The U.S. Supreme Court will hear oral arguments March 23 in a case that pits the federal government against religious employers who oppose contraceptive use.

Zubik v. Burwell centers on whether an accommodation under the Affordable Care Act’s contraceptive mandate is enough to protect the religious freedoms of nonprofit employers with strongly held religious beliefs.

The ruling in Zubik will have broad implications for contraception care nationwide and the way in which the Religious Freedom Restoration Act (RFRA) is applied going forward, said Laurie Sobel, a senior policy analyst for the Henry J. Kaiser Family Foundation.

“Ultimately, if the court were to rule in favor of Zubik, it would mean the workers and dependents of nonprofits are at risk of losing some or all contraceptive coverage,” Ms. Sobel said during a March 16 Kaiser press briefing. “The burden on women to pay out of pocket has [been] shown to really limit their choices and possibly limit [all] contraceptives for them.”

The ACA’s accommodation clause refers to an exception for organizations that oppose coverage for contraceptives but are not exempted entities, such as churches. The plaintiffs – part of seven consolidated cases that include a Catholic bishop and an order of nuns – argue that the opt-out process put in place by the government makes them complicit in offering contraception coverage indirectly.

The government contends that the exception does not impose a burden on the groups and that courts should not disregard the interest of employees who may not share their employers’ religious beliefs. The 8th U.S. Circuit Court of Appeals struck down the exception twice, ruling that forcing organizations to offer contraceptive coverage – even indirectly – violates their religious rights. The 8th Circuit’s decisions are at odds with rulings by the 2nd and 5th Circuit courts.

The case comes down to whether the plaintiffs can prove the accommodation places a substantial burden on their religious conduct, and if so, whether the government can prove its provision is the least restrictive means of advancing a compelling interest, said Marci A. Hamilton, a law professor at the Benjamin N. Cardozo School of Law, Yeshiva University, New York.

“[If the court sides with Zubik], one possible precedent this could set is that religious objectors – the employers in these cases – will be able to limit independent third-party actions,” Ms. Hamilton said during the media conference. “It doesn’t matter the faith. You can have your decisions about birth control and the cost and reproductive care determined by the faith of your employer.”

©trekandshoot/thinkstockphotos.com

A ruling for Zubik would also throw a monkey wrench in the country’s long tradition of legislative accommodations, Ms. Hamilton said, noting that there are many laws that include accommodations for certain populations.

“That means the legislative weighing of harm and safety is going to be pushed aside and essentially, we’re going to be talking about, how can every single law including the accommodations be fine-tuned for one set of believers?”

The recent death of Associate Justice Antonin Scalia, who was the court’s most outspoken conservative, could significantly impact the case’s outcome, analysts said. Justice Scalia was among majority in the 5-4 decision in Burwell v. Hobby Lobby, a 2014 opinion that protected religiously devout owners of closely held, for-profit businesses from having to offer birth control under the mandate. His absence could mean a 4-4 split in the Zubik case, which would allow the lower court rulings to stand, said Lyle Denniston, a Supreme Court analyst who writes for SCOTUSblog.

“My own sense is that the court is going to try very hard to find a way to resolve this case without a 4-4 split,” Mr. Denniston said during the Kaiser media conference. “If the Supreme Court issues a 4-4 decision, that leaves division in the lower courts, and it will vary from region to region in the country as to what the rights for women under the ACA are.”

More than 70 briefs have been issued to the high court in support of or opposition to the plaintiffs, including pleas by religious organizations, women’s advocacy groups, law professors, medical associations, and attorneys.

The American College of Obstetricians and Gynecologists and the American Academy of Family Physicians wrote in a joint brief that contraception coverage under the ACA ensures that patients have access to medically appropriate contraception without regard to their ability to pay. At the same time, the law respects an employer’s sincerely held religious objections to contraception through the accommodation, the brief said.

However, the Council for Christian Colleges & Universities argues the government’s decision to exempt some religious employers from providing contraceptive coverage while requiring others to comply with the mandate “demonstrates that the government’s approach is not the least restrictive means necessary to advance its interests.”

“Civil rights should not vary based on whether that institution is or is not affiliated with a church or other house of worship,” the council wrote in its brief to the Supreme Court. “Religious exercise is not tied to one’s affiliation but rather the source and sincerity of one’s belief and the desire to exercise it. That truth appears to be one the government has been unable to grasp or comprehend as it decides who is sufficiently ‘religious’ to have religious beliefs worthy of protection.”

[email protected]

On Twitter @legal_med

The U.S. Supreme Court will hear oral arguments March 23 in a case that pits the federal government against religious employers who oppose contraceptive use.

Zubik v. Burwell centers on whether an accommodation under the Affordable Care Act’s contraceptive mandate is enough to protect the religious freedoms of nonprofit employers with strongly held religious beliefs.

The ruling in Zubik will have broad implications for contraception care nationwide and the way in which the Religious Freedom Restoration Act (RFRA) is applied going forward, said Laurie Sobel, a senior policy analyst for the Henry J. Kaiser Family Foundation.

“Ultimately, if the court were to rule in favor of Zubik, it would mean the workers and dependents of nonprofits are at risk of losing some or all contraceptive coverage,” Ms. Sobel said during a March 16 Kaiser press briefing. “The burden on women to pay out of pocket has [been] shown to really limit their choices and possibly limit [all] contraceptives for them.”

The ACA’s accommodation clause refers to an exception for organizations that oppose coverage for contraceptives but are not exempted entities, such as churches. The plaintiffs – part of seven consolidated cases that include a Catholic bishop and an order of nuns – argue that the opt-out process put in place by the government makes them complicit in offering contraception coverage indirectly.

The government contends that the exception does not impose a burden on the groups and that courts should not disregard the interest of employees who may not share their employers’ religious beliefs. The 8th U.S. Circuit Court of Appeals struck down the exception twice, ruling that forcing organizations to offer contraceptive coverage – even indirectly – violates their religious rights. The 8th Circuit’s decisions are at odds with rulings by the 2nd and 5th Circuit courts.

The case comes down to whether the plaintiffs can prove the accommodation places a substantial burden on their religious conduct, and if so, whether the government can prove its provision is the least restrictive means of advancing a compelling interest, said Marci A. Hamilton, a law professor at the Benjamin N. Cardozo School of Law, Yeshiva University, New York.

“[If the court sides with Zubik], one possible precedent this could set is that religious objectors – the employers in these cases – will be able to limit independent third-party actions,” Ms. Hamilton said during the media conference. “It doesn’t matter the faith. You can have your decisions about birth control and the cost and reproductive care determined by the faith of your employer.”

©trekandshoot/thinkstockphotos.com

A ruling for Zubik would also throw a monkey wrench in the country’s long tradition of legislative accommodations, Ms. Hamilton said, noting that there are many laws that include accommodations for certain populations.

“That means the legislative weighing of harm and safety is going to be pushed aside and essentially, we’re going to be talking about, how can every single law including the accommodations be fine-tuned for one set of believers?”

The recent death of Associate Justice Antonin Scalia, who was the court’s most outspoken conservative, could significantly impact the case’s outcome, analysts said. Justice Scalia was among majority in the 5-4 decision in Burwell v. Hobby Lobby, a 2014 opinion that protected religiously devout owners of closely held, for-profit businesses from having to offer birth control under the mandate. His absence could mean a 4-4 split in the Zubik case, which would allow the lower court rulings to stand, said Lyle Denniston, a Supreme Court analyst who writes for SCOTUSblog.

“My own sense is that the court is going to try very hard to find a way to resolve this case without a 4-4 split,” Mr. Denniston said during the Kaiser media conference. “If the Supreme Court issues a 4-4 decision, that leaves division in the lower courts, and it will vary from region to region in the country as to what the rights for women under the ACA are.”

More than 70 briefs have been issued to the high court in support of or opposition to the plaintiffs, including pleas by religious organizations, women’s advocacy groups, law professors, medical associations, and attorneys.

The American College of Obstetricians and Gynecologists and the American Academy of Family Physicians wrote in a joint brief that contraception coverage under the ACA ensures that patients have access to medically appropriate contraception without regard to their ability to pay. At the same time, the law respects an employer’s sincerely held religious objections to contraception through the accommodation, the brief said.

However, the Council for Christian Colleges & Universities argues the government’s decision to exempt some religious employers from providing contraceptive coverage while requiring others to comply with the mandate “demonstrates that the government’s approach is not the least restrictive means necessary to advance its interests.”

“Civil rights should not vary based on whether that institution is or is not affiliated with a church or other house of worship,” the council wrote in its brief to the Supreme Court. “Religious exercise is not tied to one’s affiliation but rather the source and sincerity of one’s belief and the desire to exercise it. That truth appears to be one the government has been unable to grasp or comprehend as it decides who is sufficiently ‘religious’ to have religious beliefs worthy of protection.”

[email protected]

On Twitter @legal_med

The U.S. Supreme Court will hear oral arguments March 23 in a case that pits the federal government against religious employers who oppose contraceptive use.

Zubik v. Burwell centers on whether an accommodation under the Affordable Care Act’s contraceptive mandate is enough to protect the religious freedoms of nonprofit employers with strongly held religious beliefs.

The ruling in Zubik will have broad implications for contraception care nationwide and the way in which the Religious Freedom Restoration Act (RFRA) is applied going forward, said Laurie Sobel, a senior policy analyst for the Henry J. Kaiser Family Foundation.

“Ultimately, if the court were to rule in favor of Zubik, it would mean the workers and dependents of nonprofits are at risk of losing some or all contraceptive coverage,” Ms. Sobel said during a March 16 Kaiser press briefing. “The burden on women to pay out of pocket has [been] shown to really limit their choices and possibly limit [all] contraceptives for them.”

The ACA’s accommodation clause refers to an exception for organizations that oppose coverage for contraceptives but are not exempted entities, such as churches. The plaintiffs – part of seven consolidated cases that include a Catholic bishop and an order of nuns – argue that the opt-out process put in place by the government makes them complicit in offering contraception coverage indirectly.

The government contends that the exception does not impose a burden on the groups and that courts should not disregard the interest of employees who may not share their employers’ religious beliefs. The 8th U.S. Circuit Court of Appeals struck down the exception twice, ruling that forcing organizations to offer contraceptive coverage – even indirectly – violates their religious rights. The 8th Circuit’s decisions are at odds with rulings by the 2nd and 5th Circuit courts.

The case comes down to whether the plaintiffs can prove the accommodation places a substantial burden on their religious conduct, and if so, whether the government can prove its provision is the least restrictive means of advancing a compelling interest, said Marci A. Hamilton, a law professor at the Benjamin N. Cardozo School of Law, Yeshiva University, New York.

“[If the court sides with Zubik], one possible precedent this could set is that religious objectors – the employers in these cases – will be able to limit independent third-party actions,” Ms. Hamilton said during the media conference. “It doesn’t matter the faith. You can have your decisions about birth control and the cost and reproductive care determined by the faith of your employer.”

©trekandshoot/thinkstockphotos.com

A ruling for Zubik would also throw a monkey wrench in the country’s long tradition of legislative accommodations, Ms. Hamilton said, noting that there are many laws that include accommodations for certain populations.

“That means the legislative weighing of harm and safety is going to be pushed aside and essentially, we’re going to be talking about, how can every single law including the accommodations be fine-tuned for one set of believers?”

The recent death of Associate Justice Antonin Scalia, who was the court’s most outspoken conservative, could significantly impact the case’s outcome, analysts said. Justice Scalia was among majority in the 5-4 decision in Burwell v. Hobby Lobby, a 2014 opinion that protected religiously devout owners of closely held, for-profit businesses from having to offer birth control under the mandate. His absence could mean a 4-4 split in the Zubik case, which would allow the lower court rulings to stand, said Lyle Denniston, a Supreme Court analyst who writes for SCOTUSblog.

“My own sense is that the court is going to try very hard to find a way to resolve this case without a 4-4 split,” Mr. Denniston said during the Kaiser media conference. “If the Supreme Court issues a 4-4 decision, that leaves division in the lower courts, and it will vary from region to region in the country as to what the rights for women under the ACA are.”

More than 70 briefs have been issued to the high court in support of or opposition to the plaintiffs, including pleas by religious organizations, women’s advocacy groups, law professors, medical associations, and attorneys.

The American College of Obstetricians and Gynecologists and the American Academy of Family Physicians wrote in a joint brief that contraception coverage under the ACA ensures that patients have access to medically appropriate contraception without regard to their ability to pay. At the same time, the law respects an employer’s sincerely held religious objections to contraception through the accommodation, the brief said.

However, the Council for Christian Colleges & Universities argues the government’s decision to exempt some religious employers from providing contraceptive coverage while requiring others to comply with the mandate “demonstrates that the government’s approach is not the least restrictive means necessary to advance its interests.”

“Civil rights should not vary based on whether that institution is or is not affiliated with a church or other house of worship,” the council wrote in its brief to the Supreme Court. “Religious exercise is not tied to one’s affiliation but rather the source and sincerity of one’s belief and the desire to exercise it. That truth appears to be one the government has been unable to grasp or comprehend as it decides who is sufficiently ‘religious’ to have religious beliefs worthy of protection.”

[email protected]

On Twitter @legal_med

Second-generation antipsychotic use is associated with a previous incidence of psychiatric hospitalization in patients with bipolar disorder I but not in those with bipolar II, a study by Dr. Dong Yeon Park and associates shows.

The researchers found that the use of the second-generation agents (SGAs) was twice as common in the bipolar disorder I study group. Forty-four percent of 243 bipolar I patients used at least one of the antipsychotics, compared with 21.2% of 260 patients with bipolar disorder II.

Most bipolar I patients had a history of psychiatric hospitalization; however, hospitalization was significantly more common among patients in an SGA subgroup. In that group, more than 80% of those patients had a history of psychiatric hospitalization, compared with 58.1% of patients with bipolar I who were not taking SGAs. Comparatively, 12.7% of bipolar II patients taking SGAs had a history of psychiatric hospitalization, compared with 9.3% of bipolar II patients who were not taking SGAs.

Patients with bipolar I who were on SGAs also were more likely to be currently depressed, have current complex pharmacotherapy, and have a higher Clinical Global Impression for Bipolar Version Overall Severity score. Meanwhile, bipolar disorder II patients taking SGAs were more likely to be currently using mood stabilizers than were bipolar II patients who were not taking SGAs, reported Dr. Park, of the department of psychiatry at Seoul National Hospital, South Korea.

“More research is needed to assess differential demographic and clinical correlates of current SGA use in patients with bipolar II disorder compared to bipolar I disorder. Challenges related to the variable expense and side effects of SGAs highlight the importance of increasing knowledge of the strengths and limitations of use of these agents in patients with different types of bipolar disorders,” the investigators concluded.

Find the study in the Journal of Psychiatric Research (doi: 10.1016/j.jpsychires.2016.01.016).

[email protected]

Second-generation antipsychotic use is associated with a previous incidence of psychiatric hospitalization in patients with bipolar disorder I but not in those with bipolar II, a study by Dr. Dong Yeon Park and associates shows.

The researchers found that the use of the second-generation agents (SGAs) was twice as common in the bipolar disorder I study group. Forty-four percent of 243 bipolar I patients used at least one of the antipsychotics, compared with 21.2% of 260 patients with bipolar disorder II.

Most bipolar I patients had a history of psychiatric hospitalization; however, hospitalization was significantly more common among patients in an SGA subgroup. In that group, more than 80% of those patients had a history of psychiatric hospitalization, compared with 58.1% of patients with bipolar I who were not taking SGAs. Comparatively, 12.7% of bipolar II patients taking SGAs had a history of psychiatric hospitalization, compared with 9.3% of bipolar II patients who were not taking SGAs.

Patients with bipolar I who were on SGAs also were more likely to be currently depressed, have current complex pharmacotherapy, and have a higher Clinical Global Impression for Bipolar Version Overall Severity score. Meanwhile, bipolar disorder II patients taking SGAs were more likely to be currently using mood stabilizers than were bipolar II patients who were not taking SGAs, reported Dr. Park, of the department of psychiatry at Seoul National Hospital, South Korea.

“More research is needed to assess differential demographic and clinical correlates of current SGA use in patients with bipolar II disorder compared to bipolar I disorder. Challenges related to the variable expense and side effects of SGAs highlight the importance of increasing knowledge of the strengths and limitations of use of these agents in patients with different types of bipolar disorders,” the investigators concluded.

Find the study in the Journal of Psychiatric Research (doi: 10.1016/j.jpsychires.2016.01.016).

[email protected]

Second-generation antipsychotic use is associated with a previous incidence of psychiatric hospitalization in patients with bipolar disorder I but not in those with bipolar II, a study by Dr. Dong Yeon Park and associates shows.

The researchers found that the use of the second-generation agents (SGAs) was twice as common in the bipolar disorder I study group. Forty-four percent of 243 bipolar I patients used at least one of the antipsychotics, compared with 21.2% of 260 patients with bipolar disorder II.

Most bipolar I patients had a history of psychiatric hospitalization; however, hospitalization was significantly more common among patients in an SGA subgroup. In that group, more than 80% of those patients had a history of psychiatric hospitalization, compared with 58.1% of patients with bipolar I who were not taking SGAs. Comparatively, 12.7% of bipolar II patients taking SGAs had a history of psychiatric hospitalization, compared with 9.3% of bipolar II patients who were not taking SGAs.

Patients with bipolar I who were on SGAs also were more likely to be currently depressed, have current complex pharmacotherapy, and have a higher Clinical Global Impression for Bipolar Version Overall Severity score. Meanwhile, bipolar disorder II patients taking SGAs were more likely to be currently using mood stabilizers than were bipolar II patients who were not taking SGAs, reported Dr. Park, of the department of psychiatry at Seoul National Hospital, South Korea.

“More research is needed to assess differential demographic and clinical correlates of current SGA use in patients with bipolar II disorder compared to bipolar I disorder. Challenges related to the variable expense and side effects of SGAs highlight the importance of increasing knowledge of the strengths and limitations of use of these agents in patients with different types of bipolar disorders,” the investigators concluded.

Find the study in the Journal of Psychiatric Research (doi: 10.1016/j.jpsychires.2016.01.016).

[email protected]

A generic formulation of oxiconazole nitrate cream, 1% has been approved by the Food and Drug Administration, for the treatment of tinea pedis, tinea cruris, tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum) and tinea (pityriasis) versicolor due to Malassezia furfur.

This is the first generic version of Oxistat to be approved, according to the FDA’s statement announcing the approval.

The label for the generic, manufactured by Taro Pharmaceuticals U.S.A. is available here.

[email protected]

A generic formulation of oxiconazole nitrate cream, 1% has been approved by the Food and Drug Administration, for the treatment of tinea pedis, tinea cruris, tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum) and tinea (pityriasis) versicolor due to Malassezia furfur.

This is the first generic version of Oxistat to be approved, according to the FDA’s statement announcing the approval.

The label for the generic, manufactured by Taro Pharmaceuticals U.S.A. is available here.

[email protected]

A generic formulation of oxiconazole nitrate cream, 1% has been approved by the Food and Drug Administration, for the treatment of tinea pedis, tinea cruris, tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum) and tinea (pityriasis) versicolor due to Malassezia furfur.

This is the first generic version of Oxistat to be approved, according to the FDA’s statement announcing the approval.

The label for the generic, manufactured by Taro Pharmaceuticals U.S.A. is available here.

[email protected]

BOSTON – The operation was a success, but the patient died.

It’s an old chestnut for sure, but there is a painful kernel of truth in it, say investigators who found that patients who undergo complex cancer surgery and have serious complications are at significantly increased risk for death for at least 6 months after surgery, compared with patients who undergo the same procedure with few or no complications.

“Our work has important implications for quality assessment. I think in cancer surgery in particular we have to get away from the short-term metrics of survival, and we have to think about the implications of complications for long-term survival, even if at a very high-quality hospital we’re good at salvaging those patients who do experience those complications,” said Dr. Hari Nathan of the University of Michigan, Ann Arbor.

In a retrospective study, results of which were presented at the annual Society of Surgical Oncology Cancer Symposium, Dr. Nathan and colleagues showed that patients who underwent surgery for cancers of the esophagus and lung who had serious complications but survived at least 30 days after surgery had a more than twofold greater risk for death than did patients who had no complications, and patients with serious complications following surgery for cancer of the pancreas had a nearly twofold greater risk.

The effects of serious complications on survival persisted out to at least 180 days after surgery for each of the three procedures.

The findings suggest that just getting the patient through the operation and keeping him or her alive in the ICU is not sufficient cause for celebration by surgeons, Dr. Nathan said.

The investigators conducted the study to examine the incidence of complications following cancer surgery in older patients, the relationship between surgical complications and long-term survival, and whether the effects of complications would diminish or “wash out” over time. They reviewed Surveillance, Epidemiology and End Results–Medicare data on patients aged 65 years and older who underwent surgery with curative intent for esophageal cancer, non–small cell lung cancer, or pancreatic adenocarcinoma from 2005 through 2009.

They defined serious complications as “the appearance of a complication associated with a hospital length of stay greater than the 75th percentile for that procedure.”

The cohort included 965 patients who underwent esophageal surgery, 12,395 who had lung surgery, and 1,966 who underwent pancreatic resection. The proportion of patients over 80 years who underwent the procedures, respectively, were 12%, 18%, and 19%.

Serious complications occurred in 17% of patients with esophageal cancer, 10% of those with lung cancer, and 12% of those with cancer of the pancreas. The respective 30-day mortality rates were 6.%, 3.3%, and 3.9%.

Looking only at those patients with lung cancer who survived at least 30 days after surgery, the investigators found that median survival among those who had no complications was 79 months, compared with 60 months for those who had mild complications, and 33 months for patients who had serious complications (P less than .001)

“And indeed, when we performed adjusted survival analyses looking at all three disease sites, we saw a very consistent story: that those patients who had serious complications had decreased long-term survival for all three malignancies we looked at,” Dr. Nathan said.

Specifically, in survival analyses adjusted for sex, age, and procedure code, hazard ratios for patients with serious complications compared with those who had no complications were 2.55 for esophageal cancer patients, 2.13 for lung cancer patients, and 1.57 for pancreatic cancer patients (all comparisons significant as shown by 95% confidence intervals).

The investigators questioned whether the differences in mortality were due to the late effects of perioperative complications.

“In modern ICUs, we can keep virtually anybody alive for 30 days, and there has been a lot interest in longer-term metrics for perioperative mortality, for example, at 30 or 90 days, so we thought maybe that’s what we were seeing here,” he said. To test this idea, the investigators looked at the effects of complications on patient who survived lung cancer surgery for at least 90 days, and those who lived for at least 180 days after surgery, and they saw that the survival curves were similar to those seen with the 30-day survivors, showing significantly and persistently worse survival for patients with serious complications (P less than .001).

For each of the disease states, patients with serious complications were also significantly less likely than were those with no or mild complications to receive adjuvant chemotherapy, even after adjustment for patient age and cancer stage, two significant determinants of the likelihood of receiving chemotherapy.

And even when the effect of chemotherapy for those who did receive it was added into the survival models, patients with serious complications still had significantly worse overall survival, Dr. Nathan noted.

“Serious complications after these three cancer resections are common and they are associated with dramatically inferior long-term survival. Thirty, 60, 90, and even 180-day measures of mortality do not capture the full impact of complications on long-term survival,” he said.

Asked whether it may be possible to identify those patients at higher risk for serious complications due to comorbidities or other factors, and perhaps suggest withholding surgery from such patients, Dr. Nathan agreed, but added that “the best chance for survival for all of these patients is a high-quality surgical resection, so it’s hard to deny a patient that chance unless you think they have a really high risk of perioperative death.”

The study was internally funded. Dr. Nathan reported no significant disclosures.

BOSTON – The operation was a success, but the patient died.

It’s an old chestnut for sure, but there is a painful kernel of truth in it, say investigators who found that patients who undergo complex cancer surgery and have serious complications are at significantly increased risk for death for at least 6 months after surgery, compared with patients who undergo the same procedure with few or no complications.

“Our work has important implications for quality assessment. I think in cancer surgery in particular we have to get away from the short-term metrics of survival, and we have to think about the implications of complications for long-term survival, even if at a very high-quality hospital we’re good at salvaging those patients who do experience those complications,” said Dr. Hari Nathan of the University of Michigan, Ann Arbor.

In a retrospective study, results of which were presented at the annual Society of Surgical Oncology Cancer Symposium, Dr. Nathan and colleagues showed that patients who underwent surgery for cancers of the esophagus and lung who had serious complications but survived at least 30 days after surgery had a more than twofold greater risk for death than did patients who had no complications, and patients with serious complications following surgery for cancer of the pancreas had a nearly twofold greater risk.

The effects of serious complications on survival persisted out to at least 180 days after surgery for each of the three procedures.

The findings suggest that just getting the patient through the operation and keeping him or her alive in the ICU is not sufficient cause for celebration by surgeons, Dr. Nathan said.

The investigators conducted the study to examine the incidence of complications following cancer surgery in older patients, the relationship between surgical complications and long-term survival, and whether the effects of complications would diminish or “wash out” over time. They reviewed Surveillance, Epidemiology and End Results–Medicare data on patients aged 65 years and older who underwent surgery with curative intent for esophageal cancer, non–small cell lung cancer, or pancreatic adenocarcinoma from 2005 through 2009.

They defined serious complications as “the appearance of a complication associated with a hospital length of stay greater than the 75th percentile for that procedure.”

The cohort included 965 patients who underwent esophageal surgery, 12,395 who had lung surgery, and 1,966 who underwent pancreatic resection. The proportion of patients over 80 years who underwent the procedures, respectively, were 12%, 18%, and 19%.

Serious complications occurred in 17% of patients with esophageal cancer, 10% of those with lung cancer, and 12% of those with cancer of the pancreas. The respective 30-day mortality rates were 6.%, 3.3%, and 3.9%.

Looking only at those patients with lung cancer who survived at least 30 days after surgery, the investigators found that median survival among those who had no complications was 79 months, compared with 60 months for those who had mild complications, and 33 months for patients who had serious complications (P less than .001)

“And indeed, when we performed adjusted survival analyses looking at all three disease sites, we saw a very consistent story: that those patients who had serious complications had decreased long-term survival for all three malignancies we looked at,” Dr. Nathan said.

Specifically, in survival analyses adjusted for sex, age, and procedure code, hazard ratios for patients with serious complications compared with those who had no complications were 2.55 for esophageal cancer patients, 2.13 for lung cancer patients, and 1.57 for pancreatic cancer patients (all comparisons significant as shown by 95% confidence intervals).

The investigators questioned whether the differences in mortality were due to the late effects of perioperative complications.

“In modern ICUs, we can keep virtually anybody alive for 30 days, and there has been a lot interest in longer-term metrics for perioperative mortality, for example, at 30 or 90 days, so we thought maybe that’s what we were seeing here,” he said. To test this idea, the investigators looked at the effects of complications on patient who survived lung cancer surgery for at least 90 days, and those who lived for at least 180 days after surgery, and they saw that the survival curves were similar to those seen with the 30-day survivors, showing significantly and persistently worse survival for patients with serious complications (P less than .001).

For each of the disease states, patients with serious complications were also significantly less likely than were those with no or mild complications to receive adjuvant chemotherapy, even after adjustment for patient age and cancer stage, two significant determinants of the likelihood of receiving chemotherapy.

And even when the effect of chemotherapy for those who did receive it was added into the survival models, patients with serious complications still had significantly worse overall survival, Dr. Nathan noted.

“Serious complications after these three cancer resections are common and they are associated with dramatically inferior long-term survival. Thirty, 60, 90, and even 180-day measures of mortality do not capture the full impact of complications on long-term survival,” he said.

Asked whether it may be possible to identify those patients at higher risk for serious complications due to comorbidities or other factors, and perhaps suggest withholding surgery from such patients, Dr. Nathan agreed, but added that “the best chance for survival for all of these patients is a high-quality surgical resection, so it’s hard to deny a patient that chance unless you think they have a really high risk of perioperative death.”

The study was internally funded. Dr. Nathan reported no significant disclosures.

BOSTON – The operation was a success, but the patient died.

It’s an old chestnut for sure, but there is a painful kernel of truth in it, say investigators who found that patients who undergo complex cancer surgery and have serious complications are at significantly increased risk for death for at least 6 months after surgery, compared with patients who undergo the same procedure with few or no complications.

“Our work has important implications for quality assessment. I think in cancer surgery in particular we have to get away from the short-term metrics of survival, and we have to think about the implications of complications for long-term survival, even if at a very high-quality hospital we’re good at salvaging those patients who do experience those complications,” said Dr. Hari Nathan of the University of Michigan, Ann Arbor.

In a retrospective study, results of which were presented at the annual Society of Surgical Oncology Cancer Symposium, Dr. Nathan and colleagues showed that patients who underwent surgery for cancers of the esophagus and lung who had serious complications but survived at least 30 days after surgery had a more than twofold greater risk for death than did patients who had no complications, and patients with serious complications following surgery for cancer of the pancreas had a nearly twofold greater risk.

The effects of serious complications on survival persisted out to at least 180 days after surgery for each of the three procedures.

The findings suggest that just getting the patient through the operation and keeping him or her alive in the ICU is not sufficient cause for celebration by surgeons, Dr. Nathan said.

The investigators conducted the study to examine the incidence of complications following cancer surgery in older patients, the relationship between surgical complications and long-term survival, and whether the effects of complications would diminish or “wash out” over time. They reviewed Surveillance, Epidemiology and End Results–Medicare data on patients aged 65 years and older who underwent surgery with curative intent for esophageal cancer, non–small cell lung cancer, or pancreatic adenocarcinoma from 2005 through 2009.

They defined serious complications as “the appearance of a complication associated with a hospital length of stay greater than the 75th percentile for that procedure.”

The cohort included 965 patients who underwent esophageal surgery, 12,395 who had lung surgery, and 1,966 who underwent pancreatic resection. The proportion of patients over 80 years who underwent the procedures, respectively, were 12%, 18%, and 19%.

Serious complications occurred in 17% of patients with esophageal cancer, 10% of those with lung cancer, and 12% of those with cancer of the pancreas. The respective 30-day mortality rates were 6.%, 3.3%, and 3.9%.

Looking only at those patients with lung cancer who survived at least 30 days after surgery, the investigators found that median survival among those who had no complications was 79 months, compared with 60 months for those who had mild complications, and 33 months for patients who had serious complications (P less than .001)

“And indeed, when we performed adjusted survival analyses looking at all three disease sites, we saw a very consistent story: that those patients who had serious complications had decreased long-term survival for all three malignancies we looked at,” Dr. Nathan said.

Specifically, in survival analyses adjusted for sex, age, and procedure code, hazard ratios for patients with serious complications compared with those who had no complications were 2.55 for esophageal cancer patients, 2.13 for lung cancer patients, and 1.57 for pancreatic cancer patients (all comparisons significant as shown by 95% confidence intervals).

The investigators questioned whether the differences in mortality were due to the late effects of perioperative complications.

“In modern ICUs, we can keep virtually anybody alive for 30 days, and there has been a lot interest in longer-term metrics for perioperative mortality, for example, at 30 or 90 days, so we thought maybe that’s what we were seeing here,” he said. To test this idea, the investigators looked at the effects of complications on patient who survived lung cancer surgery for at least 90 days, and those who lived for at least 180 days after surgery, and they saw that the survival curves were similar to those seen with the 30-day survivors, showing significantly and persistently worse survival for patients with serious complications (P less than .001).

For each of the disease states, patients with serious complications were also significantly less likely than were those with no or mild complications to receive adjuvant chemotherapy, even after adjustment for patient age and cancer stage, two significant determinants of the likelihood of receiving chemotherapy.

And even when the effect of chemotherapy for those who did receive it was added into the survival models, patients with serious complications still had significantly worse overall survival, Dr. Nathan noted.

“Serious complications after these three cancer resections are common and they are associated with dramatically inferior long-term survival. Thirty, 60, 90, and even 180-day measures of mortality do not capture the full impact of complications on long-term survival,” he said.

Asked whether it may be possible to identify those patients at higher risk for serious complications due to comorbidities or other factors, and perhaps suggest withholding surgery from such patients, Dr. Nathan agreed, but added that “the best chance for survival for all of these patients is a high-quality surgical resection, so it’s hard to deny a patient that chance unless you think they have a really high risk of perioperative death.”

The study was internally funded. Dr. Nathan reported no significant disclosures.

In 1986, the United States and Canada mandated the adoption of a center brake light on all new cars. Studies had shown that this was better at getting attention than the two side lights alone, and reduced collisions.

Of course, as the years went by the safety benefit gradually faded. It never returned to the previous level, but clearly, as people got used to it, the new light faded into the background of their attention.

Today, we have electronic health record (EHR) systems that use all kinds of pop-up warnings to check INRs, to give flu shots, to consider COPD in the differential ... a million things. I’m sure the attorneys love them. (“Doctor, since the computer clearly warned you about this, why did you click ‘ignore’ and move on?”)

I don’t use one of those systems, but I talk to plenty of doctors who do. Initially, it was interesting and got their attention, then became annoying. Each pop-up window interrupted the chain of thought, distracting them from the task at hand: patient care. As time went on, they just began ignoring them. It’s easier to click “cancel” than it is have to think through something you’ve probably already considered.

So, like the center brake light, the well-intentioned pop-up window is ignored and pushed to the far side of your attention span.

Do these things improve quality of care? Probably no more than the center brake light reduces car accidents these days. They’re likely useful in training, to remind medical students and residents of things that are important, but beyond that would be a tough case to make.

I’m not saying attending physicians are infallible. We all make our share of mistakes in this world. But medicine is not a one-size-fits-all field. The EHRs, at least at present, can’t take into account as we do all the variables of each patient’s personality, social situation, compliance history, medication tolerance issues, and other factors.

Not only that, but the pop-up window saying, “Have you considered this?” is no less distracting than having to take a phone call during a visit. It’s intrusive, throws your train of thought temporarily onto another track, and requires a minute to refocus on the task at hand. In that time, you may have forgotten something equally, if not more important. Or missed some critical piece of information the patient mentioned.

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

In 1986, the United States and Canada mandated the adoption of a center brake light on all new cars. Studies had shown that this was better at getting attention than the two side lights alone, and reduced collisions.

Of course, as the years went by the safety benefit gradually faded. It never returned to the previous level, but clearly, as people got used to it, the new light faded into the background of their attention.

Today, we have electronic health record (EHR) systems that use all kinds of pop-up warnings to check INRs, to give flu shots, to consider COPD in the differential ... a million things. I’m sure the attorneys love them. (“Doctor, since the computer clearly warned you about this, why did you click ‘ignore’ and move on?”)

I don’t use one of those systems, but I talk to plenty of doctors who do. Initially, it was interesting and got their attention, then became annoying. Each pop-up window interrupted the chain of thought, distracting them from the task at hand: patient care. As time went on, they just began ignoring them. It’s easier to click “cancel” than it is have to think through something you’ve probably already considered.

So, like the center brake light, the well-intentioned pop-up window is ignored and pushed to the far side of your attention span.

Do these things improve quality of care? Probably no more than the center brake light reduces car accidents these days. They’re likely useful in training, to remind medical students and residents of things that are important, but beyond that would be a tough case to make.

I’m not saying attending physicians are infallible. We all make our share of mistakes in this world. But medicine is not a one-size-fits-all field. The EHRs, at least at present, can’t take into account as we do all the variables of each patient’s personality, social situation, compliance history, medication tolerance issues, and other factors.

Not only that, but the pop-up window saying, “Have you considered this?” is no less distracting than having to take a phone call during a visit. It’s intrusive, throws your train of thought temporarily onto another track, and requires a minute to refocus on the task at hand. In that time, you may have forgotten something equally, if not more important. Or missed some critical piece of information the patient mentioned.

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

In 1986, the United States and Canada mandated the adoption of a center brake light on all new cars. Studies had shown that this was better at getting attention than the two side lights alone, and reduced collisions.

Of course, as the years went by the safety benefit gradually faded. It never returned to the previous level, but clearly, as people got used to it, the new light faded into the background of their attention.

Today, we have electronic health record (EHR) systems that use all kinds of pop-up warnings to check INRs, to give flu shots, to consider COPD in the differential ... a million things. I’m sure the attorneys love them. (“Doctor, since the computer clearly warned you about this, why did you click ‘ignore’ and move on?”)

I don’t use one of those systems, but I talk to plenty of doctors who do. Initially, it was interesting and got their attention, then became annoying. Each pop-up window interrupted the chain of thought, distracting them from the task at hand: patient care. As time went on, they just began ignoring them. It’s easier to click “cancel” than it is have to think through something you’ve probably already considered.

So, like the center brake light, the well-intentioned pop-up window is ignored and pushed to the far side of your attention span.

Do these things improve quality of care? Probably no more than the center brake light reduces car accidents these days. They’re likely useful in training, to remind medical students and residents of things that are important, but beyond that would be a tough case to make.

I’m not saying attending physicians are infallible. We all make our share of mistakes in this world. But medicine is not a one-size-fits-all field. The EHRs, at least at present, can’t take into account as we do all the variables of each patient’s personality, social situation, compliance history, medication tolerance issues, and other factors.

Not only that, but the pop-up window saying, “Have you considered this?” is no less distracting than having to take a phone call during a visit. It’s intrusive, throws your train of thought temporarily onto another track, and requires a minute to refocus on the task at hand. In that time, you may have forgotten something equally, if not more important. Or missed some critical piece of information the patient mentioned.

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

Many more physicians seeking to subspecialize in addiction medicine will now have the official blessing of the American Board of Medical Specialties.

ABMS announced March 14 its approval of an addiction medicine subspecialty that the American Board of Preventive Medicine (ABPM) will sponsor.

Physicians who are certified by any of the 24 ABMS member boards can apply for the addiction medicine certification. The American Board of Psychiatry and Neurology offers certification in addiction psychiatry, but only to psychiatrists.

ABPM hasn’t set a date for the addiction medicine subspecialty’s first board certification exam, which the board will develop. ABPM will post updates on its website, www.theabpm.org.

“Increasing the number of well-trained and certified specialists in addiction medicine will significantly increase access to care for those in need of intervention and treatment,” said ABPM’s board chair, Dr. Denece O. Kesler, in a statement.

One in seven Americans older than 12 years meets medical criteria for an addiction to nicotine, alcohol, or other drugs, according to statistics from the National Center on Addiction and Substance Abuse. But only 11% of those who need treatment are able to receive it, in part because of a lack of addiction medicine providers.

The American Board of Addiction Medicine (ABAM) hailed the new subspecialty. “This is a great day for addiction medicine,” Dr. Robert J. Sokol, president of ABAM and the Addiction Medicine Foundation (AMF), said in a statement. “This landmark event, more than any other, recognizes addiction as a preventable and treatable disease.”

ABAM has certified 3,902 physicians, according to the organization, which is not an ABMS member board. There are 40 AMF-sponsored fellowship training programs nationally, with a commitment to establish 125 more by 2025. AMF expects the ABMS recognition will lead to the fellowships gaining the imprimatur of the Accreditation Council on Graduate Medical Education.

“This is a positive development that has the potential to address a serious public health problem,” Dr. Daniel Lieberman, vice chairman of the psychiatry and behavioral health department at George Washington University, Washington, said in an interview. “This action will reassure doctors who are interested in addiction medicine that the time and effort they put into obtaining additional training will give them the status of a subspecialist with recognized expertise. It may also encourage young doctors to consider addiction medicine as a career path.”

Meanwhile, a package of mental health reforms moving in the U.S. Senate could improve patients’ access to addiction medicine providers. One of the bills, the TREAT Act, would increase the number of substance use detoxification patients that a qualified provider is legally allowed to treat annually, from 30 patients to 100 patients. The legislation also would allow those practitioners to request permission to annually treat unlimited numbers of patients thereafter.

[email protected]

On Twitter @whitneymcknight

Many more physicians seeking to subspecialize in addiction medicine will now have the official blessing of the American Board of Medical Specialties.

ABMS announced March 14 its approval of an addiction medicine subspecialty that the American Board of Preventive Medicine (ABPM) will sponsor.

Physicians who are certified by any of the 24 ABMS member boards can apply for the addiction medicine certification. The American Board of Psychiatry and Neurology offers certification in addiction psychiatry, but only to psychiatrists.

ABPM hasn’t set a date for the addiction medicine subspecialty’s first board certification exam, which the board will develop. ABPM will post updates on its website, www.theabpm.org.

“Increasing the number of well-trained and certified specialists in addiction medicine will significantly increase access to care for those in need of intervention and treatment,” said ABPM’s board chair, Dr. Denece O. Kesler, in a statement.

One in seven Americans older than 12 years meets medical criteria for an addiction to nicotine, alcohol, or other drugs, according to statistics from the National Center on Addiction and Substance Abuse. But only 11% of those who need treatment are able to receive it, in part because of a lack of addiction medicine providers.

The American Board of Addiction Medicine (ABAM) hailed the new subspecialty. “This is a great day for addiction medicine,” Dr. Robert J. Sokol, president of ABAM and the Addiction Medicine Foundation (AMF), said in a statement. “This landmark event, more than any other, recognizes addiction as a preventable and treatable disease.”

ABAM has certified 3,902 physicians, according to the organization, which is not an ABMS member board. There are 40 AMF-sponsored fellowship training programs nationally, with a commitment to establish 125 more by 2025. AMF expects the ABMS recognition will lead to the fellowships gaining the imprimatur of the Accreditation Council on Graduate Medical Education.

“This is a positive development that has the potential to address a serious public health problem,” Dr. Daniel Lieberman, vice chairman of the psychiatry and behavioral health department at George Washington University, Washington, said in an interview. “This action will reassure doctors who are interested in addiction medicine that the time and effort they put into obtaining additional training will give them the status of a subspecialist with recognized expertise. It may also encourage young doctors to consider addiction medicine as a career path.”

Meanwhile, a package of mental health reforms moving in the U.S. Senate could improve patients’ access to addiction medicine providers. One of the bills, the TREAT Act, would increase the number of substance use detoxification patients that a qualified provider is legally allowed to treat annually, from 30 patients to 100 patients. The legislation also would allow those practitioners to request permission to annually treat unlimited numbers of patients thereafter.

[email protected]

On Twitter @whitneymcknight

Many more physicians seeking to subspecialize in addiction medicine will now have the official blessing of the American Board of Medical Specialties.

ABMS announced March 14 its approval of an addiction medicine subspecialty that the American Board of Preventive Medicine (ABPM) will sponsor.

Physicians who are certified by any of the 24 ABMS member boards can apply for the addiction medicine certification. The American Board of Psychiatry and Neurology offers certification in addiction psychiatry, but only to psychiatrists.

ABPM hasn’t set a date for the addiction medicine subspecialty’s first board certification exam, which the board will develop. ABPM will post updates on its website, www.theabpm.org.

“Increasing the number of well-trained and certified specialists in addiction medicine will significantly increase access to care for those in need of intervention and treatment,” said ABPM’s board chair, Dr. Denece O. Kesler, in a statement.

One in seven Americans older than 12 years meets medical criteria for an addiction to nicotine, alcohol, or other drugs, according to statistics from the National Center on Addiction and Substance Abuse. But only 11% of those who need treatment are able to receive it, in part because of a lack of addiction medicine providers.

The American Board of Addiction Medicine (ABAM) hailed the new subspecialty. “This is a great day for addiction medicine,” Dr. Robert J. Sokol, president of ABAM and the Addiction Medicine Foundation (AMF), said in a statement. “This landmark event, more than any other, recognizes addiction as a preventable and treatable disease.”

ABAM has certified 3,902 physicians, according to the organization, which is not an ABMS member board. There are 40 AMF-sponsored fellowship training programs nationally, with a commitment to establish 125 more by 2025. AMF expects the ABMS recognition will lead to the fellowships gaining the imprimatur of the Accreditation Council on Graduate Medical Education.

“This is a positive development that has the potential to address a serious public health problem,” Dr. Daniel Lieberman, vice chairman of the psychiatry and behavioral health department at George Washington University, Washington, said in an interview. “This action will reassure doctors who are interested in addiction medicine that the time and effort they put into obtaining additional training will give them the status of a subspecialist with recognized expertise. It may also encourage young doctors to consider addiction medicine as a career path.”

Meanwhile, a package of mental health reforms moving in the U.S. Senate could improve patients’ access to addiction medicine providers. One of the bills, the TREAT Act, would increase the number of substance use detoxification patients that a qualified provider is legally allowed to treat annually, from 30 patients to 100 patients. The legislation also would allow those practitioners to request permission to annually treat unlimited numbers of patients thereafter.

[email protected]

On Twitter @whitneymcknight

MAUI, HAWAII – One of the major happenings in the field of osteoarthritis in the past year was a disturbing report of dramatically increased risk of acute MI for at least 6 months after total knee replacement, panelists agreed at the 2016 Rheumatology Winter Clinical Symposium.

“What they found borders on frightening,” according to Dr. Martin J. Bergman of Drexel University, Philadelphia, and chief of rheumatology at Taylor Hospital in Ridley Park, Pa.

Bruce Jancin/Frontline Medical News

Dr. Bergman and copanelist Dr. Orrin M. Troum of the University of Southern California in Los Angeles highlighted key developments in osteoarthritis during the past year, including two major studies on total knee replacement, the Food and Drug Administration’s updated stronger warning on the cardiac and stroke risks of NSAIDs, a randomized trial which effectively takes hydroxychloroquine (Plaquenil) off the treatment menu for hand osteoarthritis, and a reassuring report on the safety of repeated intra-articular corticosteroid injections in patients with synovitic knee osteoarthritis.

Acute MI risk after total knee replacement

British investigators utilizing the U.K. National Health Service database retrospectively identified 13,849 patients who underwent total knee replacement (TKR) and an equal number of nonsurgical controls propensity-matched for cardiovascular risk factors. These two very large groups were followed for 5 years.

During the first month after TKR, the acute MI risk was 8.75-fold greater than in the matched controls. The elevated risk gradually declined thereafter, but it remained significantly higher than in controls until 1 year after surgery. At 3 months post surgery the TKR group was at fourfold increased risk of MI, compared with controls, and at 6 months their risk was still nearly double that of controls (Arthritis Rheumatol. 2015 Oct;67[10]:2771-9).

The British investigators also found a prolonged postsurgical elevated risk of MI in a large group of patients who underwent total hip replacement, although the magnitude of the increased risk, compared with matched controls, wasn’t as large as that seen after TKR.

Dr. Troum commented that the increased risk of MI during the first year after TKR identified in this study is something physicians now need to bring up in the risk/benefit discussion with patients considering TKR.

“Also, this study underscores that it may behoove us to make sure that these presurgical patients are really well worked up by a cardiologist or their primary care physician to mitigate that coronary risk as much as possible,” he added.

Another key finding in the U.K. study was that unlike the acute MI risk, the risk of venous thromboembolism following TKR remained elevated throughout the full 5 years of follow-up.

“Once you’ve had that surgery, you are at increased risk for venous thromboembolism. I think that’s something we have to keep in mind when a patient comes in with a history of total knee replacement and a complaint of calf pain or swelling – at that point, you have to think about deep venous thrombosis,” Dr. Bergman said.

TKR – Why wait?

In a Danish trial of 100 knee osteoarthritis patients deemed eligible for TKR, participants were randomized to prompt TKR followed by a 3-month regimen of exercise, dietary weight loss, physical therapy, and pain medication or to the nonsurgical regimen alone. At 12 months of follow-up, the prompt TKR group showed significantly greater improvement in a standardized score encompassing pain, symptoms, quality of life, and activities of daily living, even though one-quarter of patients in the nonsurgical treatment group bailed and underwent TKR before 12 months was up (N Engl J Med. 2015 Oct 22;373[17]:1597-606).

“My conclusion is that once you’ve determined that a patient needs and wants a total knee replacement, the patient should probably get it. Delaying – trying other modalities in an effort to lose weight and improve function – is really not going to buy you much in the way of time,” Dr. Bergman observed.

Hydroxychloroquine for hand osteoarthritis

At the 2015 European League Against Rheumatism (EULAR) meeting in Rome, Dutch investigators presented a randomized, double-blind trial in which 196 patients with symptomatic hand osteoarthritis received 6 months of hydroxychloroquine at 400 mg/day or placebo. Unlike in mild rheumatoid arthritis or lupus, hydroxychloroquine had no beneficial effect on hand osteoarthritis pain, disability, or quality of life measures.

“Plaquenil [Hydroxychloroquine] is not a good choice for patients with osteoarthritis of the hand. I think it’s a dead therapy,” Dr. Troum declared.

FDA expands warning on NSAIDs’ cardiovascular risk

On July 9, 2015, the FDA announced updated labels for NSAIDs. The new warning states that MI and stroke risk can increase as early as in the first week of NSAID use and appear to be dose- and duration-related. The agency also warned that patients who take an NSAID after a first MI are more likely to die within 1 year.

“This really brought a lot of folks to my office,” Dr. Troum recalled.

“Absolutely, this was big stuff,” Dr. Bergman agreed. “This became a nightmare for many of us because all of a sudden patients were scared to death about taking their NSAIDs.”

Intra-articular corticosteroids for knee osteoarthritis don’t accelerate cartilage deterioration

At last fall’s American College of Rheumatology meeting in San Francisco, Jeffrey B. Driban, Ph.D., of Tufts Medical Center, Boston, presented a double-blind, randomized trial of intra-articular injections of triamcinolone hexacetonide 40 mg versus saline quarterly for 2 years in 140 patients with symptomatic knee osteoarthritis with ultrasound evidence of synovitis. Participants underwent annual evaluation of periarticular bone and cartilage changes via MRI and dual-energy x-ray absorptiometry.

After 2 years, there was no difference between the two groups in terms of pain scores, walk time, or other functional measures. The injections – eight in total over 2 years – were safe, with new-onset hypertension and hyperglycemia rates of 3% in this obese population. And most important of all, there were no major differences between the two groups in terms of quantitative or semiquantitative structural endpoints; in other words, the injections didn’t increase the rate of structural disease progression. The intra-articular steroid group showed a modestly greater rate of loss of cartilage thickness, which the investigators deemed of uncertain clinical significance.

“The structural changes were minimal,” Dr. Troum noted. “This is only a 2-year study, but I can say that I now feel more comfortable giving these injections in patients who for whatever reason can’t get surgery.”

Dr. Bergman said that many orthopedic surgeons talk up the potential risk that intra-articular steroid injections will accelerate cartilage damage. They place an arbitrary limit on the number of injections a patient can receive.

“I think this study really helps us push back and say, ‘No, I think you’re fine in getting this procedure,’” the rheumatologist commented.

Dr. Bergman and Dr. Troum reported having no financial conflicts regarding their presentation.

[email protected]

MAUI, HAWAII – One of the major happenings in the field of osteoarthritis in the past year was a disturbing report of dramatically increased risk of acute MI for at least 6 months after total knee replacement, panelists agreed at the 2016 Rheumatology Winter Clinical Symposium.

“What they found borders on frightening,” according to Dr. Martin J. Bergman of Drexel University, Philadelphia, and chief of rheumatology at Taylor Hospital in Ridley Park, Pa.

Bruce Jancin/Frontline Medical News

Dr. Bergman and copanelist Dr. Orrin M. Troum of the University of Southern California in Los Angeles highlighted key developments in osteoarthritis during the past year, including two major studies on total knee replacement, the Food and Drug Administration’s updated stronger warning on the cardiac and stroke risks of NSAIDs, a randomized trial which effectively takes hydroxychloroquine (Plaquenil) off the treatment menu for hand osteoarthritis, and a reassuring report on the safety of repeated intra-articular corticosteroid injections in patients with synovitic knee osteoarthritis.

Acute MI risk after total knee replacement

British investigators utilizing the U.K. National Health Service database retrospectively identified 13,849 patients who underwent total knee replacement (TKR) and an equal number of nonsurgical controls propensity-matched for cardiovascular risk factors. These two very large groups were followed for 5 years.

During the first month after TKR, the acute MI risk was 8.75-fold greater than in the matched controls. The elevated risk gradually declined thereafter, but it remained significantly higher than in controls until 1 year after surgery. At 3 months post surgery the TKR group was at fourfold increased risk of MI, compared with controls, and at 6 months their risk was still nearly double that of controls (Arthritis Rheumatol. 2015 Oct;67[10]:2771-9).

The British investigators also found a prolonged postsurgical elevated risk of MI in a large group of patients who underwent total hip replacement, although the magnitude of the increased risk, compared with matched controls, wasn’t as large as that seen after TKR.

Dr. Troum commented that the increased risk of MI during the first year after TKR identified in this study is something physicians now need to bring up in the risk/benefit discussion with patients considering TKR.

“Also, this study underscores that it may behoove us to make sure that these presurgical patients are really well worked up by a cardiologist or their primary care physician to mitigate that coronary risk as much as possible,” he added.

Another key finding in the U.K. study was that unlike the acute MI risk, the risk of venous thromboembolism following TKR remained elevated throughout the full 5 years of follow-up.

“Once you’ve had that surgery, you are at increased risk for venous thromboembolism. I think that’s something we have to keep in mind when a patient comes in with a history of total knee replacement and a complaint of calf pain or swelling – at that point, you have to think about deep venous thrombosis,” Dr. Bergman said.

TKR – Why wait?

In a Danish trial of 100 knee osteoarthritis patients deemed eligible for TKR, participants were randomized to prompt TKR followed by a 3-month regimen of exercise, dietary weight loss, physical therapy, and pain medication or to the nonsurgical regimen alone. At 12 months of follow-up, the prompt TKR group showed significantly greater improvement in a standardized score encompassing pain, symptoms, quality of life, and activities of daily living, even though one-quarter of patients in the nonsurgical treatment group bailed and underwent TKR before 12 months was up (N Engl J Med. 2015 Oct 22;373[17]:1597-606).

“My conclusion is that once you’ve determined that a patient needs and wants a total knee replacement, the patient should probably get it. Delaying – trying other modalities in an effort to lose weight and improve function – is really not going to buy you much in the way of time,” Dr. Bergman observed.

Hydroxychloroquine for hand osteoarthritis

At the 2015 European League Against Rheumatism (EULAR) meeting in Rome, Dutch investigators presented a randomized, double-blind trial in which 196 patients with symptomatic hand osteoarthritis received 6 months of hydroxychloroquine at 400 mg/day or placebo. Unlike in mild rheumatoid arthritis or lupus, hydroxychloroquine had no beneficial effect on hand osteoarthritis pain, disability, or quality of life measures.

“Plaquenil [Hydroxychloroquine] is not a good choice for patients with osteoarthritis of the hand. I think it’s a dead therapy,” Dr. Troum declared.

FDA expands warning on NSAIDs’ cardiovascular risk

On July 9, 2015, the FDA announced updated labels for NSAIDs. The new warning states that MI and stroke risk can increase as early as in the first week of NSAID use and appear to be dose- and duration-related. The agency also warned that patients who take an NSAID after a first MI are more likely to die within 1 year.

“This really brought a lot of folks to my office,” Dr. Troum recalled.

“Absolutely, this was big stuff,” Dr. Bergman agreed. “This became a nightmare for many of us because all of a sudden patients were scared to death about taking their NSAIDs.”

Intra-articular corticosteroids for knee osteoarthritis don’t accelerate cartilage deterioration

At last fall’s American College of Rheumatology meeting in San Francisco, Jeffrey B. Driban, Ph.D., of Tufts Medical Center, Boston, presented a double-blind, randomized trial of intra-articular injections of triamcinolone hexacetonide 40 mg versus saline quarterly for 2 years in 140 patients with symptomatic knee osteoarthritis with ultrasound evidence of synovitis. Participants underwent annual evaluation of periarticular bone and cartilage changes via MRI and dual-energy x-ray absorptiometry.

After 2 years, there was no difference between the two groups in terms of pain scores, walk time, or other functional measures. The injections – eight in total over 2 years – were safe, with new-onset hypertension and hyperglycemia rates of 3% in this obese population. And most important of all, there were no major differences between the two groups in terms of quantitative or semiquantitative structural endpoints; in other words, the injections didn’t increase the rate of structural disease progression. The intra-articular steroid group showed a modestly greater rate of loss of cartilage thickness, which the investigators deemed of uncertain clinical significance.

“The structural changes were minimal,” Dr. Troum noted. “This is only a 2-year study, but I can say that I now feel more comfortable giving these injections in patients who for whatever reason can’t get surgery.”

Dr. Bergman said that many orthopedic surgeons talk up the potential risk that intra-articular steroid injections will accelerate cartilage damage. They place an arbitrary limit on the number of injections a patient can receive.

“I think this study really helps us push back and say, ‘No, I think you’re fine in getting this procedure,’” the rheumatologist commented.

Dr. Bergman and Dr. Troum reported having no financial conflicts regarding their presentation.

[email protected]

MAUI, HAWAII – One of the major happenings in the field of osteoarthritis in the past year was a disturbing report of dramatically increased risk of acute MI for at least 6 months after total knee replacement, panelists agreed at the 2016 Rheumatology Winter Clinical Symposium.

“What they found borders on frightening,” according to Dr. Martin J. Bergman of Drexel University, Philadelphia, and chief of rheumatology at Taylor Hospital in Ridley Park, Pa.

Bruce Jancin/Frontline Medical News

Dr. Bergman and copanelist Dr. Orrin M. Troum of the University of Southern California in Los Angeles highlighted key developments in osteoarthritis during the past year, including two major studies on total knee replacement, the Food and Drug Administration’s updated stronger warning on the cardiac and stroke risks of NSAIDs, a randomized trial which effectively takes hydroxychloroquine (Plaquenil) off the treatment menu for hand osteoarthritis, and a reassuring report on the safety of repeated intra-articular corticosteroid injections in patients with synovitic knee osteoarthritis.

Acute MI risk after total knee replacement

British investigators utilizing the U.K. National Health Service database retrospectively identified 13,849 patients who underwent total knee replacement (TKR) and an equal number of nonsurgical controls propensity-matched for cardiovascular risk factors. These two very large groups were followed for 5 years.

During the first month after TKR, the acute MI risk was 8.75-fold greater than in the matched controls. The elevated risk gradually declined thereafter, but it remained significantly higher than in controls until 1 year after surgery. At 3 months post surgery the TKR group was at fourfold increased risk of MI, compared with controls, and at 6 months their risk was still nearly double that of controls (Arthritis Rheumatol. 2015 Oct;67[10]:2771-9).

The British investigators also found a prolonged postsurgical elevated risk of MI in a large group of patients who underwent total hip replacement, although the magnitude of the increased risk, compared with matched controls, wasn’t as large as that seen after TKR.

Dr. Troum commented that the increased risk of MI during the first year after TKR identified in this study is something physicians now need to bring up in the risk/benefit discussion with patients considering TKR.

“Also, this study underscores that it may behoove us to make sure that these presurgical patients are really well worked up by a cardiologist or their primary care physician to mitigate that coronary risk as much as possible,” he added.

Another key finding in the U.K. study was that unlike the acute MI risk, the risk of venous thromboembolism following TKR remained elevated throughout the full 5 years of follow-up.

“Once you’ve had that surgery, you are at increased risk for venous thromboembolism. I think that’s something we have to keep in mind when a patient comes in with a history of total knee replacement and a complaint of calf pain or swelling – at that point, you have to think about deep venous thrombosis,” Dr. Bergman said.

TKR – Why wait?

In a Danish trial of 100 knee osteoarthritis patients deemed eligible for TKR, participants were randomized to prompt TKR followed by a 3-month regimen of exercise, dietary weight loss, physical therapy, and pain medication or to the nonsurgical regimen alone. At 12 months of follow-up, the prompt TKR group showed significantly greater improvement in a standardized score encompassing pain, symptoms, quality of life, and activities of daily living, even though one-quarter of patients in the nonsurgical treatment group bailed and underwent TKR before 12 months was up (N Engl J Med. 2015 Oct 22;373[17]:1597-606).

“My conclusion is that once you’ve determined that a patient needs and wants a total knee replacement, the patient should probably get it. Delaying – trying other modalities in an effort to lose weight and improve function – is really not going to buy you much in the way of time,” Dr. Bergman observed.

Hydroxychloroquine for hand osteoarthritis

At the 2015 European League Against Rheumatism (EULAR) meeting in Rome, Dutch investigators presented a randomized, double-blind trial in which 196 patients with symptomatic hand osteoarthritis received 6 months of hydroxychloroquine at 400 mg/day or placebo. Unlike in mild rheumatoid arthritis or lupus, hydroxychloroquine had no beneficial effect on hand osteoarthritis pain, disability, or quality of life measures.

“Plaquenil [Hydroxychloroquine] is not a good choice for patients with osteoarthritis of the hand. I think it’s a dead therapy,” Dr. Troum declared.

FDA expands warning on NSAIDs’ cardiovascular risk

On July 9, 2015, the FDA announced updated labels for NSAIDs. The new warning states that MI and stroke risk can increase as early as in the first week of NSAID use and appear to be dose- and duration-related. The agency also warned that patients who take an NSAID after a first MI are more likely to die within 1 year.

“This really brought a lot of folks to my office,” Dr. Troum recalled.

“Absolutely, this was big stuff,” Dr. Bergman agreed. “This became a nightmare for many of us because all of a sudden patients were scared to death about taking their NSAIDs.”

Intra-articular corticosteroids for knee osteoarthritis don’t accelerate cartilage deterioration

At last fall’s American College of Rheumatology meeting in San Francisco, Jeffrey B. Driban, Ph.D., of Tufts Medical Center, Boston, presented a double-blind, randomized trial of intra-articular injections of triamcinolone hexacetonide 40 mg versus saline quarterly for 2 years in 140 patients with symptomatic knee osteoarthritis with ultrasound evidence of synovitis. Participants underwent annual evaluation of periarticular bone and cartilage changes via MRI and dual-energy x-ray absorptiometry.

After 2 years, there was no difference between the two groups in terms of pain scores, walk time, or other functional measures. The injections – eight in total over 2 years – were safe, with new-onset hypertension and hyperglycemia rates of 3% in this obese population. And most important of all, there were no major differences between the two groups in terms of quantitative or semiquantitative structural endpoints; in other words, the injections didn’t increase the rate of structural disease progression. The intra-articular steroid group showed a modestly greater rate of loss of cartilage thickness, which the investigators deemed of uncertain clinical significance.

“The structural changes were minimal,” Dr. Troum noted. “This is only a 2-year study, but I can say that I now feel more comfortable giving these injections in patients who for whatever reason can’t get surgery.”

Dr. Bergman said that many orthopedic surgeons talk up the potential risk that intra-articular steroid injections will accelerate cartilage damage. They place an arbitrary limit on the number of injections a patient can receive.

“I think this study really helps us push back and say, ‘No, I think you’re fine in getting this procedure,’” the rheumatologist commented.

Dr. Bergman and Dr. Troum reported having no financial conflicts regarding their presentation.

[email protected]

In about 2002, Dr. Gary Franklin realized the state of Washington might have a problem.

A big problem.

A state resident who’d suffered a back sprain and filed a workers’ compensation claim died 2 years later – not from heart disease or cancer or stroke, but from an unintentional prescription opioid overdose, recalled Dr. Franklin, medical director of the Washington State Department of Labor and Industries.

©andrewsafonov/Thinkstock

“I had never seen anything so sad,” he said.

The case prompted the neurologist and his colleagues to review Washington state workers’ compensation claims. What they uncovered was a local trend that would explode into a national scourge: a marked increase in opioid poisonings among Washington state residents with everyday aches and pains who, in the past, would never have been prescribed opioids.

The gateway drug turned out to be oxycodone (OxyContin), which was heavily marketed at the time as a safe choice for pain relief with little abuse potential. Purdue Pharma has since paid a $600 million federal fine for deceptive marketing.

“This is the worst man-made epidemic in modern medical history,” said Dr. Franklin, also a research professor at the University of Washington, Seattle. “It was made by modern medicine, and it’s up to modern medicine to turn it around.”

For the United States to recover from the opioid crisis, Dr. Franklin said, the medical community must reduce oral opioid prescriptions for noncancer pain. Others interviewed for this story said doctors also have to overcome their aversion to in-office addiction treatment, and find new options for everyday chronic pain.

The first step is “to forget everything you were told in 1999,” said Dr. Franklin. That includes the notions that addiction is rare, opioids are indicated for noncancer chronic pain, and doses should be increased if patients become tolerant.

Those messages led to overprescribing, which in turn “led to an oversupply problem that’s feeding misuse and diversion. It’s only recently that it has become a heroin problem; the vast majority of heroin users these days start on prescription opioids,” he said.

The Washington workers’ comp claims data triggered “a complete rethinking of our approach to chronic pain and a shift to other treatment strategies,” said Dr. David Tauben, chief of pain medicine at the University of Washington, Seattle.

In 2007, Washington became one of the first states to issue opioid treatment guidelines, which are updated regularly. Among other steps, prescribers were urged to limit doses and durations.

Since then, the state has seen a nearly 40% reduction in prescription opioid poisonings. “We also found that with dose reductions” for back pain, headaches, and similar noncancer issues, “pain subsides, function improves, and patient satisfaction” goes up, said Dr. Tauben, who was involved in creating the guidelines.

Clamping down, pushing back

The Centers for Disease Control and Prevention in March released similar guidelines, including a suggested 3-day limit for acute pain prescriptions and a cap of 90 morphine milligram equivalents per day for chronic noncancer pain – the amount in a single 60-mg oxycodone tablet.

Meanwhile, Food and Drug Administration officials are planning a regulatory overhaul to address opioid approval, labeling, and prescribing concerns. In many places, doctors are also facing new opioid training requirements.

The Washington state experience suggests that such efforts are likely to help reverse the opioid crisis.

It’s not about getting rid of the drugs, explained Dr. Gail D’Onofrio, chair of emergency medicine at Yale University in New Haven, Conn.

“Opioids are really good for certain things,” especially cancer pain and, for a few days, acute pain. But “we’ve kind of lost our way,” Dr. D’Onofrio said. “We don’t need to give people 3 months of narcotics for a knee replacement” or 3 weeks of narcotics for a wisdom tooth extraction.

“We are all guilty” of overprescribing, and “just like everywhere else, we’ve seen the problems; every year, it’s getting worse,” she added. In response, “we are changing how we use opioids, adapting the guidelines from the CDC and other groups,” and tailoring them to different services.

At the Yale emergency department, oral opioid prescriptions are now generally limited to 3 days, except for renal colic patients, who might get a few days more. “We do not fill opioid scripts and don’t reorder them for patients.” Instead, “we talk to the prescriber and tell them what’s going on,” Dr. D’Onofrio explained.

Yale’s not alone in cutting back. After years of growth, U.S. oral opioid sales appear to be declining. In fact, in some quarters, there’s concern the clampdown will go too far.

The CDC received more than 4,300 comments about the draft version of its guidelines. Some patients were worried about losing access to drugs that have helped them. And, while supportive of the goals, some professional groups questioned the evidence behind the proposals and worry about undertreatment of pain, among other issues.

“The problem with a lot of the guidelines is that they’re all around limiting prescribing. They don’t really tell doctors what to do instead,” said Dr. Peter Friedmann, an addiction treatment specialist in Springfield, Mass., and chief research officer for Baystate Health.

An alternative for chronic pain

For noncancer chronic pain, recent evidence supports multimodal therapy. Opioids might bring temporary relief, but “throwing drugs at people isn’t going to solve the problem,” said Dr. Tauben, the University of Washington pain expert.

“Multimodal therapy” means focusing more on the burden of pain instead of its intensity, with team-based care. Reducing the burden – anxiety, sleeplessness, reduced mobility, and other problems – seems to reduce the significance and intensity of pain to the point where it can be managed, if needed, with nonsteroidal anti-inflammatory drugs (NSAIDs), trigger-point injections, and other nonopioid options.

Depending on the patient’s needs, primary care physicians might find themselves coordinating services from psychologists, physical therapists, social workers, or others.

For the approach to work, the impact of pain has to be accurately gauged, along with underlying psychological or social issues; to save time, the University of Washington has patients complete an online survey prior to their office visit.

There are national efforts underway to support the approach, and a growing recognition that “by doing it right, you save downstream costs. Primary care must get involved; that’s where chronic pain presents,” Dr. Tauben said.

Batting cleanup

There’s a role for primary care when patients are hooked on opioids, too. Requests for early refills and higher doses are a clue.

“Given the stigma, a lot of doctors don’t want to deal with addiction, but we have to deal with it. We need to move addiction treatment into the mainstream of what we do in medicine,” Dr. Friedmann said. “These patients are no more or no less challenging than any other patients we deal with; the only way doctors are going to find that out is by starting to manage some of them.”

He estimates that about 60% of his patients do well on buprenorphine, a sublingual, partial opioid agonist that blocks the effects of full agonists and dulls withdrawal symptoms. Incorporating it into practice “is not something you need to figure out yourself,” Dr. Friedmann noted. There are training programs and people who can help.

There simply aren’t enough methadone clinics to handle the current situation, especially in suburbs and rural areas where drug dealers have found a new market for heroin. Another option, abstinence programs, “have contributed to the problem of overdose;” people lose their tolerance, reuse, and die, he said.

Buprenorphine treatment might soon get easier. The FDA is expected to make an approval decision soon on probuphine, a matchstick-size subdermal implant that delivers buprenorphine continuously for 6 months.

Dr. Friedmann disclosed relationships with Alkermes, Inavir, and Orexo. The other doctors had no relevant disclosures.

[email protected]

In about 2002, Dr. Gary Franklin realized the state of Washington might have a problem.

A big problem.

A state resident who’d suffered a back sprain and filed a workers’ compensation claim died 2 years later – not from heart disease or cancer or stroke, but from an unintentional prescription opioid overdose, recalled Dr. Franklin, medical director of the Washington State Department of Labor and Industries.

©andrewsafonov/Thinkstock

“I had never seen anything so sad,” he said.

The case prompted the neurologist and his colleagues to review Washington state workers’ compensation claims. What they uncovered was a local trend that would explode into a national scourge: a marked increase in opioid poisonings among Washington state residents with everyday aches and pains who, in the past, would never have been prescribed opioids.

The gateway drug turned out to be oxycodone (OxyContin), which was heavily marketed at the time as a safe choice for pain relief with little abuse potential. Purdue Pharma has since paid a $600 million federal fine for deceptive marketing.

“This is the worst man-made epidemic in modern medical history,” said Dr. Franklin, also a research professor at the University of Washington, Seattle. “It was made by modern medicine, and it’s up to modern medicine to turn it around.”

For the United States to recover from the opioid crisis, Dr. Franklin said, the medical community must reduce oral opioid prescriptions for noncancer pain. Others interviewed for this story said doctors also have to overcome their aversion to in-office addiction treatment, and find new options for everyday chronic pain.

The first step is “to forget everything you were told in 1999,” said Dr. Franklin. That includes the notions that addiction is rare, opioids are indicated for noncancer chronic pain, and doses should be increased if patients become tolerant.

Those messages led to overprescribing, which in turn “led to an oversupply problem that’s feeding misuse and diversion. It’s only recently that it has become a heroin problem; the vast majority of heroin users these days start on prescription opioids,” he said.

The Washington workers’ comp claims data triggered “a complete rethinking of our approach to chronic pain and a shift to other treatment strategies,” said Dr. David Tauben, chief of pain medicine at the University of Washington, Seattle.

In 2007, Washington became one of the first states to issue opioid treatment guidelines, which are updated regularly. Among other steps, prescribers were urged to limit doses and durations.

Since then, the state has seen a nearly 40% reduction in prescription opioid poisonings. “We also found that with dose reductions” for back pain, headaches, and similar noncancer issues, “pain subsides, function improves, and patient satisfaction” goes up, said Dr. Tauben, who was involved in creating the guidelines.

Clamping down, pushing back

The Centers for Disease Control and Prevention in March released similar guidelines, including a suggested 3-day limit for acute pain prescriptions and a cap of 90 morphine milligram equivalents per day for chronic noncancer pain – the amount in a single 60-mg oxycodone tablet.

Meanwhile, Food and Drug Administration officials are planning a regulatory overhaul to address opioid approval, labeling, and prescribing concerns. In many places, doctors are also facing new opioid training requirements.

The Washington state experience suggests that such efforts are likely to help reverse the opioid crisis.

It’s not about getting rid of the drugs, explained Dr. Gail D’Onofrio, chair of emergency medicine at Yale University in New Haven, Conn.

“Opioids are really good for certain things,” especially cancer pain and, for a few days, acute pain. But “we’ve kind of lost our way,” Dr. D’Onofrio said. “We don’t need to give people 3 months of narcotics for a knee replacement” or 3 weeks of narcotics for a wisdom tooth extraction.

“We are all guilty” of overprescribing, and “just like everywhere else, we’ve seen the problems; every year, it’s getting worse,” she added. In response, “we are changing how we use opioids, adapting the guidelines from the CDC and other groups,” and tailoring them to different services.

At the Yale emergency department, oral opioid prescriptions are now generally limited to 3 days, except for renal colic patients, who might get a few days more. “We do not fill opioid scripts and don’t reorder them for patients.” Instead, “we talk to the prescriber and tell them what’s going on,” Dr. D’Onofrio explained.

Yale’s not alone in cutting back. After years of growth, U.S. oral opioid sales appear to be declining. In fact, in some quarters, there’s concern the clampdown will go too far.

The CDC received more than 4,300 comments about the draft version of its guidelines. Some patients were worried about losing access to drugs that have helped them. And, while supportive of the goals, some professional groups questioned the evidence behind the proposals and worry about undertreatment of pain, among other issues.

“The problem with a lot of the guidelines is that they’re all around limiting prescribing. They don’t really tell doctors what to do instead,” said Dr. Peter Friedmann, an addiction treatment specialist in Springfield, Mass., and chief research officer for Baystate Health.

An alternative for chronic pain

For noncancer chronic pain, recent evidence supports multimodal therapy. Opioids might bring temporary relief, but “throwing drugs at people isn’t going to solve the problem,” said Dr. Tauben, the University of Washington pain expert.

“Multimodal therapy” means focusing more on the burden of pain instead of its intensity, with team-based care. Reducing the burden – anxiety, sleeplessness, reduced mobility, and other problems – seems to reduce the significance and intensity of pain to the point where it can be managed, if needed, with nonsteroidal anti-inflammatory drugs (NSAIDs), trigger-point injections, and other nonopioid options.

Depending on the patient’s needs, primary care physicians might find themselves coordinating services from psychologists, physical therapists, social workers, or others.

For the approach to work, the impact of pain has to be accurately gauged, along with underlying psychological or social issues; to save time, the University of Washington has patients complete an online survey prior to their office visit.

There are national efforts underway to support the approach, and a growing recognition that “by doing it right, you save downstream costs. Primary care must get involved; that’s where chronic pain presents,” Dr. Tauben said.

Batting cleanup

There’s a role for primary care when patients are hooked on opioids, too. Requests for early refills and higher doses are a clue.

“Given the stigma, a lot of doctors don’t want to deal with addiction, but we have to deal with it. We need to move addiction treatment into the mainstream of what we do in medicine,” Dr. Friedmann said. “These patients are no more or no less challenging than any other patients we deal with; the only way doctors are going to find that out is by starting to manage some of them.”

He estimates that about 60% of his patients do well on buprenorphine, a sublingual, partial opioid agonist that blocks the effects of full agonists and dulls withdrawal symptoms. Incorporating it into practice “is not something you need to figure out yourself,” Dr. Friedmann noted. There are training programs and people who can help.

There simply aren’t enough methadone clinics to handle the current situation, especially in suburbs and rural areas where drug dealers have found a new market for heroin. Another option, abstinence programs, “have contributed to the problem of overdose;” people lose their tolerance, reuse, and die, he said.

Buprenorphine treatment might soon get easier. The FDA is expected to make an approval decision soon on probuphine, a matchstick-size subdermal implant that delivers buprenorphine continuously for 6 months.

Dr. Friedmann disclosed relationships with Alkermes, Inavir, and Orexo. The other doctors had no relevant disclosures.

[email protected]

In about 2002, Dr. Gary Franklin realized the state of Washington might have a problem.

A big problem.

A state resident who’d suffered a back sprain and filed a workers’ compensation claim died 2 years later – not from heart disease or cancer or stroke, but from an unintentional prescription opioid overdose, recalled Dr. Franklin, medical director of the Washington State Department of Labor and Industries.

©andrewsafonov/Thinkstock

“I had never seen anything so sad,” he said.

The case prompted the neurologist and his colleagues to review Washington state workers’ compensation claims. What they uncovered was a local trend that would explode into a national scourge: a marked increase in opioid poisonings among Washington state residents with everyday aches and pains who, in the past, would never have been prescribed opioids.

The gateway drug turned out to be oxycodone (OxyContin), which was heavily marketed at the time as a safe choice for pain relief with little abuse potential. Purdue Pharma has since paid a $600 million federal fine for deceptive marketing.

“This is the worst man-made epidemic in modern medical history,” said Dr. Franklin, also a research professor at the University of Washington, Seattle. “It was made by modern medicine, and it’s up to modern medicine to turn it around.”

For the United States to recover from the opioid crisis, Dr. Franklin said, the medical community must reduce oral opioid prescriptions for noncancer pain. Others interviewed for this story said doctors also have to overcome their aversion to in-office addiction treatment, and find new options for everyday chronic pain.

The first step is “to forget everything you were told in 1999,” said Dr. Franklin. That includes the notions that addiction is rare, opioids are indicated for noncancer chronic pain, and doses should be increased if patients become tolerant.

Those messages led to overprescribing, which in turn “led to an oversupply problem that’s feeding misuse and diversion. It’s only recently that it has become a heroin problem; the vast majority of heroin users these days start on prescription opioids,” he said.

The Washington workers’ comp claims data triggered “a complete rethinking of our approach to chronic pain and a shift to other treatment strategies,” said Dr. David Tauben, chief of pain medicine at the University of Washington, Seattle.

In 2007, Washington became one of the first states to issue opioid treatment guidelines, which are updated regularly. Among other steps, prescribers were urged to limit doses and durations.

Since then, the state has seen a nearly 40% reduction in prescription opioid poisonings. “We also found that with dose reductions” for back pain, headaches, and similar noncancer issues, “pain subsides, function improves, and patient satisfaction” goes up, said Dr. Tauben, who was involved in creating the guidelines.

Clamping down, pushing back

The Centers for Disease Control and Prevention in March released similar guidelines, including a suggested 3-day limit for acute pain prescriptions and a cap of 90 morphine milligram equivalents per day for chronic noncancer pain – the amount in a single 60-mg oxycodone tablet.

Meanwhile, Food and Drug Administration officials are planning a regulatory overhaul to address opioid approval, labeling, and prescribing concerns. In many places, doctors are also facing new opioid training requirements.

The Washington state experience suggests that such efforts are likely to help reverse the opioid crisis.

It’s not about getting rid of the drugs, explained Dr. Gail D’Onofrio, chair of emergency medicine at Yale University in New Haven, Conn.

“Opioids are really good for certain things,” especially cancer pain and, for a few days, acute pain. But “we’ve kind of lost our way,” Dr. D’Onofrio said. “We don’t need to give people 3 months of narcotics for a knee replacement” or 3 weeks of narcotics for a wisdom tooth extraction.

“We are all guilty” of overprescribing, and “just like everywhere else, we’ve seen the problems; every year, it’s getting worse,” she added. In response, “we are changing how we use opioids, adapting the guidelines from the CDC and other groups,” and tailoring them to different services.

At the Yale emergency department, oral opioid prescriptions are now generally limited to 3 days, except for renal colic patients, who might get a few days more. “We do not fill opioid scripts and don’t reorder them for patients.” Instead, “we talk to the prescriber and tell them what’s going on,” Dr. D’Onofrio explained.

Yale’s not alone in cutting back. After years of growth, U.S. oral opioid sales appear to be declining. In fact, in some quarters, there’s concern the clampdown will go too far.

The CDC received more than 4,300 comments about the draft version of its guidelines. Some patients were worried about losing access to drugs that have helped them. And, while supportive of the goals, some professional groups questioned the evidence behind the proposals and worry about undertreatment of pain, among other issues.

“The problem with a lot of the guidelines is that they’re all around limiting prescribing. They don’t really tell doctors what to do instead,” said Dr. Peter Friedmann, an addiction treatment specialist in Springfield, Mass., and chief research officer for Baystate Health.

An alternative for chronic pain

For noncancer chronic pain, recent evidence supports multimodal therapy. Opioids might bring temporary relief, but “throwing drugs at people isn’t going to solve the problem,” said Dr. Tauben, the University of Washington pain expert.

“Multimodal therapy” means focusing more on the burden of pain instead of its intensity, with team-based care. Reducing the burden – anxiety, sleeplessness, reduced mobility, and other problems – seems to reduce the significance and intensity of pain to the point where it can be managed, if needed, with nonsteroidal anti-inflammatory drugs (NSAIDs), trigger-point injections, and other nonopioid options.

Depending on the patient’s needs, primary care physicians might find themselves coordinating services from psychologists, physical therapists, social workers, or others.

For the approach to work, the impact of pain has to be accurately gauged, along with underlying psychological or social issues; to save time, the University of Washington has patients complete an online survey prior to their office visit.

There are national efforts underway to support the approach, and a growing recognition that “by doing it right, you save downstream costs. Primary care must get involved; that’s where chronic pain presents,” Dr. Tauben said.

Batting cleanup

There’s a role for primary care when patients are hooked on opioids, too. Requests for early refills and higher doses are a clue.

“Given the stigma, a lot of doctors don’t want to deal with addiction, but we have to deal with it. We need to move addiction treatment into the mainstream of what we do in medicine,” Dr. Friedmann said. “These patients are no more or no less challenging than any other patients we deal with; the only way doctors are going to find that out is by starting to manage some of them.”

He estimates that about 60% of his patients do well on buprenorphine, a sublingual, partial opioid agonist that blocks the effects of full agonists and dulls withdrawal symptoms. Incorporating it into practice “is not something you need to figure out yourself,” Dr. Friedmann noted. There are training programs and people who can help.

There simply aren’t enough methadone clinics to handle the current situation, especially in suburbs and rural areas where drug dealers have found a new market for heroin. Another option, abstinence programs, “have contributed to the problem of overdose;” people lose their tolerance, reuse, and die, he said.

Buprenorphine treatment might soon get easier. The FDA is expected to make an approval decision soon on probuphine, a matchstick-size subdermal implant that delivers buprenorphine continuously for 6 months.

Dr. Friedmann disclosed relationships with Alkermes, Inavir, and Orexo. The other doctors had no relevant disclosures.

[email protected]

There is “limited or suggestive evidence” that links Agent Orange exposure to bladder cancer and hyperthyroidism according to the biennial review of the Committee to Review the Health Effects in Vietnam Veterans of Exposure to Herbicides. The committee reviewed results from a study of veterans of the Korean War who also served in the Vietnam War that suggested an association for bladder cancer and hypothyroidism. The evidence, along with supportive epidemiologic findings, led the committee to strengthen the association between Agent Orange exposure and bladder cancer and hyperthyroidism.

The report is the final in a series of reviews mandated by Congress on the evidence of health problems that can be linked to exposure to Agent Orange and other herbicides used during the Vietnam War. Bladder cancer joins a host of other cancers and cancer-related conditions associated with Agent Orange exposure, include:

• AL Amyloidosis;

• Chronic B-cell Leukemias;

• Hodgkin Disease;

• Multiple Myeloma;

• Non-Hodgkin Lymphoma;

• Prostate Cancer;

• Respiratory Cancers (including lung cancer);

• Cancers of the lung, larynx, trachea, and bronchus; and

• Soft Tissue Sarcomas.

The committee also concluded that there was not enough evidence to support an association between any birth defects and parental exposure to herbicides. According to the committee, “intensive investigation of possible heritable effects in animal models still has not demonstrated that herbicide exposure of adult males can produce birth defects in their offspring.” The committee downgraded spina bifida to the “inadequate or insufficient” evidence category—marking just the second time that a health outcome has been moved to a weaker category of association.

The committee also addressed the question of whether Parkinson-like symptoms should qualify the assignment of Parkinson disease to the limited or suggestive category of association with Agent Orange exposure. The committee determined that given “there is no rational basis for exclusion of individuals with Parkinson-like symptoms from the service-related category denoted as Parkinson disease.” The committee also suggested that “the onus should be on the VA on a case-by-case basis to definitively establish the role of a recognized factor other than the herbicides sprayed in Vietnam.”

In the final report, the committee urged the VA to:

• Continue epidemiologic studies of exposed veterans;

•  Develop protocols to investigate paternal transmission of adverse effects to offspring;

• Study the manifestations in humans of dioxin exposure and compromised immunity, which have been clearly demonstrated in animal models; and

• Review evidence to determine whether paternal exposure to any toxicant has definitively resulted in birth defects.

A complete list of diseases associated with Agent Orange can be found at: http://www.publichealth.va.gov/exposures/agentorange/conditions/#sthash.vJTT3VdU.dpuf

There is “limited or suggestive evidence” that links Agent Orange exposure to bladder cancer and hyperthyroidism according to the biennial review of the Committee to Review the Health Effects in Vietnam Veterans of Exposure to Herbicides. The committee reviewed results from a study of veterans of the Korean War who also served in the Vietnam War that suggested an association for bladder cancer and hypothyroidism. The evidence, along with supportive epidemiologic findings, led the committee to strengthen the association between Agent Orange exposure and bladder cancer and hyperthyroidism.

The report is the final in a series of reviews mandated by Congress on the evidence of health problems that can be linked to exposure to Agent Orange and other herbicides used during the Vietnam War. Bladder cancer joins a host of other cancers and cancer-related conditions associated with Agent Orange exposure, include:

• AL Amyloidosis;

• Chronic B-cell Leukemias;

• Hodgkin Disease;

• Multiple Myeloma;

• Non-Hodgkin Lymphoma;

• Prostate Cancer;

• Respiratory Cancers (including lung cancer);

• Cancers of the lung, larynx, trachea, and bronchus; and

• Soft Tissue Sarcomas.

The committee also concluded that there was not enough evidence to support an association between any birth defects and parental exposure to herbicides. According to the committee, “intensive investigation of possible heritable effects in animal models still has not demonstrated that herbicide exposure of adult males can produce birth defects in their offspring.” The committee downgraded spina bifida to the “inadequate or insufficient” evidence category—marking just the second time that a health outcome has been moved to a weaker category of association.

The committee also addressed the question of whether Parkinson-like symptoms should qualify the assignment of Parkinson disease to the limited or suggestive category of association with Agent Orange exposure. The committee determined that given “there is no rational basis for exclusion of individuals with Parkinson-like symptoms from the service-related category denoted as Parkinson disease.” The committee also suggested that “the onus should be on the VA on a case-by-case basis to definitively establish the role of a recognized factor other than the herbicides sprayed in Vietnam.”

In the final report, the committee urged the VA to:

• Continue epidemiologic studies of exposed veterans;

•  Develop protocols to investigate paternal transmission of adverse effects to offspring;

• Study the manifestations in humans of dioxin exposure and compromised immunity, which have been clearly demonstrated in animal models; and

• Review evidence to determine whether paternal exposure to any toxicant has definitively resulted in birth defects.

A complete list of diseases associated with Agent Orange can be found at: http://www.publichealth.va.gov/exposures/agentorange/conditions/#sthash.vJTT3VdU.dpuf

There is “limited or suggestive evidence” that links Agent Orange exposure to bladder cancer and hyperthyroidism according to the biennial review of the Committee to Review the Health Effects in Vietnam Veterans of Exposure to Herbicides. The committee reviewed results from a study of veterans of the Korean War who also served in the Vietnam War that suggested an association for bladder cancer and hypothyroidism. The evidence, along with supportive epidemiologic findings, led the committee to strengthen the association between Agent Orange exposure and bladder cancer and hyperthyroidism.

The report is the final in a series of reviews mandated by Congress on the evidence of health problems that can be linked to exposure to Agent Orange and other herbicides used during the Vietnam War. Bladder cancer joins a host of other cancers and cancer-related conditions associated with Agent Orange exposure, include:

• AL Amyloidosis;

• Chronic B-cell Leukemias;

• Hodgkin Disease;

• Multiple Myeloma;

• Non-Hodgkin Lymphoma;

• Prostate Cancer;

• Respiratory Cancers (including lung cancer);

• Cancers of the lung, larynx, trachea, and bronchus; and

• Soft Tissue Sarcomas.

The committee also concluded that there was not enough evidence to support an association between any birth defects and parental exposure to herbicides. According to the committee, “intensive investigation of possible heritable effects in animal models still has not demonstrated that herbicide exposure of adult males can produce birth defects in their offspring.” The committee downgraded spina bifida to the “inadequate or insufficient” evidence category—marking just the second time that a health outcome has been moved to a weaker category of association.

The committee also addressed the question of whether Parkinson-like symptoms should qualify the assignment of Parkinson disease to the limited or suggestive category of association with Agent Orange exposure. The committee determined that given “there is no rational basis for exclusion of individuals with Parkinson-like symptoms from the service-related category denoted as Parkinson disease.” The committee also suggested that “the onus should be on the VA on a case-by-case basis to definitively establish the role of a recognized factor other than the herbicides sprayed in Vietnam.”

In the final report, the committee urged the VA to:

• Continue epidemiologic studies of exposed veterans;

•  Develop protocols to investigate paternal transmission of adverse effects to offspring;

• Study the manifestations in humans of dioxin exposure and compromised immunity, which have been clearly demonstrated in animal models; and

• Review evidence to determine whether paternal exposure to any toxicant has definitively resulted in birth defects.

A complete list of diseases associated with Agent Orange can be found at: http://www.publichealth.va.gov/exposures/agentorange/conditions/#sthash.vJTT3VdU.dpuf

A review by researchers from Hôpital Sud, Rennes, France, and McGill University, Montreal showed that surgery by robot—rather than traditional open surgery—may improve outcomes in elderly patients with pelvic cancer, however the research is sparse. For instance, only 6 published studies specifically address surgery in the elderly with endometrial cancer, the most common gynecologic malignancy in the western world. However, because surgery is challenging for these often-frail patients, minimally invasive (or minimal access) surgery could be the answer. When comparing robotics to standard laparoscopy in treating endometrial cancer, the data suggest significantly less blood loss, reduced operative time, and higher node counts.

Related: A Team Approach to Nonmelanotic Skin Cancer Procedures

Similar to many others, the researchers’ academic center was slow to adopt minimally invasive standard (MIS) laparoscopy. But within 2 years of the introduction of robotic surgery in 2007, more than 95% of patients requiring surgery to treat endometrial cancer undergo MIS. Now, the surgery is offered to each operable patient unless the cancer cannot be extracted intact or in a 15-cm diameter endobag via the vagina.

Related: Solid-Organ Transplant Recipients May Be at Greater Risk for Cancer

The researchers note that the MIS procedure has some unique risks. For example, once the patient is “docked” to the robot, the Trendelenburg position can’t be reversed without undocking. This may adversely affect the respiratory and cardiovascular system. Despite case reports about such adverse effects, though, the researchers say most data support the safety of robotic surgery in the elderly. Moreover, the newest versions of robots allow for multiple quadrant access without the need to undock.

Related:Gene Expression Signatures in Breast Cancer: A Surgical Oncologist’s Perspective

The oncologic safety of robotic surgery seems similar to that of open surgery or laparoscopic surgery. After 2 years of follow-up in 1 study, rates of progression-free survival were similar for the different methods. The researchers advise surgeons to work toward improving preoperative frailty assessments that will help tailor the right surgery for the right subgroup of elderly patients.

Lavoué V, Gotlieb W. Cancers (Basel). 2016;8(1):E12.
doi: 10.3390/cancers8010012.

A review by researchers from Hôpital Sud, Rennes, France, and McGill University, Montreal showed that surgery by robot—rather than traditional open surgery—may improve outcomes in elderly patients with pelvic cancer, however the research is sparse. For instance, only 6 published studies specifically address surgery in the elderly with endometrial cancer, the most common gynecologic malignancy in the western world. However, because surgery is challenging for these often-frail patients, minimally invasive (or minimal access) surgery could be the answer. When comparing robotics to standard laparoscopy in treating endometrial cancer, the data suggest significantly less blood loss, reduced operative time, and higher node counts.

Related: A Team Approach to Nonmelanotic Skin Cancer Procedures

Similar to many others, the researchers’ academic center was slow to adopt minimally invasive standard (MIS) laparoscopy. But within 2 years of the introduction of robotic surgery in 2007, more than 95% of patients requiring surgery to treat endometrial cancer undergo MIS. Now, the surgery is offered to each operable patient unless the cancer cannot be extracted intact or in a 15-cm diameter endobag via the vagina.

Related: Solid-Organ Transplant Recipients May Be at Greater Risk for Cancer

The researchers note that the MIS procedure has some unique risks. For example, once the patient is “docked” to the robot, the Trendelenburg position can’t be reversed without undocking. This may adversely affect the respiratory and cardiovascular system. Despite case reports about such adverse effects, though, the researchers say most data support the safety of robotic surgery in the elderly. Moreover, the newest versions of robots allow for multiple quadrant access without the need to undock.

Related:Gene Expression Signatures in Breast Cancer: A Surgical Oncologist’s Perspective

The oncologic safety of robotic surgery seems similar to that of open surgery or laparoscopic surgery. After 2 years of follow-up in 1 study, rates of progression-free survival were similar for the different methods. The researchers advise surgeons to work toward improving preoperative frailty assessments that will help tailor the right surgery for the right subgroup of elderly patients.

Lavoué V, Gotlieb W. Cancers (Basel). 2016;8(1):E12.
doi: 10.3390/cancers8010012.

A review by researchers from Hôpital Sud, Rennes, France, and McGill University, Montreal showed that surgery by robot—rather than traditional open surgery—may improve outcomes in elderly patients with pelvic cancer, however the research is sparse. For instance, only 6 published studies specifically address surgery in the elderly with endometrial cancer, the most common gynecologic malignancy in the western world. However, because surgery is challenging for these often-frail patients, minimally invasive (or minimal access) surgery could be the answer. When comparing robotics to standard laparoscopy in treating endometrial cancer, the data suggest significantly less blood loss, reduced operative time, and higher node counts.

Related: A Team Approach to Nonmelanotic Skin Cancer Procedures

Similar to many others, the researchers’ academic center was slow to adopt minimally invasive standard (MIS) laparoscopy. But within 2 years of the introduction of robotic surgery in 2007, more than 95% of patients requiring surgery to treat endometrial cancer undergo MIS. Now, the surgery is offered to each operable patient unless the cancer cannot be extracted intact or in a 15-cm diameter endobag via the vagina.

Related: Solid-Organ Transplant Recipients May Be at Greater Risk for Cancer

The researchers note that the MIS procedure has some unique risks. For example, once the patient is “docked” to the robot, the Trendelenburg position can’t be reversed without undocking. This may adversely affect the respiratory and cardiovascular system. Despite case reports about such adverse effects, though, the researchers say most data support the safety of robotic surgery in the elderly. Moreover, the newest versions of robots allow for multiple quadrant access without the need to undock.

Related:Gene Expression Signatures in Breast Cancer: A Surgical Oncologist’s Perspective

The oncologic safety of robotic surgery seems similar to that of open surgery or laparoscopic surgery. After 2 years of follow-up in 1 study, rates of progression-free survival were similar for the different methods. The researchers advise surgeons to work toward improving preoperative frailty assessments that will help tailor the right surgery for the right subgroup of elderly patients.

Lavoué V, Gotlieb W. Cancers (Basel). 2016;8(1):E12.
doi: 10.3390/cancers8010012.