landmark California case, Barber v. Superior Court of Los Angeles County,9 the court recognized that "a physician is authorized under the standards of medical practice to discontinue a form of therapy which in his medical judgment is useless. ... If the treating physicians have determined that continued use of a respirator is useless, then they may decide to discontinue it without fear of civil or criminal liability."
In Kansas v. Naramore,10 the state appeals court reversed and entered a verdict of acquittal despite a jury finding Dr. Naramore guilty over his provision of palliative treatment. The court noted that the burden of proof to establish the criminal guilt of a physician for acts arising out of providing medical treatment is higher than that necessary to find medical malpractice or to impose medical licensure discipline. It held that "with no direct evidence of criminal intent, it is highly disturbing that testimony by such an impressive array of apparently objective medical experts, who found the defendant’s actions to be not only noncriminal, but medically appropriate, can be dismissed as ‘unbelievable’ and not even capable of generating reasonable doubt."
Notwithstanding widely accepted ethical notions of medical futility, there are state and federal statutes touching on DNR orders that warrant careful attention.
For example, New York Public Health Law Section 2962, paragraph 1, states: "Every person admitted to a hospital shall be presumed to consent to the administration of cardiopulmonary resuscitation in the event of cardiac or respiratory arrest, unless there is consent to the issuance of an order not to resuscitate as provided in this article." This raises the question as to whether it is ever legally permissible to enter a unilateral DNR order against the wishes of the patient.
On the other hand, Hawaii Revised Statutes 327E-13(d) notes: "This chapter shall not authorize or require a health care provider or institution to provide health care contrary to generally accepted health care standards." This has been interpreted as allowing the prevailing standard of care to serve as the yardstick of propriety.
Finally, the federal "antidumping" law governing emergency treatment in hospitals, widely known as EMTALA (Emergency Medical Treatment & Labor Act), requires all emergency departments to provide treatment necessary to prevent the material deterioration of the individual’s condition. This would always include the use of CPR unless specifically rejected by the patient or surrogate, because the law does not contain a "standard of care" or futility exception.
References
1. Capron, A.M., Abandoning a Waning Life. Hastings Center Report 1995;25:24-6.
2. In re the conservatorship of Helga M. Wanglie, No. PX-91-283, District Probate Division, 4th Judicial District of the County of Hennepin, State of Minnesota.
3. In the Matter of Baby "K", 16 F.3d F. Supp. 590 (E.D. VA 1993). WL 38674 (4th Cir. 1994).
4. In re K.I., 735 A.2d 448 (D.C. Ct. App. 1999).
5. Code of Ethics of the AMA, section 2.22, 2012-2013 edition.
7. Ann. Int. Med. 1990;112:949-54.
8. Code of Ethics of the AMA, section 2.035, 2012-2013 edition.
9. Barber v. Superior Court of Los Angeles County, 147 Cal. App. 3d 1006 (1983).
10. Kansas v. Naramore, 965 P.2d 211 (Kan. 1998).
Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].
