Alicia Ault

$13 Million Accutane Verdict

Hoffmann-La Roche has been ordered to pay $13 million to three plaintiffs who claimed that they developed inflammatory bowel disease from taking Accutane (isotretinoin). The New Jersey State Superior Court jury agreed that Roche did not provide adequate warning and awarded damages to the three patients. Their attorneys, at New York-based Seeger Weiss, said that the three developed Crohn's disease, ulcerative colitis, or another form of IBD while taking the drug or shortly afterward. "This is an important outcome and consistent with the recognition by the medical community that Accutane is a trigger for IBD," plaintiffs' attorney David Buchanan said in a statement. Roche said in its own statement that it was disappointed in the jury's decision and that it planned to appeal. The company added that even though Accutane labeling "has contained a warning about IBD for more than 20 years … there is no reliable scientific evidence that Accutane actually causes IBD."

FDA Sunscreen Rules Being Sought

The Skin Cancer Foundation, Ciba Corp., Fallene Ltd., and Rep. Nita Lowey (R-N.Y.) join a growing list of organizations, sunblock manufacturers, and lawmakers calling on the Food and Drug Administration to finalize sunscreen standards. "The American public is underprotected and operating with a false sense of security in the face of the life-threatening dangers of sun exposure," Rep. Lowey said at a briefing. The two companies and several dermatologists then submitted a Citizen's Petition to the FDA seeking final standards and approval of sunscreen ingredients that protect against UVA—specifically, Ciba's Tinosorb. Last summer, Sen. Christopher Dodd (D-Conn.) and Sen. Jack Reed (D-R.I.) introduced a bill to require final sunscreen rules by next month. The legislation is supported by the American Cancer Society, the Melanoma Research Foundation, Citizens for Sun Protection, the Environmental Working Group, and sunscreen manufacturers Banana Boat and Hawaiian Tropic. Connecticut Attorney General Richard Blumenthal also has petitioned the FDA to implement standards.

Benzoyl Peroxide Recall

CSI USA Inc. is recalling all lots of its over-the-counter 10% benzoyl peroxide acne cream because it's contaminated with Burkholderia cepacia bacteria. The company and the FDA said that consumers—especially those who have cuts, scrapes, or rashes, or who have weakened immune systems—should stop using the products because of infection risk. The brands are DG Maximum Strength Acne Medicated Gel (sold at Dollar General), Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication (sold at Kroger), and Equate: Medicated Acne Gel (sold at Wal-Mart). There has been no report of an adverse event so far. More information is available at

www.acnemedrecall.com

MedPAC Calls for Disclosure

Congress should pass legislation to require drug, device, and medical supply makers and distributors, along with hospitals, to disclose their financial ties to physicians and physician groups, the Medicare Payment Advisory Commission has decided. The companies also should be required to disclose financial relationships with pharmacies, pharmacists, health plans, pharmacy benefit managers, hospitals, medical schools, continuing medical education organizations, patient organizations, and professional organizations. MedPAC said it will urge Congress to require drug manufacturers to post to a Web site all details about free drug samples given to providers. MedPAC advises Congress on Medicare issues, but lawmakers are not required to implement the commission's recommendations.

Pharmaceutical Sales Outlook

The U.S. pharmaceutical market is expected to grow 1%–2% in 2009, resulting in sales of $292 billion to $302 billion, according to analysis from the health care market research firm IMS Health. This latest projection is down from the 2%–3% increase projected by IMS earlier this year and reflects the expected impact of patent expirations, fewer launches of new products, and the slowing U.S. economy. Worldwide pharmaceutical sales are expected to grow 4.5%–5.5% in 2009, similar to growth this year. "The market will continue to contend with a number of forces—among them the shift in growth from developed countries to emerging ones, specialist-driven products playing a larger role, blockbuster drugs losing patent protection, and the rising influence of regulators and payers on health care decisions," Murray Aitken, a senior vice president at IMS, said in a statement.

$13 Million Accutane Verdict

Hoffmann-La Roche has been ordered to pay $13 million to three plaintiffs who claimed that they developed inflammatory bowel disease from taking Accutane (isotretinoin). The New Jersey State Superior Court jury agreed that Roche did not provide adequate warning and awarded damages to the three patients. Their attorneys, at New York-based Seeger Weiss, said that the three developed Crohn's disease, ulcerative colitis, or another form of IBD while taking the drug or shortly afterward. "This is an important outcome and consistent with the recognition by the medical community that Accutane is a trigger for IBD," plaintiffs' attorney David Buchanan said in a statement. Roche said in its own statement that it was disappointed in the jury's decision and that it planned to appeal. The company added that even though Accutane labeling "has contained a warning about IBD for more than 20 years … there is no reliable scientific evidence that Accutane actually causes IBD."

FDA Sunscreen Rules Being Sought

The Skin Cancer Foundation, Ciba Corp., Fallene Ltd., and Rep. Nita Lowey (R-N.Y.) join a growing list of organizations, sunblock manufacturers, and lawmakers calling on the Food and Drug Administration to finalize sunscreen standards. "The American public is underprotected and operating with a false sense of security in the face of the life-threatening dangers of sun exposure," Rep. Lowey said at a briefing. The two companies and several dermatologists then submitted a Citizen's Petition to the FDA seeking final standards and approval of sunscreen ingredients that protect against UVA—specifically, Ciba's Tinosorb. Last summer, Sen. Christopher Dodd (D-Conn.) and Sen. Jack Reed (D-R.I.) introduced a bill to require final sunscreen rules by next month. The legislation is supported by the American Cancer Society, the Melanoma Research Foundation, Citizens for Sun Protection, the Environmental Working Group, and sunscreen manufacturers Banana Boat and Hawaiian Tropic. Connecticut Attorney General Richard Blumenthal also has petitioned the FDA to implement standards.

Benzoyl Peroxide Recall

CSI USA Inc. is recalling all lots of its over-the-counter 10% benzoyl peroxide acne cream because it's contaminated with Burkholderia cepacia bacteria. The company and the FDA said that consumers—especially those who have cuts, scrapes, or rashes, or who have weakened immune systems—should stop using the products because of infection risk. The brands are DG Maximum Strength Acne Medicated Gel (sold at Dollar General), Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication (sold at Kroger), and Equate: Medicated Acne Gel (sold at Wal-Mart). There has been no report of an adverse event so far. More information is available at

www.acnemedrecall.com

MedPAC Calls for Disclosure

Congress should pass legislation to require drug, device, and medical supply makers and distributors, along with hospitals, to disclose their financial ties to physicians and physician groups, the Medicare Payment Advisory Commission has decided. The companies also should be required to disclose financial relationships with pharmacies, pharmacists, health plans, pharmacy benefit managers, hospitals, medical schools, continuing medical education organizations, patient organizations, and professional organizations. MedPAC said it will urge Congress to require drug manufacturers to post to a Web site all details about free drug samples given to providers. MedPAC advises Congress on Medicare issues, but lawmakers are not required to implement the commission's recommendations.

Pharmaceutical Sales Outlook

The U.S. pharmaceutical market is expected to grow 1%–2% in 2009, resulting in sales of $292 billion to $302 billion, according to analysis from the health care market research firm IMS Health. This latest projection is down from the 2%–3% increase projected by IMS earlier this year and reflects the expected impact of patent expirations, fewer launches of new products, and the slowing U.S. economy. Worldwide pharmaceutical sales are expected to grow 4.5%–5.5% in 2009, similar to growth this year. "The market will continue to contend with a number of forces—among them the shift in growth from developed countries to emerging ones, specialist-driven products playing a larger role, blockbuster drugs losing patent protection, and the rising influence of regulators and payers on health care decisions," Murray Aitken, a senior vice president at IMS, said in a statement.

$13 Million Accutane Verdict

Hoffmann-La Roche has been ordered to pay $13 million to three plaintiffs who claimed that they developed inflammatory bowel disease from taking Accutane (isotretinoin). The New Jersey State Superior Court jury agreed that Roche did not provide adequate warning and awarded damages to the three patients. Their attorneys, at New York-based Seeger Weiss, said that the three developed Crohn's disease, ulcerative colitis, or another form of IBD while taking the drug or shortly afterward. "This is an important outcome and consistent with the recognition by the medical community that Accutane is a trigger for IBD," plaintiffs' attorney David Buchanan said in a statement. Roche said in its own statement that it was disappointed in the jury's decision and that it planned to appeal. The company added that even though Accutane labeling "has contained a warning about IBD for more than 20 years … there is no reliable scientific evidence that Accutane actually causes IBD."

FDA Sunscreen Rules Being Sought

The Skin Cancer Foundation, Ciba Corp., Fallene Ltd., and Rep. Nita Lowey (R-N.Y.) join a growing list of organizations, sunblock manufacturers, and lawmakers calling on the Food and Drug Administration to finalize sunscreen standards. "The American public is underprotected and operating with a false sense of security in the face of the life-threatening dangers of sun exposure," Rep. Lowey said at a briefing. The two companies and several dermatologists then submitted a Citizen's Petition to the FDA seeking final standards and approval of sunscreen ingredients that protect against UVA—specifically, Ciba's Tinosorb. Last summer, Sen. Christopher Dodd (D-Conn.) and Sen. Jack Reed (D-R.I.) introduced a bill to require final sunscreen rules by next month. The legislation is supported by the American Cancer Society, the Melanoma Research Foundation, Citizens for Sun Protection, the Environmental Working Group, and sunscreen manufacturers Banana Boat and Hawaiian Tropic. Connecticut Attorney General Richard Blumenthal also has petitioned the FDA to implement standards.

Benzoyl Peroxide Recall

CSI USA Inc. is recalling all lots of its over-the-counter 10% benzoyl peroxide acne cream because it's contaminated with Burkholderia cepacia bacteria. The company and the FDA said that consumers—especially those who have cuts, scrapes, or rashes, or who have weakened immune systems—should stop using the products because of infection risk. The brands are DG Maximum Strength Acne Medicated Gel (sold at Dollar General), Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication (sold at Kroger), and Equate: Medicated Acne Gel (sold at Wal-Mart). There has been no report of an adverse event so far. More information is available at

www.acnemedrecall.com

MedPAC Calls for Disclosure

Congress should pass legislation to require drug, device, and medical supply makers and distributors, along with hospitals, to disclose their financial ties to physicians and physician groups, the Medicare Payment Advisory Commission has decided. The companies also should be required to disclose financial relationships with pharmacies, pharmacists, health plans, pharmacy benefit managers, hospitals, medical schools, continuing medical education organizations, patient organizations, and professional organizations. MedPAC said it will urge Congress to require drug manufacturers to post to a Web site all details about free drug samples given to providers. MedPAC advises Congress on Medicare issues, but lawmakers are not required to implement the commission's recommendations.

Pharmaceutical Sales Outlook

The U.S. pharmaceutical market is expected to grow 1%–2% in 2009, resulting in sales of $292 billion to $302 billion, according to analysis from the health care market research firm IMS Health. This latest projection is down from the 2%–3% increase projected by IMS earlier this year and reflects the expected impact of patent expirations, fewer launches of new products, and the slowing U.S. economy. Worldwide pharmaceutical sales are expected to grow 4.5%–5.5% in 2009, similar to growth this year. "The market will continue to contend with a number of forces—among them the shift in growth from developed countries to emerging ones, specialist-driven products playing a larger role, blockbuster drugs losing patent protection, and the rising influence of regulators and payers on health care decisions," Murray Aitken, a senior vice president at IMS, said in a statement.

WASHINGTON — Combat conditions in Iraq and Afghanistan that foster posttraumatic stress disorder are creating a need for interventions among returning veterans to prevent substance abuse that can emerge as a coping mechanism, according to mental health experts.

Combat is a known stressor with about 15% of Vietnam War veterans still experiencing PTSD 30 years after that conflict officially ended. Vietnam veterans account for some 500,000 current PTSD cases in the United States, said Terence Keane, Ph.D., director of the behavioral science division at the National Center for Posttraumatic Stress Disorder at the VA Boston Healthcare System.

Studies have estimated that 15%-30% of veterans of Iraq and Afghanistan have mental health issues, including PTSD. Almost 2 million people have been deployed to those two theaters; there have been more than 4,500 deaths and 35,000 injuries. About 164,000 personnel are currently deployed, according to John Rodolico, Ph.D., of the psychology department at Harvard Medical School, Boston, and a former U.S. marine who spoke at the Association for Medical Education and Research in Substance Abuse annual meeting, which was also sponsored by Brown Medical School.

Dr. Keane and a colleague, D.H. Barlow, proposed an etiologic model of the many factors that contribute to the condition.

The model posits that a genetic vulnerability combined with a biologic vulnerability in the face of trauma creates an alarm, which then turns into a kind of permanent alarm in the face of new traumas. The anxious apprehension that an event will happen again leads to adverse coping mechanisms such as drinking and drug taking.

Specific aspects of the Iraq and Afghanistan conflicts and the makeup of the current military personnel are contributing to an increase of PTSD cases, said Dr. Keane and Dr. Rodolico. Half the military personnel are reservists, which means that they return to the civilian world instead of a military base, where they might be met with more understanding of their combat experiences.

Soldiers in the Iraq and Afghanistan conflicts have multiple tours of duty. Many studies have shown that increased exposure to combat gives rise to a greater likelihood of occurrence of PTSD, said Dr. Keane. Improvised explosive devices (IEDs) and hidden enemies pose constant threats, he said. The summer and winter temperatures are extreme. Many soldiers feel a sense of shame from the treatment of prisoners at Abu Ghraib and Guantanamo Bay, Cuba, said Dr. Keane.

Effective therapies for PTSD are available but veterans aren't getting access to them, he said. Some are turning to drugs and alcohol, but the problem has not yet been quantified, said Dr. Keane. One challenge for mental health professionals in the combat context is to determine how traumatic brain injury, chronic pain, and addictions affect PTSD and its treatment, said Dr. Keane.

After the media reported on the lack of mental health treatment for veterans, the military began an operation in 2005 to increase access and awareness, said Dr. Rodolico. The Department of Defense established mental health clinics in base areas of Iraq and Afghanistan, and prescribers were given a whole host of new drugs to offer patients. But the professionals still weren't reaching soldiers where they were fighting, he said.

The mental health providers began accompanying soldiers on missions—a tough sell for commanders, who didn't want anyone slowing down the missions, or perhaps, removing soldiers from combat, said Dr. Rodolico. But the mental health teams were able to convince the military command of the benefits of interventions.

During Dr. Rodolico's time in Iraq, 98% of soldiers who were seen by mental health professionals were returned to active duty. The most common problems were combat stress reactions such as sleep disturbances, fatigue, concentration disturbances, anxiety, dysphoria, and emotional numbing, he said.

It will be interesting to study how soldiers are coping after their return, said Dr. Rodolico. Alcohol abuse is not common in the combat theater—or at least not in the open—as it supposedly is a “dry” operation. There are cultural and religious prescriptions against alcohol in those countries, and there is a general order forbidding drinking in Iraq and Afghanistan, said Dr. Rodolico.

WASHINGTON — Combat conditions in Iraq and Afghanistan that foster posttraumatic stress disorder are creating a need for interventions among returning veterans to prevent substance abuse that can emerge as a coping mechanism, according to mental health experts.

Combat is a known stressor with about 15% of Vietnam War veterans still experiencing PTSD 30 years after that conflict officially ended. Vietnam veterans account for some 500,000 current PTSD cases in the United States, said Terence Keane, Ph.D., director of the behavioral science division at the National Center for Posttraumatic Stress Disorder at the VA Boston Healthcare System.

Studies have estimated that 15%-30% of veterans of Iraq and Afghanistan have mental health issues, including PTSD. Almost 2 million people have been deployed to those two theaters; there have been more than 4,500 deaths and 35,000 injuries. About 164,000 personnel are currently deployed, according to John Rodolico, Ph.D., of the psychology department at Harvard Medical School, Boston, and a former U.S. marine who spoke at the Association for Medical Education and Research in Substance Abuse annual meeting, which was also sponsored by Brown Medical School.

Dr. Keane and a colleague, D.H. Barlow, proposed an etiologic model of the many factors that contribute to the condition.

The model posits that a genetic vulnerability combined with a biologic vulnerability in the face of trauma creates an alarm, which then turns into a kind of permanent alarm in the face of new traumas. The anxious apprehension that an event will happen again leads to adverse coping mechanisms such as drinking and drug taking.

Specific aspects of the Iraq and Afghanistan conflicts and the makeup of the current military personnel are contributing to an increase of PTSD cases, said Dr. Keane and Dr. Rodolico. Half the military personnel are reservists, which means that they return to the civilian world instead of a military base, where they might be met with more understanding of their combat experiences.

Soldiers in the Iraq and Afghanistan conflicts have multiple tours of duty. Many studies have shown that increased exposure to combat gives rise to a greater likelihood of occurrence of PTSD, said Dr. Keane. Improvised explosive devices (IEDs) and hidden enemies pose constant threats, he said. The summer and winter temperatures are extreme. Many soldiers feel a sense of shame from the treatment of prisoners at Abu Ghraib and Guantanamo Bay, Cuba, said Dr. Keane.

Effective therapies for PTSD are available but veterans aren't getting access to them, he said. Some are turning to drugs and alcohol, but the problem has not yet been quantified, said Dr. Keane. One challenge for mental health professionals in the combat context is to determine how traumatic brain injury, chronic pain, and addictions affect PTSD and its treatment, said Dr. Keane.

After the media reported on the lack of mental health treatment for veterans, the military began an operation in 2005 to increase access and awareness, said Dr. Rodolico. The Department of Defense established mental health clinics in base areas of Iraq and Afghanistan, and prescribers were given a whole host of new drugs to offer patients. But the professionals still weren't reaching soldiers where they were fighting, he said.

The mental health providers began accompanying soldiers on missions—a tough sell for commanders, who didn't want anyone slowing down the missions, or perhaps, removing soldiers from combat, said Dr. Rodolico. But the mental health teams were able to convince the military command of the benefits of interventions.

During Dr. Rodolico's time in Iraq, 98% of soldiers who were seen by mental health professionals were returned to active duty. The most common problems were combat stress reactions such as sleep disturbances, fatigue, concentration disturbances, anxiety, dysphoria, and emotional numbing, he said.

It will be interesting to study how soldiers are coping after their return, said Dr. Rodolico. Alcohol abuse is not common in the combat theater—or at least not in the open—as it supposedly is a “dry” operation. There are cultural and religious prescriptions against alcohol in those countries, and there is a general order forbidding drinking in Iraq and Afghanistan, said Dr. Rodolico.

WASHINGTON — Combat conditions in Iraq and Afghanistan that foster posttraumatic stress disorder are creating a need for interventions among returning veterans to prevent substance abuse that can emerge as a coping mechanism, according to mental health experts.

Combat is a known stressor with about 15% of Vietnam War veterans still experiencing PTSD 30 years after that conflict officially ended. Vietnam veterans account for some 500,000 current PTSD cases in the United States, said Terence Keane, Ph.D., director of the behavioral science division at the National Center for Posttraumatic Stress Disorder at the VA Boston Healthcare System.

Studies have estimated that 15%-30% of veterans of Iraq and Afghanistan have mental health issues, including PTSD. Almost 2 million people have been deployed to those two theaters; there have been more than 4,500 deaths and 35,000 injuries. About 164,000 personnel are currently deployed, according to John Rodolico, Ph.D., of the psychology department at Harvard Medical School, Boston, and a former U.S. marine who spoke at the Association for Medical Education and Research in Substance Abuse annual meeting, which was also sponsored by Brown Medical School.

Dr. Keane and a colleague, D.H. Barlow, proposed an etiologic model of the many factors that contribute to the condition.

The model posits that a genetic vulnerability combined with a biologic vulnerability in the face of trauma creates an alarm, which then turns into a kind of permanent alarm in the face of new traumas. The anxious apprehension that an event will happen again leads to adverse coping mechanisms such as drinking and drug taking.

Specific aspects of the Iraq and Afghanistan conflicts and the makeup of the current military personnel are contributing to an increase of PTSD cases, said Dr. Keane and Dr. Rodolico. Half the military personnel are reservists, which means that they return to the civilian world instead of a military base, where they might be met with more understanding of their combat experiences.

Soldiers in the Iraq and Afghanistan conflicts have multiple tours of duty. Many studies have shown that increased exposure to combat gives rise to a greater likelihood of occurrence of PTSD, said Dr. Keane. Improvised explosive devices (IEDs) and hidden enemies pose constant threats, he said. The summer and winter temperatures are extreme. Many soldiers feel a sense of shame from the treatment of prisoners at Abu Ghraib and Guantanamo Bay, Cuba, said Dr. Keane.

Effective therapies for PTSD are available but veterans aren't getting access to them, he said. Some are turning to drugs and alcohol, but the problem has not yet been quantified, said Dr. Keane. One challenge for mental health professionals in the combat context is to determine how traumatic brain injury, chronic pain, and addictions affect PTSD and its treatment, said Dr. Keane.

After the media reported on the lack of mental health treatment for veterans, the military began an operation in 2005 to increase access and awareness, said Dr. Rodolico. The Department of Defense established mental health clinics in base areas of Iraq and Afghanistan, and prescribers were given a whole host of new drugs to offer patients. But the professionals still weren't reaching soldiers where they were fighting, he said.

The mental health providers began accompanying soldiers on missions—a tough sell for commanders, who didn't want anyone slowing down the missions, or perhaps, removing soldiers from combat, said Dr. Rodolico. But the mental health teams were able to convince the military command of the benefits of interventions.

During Dr. Rodolico's time in Iraq, 98% of soldiers who were seen by mental health professionals were returned to active duty. The most common problems were combat stress reactions such as sleep disturbances, fatigue, concentration disturbances, anxiety, dysphoria, and emotional numbing, he said.

It will be interesting to study how soldiers are coping after their return, said Dr. Rodolico. Alcohol abuse is not common in the combat theater—or at least not in the open—as it supposedly is a “dry” operation. There are cultural and religious prescriptions against alcohol in those countries, and there is a general order forbidding drinking in Iraq and Afghanistan, said Dr. Rodolico.

Vytorin Marketing Investigated

Merck and Schering-Plough's problems with Vytorin are continuing. The companies had already disclosed that marketing of the cholesterol-lowering drug was being investigated by the New York, New Jersey, and Connecticut attorneys general. Now, in its third-quarter filing with the Securities and Exchange Commission, Merck says that it has received inquiries from 35 state attorneys general looking into whether Vytorin marketing violated state consumer protection laws. In addition, Merck has received a letter from the Department of Justice stating that it, too, is investigating the promotion of Vytorin, which contains ezetimibe and simvastatin, to Medicare beneficiaries. The companies are cooperating with the investigations, according to the filing, which also noted that 140 civil class action lawsuits have been filed.

Smoke-Free Law Cuts MI Deaths

Heart attack deaths have been reduced by as many as 600 in Massachusetts in each of the 4 years since smoking was banned in restaurants and bars, according to an analysis by the state department of public health and the Harvard School of Public Health, Boston. Data were analyzed on heart attack deaths from 1999 to 2006 for 351 Massachusetts cities and towns. In areas with weak laws or no laws before the state law was enacted in 2004, there was a relatively slow decrease in deaths. After the law was enacted, there was a much sharper decrease. Areas with strong laws already had seen a fairly big decline in deaths, according to the study. The researchers concluded that reduced exposure to secondhand smoke had a “significant effect in reducing heart attack deaths.”

Inquiries Into AtriCure

West Chester, Ohio-based AtriCure has revealed that the Department of Justice is investigating its marketing practices. The company said that it received a letter in late October stating that Justice is looking into whether AtriCure illegally marketed its surgical ablation system off-label to treat atrial fibrillation. The federal agency is also investigating whether the company committed fraud by urging hospitals to use incorrect billing codes for the ablation procedures. AtriCure said in a statement that it intended to cooperate with the investigation.

Unspecified Chest Pain in Women

Women are diagnosed and hospitalized for unspecified chest pain more often than men, according to the Agency for Healthcare Research and Quality. In 2006, 379,000 men were admitted for unspecified chest pain, and 477,000 women were hospitalized with the same diagnosis. Interestingly, however, men are admitted much more frequently for coronary artery disease—747,000 in 2006, compared with 451,000 women. Men also account for 60% of admissions for heart attacks. Admissions for heart failure and irregular heart beat are similar for both genders. The data come from the 2006 Nationwide Inpatient Sample.

Resuscitation Practices Ineffective

An overwhelming majority of emergency physicians believe that resuscitation practices in the United States are not very effective, according to a survey released by the American College of Emergency Physicians. In addition, more than half of emergency physicians surveyed believe that poor survival rates from sudden cardiac arrest are related to the aging population, while one-quarter of respondents said that obesity has contributed most to poor survival rates. Increased bystander CPR, faster patient-to-doctor time, improved data collection and sharing, and greater use of technology all are critical to improving resuscitation, the survey concluded. “It is necessary for communities to encourage more CPR trainings, offer more access to a broader range of critical life-saving technologies, and report sudden cardiac arrest cases more consistently,” said ACEP President Nick Jouriles.

Poor Marks for PQRI

Most physicians who participated in Medicare's 2007 Physician Quality Reporting Initiative found the program at least moderately difficult, according to a survey conducted by the American Medical Association. Only 22% of respondents to the online survey were able to successfully download their feedback report. Of those who downloaded the report, less than half found it helpful. In an open-ended question about their experience with the program, nearly all the responses were negatives, according to the association. The results are based on responses from 408 physicians. The AMA plans to work with Congress and the administration to alter the program to provide physicians with interim feedback reports an appeals process. A recent survey from the Medical Group Management Association reported similar problems in accessing feedback reports.

Vytorin Marketing Investigated

Merck and Schering-Plough's problems with Vytorin are continuing. The companies had already disclosed that marketing of the cholesterol-lowering drug was being investigated by the New York, New Jersey, and Connecticut attorneys general. Now, in its third-quarter filing with the Securities and Exchange Commission, Merck says that it has received inquiries from 35 state attorneys general looking into whether Vytorin marketing violated state consumer protection laws. In addition, Merck has received a letter from the Department of Justice stating that it, too, is investigating the promotion of Vytorin, which contains ezetimibe and simvastatin, to Medicare beneficiaries. The companies are cooperating with the investigations, according to the filing, which also noted that 140 civil class action lawsuits have been filed.

Smoke-Free Law Cuts MI Deaths

Heart attack deaths have been reduced by as many as 600 in Massachusetts in each of the 4 years since smoking was banned in restaurants and bars, according to an analysis by the state department of public health and the Harvard School of Public Health, Boston. Data were analyzed on heart attack deaths from 1999 to 2006 for 351 Massachusetts cities and towns. In areas with weak laws or no laws before the state law was enacted in 2004, there was a relatively slow decrease in deaths. After the law was enacted, there was a much sharper decrease. Areas with strong laws already had seen a fairly big decline in deaths, according to the study. The researchers concluded that reduced exposure to secondhand smoke had a “significant effect in reducing heart attack deaths.”

Inquiries Into AtriCure

West Chester, Ohio-based AtriCure has revealed that the Department of Justice is investigating its marketing practices. The company said that it received a letter in late October stating that Justice is looking into whether AtriCure illegally marketed its surgical ablation system off-label to treat atrial fibrillation. The federal agency is also investigating whether the company committed fraud by urging hospitals to use incorrect billing codes for the ablation procedures. AtriCure said in a statement that it intended to cooperate with the investigation.

Unspecified Chest Pain in Women

Women are diagnosed and hospitalized for unspecified chest pain more often than men, according to the Agency for Healthcare Research and Quality. In 2006, 379,000 men were admitted for unspecified chest pain, and 477,000 women were hospitalized with the same diagnosis. Interestingly, however, men are admitted much more frequently for coronary artery disease—747,000 in 2006, compared with 451,000 women. Men also account for 60% of admissions for heart attacks. Admissions for heart failure and irregular heart beat are similar for both genders. The data come from the 2006 Nationwide Inpatient Sample.

Resuscitation Practices Ineffective

An overwhelming majority of emergency physicians believe that resuscitation practices in the United States are not very effective, according to a survey released by the American College of Emergency Physicians. In addition, more than half of emergency physicians surveyed believe that poor survival rates from sudden cardiac arrest are related to the aging population, while one-quarter of respondents said that obesity has contributed most to poor survival rates. Increased bystander CPR, faster patient-to-doctor time, improved data collection and sharing, and greater use of technology all are critical to improving resuscitation, the survey concluded. “It is necessary for communities to encourage more CPR trainings, offer more access to a broader range of critical life-saving technologies, and report sudden cardiac arrest cases more consistently,” said ACEP President Nick Jouriles.

Poor Marks for PQRI

Most physicians who participated in Medicare's 2007 Physician Quality Reporting Initiative found the program at least moderately difficult, according to a survey conducted by the American Medical Association. Only 22% of respondents to the online survey were able to successfully download their feedback report. Of those who downloaded the report, less than half found it helpful. In an open-ended question about their experience with the program, nearly all the responses were negatives, according to the association. The results are based on responses from 408 physicians. The AMA plans to work with Congress and the administration to alter the program to provide physicians with interim feedback reports an appeals process. A recent survey from the Medical Group Management Association reported similar problems in accessing feedback reports.

Vytorin Marketing Investigated

Merck and Schering-Plough's problems with Vytorin are continuing. The companies had already disclosed that marketing of the cholesterol-lowering drug was being investigated by the New York, New Jersey, and Connecticut attorneys general. Now, in its third-quarter filing with the Securities and Exchange Commission, Merck says that it has received inquiries from 35 state attorneys general looking into whether Vytorin marketing violated state consumer protection laws. In addition, Merck has received a letter from the Department of Justice stating that it, too, is investigating the promotion of Vytorin, which contains ezetimibe and simvastatin, to Medicare beneficiaries. The companies are cooperating with the investigations, according to the filing, which also noted that 140 civil class action lawsuits have been filed.

Smoke-Free Law Cuts MI Deaths

Heart attack deaths have been reduced by as many as 600 in Massachusetts in each of the 4 years since smoking was banned in restaurants and bars, according to an analysis by the state department of public health and the Harvard School of Public Health, Boston. Data were analyzed on heart attack deaths from 1999 to 2006 for 351 Massachusetts cities and towns. In areas with weak laws or no laws before the state law was enacted in 2004, there was a relatively slow decrease in deaths. After the law was enacted, there was a much sharper decrease. Areas with strong laws already had seen a fairly big decline in deaths, according to the study. The researchers concluded that reduced exposure to secondhand smoke had a “significant effect in reducing heart attack deaths.”

Inquiries Into AtriCure

West Chester, Ohio-based AtriCure has revealed that the Department of Justice is investigating its marketing practices. The company said that it received a letter in late October stating that Justice is looking into whether AtriCure illegally marketed its surgical ablation system off-label to treat atrial fibrillation. The federal agency is also investigating whether the company committed fraud by urging hospitals to use incorrect billing codes for the ablation procedures. AtriCure said in a statement that it intended to cooperate with the investigation.

Unspecified Chest Pain in Women

Women are diagnosed and hospitalized for unspecified chest pain more often than men, according to the Agency for Healthcare Research and Quality. In 2006, 379,000 men were admitted for unspecified chest pain, and 477,000 women were hospitalized with the same diagnosis. Interestingly, however, men are admitted much more frequently for coronary artery disease—747,000 in 2006, compared with 451,000 women. Men also account for 60% of admissions for heart attacks. Admissions for heart failure and irregular heart beat are similar for both genders. The data come from the 2006 Nationwide Inpatient Sample.

Resuscitation Practices Ineffective

An overwhelming majority of emergency physicians believe that resuscitation practices in the United States are not very effective, according to a survey released by the American College of Emergency Physicians. In addition, more than half of emergency physicians surveyed believe that poor survival rates from sudden cardiac arrest are related to the aging population, while one-quarter of respondents said that obesity has contributed most to poor survival rates. Increased bystander CPR, faster patient-to-doctor time, improved data collection and sharing, and greater use of technology all are critical to improving resuscitation, the survey concluded. “It is necessary for communities to encourage more CPR trainings, offer more access to a broader range of critical life-saving technologies, and report sudden cardiac arrest cases more consistently,” said ACEP President Nick Jouriles.

Poor Marks for PQRI

Most physicians who participated in Medicare's 2007 Physician Quality Reporting Initiative found the program at least moderately difficult, according to a survey conducted by the American Medical Association. Only 22% of respondents to the online survey were able to successfully download their feedback report. Of those who downloaded the report, less than half found it helpful. In an open-ended question about their experience with the program, nearly all the responses were negatives, according to the association. The results are based on responses from 408 physicians. The AMA plans to work with Congress and the administration to alter the program to provide physicians with interim feedback reports an appeals process. A recent survey from the Medical Group Management Association reported similar problems in accessing feedback reports.

Medicare is making good on a promise to reduce what it sees as runaway costs for certain imaging services in its final rule on hospital outpatient payments for 2009.

The Centers for Medicare and Medicaid Services (CMS) also said that it will continue to hold outpatient departments accountable for quality of care by reducing payment when there has been a failure to meet reporting requirements.

The rule also covers ambulatory surgery centers (ASCs), and contains a separate set of requirements for those facilities.

In July, the CMS had proposed to increase outpatient pay by 3% in 2009; that has been increased to 3.6% in the final rule. Hospitals (and other entities that receive payments under the outpatient system) that do not report on the 11 quality measures required for 2009 will see their payments reduced by 2% in 2010, for an update of 1.6%.

Quality is a big centerpiece of the new rule. The CMS put hospital outpatient departments on notice that, in the near future, it expects to propose the withholding of payment for care related to illnesses or injuries acquired during the outpatient encounter. Hospitals are already being held accountable for acquired conditions on the inpatient side.

The final rule, published in the Nov. 18 Federal Register, applies to 4,000 outpatient departments, according to the CMS. The agency expects to pay $30 billion in 2009 for outpatient services, up from an estimated $28 billion this year.

Imaging services received a special focus. As proposed earlier in the year, the CMS said that it will now make only a single payment for multiple images made in a single outpatient session. The agency created five imaging-payment groups: ultrasound; computed tomography and computed tomographic angiography without contrast; CT and CTA with contrast; magnetic resonance imaging and magnetic resonance angiography without contrast; and MRI and MRA with contrast.

This new scheme may result in underpayment, according to Madeleine Smith, senior vice president of payment and health care delivery policy at the Advanced Medical Technology Association (AdvaMed), a medical device trade group. AdvaMed expressed concern about the policy when it was proposed because it may provide insufficient payments for multiple procedures when contrast is used with every procedure. AdvaMed also objected to the CMS's proposal that outpatient departments report on four imaging-quality measures in 2009. The measures included MRI of the lumbar spine for lower back pain; mammography follow-up rates; certain abdominal CT scans with contrast; and thorax CT with contrast.

The measures were reviewed by the National Quality Forum, but two of the four, certain CT scans and mammography follow-up rates, were rejected, said Ms. Smith in an interview.

Dr. Kim Allan Williams, director of nuclear cardiology at the University of Chicago, said that the imaging-payment groups and efficiency measures will have little to no effect on cardiology.

A bigger worry is the reduction in reimbursement for cardiac CT and for cardiac positron emission tomography in 2009, said Dr. Williams in an interview, adding that these technologies are “being low-balled for good mathematical—but not good clinical—reasons.”

Most device-related procedures in cardiology, neurology, and gynecology will receive minimal increases in payment. But some will see fairly large cuts, including implantation of left ventricular pacing leads (45% reduction) and placement of neurostimulator electrodes (49% reduction).

The agency also followed through on its proposal to institute four new payment groups for visits to “Type B” emergency departments (defined as those that are not open around the clock). Type B reimbursement will be lower than reimbursement for full-service emergency departments.

The agency estimates that it will pay almost $4 billion to 5,100 ASCs in 2009. Overall, ASCs will be paid about 59% of what outpatient departments receive for the same surgical procedure, down from 63% in 2008. However, 27 more procedures will be covered in 2009.

Medicare also is updating conditions for coverage that ASCs must meet. Among those: that the ASC must be more transparent about physicians' financial interests, and that appropriate postsurgical care must be ensured.

Medicare is making good on a promise to reduce what it sees as runaway costs for certain imaging services in its final rule on hospital outpatient payments for 2009.

The Centers for Medicare and Medicaid Services (CMS) also said that it will continue to hold outpatient departments accountable for quality of care by reducing payment when there has been a failure to meet reporting requirements.

The rule also covers ambulatory surgery centers (ASCs), and contains a separate set of requirements for those facilities.

In July, the CMS had proposed to increase outpatient pay by 3% in 2009; that has been increased to 3.6% in the final rule. Hospitals (and other entities that receive payments under the outpatient system) that do not report on the 11 quality measures required for 2009 will see their payments reduced by 2% in 2010, for an update of 1.6%.

Quality is a big centerpiece of the new rule. The CMS put hospital outpatient departments on notice that, in the near future, it expects to propose the withholding of payment for care related to illnesses or injuries acquired during the outpatient encounter. Hospitals are already being held accountable for acquired conditions on the inpatient side.

The final rule, published in the Nov. 18 Federal Register, applies to 4,000 outpatient departments, according to the CMS. The agency expects to pay $30 billion in 2009 for outpatient services, up from an estimated $28 billion this year.

Imaging services received a special focus. As proposed earlier in the year, the CMS said that it will now make only a single payment for multiple images made in a single outpatient session. The agency created five imaging-payment groups: ultrasound; computed tomography and computed tomographic angiography without contrast; CT and CTA with contrast; magnetic resonance imaging and magnetic resonance angiography without contrast; and MRI and MRA with contrast.

This new scheme may result in underpayment, according to Madeleine Smith, senior vice president of payment and health care delivery policy at the Advanced Medical Technology Association (AdvaMed), a medical device trade group. AdvaMed expressed concern about the policy when it was proposed because it may provide insufficient payments for multiple procedures when contrast is used with every procedure. AdvaMed also objected to the CMS's proposal that outpatient departments report on four imaging-quality measures in 2009. The measures included MRI of the lumbar spine for lower back pain; mammography follow-up rates; certain abdominal CT scans with contrast; and thorax CT with contrast.

The measures were reviewed by the National Quality Forum, but two of the four, certain CT scans and mammography follow-up rates, were rejected, said Ms. Smith in an interview.

Dr. Kim Allan Williams, director of nuclear cardiology at the University of Chicago, said that the imaging-payment groups and efficiency measures will have little to no effect on cardiology.

A bigger worry is the reduction in reimbursement for cardiac CT and for cardiac positron emission tomography in 2009, said Dr. Williams in an interview, adding that these technologies are “being low-balled for good mathematical—but not good clinical—reasons.”

Most device-related procedures in cardiology, neurology, and gynecology will receive minimal increases in payment. But some will see fairly large cuts, including implantation of left ventricular pacing leads (45% reduction) and placement of neurostimulator electrodes (49% reduction).

The agency also followed through on its proposal to institute four new payment groups for visits to “Type B” emergency departments (defined as those that are not open around the clock). Type B reimbursement will be lower than reimbursement for full-service emergency departments.

The agency estimates that it will pay almost $4 billion to 5,100 ASCs in 2009. Overall, ASCs will be paid about 59% of what outpatient departments receive for the same surgical procedure, down from 63% in 2008. However, 27 more procedures will be covered in 2009.

Medicare also is updating conditions for coverage that ASCs must meet. Among those: that the ASC must be more transparent about physicians' financial interests, and that appropriate postsurgical care must be ensured.

Medicare is making good on a promise to reduce what it sees as runaway costs for certain imaging services in its final rule on hospital outpatient payments for 2009.

The Centers for Medicare and Medicaid Services (CMS) also said that it will continue to hold outpatient departments accountable for quality of care by reducing payment when there has been a failure to meet reporting requirements.

The rule also covers ambulatory surgery centers (ASCs), and contains a separate set of requirements for those facilities.

In July, the CMS had proposed to increase outpatient pay by 3% in 2009; that has been increased to 3.6% in the final rule. Hospitals (and other entities that receive payments under the outpatient system) that do not report on the 11 quality measures required for 2009 will see their payments reduced by 2% in 2010, for an update of 1.6%.

Quality is a big centerpiece of the new rule. The CMS put hospital outpatient departments on notice that, in the near future, it expects to propose the withholding of payment for care related to illnesses or injuries acquired during the outpatient encounter. Hospitals are already being held accountable for acquired conditions on the inpatient side.

The final rule, published in the Nov. 18 Federal Register, applies to 4,000 outpatient departments, according to the CMS. The agency expects to pay $30 billion in 2009 for outpatient services, up from an estimated $28 billion this year.

Imaging services received a special focus. As proposed earlier in the year, the CMS said that it will now make only a single payment for multiple images made in a single outpatient session. The agency created five imaging-payment groups: ultrasound; computed tomography and computed tomographic angiography without contrast; CT and CTA with contrast; magnetic resonance imaging and magnetic resonance angiography without contrast; and MRI and MRA with contrast.

This new scheme may result in underpayment, according to Madeleine Smith, senior vice president of payment and health care delivery policy at the Advanced Medical Technology Association (AdvaMed), a medical device trade group. AdvaMed expressed concern about the policy when it was proposed because it may provide insufficient payments for multiple procedures when contrast is used with every procedure. AdvaMed also objected to the CMS's proposal that outpatient departments report on four imaging-quality measures in 2009. The measures included MRI of the lumbar spine for lower back pain; mammography follow-up rates; certain abdominal CT scans with contrast; and thorax CT with contrast.

The measures were reviewed by the National Quality Forum, but two of the four, certain CT scans and mammography follow-up rates, were rejected, said Ms. Smith in an interview.

Dr. Kim Allan Williams, director of nuclear cardiology at the University of Chicago, said that the imaging-payment groups and efficiency measures will have little to no effect on cardiology.

A bigger worry is the reduction in reimbursement for cardiac CT and for cardiac positron emission tomography in 2009, said Dr. Williams in an interview, adding that these technologies are “being low-balled for good mathematical—but not good clinical—reasons.”

Most device-related procedures in cardiology, neurology, and gynecology will receive minimal increases in payment. But some will see fairly large cuts, including implantation of left ventricular pacing leads (45% reduction) and placement of neurostimulator electrodes (49% reduction).

The agency also followed through on its proposal to institute four new payment groups for visits to “Type B” emergency departments (defined as those that are not open around the clock). Type B reimbursement will be lower than reimbursement for full-service emergency departments.

The agency estimates that it will pay almost $4 billion to 5,100 ASCs in 2009. Overall, ASCs will be paid about 59% of what outpatient departments receive for the same surgical procedure, down from 63% in 2008. However, 27 more procedures will be covered in 2009.

Medicare also is updating conditions for coverage that ASCs must meet. Among those: that the ASC must be more transparent about physicians' financial interests, and that appropriate postsurgical care must be ensured.

A survey of internists and rheumatologists suggests that prescribing active “placebos” is relatively common, even though ethicists generally frown on the use of such therapies, especially if the patient is not informed.

The survey was conducted by five ethicists from the National Institutes of Health; the University of Chicago; and Harvard Medical School, Boston, who said they were interested in exploring physicians' attitudes about placebo treatments because there is little systematic data on the topic (BMJ 2008;337:a1938 [doi: 10.1136/bmj.a1938]).

They surveyed 1,200 randomly selected physicians, half of whom were internists, and half, rheumatologists; 679 physicians (57%) agreed to participate and received $20 for completing the survey. The respondents comprised 334 internists and 345 rheumatologists.

Depending on how the question was asked, 46%–58% of the physicians said they prescribed placebos on a regular basis, and 399 of 642 said it was ethically permissible to do so.

The study was somewhat deceptive, however, said Dr. Roy Altman, a rheumatologist in Agua Dulce, Calif., who was not involved with the study. The authors did not ask the physicians if they were merely going along with patients who were already taking placebos, Dr. Altman said in an interview.

He said that if a patient is taking a placebo that he knows is not harmful, he generally won't stop him or her. “I'm not supporting the practice of giving placebos,” he said, adding, “[but] I think it's something that's a part of medicine and I don't think you can take it away.”

The authors noted that, to avoid using the word “placebo,” they began with broad questions. For example, they asked physicians to respond to a hypothetical scenario in which a dextrose tablet had proven superior to no treatment. Would they recommend it as a therapy for nondiabetics with fibromyalgia? Twenty-four percent of physicians (160 of the 654 who answered these questions) said it was very likely they'd use the sugar pill; 34% (221 of 654) said it was moderately likely. But 31% (205) said it was unlikely and 10% (68) said definitely not.

They were then asked how often they recommend a therapy because they believe it will enhance the patient's experience. Fifty-nine percent (380 of 642) said it was permissible to recommend such a treatment; 31% (197) said it was permissible, but only in rare circumstances; and only 7% (46) said it was never permissible.

Finally, physicians were asked what therapies they had used primarily as a placebo treatment. Placebo was defined as “a treatment whose benefits derive from positive patient expectations and not from the physiological mechanism of the treatment itself.”

Fifty-five percent of the respondents (370 of 679) said they had recommended—but not necessarily prescribed—some type of placebo in the past year. A total of 267 of 648 physicians (41%) prescribed over-the-counter analgesics and 243 of 648 physicians (38%) prescribed vitamins. Sedatives were prescribed by 86 of 652 physicians (13%); the same number prescribed antibiotics. Saline and sugar pills were used by 18 of 623 and 12 of 642 physicians (3% and 2%, respectively).

When asked how these treatments were described to patients, 18% (62 of the 352 who actually prescribed placebos) said they were “medicine.” About 285 physicians said they had not prescribed placebos. Only 18 physicians (5%) said they identify the treatments as a placebo. A large percentage—68%, or 241 of the 352—described the placebo as a medicine not typically used for the condition that might benefit the patient.

An American Medical Association policy on the use of placebos is a bit murky; it advises against their use without the patient's knowledge or if the placebo could cause medical harm. A placebo can be prescribed “only if the patient is informed of and agrees to its use,” but the physician does not have to identify the placebo, or explain its potential effect, according to the policy.

In an interview, Dr. Norman Gaylis said that he believes the use of active placebos is “an inappropriate way to treat a patient.” Giving a patient naproxen, for instance, “has potential for significant side effects to the kidney, so that's not a placebo,” said Dr. Gaylis, a rheumatologist in private practice in Aventura, Fla.

Although the placebo effect is well documented in medicine and can be effective, he said, “the first thing for us is to not harm our patients.”

A survey of internists and rheumatologists suggests that prescribing active “placebos” is relatively common, even though ethicists generally frown on the use of such therapies, especially if the patient is not informed.

The survey was conducted by five ethicists from the National Institutes of Health; the University of Chicago; and Harvard Medical School, Boston, who said they were interested in exploring physicians' attitudes about placebo treatments because there is little systematic data on the topic (BMJ 2008;337:a1938 [doi: 10.1136/bmj.a1938]).

They surveyed 1,200 randomly selected physicians, half of whom were internists, and half, rheumatologists; 679 physicians (57%) agreed to participate and received $20 for completing the survey. The respondents comprised 334 internists and 345 rheumatologists.

Depending on how the question was asked, 46%–58% of the physicians said they prescribed placebos on a regular basis, and 399 of 642 said it was ethically permissible to do so.

The study was somewhat deceptive, however, said Dr. Roy Altman, a rheumatologist in Agua Dulce, Calif., who was not involved with the study. The authors did not ask the physicians if they were merely going along with patients who were already taking placebos, Dr. Altman said in an interview.

He said that if a patient is taking a placebo that he knows is not harmful, he generally won't stop him or her. “I'm not supporting the practice of giving placebos,” he said, adding, “[but] I think it's something that's a part of medicine and I don't think you can take it away.”

The authors noted that, to avoid using the word “placebo,” they began with broad questions. For example, they asked physicians to respond to a hypothetical scenario in which a dextrose tablet had proven superior to no treatment. Would they recommend it as a therapy for nondiabetics with fibromyalgia? Twenty-four percent of physicians (160 of the 654 who answered these questions) said it was very likely they'd use the sugar pill; 34% (221 of 654) said it was moderately likely. But 31% (205) said it was unlikely and 10% (68) said definitely not.

They were then asked how often they recommend a therapy because they believe it will enhance the patient's experience. Fifty-nine percent (380 of 642) said it was permissible to recommend such a treatment; 31% (197) said it was permissible, but only in rare circumstances; and only 7% (46) said it was never permissible.

Finally, physicians were asked what therapies they had used primarily as a placebo treatment. Placebo was defined as “a treatment whose benefits derive from positive patient expectations and not from the physiological mechanism of the treatment itself.”

Fifty-five percent of the respondents (370 of 679) said they had recommended—but not necessarily prescribed—some type of placebo in the past year. A total of 267 of 648 physicians (41%) prescribed over-the-counter analgesics and 243 of 648 physicians (38%) prescribed vitamins. Sedatives were prescribed by 86 of 652 physicians (13%); the same number prescribed antibiotics. Saline and sugar pills were used by 18 of 623 and 12 of 642 physicians (3% and 2%, respectively).

When asked how these treatments were described to patients, 18% (62 of the 352 who actually prescribed placebos) said they were “medicine.” About 285 physicians said they had not prescribed placebos. Only 18 physicians (5%) said they identify the treatments as a placebo. A large percentage—68%, or 241 of the 352—described the placebo as a medicine not typically used for the condition that might benefit the patient.

An American Medical Association policy on the use of placebos is a bit murky; it advises against their use without the patient's knowledge or if the placebo could cause medical harm. A placebo can be prescribed “only if the patient is informed of and agrees to its use,” but the physician does not have to identify the placebo, or explain its potential effect, according to the policy.

In an interview, Dr. Norman Gaylis said that he believes the use of active placebos is “an inappropriate way to treat a patient.” Giving a patient naproxen, for instance, “has potential for significant side effects to the kidney, so that's not a placebo,” said Dr. Gaylis, a rheumatologist in private practice in Aventura, Fla.

Although the placebo effect is well documented in medicine and can be effective, he said, “the first thing for us is to not harm our patients.”

A survey of internists and rheumatologists suggests that prescribing active “placebos” is relatively common, even though ethicists generally frown on the use of such therapies, especially if the patient is not informed.

The survey was conducted by five ethicists from the National Institutes of Health; the University of Chicago; and Harvard Medical School, Boston, who said they were interested in exploring physicians' attitudes about placebo treatments because there is little systematic data on the topic (BMJ 2008;337:a1938 [doi: 10.1136/bmj.a1938]).

They surveyed 1,200 randomly selected physicians, half of whom were internists, and half, rheumatologists; 679 physicians (57%) agreed to participate and received $20 for completing the survey. The respondents comprised 334 internists and 345 rheumatologists.

Depending on how the question was asked, 46%–58% of the physicians said they prescribed placebos on a regular basis, and 399 of 642 said it was ethically permissible to do so.

The study was somewhat deceptive, however, said Dr. Roy Altman, a rheumatologist in Agua Dulce, Calif., who was not involved with the study. The authors did not ask the physicians if they were merely going along with patients who were already taking placebos, Dr. Altman said in an interview.

He said that if a patient is taking a placebo that he knows is not harmful, he generally won't stop him or her. “I'm not supporting the practice of giving placebos,” he said, adding, “[but] I think it's something that's a part of medicine and I don't think you can take it away.”

The authors noted that, to avoid using the word “placebo,” they began with broad questions. For example, they asked physicians to respond to a hypothetical scenario in which a dextrose tablet had proven superior to no treatment. Would they recommend it as a therapy for nondiabetics with fibromyalgia? Twenty-four percent of physicians (160 of the 654 who answered these questions) said it was very likely they'd use the sugar pill; 34% (221 of 654) said it was moderately likely. But 31% (205) said it was unlikely and 10% (68) said definitely not.

They were then asked how often they recommend a therapy because they believe it will enhance the patient's experience. Fifty-nine percent (380 of 642) said it was permissible to recommend such a treatment; 31% (197) said it was permissible, but only in rare circumstances; and only 7% (46) said it was never permissible.

Finally, physicians were asked what therapies they had used primarily as a placebo treatment. Placebo was defined as “a treatment whose benefits derive from positive patient expectations and not from the physiological mechanism of the treatment itself.”

Fifty-five percent of the respondents (370 of 679) said they had recommended—but not necessarily prescribed—some type of placebo in the past year. A total of 267 of 648 physicians (41%) prescribed over-the-counter analgesics and 243 of 648 physicians (38%) prescribed vitamins. Sedatives were prescribed by 86 of 652 physicians (13%); the same number prescribed antibiotics. Saline and sugar pills were used by 18 of 623 and 12 of 642 physicians (3% and 2%, respectively).

When asked how these treatments were described to patients, 18% (62 of the 352 who actually prescribed placebos) said they were “medicine.” About 285 physicians said they had not prescribed placebos. Only 18 physicians (5%) said they identify the treatments as a placebo. A large percentage—68%, or 241 of the 352—described the placebo as a medicine not typically used for the condition that might benefit the patient.

An American Medical Association policy on the use of placebos is a bit murky; it advises against their use without the patient's knowledge or if the placebo could cause medical harm. A placebo can be prescribed “only if the patient is informed of and agrees to its use,” but the physician does not have to identify the placebo, or explain its potential effect, according to the policy.

In an interview, Dr. Norman Gaylis said that he believes the use of active placebos is “an inappropriate way to treat a patient.” Giving a patient naproxen, for instance, “has potential for significant side effects to the kidney, so that's not a placebo,” said Dr. Gaylis, a rheumatologist in private practice in Aventura, Fla.

Although the placebo effect is well documented in medicine and can be effective, he said, “the first thing for us is to not harm our patients.”

WASHINGTON — The topic of long-term care isn't making the cut as part of otherwise animated discussions of possible health care reform in the next administration, according to speakers at a meeting sponsored by the Brookings Institution.

Sen. Ron Wyden (D-Ore.) said although there will be movement toward overhauling the health system, long-term care (LTC) is not on the radar screen. “We have to make sure long-term care is not the afterthought, the forgotten stepchild.”

Rep. Jim McCrery (R-La.) commented that there was more willingness and consensus than usual around health reform, but also said that LTC is in danger of being overlooked. He called for leadership to avoid that policy mistake.

While the debate over how to finance long-term care is being silenced, nursing home and home-care spending show no signs of slowing down. Medicaid is the primary payer for these services—and states are grappling with how to manage Medicaid budgets in an environment of declining tax revenues.

According to recent studies, about half of nursing home and home-care costs are covered by Medicaid, with Medicare covering another 20%–30% of the bills. The Government Accountability Office recently estimated LTC cost $193 billion in 2004, with 10% covered by private insurance.

Larry Minnix, president and CEO of the American Association of Homes and Services for the Aging, said that caregivers spend an average of $5,500 annually out of pocket on assistance for elderly and disabled family members. Long-term care is an insurable event, he said.

Yet very few Americans have purchased private LTC insurance. Buck Stinson, president of the LTC division at Genworth Financial, the largest LTC insurer in the United States, said an estimated 7 million people hold private LTC policies.

He noted that policies were attracting younger buyers—currently, the average age of a purchaser is 57—which should help spread the industry's risk and bring premium prices down. If the government stepped in as a reinsurer, more private companies could enter the market and offer more affordable policies, he said.

Mr. Minnix suggested a pay-as-you-go system with all workers, starting at age 21, paying premiums to a quasi-governmental LTC program.

Sen. Wyden said that a voluntary contribution system would make LTC financing more palatable to the American public and to Congress, which is required to fund only budget-neutral programs. It would generate “huge waves of support from both sides of the aisle,” said Sen. Wyden.

WASHINGTON — The topic of long-term care isn't making the cut as part of otherwise animated discussions of possible health care reform in the next administration, according to speakers at a meeting sponsored by the Brookings Institution.

Sen. Ron Wyden (D-Ore.) said although there will be movement toward overhauling the health system, long-term care (LTC) is not on the radar screen. “We have to make sure long-term care is not the afterthought, the forgotten stepchild.”

Rep. Jim McCrery (R-La.) commented that there was more willingness and consensus than usual around health reform, but also said that LTC is in danger of being overlooked. He called for leadership to avoid that policy mistake.

While the debate over how to finance long-term care is being silenced, nursing home and home-care spending show no signs of slowing down. Medicaid is the primary payer for these services—and states are grappling with how to manage Medicaid budgets in an environment of declining tax revenues.

According to recent studies, about half of nursing home and home-care costs are covered by Medicaid, with Medicare covering another 20%–30% of the bills. The Government Accountability Office recently estimated LTC cost $193 billion in 2004, with 10% covered by private insurance.

Larry Minnix, president and CEO of the American Association of Homes and Services for the Aging, said that caregivers spend an average of $5,500 annually out of pocket on assistance for elderly and disabled family members. Long-term care is an insurable event, he said.

Yet very few Americans have purchased private LTC insurance. Buck Stinson, president of the LTC division at Genworth Financial, the largest LTC insurer in the United States, said an estimated 7 million people hold private LTC policies.

He noted that policies were attracting younger buyers—currently, the average age of a purchaser is 57—which should help spread the industry's risk and bring premium prices down. If the government stepped in as a reinsurer, more private companies could enter the market and offer more affordable policies, he said.

Mr. Minnix suggested a pay-as-you-go system with all workers, starting at age 21, paying premiums to a quasi-governmental LTC program.

Sen. Wyden said that a voluntary contribution system would make LTC financing more palatable to the American public and to Congress, which is required to fund only budget-neutral programs. It would generate “huge waves of support from both sides of the aisle,” said Sen. Wyden.

WASHINGTON — The topic of long-term care isn't making the cut as part of otherwise animated discussions of possible health care reform in the next administration, according to speakers at a meeting sponsored by the Brookings Institution.

Sen. Ron Wyden (D-Ore.) said although there will be movement toward overhauling the health system, long-term care (LTC) is not on the radar screen. “We have to make sure long-term care is not the afterthought, the forgotten stepchild.”

Rep. Jim McCrery (R-La.) commented that there was more willingness and consensus than usual around health reform, but also said that LTC is in danger of being overlooked. He called for leadership to avoid that policy mistake.

While the debate over how to finance long-term care is being silenced, nursing home and home-care spending show no signs of slowing down. Medicaid is the primary payer for these services—and states are grappling with how to manage Medicaid budgets in an environment of declining tax revenues.

According to recent studies, about half of nursing home and home-care costs are covered by Medicaid, with Medicare covering another 20%–30% of the bills. The Government Accountability Office recently estimated LTC cost $193 billion in 2004, with 10% covered by private insurance.

Larry Minnix, president and CEO of the American Association of Homes and Services for the Aging, said that caregivers spend an average of $5,500 annually out of pocket on assistance for elderly and disabled family members. Long-term care is an insurable event, he said.

Yet very few Americans have purchased private LTC insurance. Buck Stinson, president of the LTC division at Genworth Financial, the largest LTC insurer in the United States, said an estimated 7 million people hold private LTC policies.

He noted that policies were attracting younger buyers—currently, the average age of a purchaser is 57—which should help spread the industry's risk and bring premium prices down. If the government stepped in as a reinsurer, more private companies could enter the market and offer more affordable policies, he said.

Mr. Minnix suggested a pay-as-you-go system with all workers, starting at age 21, paying premiums to a quasi-governmental LTC program.

Sen. Wyden said that a voluntary contribution system would make LTC financing more palatable to the American public and to Congress, which is required to fund only budget-neutral programs. It would generate “huge waves of support from both sides of the aisle,” said Sen. Wyden.

WASHINGTON — The Medicare Payment Advisory Commission recently debated whether to recommend that payments for the hospital and postacute care be bundled together.

The issue arose out of concerns about frequent rehospitalizations and readmissions to skilled nursing facilities (SNF).

Analysis of data from 2004 to 2006 showed that 63% of skilled nursing facility residents were admitted to a hospital then discharged back to an SNF; 31% had two or more SNF-hospital-SNF cycles, MedPAC staff member Carol Carter said at a recent meeting of the commission.

A previous report by the Health and Human Services Department's Office of Inspector General found that patients who had three or more such cycles had a lower quality of care, said Ms. Carter.

The MedPAC analysis also found that patients who had repeat hospitalizations and readmissions to SNFs were more likely to be dual-eligible for Medicare and Medicaid and to be sicker than other patients. Of the readmissions, 51% were dual-eligible, compared with 33% of those who did not have repeat visits. Patients who had four or more hospital-SNF stay cycles during the 2-year period were also more likely to be classified as clinically complex than were nonrepeat patients, said Ms. Carter.

Some 74% of repeat patients were hospitalized for what were classified as “potentially avoidable” conditions, such as heart failure, respiratory infections, and urinary tract infections, she said.

Repeat hospital-SNF visits were much higher for patients in freestanding SNFs and in for-profit SNFs, Ms. Carter said.

She added it was probably not possible to eliminate all hospital readmissions. But she suggested aligning payment incentives between SNFs and hospitals, saying each entity could, under the current system, be rewarded for admissions to their facilities. She said SNFs can often convert patients from lower-paying Medicaid to higherpaying Medicare after a long hospital stay.

Ms. Carter proposed the Centers for Medicare and Medicaid Services start publicly reporting rehospitalization and readmission rates and consider using potentially avoidable rehospitalizations as a pay-for-performance measure.

Finally, she recommended bundling payments for the hospital and SNF, following the same path MedPAC has suggested for hospitals to hold inpatient and outpatient providers accountable for readmissions.

MedPAC meets again this month and in December, in preparation for its March report to Congress. It did not say when it would again take up the issue of rehospitalized SNF patients.

WASHINGTON — The Medicare Payment Advisory Commission recently debated whether to recommend that payments for the hospital and postacute care be bundled together.

The issue arose out of concerns about frequent rehospitalizations and readmissions to skilled nursing facilities (SNF).

Analysis of data from 2004 to 2006 showed that 63% of skilled nursing facility residents were admitted to a hospital then discharged back to an SNF; 31% had two or more SNF-hospital-SNF cycles, MedPAC staff member Carol Carter said at a recent meeting of the commission.

A previous report by the Health and Human Services Department's Office of Inspector General found that patients who had three or more such cycles had a lower quality of care, said Ms. Carter.

The MedPAC analysis also found that patients who had repeat hospitalizations and readmissions to SNFs were more likely to be dual-eligible for Medicare and Medicaid and to be sicker than other patients. Of the readmissions, 51% were dual-eligible, compared with 33% of those who did not have repeat visits. Patients who had four or more hospital-SNF stay cycles during the 2-year period were also more likely to be classified as clinically complex than were nonrepeat patients, said Ms. Carter.

Some 74% of repeat patients were hospitalized for what were classified as “potentially avoidable” conditions, such as heart failure, respiratory infections, and urinary tract infections, she said.

Repeat hospital-SNF visits were much higher for patients in freestanding SNFs and in for-profit SNFs, Ms. Carter said.

She added it was probably not possible to eliminate all hospital readmissions. But she suggested aligning payment incentives between SNFs and hospitals, saying each entity could, under the current system, be rewarded for admissions to their facilities. She said SNFs can often convert patients from lower-paying Medicaid to higherpaying Medicare after a long hospital stay.

Ms. Carter proposed the Centers for Medicare and Medicaid Services start publicly reporting rehospitalization and readmission rates and consider using potentially avoidable rehospitalizations as a pay-for-performance measure.

Finally, she recommended bundling payments for the hospital and SNF, following the same path MedPAC has suggested for hospitals to hold inpatient and outpatient providers accountable for readmissions.

MedPAC meets again this month and in December, in preparation for its March report to Congress. It did not say when it would again take up the issue of rehospitalized SNF patients.

WASHINGTON — The Medicare Payment Advisory Commission recently debated whether to recommend that payments for the hospital and postacute care be bundled together.

The issue arose out of concerns about frequent rehospitalizations and readmissions to skilled nursing facilities (SNF).

Analysis of data from 2004 to 2006 showed that 63% of skilled nursing facility residents were admitted to a hospital then discharged back to an SNF; 31% had two or more SNF-hospital-SNF cycles, MedPAC staff member Carol Carter said at a recent meeting of the commission.

A previous report by the Health and Human Services Department's Office of Inspector General found that patients who had three or more such cycles had a lower quality of care, said Ms. Carter.

The MedPAC analysis also found that patients who had repeat hospitalizations and readmissions to SNFs were more likely to be dual-eligible for Medicare and Medicaid and to be sicker than other patients. Of the readmissions, 51% were dual-eligible, compared with 33% of those who did not have repeat visits. Patients who had four or more hospital-SNF stay cycles during the 2-year period were also more likely to be classified as clinically complex than were nonrepeat patients, said Ms. Carter.

Some 74% of repeat patients were hospitalized for what were classified as “potentially avoidable” conditions, such as heart failure, respiratory infections, and urinary tract infections, she said.

Repeat hospital-SNF visits were much higher for patients in freestanding SNFs and in for-profit SNFs, Ms. Carter said.

She added it was probably not possible to eliminate all hospital readmissions. But she suggested aligning payment incentives between SNFs and hospitals, saying each entity could, under the current system, be rewarded for admissions to their facilities. She said SNFs can often convert patients from lower-paying Medicaid to higherpaying Medicare after a long hospital stay.

Ms. Carter proposed the Centers for Medicare and Medicaid Services start publicly reporting rehospitalization and readmission rates and consider using potentially avoidable rehospitalizations as a pay-for-performance measure.

Finally, she recommended bundling payments for the hospital and SNF, following the same path MedPAC has suggested for hospitals to hold inpatient and outpatient providers accountable for readmissions.

MedPAC meets again this month and in December, in preparation for its March report to Congress. It did not say when it would again take up the issue of rehospitalized SNF patients.

Medicare is making good on a promise to reduce what it sees as runaway costs for certain imaging services in its final rule on hospital outpatient payments for 2009.

The Centers for Medicare and Medicaid Services (CMS) also said that it will continue to hold outpatient departments accountable for quality of care by reducing payment when there has been a failure to meet reporting requirements.

The rule also covers ambulatory surgery centers (ASCs), and contains a separate set of requirements for those facilities.

In July, the CMS had proposed to increase outpatient pay by 3% in 2009; that has been increased to 3.6% in the final rule. Hospitals (and other entities that receive payments under the outpatient system) that do not report on the 11 quality measures required for 2009 will see their payments reduced by 2% in 2010, for an update of 1.6%.

Quality is a big centerpiece of the new rule. The CMS put hospital outpatient departments on notice that, in the near future, it expects to propose the withholding of payment for care related to illnesses or injuries acquired during the outpatient encounter. Hospitals are already being held accountable for acquired conditions on the inpatient side.

The final rule, published in the Nov. 18 Federal Register, applies to 4,000 outpatient departments, according to the CMS. The agency expects to pay $30 billion in 2009 for outpatient services, up from an estimated $28 billion this year.

As proposed earlier in the year, the CMS said that it will now make only a single payment for multiple images made in a single outpatient session.

The agency created five imaging-payment groups: ultrasound; computed tomography and computed tomographic angiography without contrast; CT and CTA with contrast; magnetic resonance imaging and magnetic resonance angiography without contrast; and MRI and MRA with contrast.

Most device-related procedures in cardiology, neurology, and gynecology will receive minimal increases in payment.

The agency also followed through on its proposal to institute four new payment groups for visits to “Type B” emergency departments (defined as those that are not open around the clock). Type B reimbursement will be lower than reimbursement for full-service emergency departments.

Medicare is making good on a promise to reduce what it sees as runaway costs for certain imaging services in its final rule on hospital outpatient payments for 2009.

The Centers for Medicare and Medicaid Services (CMS) also said that it will continue to hold outpatient departments accountable for quality of care by reducing payment when there has been a failure to meet reporting requirements.

The rule also covers ambulatory surgery centers (ASCs), and contains a separate set of requirements for those facilities.

In July, the CMS had proposed to increase outpatient pay by 3% in 2009; that has been increased to 3.6% in the final rule. Hospitals (and other entities that receive payments under the outpatient system) that do not report on the 11 quality measures required for 2009 will see their payments reduced by 2% in 2010, for an update of 1.6%.

Quality is a big centerpiece of the new rule. The CMS put hospital outpatient departments on notice that, in the near future, it expects to propose the withholding of payment for care related to illnesses or injuries acquired during the outpatient encounter. Hospitals are already being held accountable for acquired conditions on the inpatient side.

The final rule, published in the Nov. 18 Federal Register, applies to 4,000 outpatient departments, according to the CMS. The agency expects to pay $30 billion in 2009 for outpatient services, up from an estimated $28 billion this year.

As proposed earlier in the year, the CMS said that it will now make only a single payment for multiple images made in a single outpatient session.

The agency created five imaging-payment groups: ultrasound; computed tomography and computed tomographic angiography without contrast; CT and CTA with contrast; magnetic resonance imaging and magnetic resonance angiography without contrast; and MRI and MRA with contrast.

Most device-related procedures in cardiology, neurology, and gynecology will receive minimal increases in payment.

The agency also followed through on its proposal to institute four new payment groups for visits to “Type B” emergency departments (defined as those that are not open around the clock). Type B reimbursement will be lower than reimbursement for full-service emergency departments.

Medicare is making good on a promise to reduce what it sees as runaway costs for certain imaging services in its final rule on hospital outpatient payments for 2009.

The Centers for Medicare and Medicaid Services (CMS) also said that it will continue to hold outpatient departments accountable for quality of care by reducing payment when there has been a failure to meet reporting requirements.

The rule also covers ambulatory surgery centers (ASCs), and contains a separate set of requirements for those facilities.

In July, the CMS had proposed to increase outpatient pay by 3% in 2009; that has been increased to 3.6% in the final rule. Hospitals (and other entities that receive payments under the outpatient system) that do not report on the 11 quality measures required for 2009 will see their payments reduced by 2% in 2010, for an update of 1.6%.

Quality is a big centerpiece of the new rule. The CMS put hospital outpatient departments on notice that, in the near future, it expects to propose the withholding of payment for care related to illnesses or injuries acquired during the outpatient encounter. Hospitals are already being held accountable for acquired conditions on the inpatient side.

The final rule, published in the Nov. 18 Federal Register, applies to 4,000 outpatient departments, according to the CMS. The agency expects to pay $30 billion in 2009 for outpatient services, up from an estimated $28 billion this year.

As proposed earlier in the year, the CMS said that it will now make only a single payment for multiple images made in a single outpatient session.

The agency created five imaging-payment groups: ultrasound; computed tomography and computed tomographic angiography without contrast; CT and CTA with contrast; magnetic resonance imaging and magnetic resonance angiography without contrast; and MRI and MRA with contrast.

Most device-related procedures in cardiology, neurology, and gynecology will receive minimal increases in payment.

The agency also followed through on its proposal to institute four new payment groups for visits to “Type B” emergency departments (defined as those that are not open around the clock). Type B reimbursement will be lower than reimbursement for full-service emergency departments.

Army and NIMH to Study Suicides

The National Institute of Mental Health has signed a memorandum of understanding with the U.S. Army to study suicide and suicidal behavior among active-duty soldiers, National Guard members, and Army Reservists. The 5-year, $50 million effort will be the largest study of suicide ever undertaken by the institute, according to a statement. The goal is to identify risk and protective factors for suicide, and to help the Army develop effective intervention programs. In 2007, 115 Army members committed suicide; of those, 36 committed suicide while deployed, 50 did so post deployment, and 29 had never been deployed.

Mental Illness and Hospitalizations

About 8.5 million hospital admissions in 2006 involved patients with a mental illness or a mental health comorbidity, according to the Agency for Healthcare Research and Quality. Of those, about 1.4 million patients were admitted with a mental health diagnosis while about 7.1 million were admitted for a physical condition and had a mental health comorbidity. The AHRQ report said the largest number of admissions (about 730,000) was for depression or other mood disorders. The next largest (about 381,000) was for schizophrenia and other psychotic conditions. About 131,000 patients were hospitalized for dementia or delirium, about 76,000 for anxiety or adjustment disorders, and about 34,000 for attention-deficit/hyperactivity disorder or personality disorders. The data come from the AHRQ report, Hospital Stays Related to Mental Health, 2006, based on the Nationwide Inpatient Sample.

Many Have Drug 'Gap' Coverage

A total of 13% of Medicare beneficiaries enrolled in Part D prescription drug plans and 63% of those in Medicare Advantage plans with prescription benefits had some form of coverage in the “doughnut hole,” or coverage gap, according to a Centers for Medicare and Medicaid Services study on Part D drug claims. The study, which included data on Medicare drug claims for the 25 million Part D beneficiaries, also indicated that the vast majority of enrollees used the drug benefit: In the program's first year, 90% of enrollees filled at least one prescription. In addition, the use of generic drugs has been high in Part D, rising from 60% in 2006 to nearly 68% in the first quarter of this year.

Program Cuts Illicit Drug Use

A government-supported program used to screen patients seeking health care for signs of substance abuse can reduce illicit drug use among patients seeking medical care in a wide variety of health care settings, a study found. The Screening, Brief Intervention, and Referral to Treatment program uses a variety of techniques to screen patients for signs of substance abuse. If a patient screens positive, immediate steps are taken to help the patient effectively deal with the problem. The study, published in Drug and Alcohol Dependence, found that rates of illicit drug use dropped by nearly 68% by 6 months after screening. Illicit drug users receiving brief treatment or referral to specialty treatment also reported other quality of life improvements. The Substance Abuse and Mental Health Services Administration has been awarding grants to expand the program since 2003.

Nondrug Approaches to PTSD Tested

Researchers at the Southeast Louisiana Veterans Health Care System will test a series of interventions, from yoga to guided imagery, to treat posttraumatic stress disorder and major depression in veterans returning from Iraq and Afghanistan, and their families. The randomized controlled study was funded by a grant from the Department of Defense's new Center of Excellence for Psychological Health and Traumatic Brain Injury. The $411,000, 2-year grant will study the effectiveness of a technique that includes meditation, biofeedback, and small group support. The technique was developed by the Washington-based Center for Mind-Body Medicine.

U.S. Pharmaceutical Sales Outlook

The U.S. pharmaceutical market is expected to grow 1%-2% in 2009, resulting in sales of about $292-$302 billion, according to analysis from the health care market research firm IMS Health. This latest projection is down from the 2%-3% increase projected by IMS earlier this year, and reflects the expected impact of patent expirations, fewer launches of new products, and the slowing U.S. economy. Worldwide pharmaceutical sales are expected to grow 4.5%-5.5% in 2009, similar to growth this year.

HIPAA Enforcement 'Limited'

The Centers for Medicare and Medicaid Services has not provided effective oversight and has taken only “limited actions” to ensure that covered entities adequately implement patient privacy regulations contained in the Health Insurance Portability and Accountability Act of 1996, according to a report from the Health and Human Services Department's Office of Inspector General. The OIG found that the CMS had not conducted any compliance reviews of covered entities, and instead relied on complaints to target investigations. However, the CMS has received very few complaints about violations, the report said. “As a result, the CMS had no effective mechanism to ensure that covered entities were complying with the HIPAA security rule” or that electronic health information was being adequately protected, the report concluded. CMS has taken steps to begin conducting compliance reviews in an effort to identify security problems and vulnerabilities under HIPAA, the OIG said.

Army and NIMH to Study Suicides

The National Institute of Mental Health has signed a memorandum of understanding with the U.S. Army to study suicide and suicidal behavior among active-duty soldiers, National Guard members, and Army Reservists. The 5-year, $50 million effort will be the largest study of suicide ever undertaken by the institute, according to a statement. The goal is to identify risk and protective factors for suicide, and to help the Army develop effective intervention programs. In 2007, 115 Army members committed suicide; of those, 36 committed suicide while deployed, 50 did so post deployment, and 29 had never been deployed.

Mental Illness and Hospitalizations

About 8.5 million hospital admissions in 2006 involved patients with a mental illness or a mental health comorbidity, according to the Agency for Healthcare Research and Quality. Of those, about 1.4 million patients were admitted with a mental health diagnosis while about 7.1 million were admitted for a physical condition and had a mental health comorbidity. The AHRQ report said the largest number of admissions (about 730,000) was for depression or other mood disorders. The next largest (about 381,000) was for schizophrenia and other psychotic conditions. About 131,000 patients were hospitalized for dementia or delirium, about 76,000 for anxiety or adjustment disorders, and about 34,000 for attention-deficit/hyperactivity disorder or personality disorders. The data come from the AHRQ report, Hospital Stays Related to Mental Health, 2006, based on the Nationwide Inpatient Sample.

Many Have Drug 'Gap' Coverage

A total of 13% of Medicare beneficiaries enrolled in Part D prescription drug plans and 63% of those in Medicare Advantage plans with prescription benefits had some form of coverage in the “doughnut hole,” or coverage gap, according to a Centers for Medicare and Medicaid Services study on Part D drug claims. The study, which included data on Medicare drug claims for the 25 million Part D beneficiaries, also indicated that the vast majority of enrollees used the drug benefit: In the program's first year, 90% of enrollees filled at least one prescription. In addition, the use of generic drugs has been high in Part D, rising from 60% in 2006 to nearly 68% in the first quarter of this year.

Program Cuts Illicit Drug Use

A government-supported program used to screen patients seeking health care for signs of substance abuse can reduce illicit drug use among patients seeking medical care in a wide variety of health care settings, a study found. The Screening, Brief Intervention, and Referral to Treatment program uses a variety of techniques to screen patients for signs of substance abuse. If a patient screens positive, immediate steps are taken to help the patient effectively deal with the problem. The study, published in Drug and Alcohol Dependence, found that rates of illicit drug use dropped by nearly 68% by 6 months after screening. Illicit drug users receiving brief treatment or referral to specialty treatment also reported other quality of life improvements. The Substance Abuse and Mental Health Services Administration has been awarding grants to expand the program since 2003.

Nondrug Approaches to PTSD Tested

Researchers at the Southeast Louisiana Veterans Health Care System will test a series of interventions, from yoga to guided imagery, to treat posttraumatic stress disorder and major depression in veterans returning from Iraq and Afghanistan, and their families. The randomized controlled study was funded by a grant from the Department of Defense's new Center of Excellence for Psychological Health and Traumatic Brain Injury. The $411,000, 2-year grant will study the effectiveness of a technique that includes meditation, biofeedback, and small group support. The technique was developed by the Washington-based Center for Mind-Body Medicine.

U.S. Pharmaceutical Sales Outlook

The U.S. pharmaceutical market is expected to grow 1%-2% in 2009, resulting in sales of about $292-$302 billion, according to analysis from the health care market research firm IMS Health. This latest projection is down from the 2%-3% increase projected by IMS earlier this year, and reflects the expected impact of patent expirations, fewer launches of new products, and the slowing U.S. economy. Worldwide pharmaceutical sales are expected to grow 4.5%-5.5% in 2009, similar to growth this year.

HIPAA Enforcement 'Limited'

The Centers for Medicare and Medicaid Services has not provided effective oversight and has taken only “limited actions” to ensure that covered entities adequately implement patient privacy regulations contained in the Health Insurance Portability and Accountability Act of 1996, according to a report from the Health and Human Services Department's Office of Inspector General. The OIG found that the CMS had not conducted any compliance reviews of covered entities, and instead relied on complaints to target investigations. However, the CMS has received very few complaints about violations, the report said. “As a result, the CMS had no effective mechanism to ensure that covered entities were complying with the HIPAA security rule” or that electronic health information was being adequately protected, the report concluded. CMS has taken steps to begin conducting compliance reviews in an effort to identify security problems and vulnerabilities under HIPAA, the OIG said.

Army and NIMH to Study Suicides

The National Institute of Mental Health has signed a memorandum of understanding with the U.S. Army to study suicide and suicidal behavior among active-duty soldiers, National Guard members, and Army Reservists. The 5-year, $50 million effort will be the largest study of suicide ever undertaken by the institute, according to a statement. The goal is to identify risk and protective factors for suicide, and to help the Army develop effective intervention programs. In 2007, 115 Army members committed suicide; of those, 36 committed suicide while deployed, 50 did so post deployment, and 29 had never been deployed.

Mental Illness and Hospitalizations

About 8.5 million hospital admissions in 2006 involved patients with a mental illness or a mental health comorbidity, according to the Agency for Healthcare Research and Quality. Of those, about 1.4 million patients were admitted with a mental health diagnosis while about 7.1 million were admitted for a physical condition and had a mental health comorbidity. The AHRQ report said the largest number of admissions (about 730,000) was for depression or other mood disorders. The next largest (about 381,000) was for schizophrenia and other psychotic conditions. About 131,000 patients were hospitalized for dementia or delirium, about 76,000 for anxiety or adjustment disorders, and about 34,000 for attention-deficit/hyperactivity disorder or personality disorders. The data come from the AHRQ report, Hospital Stays Related to Mental Health, 2006, based on the Nationwide Inpatient Sample.

Many Have Drug 'Gap' Coverage

A total of 13% of Medicare beneficiaries enrolled in Part D prescription drug plans and 63% of those in Medicare Advantage plans with prescription benefits had some form of coverage in the “doughnut hole,” or coverage gap, according to a Centers for Medicare and Medicaid Services study on Part D drug claims. The study, which included data on Medicare drug claims for the 25 million Part D beneficiaries, also indicated that the vast majority of enrollees used the drug benefit: In the program's first year, 90% of enrollees filled at least one prescription. In addition, the use of generic drugs has been high in Part D, rising from 60% in 2006 to nearly 68% in the first quarter of this year.

Program Cuts Illicit Drug Use

A government-supported program used to screen patients seeking health care for signs of substance abuse can reduce illicit drug use among patients seeking medical care in a wide variety of health care settings, a study found. The Screening, Brief Intervention, and Referral to Treatment program uses a variety of techniques to screen patients for signs of substance abuse. If a patient screens positive, immediate steps are taken to help the patient effectively deal with the problem. The study, published in Drug and Alcohol Dependence, found that rates of illicit drug use dropped by nearly 68% by 6 months after screening. Illicit drug users receiving brief treatment or referral to specialty treatment also reported other quality of life improvements. The Substance Abuse and Mental Health Services Administration has been awarding grants to expand the program since 2003.

Nondrug Approaches to PTSD Tested

Researchers at the Southeast Louisiana Veterans Health Care System will test a series of interventions, from yoga to guided imagery, to treat posttraumatic stress disorder and major depression in veterans returning from Iraq and Afghanistan, and their families. The randomized controlled study was funded by a grant from the Department of Defense's new Center of Excellence for Psychological Health and Traumatic Brain Injury. The $411,000, 2-year grant will study the effectiveness of a technique that includes meditation, biofeedback, and small group support. The technique was developed by the Washington-based Center for Mind-Body Medicine.

U.S. Pharmaceutical Sales Outlook

The U.S. pharmaceutical market is expected to grow 1%-2% in 2009, resulting in sales of about $292-$302 billion, according to analysis from the health care market research firm IMS Health. This latest projection is down from the 2%-3% increase projected by IMS earlier this year, and reflects the expected impact of patent expirations, fewer launches of new products, and the slowing U.S. economy. Worldwide pharmaceutical sales are expected to grow 4.5%-5.5% in 2009, similar to growth this year.

HIPAA Enforcement 'Limited'

The Centers for Medicare and Medicaid Services has not provided effective oversight and has taken only “limited actions” to ensure that covered entities adequately implement patient privacy regulations contained in the Health Insurance Portability and Accountability Act of 1996, according to a report from the Health and Human Services Department's Office of Inspector General. The OIG found that the CMS had not conducted any compliance reviews of covered entities, and instead relied on complaints to target investigations. However, the CMS has received very few complaints about violations, the report said. “As a result, the CMS had no effective mechanism to ensure that covered entities were complying with the HIPAA security rule” or that electronic health information was being adequately protected, the report concluded. CMS has taken steps to begin conducting compliance reviews in an effort to identify security problems and vulnerabilities under HIPAA, the OIG said.

A survey of internists and rheumatologists suggests that prescribing active “placebos” is relatively common, even though ethicists generally frown on the use of such therapies, especially if the patient is not informed.

The survey was conducted by five ethicists from the National Institutes of Health; the University of Chicago; and Harvard Medical School, Boston, who said they were interested in exploring physicians' attitudes about placebo treatments because there is little systematic data on the topic (BMJ 2008;337:a1938 [doi:10.1136/bmj.a1938]).

They surveyed 1,200 randomly selected physicians, half of whom were internists, and half, rheumatologists; 679 physicians (57%) agreed to participate and received $20 for completing the survey. The respondents comprised 334 internists and 345 rheumatologists.

Depending on how the question was asked, 46%−58% of the physicians said they prescribed placebos on a regular basis, and 399 of 642 (62%) said it was ethically permissible to do so.

The study was somewhat deceptive, however, said Dr. Roy Altman, a rheumatologist in Agua Dulce, Calif., who was not involved with the study. The authors did not ask the physicians if they were merely going along with patients who were already taking placebos, Dr. Altman said in an interview.

He said that if a patient is taking a placebo that he knows is not harmful, he generally won't stop him or her. “I'm not supporting the practice of giving placebos,” he said, adding, “[but] I think it's something that's a part of medicine and I don't think you can take it away.”

The authors noted that, to avoid using the word “placebo,” they began with broad questions. For example, they asked physicians to respond to a hypothetical scenario in which a dextrose tablet had proven superior to no treatment. Would they recommend it as a therapy for nondiabetics with fibromyalgia? Twenty-four percent of physicians (160 of the 654 who answered) said it was very likely they'd use the sugar pill; 34% (221 of 654) said it was moderately likely. But 31% (205) said it was unlikely and 10% (68) said definitely not.

They were then asked how often they recommend a therapy because they believe it will enhance the patient's experience. Fifty-nine percent (380 of 642) said it was permissible to recommend such a treatment; 31% (197) said it was permissible, but only in rare circumstances; and only 7% (46) said it was never permissible.

Finally, physicians were asked what therapies they had used primarily as a placebo treatment. Placebo was defined as “a treatment whose benefits derive from positive patient expectations and not from the physiological mechanism of the treatment itself.”

Fifty-five percent of the respondents (370 of 679) said they had recommended—but not necessarily prescribed—some type of placebo in the past year. A total of 267 of 648 physicians (41%) prescribed over-the-counter analgesics, and 243 of 648 physicians (38%) prescribed vitamins. Sedatives were prescribed by 86 of 652 physicians (13%); the same number prescribed antibiotics. Saline and sugar pills were used by 18 of 623 and 12 of 642 physicians (3% and 2%, respectively).

When asked how these treatments were described to patients, 18% (62 of the 352 who actually prescribed placebos) said they were “medicine.” About 285 physicians said they had not prescribed placebos. Only 18 physicians (5%) said they identify the treatments as a placebo. A large percentage—68%, or 241 of the 352—described the placebo as a medicine not typically used for the condition that might benefit the patient.

Neither age, sex, race, specialty, practice setting, nor geographic region was associated with having recommended a placebo.

An American Medical Association policy on the use of placebos is a bit murky; it advises against their use without the patient's knowledge or if the placebo could cause medical harm. A placebo can be prescribed “only if the patient is informed of and agrees to its use,” but the physician does not have to identify the placebo, or explain its potential effect, according to the policy.

In an interview, Dr. Norman Gaylis said that he believes the use of active placebos is “an inappropriate way to treat a patient.” Giving a patient naproxen, for instance, “has potential for significant side effects in the kidney, so that's not a placebo,” said Dr. Gaylis, a rheumatologist in private practice in Aventura, Fla.

Although the placebo effect is well documented in medicine and can be effective, he said, “the first thing for us is to not harm our patients.”

A survey of internists and rheumatologists suggests that prescribing active “placebos” is relatively common, even though ethicists generally frown on the use of such therapies, especially if the patient is not informed.

The survey was conducted by five ethicists from the National Institutes of Health; the University of Chicago; and Harvard Medical School, Boston, who said they were interested in exploring physicians' attitudes about placebo treatments because there is little systematic data on the topic (BMJ 2008;337:a1938 [doi:10.1136/bmj.a1938]).

They surveyed 1,200 randomly selected physicians, half of whom were internists, and half, rheumatologists; 679 physicians (57%) agreed to participate and received $20 for completing the survey. The respondents comprised 334 internists and 345 rheumatologists.

Depending on how the question was asked, 46%−58% of the physicians said they prescribed placebos on a regular basis, and 399 of 642 (62%) said it was ethically permissible to do so.

The study was somewhat deceptive, however, said Dr. Roy Altman, a rheumatologist in Agua Dulce, Calif., who was not involved with the study. The authors did not ask the physicians if they were merely going along with patients who were already taking placebos, Dr. Altman said in an interview.

He said that if a patient is taking a placebo that he knows is not harmful, he generally won't stop him or her. “I'm not supporting the practice of giving placebos,” he said, adding, “[but] I think it's something that's a part of medicine and I don't think you can take it away.”

The authors noted that, to avoid using the word “placebo,” they began with broad questions. For example, they asked physicians to respond to a hypothetical scenario in which a dextrose tablet had proven superior to no treatment. Would they recommend it as a therapy for nondiabetics with fibromyalgia? Twenty-four percent of physicians (160 of the 654 who answered) said it was very likely they'd use the sugar pill; 34% (221 of 654) said it was moderately likely. But 31% (205) said it was unlikely and 10% (68) said definitely not.

They were then asked how often they recommend a therapy because they believe it will enhance the patient's experience. Fifty-nine percent (380 of 642) said it was permissible to recommend such a treatment; 31% (197) said it was permissible, but only in rare circumstances; and only 7% (46) said it was never permissible.

Finally, physicians were asked what therapies they had used primarily as a placebo treatment. Placebo was defined as “a treatment whose benefits derive from positive patient expectations and not from the physiological mechanism of the treatment itself.”

Fifty-five percent of the respondents (370 of 679) said they had recommended—but not necessarily prescribed—some type of placebo in the past year. A total of 267 of 648 physicians (41%) prescribed over-the-counter analgesics, and 243 of 648 physicians (38%) prescribed vitamins. Sedatives were prescribed by 86 of 652 physicians (13%); the same number prescribed antibiotics. Saline and sugar pills were used by 18 of 623 and 12 of 642 physicians (3% and 2%, respectively).

When asked how these treatments were described to patients, 18% (62 of the 352 who actually prescribed placebos) said they were “medicine.” About 285 physicians said they had not prescribed placebos. Only 18 physicians (5%) said they identify the treatments as a placebo. A large percentage—68%, or 241 of the 352—described the placebo as a medicine not typically used for the condition that might benefit the patient.

Neither age, sex, race, specialty, practice setting, nor geographic region was associated with having recommended a placebo.

An American Medical Association policy on the use of placebos is a bit murky; it advises against their use without the patient's knowledge or if the placebo could cause medical harm. A placebo can be prescribed “only if the patient is informed of and agrees to its use,” but the physician does not have to identify the placebo, or explain its potential effect, according to the policy.

In an interview, Dr. Norman Gaylis said that he believes the use of active placebos is “an inappropriate way to treat a patient.” Giving a patient naproxen, for instance, “has potential for significant side effects in the kidney, so that's not a placebo,” said Dr. Gaylis, a rheumatologist in private practice in Aventura, Fla.

Although the placebo effect is well documented in medicine and can be effective, he said, “the first thing for us is to not harm our patients.”

A survey of internists and rheumatologists suggests that prescribing active “placebos” is relatively common, even though ethicists generally frown on the use of such therapies, especially if the patient is not informed.

The survey was conducted by five ethicists from the National Institutes of Health; the University of Chicago; and Harvard Medical School, Boston, who said they were interested in exploring physicians' attitudes about placebo treatments because there is little systematic data on the topic (BMJ 2008;337:a1938 [doi:10.1136/bmj.a1938]).

They surveyed 1,200 randomly selected physicians, half of whom were internists, and half, rheumatologists; 679 physicians (57%) agreed to participate and received $20 for completing the survey. The respondents comprised 334 internists and 345 rheumatologists.

Depending on how the question was asked, 46%−58% of the physicians said they prescribed placebos on a regular basis, and 399 of 642 (62%) said it was ethically permissible to do so.

The study was somewhat deceptive, however, said Dr. Roy Altman, a rheumatologist in Agua Dulce, Calif., who was not involved with the study. The authors did not ask the physicians if they were merely going along with patients who were already taking placebos, Dr. Altman said in an interview.

He said that if a patient is taking a placebo that he knows is not harmful, he generally won't stop him or her. “I'm not supporting the practice of giving placebos,” he said, adding, “[but] I think it's something that's a part of medicine and I don't think you can take it away.”

The authors noted that, to avoid using the word “placebo,” they began with broad questions. For example, they asked physicians to respond to a hypothetical scenario in which a dextrose tablet had proven superior to no treatment. Would they recommend it as a therapy for nondiabetics with fibromyalgia? Twenty-four percent of physicians (160 of the 654 who answered) said it was very likely they'd use the sugar pill; 34% (221 of 654) said it was moderately likely. But 31% (205) said it was unlikely and 10% (68) said definitely not.

They were then asked how often they recommend a therapy because they believe it will enhance the patient's experience. Fifty-nine percent (380 of 642) said it was permissible to recommend such a treatment; 31% (197) said it was permissible, but only in rare circumstances; and only 7% (46) said it was never permissible.

Finally, physicians were asked what therapies they had used primarily as a placebo treatment. Placebo was defined as “a treatment whose benefits derive from positive patient expectations and not from the physiological mechanism of the treatment itself.”

Fifty-five percent of the respondents (370 of 679) said they had recommended—but not necessarily prescribed—some type of placebo in the past year. A total of 267 of 648 physicians (41%) prescribed over-the-counter analgesics, and 243 of 648 physicians (38%) prescribed vitamins. Sedatives were prescribed by 86 of 652 physicians (13%); the same number prescribed antibiotics. Saline and sugar pills were used by 18 of 623 and 12 of 642 physicians (3% and 2%, respectively).

When asked how these treatments were described to patients, 18% (62 of the 352 who actually prescribed placebos) said they were “medicine.” About 285 physicians said they had not prescribed placebos. Only 18 physicians (5%) said they identify the treatments as a placebo. A large percentage—68%, or 241 of the 352—described the placebo as a medicine not typically used for the condition that might benefit the patient.

Neither age, sex, race, specialty, practice setting, nor geographic region was associated with having recommended a placebo.

An American Medical Association policy on the use of placebos is a bit murky; it advises against their use without the patient's knowledge or if the placebo could cause medical harm. A placebo can be prescribed “only if the patient is informed of and agrees to its use,” but the physician does not have to identify the placebo, or explain its potential effect, according to the policy.

In an interview, Dr. Norman Gaylis said that he believes the use of active placebos is “an inappropriate way to treat a patient.” Giving a patient naproxen, for instance, “has potential for significant side effects in the kidney, so that's not a placebo,” said Dr. Gaylis, a rheumatologist in private practice in Aventura, Fla.

Although the placebo effect is well documented in medicine and can be effective, he said, “the first thing for us is to not harm our patients.”