Alicia Ault

A new advocacy coalition is putting pressure on the Accreditation Council for Graduate Medical Education to speed up its process of developing new recommendations on work hour restrictions for residents—and to closely follow the Institute of Medicine's recommendations by further reducing hours.

The coalition, led by Public Citizen, sent a letter to Dr. Thomas J. Nasca, ACGME's executive director, urging the accrediting body to adopt rules that aim to reduce sleep deprivation and to better protect patients, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a briefing with reporters.

“The available evidence suggests that the public is deeply concerned about the current work hours of medical residents,” stated the letter, which is posted at www.wakeupdoctor.org

At the briefing, Dr. John Ingell, a fourth-year surgical resident at the University of New Mexico, Albuquerque, said that he became less compassionate when severely fatigued. Concentration also suffered, said Dr. Ingell, who is on the board of the Service Employees International Union's medical resident section.

Dan Henderson, a third-year medical student at the University of Connecticut, Farmington, said that at the time, he was proud to work 12 hours or more a day or a 30-hour continuous shift on his surgical rotation. Now, he feels “ashamed,” because he has realized that such efforts did not improve his education and had a negative effect on his feelings for patients.

He said he supported the limit on work hours recommended by the IOM in 2008. The IOM urged a reduction from 30-hour shifts to shifts no longer than 16 hours. “I really think medicine needs a wake- up call and needs to move into the 21st century,” said Mr. Henderson.

The ACGME had planned on reviewing the work hours 5 years after they were first reduced, which happened to coincide with the IOM's report, Dr. Nasca said in an interview. The 16-member Duty Hours Task Force has been meeting since last July. New draft standards are likely to be issued by late April, and then available for public comment for 45 days, he said.

At the briefing, Dr. Charles A. Czeisler, professor of sleep medicine at Harvard Medical School, Boston, said that the current ACGME standards are widely flouted. Confidential surveys of residents have shown “widespread falsification” by trainees on their actual work hours, he noted.

Dr. Nasca responded that the ACGME is an educational accreditor, “not an employment regulator…. Our goal is to ensure substantial compliance with the regulations.”

There is a tension between the educational mission, safety, and other factors, acknowledged Dr. Nasca, adding that this is why the Duty Hours Task Force had gathered evidence and opinions from more than 140 organizations.

“There's a constant balance we have to take between setting realistic expectations for how residents are scheduled for duty and the expectations that programs comply with those, coupled with the desire to inculcate in physicians a sense of personal responsibility for the safety and care of each individual patient,” said Dr. Nasca.

The risk of fatigue also has to be balanced against the risk of increased errors when patients are handed off to an increasing number of caregivers, he said.

A new advocacy coalition is putting pressure on the Accreditation Council for Graduate Medical Education to speed up its process of developing new recommendations on work hour restrictions for residents—and to closely follow the Institute of Medicine's recommendations by further reducing hours.

The coalition, led by Public Citizen, sent a letter to Dr. Thomas J. Nasca, ACGME's executive director, urging the accrediting body to adopt rules that aim to reduce sleep deprivation and to better protect patients, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a briefing with reporters.

“The available evidence suggests that the public is deeply concerned about the current work hours of medical residents,” stated the letter, which is posted at www.wakeupdoctor.org

At the briefing, Dr. John Ingell, a fourth-year surgical resident at the University of New Mexico, Albuquerque, said that he became less compassionate when severely fatigued. Concentration also suffered, said Dr. Ingell, who is on the board of the Service Employees International Union's medical resident section.

Dan Henderson, a third-year medical student at the University of Connecticut, Farmington, said that at the time, he was proud to work 12 hours or more a day or a 30-hour continuous shift on his surgical rotation. Now, he feels “ashamed,” because he has realized that such efforts did not improve his education and had a negative effect on his feelings for patients.

He said he supported the limit on work hours recommended by the IOM in 2008. The IOM urged a reduction from 30-hour shifts to shifts no longer than 16 hours. “I really think medicine needs a wake- up call and needs to move into the 21st century,” said Mr. Henderson.

The ACGME had planned on reviewing the work hours 5 years after they were first reduced, which happened to coincide with the IOM's report, Dr. Nasca said in an interview. The 16-member Duty Hours Task Force has been meeting since last July. New draft standards are likely to be issued by late April, and then available for public comment for 45 days, he said.

At the briefing, Dr. Charles A. Czeisler, professor of sleep medicine at Harvard Medical School, Boston, said that the current ACGME standards are widely flouted. Confidential surveys of residents have shown “widespread falsification” by trainees on their actual work hours, he noted.

Dr. Nasca responded that the ACGME is an educational accreditor, “not an employment regulator…. Our goal is to ensure substantial compliance with the regulations.”

There is a tension between the educational mission, safety, and other factors, acknowledged Dr. Nasca, adding that this is why the Duty Hours Task Force had gathered evidence and opinions from more than 140 organizations.

“There's a constant balance we have to take between setting realistic expectations for how residents are scheduled for duty and the expectations that programs comply with those, coupled with the desire to inculcate in physicians a sense of personal responsibility for the safety and care of each individual patient,” said Dr. Nasca.

The risk of fatigue also has to be balanced against the risk of increased errors when patients are handed off to an increasing number of caregivers, he said.

A new advocacy coalition is putting pressure on the Accreditation Council for Graduate Medical Education to speed up its process of developing new recommendations on work hour restrictions for residents—and to closely follow the Institute of Medicine's recommendations by further reducing hours.

The coalition, led by Public Citizen, sent a letter to Dr. Thomas J. Nasca, ACGME's executive director, urging the accrediting body to adopt rules that aim to reduce sleep deprivation and to better protect patients, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a briefing with reporters.

“The available evidence suggests that the public is deeply concerned about the current work hours of medical residents,” stated the letter, which is posted at www.wakeupdoctor.org

At the briefing, Dr. John Ingell, a fourth-year surgical resident at the University of New Mexico, Albuquerque, said that he became less compassionate when severely fatigued. Concentration also suffered, said Dr. Ingell, who is on the board of the Service Employees International Union's medical resident section.

Dan Henderson, a third-year medical student at the University of Connecticut, Farmington, said that at the time, he was proud to work 12 hours or more a day or a 30-hour continuous shift on his surgical rotation. Now, he feels “ashamed,” because he has realized that such efforts did not improve his education and had a negative effect on his feelings for patients.

He said he supported the limit on work hours recommended by the IOM in 2008. The IOM urged a reduction from 30-hour shifts to shifts no longer than 16 hours. “I really think medicine needs a wake- up call and needs to move into the 21st century,” said Mr. Henderson.

The ACGME had planned on reviewing the work hours 5 years after they were first reduced, which happened to coincide with the IOM's report, Dr. Nasca said in an interview. The 16-member Duty Hours Task Force has been meeting since last July. New draft standards are likely to be issued by late April, and then available for public comment for 45 days, he said.

At the briefing, Dr. Charles A. Czeisler, professor of sleep medicine at Harvard Medical School, Boston, said that the current ACGME standards are widely flouted. Confidential surveys of residents have shown “widespread falsification” by trainees on their actual work hours, he noted.

Dr. Nasca responded that the ACGME is an educational accreditor, “not an employment regulator…. Our goal is to ensure substantial compliance with the regulations.”

There is a tension between the educational mission, safety, and other factors, acknowledged Dr. Nasca, adding that this is why the Duty Hours Task Force had gathered evidence and opinions from more than 140 organizations.

“There's a constant balance we have to take between setting realistic expectations for how residents are scheduled for duty and the expectations that programs comply with those, coupled with the desire to inculcate in physicians a sense of personal responsibility for the safety and care of each individual patient,” said Dr. Nasca.

The risk of fatigue also has to be balanced against the risk of increased errors when patients are handed off to an increasing number of caregivers, he said.

A new advocacy coalition is putting pressure on the Accreditation Council for Graduate Medical Education to speed up its process of developing new recommendations on work hour restrictions for residents, and to closely follow the Institute of Medicine's recommendations by further reducing hours.

The coalition, led by Public Citizen, sent a letter to Dr. Thomas J. Nasca, ACGME's executive director, urging the accrediting body to adopt rules that aim to reduce sleep deprivation and to better protect patients, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a briefing with reporters. “The available evidence suggests that the public is deeply concerned about the current work hours of medical residents,” as stated in the letter to Dr. Nasca. The letter is posted at www.wakeupdoctor.org

At the briefing, Dr. John Ingell, a surgical resident at the University of New Mexico, Albuquerque, said that he noticed he became less compassionate when severely fatigued. Concentration also suffered, said Dr. Ingell, who is on the board of the Service Employees International Union's medical resident section.

Dan Henderson, a medical student at the University of Connecticut, Farmington, said that at the time, he was proud to work 12 hours or more a day or a 30-hour continuous shift on his surgical rotation. Now, he feels “ashamed,” because he realizes that such efforts did not improve his education and also had a negative effect on his feelings for patients.

He said he supported the limit on work hours recommended by the IOM in 2008. The IOM urged a reduction from 30-hour shifts to shifts lasting no longer than 16 hours. “I really think medicine needs a wake-up call and needs to move into the 21st century,” said Mr. Henderson.

The ACGME had planned on reviewing the work hours 5 years after they were first reduced, which happened to coincide with the IOM's report, said Dr. Nasca in an interview. The 16-member Duty Hours Task Force has been meeting since last July. New draft standards are likely to be issued by late April, and will then be available for public comment for 45 days, he said.

At the briefing, Dr. Charles A. Czeisler, professor of sleep medicine at Harvard Medical School, Boston, said that the current ACGME standards are widely flouted. He said confidential surveys of residents have shown “widespread falsification” by trainees on their actual work hours. Dr. Nasca responded that his organization was an educational accreditor, “not an employment regulator.”

Added Dr. Nasca, “Our goal is to ensure substantial compliance with the regulations.”

There is a tension between the educational mission, safety, and other factors, acknowledged Dr. Nasca, adding that this is why the Duty Hours Task Force had gathered evidence and opinions from more than 140 organizations.

“There's a constant balance we have to take between setting realistic expectations for how residents are scheduled for duty and the expectations that programs comply with those, coupled with the desire to inculcate in physicians a sense of personal responsibility for the safety and care of each individual patient,” said Dr. Nasca.

The risk of fatigue also has to be balanced against the risk of increased errors when patients are handed off to an increasing number of caregivers, he said. The evidence is conflicting on whether reduced work hours improves patient safety, added Dr. Nasca.

However, he said he welcomed the new group's attention to work hours. “This is an important issue for the public to understand,” Dr. Nasca said.

A new advocacy coalition is putting pressure on the Accreditation Council for Graduate Medical Education to speed up its process of developing new recommendations on work hour restrictions for residents, and to closely follow the Institute of Medicine's recommendations by further reducing hours.

The coalition, led by Public Citizen, sent a letter to Dr. Thomas J. Nasca, ACGME's executive director, urging the accrediting body to adopt rules that aim to reduce sleep deprivation and to better protect patients, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a briefing with reporters. “The available evidence suggests that the public is deeply concerned about the current work hours of medical residents,” as stated in the letter to Dr. Nasca. The letter is posted at www.wakeupdoctor.org

At the briefing, Dr. John Ingell, a surgical resident at the University of New Mexico, Albuquerque, said that he noticed he became less compassionate when severely fatigued. Concentration also suffered, said Dr. Ingell, who is on the board of the Service Employees International Union's medical resident section.

Dan Henderson, a medical student at the University of Connecticut, Farmington, said that at the time, he was proud to work 12 hours or more a day or a 30-hour continuous shift on his surgical rotation. Now, he feels “ashamed,” because he realizes that such efforts did not improve his education and also had a negative effect on his feelings for patients.

He said he supported the limit on work hours recommended by the IOM in 2008. The IOM urged a reduction from 30-hour shifts to shifts lasting no longer than 16 hours. “I really think medicine needs a wake-up call and needs to move into the 21st century,” said Mr. Henderson.

The ACGME had planned on reviewing the work hours 5 years after they were first reduced, which happened to coincide with the IOM's report, said Dr. Nasca in an interview. The 16-member Duty Hours Task Force has been meeting since last July. New draft standards are likely to be issued by late April, and will then be available for public comment for 45 days, he said.

At the briefing, Dr. Charles A. Czeisler, professor of sleep medicine at Harvard Medical School, Boston, said that the current ACGME standards are widely flouted. He said confidential surveys of residents have shown “widespread falsification” by trainees on their actual work hours. Dr. Nasca responded that his organization was an educational accreditor, “not an employment regulator.”

Added Dr. Nasca, “Our goal is to ensure substantial compliance with the regulations.”

There is a tension between the educational mission, safety, and other factors, acknowledged Dr. Nasca, adding that this is why the Duty Hours Task Force had gathered evidence and opinions from more than 140 organizations.

“There's a constant balance we have to take between setting realistic expectations for how residents are scheduled for duty and the expectations that programs comply with those, coupled with the desire to inculcate in physicians a sense of personal responsibility for the safety and care of each individual patient,” said Dr. Nasca.

The risk of fatigue also has to be balanced against the risk of increased errors when patients are handed off to an increasing number of caregivers, he said. The evidence is conflicting on whether reduced work hours improves patient safety, added Dr. Nasca.

However, he said he welcomed the new group's attention to work hours. “This is an important issue for the public to understand,” Dr. Nasca said.

A new advocacy coalition is putting pressure on the Accreditation Council for Graduate Medical Education to speed up its process of developing new recommendations on work hour restrictions for residents, and to closely follow the Institute of Medicine's recommendations by further reducing hours.

The coalition, led by Public Citizen, sent a letter to Dr. Thomas J. Nasca, ACGME's executive director, urging the accrediting body to adopt rules that aim to reduce sleep deprivation and to better protect patients, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a briefing with reporters. “The available evidence suggests that the public is deeply concerned about the current work hours of medical residents,” as stated in the letter to Dr. Nasca. The letter is posted at www.wakeupdoctor.org

At the briefing, Dr. John Ingell, a surgical resident at the University of New Mexico, Albuquerque, said that he noticed he became less compassionate when severely fatigued. Concentration also suffered, said Dr. Ingell, who is on the board of the Service Employees International Union's medical resident section.

Dan Henderson, a medical student at the University of Connecticut, Farmington, said that at the time, he was proud to work 12 hours or more a day or a 30-hour continuous shift on his surgical rotation. Now, he feels “ashamed,” because he realizes that such efforts did not improve his education and also had a negative effect on his feelings for patients.

He said he supported the limit on work hours recommended by the IOM in 2008. The IOM urged a reduction from 30-hour shifts to shifts lasting no longer than 16 hours. “I really think medicine needs a wake-up call and needs to move into the 21st century,” said Mr. Henderson.

The ACGME had planned on reviewing the work hours 5 years after they were first reduced, which happened to coincide with the IOM's report, said Dr. Nasca in an interview. The 16-member Duty Hours Task Force has been meeting since last July. New draft standards are likely to be issued by late April, and will then be available for public comment for 45 days, he said.

At the briefing, Dr. Charles A. Czeisler, professor of sleep medicine at Harvard Medical School, Boston, said that the current ACGME standards are widely flouted. He said confidential surveys of residents have shown “widespread falsification” by trainees on their actual work hours. Dr. Nasca responded that his organization was an educational accreditor, “not an employment regulator.”

Added Dr. Nasca, “Our goal is to ensure substantial compliance with the regulations.”

There is a tension between the educational mission, safety, and other factors, acknowledged Dr. Nasca, adding that this is why the Duty Hours Task Force had gathered evidence and opinions from more than 140 organizations.

“There's a constant balance we have to take between setting realistic expectations for how residents are scheduled for duty and the expectations that programs comply with those, coupled with the desire to inculcate in physicians a sense of personal responsibility for the safety and care of each individual patient,” said Dr. Nasca.

The risk of fatigue also has to be balanced against the risk of increased errors when patients are handed off to an increasing number of caregivers, he said. The evidence is conflicting on whether reduced work hours improves patient safety, added Dr. Nasca.

However, he said he welcomed the new group's attention to work hours. “This is an important issue for the public to understand,” Dr. Nasca said.

The Centers for Medicare and Medicaid Services has named the national accrediting organizations charged with oversight of physician and nonphysician organizations that provide computed tomography, magnetic resonance imaging, positron emission tomography, and nuclear medicine exams under the technical component of the Medicare Fee Schedule.

The American College of Radiology (ACR), the Intersocietal Accreditation Commission (IAC), and the Joint Commission will furnish accreditation services and report back to the CMS on their survey processes.

The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) requires that all suppliers of advanced imaging become accredited by Jan. 1, 2012.

“The three organizations that will be accrediting suppliers have the expertise and authority to set a standard of excellence industry-wide,” Dr. Barry Straube, chief medical officer of the CMS, said in a statement announcing the selection of the accrediting bodies.

The groups will be responsible for judging and verifying the qualifications of nonphysician personnel who perform the imaging as well as the qualifications of medical directors and supervising physicians; checking safety procedures; verifying procedures to ensure reliability, clarity, and accuracy of imaging; and checking procedures to help patients obtain imaging studies upon request.

Providers of x-rays, ultrasound, and fluoroscopy will not be subject to the accreditation process.

The American College of Cardiology will be working with members to make sure they understand the accreditation requirements, said an ACC spokesperson. The professional society is working closely with the IAC, but cardiologists are free to choose any of the three accrediting organizations, she said.

Rheumatologist Norman B. Gaylis applauded the required certification of other imaging used in the office setting. “This action is not punitive. It is intended to achieve quality,” said Dr. Gaylis, Aventura, Fla., who is in president and a founding member of the International Society of Extremity MRI in Rheumatology.

The certification process may increase payers' willingness to reimburse for office-based imaging. Furthermore, it gives patients the assurance that the staff and equipment have met accrediting standards, he added.

Office-based MRI has been exempt from certification requirements. However, that will end in January 2012, when all physician offices that use MRI will have to be accredited to do so.

The Centers for Medicare and Medicaid Services has named the national accrediting organizations charged with oversight of physician and nonphysician organizations that provide computed tomography, magnetic resonance imaging, positron emission tomography, and nuclear medicine exams under the technical component of the Medicare Fee Schedule.

The American College of Radiology (ACR), the Intersocietal Accreditation Commission (IAC), and the Joint Commission will furnish accreditation services and report back to the CMS on their survey processes.

The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) requires that all suppliers of advanced imaging become accredited by Jan. 1, 2012.

“The three organizations that will be accrediting suppliers have the expertise and authority to set a standard of excellence industry-wide,” Dr. Barry Straube, chief medical officer of the CMS, said in a statement announcing the selection of the accrediting bodies.

The groups will be responsible for judging and verifying the qualifications of nonphysician personnel who perform the imaging as well as the qualifications of medical directors and supervising physicians; checking safety procedures; verifying procedures to ensure reliability, clarity, and accuracy of imaging; and checking procedures to help patients obtain imaging studies upon request.

Providers of x-rays, ultrasound, and fluoroscopy will not be subject to the accreditation process.

The American College of Cardiology will be working with members to make sure they understand the accreditation requirements, said an ACC spokesperson. The professional society is working closely with the IAC, but cardiologists are free to choose any of the three accrediting organizations, she said.

Rheumatologist Norman B. Gaylis applauded the required certification of other imaging used in the office setting. “This action is not punitive. It is intended to achieve quality,” said Dr. Gaylis, Aventura, Fla., who is in president and a founding member of the International Society of Extremity MRI in Rheumatology.

The certification process may increase payers' willingness to reimburse for office-based imaging. Furthermore, it gives patients the assurance that the staff and equipment have met accrediting standards, he added.

Office-based MRI has been exempt from certification requirements. However, that will end in January 2012, when all physician offices that use MRI will have to be accredited to do so.

The Centers for Medicare and Medicaid Services has named the national accrediting organizations charged with oversight of physician and nonphysician organizations that provide computed tomography, magnetic resonance imaging, positron emission tomography, and nuclear medicine exams under the technical component of the Medicare Fee Schedule.

The American College of Radiology (ACR), the Intersocietal Accreditation Commission (IAC), and the Joint Commission will furnish accreditation services and report back to the CMS on their survey processes.

The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) requires that all suppliers of advanced imaging become accredited by Jan. 1, 2012.

“The three organizations that will be accrediting suppliers have the expertise and authority to set a standard of excellence industry-wide,” Dr. Barry Straube, chief medical officer of the CMS, said in a statement announcing the selection of the accrediting bodies.

The groups will be responsible for judging and verifying the qualifications of nonphysician personnel who perform the imaging as well as the qualifications of medical directors and supervising physicians; checking safety procedures; verifying procedures to ensure reliability, clarity, and accuracy of imaging; and checking procedures to help patients obtain imaging studies upon request.

Providers of x-rays, ultrasound, and fluoroscopy will not be subject to the accreditation process.

The American College of Cardiology will be working with members to make sure they understand the accreditation requirements, said an ACC spokesperson. The professional society is working closely with the IAC, but cardiologists are free to choose any of the three accrediting organizations, she said.

Rheumatologist Norman B. Gaylis applauded the required certification of other imaging used in the office setting. “This action is not punitive. It is intended to achieve quality,” said Dr. Gaylis, Aventura, Fla., who is in president and a founding member of the International Society of Extremity MRI in Rheumatology.

The certification process may increase payers' willingness to reimburse for office-based imaging. Furthermore, it gives patients the assurance that the staff and equipment have met accrediting standards, he added.

Office-based MRI has been exempt from certification requirements. However, that will end in January 2012, when all physician offices that use MRI will have to be accredited to do so.

The Food and Drug Administration updated the labeling for clopidogrel to emphasize that new data definitively shows that the drug is less effective—and may not work at all—in patients defined as “poor metabolizers.”

The agency is notifying physicians that testing is available for the genotypes that are associated with poor metabolism, but it stopped short of recommending that all patients receive such testing before starting a course of clopidogrel (Plavix).

About 2%-14% of the population probably have those alleles and are poor metabolizers, with the rate varying by racial background, according to the FDA.

The issue of reduced metabolism was first highlighted in the clopidogrel label in May 2009. But the agency decided to add a stronger, boxed warning to clopidogrel because of the mounting evidence about poor metabolizers, including a required postmarketing study conducted by the drug's manufacturer, Sanofi-Aventis, that was submitted to the FDA, said Mary Ross Southworth, Pharm. D., a clinical analyst in the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research, in a briefing with reporters.

That 40-patient study confirmed that patients with the *2 and *3 alleles of the CYP2C19 liver enzyme were likely to be poor metabolizers. The *4, *5, *6, *7 and *8 alleles are associated with little to no metabolism of clopidogrel but occur less commonly than *2 and *3 alleles.

In acute situations, such as during a MI or coronary angioplasty, waiting for test results won't be reasonable, said Dr. Robert Temple, deputy director for clinical science in FDA's Center for Drug Evaluation and Research, in the briefing.

For chronic use of clopidogrel in poor metabolizers, the FDA is urging physicians to consider use of other antiplatelets, such as ticlopidine (Ticlid) or prasugrel (Effient), or potentially increasing the clopidogrel dose.

Ms. Southworth and Dr. Temple acknowledged that physicians would likely have to test patients to determine first if they were poor metabolizers, but said that there are not enough data to say that testing should be required.

Only one diagnostic for liver enzyme metabolism—the Amplichip, made by Roche—has been approved, and it is not specifically approved for CYP2C19, said Dr. Courtney Harper, director of the division of chemistry and toxicology devices at the FDA's Center for Devices and Radiologic Health. Roche cannot promote the test, since it would be an off-label use.

The Food and Drug Administration updated the labeling for clopidogrel to emphasize that new data definitively shows that the drug is less effective—and may not work at all—in patients defined as “poor metabolizers.”

The agency is notifying physicians that testing is available for the genotypes that are associated with poor metabolism, but it stopped short of recommending that all patients receive such testing before starting a course of clopidogrel (Plavix).

About 2%-14% of the population probably have those alleles and are poor metabolizers, with the rate varying by racial background, according to the FDA.

The issue of reduced metabolism was first highlighted in the clopidogrel label in May 2009. But the agency decided to add a stronger, boxed warning to clopidogrel because of the mounting evidence about poor metabolizers, including a required postmarketing study conducted by the drug's manufacturer, Sanofi-Aventis, that was submitted to the FDA, said Mary Ross Southworth, Pharm. D., a clinical analyst in the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research, in a briefing with reporters.

That 40-patient study confirmed that patients with the *2 and *3 alleles of the CYP2C19 liver enzyme were likely to be poor metabolizers. The *4, *5, *6, *7 and *8 alleles are associated with little to no metabolism of clopidogrel but occur less commonly than *2 and *3 alleles.

In acute situations, such as during a MI or coronary angioplasty, waiting for test results won't be reasonable, said Dr. Robert Temple, deputy director for clinical science in FDA's Center for Drug Evaluation and Research, in the briefing.

For chronic use of clopidogrel in poor metabolizers, the FDA is urging physicians to consider use of other antiplatelets, such as ticlopidine (Ticlid) or prasugrel (Effient), or potentially increasing the clopidogrel dose.

Ms. Southworth and Dr. Temple acknowledged that physicians would likely have to test patients to determine first if they were poor metabolizers, but said that there are not enough data to say that testing should be required.

Only one diagnostic for liver enzyme metabolism—the Amplichip, made by Roche—has been approved, and it is not specifically approved for CYP2C19, said Dr. Courtney Harper, director of the division of chemistry and toxicology devices at the FDA's Center for Devices and Radiologic Health. Roche cannot promote the test, since it would be an off-label use.

The Food and Drug Administration updated the labeling for clopidogrel to emphasize that new data definitively shows that the drug is less effective—and may not work at all—in patients defined as “poor metabolizers.”

The agency is notifying physicians that testing is available for the genotypes that are associated with poor metabolism, but it stopped short of recommending that all patients receive such testing before starting a course of clopidogrel (Plavix).

About 2%-14% of the population probably have those alleles and are poor metabolizers, with the rate varying by racial background, according to the FDA.

The issue of reduced metabolism was first highlighted in the clopidogrel label in May 2009. But the agency decided to add a stronger, boxed warning to clopidogrel because of the mounting evidence about poor metabolizers, including a required postmarketing study conducted by the drug's manufacturer, Sanofi-Aventis, that was submitted to the FDA, said Mary Ross Southworth, Pharm. D., a clinical analyst in the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research, in a briefing with reporters.

That 40-patient study confirmed that patients with the *2 and *3 alleles of the CYP2C19 liver enzyme were likely to be poor metabolizers. The *4, *5, *6, *7 and *8 alleles are associated with little to no metabolism of clopidogrel but occur less commonly than *2 and *3 alleles.

In acute situations, such as during a MI or coronary angioplasty, waiting for test results won't be reasonable, said Dr. Robert Temple, deputy director for clinical science in FDA's Center for Drug Evaluation and Research, in the briefing.

For chronic use of clopidogrel in poor metabolizers, the FDA is urging physicians to consider use of other antiplatelets, such as ticlopidine (Ticlid) or prasugrel (Effient), or potentially increasing the clopidogrel dose.

Ms. Southworth and Dr. Temple acknowledged that physicians would likely have to test patients to determine first if they were poor metabolizers, but said that there are not enough data to say that testing should be required.

Only one diagnostic for liver enzyme metabolism—the Amplichip, made by Roche—has been approved, and it is not specifically approved for CYP2C19, said Dr. Courtney Harper, director of the division of chemistry and toxicology devices at the FDA's Center for Devices and Radiologic Health. Roche cannot promote the test, since it would be an off-label use.

The Federal Trade Commission has obtained a settlement from the Indoor Tanning Association in which the industry group has agreed that it will no longer make false health and safety claims about indoor tanning.

The American Academy of Dermatology (AAD) applauded the action, noting that it had complained to the FTC in the wake of an advertising campaign launched by the Indoor Tanning Association (ITA) in March 2008. That campaign made a number of false claims, according to the FTC. Among them: that indoor tanning is approved by the government; that it is safer than outdoor tanning; and that vitamin D supplements may impair immunity.

The ITA ad campaign also claimed that the National Academy of Sciences had determined that “the risks of not getting enough ultraviolet light far outweigh the hypothetical risk of skin cancer.”

“The messages promoted by the indoor tanning industry fly in the face of scientific evidence,” said David C. Vladeck, director of the FTC's Bureau of Consumer Protection in a statement announcing the settlement.

According to the draft settlement, ITA is prohibited from “making the misrepresentations challenged in the complaint, from misrepresenting any tests or studies, and from providing deceptive advertisements to its members.” Future ads must make certain disclosures. Ads that make claims about health benefits or safety of indoor tanning have to say: “Exposure to ultraviolet radiation may increase the likelihood of developing skin cancer and can cause serious eye injury.”

The Federal Trade Commission has obtained a settlement from the Indoor Tanning Association in which the industry group has agreed that it will no longer make false health and safety claims about indoor tanning.

The American Academy of Dermatology (AAD) applauded the action, noting that it had complained to the FTC in the wake of an advertising campaign launched by the Indoor Tanning Association (ITA) in March 2008. That campaign made a number of false claims, according to the FTC. Among them: that indoor tanning is approved by the government; that it is safer than outdoor tanning; and that vitamin D supplements may impair immunity.

The ITA ad campaign also claimed that the National Academy of Sciences had determined that “the risks of not getting enough ultraviolet light far outweigh the hypothetical risk of skin cancer.”

“The messages promoted by the indoor tanning industry fly in the face of scientific evidence,” said David C. Vladeck, director of the FTC's Bureau of Consumer Protection in a statement announcing the settlement.

According to the draft settlement, ITA is prohibited from “making the misrepresentations challenged in the complaint, from misrepresenting any tests or studies, and from providing deceptive advertisements to its members.” Future ads must make certain disclosures. Ads that make claims about health benefits or safety of indoor tanning have to say: “Exposure to ultraviolet radiation may increase the likelihood of developing skin cancer and can cause serious eye injury.”

The Federal Trade Commission has obtained a settlement from the Indoor Tanning Association in which the industry group has agreed that it will no longer make false health and safety claims about indoor tanning.

The American Academy of Dermatology (AAD) applauded the action, noting that it had complained to the FTC in the wake of an advertising campaign launched by the Indoor Tanning Association (ITA) in March 2008. That campaign made a number of false claims, according to the FTC. Among them: that indoor tanning is approved by the government; that it is safer than outdoor tanning; and that vitamin D supplements may impair immunity.

The ITA ad campaign also claimed that the National Academy of Sciences had determined that “the risks of not getting enough ultraviolet light far outweigh the hypothetical risk of skin cancer.”

“The messages promoted by the indoor tanning industry fly in the face of scientific evidence,” said David C. Vladeck, director of the FTC's Bureau of Consumer Protection in a statement announcing the settlement.

According to the draft settlement, ITA is prohibited from “making the misrepresentations challenged in the complaint, from misrepresenting any tests or studies, and from providing deceptive advertisements to its members.” Future ads must make certain disclosures. Ads that make claims about health benefits or safety of indoor tanning have to say: “Exposure to ultraviolet radiation may increase the likelihood of developing skin cancer and can cause serious eye injury.”

Manufacturers of computed tomography machines announced that they have agreed to a standardized set of features that will help ensure that patients receive the appropriate radiation dose when being scanned.

In a conference call with reporters, Dave Fisher, executive director of the Medical Imaging & Technology Alliance (MITA), said that the industry had been working for years to make CT machines safer and that the timing of the announcement was not related to either the Food and Drug Administration's recent heightened interest in radiation or an impending House Energy & Commerce Health Subcommittee hearing on radiation safety.

The five CT manufacturers—General Electric, Siemens, Philips, Toshiba, and Hitachi—all agreed to participate in the MITA “dose check” initiative, said Mr. Fisher.

There are three new main safety features.

First, machine operators will receive an on-screen alert—possibly in the form of a pop-up window—when they exceed recommended dose levels. The alert is akin to a yellow caution flag, said Mr. Fisher. The recommended dose—the reference dose—will be determined by clinicians at hospitals and imaging centers, not manufacturers, he said.

The second safeguard will also likely come as a pop-up window: a warning if the dose reaches hazardous levels that could result in burns, hair loss, or other injuries. This “red flag” can be configured to prevent the scan, Mr. Fisher said.

Again, clinicians, not manufacturers, will have the power to determine whether they want to block a scan or have some other series of instructions or steps to prevent harm, he said.

Finally, manufacturers have agreed to a standardized method of image storage so that they can be incorporated into a registry—if such a registry is developed, as the Obama administration has proposed.

The new features will not likely be available until late 2010 or early 2011, Mr. Fisher said. They may come as software upgrades to older machines or add-ons to new scanners being developed now. The process may be delayed if the FDA decides that the features need regulatory clearance, said Mr. Fisher.

In a statement, MITA said that the safety initiative is being supported by the American Society of Radiologic Technologists and the Alliance for Radiation Safety in Pediatric Imaging.

“The safeguards proposed by MITA represent a major step forward in managing radiation dose during CT scans performed on children, who are much more sensitive to radiation than adults,” Dr. Marilyn Goske, chairwoman of the alliance and a professor at Cincinnati Children's Hospital Medical Center, said in a statement.

Manufacturers of computed tomography machines announced that they have agreed to a standardized set of features that will help ensure that patients receive the appropriate radiation dose when being scanned.

In a conference call with reporters, Dave Fisher, executive director of the Medical Imaging & Technology Alliance (MITA), said that the industry had been working for years to make CT machines safer and that the timing of the announcement was not related to either the Food and Drug Administration's recent heightened interest in radiation or an impending House Energy & Commerce Health Subcommittee hearing on radiation safety.

The five CT manufacturers—General Electric, Siemens, Philips, Toshiba, and Hitachi—all agreed to participate in the MITA “dose check” initiative, said Mr. Fisher.

There are three new main safety features.

First, machine operators will receive an on-screen alert—possibly in the form of a pop-up window—when they exceed recommended dose levels. The alert is akin to a yellow caution flag, said Mr. Fisher. The recommended dose—the reference dose—will be determined by clinicians at hospitals and imaging centers, not manufacturers, he said.

The second safeguard will also likely come as a pop-up window: a warning if the dose reaches hazardous levels that could result in burns, hair loss, or other injuries. This “red flag” can be configured to prevent the scan, Mr. Fisher said.

Again, clinicians, not manufacturers, will have the power to determine whether they want to block a scan or have some other series of instructions or steps to prevent harm, he said.

Finally, manufacturers have agreed to a standardized method of image storage so that they can be incorporated into a registry—if such a registry is developed, as the Obama administration has proposed.

The new features will not likely be available until late 2010 or early 2011, Mr. Fisher said. They may come as software upgrades to older machines or add-ons to new scanners being developed now. The process may be delayed if the FDA decides that the features need regulatory clearance, said Mr. Fisher.

In a statement, MITA said that the safety initiative is being supported by the American Society of Radiologic Technologists and the Alliance for Radiation Safety in Pediatric Imaging.

“The safeguards proposed by MITA represent a major step forward in managing radiation dose during CT scans performed on children, who are much more sensitive to radiation than adults,” Dr. Marilyn Goske, chairwoman of the alliance and a professor at Cincinnati Children's Hospital Medical Center, said in a statement.

Manufacturers of computed tomography machines announced that they have agreed to a standardized set of features that will help ensure that patients receive the appropriate radiation dose when being scanned.

In a conference call with reporters, Dave Fisher, executive director of the Medical Imaging & Technology Alliance (MITA), said that the industry had been working for years to make CT machines safer and that the timing of the announcement was not related to either the Food and Drug Administration's recent heightened interest in radiation or an impending House Energy & Commerce Health Subcommittee hearing on radiation safety.

The five CT manufacturers—General Electric, Siemens, Philips, Toshiba, and Hitachi—all agreed to participate in the MITA “dose check” initiative, said Mr. Fisher.

There are three new main safety features.

First, machine operators will receive an on-screen alert—possibly in the form of a pop-up window—when they exceed recommended dose levels. The alert is akin to a yellow caution flag, said Mr. Fisher. The recommended dose—the reference dose—will be determined by clinicians at hospitals and imaging centers, not manufacturers, he said.

The second safeguard will also likely come as a pop-up window: a warning if the dose reaches hazardous levels that could result in burns, hair loss, or other injuries. This “red flag” can be configured to prevent the scan, Mr. Fisher said.

Again, clinicians, not manufacturers, will have the power to determine whether they want to block a scan or have some other series of instructions or steps to prevent harm, he said.

Finally, manufacturers have agreed to a standardized method of image storage so that they can be incorporated into a registry—if such a registry is developed, as the Obama administration has proposed.

The new features will not likely be available until late 2010 or early 2011, Mr. Fisher said. They may come as software upgrades to older machines or add-ons to new scanners being developed now. The process may be delayed if the FDA decides that the features need regulatory clearance, said Mr. Fisher.

In a statement, MITA said that the safety initiative is being supported by the American Society of Radiologic Technologists and the Alliance for Radiation Safety in Pediatric Imaging.

“The safeguards proposed by MITA represent a major step forward in managing radiation dose during CT scans performed on children, who are much more sensitive to radiation than adults,” Dr. Marilyn Goske, chairwoman of the alliance and a professor at Cincinnati Children's Hospital Medical Center, said in a statement.

WASHINGTON — There have been some significant victories in the almost 40 years since President Richard M. Nixon signed the National Cancer Act in 1971, declaring the “war on cancer,” according to commentary offered by American Cancer Society epidemiologists at a briefing sponsored by the Journal of the American Medical Association.

Even so, despite more than $100 billion spent by the United States government alone over those years, cancer is still the second-leading cause of death in the United States and, by the end of this year, is projected to be the leading cause of death worldwide.

Susan M. Gapstur, Ph.D., vice president at the ACS, presented an overview of the progress in the war so far at the briefing. Her commentary was co-authored with Dr. Michael J. Thun, who is also with the cancer society (JAMA 2010;303:1084-5).

Claims of defeat or stasis in the war are inaccurate, given surveillance reports that show an almost 16% decrease in the death rate from all cancers combined between 1991 and 2006, said Dr. Gapstur. There has been a 1% annual drop in the incidence rate between 1999 and 2006, she noted in her paper.

Mortality rates for men have dropped 21% since their peak in 1990, and mortality rates for women have dropped 12% since their peak in 1991, she said. The overall drop in death rates since 1970 has been about 6%.

The ACS estimates that some 765,000 cancer deaths have been avoided since 1990.

But the decline in mortality is more impressive when taken into context, she said. Since 1970, the U.S. population has grown 30%, and there has been a twofold increase in adults aged 55 years or older. That segment of the population accounts for three-quarters of the cancer incidence.

Incidence rates and the sheer number of people dying from cancer are expected to rise with the aging of the U.S. population. During their lifetime, one in two men and one in three women will be diagnosed with cancer.

The ACS estimates that there were 1.5 million new diagnoses in 2009 and 560,000 deaths.

The billions of dollars spent on public and private research have helped determine that cancer is incredibly variable and individualized. There are more than 100 different anatomical and histological subtypes of the disease. Many of these illnesses have “multiple molecular variants with different [prognoses], clinical features, and susceptibility to treatment,” wrote Dr. Gapstur and Dr. Thun.

There have been successes, chief among them the decline in cigarette smoking that has led to a 40% reduction in cancer mortality for men from the peak rates, largely due to a huge decline in lung cancer deaths.

Early detection through Papanicolaou testing has also reduced the death rate from cervical cancer. Screening technologies hold the same promise for breast and colon cancer, and to a more debatable extent, prostate cancer, according to the authors.

Treatment advances have led to more success stories in pediatric cancers. Dr. Gapstur noted that some 80% of pediatric cancer patients survive 5 years or more. Therapeutic advances have also led to better prognoses for Hodgkin's disease, testicular cancer, and chronic myelogenous leukemia, they said.

Localized cancers also are being treated with greater success, leading to better prognoses. But metastatic cancers and certain, more lethal diseases, such as cancers of the brain, liver, lung, ovary, and pancreas, are still a “critical problem,” the authors wrote.

Death rates are rising for esophageal and liver cancer and melanoma in men, and for pancreatic and liver cancer in women.

These cancers may be obesity related, said Dr. Gapstur, who noted that the obesity epidemic could fuel rising cancer death rates in the future.

Disclosures: Dr. Gapstur and Dr. Thun reported having no conflicts of interest.

WASHINGTON — There have been some significant victories in the almost 40 years since President Richard M. Nixon signed the National Cancer Act in 1971, declaring the “war on cancer,” according to commentary offered by American Cancer Society epidemiologists at a briefing sponsored by the Journal of the American Medical Association.

Even so, despite more than $100 billion spent by the United States government alone over those years, cancer is still the second-leading cause of death in the United States and, by the end of this year, is projected to be the leading cause of death worldwide.

Susan M. Gapstur, Ph.D., vice president at the ACS, presented an overview of the progress in the war so far at the briefing. Her commentary was co-authored with Dr. Michael J. Thun, who is also with the cancer society (JAMA 2010;303:1084-5).

Claims of defeat or stasis in the war are inaccurate, given surveillance reports that show an almost 16% decrease in the death rate from all cancers combined between 1991 and 2006, said Dr. Gapstur. There has been a 1% annual drop in the incidence rate between 1999 and 2006, she noted in her paper.

Mortality rates for men have dropped 21% since their peak in 1990, and mortality rates for women have dropped 12% since their peak in 1991, she said. The overall drop in death rates since 1970 has been about 6%.

The ACS estimates that some 765,000 cancer deaths have been avoided since 1990.

But the decline in mortality is more impressive when taken into context, she said. Since 1970, the U.S. population has grown 30%, and there has been a twofold increase in adults aged 55 years or older. That segment of the population accounts for three-quarters of the cancer incidence.

Incidence rates and the sheer number of people dying from cancer are expected to rise with the aging of the U.S. population. During their lifetime, one in two men and one in three women will be diagnosed with cancer.

The ACS estimates that there were 1.5 million new diagnoses in 2009 and 560,000 deaths.

The billions of dollars spent on public and private research have helped determine that cancer is incredibly variable and individualized. There are more than 100 different anatomical and histological subtypes of the disease. Many of these illnesses have “multiple molecular variants with different [prognoses], clinical features, and susceptibility to treatment,” wrote Dr. Gapstur and Dr. Thun.

There have been successes, chief among them the decline in cigarette smoking that has led to a 40% reduction in cancer mortality for men from the peak rates, largely due to a huge decline in lung cancer deaths.

Early detection through Papanicolaou testing has also reduced the death rate from cervical cancer. Screening technologies hold the same promise for breast and colon cancer, and to a more debatable extent, prostate cancer, according to the authors.

Treatment advances have led to more success stories in pediatric cancers. Dr. Gapstur noted that some 80% of pediatric cancer patients survive 5 years or more. Therapeutic advances have also led to better prognoses for Hodgkin's disease, testicular cancer, and chronic myelogenous leukemia, they said.

Localized cancers also are being treated with greater success, leading to better prognoses. But metastatic cancers and certain, more lethal diseases, such as cancers of the brain, liver, lung, ovary, and pancreas, are still a “critical problem,” the authors wrote.

Death rates are rising for esophageal and liver cancer and melanoma in men, and for pancreatic and liver cancer in women.

These cancers may be obesity related, said Dr. Gapstur, who noted that the obesity epidemic could fuel rising cancer death rates in the future.

Disclosures: Dr. Gapstur and Dr. Thun reported having no conflicts of interest.

WASHINGTON — There have been some significant victories in the almost 40 years since President Richard M. Nixon signed the National Cancer Act in 1971, declaring the “war on cancer,” according to commentary offered by American Cancer Society epidemiologists at a briefing sponsored by the Journal of the American Medical Association.

Even so, despite more than $100 billion spent by the United States government alone over those years, cancer is still the second-leading cause of death in the United States and, by the end of this year, is projected to be the leading cause of death worldwide.

Susan M. Gapstur, Ph.D., vice president at the ACS, presented an overview of the progress in the war so far at the briefing. Her commentary was co-authored with Dr. Michael J. Thun, who is also with the cancer society (JAMA 2010;303:1084-5).

Claims of defeat or stasis in the war are inaccurate, given surveillance reports that show an almost 16% decrease in the death rate from all cancers combined between 1991 and 2006, said Dr. Gapstur. There has been a 1% annual drop in the incidence rate between 1999 and 2006, she noted in her paper.

Mortality rates for men have dropped 21% since their peak in 1990, and mortality rates for women have dropped 12% since their peak in 1991, she said. The overall drop in death rates since 1970 has been about 6%.

The ACS estimates that some 765,000 cancer deaths have been avoided since 1990.

But the decline in mortality is more impressive when taken into context, she said. Since 1970, the U.S. population has grown 30%, and there has been a twofold increase in adults aged 55 years or older. That segment of the population accounts for three-quarters of the cancer incidence.

Incidence rates and the sheer number of people dying from cancer are expected to rise with the aging of the U.S. population. During their lifetime, one in two men and one in three women will be diagnosed with cancer.

The ACS estimates that there were 1.5 million new diagnoses in 2009 and 560,000 deaths.

The billions of dollars spent on public and private research have helped determine that cancer is incredibly variable and individualized. There are more than 100 different anatomical and histological subtypes of the disease. Many of these illnesses have “multiple molecular variants with different [prognoses], clinical features, and susceptibility to treatment,” wrote Dr. Gapstur and Dr. Thun.

There have been successes, chief among them the decline in cigarette smoking that has led to a 40% reduction in cancer mortality for men from the peak rates, largely due to a huge decline in lung cancer deaths.

Early detection through Papanicolaou testing has also reduced the death rate from cervical cancer. Screening technologies hold the same promise for breast and colon cancer, and to a more debatable extent, prostate cancer, according to the authors.

Treatment advances have led to more success stories in pediatric cancers. Dr. Gapstur noted that some 80% of pediatric cancer patients survive 5 years or more. Therapeutic advances have also led to better prognoses for Hodgkin's disease, testicular cancer, and chronic myelogenous leukemia, they said.

Localized cancers also are being treated with greater success, leading to better prognoses. But metastatic cancers and certain, more lethal diseases, such as cancers of the brain, liver, lung, ovary, and pancreas, are still a “critical problem,” the authors wrote.

Death rates are rising for esophageal and liver cancer and melanoma in men, and for pancreatic and liver cancer in women.

These cancers may be obesity related, said Dr. Gapstur, who noted that the obesity epidemic could fuel rising cancer death rates in the future.

Disclosures: Dr. Gapstur and Dr. Thun reported having no conflicts of interest.

WASHINGTON — Due partly to a lack of outpatient access to palliative care, cancer patients are being referred too late in their disease process to benefit from the quality of life–enhancing therapies and supportive care available to them through such programs, according to a new study.

Palliative care referrals “are a little too limited and a little too late,” Dr. David Hui said at a press briefing sponsored by the Journal of the American Medical Association.

He and his colleagues from the University of Texas M.D. Anderson Cancer Center, Houston, and the National Cancer Institute (NCI) in Bethesda, Md., surveyed cancer center executives and palliative care program leaders at 142 cancer centers to determine the state of palliative care in the United States. They compared availability and integration of palliative care at 71 NCI-designated cancer centers with 71 non-NCI centers (JAMA 2010;303:1054-61).

To show just how few patients are referred to palliative care—outpatient services, in particular—Dr. Hui said that there are a median 833 outpatient visits per year at NCI-designated centers, but only a median 14 referrals.

The survey showed how little palliative care has changed in the last 10 years, he said. There is little standardization of care, and less than half of palliative care programs had an outpatient clinic, a specialized palliative care unit, or a hospice.

“The relative lack of outpatient clinics can be a barrier,” said Dr. Hui. Oncology is primarily provided in the outpatient setting. Outpatient palliative care clinics could help integrate palliation earlier in the disease process, he and his colleagues wrote. Delayed referral has been shown to limit the effectiveness of palliation, according to the authors.

And yet, in their survey, the researchers found that the median time from referral to palliation to death was 7 days for inpatient teams and 90 days for outpatient teams.

“Seven days doesn't allow us to do a lot for the patient,” said Dr. Hui at the briefing. While 90 days was better, it was still likely not early enough to provide services that patients needed, he said.

Dr. Hui acknowledged that lack of referrals and delays might be because the term “palliative care” often had a negative connotation for physicians and patients. He said there had been some move to find terminology that indicated supportive, rather than end-of-life care.

Many professional societies have been calling for earlier introduction to palliation, and the American Society of Clinical Oncology (ASCO) is urging full integration of palliative care into comprehensive cancer care by 2020.

The NCI-designated centers were statistically more likely to have a palliative care program, and also to have dedicated outpatient programs. Fifty of the 51 NCI-designated centers had an active palliative care program, while 39 of the 50 non-NCI centers had an active program. NCI centers were also significantly more likely to have a dedicated palliative care physician and a multidisciplinary inpatient consultation team.

According to the palliative care program leaders who were surveyed, palliative care has existed for longer at NCI centers. But the leaders themselves are not necessarily rooted in palliative care. Only a third said they had a professional background in palliative care. Board certification in palliative care was not a requirement for physicians or nurses at most programs, but was more commonly required at NCI centers.

Executives were asked about perceived and real barriers to establishing palliative care programs and to more fully integrating them into the comprehensive cancer care continuum. The most commonly cited reasons were poor reimbursement and limited institutional resources. But the executives also gave their programs high ratings and said that palliative care services were much improved from 5 years ago.

The cancer center executives were also supportive of full integration, more so at NCI-designated centers. Although executives supported the concept, they were less willing to hire more physicians and nurses, or fund more palliative care beds, Dr. Hui said.

For palliative care to grow, more training and educational opportunities are essential, he said. Dr. Hui and his fellow authors noted the “troublesome finding” in their study that less than half of the cancer centers offer palliative care fellowships or mandatory palliative care rotations for medical oncology fellows.

Disclosures: Dr. Hui reported no conflicts of interest.

National Cancer Institute–designated centers were more likely to have a palliative care program.

Source ©Simon Roberts/Getty Images

WASHINGTON — Due partly to a lack of outpatient access to palliative care, cancer patients are being referred too late in their disease process to benefit from the quality of life–enhancing therapies and supportive care available to them through such programs, according to a new study.

Palliative care referrals “are a little too limited and a little too late,” Dr. David Hui said at a press briefing sponsored by the Journal of the American Medical Association.

He and his colleagues from the University of Texas M.D. Anderson Cancer Center, Houston, and the National Cancer Institute (NCI) in Bethesda, Md., surveyed cancer center executives and palliative care program leaders at 142 cancer centers to determine the state of palliative care in the United States. They compared availability and integration of palliative care at 71 NCI-designated cancer centers with 71 non-NCI centers (JAMA 2010;303:1054-61).

To show just how few patients are referred to palliative care—outpatient services, in particular—Dr. Hui said that there are a median 833 outpatient visits per year at NCI-designated centers, but only a median 14 referrals.

The survey showed how little palliative care has changed in the last 10 years, he said. There is little standardization of care, and less than half of palliative care programs had an outpatient clinic, a specialized palliative care unit, or a hospice.

“The relative lack of outpatient clinics can be a barrier,” said Dr. Hui. Oncology is primarily provided in the outpatient setting. Outpatient palliative care clinics could help integrate palliation earlier in the disease process, he and his colleagues wrote. Delayed referral has been shown to limit the effectiveness of palliation, according to the authors.

And yet, in their survey, the researchers found that the median time from referral to palliation to death was 7 days for inpatient teams and 90 days for outpatient teams.

“Seven days doesn't allow us to do a lot for the patient,” said Dr. Hui at the briefing. While 90 days was better, it was still likely not early enough to provide services that patients needed, he said.

Dr. Hui acknowledged that lack of referrals and delays might be because the term “palliative care” often had a negative connotation for physicians and patients. He said there had been some move to find terminology that indicated supportive, rather than end-of-life care.

Many professional societies have been calling for earlier introduction to palliation, and the American Society of Clinical Oncology (ASCO) is urging full integration of palliative care into comprehensive cancer care by 2020.

The NCI-designated centers were statistically more likely to have a palliative care program, and also to have dedicated outpatient programs. Fifty of the 51 NCI-designated centers had an active palliative care program, while 39 of the 50 non-NCI centers had an active program. NCI centers were also significantly more likely to have a dedicated palliative care physician and a multidisciplinary inpatient consultation team.

According to the palliative care program leaders who were surveyed, palliative care has existed for longer at NCI centers. But the leaders themselves are not necessarily rooted in palliative care. Only a third said they had a professional background in palliative care. Board certification in palliative care was not a requirement for physicians or nurses at most programs, but was more commonly required at NCI centers.

Executives were asked about perceived and real barriers to establishing palliative care programs and to more fully integrating them into the comprehensive cancer care continuum. The most commonly cited reasons were poor reimbursement and limited institutional resources. But the executives also gave their programs high ratings and said that palliative care services were much improved from 5 years ago.

The cancer center executives were also supportive of full integration, more so at NCI-designated centers. Although executives supported the concept, they were less willing to hire more physicians and nurses, or fund more palliative care beds, Dr. Hui said.

For palliative care to grow, more training and educational opportunities are essential, he said. Dr. Hui and his fellow authors noted the “troublesome finding” in their study that less than half of the cancer centers offer palliative care fellowships or mandatory palliative care rotations for medical oncology fellows.

Disclosures: Dr. Hui reported no conflicts of interest.

National Cancer Institute–designated centers were more likely to have a palliative care program.

Source ©Simon Roberts/Getty Images

WASHINGTON — Due partly to a lack of outpatient access to palliative care, cancer patients are being referred too late in their disease process to benefit from the quality of life–enhancing therapies and supportive care available to them through such programs, according to a new study.

Palliative care referrals “are a little too limited and a little too late,” Dr. David Hui said at a press briefing sponsored by the Journal of the American Medical Association.

He and his colleagues from the University of Texas M.D. Anderson Cancer Center, Houston, and the National Cancer Institute (NCI) in Bethesda, Md., surveyed cancer center executives and palliative care program leaders at 142 cancer centers to determine the state of palliative care in the United States. They compared availability and integration of palliative care at 71 NCI-designated cancer centers with 71 non-NCI centers (JAMA 2010;303:1054-61).

To show just how few patients are referred to palliative care—outpatient services, in particular—Dr. Hui said that there are a median 833 outpatient visits per year at NCI-designated centers, but only a median 14 referrals.

The survey showed how little palliative care has changed in the last 10 years, he said. There is little standardization of care, and less than half of palliative care programs had an outpatient clinic, a specialized palliative care unit, or a hospice.

“The relative lack of outpatient clinics can be a barrier,” said Dr. Hui. Oncology is primarily provided in the outpatient setting. Outpatient palliative care clinics could help integrate palliation earlier in the disease process, he and his colleagues wrote. Delayed referral has been shown to limit the effectiveness of palliation, according to the authors.

And yet, in their survey, the researchers found that the median time from referral to palliation to death was 7 days for inpatient teams and 90 days for outpatient teams.

“Seven days doesn't allow us to do a lot for the patient,” said Dr. Hui at the briefing. While 90 days was better, it was still likely not early enough to provide services that patients needed, he said.

Dr. Hui acknowledged that lack of referrals and delays might be because the term “palliative care” often had a negative connotation for physicians and patients. He said there had been some move to find terminology that indicated supportive, rather than end-of-life care.

Many professional societies have been calling for earlier introduction to palliation, and the American Society of Clinical Oncology (ASCO) is urging full integration of palliative care into comprehensive cancer care by 2020.

The NCI-designated centers were statistically more likely to have a palliative care program, and also to have dedicated outpatient programs. Fifty of the 51 NCI-designated centers had an active palliative care program, while 39 of the 50 non-NCI centers had an active program. NCI centers were also significantly more likely to have a dedicated palliative care physician and a multidisciplinary inpatient consultation team.

According to the palliative care program leaders who were surveyed, palliative care has existed for longer at NCI centers. But the leaders themselves are not necessarily rooted in palliative care. Only a third said they had a professional background in palliative care. Board certification in palliative care was not a requirement for physicians or nurses at most programs, but was more commonly required at NCI centers.

Executives were asked about perceived and real barriers to establishing palliative care programs and to more fully integrating them into the comprehensive cancer care continuum. The most commonly cited reasons were poor reimbursement and limited institutional resources. But the executives also gave their programs high ratings and said that palliative care services were much improved from 5 years ago.

The cancer center executives were also supportive of full integration, more so at NCI-designated centers. Although executives supported the concept, they were less willing to hire more physicians and nurses, or fund more palliative care beds, Dr. Hui said.

For palliative care to grow, more training and educational opportunities are essential, he said. Dr. Hui and his fellow authors noted the “troublesome finding” in their study that less than half of the cancer centers offer palliative care fellowships or mandatory palliative care rotations for medical oncology fellows.

Disclosures: Dr. Hui reported no conflicts of interest.

National Cancer Institute–designated centers were more likely to have a palliative care program.

Source ©Simon Roberts/Getty Images

WASHINGTON — New federal data show that, among 12-year-olds, inhalants are the most abused drug, exceeding abuse of marijuana, cocaine, and hallucinogens combined.

From 2006 to 2008, almost 7% of 12-year-olds said that they had used an inhalant to get high, according to the National Survey on Drug Use and Health, sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA). That compares with a lifetime use rate of 5% for prescription drugs and 1.4% for marijuana. Alcohol remains the most abused substance overall among 12-year-olds.

Officials from SAMHSA, the National Institute on Drug Abuse, the National Inhalant Prevention Coalition, and the White House Office of National Drug Control Policy gathered in Washington to discuss the inhalant use data, and to urge parents and physicians to educate children about the dangers of “huffing.”

Although federal statistics show a decline over the last decade in the numbers of people first using inhalants, the numbers are still large: 729,000 Americans tried inhalants in 2008, with 489,000 of them in the 12- to-17-year-old age group. That's down from 821,000 total in 1998, but up slightly from 455,000 in 1998 in the younger age group. Officials also said they are concerned that from 2007 to 2008, fewer eighth graders perceived inhalant use as harmful in the Monitoring the Future Survey conducted for NIDA.

Usually, a decline in risk perception is followed by an uptick in usage, officials said at the briefing.

Inhalant use is largely a phenomenon among whites, but large numbers of Hispanic and African Americans also abuse the chemicals. The mean age for first-time inhalant use is 16—a year younger than for any other illicit substance, according to SAMHSA.

SAMHSA Administrator Pamela Hyde said inhalant use often precedes a move to other drugs. And, according to Ashley Upchurch, a 17-year-old recovering inhalant addict who spoke at the briefing, inhalants often are used to enhance the high from other drugs or alcohol.

Inhalants are easy to obtain and can often be abused without detection.

The chemicals can be found in household cleaners, paint thinner, fabric protector, magic markers, glue, hairspray, nail polish remover, and dessert topping sprays, among a myriad of other products. For Ms. Upchurch, the inhalant of choice was a pressurized can used to force dust out of computer keyboards and other electronics.

The chemicals can lead to short-term memory loss, emotional instability, problems with gait and speech, and over the long term, more permanent neurologic and cardiac symptoms. “As risky as inhalants are, many kids don't see the drugs that way,” said Dr. Timothy Condon, deputy director of NIDA. Dr. Condon said warnings about huffing dangers weren't “hype,” adding that “inhalants can be deadly.”

Dr. Jennifer N. Caudle, director of the family medicine section at Sinai Hospital, Baltimore, said there was a phenomenon called sudden sniffing death, in which the inhaler dies from cardiac arrest. Dr. Caudle and her colleagues at the American Osteopathic Association are joining with the Inhalant Prevention Coalition to publicize huffing dangers.

Almost 7% of 12-year-olds said they had used an inhalant to get high.

Source ©David Freund/iStockphoto.com

WASHINGTON — New federal data show that, among 12-year-olds, inhalants are the most abused drug, exceeding abuse of marijuana, cocaine, and hallucinogens combined.

From 2006 to 2008, almost 7% of 12-year-olds said that they had used an inhalant to get high, according to the National Survey on Drug Use and Health, sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA). That compares with a lifetime use rate of 5% for prescription drugs and 1.4% for marijuana. Alcohol remains the most abused substance overall among 12-year-olds.

Officials from SAMHSA, the National Institute on Drug Abuse, the National Inhalant Prevention Coalition, and the White House Office of National Drug Control Policy gathered in Washington to discuss the inhalant use data, and to urge parents and physicians to educate children about the dangers of “huffing.”

Although federal statistics show a decline over the last decade in the numbers of people first using inhalants, the numbers are still large: 729,000 Americans tried inhalants in 2008, with 489,000 of them in the 12- to-17-year-old age group. That's down from 821,000 total in 1998, but up slightly from 455,000 in 1998 in the younger age group. Officials also said they are concerned that from 2007 to 2008, fewer eighth graders perceived inhalant use as harmful in the Monitoring the Future Survey conducted for NIDA.

Usually, a decline in risk perception is followed by an uptick in usage, officials said at the briefing.

Inhalant use is largely a phenomenon among whites, but large numbers of Hispanic and African Americans also abuse the chemicals. The mean age for first-time inhalant use is 16—a year younger than for any other illicit substance, according to SAMHSA.

SAMHSA Administrator Pamela Hyde said inhalant use often precedes a move to other drugs. And, according to Ashley Upchurch, a 17-year-old recovering inhalant addict who spoke at the briefing, inhalants often are used to enhance the high from other drugs or alcohol.

Inhalants are easy to obtain and can often be abused without detection.

The chemicals can be found in household cleaners, paint thinner, fabric protector, magic markers, glue, hairspray, nail polish remover, and dessert topping sprays, among a myriad of other products. For Ms. Upchurch, the inhalant of choice was a pressurized can used to force dust out of computer keyboards and other electronics.

The chemicals can lead to short-term memory loss, emotional instability, problems with gait and speech, and over the long term, more permanent neurologic and cardiac symptoms. “As risky as inhalants are, many kids don't see the drugs that way,” said Dr. Timothy Condon, deputy director of NIDA. Dr. Condon said warnings about huffing dangers weren't “hype,” adding that “inhalants can be deadly.”

Dr. Jennifer N. Caudle, director of the family medicine section at Sinai Hospital, Baltimore, said there was a phenomenon called sudden sniffing death, in which the inhaler dies from cardiac arrest. Dr. Caudle and her colleagues at the American Osteopathic Association are joining with the Inhalant Prevention Coalition to publicize huffing dangers.

Almost 7% of 12-year-olds said they had used an inhalant to get high.

Source ©David Freund/iStockphoto.com

WASHINGTON — New federal data show that, among 12-year-olds, inhalants are the most abused drug, exceeding abuse of marijuana, cocaine, and hallucinogens combined.

From 2006 to 2008, almost 7% of 12-year-olds said that they had used an inhalant to get high, according to the National Survey on Drug Use and Health, sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA). That compares with a lifetime use rate of 5% for prescription drugs and 1.4% for marijuana. Alcohol remains the most abused substance overall among 12-year-olds.

Officials from SAMHSA, the National Institute on Drug Abuse, the National Inhalant Prevention Coalition, and the White House Office of National Drug Control Policy gathered in Washington to discuss the inhalant use data, and to urge parents and physicians to educate children about the dangers of “huffing.”

Although federal statistics show a decline over the last decade in the numbers of people first using inhalants, the numbers are still large: 729,000 Americans tried inhalants in 2008, with 489,000 of them in the 12- to-17-year-old age group. That's down from 821,000 total in 1998, but up slightly from 455,000 in 1998 in the younger age group. Officials also said they are concerned that from 2007 to 2008, fewer eighth graders perceived inhalant use as harmful in the Monitoring the Future Survey conducted for NIDA.

Usually, a decline in risk perception is followed by an uptick in usage, officials said at the briefing.

Inhalant use is largely a phenomenon among whites, but large numbers of Hispanic and African Americans also abuse the chemicals. The mean age for first-time inhalant use is 16—a year younger than for any other illicit substance, according to SAMHSA.

SAMHSA Administrator Pamela Hyde said inhalant use often precedes a move to other drugs. And, according to Ashley Upchurch, a 17-year-old recovering inhalant addict who spoke at the briefing, inhalants often are used to enhance the high from other drugs or alcohol.

Inhalants are easy to obtain and can often be abused without detection.

The chemicals can be found in household cleaners, paint thinner, fabric protector, magic markers, glue, hairspray, nail polish remover, and dessert topping sprays, among a myriad of other products. For Ms. Upchurch, the inhalant of choice was a pressurized can used to force dust out of computer keyboards and other electronics.

The chemicals can lead to short-term memory loss, emotional instability, problems with gait and speech, and over the long term, more permanent neurologic and cardiac symptoms. “As risky as inhalants are, many kids don't see the drugs that way,” said Dr. Timothy Condon, deputy director of NIDA. Dr. Condon said warnings about huffing dangers weren't “hype,” adding that “inhalants can be deadly.”

Dr. Jennifer N. Caudle, director of the family medicine section at Sinai Hospital, Baltimore, said there was a phenomenon called sudden sniffing death, in which the inhaler dies from cardiac arrest. Dr. Caudle and her colleagues at the American Osteopathic Association are joining with the Inhalant Prevention Coalition to publicize huffing dangers.

Almost 7% of 12-year-olds said they had used an inhalant to get high.

Source ©David Freund/iStockphoto.com

Zyprexa Among Stolen Drugs

Thieves broke into an Eli Lilly & Co. warehouse in Enfield, Conn., in mid-March and stole some $75 million worth of pharmaceuticals. The company is working with the Food and Drug Administration (FDA) to recover the products, which included Zyprexa, Cymbalta, Prozac, and Strattera. According to a story in the Wall Street Journal, the theft might have been the biggest ever recorded for pharmaceuticals. Lilly has stopped distributing all of the affected lots. A full listing of the products and the stolen lots can be found on the FDA's Cargo Theft Web site and on Lilly's Web site.

Seeking Parity for Medicare

Sen. John Kerry (D-Mass.) has introduced a bill that would eliminate the 190-day cap on inpatient psychiatric days for Medicare patients. The Medicare Mental Health Inpatient Equity Act (S. 3028) would make coverage for Medicare enrollees on par with that received by people who have private health insurance. There is no lifetime limit on any other Medicare inpatient specialty care. “This arcane and outdated policy runs counter to every battle we've fought to equalize mental health care in this country,” said Sen. Kerry in a statement. The bill is cosponsored by Sen. Olympia Snowe (R-Maine) and supported by 48 national organizations, including the American Association for Geriatric Psychiatry and the American Psychiatric Association.

Psych Drugs for Psych Conditions

The Substance Abuse and Mental Health Administration (SAMHSA) says that a new study indicates that most psychiatric medications are being prescribed for psychiatric conditions. The agency aimed to look into whether antipsychotics, antidepressants, and antianxiety drugs were being used in an appropriate manner. Antipsychotics were prescribed for psychiatric conditions 99% of the time, with the majority for mood disorders and schizophrenia or other psychotic disorders. Antidepressants were prescribed for psychiatric conditions 93% of the time; the nonpsychiatric conditions included headaches, connective tissue disease, and back problems. Antianxiety drugs only were used 72% of the time for psychiatric conditions. They also were prescribed for allergic reactions, back problems, and anxiety related to medical interventions. The study analyzed data from the 2005 National Disease and Therapeutic Index, a survey of 4,000 office-based physicians conducted by IMS Health. It appears in the March issue of CNS Drugs.

HHS Extends Medicaid Relief

The Department of Health and Hu- man Services is giving states a $4.3 billion break on prescription drugs for people who qualify for both Medicare and Medicaid. That's how much less the federal government will charge states through this year for Medicare coverage of drugs for “dual eligibles.” “We believe [this] action will help states as they struggle to maintain Medicaid and other budget priorities in these difficult economic times,” HHS Secretary Kathleen Sebelius said in a statement. The relief comes from the American Recovery and Reinvestment Act, which granted a temporary increase in the amount states receive from the federal government for Medicaid. The new action applies the funding adjustment to the period Oct. 1, 2008, through Dec. 31, 2010. In his proposed budget for 2011, President Obama called for again extending the funding break, through June 30, 2011.

PhRMA Urges Web-Ad Standards

The Pharmaceutical Research and Manufacturers of America urged the FDA to work with drug companies to develop standards for them to communicate online about products. The industry group submitted lengthy comments to the FDA, which has been seeking public input on ways it might regulate advertising and other communication appearing on Web sites and social media. PhRMA said the agency could develop an icon for use on “space-constrained media” to take users directly to FDA-regulated risk and benefit information. Such constrained spaces might include company-sponsored links that come up on search engines.

More Quality Reporting Woes

Medical practice leaders continued to cite multiple administrative challenges with Medicare's Physician Quality Reporting Initiative, according to a survey from the Medical Group Management Association. Specifically, the 429 medical practices surveyed said the process for accessing PQRI feedback reports was “unnecessarily arduous” and that the reports themselves were not satisfactory. According to the MGMA, less than half of the medical practices that attempted to participate in the 2008 PQRI were able to access their 2008 feedback reports. For those that did get the data, it took an average of 9 hours to download the report. Sixty percent of practices that got the reports said they were dissatisfied or very dissatisfied with the presentation of the information, and two-thirds said they were dissatisfied or very dissatisfied with the report's ability to guide them in improving patient care outcomes.

Zyprexa Among Stolen Drugs

Thieves broke into an Eli Lilly & Co. warehouse in Enfield, Conn., in mid-March and stole some $75 million worth of pharmaceuticals. The company is working with the Food and Drug Administration (FDA) to recover the products, which included Zyprexa, Cymbalta, Prozac, and Strattera. According to a story in the Wall Street Journal, the theft might have been the biggest ever recorded for pharmaceuticals. Lilly has stopped distributing all of the affected lots. A full listing of the products and the stolen lots can be found on the FDA's Cargo Theft Web site and on Lilly's Web site.

Seeking Parity for Medicare

Sen. John Kerry (D-Mass.) has introduced a bill that would eliminate the 190-day cap on inpatient psychiatric days for Medicare patients. The Medicare Mental Health Inpatient Equity Act (S. 3028) would make coverage for Medicare enrollees on par with that received by people who have private health insurance. There is no lifetime limit on any other Medicare inpatient specialty care. “This arcane and outdated policy runs counter to every battle we've fought to equalize mental health care in this country,” said Sen. Kerry in a statement. The bill is cosponsored by Sen. Olympia Snowe (R-Maine) and supported by 48 national organizations, including the American Association for Geriatric Psychiatry and the American Psychiatric Association.

Psych Drugs for Psych Conditions

The Substance Abuse and Mental Health Administration (SAMHSA) says that a new study indicates that most psychiatric medications are being prescribed for psychiatric conditions. The agency aimed to look into whether antipsychotics, antidepressants, and antianxiety drugs were being used in an appropriate manner. Antipsychotics were prescribed for psychiatric conditions 99% of the time, with the majority for mood disorders and schizophrenia or other psychotic disorders. Antidepressants were prescribed for psychiatric conditions 93% of the time; the nonpsychiatric conditions included headaches, connective tissue disease, and back problems. Antianxiety drugs only were used 72% of the time for psychiatric conditions. They also were prescribed for allergic reactions, back problems, and anxiety related to medical interventions. The study analyzed data from the 2005 National Disease and Therapeutic Index, a survey of 4,000 office-based physicians conducted by IMS Health. It appears in the March issue of CNS Drugs.

HHS Extends Medicaid Relief

The Department of Health and Hu- man Services is giving states a $4.3 billion break on prescription drugs for people who qualify for both Medicare and Medicaid. That's how much less the federal government will charge states through this year for Medicare coverage of drugs for “dual eligibles.” “We believe [this] action will help states as they struggle to maintain Medicaid and other budget priorities in these difficult economic times,” HHS Secretary Kathleen Sebelius said in a statement. The relief comes from the American Recovery and Reinvestment Act, which granted a temporary increase in the amount states receive from the federal government for Medicaid. The new action applies the funding adjustment to the period Oct. 1, 2008, through Dec. 31, 2010. In his proposed budget for 2011, President Obama called for again extending the funding break, through June 30, 2011.

PhRMA Urges Web-Ad Standards

The Pharmaceutical Research and Manufacturers of America urged the FDA to work with drug companies to develop standards for them to communicate online about products. The industry group submitted lengthy comments to the FDA, which has been seeking public input on ways it might regulate advertising and other communication appearing on Web sites and social media. PhRMA said the agency could develop an icon for use on “space-constrained media” to take users directly to FDA-regulated risk and benefit information. Such constrained spaces might include company-sponsored links that come up on search engines.

More Quality Reporting Woes

Medical practice leaders continued to cite multiple administrative challenges with Medicare's Physician Quality Reporting Initiative, according to a survey from the Medical Group Management Association. Specifically, the 429 medical practices surveyed said the process for accessing PQRI feedback reports was “unnecessarily arduous” and that the reports themselves were not satisfactory. According to the MGMA, less than half of the medical practices that attempted to participate in the 2008 PQRI were able to access their 2008 feedback reports. For those that did get the data, it took an average of 9 hours to download the report. Sixty percent of practices that got the reports said they were dissatisfied or very dissatisfied with the presentation of the information, and two-thirds said they were dissatisfied or very dissatisfied with the report's ability to guide them in improving patient care outcomes.

Zyprexa Among Stolen Drugs

Thieves broke into an Eli Lilly & Co. warehouse in Enfield, Conn., in mid-March and stole some $75 million worth of pharmaceuticals. The company is working with the Food and Drug Administration (FDA) to recover the products, which included Zyprexa, Cymbalta, Prozac, and Strattera. According to a story in the Wall Street Journal, the theft might have been the biggest ever recorded for pharmaceuticals. Lilly has stopped distributing all of the affected lots. A full listing of the products and the stolen lots can be found on the FDA's Cargo Theft Web site and on Lilly's Web site.

Seeking Parity for Medicare

Sen. John Kerry (D-Mass.) has introduced a bill that would eliminate the 190-day cap on inpatient psychiatric days for Medicare patients. The Medicare Mental Health Inpatient Equity Act (S. 3028) would make coverage for Medicare enrollees on par with that received by people who have private health insurance. There is no lifetime limit on any other Medicare inpatient specialty care. “This arcane and outdated policy runs counter to every battle we've fought to equalize mental health care in this country,” said Sen. Kerry in a statement. The bill is cosponsored by Sen. Olympia Snowe (R-Maine) and supported by 48 national organizations, including the American Association for Geriatric Psychiatry and the American Psychiatric Association.

Psych Drugs for Psych Conditions

The Substance Abuse and Mental Health Administration (SAMHSA) says that a new study indicates that most psychiatric medications are being prescribed for psychiatric conditions. The agency aimed to look into whether antipsychotics, antidepressants, and antianxiety drugs were being used in an appropriate manner. Antipsychotics were prescribed for psychiatric conditions 99% of the time, with the majority for mood disorders and schizophrenia or other psychotic disorders. Antidepressants were prescribed for psychiatric conditions 93% of the time; the nonpsychiatric conditions included headaches, connective tissue disease, and back problems. Antianxiety drugs only were used 72% of the time for psychiatric conditions. They also were prescribed for allergic reactions, back problems, and anxiety related to medical interventions. The study analyzed data from the 2005 National Disease and Therapeutic Index, a survey of 4,000 office-based physicians conducted by IMS Health. It appears in the March issue of CNS Drugs.

HHS Extends Medicaid Relief

The Department of Health and Hu- man Services is giving states a $4.3 billion break on prescription drugs for people who qualify for both Medicare and Medicaid. That's how much less the federal government will charge states through this year for Medicare coverage of drugs for “dual eligibles.” “We believe [this] action will help states as they struggle to maintain Medicaid and other budget priorities in these difficult economic times,” HHS Secretary Kathleen Sebelius said in a statement. The relief comes from the American Recovery and Reinvestment Act, which granted a temporary increase in the amount states receive from the federal government for Medicaid. The new action applies the funding adjustment to the period Oct. 1, 2008, through Dec. 31, 2010. In his proposed budget for 2011, President Obama called for again extending the funding break, through June 30, 2011.

PhRMA Urges Web-Ad Standards

The Pharmaceutical Research and Manufacturers of America urged the FDA to work with drug companies to develop standards for them to communicate online about products. The industry group submitted lengthy comments to the FDA, which has been seeking public input on ways it might regulate advertising and other communication appearing on Web sites and social media. PhRMA said the agency could develop an icon for use on “space-constrained media” to take users directly to FDA-regulated risk and benefit information. Such constrained spaces might include company-sponsored links that come up on search engines.

More Quality Reporting Woes

Medical practice leaders continued to cite multiple administrative challenges with Medicare's Physician Quality Reporting Initiative, according to a survey from the Medical Group Management Association. Specifically, the 429 medical practices surveyed said the process for accessing PQRI feedback reports was “unnecessarily arduous” and that the reports themselves were not satisfactory. According to the MGMA, less than half of the medical practices that attempted to participate in the 2008 PQRI were able to access their 2008 feedback reports. For those that did get the data, it took an average of 9 hours to download the report. Sixty percent of practices that got the reports said they were dissatisfied or very dissatisfied with the presentation of the information, and two-thirds said they were dissatisfied or very dissatisfied with the report's ability to guide them in improving patient care outcomes.