Alicia Ault

NEW ORLEANS – The American Stroke Association is developing a host of new guidelines and statements, including a consensus statement on the definition of stroke and a scientific review of new anticoagulants.

The first new guideline – on the Management of Aneurysmal Subarachnoid Hemorrhage (SAH) – is complete and has been submitted for publication, said Dr. Colin Derdeyn, a member of the ASA’s Stroke Scientific Statement Oversight Committee.

Dr. Derdeyn is the program director for endovascular surgical neuroradiology at Washington University in St. Louis.

The SAH paper was authored by 13 clinicians who represent all disciplines involved in subarachnoid hemorrhage care, said Dr. Alejandro Rabinstein, who is vice chair of the group that wrote the guidelines.

There will be some new sections and some revised sections for 2012, said Dr. Rabinstein, a professor of neurology at the Mayo Clinic, Rochester, Minn. Dr. Rabinstein said that it has evolved into a more balanced document.

Also to be completed soon is a paper on the "Early Management of Patients with Ischemic Stroke." The paper will be very detailed, with more than 1,000 references and 15 authors, Dr. Rabinstein said. The chairman of the writing committee is Dr. Edward Jauch, professor of medicine at the Medical University of South Carolina, Charleston. The vice-chair is Dr. Jeffrey Saver, director of stroke and vascular neurology at the University of California, Los Angeles, Health System.

Two new papers – one reviewing the new anticoagulants on the market, and the other a consensus statement on the definition of stroke – are likely to garner a lot of attention, both as they are developed and when they are completed, Dr. Rabinstein said. "Novel Anticoagulants for the Prevention of Stroke in Atrial Fibrillation" will be completed fairly soon; it will be a science advisory, not a guideline or consensus statement. It will review the evidence on dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban. It will basically attempt to make sense of "the anticoagulant avalanche," Dr. Rabinstein said. The cochairs are Dr. Karen Furie, director of the stroke service and stroke prevention clinic at Massachusetts General Hospital, Boston, and Dr. Larry Goldstein, director of the Duke Stroke Center in Durham, N.C.

The consensus statement on the updated definition of stroke will be "a little bit more contentious," Dr. Rabinstein said. The goal is to update the definition of a transient ischemic attack. Among the questions to be addressed are whether an inclusion of the duration of symptoms is appropriate, and whether imaging should be required. The cochairs are Dr. Ralph Sacco, president of the American Heart Association and chairman of neurology at the University of Miami, and Dr. Scott Kasner, director of the comprehensive stroke center at the University of Pennsylvania, Philadelphia.

Another consensus will be issued on "Risk Adjustment for Stroke Outcome Measures." The goal is to recommend which variables should be included in risk adjustment models to assess the main stroke outcomes – before such benchmarks are imposed from the outside, Dr. Rabinstein said. The measures will be extremely important in both quality of care reporting and reimbursement going forward, he noted at the meeting, which was sponsored by the American Heart Association.

Several additional scientific statements are in development. One, "Stroke as Outcome and Risk Equivalent in Vascular Disease Risk Scores," will review the evidence supporting the inclusion of stroke in the outcome cluster of a risk equivalent and the designation of stroke itself as a risk equivalent to coronary events.

A statement will be issued next year on declining stroke mortality. Stroke was previously the third-leading cause of death; it is now the fourth, Dr. Rabinstein said. The goal is to determine the factors behind the decline: whether it is due to better prevention and treatment, and if so, to further explain how the decline translated into fewer deaths. Another aim is to figure out how to reproduce such knowledge in the future.

Dr. Robert Holloway, a professor of neurology at the University of Rochester (N.Y.) who is also board certified in palliative medicine, is chairing a group that is developing a statement on "Palliative Care and End of Life." The statement will review best end-of-life practices and provide recommendations on how to optimize care for patients with terminal cerebrovascular disease.

Finally, the ASA is trying to develop a statement on "Cervical Dissections and Chiropractic Manipulation." Dr. José Biller, chairman of neurology at Loyola University, Maywood, Ill., will lead the group. Some of the issues to be addressed include determining the risk of cervical arterial dissection in patients undergoing neck manipulations and how to avoid complications. So far, chiropractic organizations have declined to be a part of the statement process, Dr. Rabinstein said.

NEW ORLEANS – The American Stroke Association is developing a host of new guidelines and statements, including a consensus statement on the definition of stroke and a scientific review of new anticoagulants.

The first new guideline – on the Management of Aneurysmal Subarachnoid Hemorrhage (SAH) – is complete and has been submitted for publication, said Dr. Colin Derdeyn, a member of the ASA’s Stroke Scientific Statement Oversight Committee.

Dr. Derdeyn is the program director for endovascular surgical neuroradiology at Washington University in St. Louis.

The SAH paper was authored by 13 clinicians who represent all disciplines involved in subarachnoid hemorrhage care, said Dr. Alejandro Rabinstein, who is vice chair of the group that wrote the guidelines.

There will be some new sections and some revised sections for 2012, said Dr. Rabinstein, a professor of neurology at the Mayo Clinic, Rochester, Minn. Dr. Rabinstein said that it has evolved into a more balanced document.

Also to be completed soon is a paper on the "Early Management of Patients with Ischemic Stroke." The paper will be very detailed, with more than 1,000 references and 15 authors, Dr. Rabinstein said. The chairman of the writing committee is Dr. Edward Jauch, professor of medicine at the Medical University of South Carolina, Charleston. The vice-chair is Dr. Jeffrey Saver, director of stroke and vascular neurology at the University of California, Los Angeles, Health System.

Two new papers – one reviewing the new anticoagulants on the market, and the other a consensus statement on the definition of stroke – are likely to garner a lot of attention, both as they are developed and when they are completed, Dr. Rabinstein said. "Novel Anticoagulants for the Prevention of Stroke in Atrial Fibrillation" will be completed fairly soon; it will be a science advisory, not a guideline or consensus statement. It will review the evidence on dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban. It will basically attempt to make sense of "the anticoagulant avalanche," Dr. Rabinstein said. The cochairs are Dr. Karen Furie, director of the stroke service and stroke prevention clinic at Massachusetts General Hospital, Boston, and Dr. Larry Goldstein, director of the Duke Stroke Center in Durham, N.C.

The consensus statement on the updated definition of stroke will be "a little bit more contentious," Dr. Rabinstein said. The goal is to update the definition of a transient ischemic attack. Among the questions to be addressed are whether an inclusion of the duration of symptoms is appropriate, and whether imaging should be required. The cochairs are Dr. Ralph Sacco, president of the American Heart Association and chairman of neurology at the University of Miami, and Dr. Scott Kasner, director of the comprehensive stroke center at the University of Pennsylvania, Philadelphia.

Another consensus will be issued on "Risk Adjustment for Stroke Outcome Measures." The goal is to recommend which variables should be included in risk adjustment models to assess the main stroke outcomes – before such benchmarks are imposed from the outside, Dr. Rabinstein said. The measures will be extremely important in both quality of care reporting and reimbursement going forward, he noted at the meeting, which was sponsored by the American Heart Association.

Several additional scientific statements are in development. One, "Stroke as Outcome and Risk Equivalent in Vascular Disease Risk Scores," will review the evidence supporting the inclusion of stroke in the outcome cluster of a risk equivalent and the designation of stroke itself as a risk equivalent to coronary events.

A statement will be issued next year on declining stroke mortality. Stroke was previously the third-leading cause of death; it is now the fourth, Dr. Rabinstein said. The goal is to determine the factors behind the decline: whether it is due to better prevention and treatment, and if so, to further explain how the decline translated into fewer deaths. Another aim is to figure out how to reproduce such knowledge in the future.

Dr. Robert Holloway, a professor of neurology at the University of Rochester (N.Y.) who is also board certified in palliative medicine, is chairing a group that is developing a statement on "Palliative Care and End of Life." The statement will review best end-of-life practices and provide recommendations on how to optimize care for patients with terminal cerebrovascular disease.

Finally, the ASA is trying to develop a statement on "Cervical Dissections and Chiropractic Manipulation." Dr. José Biller, chairman of neurology at Loyola University, Maywood, Ill., will lead the group. Some of the issues to be addressed include determining the risk of cervical arterial dissection in patients undergoing neck manipulations and how to avoid complications. So far, chiropractic organizations have declined to be a part of the statement process, Dr. Rabinstein said.

NEW ORLEANS – The American Stroke Association is developing a host of new guidelines and statements, including a consensus statement on the definition of stroke and a scientific review of new anticoagulants.

The first new guideline – on the Management of Aneurysmal Subarachnoid Hemorrhage (SAH) – is complete and has been submitted for publication, said Dr. Colin Derdeyn, a member of the ASA’s Stroke Scientific Statement Oversight Committee.

Dr. Derdeyn is the program director for endovascular surgical neuroradiology at Washington University in St. Louis.

The SAH paper was authored by 13 clinicians who represent all disciplines involved in subarachnoid hemorrhage care, said Dr. Alejandro Rabinstein, who is vice chair of the group that wrote the guidelines.

There will be some new sections and some revised sections for 2012, said Dr. Rabinstein, a professor of neurology at the Mayo Clinic, Rochester, Minn. Dr. Rabinstein said that it has evolved into a more balanced document.

Also to be completed soon is a paper on the "Early Management of Patients with Ischemic Stroke." The paper will be very detailed, with more than 1,000 references and 15 authors, Dr. Rabinstein said. The chairman of the writing committee is Dr. Edward Jauch, professor of medicine at the Medical University of South Carolina, Charleston. The vice-chair is Dr. Jeffrey Saver, director of stroke and vascular neurology at the University of California, Los Angeles, Health System.

Two new papers – one reviewing the new anticoagulants on the market, and the other a consensus statement on the definition of stroke – are likely to garner a lot of attention, both as they are developed and when they are completed, Dr. Rabinstein said. "Novel Anticoagulants for the Prevention of Stroke in Atrial Fibrillation" will be completed fairly soon; it will be a science advisory, not a guideline or consensus statement. It will review the evidence on dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban. It will basically attempt to make sense of "the anticoagulant avalanche," Dr. Rabinstein said. The cochairs are Dr. Karen Furie, director of the stroke service and stroke prevention clinic at Massachusetts General Hospital, Boston, and Dr. Larry Goldstein, director of the Duke Stroke Center in Durham, N.C.

The consensus statement on the updated definition of stroke will be "a little bit more contentious," Dr. Rabinstein said. The goal is to update the definition of a transient ischemic attack. Among the questions to be addressed are whether an inclusion of the duration of symptoms is appropriate, and whether imaging should be required. The cochairs are Dr. Ralph Sacco, president of the American Heart Association and chairman of neurology at the University of Miami, and Dr. Scott Kasner, director of the comprehensive stroke center at the University of Pennsylvania, Philadelphia.

Another consensus will be issued on "Risk Adjustment for Stroke Outcome Measures." The goal is to recommend which variables should be included in risk adjustment models to assess the main stroke outcomes – before such benchmarks are imposed from the outside, Dr. Rabinstein said. The measures will be extremely important in both quality of care reporting and reimbursement going forward, he noted at the meeting, which was sponsored by the American Heart Association.

Several additional scientific statements are in development. One, "Stroke as Outcome and Risk Equivalent in Vascular Disease Risk Scores," will review the evidence supporting the inclusion of stroke in the outcome cluster of a risk equivalent and the designation of stroke itself as a risk equivalent to coronary events.

A statement will be issued next year on declining stroke mortality. Stroke was previously the third-leading cause of death; it is now the fourth, Dr. Rabinstein said. The goal is to determine the factors behind the decline: whether it is due to better prevention and treatment, and if so, to further explain how the decline translated into fewer deaths. Another aim is to figure out how to reproduce such knowledge in the future.

Dr. Robert Holloway, a professor of neurology at the University of Rochester (N.Y.) who is also board certified in palliative medicine, is chairing a group that is developing a statement on "Palliative Care and End of Life." The statement will review best end-of-life practices and provide recommendations on how to optimize care for patients with terminal cerebrovascular disease.

Finally, the ASA is trying to develop a statement on "Cervical Dissections and Chiropractic Manipulation." Dr. José Biller, chairman of neurology at Loyola University, Maywood, Ill., will lead the group. Some of the issues to be addressed include determining the risk of cervical arterial dissection in patients undergoing neck manipulations and how to avoid complications. So far, chiropractic organizations have declined to be a part of the statement process, Dr. Rabinstein said.

The Food and Drug Administration announced on Feb. 21 that it had lined up several manufacturers that can provide enough doxorubicin and methotrexate to alleviate current shortages of these vital cancer drugs starting immediately.

Doxorubicin has been in short supply off and on for the last several years. It is approved for use in AIDS-related Kaposi’s sarcoma, multiple myeloma, and ovarian cancer.

Shortages of methotrexate date back at least 5 or 6 years. The most recent methotrexate shortage – which began in November, when the main manufacturer, Ben Venue Laboratories in Bedford, Ohio, had to go off-line due to quality issues – has had an impact on the treatment of acute lymphoblastic leukemia, according to the agency and pediatric oncologists. The New York Times reported on Feb. 10 that hospitals could start running out of methotrexate within 2 weeks.

The restoration of supplies of both drugs "is all good news for patients," said FDA Commissioner Margaret Hamburg at a briefing with reporters. Dr. Hamburg and other FDA officials touted the agency’s proactive moves in addressing the shortages.

For doxorubicin (Doxil), the FDA began looking for alternative manufacturers, although agency officials did not say when. At least one company, Sun Pharma Global FZE, made the drug overseas, said Dr. Sandra Kweder, deputy director in the FDA’s Office of New Drugs, at the briefing. That version of doxorubicin – called LipoDox – is not yet approved in the United States, but the FDA is allowing temporary importation.

The move is largely possible because the company received previous FDA approvals and thus has been subject to FDA inspection before, said Dr. Kweder. "We feel confident in the safety and utility of this product," she said.

With methotrexate, the drug shortage team began working with alternative manufacturers, including Hospira, Mylan, and Sandoz Pharmaceuticals, when Ben Venue began having issues, said Dr. Hamburg.

Ben Venue accumulated some emergency supplies before its shutdown; those will be released soon. Still, it was evident there could be a dire shortage, said Dr. Hamburg.

Preservative-free methotrexate was especially needed for pediatric uses.

Schaumburg, Ill.–based APP Pharmaceuticals is another of the companies that stepped up to help deal with the shortage. The company first ramped up production of methotrexate with preservative, said Mitchell Ehrlich, vice president for quality assurance at APP.

APP then worked with the FDA to expedite review of a generic drug application to produce preservative-free methotrexate. That application was approved on Feb. 17. The company will begin supplying the preservative-free formulation within 4 to 6 weeks, said Mr. Ehrlich.

Hospira, based in Lake Forest, Ill., also ramped up supply and began shipping on Feb. 21, starting with 31,000 vials. That is a 1-month supply, said CEO Michael Ball, at the briefing. The week of Feb. 27, the company will release an additional 34,000 vials, he said. That should be enough to provide a cushion while other companies come on-line.

ASCO: More Needs to Be Done

Also on Feb. 21, the FDA issued draft guidance directing manufacturers and distributors on processes for notifying the agency of problems that could potentially lead to shortages.

At the briefing, patient and physician organizations applauded the FDA’s actions. But they also said that more needs to be done.

"Many other drugs remain in shortage and we need permanent solutions," said Dr. Michael Link, president of the American Society of Clinical Oncology. He called on Congress to appoint a joint House-Senate working group to build on legislation making its way across Capitol Hill and come up with a permanent solution within 60 days.

As part of that solution, ASCO is also seeking a requirement that all manufacturers give advance notice of potential shortages, at least 6 months in advance or as soon as such problems become known. It also wants Congress to provide incentives for companies to develop contingency plans, or to encourage manufacturers to continue to produce drugs, if they are essential and susceptible to shortage. Finally, Dr. Link called on Congress to pass a law establishing generic user fees.

Children’s Oncology Group: Give Us a Law Within 4 Weeks

Dr. Peter Adamson, chairman of the Children’s Oncology Group, was more blunt. "I understand that passing legislation is complex and difficult," he said. "I suspect, however, that it is no more difficult than curing a child with cancer." He challenged lawmakers to enact a solution within four weeks.

"The encouraging news we heard today is not the end of this story. There are potential future crises waiting to happen," said Dr. Adamson.

American Cancer Society: FDA Action Is Critical

Dr. Leonard Lichtenfeld, deputy chief medical officer of the American Cancer Society, said that shortages had driven some patients to buy drugs at vastly inflated prices on the gray market, or to do without.

"The actions announced today will help to boost the supply of some of the most badly needed cancer drugs by patients across the country," he said. "It is critical that the FDA ensure that the added supply of these drugs is safe and made easily available to the patients who urgently need them."

The Food and Drug Administration announced on Feb. 21 that it had lined up several manufacturers that can provide enough doxorubicin and methotrexate to alleviate current shortages of these vital cancer drugs starting immediately.

Doxorubicin has been in short supply off and on for the last several years. It is approved for use in AIDS-related Kaposi’s sarcoma, multiple myeloma, and ovarian cancer.

Shortages of methotrexate date back at least 5 or 6 years. The most recent methotrexate shortage – which began in November, when the main manufacturer, Ben Venue Laboratories in Bedford, Ohio, had to go off-line due to quality issues – has had an impact on the treatment of acute lymphoblastic leukemia, according to the agency and pediatric oncologists. The New York Times reported on Feb. 10 that hospitals could start running out of methotrexate within 2 weeks.

The restoration of supplies of both drugs "is all good news for patients," said FDA Commissioner Margaret Hamburg at a briefing with reporters. Dr. Hamburg and other FDA officials touted the agency’s proactive moves in addressing the shortages.

For doxorubicin (Doxil), the FDA began looking for alternative manufacturers, although agency officials did not say when. At least one company, Sun Pharma Global FZE, made the drug overseas, said Dr. Sandra Kweder, deputy director in the FDA’s Office of New Drugs, at the briefing. That version of doxorubicin – called LipoDox – is not yet approved in the United States, but the FDA is allowing temporary importation.

The move is largely possible because the company received previous FDA approvals and thus has been subject to FDA inspection before, said Dr. Kweder. "We feel confident in the safety and utility of this product," she said.

With methotrexate, the drug shortage team began working with alternative manufacturers, including Hospira, Mylan, and Sandoz Pharmaceuticals, when Ben Venue began having issues, said Dr. Hamburg.

Ben Venue accumulated some emergency supplies before its shutdown; those will be released soon. Still, it was evident there could be a dire shortage, said Dr. Hamburg.

Preservative-free methotrexate was especially needed for pediatric uses.

Schaumburg, Ill.–based APP Pharmaceuticals is another of the companies that stepped up to help deal with the shortage. The company first ramped up production of methotrexate with preservative, said Mitchell Ehrlich, vice president for quality assurance at APP.

APP then worked with the FDA to expedite review of a generic drug application to produce preservative-free methotrexate. That application was approved on Feb. 17. The company will begin supplying the preservative-free formulation within 4 to 6 weeks, said Mr. Ehrlich.

Hospira, based in Lake Forest, Ill., also ramped up supply and began shipping on Feb. 21, starting with 31,000 vials. That is a 1-month supply, said CEO Michael Ball, at the briefing. The week of Feb. 27, the company will release an additional 34,000 vials, he said. That should be enough to provide a cushion while other companies come on-line.

ASCO: More Needs to Be Done

Also on Feb. 21, the FDA issued draft guidance directing manufacturers and distributors on processes for notifying the agency of problems that could potentially lead to shortages.

At the briefing, patient and physician organizations applauded the FDA’s actions. But they also said that more needs to be done.

"Many other drugs remain in shortage and we need permanent solutions," said Dr. Michael Link, president of the American Society of Clinical Oncology. He called on Congress to appoint a joint House-Senate working group to build on legislation making its way across Capitol Hill and come up with a permanent solution within 60 days.

As part of that solution, ASCO is also seeking a requirement that all manufacturers give advance notice of potential shortages, at least 6 months in advance or as soon as such problems become known. It also wants Congress to provide incentives for companies to develop contingency plans, or to encourage manufacturers to continue to produce drugs, if they are essential and susceptible to shortage. Finally, Dr. Link called on Congress to pass a law establishing generic user fees.

Children’s Oncology Group: Give Us a Law Within 4 Weeks

Dr. Peter Adamson, chairman of the Children’s Oncology Group, was more blunt. "I understand that passing legislation is complex and difficult," he said. "I suspect, however, that it is no more difficult than curing a child with cancer." He challenged lawmakers to enact a solution within four weeks.

"The encouraging news we heard today is not the end of this story. There are potential future crises waiting to happen," said Dr. Adamson.

American Cancer Society: FDA Action Is Critical

Dr. Leonard Lichtenfeld, deputy chief medical officer of the American Cancer Society, said that shortages had driven some patients to buy drugs at vastly inflated prices on the gray market, or to do without.

"The actions announced today will help to boost the supply of some of the most badly needed cancer drugs by patients across the country," he said. "It is critical that the FDA ensure that the added supply of these drugs is safe and made easily available to the patients who urgently need them."

The Food and Drug Administration announced on Feb. 21 that it had lined up several manufacturers that can provide enough doxorubicin and methotrexate to alleviate current shortages of these vital cancer drugs starting immediately.

Doxorubicin has been in short supply off and on for the last several years. It is approved for use in AIDS-related Kaposi’s sarcoma, multiple myeloma, and ovarian cancer.

Shortages of methotrexate date back at least 5 or 6 years. The most recent methotrexate shortage – which began in November, when the main manufacturer, Ben Venue Laboratories in Bedford, Ohio, had to go off-line due to quality issues – has had an impact on the treatment of acute lymphoblastic leukemia, according to the agency and pediatric oncologists. The New York Times reported on Feb. 10 that hospitals could start running out of methotrexate within 2 weeks.

The restoration of supplies of both drugs "is all good news for patients," said FDA Commissioner Margaret Hamburg at a briefing with reporters. Dr. Hamburg and other FDA officials touted the agency’s proactive moves in addressing the shortages.

For doxorubicin (Doxil), the FDA began looking for alternative manufacturers, although agency officials did not say when. At least one company, Sun Pharma Global FZE, made the drug overseas, said Dr. Sandra Kweder, deputy director in the FDA’s Office of New Drugs, at the briefing. That version of doxorubicin – called LipoDox – is not yet approved in the United States, but the FDA is allowing temporary importation.

The move is largely possible because the company received previous FDA approvals and thus has been subject to FDA inspection before, said Dr. Kweder. "We feel confident in the safety and utility of this product," she said.

With methotrexate, the drug shortage team began working with alternative manufacturers, including Hospira, Mylan, and Sandoz Pharmaceuticals, when Ben Venue began having issues, said Dr. Hamburg.

Ben Venue accumulated some emergency supplies before its shutdown; those will be released soon. Still, it was evident there could be a dire shortage, said Dr. Hamburg.

Preservative-free methotrexate was especially needed for pediatric uses.

Schaumburg, Ill.–based APP Pharmaceuticals is another of the companies that stepped up to help deal with the shortage. The company first ramped up production of methotrexate with preservative, said Mitchell Ehrlich, vice president for quality assurance at APP.

APP then worked with the FDA to expedite review of a generic drug application to produce preservative-free methotrexate. That application was approved on Feb. 17. The company will begin supplying the preservative-free formulation within 4 to 6 weeks, said Mr. Ehrlich.

Hospira, based in Lake Forest, Ill., also ramped up supply and began shipping on Feb. 21, starting with 31,000 vials. That is a 1-month supply, said CEO Michael Ball, at the briefing. The week of Feb. 27, the company will release an additional 34,000 vials, he said. That should be enough to provide a cushion while other companies come on-line.

ASCO: More Needs to Be Done

Also on Feb. 21, the FDA issued draft guidance directing manufacturers and distributors on processes for notifying the agency of problems that could potentially lead to shortages.

At the briefing, patient and physician organizations applauded the FDA’s actions. But they also said that more needs to be done.

"Many other drugs remain in shortage and we need permanent solutions," said Dr. Michael Link, president of the American Society of Clinical Oncology. He called on Congress to appoint a joint House-Senate working group to build on legislation making its way across Capitol Hill and come up with a permanent solution within 60 days.

As part of that solution, ASCO is also seeking a requirement that all manufacturers give advance notice of potential shortages, at least 6 months in advance or as soon as such problems become known. It also wants Congress to provide incentives for companies to develop contingency plans, or to encourage manufacturers to continue to produce drugs, if they are essential and susceptible to shortage. Finally, Dr. Link called on Congress to pass a law establishing generic user fees.

Children’s Oncology Group: Give Us a Law Within 4 Weeks

Dr. Peter Adamson, chairman of the Children’s Oncology Group, was more blunt. "I understand that passing legislation is complex and difficult," he said. "I suspect, however, that it is no more difficult than curing a child with cancer." He challenged lawmakers to enact a solution within four weeks.

"The encouraging news we heard today is not the end of this story. There are potential future crises waiting to happen," said Dr. Adamson.

American Cancer Society: FDA Action Is Critical

Dr. Leonard Lichtenfeld, deputy chief medical officer of the American Cancer Society, said that shortages had driven some patients to buy drugs at vastly inflated prices on the gray market, or to do without.

"The actions announced today will help to boost the supply of some of the most badly needed cancer drugs by patients across the country," he said. "It is critical that the FDA ensure that the added supply of these drugs is safe and made easily available to the patients who urgently need them."

The Health and Human Services department announced Feb. 16 that it would delay implementation of the ICD-10 codes, formally known as the International Classification of Diseases, 10th Edition, diagnosis and procedure codes.

Physician organizations had sought just such a delay, stating that it would be unduly burdensome to switch to the new system at a time when clinicians were also adjusting to information technology requirements under the Affordable Care Act. The ICD-10 had been scheduled to go into effect on Oct. 1, 2013.

No new compliance date was announced.

"We have heard from many in the provider community who have concerns about the administrative burdens they face in the years ahead," HHS Secretary Kathleen Sebelius said in a statement. "We are committing to work with the provider community to reexamine the pace at which HHS and the nation implement these important improvements to our health care system."

The American Medical Association was among those seeking relief from ICD-10. The organization “continues to urge HHS to improve the regulatory climate for physicians by halting the implementation of ICD-10,” a spokesman said in an interview.*

The new system would have an estimated 68,000 codes, replacing the 13,000 codes contained in the current system (ICD-9), according to the AMA. At its interim meeting in November 2011, the AMA House of Delegates called on the organization to do all it could to stop the new system from being put into place.

In January, the AMA wrote to House Speaker John Boehner (R-Ohio) asking him to find a way to stop implementation of ICD-10. Physicians could face implementation costs anywhere from $83,290 to more than $2.7 million, depending on the size of the practice, according to the letter.

In a statement, AMA President Peter Carmel noted that the organization appreciated "Secretary Sebelius’ swift response," and added that the group "looks forward to having a productive dialogue with the administration regarding the impact of ICD-10 and decreasing unnecessary hassles for physicians so they can take care of their patients."

*This story updated Feb. 22 to clarify the AMA position on ICD-10.

The Health and Human Services department announced Feb. 16 that it would delay implementation of the ICD-10 codes, formally known as the International Classification of Diseases, 10th Edition, diagnosis and procedure codes.

Physician organizations had sought just such a delay, stating that it would be unduly burdensome to switch to the new system at a time when clinicians were also adjusting to information technology requirements under the Affordable Care Act. The ICD-10 had been scheduled to go into effect on Oct. 1, 2013.

No new compliance date was announced.

"We have heard from many in the provider community who have concerns about the administrative burdens they face in the years ahead," HHS Secretary Kathleen Sebelius said in a statement. "We are committing to work with the provider community to reexamine the pace at which HHS and the nation implement these important improvements to our health care system."

The American Medical Association was among those seeking relief from ICD-10. The organization “continues to urge HHS to improve the regulatory climate for physicians by halting the implementation of ICD-10,” a spokesman said in an interview.*

The new system would have an estimated 68,000 codes, replacing the 13,000 codes contained in the current system (ICD-9), according to the AMA. At its interim meeting in November 2011, the AMA House of Delegates called on the organization to do all it could to stop the new system from being put into place.

In January, the AMA wrote to House Speaker John Boehner (R-Ohio) asking him to find a way to stop implementation of ICD-10. Physicians could face implementation costs anywhere from $83,290 to more than $2.7 million, depending on the size of the practice, according to the letter.

In a statement, AMA President Peter Carmel noted that the organization appreciated "Secretary Sebelius’ swift response," and added that the group "looks forward to having a productive dialogue with the administration regarding the impact of ICD-10 and decreasing unnecessary hassles for physicians so they can take care of their patients."

*This story updated Feb. 22 to clarify the AMA position on ICD-10.

The Health and Human Services department announced Feb. 16 that it would delay implementation of the ICD-10 codes, formally known as the International Classification of Diseases, 10th Edition, diagnosis and procedure codes.

Physician organizations had sought just such a delay, stating that it would be unduly burdensome to switch to the new system at a time when clinicians were also adjusting to information technology requirements under the Affordable Care Act. The ICD-10 had been scheduled to go into effect on Oct. 1, 2013.

No new compliance date was announced.

"We have heard from many in the provider community who have concerns about the administrative burdens they face in the years ahead," HHS Secretary Kathleen Sebelius said in a statement. "We are committing to work with the provider community to reexamine the pace at which HHS and the nation implement these important improvements to our health care system."

The American Medical Association was among those seeking relief from ICD-10. The organization “continues to urge HHS to improve the regulatory climate for physicians by halting the implementation of ICD-10,” a spokesman said in an interview.*

The new system would have an estimated 68,000 codes, replacing the 13,000 codes contained in the current system (ICD-9), according to the AMA. At its interim meeting in November 2011, the AMA House of Delegates called on the organization to do all it could to stop the new system from being put into place.

In January, the AMA wrote to House Speaker John Boehner (R-Ohio) asking him to find a way to stop implementation of ICD-10. Physicians could face implementation costs anywhere from $83,290 to more than $2.7 million, depending on the size of the practice, according to the letter.

In a statement, AMA President Peter Carmel noted that the organization appreciated "Secretary Sebelius’ swift response," and added that the group "looks forward to having a productive dialogue with the administration regarding the impact of ICD-10 and decreasing unnecessary hassles for physicians so they can take care of their patients."

*This story updated Feb. 22 to clarify the AMA position on ICD-10.

The Food and Drug Administration on Feb. 9 issued some guidelines for industry on how to develop so-called biosimilar products.

The agency has been open to receiving applications for such products since a specific approval pathway was created under the Affordable Care Act in March 2010, but without specific guidance, there have been no such applications so far, according to FDA officials.

"These draft documents are designed to help industry develop biosimilar versions of approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers," said Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a statement.

The three "draft guidances" the agency issued "should help biosimilar developers move forward to understand the agency’s expectations," and also provide a "transparent, clear, predictable regulatory pathway," said Dr. Rachel Sherman, director in the Office of Medical Policy at the FDA’s Center for Drug Evaluation and Research.

Biosimilars are biological products that are highly similar to an already approved biological product, according to the FDA.

The first draft guidance, "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product," is considered the key document, said Dr. Sherman. It outlines the basic requirements for how a company can show that its product is similar to the biologic that’s already approved. Developers will have to primarily go through a series of analytical tests to prove similarity.

The FDA would then weigh that information in determining whether the product would require further animal or human testing, said Dr. Sherman.

A biosimilar will not automatically be deemed interchangeable with an existing product. That is a separate determination, she said, noting that it would require further safety and efficacy testing.

So far, the agency has received requests for consultations from 35 companies seeking to develop biosimilars for 11 reference products, said Dr. Sherman. The agency has held 21 meetings. But there have been no formal applications for approval.

The two other guidance documents were, "Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product, which gives "excruciating detail" about the analytics to be used, said Dr. Sherman, and "Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009."

The latter document contains many of the questions companies have asked in previous consultations with the FDA, said Dr. Sherman. She expects that to be updated as the process evolves. The FDA will hold a public meeting to gather comments on the draft guidances, Dr. Sherman said.

Dr. Richard Dolinar, a clinical endocrinologist in Phoenix and chairman of the Alliance for Safe Biologic Medicines said in a statement that the organization welcomed the draft guidance documents as "an important step forward in expanding access to existing biological therapies."

ASBM members include companies concerned about biosimilar encroachment, such as Amgen and Genentech, and the Biotech Industry Organization, and along with several patient advocacy groups.

The Food and Drug Administration on Feb. 9 issued some guidelines for industry on how to develop so-called biosimilar products.

The agency has been open to receiving applications for such products since a specific approval pathway was created under the Affordable Care Act in March 2010, but without specific guidance, there have been no such applications so far, according to FDA officials.

"These draft documents are designed to help industry develop biosimilar versions of approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers," said Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a statement.

The three "draft guidances" the agency issued "should help biosimilar developers move forward to understand the agency’s expectations," and also provide a "transparent, clear, predictable regulatory pathway," said Dr. Rachel Sherman, director in the Office of Medical Policy at the FDA’s Center for Drug Evaluation and Research.

Biosimilars are biological products that are highly similar to an already approved biological product, according to the FDA.

The first draft guidance, "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product," is considered the key document, said Dr. Sherman. It outlines the basic requirements for how a company can show that its product is similar to the biologic that’s already approved. Developers will have to primarily go through a series of analytical tests to prove similarity.

The FDA would then weigh that information in determining whether the product would require further animal or human testing, said Dr. Sherman.

A biosimilar will not automatically be deemed interchangeable with an existing product. That is a separate determination, she said, noting that it would require further safety and efficacy testing.

So far, the agency has received requests for consultations from 35 companies seeking to develop biosimilars for 11 reference products, said Dr. Sherman. The agency has held 21 meetings. But there have been no formal applications for approval.

The two other guidance documents were, "Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product, which gives "excruciating detail" about the analytics to be used, said Dr. Sherman, and "Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009."

The latter document contains many of the questions companies have asked in previous consultations with the FDA, said Dr. Sherman. She expects that to be updated as the process evolves. The FDA will hold a public meeting to gather comments on the draft guidances, Dr. Sherman said.

Dr. Richard Dolinar, a clinical endocrinologist in Phoenix and chairman of the Alliance for Safe Biologic Medicines said in a statement that the organization welcomed the draft guidance documents as "an important step forward in expanding access to existing biological therapies."

ASBM members include companies concerned about biosimilar encroachment, such as Amgen and Genentech, and the Biotech Industry Organization, and along with several patient advocacy groups.

The Food and Drug Administration on Feb. 9 issued some guidelines for industry on how to develop so-called biosimilar products.

The agency has been open to receiving applications for such products since a specific approval pathway was created under the Affordable Care Act in March 2010, but without specific guidance, there have been no such applications so far, according to FDA officials.

"These draft documents are designed to help industry develop biosimilar versions of approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers," said Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a statement.

The three "draft guidances" the agency issued "should help biosimilar developers move forward to understand the agency’s expectations," and also provide a "transparent, clear, predictable regulatory pathway," said Dr. Rachel Sherman, director in the Office of Medical Policy at the FDA’s Center for Drug Evaluation and Research.

Biosimilars are biological products that are highly similar to an already approved biological product, according to the FDA.

The first draft guidance, "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product," is considered the key document, said Dr. Sherman. It outlines the basic requirements for how a company can show that its product is similar to the biologic that’s already approved. Developers will have to primarily go through a series of analytical tests to prove similarity.

The FDA would then weigh that information in determining whether the product would require further animal or human testing, said Dr. Sherman.

A biosimilar will not automatically be deemed interchangeable with an existing product. That is a separate determination, she said, noting that it would require further safety and efficacy testing.

So far, the agency has received requests for consultations from 35 companies seeking to develop biosimilars for 11 reference products, said Dr. Sherman. The agency has held 21 meetings. But there have been no formal applications for approval.

The two other guidance documents were, "Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product, which gives "excruciating detail" about the analytics to be used, said Dr. Sherman, and "Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009."

The latter document contains many of the questions companies have asked in previous consultations with the FDA, said Dr. Sherman. She expects that to be updated as the process evolves. The FDA will hold a public meeting to gather comments on the draft guidances, Dr. Sherman said.

Dr. Richard Dolinar, a clinical endocrinologist in Phoenix and chairman of the Alliance for Safe Biologic Medicines said in a statement that the organization welcomed the draft guidance documents as "an important step forward in expanding access to existing biological therapies."

ASBM members include companies concerned about biosimilar encroachment, such as Amgen and Genentech, and the Biotech Industry Organization, and along with several patient advocacy groups.

HOT SPRINGS, VA. – Since tort reform in Texas, the number of lawsuits and associated costs have decreased, but patient complaints to the state medical board and board investigations of physicians have risen, according to an analysis presented at the annual meeting of the Southern Surgical Association.

Dr. Ronald M. Stewart and his colleagues from the University of Texas Health Science Center at San Antonio obtained publicly available data from the Texas Medical Board and compared the 7-year period before tort reform (1996-2002) and the 6 years after the law was enacted (2004-2010).

The data were adjusted for the increase in the physician population; before reform there were about 170 physicians per 100,000 residents. After the law went into effect, the number rose to 195 physicians per 100,000, said Dr. Stewart. Before reform, about 125 complaints per 1,000 physicians were made to the medical board. That number increased by 13% after reform, to around 140 complaints per 1,000 physicians, said Dr. Stewart.

The rate of investigations increased from 38 per 1,000 to 52 per 1,000, with 5% of physicians the subject of a medical board inquiry. Postreform, there were more disciplinary actions when compared with open investigations, at about 8 per 1,000 in the latter period. Before reform, 0.5 per 1,000 physicians were ordered to revoke or to voluntarily surrender their licenses; after reform, that value rose to 0.8 per 1,000, a significant increase, noted Dr. Stewart.

The most striking change before and after reform was the decline in financial penalties. The state collected a total of $4.7 million in the postreform period. To put that figure into context, the San Antonio department of surgery alone spent $4.8 million on liability settlements in the prereform period, said Dr. Stewart.

It’s not clear why complaints and disciplinary actions went up, Dr. Stewart said. Having access to electronic information and greater awareness of the ability to complain to the medical board probably spurred more patient reporting.

The increases in investigations and disciplinary actions were mainly driven by the legislature, according to Dr. Stewart. The lawmakers mandated greater oversight by the medical board, so that undoubtedly led an enforcement increase.

Dr. Stewart said that putting malpractice in the hands of the medical board had decreased costs and been generally positive. For instance, he said, the medical board process is transparent and allows more input from stakeholders like physicians.

"There’s no question that the benefits of tort reform in my opinion outweigh the potential negative consequences to physicians," he said.

Dr. Stewart and Dr. Postier reported no financial conflicts. ☐

HOT SPRINGS, VA. – Since tort reform in Texas, the number of lawsuits and associated costs have decreased, but patient complaints to the state medical board and board investigations of physicians have risen, according to an analysis presented at the annual meeting of the Southern Surgical Association.

Dr. Ronald M. Stewart and his colleagues from the University of Texas Health Science Center at San Antonio obtained publicly available data from the Texas Medical Board and compared the 7-year period before tort reform (1996-2002) and the 6 years after the law was enacted (2004-2010).

The data were adjusted for the increase in the physician population; before reform there were about 170 physicians per 100,000 residents. After the law went into effect, the number rose to 195 physicians per 100,000, said Dr. Stewart. Before reform, about 125 complaints per 1,000 physicians were made to the medical board. That number increased by 13% after reform, to around 140 complaints per 1,000 physicians, said Dr. Stewart.

The rate of investigations increased from 38 per 1,000 to 52 per 1,000, with 5% of physicians the subject of a medical board inquiry. Postreform, there were more disciplinary actions when compared with open investigations, at about 8 per 1,000 in the latter period. Before reform, 0.5 per 1,000 physicians were ordered to revoke or to voluntarily surrender their licenses; after reform, that value rose to 0.8 per 1,000, a significant increase, noted Dr. Stewart.

The most striking change before and after reform was the decline in financial penalties. The state collected a total of $4.7 million in the postreform period. To put that figure into context, the San Antonio department of surgery alone spent $4.8 million on liability settlements in the prereform period, said Dr. Stewart.

It’s not clear why complaints and disciplinary actions went up, Dr. Stewart said. Having access to electronic information and greater awareness of the ability to complain to the medical board probably spurred more patient reporting.

The increases in investigations and disciplinary actions were mainly driven by the legislature, according to Dr. Stewart. The lawmakers mandated greater oversight by the medical board, so that undoubtedly led an enforcement increase.

Dr. Stewart said that putting malpractice in the hands of the medical board had decreased costs and been generally positive. For instance, he said, the medical board process is transparent and allows more input from stakeholders like physicians.

"There’s no question that the benefits of tort reform in my opinion outweigh the potential negative consequences to physicians," he said.

Dr. Stewart and Dr. Postier reported no financial conflicts. ☐

HOT SPRINGS, VA. – Since tort reform in Texas, the number of lawsuits and associated costs have decreased, but patient complaints to the state medical board and board investigations of physicians have risen, according to an analysis presented at the annual meeting of the Southern Surgical Association.

Dr. Ronald M. Stewart and his colleagues from the University of Texas Health Science Center at San Antonio obtained publicly available data from the Texas Medical Board and compared the 7-year period before tort reform (1996-2002) and the 6 years after the law was enacted (2004-2010).

The data were adjusted for the increase in the physician population; before reform there were about 170 physicians per 100,000 residents. After the law went into effect, the number rose to 195 physicians per 100,000, said Dr. Stewart. Before reform, about 125 complaints per 1,000 physicians were made to the medical board. That number increased by 13% after reform, to around 140 complaints per 1,000 physicians, said Dr. Stewart.

The rate of investigations increased from 38 per 1,000 to 52 per 1,000, with 5% of physicians the subject of a medical board inquiry. Postreform, there were more disciplinary actions when compared with open investigations, at about 8 per 1,000 in the latter period. Before reform, 0.5 per 1,000 physicians were ordered to revoke or to voluntarily surrender their licenses; after reform, that value rose to 0.8 per 1,000, a significant increase, noted Dr. Stewart.

The most striking change before and after reform was the decline in financial penalties. The state collected a total of $4.7 million in the postreform period. To put that figure into context, the San Antonio department of surgery alone spent $4.8 million on liability settlements in the prereform period, said Dr. Stewart.

It’s not clear why complaints and disciplinary actions went up, Dr. Stewart said. Having access to electronic information and greater awareness of the ability to complain to the medical board probably spurred more patient reporting.

The increases in investigations and disciplinary actions were mainly driven by the legislature, according to Dr. Stewart. The lawmakers mandated greater oversight by the medical board, so that undoubtedly led an enforcement increase.

Dr. Stewart said that putting malpractice in the hands of the medical board had decreased costs and been generally positive. For instance, he said, the medical board process is transparent and allows more input from stakeholders like physicians.

"There’s no question that the benefits of tort reform in my opinion outweigh the potential negative consequences to physicians," he said.

Dr. Stewart and Dr. Postier reported no financial conflicts. ☐

NEW ORLEANS  – A review of a stroke registry shows that it may be safe to give clot-busting therapy to "wake-up" stroke patients who have the same clinical and imaging features as those of patients who are traditionally considered eligible for the therapies.

Clinicians have traditionally shied away from giving clot-busters to patients who have stroke symptoms upon awakening because the time of onset is generally unknown. But many of these patients likely have experienced the stroke within a few hours of arriving for treatment and could benefit from a clot-busting intervention, Dr. Dulka Manawadu said during a press briefing at the International Stroke Conference.

Determining how to identify which wake-up patients could benefit "is an area of growing importance because it may allow us to extend the indication for this effective treatment," said Dr. Manawadu, a stroke and general medicine consultant at King’s College Hospital in London.

Dr. Manawadu and her colleagues at King’s College analyzed patients in the hospital’s stroke registry who received alteplase (Activase) between January 2009 and December 2010. The study analyzed data for 326 unselected and consecutive patients with a stroke onset of 0 to 4.5 hours with a National Institute of Health Stroke Scale (NIHSS) score of 5 or greater, and 68 unselected, consecutive patients who awoke with symptoms, had an NIHSS of 5 or greater, and had an unknown time of onset.

At King’s College Hospital, clinicians can give thrombolysis to wake-up patients on a compassionate basis. Decisions are made on a case-by-case basis, and treatment is given with consent, said Dr. Manawadu. The patient’s history, clinical signs of stroke, and scan findings are all taken into consideration. Outside of the time constraint, wake-up patients have to meet all other eligibility criteria for clot-busting treatment. A nonenhanced CT scan must show an Alberta Stroke Program Early CT Score (ASPECTS) of 7 or greater. CT Perfusion (CTP) mismatch was also used to assess eligibility in some wake-up patients, but was not mandatory.

The mean age was 73 years for both arms. There was no significant difference between the groups in most baseline characteristics. However, there was significantly greater use of CTP in the wake-up group: 44 patients, or 65%, compared with 84 patients, or 26% of the comparator group. The wake-up patients also had a higher incidence of large-vessel stroke.

The outcomes were statistically similar for both groups, except for mean NIHSS scores at 24 hours. The mean score was significantly lower for the wake-up group than for the reference group (7.2 vs. 11.5). The rates were similar between the groups for having any intracranial hemorrhage ([ICH], 22% vs. 20%, respectively) or symptomatic ICH (2.9% vs. 3.4%). At 3 months after stroke, wake-up patients had a lower death rate (15% vs. 25%).

When the data for wake-up stroke patients were stratified by age, patients older than 80 years fared significantly worse than did those under 80.

The study was limited in that it was retrospective, but it did include all comers, Dr. Manawadu said. Despite the findings from the registry analysis, there have been no changes in protocol at King’s College; wake-up patients are still given thrombolysis on a case-by-case basis, she said.

Dr. Lee H. Schwamm, director of the telestroke and acute stroke services at Massachusetts General Hospital, Boston, said that parts of the study are reassuring and consistent with what would be expected. A surprising finding was that "the use of CT scanning alone was able to identify this cohort safely, and they could be treated with similar outcomes."

It is surprising in part because CT generally is not very sensitive in detecting ischemic stroke. If the findings hold up, it would be important because CT is more widely available than is MRI, Dr. Schwamm said in an interview.

Currently, few American clinicians are using clot-busting therapy for wake-up patients, and it would be premature to use the King’s College study as a basis for thrombolysis in those patients, Dr. Schwamm said.

The conference was sponsored by the American Heart Association. The study was funded by the Institutional Research and Development Board at King’s College Hospital, London. Dr. Manawadu and her colleagues reported having no relevant disclosures.

NEW ORLEANS  – A review of a stroke registry shows that it may be safe to give clot-busting therapy to "wake-up" stroke patients who have the same clinical and imaging features as those of patients who are traditionally considered eligible for the therapies.

Clinicians have traditionally shied away from giving clot-busters to patients who have stroke symptoms upon awakening because the time of onset is generally unknown. But many of these patients likely have experienced the stroke within a few hours of arriving for treatment and could benefit from a clot-busting intervention, Dr. Dulka Manawadu said during a press briefing at the International Stroke Conference.

Determining how to identify which wake-up patients could benefit "is an area of growing importance because it may allow us to extend the indication for this effective treatment," said Dr. Manawadu, a stroke and general medicine consultant at King’s College Hospital in London.

Dr. Manawadu and her colleagues at King’s College analyzed patients in the hospital’s stroke registry who received alteplase (Activase) between January 2009 and December 2010. The study analyzed data for 326 unselected and consecutive patients with a stroke onset of 0 to 4.5 hours with a National Institute of Health Stroke Scale (NIHSS) score of 5 or greater, and 68 unselected, consecutive patients who awoke with symptoms, had an NIHSS of 5 or greater, and had an unknown time of onset.

At King’s College Hospital, clinicians can give thrombolysis to wake-up patients on a compassionate basis. Decisions are made on a case-by-case basis, and treatment is given with consent, said Dr. Manawadu. The patient’s history, clinical signs of stroke, and scan findings are all taken into consideration. Outside of the time constraint, wake-up patients have to meet all other eligibility criteria for clot-busting treatment. A nonenhanced CT scan must show an Alberta Stroke Program Early CT Score (ASPECTS) of 7 or greater. CT Perfusion (CTP) mismatch was also used to assess eligibility in some wake-up patients, but was not mandatory.

The mean age was 73 years for both arms. There was no significant difference between the groups in most baseline characteristics. However, there was significantly greater use of CTP in the wake-up group: 44 patients, or 65%, compared with 84 patients, or 26% of the comparator group. The wake-up patients also had a higher incidence of large-vessel stroke.

The outcomes were statistically similar for both groups, except for mean NIHSS scores at 24 hours. The mean score was significantly lower for the wake-up group than for the reference group (7.2 vs. 11.5). The rates were similar between the groups for having any intracranial hemorrhage ([ICH], 22% vs. 20%, respectively) or symptomatic ICH (2.9% vs. 3.4%). At 3 months after stroke, wake-up patients had a lower death rate (15% vs. 25%).

When the data for wake-up stroke patients were stratified by age, patients older than 80 years fared significantly worse than did those under 80.

The study was limited in that it was retrospective, but it did include all comers, Dr. Manawadu said. Despite the findings from the registry analysis, there have been no changes in protocol at King’s College; wake-up patients are still given thrombolysis on a case-by-case basis, she said.

Dr. Lee H. Schwamm, director of the telestroke and acute stroke services at Massachusetts General Hospital, Boston, said that parts of the study are reassuring and consistent with what would be expected. A surprising finding was that "the use of CT scanning alone was able to identify this cohort safely, and they could be treated with similar outcomes."

It is surprising in part because CT generally is not very sensitive in detecting ischemic stroke. If the findings hold up, it would be important because CT is more widely available than is MRI, Dr. Schwamm said in an interview.

Currently, few American clinicians are using clot-busting therapy for wake-up patients, and it would be premature to use the King’s College study as a basis for thrombolysis in those patients, Dr. Schwamm said.

The conference was sponsored by the American Heart Association. The study was funded by the Institutional Research and Development Board at King’s College Hospital, London. Dr. Manawadu and her colleagues reported having no relevant disclosures.

NEW ORLEANS  – A review of a stroke registry shows that it may be safe to give clot-busting therapy to "wake-up" stroke patients who have the same clinical and imaging features as those of patients who are traditionally considered eligible for the therapies.

Clinicians have traditionally shied away from giving clot-busters to patients who have stroke symptoms upon awakening because the time of onset is generally unknown. But many of these patients likely have experienced the stroke within a few hours of arriving for treatment and could benefit from a clot-busting intervention, Dr. Dulka Manawadu said during a press briefing at the International Stroke Conference.

Determining how to identify which wake-up patients could benefit "is an area of growing importance because it may allow us to extend the indication for this effective treatment," said Dr. Manawadu, a stroke and general medicine consultant at King’s College Hospital in London.

Dr. Manawadu and her colleagues at King’s College analyzed patients in the hospital’s stroke registry who received alteplase (Activase) between January 2009 and December 2010. The study analyzed data for 326 unselected and consecutive patients with a stroke onset of 0 to 4.5 hours with a National Institute of Health Stroke Scale (NIHSS) score of 5 or greater, and 68 unselected, consecutive patients who awoke with symptoms, had an NIHSS of 5 or greater, and had an unknown time of onset.

At King’s College Hospital, clinicians can give thrombolysis to wake-up patients on a compassionate basis. Decisions are made on a case-by-case basis, and treatment is given with consent, said Dr. Manawadu. The patient’s history, clinical signs of stroke, and scan findings are all taken into consideration. Outside of the time constraint, wake-up patients have to meet all other eligibility criteria for clot-busting treatment. A nonenhanced CT scan must show an Alberta Stroke Program Early CT Score (ASPECTS) of 7 or greater. CT Perfusion (CTP) mismatch was also used to assess eligibility in some wake-up patients, but was not mandatory.

The mean age was 73 years for both arms. There was no significant difference between the groups in most baseline characteristics. However, there was significantly greater use of CTP in the wake-up group: 44 patients, or 65%, compared with 84 patients, or 26% of the comparator group. The wake-up patients also had a higher incidence of large-vessel stroke.

The outcomes were statistically similar for both groups, except for mean NIHSS scores at 24 hours. The mean score was significantly lower for the wake-up group than for the reference group (7.2 vs. 11.5). The rates were similar between the groups for having any intracranial hemorrhage ([ICH], 22% vs. 20%, respectively) or symptomatic ICH (2.9% vs. 3.4%). At 3 months after stroke, wake-up patients had a lower death rate (15% vs. 25%).

When the data for wake-up stroke patients were stratified by age, patients older than 80 years fared significantly worse than did those under 80.

The study was limited in that it was retrospective, but it did include all comers, Dr. Manawadu said. Despite the findings from the registry analysis, there have been no changes in protocol at King’s College; wake-up patients are still given thrombolysis on a case-by-case basis, she said.

Dr. Lee H. Schwamm, director of the telestroke and acute stroke services at Massachusetts General Hospital, Boston, said that parts of the study are reassuring and consistent with what would be expected. A surprising finding was that "the use of CT scanning alone was able to identify this cohort safely, and they could be treated with similar outcomes."

It is surprising in part because CT generally is not very sensitive in detecting ischemic stroke. If the findings hold up, it would be important because CT is more widely available than is MRI, Dr. Schwamm said in an interview.

Currently, few American clinicians are using clot-busting therapy for wake-up patients, and it would be premature to use the King’s College study as a basis for thrombolysis in those patients, Dr. Schwamm said.

The conference was sponsored by the American Heart Association. The study was funded by the Institutional Research and Development Board at King’s College Hospital, London. Dr. Manawadu and her colleagues reported having no relevant disclosures.

NEW ORLEANS – Patients with a very low or a very high hematocrit are at higher risk for death after a stroke, and anemic patients are at greatest risk, according to a study presented at the International Stroke Conference sponsored by the American Heart Association on Feb. 2.

Previous studies have shown that extremes of hematocrit increase mortality after myocardial infarction, congestive heart failure, and kidney disease. Dr. Jason J. Sico of the VA Connecticut Healthcare System and researchers from the Department of Veterans Affairs medical system explored whether there was a similar association in stroke. Previous stroke studies had not adjusted for stroke severity or a large number of comorbidities.

They found that "among stroke patients, severe anemia is a potent predictor of dying throughout the first year after a stroke," said Dr. Sico, who is also an assistant professor of neurology at Yale University, New Haven, Conn.

The researchers abstracted medical records for a sample from 131 Veterans Health Administration (VHA) hospitals of 3,965 patients admitted for a confirmed diagnosis of ischemic stroke in fiscal 2007. Patients with unavailable hematocrits, those who received thrombolytics, or those whose charts had inconsistent death dates were also excluded.

"Among stroke patients, severe anemia is a potent predictor of dying throughout the first year after a stroke."

The hematocrit, taken from 24 hours of admission, was divided into six tiers: less than or equal to 27% (defined as severe anemia); 28%-32% (moderate anemia); 33%-37% (mild anemia); 38%-42% (normal); 43%-47% (normal); and greater than or equal to 48% (polycythemia).

Researchers adjusted for age, National Institutes of Health Stroke Scale (NIHSS) score, comorbidities (including pneumonia, hypertension, hypercholesterolemia, diabetes, and history of cancer and heart disease), and Acute Physiology and Chronic Health Evaluation (APACHE)-III scores.

A total of 2% of the 3,750 patients analyzed had severe anemia, 6.2% had moderate anemia, and 17.9% had mild anemia. About 64% were in the normal categories. A total of 9% had a high hematocrit of greater than or equal to 48%.

People with lower hematocrits tended to be older and have higher APACHE scores, a higher Charlson index, a history of heart disease, and were more likely to have diabetes.

The risk of death was 2.5 to 3.5 times higher for patients with severe anemia (P = .013 for in-hospital and 30-day mortality; P = .002 at 6 months and P = .001 at 1 year). A high hematocrit was independently associated only with in-hospital mortality (OR 2.9, P = .004).

The study showed that having a history of severe anemia put stroke patients at a higher risk of death than having a history of other conditions, including cancer and heart disease, said Dr. Sico.

There are several potential mechanisms to explain why anemia might increase the risk of death, he said in an interview. With lower hematocrits, less blood and less oxygen circulate to various parts of the body. Long-term anemia also impairs the ability of the brain’s blood vessels to respond appropriately to a stroke.

A higher hematocrit also decreases blood flow to brain, said Dr. Sico. It causes a more turbulent blood flow to the brain, which could predispose the stroke patient to having a bad outcome.

Dr. Sico said that the study’s findings were limited to men because no women had been analyzed.

But he concluded that stroke patients with low or high hematocrits should be evaluated for potentially reversible causes, and that they should also be closely monitored during the post-stroke period.

Dr. Sico reported having no financial disclosures. The study was funded by the VA Health Services Research and Development Quality Enhancement Research Initiative.

NEW ORLEANS – Patients with a very low or a very high hematocrit are at higher risk for death after a stroke, and anemic patients are at greatest risk, according to a study presented at the International Stroke Conference sponsored by the American Heart Association on Feb. 2.

Previous studies have shown that extremes of hematocrit increase mortality after myocardial infarction, congestive heart failure, and kidney disease. Dr. Jason J. Sico of the VA Connecticut Healthcare System and researchers from the Department of Veterans Affairs medical system explored whether there was a similar association in stroke. Previous stroke studies had not adjusted for stroke severity or a large number of comorbidities.

They found that "among stroke patients, severe anemia is a potent predictor of dying throughout the first year after a stroke," said Dr. Sico, who is also an assistant professor of neurology at Yale University, New Haven, Conn.

The researchers abstracted medical records for a sample from 131 Veterans Health Administration (VHA) hospitals of 3,965 patients admitted for a confirmed diagnosis of ischemic stroke in fiscal 2007. Patients with unavailable hematocrits, those who received thrombolytics, or those whose charts had inconsistent death dates were also excluded.

"Among stroke patients, severe anemia is a potent predictor of dying throughout the first year after a stroke."

The hematocrit, taken from 24 hours of admission, was divided into six tiers: less than or equal to 27% (defined as severe anemia); 28%-32% (moderate anemia); 33%-37% (mild anemia); 38%-42% (normal); 43%-47% (normal); and greater than or equal to 48% (polycythemia).

Researchers adjusted for age, National Institutes of Health Stroke Scale (NIHSS) score, comorbidities (including pneumonia, hypertension, hypercholesterolemia, diabetes, and history of cancer and heart disease), and Acute Physiology and Chronic Health Evaluation (APACHE)-III scores.

A total of 2% of the 3,750 patients analyzed had severe anemia, 6.2% had moderate anemia, and 17.9% had mild anemia. About 64% were in the normal categories. A total of 9% had a high hematocrit of greater than or equal to 48%.

People with lower hematocrits tended to be older and have higher APACHE scores, a higher Charlson index, a history of heart disease, and were more likely to have diabetes.

The risk of death was 2.5 to 3.5 times higher for patients with severe anemia (P = .013 for in-hospital and 30-day mortality; P = .002 at 6 months and P = .001 at 1 year). A high hematocrit was independently associated only with in-hospital mortality (OR 2.9, P = .004).

The study showed that having a history of severe anemia put stroke patients at a higher risk of death than having a history of other conditions, including cancer and heart disease, said Dr. Sico.

There are several potential mechanisms to explain why anemia might increase the risk of death, he said in an interview. With lower hematocrits, less blood and less oxygen circulate to various parts of the body. Long-term anemia also impairs the ability of the brain’s blood vessels to respond appropriately to a stroke.

A higher hematocrit also decreases blood flow to brain, said Dr. Sico. It causes a more turbulent blood flow to the brain, which could predispose the stroke patient to having a bad outcome.

Dr. Sico said that the study’s findings were limited to men because no women had been analyzed.

But he concluded that stroke patients with low or high hematocrits should be evaluated for potentially reversible causes, and that they should also be closely monitored during the post-stroke period.

Dr. Sico reported having no financial disclosures. The study was funded by the VA Health Services Research and Development Quality Enhancement Research Initiative.

NEW ORLEANS – Patients with a very low or a very high hematocrit are at higher risk for death after a stroke, and anemic patients are at greatest risk, according to a study presented at the International Stroke Conference sponsored by the American Heart Association on Feb. 2.

Previous studies have shown that extremes of hematocrit increase mortality after myocardial infarction, congestive heart failure, and kidney disease. Dr. Jason J. Sico of the VA Connecticut Healthcare System and researchers from the Department of Veterans Affairs medical system explored whether there was a similar association in stroke. Previous stroke studies had not adjusted for stroke severity or a large number of comorbidities.

They found that "among stroke patients, severe anemia is a potent predictor of dying throughout the first year after a stroke," said Dr. Sico, who is also an assistant professor of neurology at Yale University, New Haven, Conn.

The researchers abstracted medical records for a sample from 131 Veterans Health Administration (VHA) hospitals of 3,965 patients admitted for a confirmed diagnosis of ischemic stroke in fiscal 2007. Patients with unavailable hematocrits, those who received thrombolytics, or those whose charts had inconsistent death dates were also excluded.

"Among stroke patients, severe anemia is a potent predictor of dying throughout the first year after a stroke."

The hematocrit, taken from 24 hours of admission, was divided into six tiers: less than or equal to 27% (defined as severe anemia); 28%-32% (moderate anemia); 33%-37% (mild anemia); 38%-42% (normal); 43%-47% (normal); and greater than or equal to 48% (polycythemia).

Researchers adjusted for age, National Institutes of Health Stroke Scale (NIHSS) score, comorbidities (including pneumonia, hypertension, hypercholesterolemia, diabetes, and history of cancer and heart disease), and Acute Physiology and Chronic Health Evaluation (APACHE)-III scores.

A total of 2% of the 3,750 patients analyzed had severe anemia, 6.2% had moderate anemia, and 17.9% had mild anemia. About 64% were in the normal categories. A total of 9% had a high hematocrit of greater than or equal to 48%.

People with lower hematocrits tended to be older and have higher APACHE scores, a higher Charlson index, a history of heart disease, and were more likely to have diabetes.

The risk of death was 2.5 to 3.5 times higher for patients with severe anemia (P = .013 for in-hospital and 30-day mortality; P = .002 at 6 months and P = .001 at 1 year). A high hematocrit was independently associated only with in-hospital mortality (OR 2.9, P = .004).

The study showed that having a history of severe anemia put stroke patients at a higher risk of death than having a history of other conditions, including cancer and heart disease, said Dr. Sico.

There are several potential mechanisms to explain why anemia might increase the risk of death, he said in an interview. With lower hematocrits, less blood and less oxygen circulate to various parts of the body. Long-term anemia also impairs the ability of the brain’s blood vessels to respond appropriately to a stroke.

A higher hematocrit also decreases blood flow to brain, said Dr. Sico. It causes a more turbulent blood flow to the brain, which could predispose the stroke patient to having a bad outcome.

Dr. Sico said that the study’s findings were limited to men because no women had been analyzed.

But he concluded that stroke patients with low or high hematocrits should be evaluated for potentially reversible causes, and that they should also be closely monitored during the post-stroke period.

Dr. Sico reported having no financial disclosures. The study was funded by the VA Health Services Research and Development Quality Enhancement Research Initiative.

NEW ORLEANS – Continuous cardiac outpatient telemetry monitoring for at least 21 days may be necessary to accurately identify atrial fibrillation as the cause of cryptogenic stroke, according to the results of a single-center, retrospective study.

Identifying these patients is important because many could be treated with anticoagulants that would reduce their stroke risk, said Dr. Daniel J. Miller, a neurologist at Henry Ford Hospital, Detroit.

About a third of all strokes are of unknown etiology. Paroxysmal atrial fibrillation (AF) is a potential cause of cryptogenic stroke and transient ischemic attacks (TIAs), and carries a high risk of future strokes, Dr. Miller said during a press briefing at the International Stroke Conference.

Physicians have not been sure about the best way to monitor these patients or how long to monitor them.

He and his colleagues followed-up on two small studies: one conducted by Dr. Ashis H. Tayal and colleagues (Neurology 2008;71:1696-1701) and another by Dr. Archit Bhatt and associates (Stroke Res. Treat. 2011 [doi:10.4061/2011/172074]). The Tayal study showed a 23% AF detection rate in cryptogenic stroke patients monitored for longer than 21 days. The Bhatt study found a similar AF rate in cryptogenic stroke.

Dr. Miller and his coinvestigators reviewed the records of 156 Henry Ford Hospital patients who’d had a cryptogenic stroke or TIA and had undergone monitoring with the Cardionet Mobile Cardiac Outpatient Telemetry (MCOT) device, which is commonly used at Henry Ford

The patients had a mean age of 68 years and half were women. The vast majority (97%) were not taking an anticoagulant. Hypertension was common, present in 87% of the patients. They had a fairly low mean score of 3 on the National Institutes of Health Stroke Scale (NIHSS), indicating that the stroke had not been severe.

After monitoring, 27 (17.3%) of the 156 patients had paroxysmal AF. The AF events lasted less than 30 seconds in two-thirds of the patients and longer than 30 seconds in 26%. The remaining 8% had persistently occurring AF. This finding was not surprising and was consistent with the Tayal report, Dr. Miller said in an interview. The monitors are very sensitive, in particular for those events longer than 30 seconds, but they might miss some episodes of less than 30 seconds, he said.

The review showed that the rate of AF detection rose with increased duration of monitoring. The detection rate on a Kaplan-Meier curve was estimated to be 4% at 48 hours, 9% at 7 days, 14% at 14 days, and 20% by 21 days. "Our study does show that in order to capture all these events you should continue to monitor for at least 21 days," Dr. Miller said.

A multivariate Cox regression analysis showed that for all patients, female gender (P = .002), premature atrial complexes (PAC) on electrocardiogram (P = .001), a 1-cm increase in the diameter of the left atrium (P = .033), and a 10% decline in left ventricular ejection fraction (P = .008) all were associated with increased risk of AF. For stroke patients, female gender, PAC, and increasing stroke severity on the NIHSS were all associated with increased risk.

PAC, a premature beat from the atrium, has been shown to be associated with AF. It was an especially strong predictor of AF in this study, Dr. Miller said.

He urged further study to determine optimal monitoring beyond 21 days for patients with cryptogenic stroke or TIA.

NEW ORLEANS – Continuous cardiac outpatient telemetry monitoring for at least 21 days may be necessary to accurately identify atrial fibrillation as the cause of cryptogenic stroke, according to the results of a single-center, retrospective study.

Identifying these patients is important because many could be treated with anticoagulants that would reduce their stroke risk, said Dr. Daniel J. Miller, a neurologist at Henry Ford Hospital, Detroit.

About a third of all strokes are of unknown etiology. Paroxysmal atrial fibrillation (AF) is a potential cause of cryptogenic stroke and transient ischemic attacks (TIAs), and carries a high risk of future strokes, Dr. Miller said during a press briefing at the International Stroke Conference.

Physicians have not been sure about the best way to monitor these patients or how long to monitor them.

He and his colleagues followed-up on two small studies: one conducted by Dr. Ashis H. Tayal and colleagues (Neurology 2008;71:1696-1701) and another by Dr. Archit Bhatt and associates (Stroke Res. Treat. 2011 [doi:10.4061/2011/172074]). The Tayal study showed a 23% AF detection rate in cryptogenic stroke patients monitored for longer than 21 days. The Bhatt study found a similar AF rate in cryptogenic stroke.

Dr. Miller and his coinvestigators reviewed the records of 156 Henry Ford Hospital patients who’d had a cryptogenic stroke or TIA and had undergone monitoring with the Cardionet Mobile Cardiac Outpatient Telemetry (MCOT) device, which is commonly used at Henry Ford

The patients had a mean age of 68 years and half were women. The vast majority (97%) were not taking an anticoagulant. Hypertension was common, present in 87% of the patients. They had a fairly low mean score of 3 on the National Institutes of Health Stroke Scale (NIHSS), indicating that the stroke had not been severe.

After monitoring, 27 (17.3%) of the 156 patients had paroxysmal AF. The AF events lasted less than 30 seconds in two-thirds of the patients and longer than 30 seconds in 26%. The remaining 8% had persistently occurring AF. This finding was not surprising and was consistent with the Tayal report, Dr. Miller said in an interview. The monitors are very sensitive, in particular for those events longer than 30 seconds, but they might miss some episodes of less than 30 seconds, he said.

The review showed that the rate of AF detection rose with increased duration of monitoring. The detection rate on a Kaplan-Meier curve was estimated to be 4% at 48 hours, 9% at 7 days, 14% at 14 days, and 20% by 21 days. "Our study does show that in order to capture all these events you should continue to monitor for at least 21 days," Dr. Miller said.

A multivariate Cox regression analysis showed that for all patients, female gender (P = .002), premature atrial complexes (PAC) on electrocardiogram (P = .001), a 1-cm increase in the diameter of the left atrium (P = .033), and a 10% decline in left ventricular ejection fraction (P = .008) all were associated with increased risk of AF. For stroke patients, female gender, PAC, and increasing stroke severity on the NIHSS were all associated with increased risk.

PAC, a premature beat from the atrium, has been shown to be associated with AF. It was an especially strong predictor of AF in this study, Dr. Miller said.

He urged further study to determine optimal monitoring beyond 21 days for patients with cryptogenic stroke or TIA.

NEW ORLEANS – Continuous cardiac outpatient telemetry monitoring for at least 21 days may be necessary to accurately identify atrial fibrillation as the cause of cryptogenic stroke, according to the results of a single-center, retrospective study.

Identifying these patients is important because many could be treated with anticoagulants that would reduce their stroke risk, said Dr. Daniel J. Miller, a neurologist at Henry Ford Hospital, Detroit.

About a third of all strokes are of unknown etiology. Paroxysmal atrial fibrillation (AF) is a potential cause of cryptogenic stroke and transient ischemic attacks (TIAs), and carries a high risk of future strokes, Dr. Miller said during a press briefing at the International Stroke Conference.

Physicians have not been sure about the best way to monitor these patients or how long to monitor them.

He and his colleagues followed-up on two small studies: one conducted by Dr. Ashis H. Tayal and colleagues (Neurology 2008;71:1696-1701) and another by Dr. Archit Bhatt and associates (Stroke Res. Treat. 2011 [doi:10.4061/2011/172074]). The Tayal study showed a 23% AF detection rate in cryptogenic stroke patients monitored for longer than 21 days. The Bhatt study found a similar AF rate in cryptogenic stroke.

Dr. Miller and his coinvestigators reviewed the records of 156 Henry Ford Hospital patients who’d had a cryptogenic stroke or TIA and had undergone monitoring with the Cardionet Mobile Cardiac Outpatient Telemetry (MCOT) device, which is commonly used at Henry Ford

The patients had a mean age of 68 years and half were women. The vast majority (97%) were not taking an anticoagulant. Hypertension was common, present in 87% of the patients. They had a fairly low mean score of 3 on the National Institutes of Health Stroke Scale (NIHSS), indicating that the stroke had not been severe.

After monitoring, 27 (17.3%) of the 156 patients had paroxysmal AF. The AF events lasted less than 30 seconds in two-thirds of the patients and longer than 30 seconds in 26%. The remaining 8% had persistently occurring AF. This finding was not surprising and was consistent with the Tayal report, Dr. Miller said in an interview. The monitors are very sensitive, in particular for those events longer than 30 seconds, but they might miss some episodes of less than 30 seconds, he said.

The review showed that the rate of AF detection rose with increased duration of monitoring. The detection rate on a Kaplan-Meier curve was estimated to be 4% at 48 hours, 9% at 7 days, 14% at 14 days, and 20% by 21 days. "Our study does show that in order to capture all these events you should continue to monitor for at least 21 days," Dr. Miller said.

A multivariate Cox regression analysis showed that for all patients, female gender (P = .002), premature atrial complexes (PAC) on electrocardiogram (P = .001), a 1-cm increase in the diameter of the left atrium (P = .033), and a 10% decline in left ventricular ejection fraction (P = .008) all were associated with increased risk of AF. For stroke patients, female gender, PAC, and increasing stroke severity on the NIHSS were all associated with increased risk.

PAC, a premature beat from the atrium, has been shown to be associated with AF. It was an especially strong predictor of AF in this study, Dr. Miller said.

He urged further study to determine optimal monitoring beyond 21 days for patients with cryptogenic stroke or TIA.

NEW ORLEANS – There may be a correlation between infection and stroke in children, according to research presented at the International Stroke Conference.

Acute infection is considered to be a risk factor for stroke in adults, so researchers from the University of California, San Francisco, decided to study whether it might also be a potential risk in children, who experience frequent infections.

Stroke, however, is still extremely rare in children: The incidence of acute arterial ischemic stroke is 2.4 per 100,000 children annually in the United States. A large proportion of those cases have no known cause, said Nancy K. Hills, Ph.D., assistant adjunct professor of neurology at UCSF, at a press briefing. Many of those children, however, have an underlying arteriopathy.

Dr. Hills and her colleagues found that children who had a stroke were eight times more likely to have visited a health provider for an infection within 1 month before the stroke, compared with controls. More than 1 month before the stroke, however, there was no difference in the number of visits for infection between cases and controls. The researchers could not prove a direct link between infection and stroke. "We really believe it’s not the infection that’s causing the stroke," Dr. Hills said.

"It’s not something that parents of healthy children need to worry about," she said, adding that the infections are "probably a trigger for something else." The researchers believe that the children who had infection and stroke "probably have some underlying predisposition that causes them to have an unusual response to a common infection."

The retrospective study examined medical records for 2.5 million children – aged 29 days to 19 years – who were members of Kaiser Permanente from 1993 to 2007. The investigators identified 126 acute ischemic strokes, and then randomly selected 378 age-matched controls (three controls per case) from the Kaiser population. The median age was 10.5 years, and there was a relatively similar mix of male and females. All races were proportionately represented, said Dr. Hills.

The researchers looked at both diagnosed infections and symptoms that were indicative of infection. Any history of infection after a stroke diagnosis was excluded. Once the index stroke was established, the researchers categorized infectious visits according to time frames: 0-2 days, 3-7 days, 8-28 days, 1-3 months, 3-6 months, 6-12 months, and 12-24 months before the stroke.

They found that children who had a stroke were much more likely to have had a visit for infection within 1 month of the index stroke (odds ratio, 8.37). The odds ratio increased to 182 for a visit for infection within 2 days of the stroke. Twenty-nine percent of those who had a stroke had a visit in the 2 days prior to the stroke, compared with 1% of controls for the same dates. In the 3- to 7-day window, 13% of children who had a stroke had an infection, compared with 2% of controls.

The authors concluded that the risk of stroke is substantially elevated within the week after a visit for infection, but that it is likely that these children have some susceptibility to stroke, and that the infection puts them in a prothrombotic state, Dr. Hills said at the meeting, which was sponsored by the American Heart Association.

She pointed out several limitations to the study, including the fact that the number of infections in both the cases and controls was likely underestimated. Also, the infections were not generally confirmed by lab data; they were based on empirical diagnoses.

The study was funded by the National Institute of Neurological Disorders and Stroke. The authors reported no relevant financial conflicts.

NEW ORLEANS – There may be a correlation between infection and stroke in children, according to research presented at the International Stroke Conference.

Acute infection is considered to be a risk factor for stroke in adults, so researchers from the University of California, San Francisco, decided to study whether it might also be a potential risk in children, who experience frequent infections.

Stroke, however, is still extremely rare in children: The incidence of acute arterial ischemic stroke is 2.4 per 100,000 children annually in the United States. A large proportion of those cases have no known cause, said Nancy K. Hills, Ph.D., assistant adjunct professor of neurology at UCSF, at a press briefing. Many of those children, however, have an underlying arteriopathy.

Dr. Hills and her colleagues found that children who had a stroke were eight times more likely to have visited a health provider for an infection within 1 month before the stroke, compared with controls. More than 1 month before the stroke, however, there was no difference in the number of visits for infection between cases and controls. The researchers could not prove a direct link between infection and stroke. "We really believe it’s not the infection that’s causing the stroke," Dr. Hills said.

"It’s not something that parents of healthy children need to worry about," she said, adding that the infections are "probably a trigger for something else." The researchers believe that the children who had infection and stroke "probably have some underlying predisposition that causes them to have an unusual response to a common infection."

The retrospective study examined medical records for 2.5 million children – aged 29 days to 19 years – who were members of Kaiser Permanente from 1993 to 2007. The investigators identified 126 acute ischemic strokes, and then randomly selected 378 age-matched controls (three controls per case) from the Kaiser population. The median age was 10.5 years, and there was a relatively similar mix of male and females. All races were proportionately represented, said Dr. Hills.

The researchers looked at both diagnosed infections and symptoms that were indicative of infection. Any history of infection after a stroke diagnosis was excluded. Once the index stroke was established, the researchers categorized infectious visits according to time frames: 0-2 days, 3-7 days, 8-28 days, 1-3 months, 3-6 months, 6-12 months, and 12-24 months before the stroke.

They found that children who had a stroke were much more likely to have had a visit for infection within 1 month of the index stroke (odds ratio, 8.37). The odds ratio increased to 182 for a visit for infection within 2 days of the stroke. Twenty-nine percent of those who had a stroke had a visit in the 2 days prior to the stroke, compared with 1% of controls for the same dates. In the 3- to 7-day window, 13% of children who had a stroke had an infection, compared with 2% of controls.

The authors concluded that the risk of stroke is substantially elevated within the week after a visit for infection, but that it is likely that these children have some susceptibility to stroke, and that the infection puts them in a prothrombotic state, Dr. Hills said at the meeting, which was sponsored by the American Heart Association.

She pointed out several limitations to the study, including the fact that the number of infections in both the cases and controls was likely underestimated. Also, the infections were not generally confirmed by lab data; they were based on empirical diagnoses.

The study was funded by the National Institute of Neurological Disorders and Stroke. The authors reported no relevant financial conflicts.

NEW ORLEANS – There may be a correlation between infection and stroke in children, according to research presented at the International Stroke Conference.

Acute infection is considered to be a risk factor for stroke in adults, so researchers from the University of California, San Francisco, decided to study whether it might also be a potential risk in children, who experience frequent infections.

Stroke, however, is still extremely rare in children: The incidence of acute arterial ischemic stroke is 2.4 per 100,000 children annually in the United States. A large proportion of those cases have no known cause, said Nancy K. Hills, Ph.D., assistant adjunct professor of neurology at UCSF, at a press briefing. Many of those children, however, have an underlying arteriopathy.

Dr. Hills and her colleagues found that children who had a stroke were eight times more likely to have visited a health provider for an infection within 1 month before the stroke, compared with controls. More than 1 month before the stroke, however, there was no difference in the number of visits for infection between cases and controls. The researchers could not prove a direct link between infection and stroke. "We really believe it’s not the infection that’s causing the stroke," Dr. Hills said.

"It’s not something that parents of healthy children need to worry about," she said, adding that the infections are "probably a trigger for something else." The researchers believe that the children who had infection and stroke "probably have some underlying predisposition that causes them to have an unusual response to a common infection."

The retrospective study examined medical records for 2.5 million children – aged 29 days to 19 years – who were members of Kaiser Permanente from 1993 to 2007. The investigators identified 126 acute ischemic strokes, and then randomly selected 378 age-matched controls (three controls per case) from the Kaiser population. The median age was 10.5 years, and there was a relatively similar mix of male and females. All races were proportionately represented, said Dr. Hills.

The researchers looked at both diagnosed infections and symptoms that were indicative of infection. Any history of infection after a stroke diagnosis was excluded. Once the index stroke was established, the researchers categorized infectious visits according to time frames: 0-2 days, 3-7 days, 8-28 days, 1-3 months, 3-6 months, 6-12 months, and 12-24 months before the stroke.

They found that children who had a stroke were much more likely to have had a visit for infection within 1 month of the index stroke (odds ratio, 8.37). The odds ratio increased to 182 for a visit for infection within 2 days of the stroke. Twenty-nine percent of those who had a stroke had a visit in the 2 days prior to the stroke, compared with 1% of controls for the same dates. In the 3- to 7-day window, 13% of children who had a stroke had an infection, compared with 2% of controls.

The authors concluded that the risk of stroke is substantially elevated within the week after a visit for infection, but that it is likely that these children have some susceptibility to stroke, and that the infection puts them in a prothrombotic state, Dr. Hills said at the meeting, which was sponsored by the American Heart Association.

She pointed out several limitations to the study, including the fact that the number of infections in both the cases and controls was likely underestimated. Also, the infections were not generally confirmed by lab data; they were based on empirical diagnoses.

The study was funded by the National Institute of Neurological Disorders and Stroke. The authors reported no relevant financial conflicts.

WASHINGTON – The historically low growth in health spending in 2009 continued through 2010, driven largely by the recession, officials from the Centers for Medicare and Medicaid announced Jan. 9.

Health spending in the United States grew 3.9% in 2010, to a total of $2.6 trillion or $8,402 per person. That was a 0.1% rise from 2009, which was already at an all-time low growth rate, according to the CMS.

As the nation's economy slumped throughout 2009 and 2010, consumers cut back on elective surgical procedures, emergency department visits, physician office visits, and prescription drug use, according to the officials.

“Even though the recession officially ended in 2009, its impact on the health sector appears to have continued into 2010,” said Anne Martin, an economist with the CMS.

Employers shifted the costs of insurance and care to employees. This, in turn, drove up out-of-pocket spending in 2010.

But overall, consumers spent only 1.8% more out-of-pocket in 2010 than they had in 2009, which was a slow rate of growth when compared with historical patterns, Ms. Martin said.

Consumers reacted to cost-shifting by choosing health insurance plans that offered lower premiums and higher deductibles, and by reducing, where they could, use of personal health care services. Medical prices and the U.S. population remained relatively stable before, during, and after the recession, and yet, personal health spending fell, indicating a willful pullback.

“The slower growth in personal health care spending was mainly driven by the slowdown in the use and intensity of health care goods and services,” Ms. Martin said.

The agency documented a shrinkage in use of hospital care and physician services as compared with historical levels.

Hospital spending grew only 5% to $814 billion in 2010, compared with 6% in 2009. There was a decline in median inpatient admissions, and slower growth in emergency department visits, outpatient visits, and outpatient surgeries.

Overall spending on physician and clinical services – totaling $515 billion in 2010 – accounted for 20% of total health spending. As consumers went to their doctors less frequently, fewer prescriptions were written. And, many of the prescriptions that were dispensed were for less expensive generic drugs. These and other factors led to the slowest rate of growth in prescription drug spending ever recorded – a 1% increase from 2009 to $259 billion. The data were published in the journal Health Affairs (Health Aff. 2012 [doi: 10.1377/hlthaff.2011.1135]).

Growth in spending on physician and clinical services also was historically low, growing 2.5% in 2010 as compared with 3.3% in 2009, according to Ms. Martin.

Meanwhile, as employers and private insurers reduced the amount they spent on health care, the federal government's share of health spending rose – to 29% or a total of $742 billion in 2010. The rise in federal spending also was attributed to federal subsidies to state Medicaid programs. Medicaid accounted for about 15% of the nation's health bill in 2010, at $401 billion.

In 2009, the federal government spent 22% more than it did in 2008; in 2010, spending rose by almost 9%. That compares with a 10% decrease in spending by states and localities in 2008, and a 4% increase in 2010.

Medicare saw an increase in enrollment, both in the Medicare Advantage managed care program and traditional fee-for-service Medicare.

The increase in traditional enrollment reversed a several-year pattern of decline. Overall, Medicare spending increased 5% in 2010 to $524 billion, but per-enrollee spending did not rise as quickly as it had in 2009.

This is because there was a big reduction in payments for certain types of home health services, but also because of low use of physician services.

Small increases in physician fees in 2009 and 2010 also kept a lid on Medicare spending.

Those increases were instituted by Congress in response to cuts that would otherwise have been required by Medicare's Sustainable Growth Rate formula.

The Affordable Care Act had a negligible impact on overall spending, perhaps accounting for less than 0.1% of the slowdown, according to the CMS economists. This is because few provisions were in effect in 2010, and some, such as coverage for patients with preexisting conditions, did not enroll as many people as had been expected.

WASHINGTON – The historically low growth in health spending in 2009 continued through 2010, driven largely by the recession, officials from the Centers for Medicare and Medicaid announced Jan. 9.

Health spending in the United States grew 3.9% in 2010, to a total of $2.6 trillion or $8,402 per person. That was a 0.1% rise from 2009, which was already at an all-time low growth rate, according to the CMS.

As the nation's economy slumped throughout 2009 and 2010, consumers cut back on elective surgical procedures, emergency department visits, physician office visits, and prescription drug use, according to the officials.

“Even though the recession officially ended in 2009, its impact on the health sector appears to have continued into 2010,” said Anne Martin, an economist with the CMS.

Employers shifted the costs of insurance and care to employees. This, in turn, drove up out-of-pocket spending in 2010.

But overall, consumers spent only 1.8% more out-of-pocket in 2010 than they had in 2009, which was a slow rate of growth when compared with historical patterns, Ms. Martin said.

Consumers reacted to cost-shifting by choosing health insurance plans that offered lower premiums and higher deductibles, and by reducing, where they could, use of personal health care services. Medical prices and the U.S. population remained relatively stable before, during, and after the recession, and yet, personal health spending fell, indicating a willful pullback.

“The slower growth in personal health care spending was mainly driven by the slowdown in the use and intensity of health care goods and services,” Ms. Martin said.

The agency documented a shrinkage in use of hospital care and physician services as compared with historical levels.

Hospital spending grew only 5% to $814 billion in 2010, compared with 6% in 2009. There was a decline in median inpatient admissions, and slower growth in emergency department visits, outpatient visits, and outpatient surgeries.

Overall spending on physician and clinical services – totaling $515 billion in 2010 – accounted for 20% of total health spending. As consumers went to their doctors less frequently, fewer prescriptions were written. And, many of the prescriptions that were dispensed were for less expensive generic drugs. These and other factors led to the slowest rate of growth in prescription drug spending ever recorded – a 1% increase from 2009 to $259 billion. The data were published in the journal Health Affairs (Health Aff. 2012 [doi: 10.1377/hlthaff.2011.1135]).

Growth in spending on physician and clinical services also was historically low, growing 2.5% in 2010 as compared with 3.3% in 2009, according to Ms. Martin.

Meanwhile, as employers and private insurers reduced the amount they spent on health care, the federal government's share of health spending rose – to 29% or a total of $742 billion in 2010. The rise in federal spending also was attributed to federal subsidies to state Medicaid programs. Medicaid accounted for about 15% of the nation's health bill in 2010, at $401 billion.

In 2009, the federal government spent 22% more than it did in 2008; in 2010, spending rose by almost 9%. That compares with a 10% decrease in spending by states and localities in 2008, and a 4% increase in 2010.

Medicare saw an increase in enrollment, both in the Medicare Advantage managed care program and traditional fee-for-service Medicare.

The increase in traditional enrollment reversed a several-year pattern of decline. Overall, Medicare spending increased 5% in 2010 to $524 billion, but per-enrollee spending did not rise as quickly as it had in 2009.

This is because there was a big reduction in payments for certain types of home health services, but also because of low use of physician services.

Small increases in physician fees in 2009 and 2010 also kept a lid on Medicare spending.

Those increases were instituted by Congress in response to cuts that would otherwise have been required by Medicare's Sustainable Growth Rate formula.

The Affordable Care Act had a negligible impact on overall spending, perhaps accounting for less than 0.1% of the slowdown, according to the CMS economists. This is because few provisions were in effect in 2010, and some, such as coverage for patients with preexisting conditions, did not enroll as many people as had been expected.

WASHINGTON – The historically low growth in health spending in 2009 continued through 2010, driven largely by the recession, officials from the Centers for Medicare and Medicaid announced Jan. 9.

Health spending in the United States grew 3.9% in 2010, to a total of $2.6 trillion or $8,402 per person. That was a 0.1% rise from 2009, which was already at an all-time low growth rate, according to the CMS.

As the nation's economy slumped throughout 2009 and 2010, consumers cut back on elective surgical procedures, emergency department visits, physician office visits, and prescription drug use, according to the officials.

“Even though the recession officially ended in 2009, its impact on the health sector appears to have continued into 2010,” said Anne Martin, an economist with the CMS.

Employers shifted the costs of insurance and care to employees. This, in turn, drove up out-of-pocket spending in 2010.

But overall, consumers spent only 1.8% more out-of-pocket in 2010 than they had in 2009, which was a slow rate of growth when compared with historical patterns, Ms. Martin said.

Consumers reacted to cost-shifting by choosing health insurance plans that offered lower premiums and higher deductibles, and by reducing, where they could, use of personal health care services. Medical prices and the U.S. population remained relatively stable before, during, and after the recession, and yet, personal health spending fell, indicating a willful pullback.

“The slower growth in personal health care spending was mainly driven by the slowdown in the use and intensity of health care goods and services,” Ms. Martin said.

The agency documented a shrinkage in use of hospital care and physician services as compared with historical levels.

Hospital spending grew only 5% to $814 billion in 2010, compared with 6% in 2009. There was a decline in median inpatient admissions, and slower growth in emergency department visits, outpatient visits, and outpatient surgeries.

Overall spending on physician and clinical services – totaling $515 billion in 2010 – accounted for 20% of total health spending. As consumers went to their doctors less frequently, fewer prescriptions were written. And, many of the prescriptions that were dispensed were for less expensive generic drugs. These and other factors led to the slowest rate of growth in prescription drug spending ever recorded – a 1% increase from 2009 to $259 billion. The data were published in the journal Health Affairs (Health Aff. 2012 [doi: 10.1377/hlthaff.2011.1135]).

Growth in spending on physician and clinical services also was historically low, growing 2.5% in 2010 as compared with 3.3% in 2009, according to Ms. Martin.

Meanwhile, as employers and private insurers reduced the amount they spent on health care, the federal government's share of health spending rose – to 29% or a total of $742 billion in 2010. The rise in federal spending also was attributed to federal subsidies to state Medicaid programs. Medicaid accounted for about 15% of the nation's health bill in 2010, at $401 billion.

In 2009, the federal government spent 22% more than it did in 2008; in 2010, spending rose by almost 9%. That compares with a 10% decrease in spending by states and localities in 2008, and a 4% increase in 2010.

Medicare saw an increase in enrollment, both in the Medicare Advantage managed care program and traditional fee-for-service Medicare.

The increase in traditional enrollment reversed a several-year pattern of decline. Overall, Medicare spending increased 5% in 2010 to $524 billion, but per-enrollee spending did not rise as quickly as it had in 2009.

This is because there was a big reduction in payments for certain types of home health services, but also because of low use of physician services.

Small increases in physician fees in 2009 and 2010 also kept a lid on Medicare spending.

Those increases were instituted by Congress in response to cuts that would otherwise have been required by Medicare's Sustainable Growth Rate formula.

The Affordable Care Act had a negligible impact on overall spending, perhaps accounting for less than 0.1% of the slowdown, according to the CMS economists. This is because few provisions were in effect in 2010, and some, such as coverage for patients with preexisting conditions, did not enroll as many people as had been expected.