Alicia Ault

The Food and Drug Administration issued a warning to physicians and consumers that proton pump inhibitors may increase the risk of hip, wrist, and spine fractures.

The agency said that it is changing the labeling for prescription and over-the-counter versions of proton pump inhibitors (PPIs) to reflect new safety information that is the result of the FDA's review of seven epidemiologic studies. Most of the observed risk was in people older than age 50 years and those who took high doses or used the drugs for more than a year, said the agency.

Prescription PPIs include esomeprazole (Nexium), dexlansoprazole (Dexilant), omeprazole (Prilosec, Zegerid), lansoprazole (Prevacid), pantoprazole (Protonix), and rabeprazole (Aciphex). There are OTC versions of Prilosec, Zegerid, and Prevacid.

“When prescribing proton pump inhibitors, health care professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition,” Dr. Joyce Korvick, the deputy director for safety in the FDA's Division of Gastroenterology Products, in a statement.

The agency did not have access to the raw data in the studies; it merely reviewed what was published. However, said the FDA, it accepted the results because the studies appear to be well designed.

The full agency communication is online located at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213206.htm

The Food and Drug Administration issued a warning to physicians and consumers that proton pump inhibitors may increase the risk of hip, wrist, and spine fractures.

The agency said that it is changing the labeling for prescription and over-the-counter versions of proton pump inhibitors (PPIs) to reflect new safety information that is the result of the FDA's review of seven epidemiologic studies. Most of the observed risk was in people older than age 50 years and those who took high doses or used the drugs for more than a year, said the agency.

Prescription PPIs include esomeprazole (Nexium), dexlansoprazole (Dexilant), omeprazole (Prilosec, Zegerid), lansoprazole (Prevacid), pantoprazole (Protonix), and rabeprazole (Aciphex). There are OTC versions of Prilosec, Zegerid, and Prevacid.

“When prescribing proton pump inhibitors, health care professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition,” Dr. Joyce Korvick, the deputy director for safety in the FDA's Division of Gastroenterology Products, in a statement.

The agency did not have access to the raw data in the studies; it merely reviewed what was published. However, said the FDA, it accepted the results because the studies appear to be well designed.

The full agency communication is online located at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213206.htm

The Food and Drug Administration issued a warning to physicians and consumers that proton pump inhibitors may increase the risk of hip, wrist, and spine fractures.

The agency said that it is changing the labeling for prescription and over-the-counter versions of proton pump inhibitors (PPIs) to reflect new safety information that is the result of the FDA's review of seven epidemiologic studies. Most of the observed risk was in people older than age 50 years and those who took high doses or used the drugs for more than a year, said the agency.

Prescription PPIs include esomeprazole (Nexium), dexlansoprazole (Dexilant), omeprazole (Prilosec, Zegerid), lansoprazole (Prevacid), pantoprazole (Protonix), and rabeprazole (Aciphex). There are OTC versions of Prilosec, Zegerid, and Prevacid.

“When prescribing proton pump inhibitors, health care professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition,” Dr. Joyce Korvick, the deputy director for safety in the FDA's Division of Gastroenterology Products, in a statement.

The agency did not have access to the raw data in the studies; it merely reviewed what was published. However, said the FDA, it accepted the results because the studies appear to be well designed.

The full agency communication is online located at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm213206.htm

ISMP: Avandia at Top in Drug Deaths

Type 2 diabetes drug rosiglitazone (Avandia) accounted for 1,354 patient deaths in 2009, more than any other prescription drug, according to a June report from the Institute for Safe Medication Practices. However, the institute blamed publicity about the drug's cardiovascular risks in part for the large number of fatalities reported to the Food and Drug Administration (see page 1 article for more on Avandia). “The manufacturer, GlaxoSmithKline, told us earlier that it believed many of the adverse drug event reports for rosiglitazone were associated with possible lawsuits against the company,” the report said. The institute excluded reports it knew involved legal claims but said it couldn't rule out the bad publicity as the reason for some other reports of cardiovascular events and deaths associated with rosiglitazone. Other drugs tied to large numbers of deaths last year include deferasirox (1,320 deaths), digoxin (506 deaths), and fentanyl (397). Almost 20,000 medication-associated deaths were reported to the FDA, a 14% increase over 2008 and a threefold increase over 2000, according to the institute. The report attributed the drug-related mortality increase to three factors: increased awareness of drug risks, lack of progress in managing drugs with known risks, and reports of discontinued treatment and death stemming from increasingly common direct company-consumer contacts. The full report is available at

www.ismp.org/quarterwatch/2009Q4.pdf

CMS Reconsiders MRI Coverage

The Centers for Medicare and Medicaid Services is taking another look at its decision to bar coverage of magnetic resonance imaging for people who have cardiac pacemakers or metallic clips on vascular aneurysms. Dr. Robert Russo, director of the cardiac MRI program at the Scripps Clinic in San Diego asked the CMS to reopen the issue of coverage for those patients. He is seeking to have it approved if the MRI is performed on people bearing the devices as part of an FDA-approved, prospective trial to determine the risk of the procedure. Comments on the proposal were being accepted through July 28, and the CMS said that it expected to issue a preliminary decision by Dec. 28.

FDA to Share Drug-Risk Findings

The FDA will post on its Web site summaries of postmarketing safety analyses on recently approved drugs and biologics, including brief discussions of steps being taken to address identified safety issues. The new summaries will cover side effects that might not become apparent until after a medicine becomes available to a large, diverse population, including previously unidentified risks and known adverse events that occur more frequently than expected. The initial reports will contain information on drugs and biologics approved since September 2007, including several drugs for infections, hypertension, and depression, the agency said.

J&J Discloses Physician Payments

Following in the footsteps of Pfizer, GlaxoSmithKline, and, most recently, Medtronic, Johnson & Johnson said that it is disclosing how much it pays physician speakers and consultants, at least for a number of its pharmaceutical subsidiaries. Unlike at other companies, however, the data cover only J&J divisions that were subject to corporate integrity agreements with the federal government, according to a company spokesman. Those divisions are PriCara, Ortho-McNeil Pharmaceutical, Ortho-McNeil Neurologics, Janssen, and McNeil Pediatrics. Payment disclosures are listed at those units' individual Web sites, such as

www.janssen.com/transparency.html

Men Less Likely to Get Care

Men are much less likely than are women to seek routine medical care: Just over half of U.S. men see a doctor, nurse practitioner, or physician assistant for routine care, compared with nearly three-quarters of women, according to the Agency for Healthcare Research and Quality. Only about 35% of Hispanic men and 43% of black men made routine appointments, compared with 63% of white men, and uninsured people were only about half as likely as were those with private insurance to make a routine care appointment, the agency said.

State Expands Medicaid to Adults

Connecticut has added low-income, childless adults to its Medicaid program under the nation's new health care reform law. It's the first state to take advantage of the law's incentives to expand “permanent” coverage to such individuals, which could previously be covered only under Medicaid waivers. Connecticut said it initially will cover childless adults who make up to 56% of the federal poverty level, or $6,650 per year, estimated to be about 45,000 extra people. Health care reform requires states to cover all low-income individuals in Medicaid starting in 2014, but also allows states to get federal funding to enroll them early.

ISMP: Avandia at Top in Drug Deaths

Type 2 diabetes drug rosiglitazone (Avandia) accounted for 1,354 patient deaths in 2009, more than any other prescription drug, according to a June report from the Institute for Safe Medication Practices. However, the institute blamed publicity about the drug's cardiovascular risks in part for the large number of fatalities reported to the Food and Drug Administration (see page 1 article for more on Avandia). “The manufacturer, GlaxoSmithKline, told us earlier that it believed many of the adverse drug event reports for rosiglitazone were associated with possible lawsuits against the company,” the report said. The institute excluded reports it knew involved legal claims but said it couldn't rule out the bad publicity as the reason for some other reports of cardiovascular events and deaths associated with rosiglitazone. Other drugs tied to large numbers of deaths last year include deferasirox (1,320 deaths), digoxin (506 deaths), and fentanyl (397). Almost 20,000 medication-associated deaths were reported to the FDA, a 14% increase over 2008 and a threefold increase over 2000, according to the institute. The report attributed the drug-related mortality increase to three factors: increased awareness of drug risks, lack of progress in managing drugs with known risks, and reports of discontinued treatment and death stemming from increasingly common direct company-consumer contacts. The full report is available at

www.ismp.org/quarterwatch/2009Q4.pdf

CMS Reconsiders MRI Coverage

The Centers for Medicare and Medicaid Services is taking another look at its decision to bar coverage of magnetic resonance imaging for people who have cardiac pacemakers or metallic clips on vascular aneurysms. Dr. Robert Russo, director of the cardiac MRI program at the Scripps Clinic in San Diego asked the CMS to reopen the issue of coverage for those patients. He is seeking to have it approved if the MRI is performed on people bearing the devices as part of an FDA-approved, prospective trial to determine the risk of the procedure. Comments on the proposal were being accepted through July 28, and the CMS said that it expected to issue a preliminary decision by Dec. 28.

FDA to Share Drug-Risk Findings

The FDA will post on its Web site summaries of postmarketing safety analyses on recently approved drugs and biologics, including brief discussions of steps being taken to address identified safety issues. The new summaries will cover side effects that might not become apparent until after a medicine becomes available to a large, diverse population, including previously unidentified risks and known adverse events that occur more frequently than expected. The initial reports will contain information on drugs and biologics approved since September 2007, including several drugs for infections, hypertension, and depression, the agency said.

J&J Discloses Physician Payments

Following in the footsteps of Pfizer, GlaxoSmithKline, and, most recently, Medtronic, Johnson & Johnson said that it is disclosing how much it pays physician speakers and consultants, at least for a number of its pharmaceutical subsidiaries. Unlike at other companies, however, the data cover only J&J divisions that were subject to corporate integrity agreements with the federal government, according to a company spokesman. Those divisions are PriCara, Ortho-McNeil Pharmaceutical, Ortho-McNeil Neurologics, Janssen, and McNeil Pediatrics. Payment disclosures are listed at those units' individual Web sites, such as

www.janssen.com/transparency.html

Men Less Likely to Get Care

Men are much less likely than are women to seek routine medical care: Just over half of U.S. men see a doctor, nurse practitioner, or physician assistant for routine care, compared with nearly three-quarters of women, according to the Agency for Healthcare Research and Quality. Only about 35% of Hispanic men and 43% of black men made routine appointments, compared with 63% of white men, and uninsured people were only about half as likely as were those with private insurance to make a routine care appointment, the agency said.

State Expands Medicaid to Adults

Connecticut has added low-income, childless adults to its Medicaid program under the nation's new health care reform law. It's the first state to take advantage of the law's incentives to expand “permanent” coverage to such individuals, which could previously be covered only under Medicaid waivers. Connecticut said it initially will cover childless adults who make up to 56% of the federal poverty level, or $6,650 per year, estimated to be about 45,000 extra people. Health care reform requires states to cover all low-income individuals in Medicaid starting in 2014, but also allows states to get federal funding to enroll them early.

ISMP: Avandia at Top in Drug Deaths

Type 2 diabetes drug rosiglitazone (Avandia) accounted for 1,354 patient deaths in 2009, more than any other prescription drug, according to a June report from the Institute for Safe Medication Practices. However, the institute blamed publicity about the drug's cardiovascular risks in part for the large number of fatalities reported to the Food and Drug Administration (see page 1 article for more on Avandia). “The manufacturer, GlaxoSmithKline, told us earlier that it believed many of the adverse drug event reports for rosiglitazone were associated with possible lawsuits against the company,” the report said. The institute excluded reports it knew involved legal claims but said it couldn't rule out the bad publicity as the reason for some other reports of cardiovascular events and deaths associated with rosiglitazone. Other drugs tied to large numbers of deaths last year include deferasirox (1,320 deaths), digoxin (506 deaths), and fentanyl (397). Almost 20,000 medication-associated deaths were reported to the FDA, a 14% increase over 2008 and a threefold increase over 2000, according to the institute. The report attributed the drug-related mortality increase to three factors: increased awareness of drug risks, lack of progress in managing drugs with known risks, and reports of discontinued treatment and death stemming from increasingly common direct company-consumer contacts. The full report is available at

www.ismp.org/quarterwatch/2009Q4.pdf

CMS Reconsiders MRI Coverage

The Centers for Medicare and Medicaid Services is taking another look at its decision to bar coverage of magnetic resonance imaging for people who have cardiac pacemakers or metallic clips on vascular aneurysms. Dr. Robert Russo, director of the cardiac MRI program at the Scripps Clinic in San Diego asked the CMS to reopen the issue of coverage for those patients. He is seeking to have it approved if the MRI is performed on people bearing the devices as part of an FDA-approved, prospective trial to determine the risk of the procedure. Comments on the proposal were being accepted through July 28, and the CMS said that it expected to issue a preliminary decision by Dec. 28.

FDA to Share Drug-Risk Findings

The FDA will post on its Web site summaries of postmarketing safety analyses on recently approved drugs and biologics, including brief discussions of steps being taken to address identified safety issues. The new summaries will cover side effects that might not become apparent until after a medicine becomes available to a large, diverse population, including previously unidentified risks and known adverse events that occur more frequently than expected. The initial reports will contain information on drugs and biologics approved since September 2007, including several drugs for infections, hypertension, and depression, the agency said.

J&J Discloses Physician Payments

Following in the footsteps of Pfizer, GlaxoSmithKline, and, most recently, Medtronic, Johnson & Johnson said that it is disclosing how much it pays physician speakers and consultants, at least for a number of its pharmaceutical subsidiaries. Unlike at other companies, however, the data cover only J&J divisions that were subject to corporate integrity agreements with the federal government, according to a company spokesman. Those divisions are PriCara, Ortho-McNeil Pharmaceutical, Ortho-McNeil Neurologics, Janssen, and McNeil Pediatrics. Payment disclosures are listed at those units' individual Web sites, such as

www.janssen.com/transparency.html

Men Less Likely to Get Care

Men are much less likely than are women to seek routine medical care: Just over half of U.S. men see a doctor, nurse practitioner, or physician assistant for routine care, compared with nearly three-quarters of women, according to the Agency for Healthcare Research and Quality. Only about 35% of Hispanic men and 43% of black men made routine appointments, compared with 63% of white men, and uninsured people were only about half as likely as were those with private insurance to make a routine care appointment, the agency said.

State Expands Medicaid to Adults

Connecticut has added low-income, childless adults to its Medicaid program under the nation's new health care reform law. It's the first state to take advantage of the law's incentives to expand “permanent” coverage to such individuals, which could previously be covered only under Medicaid waivers. Connecticut said it initially will cover childless adults who make up to 56% of the federal poverty level, or $6,650 per year, estimated to be about 45,000 extra people. Health care reform requires states to cover all low-income individuals in Medicaid starting in 2014, but also allows states to get federal funding to enroll them early.

The number of uninsured Americans rose last year, with 21% of all adults aged 18–64 years reporting that they were uninsured at the time that they were interviewed for the National Health Interview Survey, federal officials reported June 16.

That's up from 19.7% the previous year and reflects a trend over the past decade of an increasing lack of health insurance, at least among adults, according to a survey by the National Center for Health Statistics, a part of the Centers for Disease Control and Prevention. Rates of coverage for children, on the other hand, have mostly improved.

Since 1999, increasing proportions of people have reported that they were uninsured at the time of the annual survey, for part of the year prior to their interviews, and for a year or more, said the NCHS in its report, which was released early and will be published in CDC's Morbidity and Mortality Weekly Report.

Overall, 46.3 million people—or 15.4% of the population—were uninsured at the time they were interviewed in 2009. The survey found that even greater numbers of people reported that they were uninsured for at least part of the year before the interview—some 58.5 million—but that a slightly smaller number, 32.8 million, had been uninsured for more than a year at the time they were queried.

A greater proportion of children than adults were covered by public health plans, which could explain the children's higher rate of coverage, according to the survey. In 2009, 37.7% of children under age 18 were covered by a public plan, up from 34.2% the previous year. Rates of public coverage for low-income children increased. Federal officials in both the Obama and Bush administrations have emphasized enrolling more eligible children in the public Children's Health Insurance Plan, which is administered by states.

Conversely, only 14.4% of adults aged 18–64 years had public coverage. And private coverage for adults declined from 68% in 2008 to 66% in 2009, according to the survey. There was no significant change in private coverage for children of any income level.

Hispanics were least likely to have insurance, with one-third reporting no insurance at the time of the interview or for part of the past year. A quarter had had no coverage for more than a year.

Not surprisingly, states with larger Hispanic populations had greater proportions of uninsured. One-quarter of Texas and Florida residents under age 65 years were uninsured at the time of the interview. One-fifth did not have coverage in California and Georgia. In Florida, 13% of children lacked coverage when interviewed, and in Texas, that number was almost 17%.

Nine states had lower rates of uninsured than the national average of 17.5%: Illinois, Massachusetts, Michigan, New Jersey, New York, Ohio, Pennsylvania, Washington, and Wisconsin.

For more information, go to www.cdc.gov/nchs

The number of uninsured Americans rose last year, with 21% of all adults aged 18–64 years reporting that they were uninsured at the time that they were interviewed for the National Health Interview Survey, federal officials reported June 16.

That's up from 19.7% the previous year and reflects a trend over the past decade of an increasing lack of health insurance, at least among adults, according to a survey by the National Center for Health Statistics, a part of the Centers for Disease Control and Prevention. Rates of coverage for children, on the other hand, have mostly improved.

Since 1999, increasing proportions of people have reported that they were uninsured at the time of the annual survey, for part of the year prior to their interviews, and for a year or more, said the NCHS in its report, which was released early and will be published in CDC's Morbidity and Mortality Weekly Report.

Overall, 46.3 million people—or 15.4% of the population—were uninsured at the time they were interviewed in 2009. The survey found that even greater numbers of people reported that they were uninsured for at least part of the year before the interview—some 58.5 million—but that a slightly smaller number, 32.8 million, had been uninsured for more than a year at the time they were queried.

A greater proportion of children than adults were covered by public health plans, which could explain the children's higher rate of coverage, according to the survey. In 2009, 37.7% of children under age 18 were covered by a public plan, up from 34.2% the previous year. Rates of public coverage for low-income children increased. Federal officials in both the Obama and Bush administrations have emphasized enrolling more eligible children in the public Children's Health Insurance Plan, which is administered by states.

Conversely, only 14.4% of adults aged 18–64 years had public coverage. And private coverage for adults declined from 68% in 2008 to 66% in 2009, according to the survey. There was no significant change in private coverage for children of any income level.

Hispanics were least likely to have insurance, with one-third reporting no insurance at the time of the interview or for part of the past year. A quarter had had no coverage for more than a year.

Not surprisingly, states with larger Hispanic populations had greater proportions of uninsured. One-quarter of Texas and Florida residents under age 65 years were uninsured at the time of the interview. One-fifth did not have coverage in California and Georgia. In Florida, 13% of children lacked coverage when interviewed, and in Texas, that number was almost 17%.

Nine states had lower rates of uninsured than the national average of 17.5%: Illinois, Massachusetts, Michigan, New Jersey, New York, Ohio, Pennsylvania, Washington, and Wisconsin.

For more information, go to www.cdc.gov/nchs

The number of uninsured Americans rose last year, with 21% of all adults aged 18–64 years reporting that they were uninsured at the time that they were interviewed for the National Health Interview Survey, federal officials reported June 16.

That's up from 19.7% the previous year and reflects a trend over the past decade of an increasing lack of health insurance, at least among adults, according to a survey by the National Center for Health Statistics, a part of the Centers for Disease Control and Prevention. Rates of coverage for children, on the other hand, have mostly improved.

Since 1999, increasing proportions of people have reported that they were uninsured at the time of the annual survey, for part of the year prior to their interviews, and for a year or more, said the NCHS in its report, which was released early and will be published in CDC's Morbidity and Mortality Weekly Report.

Overall, 46.3 million people—or 15.4% of the population—were uninsured at the time they were interviewed in 2009. The survey found that even greater numbers of people reported that they were uninsured for at least part of the year before the interview—some 58.5 million—but that a slightly smaller number, 32.8 million, had been uninsured for more than a year at the time they were queried.

A greater proportion of children than adults were covered by public health plans, which could explain the children's higher rate of coverage, according to the survey. In 2009, 37.7% of children under age 18 were covered by a public plan, up from 34.2% the previous year. Rates of public coverage for low-income children increased. Federal officials in both the Obama and Bush administrations have emphasized enrolling more eligible children in the public Children's Health Insurance Plan, which is administered by states.

Conversely, only 14.4% of adults aged 18–64 years had public coverage. And private coverage for adults declined from 68% in 2008 to 66% in 2009, according to the survey. There was no significant change in private coverage for children of any income level.

Hispanics were least likely to have insurance, with one-third reporting no insurance at the time of the interview or for part of the past year. A quarter had had no coverage for more than a year.

Not surprisingly, states with larger Hispanic populations had greater proportions of uninsured. One-quarter of Texas and Florida residents under age 65 years were uninsured at the time of the interview. One-fifth did not have coverage in California and Georgia. In Florida, 13% of children lacked coverage when interviewed, and in Texas, that number was almost 17%.

Nine states had lower rates of uninsured than the national average of 17.5%: Illinois, Massachusetts, Michigan, New Jersey, New York, Ohio, Pennsylvania, Washington, and Wisconsin.

For more information, go to www.cdc.gov/nchs

WASHINGTON — Direct-to-consumer genetic tests are deceptively marketed and often give misleading results that are of little or no practical use, said the U.S. Government Accountability Office in a report at a hearing of the House Energy and Commerce Committee's Subcommittee on Oversight and Investigations.

Subcommittee chairman Rep. Bart Stupak (D-Mich.) called on the three genetic testing companies in attendance to stop marketing their products to consumers until the Food and Drug Administration or National Institutes of Health can establish standards for how the testing should be conducted and how the results should be shared with consumers.

Currently, the tests are being sold without FDA approval. But Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said that the agency has been trying to assess how to regulate the products. A genetic test is subject to FDA oversight if it is a medical device being used in the diagnosis of disease or to cure, mitigate, treat, or prevent disease.

The agency has basically hung back on enforcing the rule of the law on the direct-to-consumer (DTC) tests but now is clamping down, said Dr. Shuren. In May, the FDA told Pathway Genomics Inc. that it had to get approval for its genetic health report, which it was going to sell at Walgreens stores. Pathway is no longer marketing directly to consumers.

Pathway's agreement with Walgreens “lit a fire” at the FDA, said Dr. Shuren. “We thought at this point, it's time to take action,” he said.

In June, the FDA sent similar warnings to 4 other companies: Knome Inc., Navigenics Inc., deCODE genetics, and 23andMe, and, on July 19, the agency warned 15 more companies.

The Government Accountability Office (GAO) investigated companies selling DTC tests in 2006 but was asked by the subcommittee to revisit the market in the wake of reports that companies were more “reputable.” The agency bought 10 tests each from four companies—23andMe, deCODE genetics, Pathway Genomics, and Navigenics—using five volunteer DNA donors.

Each volunteer used his or her own information when submitting one test, and submitted fictitious information for the second test. Each kit cost between $300 and $1,000.

All five donors received conflicting results. A total of 68% of the time, the donors received a different prediction for the same disease being tested, according to Gregory Kutz, managing director of the GAO's Forensic Audit and Special Investigations Unit. In one case, a donor with a pacemaker implanted for 13 years to treat atrial fibrillation was told he was at a lower risk for developing the condition.

“These results show that these tests aren't ready for prime time,” said Mr. Kutz. And yet, the market for the tests is at about $1 billion a year and is growing some 20%–30% a year, he said.

The GAO also made undercover calls to 15 companies, including the 4 from which the agency bought test kits, asking about test reliability, privacy policies, and to inquire about supplements that some of the testing firms were selling. Four of the companies claimed that “a consumer's DNA could be used to create personalized supplements that would cure diseases,” said the GAO in its report.

Representatives from 23andMe, Navigenics, and Pathway Genomics all defended their products at the hearing, but added that they agreed that more regulation of the industry was needed.

WASHINGTON — Direct-to-consumer genetic tests are deceptively marketed and often give misleading results that are of little or no practical use, said the U.S. Government Accountability Office in a report at a hearing of the House Energy and Commerce Committee's Subcommittee on Oversight and Investigations.

Subcommittee chairman Rep. Bart Stupak (D-Mich.) called on the three genetic testing companies in attendance to stop marketing their products to consumers until the Food and Drug Administration or National Institutes of Health can establish standards for how the testing should be conducted and how the results should be shared with consumers.

Currently, the tests are being sold without FDA approval. But Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said that the agency has been trying to assess how to regulate the products. A genetic test is subject to FDA oversight if it is a medical device being used in the diagnosis of disease or to cure, mitigate, treat, or prevent disease.

The agency has basically hung back on enforcing the rule of the law on the direct-to-consumer (DTC) tests but now is clamping down, said Dr. Shuren. In May, the FDA told Pathway Genomics Inc. that it had to get approval for its genetic health report, which it was going to sell at Walgreens stores. Pathway is no longer marketing directly to consumers.

Pathway's agreement with Walgreens “lit a fire” at the FDA, said Dr. Shuren. “We thought at this point, it's time to take action,” he said.

In June, the FDA sent similar warnings to 4 other companies: Knome Inc., Navigenics Inc., deCODE genetics, and 23andMe, and, on July 19, the agency warned 15 more companies.

The Government Accountability Office (GAO) investigated companies selling DTC tests in 2006 but was asked by the subcommittee to revisit the market in the wake of reports that companies were more “reputable.” The agency bought 10 tests each from four companies—23andMe, deCODE genetics, Pathway Genomics, and Navigenics—using five volunteer DNA donors.

Each volunteer used his or her own information when submitting one test, and submitted fictitious information for the second test. Each kit cost between $300 and $1,000.

All five donors received conflicting results. A total of 68% of the time, the donors received a different prediction for the same disease being tested, according to Gregory Kutz, managing director of the GAO's Forensic Audit and Special Investigations Unit. In one case, a donor with a pacemaker implanted for 13 years to treat atrial fibrillation was told he was at a lower risk for developing the condition.

“These results show that these tests aren't ready for prime time,” said Mr. Kutz. And yet, the market for the tests is at about $1 billion a year and is growing some 20%–30% a year, he said.

The GAO also made undercover calls to 15 companies, including the 4 from which the agency bought test kits, asking about test reliability, privacy policies, and to inquire about supplements that some of the testing firms were selling. Four of the companies claimed that “a consumer's DNA could be used to create personalized supplements that would cure diseases,” said the GAO in its report.

Representatives from 23andMe, Navigenics, and Pathway Genomics all defended their products at the hearing, but added that they agreed that more regulation of the industry was needed.

WASHINGTON — Direct-to-consumer genetic tests are deceptively marketed and often give misleading results that are of little or no practical use, said the U.S. Government Accountability Office in a report at a hearing of the House Energy and Commerce Committee's Subcommittee on Oversight and Investigations.

Subcommittee chairman Rep. Bart Stupak (D-Mich.) called on the three genetic testing companies in attendance to stop marketing their products to consumers until the Food and Drug Administration or National Institutes of Health can establish standards for how the testing should be conducted and how the results should be shared with consumers.

Currently, the tests are being sold without FDA approval. But Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said that the agency has been trying to assess how to regulate the products. A genetic test is subject to FDA oversight if it is a medical device being used in the diagnosis of disease or to cure, mitigate, treat, or prevent disease.

The agency has basically hung back on enforcing the rule of the law on the direct-to-consumer (DTC) tests but now is clamping down, said Dr. Shuren. In May, the FDA told Pathway Genomics Inc. that it had to get approval for its genetic health report, which it was going to sell at Walgreens stores. Pathway is no longer marketing directly to consumers.

Pathway's agreement with Walgreens “lit a fire” at the FDA, said Dr. Shuren. “We thought at this point, it's time to take action,” he said.

In June, the FDA sent similar warnings to 4 other companies: Knome Inc., Navigenics Inc., deCODE genetics, and 23andMe, and, on July 19, the agency warned 15 more companies.

The Government Accountability Office (GAO) investigated companies selling DTC tests in 2006 but was asked by the subcommittee to revisit the market in the wake of reports that companies were more “reputable.” The agency bought 10 tests each from four companies—23andMe, deCODE genetics, Pathway Genomics, and Navigenics—using five volunteer DNA donors.

Each volunteer used his or her own information when submitting one test, and submitted fictitious information for the second test. Each kit cost between $300 and $1,000.

All five donors received conflicting results. A total of 68% of the time, the donors received a different prediction for the same disease being tested, according to Gregory Kutz, managing director of the GAO's Forensic Audit and Special Investigations Unit. In one case, a donor with a pacemaker implanted for 13 years to treat atrial fibrillation was told he was at a lower risk for developing the condition.

“These results show that these tests aren't ready for prime time,” said Mr. Kutz. And yet, the market for the tests is at about $1 billion a year and is growing some 20%–30% a year, he said.

The GAO also made undercover calls to 15 companies, including the 4 from which the agency bought test kits, asking about test reliability, privacy policies, and to inquire about supplements that some of the testing firms were selling. Four of the companies claimed that “a consumer's DNA could be used to create personalized supplements that would cure diseases,” said the GAO in its report.

Representatives from 23andMe, Navigenics, and Pathway Genomics all defended their products at the hearing, but added that they agreed that more regulation of the industry was needed.

COLLEGE PARK, MD. — The Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee voted 7-1 to recommend approval of the platelet inhibitor ticagrelor to treat non–ST elevation myocardial infarction and ST-elevation myocardial infarction in patients intended to receive primary coronary intervention or who would be managed medically.

The panel did not directly address other indications being sought by ticagrelor's maker, AstraZeneca, including its use in unstable angina and after a coronary artery bypass graft (CABG). But in an interview after the meeting, FDA official Robert Temple said that the panel had basically covered all the populations that would be considered under the rubric of acute coronary syndrome (ACS). As the agency weighs approval, it will decide whether to grant specific indications, said Dr. Temple, who is head of the office reviewing ticagrelor (Brilinta).

According to the company, ticagrelor is the first reversibly binding oral adenosine diphosphate receptor antagonist. It selectively inhibits P2Y12, a key target receptor for ADP.

FDA committee member Mori J. Krantz was the lone panelist who voted against approval. He said that he was concerned about data from PLATO (A Study of Platelet Inhibition and Patient Outcomes), a pivotal study showing that patients in the United States did not fare as well as those in overseas sites. “That it went in the opposite direction is a little discomforting,” said Dr. Krantz of the University of Colorado, Denver.

Committee chairman Sanjay Kaul voted in favor of approval, but said, “I am concerned, however, about the data going in the wrong direction in the United States.” He urged the FDA to require a postapproval study that would include a substantial number of Americans and look in particular at unstable angina.

The FDA generally follows its panels' advice.

The PLATO data were first presented at the European Society of Cardiology in 2009 and published online in the New England Journal of Medicine in August 2009. The randomized, double-blind trial compared ticagrelor with clopidogrel in all-comer ACS patients. The study enrolled 18,624 patients at 862 centers in 43 countries.

AstraZeneca said that PLATO proved that ticagrelor was superior to clopidogrel, with a 16% reduction in relative risk for the primary composite end point of cardiovascular death, myocardial infarction, or stroke. The company claimed there was no difference in major bleeding as defined by the trial, but acknowledged that there was a slightly higher number of patients with intracranial hemorrhage, including fatal hemorrhage.

The FDA reviewers said that they also found a higher rate of bleeding after CABG. But the main concern—and the primary reason for the panel meeting—was why there were more cardiovascular events in Americans. AstraZeneca said that a post hoc analysis determined that Americans were taking higher doses of aspirin, which led to more heart attacks, strokes, and deaths.

After lengthy debate, the committee said the difference could not be attributed to chance alone or to the aspirin dosages. Differences in clinical practice in the United States were the more likely explanation, said several panelists.

Members of FDA advisory panels have been cleared of conflicts related to the topic under discussion.

The agency is due to make a decision on the application for approval by Sept. 18.

COLLEGE PARK, MD. — The Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee voted 7-1 to recommend approval of the platelet inhibitor ticagrelor to treat non–ST elevation myocardial infarction and ST-elevation myocardial infarction in patients intended to receive primary coronary intervention or who would be managed medically.

The panel did not directly address other indications being sought by ticagrelor's maker, AstraZeneca, including its use in unstable angina and after a coronary artery bypass graft (CABG). But in an interview after the meeting, FDA official Robert Temple said that the panel had basically covered all the populations that would be considered under the rubric of acute coronary syndrome (ACS). As the agency weighs approval, it will decide whether to grant specific indications, said Dr. Temple, who is head of the office reviewing ticagrelor (Brilinta).

According to the company, ticagrelor is the first reversibly binding oral adenosine diphosphate receptor antagonist. It selectively inhibits P2Y12, a key target receptor for ADP.

FDA committee member Mori J. Krantz was the lone panelist who voted against approval. He said that he was concerned about data from PLATO (A Study of Platelet Inhibition and Patient Outcomes), a pivotal study showing that patients in the United States did not fare as well as those in overseas sites. “That it went in the opposite direction is a little discomforting,” said Dr. Krantz of the University of Colorado, Denver.

Committee chairman Sanjay Kaul voted in favor of approval, but said, “I am concerned, however, about the data going in the wrong direction in the United States.” He urged the FDA to require a postapproval study that would include a substantial number of Americans and look in particular at unstable angina.

The FDA generally follows its panels' advice.

The PLATO data were first presented at the European Society of Cardiology in 2009 and published online in the New England Journal of Medicine in August 2009. The randomized, double-blind trial compared ticagrelor with clopidogrel in all-comer ACS patients. The study enrolled 18,624 patients at 862 centers in 43 countries.

AstraZeneca said that PLATO proved that ticagrelor was superior to clopidogrel, with a 16% reduction in relative risk for the primary composite end point of cardiovascular death, myocardial infarction, or stroke. The company claimed there was no difference in major bleeding as defined by the trial, but acknowledged that there was a slightly higher number of patients with intracranial hemorrhage, including fatal hemorrhage.

The FDA reviewers said that they also found a higher rate of bleeding after CABG. But the main concern—and the primary reason for the panel meeting—was why there were more cardiovascular events in Americans. AstraZeneca said that a post hoc analysis determined that Americans were taking higher doses of aspirin, which led to more heart attacks, strokes, and deaths.

After lengthy debate, the committee said the difference could not be attributed to chance alone or to the aspirin dosages. Differences in clinical practice in the United States were the more likely explanation, said several panelists.

Members of FDA advisory panels have been cleared of conflicts related to the topic under discussion.

The agency is due to make a decision on the application for approval by Sept. 18.

COLLEGE PARK, MD. — The Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee voted 7-1 to recommend approval of the platelet inhibitor ticagrelor to treat non–ST elevation myocardial infarction and ST-elevation myocardial infarction in patients intended to receive primary coronary intervention or who would be managed medically.

The panel did not directly address other indications being sought by ticagrelor's maker, AstraZeneca, including its use in unstable angina and after a coronary artery bypass graft (CABG). But in an interview after the meeting, FDA official Robert Temple said that the panel had basically covered all the populations that would be considered under the rubric of acute coronary syndrome (ACS). As the agency weighs approval, it will decide whether to grant specific indications, said Dr. Temple, who is head of the office reviewing ticagrelor (Brilinta).

According to the company, ticagrelor is the first reversibly binding oral adenosine diphosphate receptor antagonist. It selectively inhibits P2Y12, a key target receptor for ADP.

FDA committee member Mori J. Krantz was the lone panelist who voted against approval. He said that he was concerned about data from PLATO (A Study of Platelet Inhibition and Patient Outcomes), a pivotal study showing that patients in the United States did not fare as well as those in overseas sites. “That it went in the opposite direction is a little discomforting,” said Dr. Krantz of the University of Colorado, Denver.

Committee chairman Sanjay Kaul voted in favor of approval, but said, “I am concerned, however, about the data going in the wrong direction in the United States.” He urged the FDA to require a postapproval study that would include a substantial number of Americans and look in particular at unstable angina.

The FDA generally follows its panels' advice.

The PLATO data were first presented at the European Society of Cardiology in 2009 and published online in the New England Journal of Medicine in August 2009. The randomized, double-blind trial compared ticagrelor with clopidogrel in all-comer ACS patients. The study enrolled 18,624 patients at 862 centers in 43 countries.

AstraZeneca said that PLATO proved that ticagrelor was superior to clopidogrel, with a 16% reduction in relative risk for the primary composite end point of cardiovascular death, myocardial infarction, or stroke. The company claimed there was no difference in major bleeding as defined by the trial, but acknowledged that there was a slightly higher number of patients with intracranial hemorrhage, including fatal hemorrhage.

The FDA reviewers said that they also found a higher rate of bleeding after CABG. But the main concern—and the primary reason for the panel meeting—was why there were more cardiovascular events in Americans. AstraZeneca said that a post hoc analysis determined that Americans were taking higher doses of aspirin, which led to more heart attacks, strokes, and deaths.

After lengthy debate, the committee said the difference could not be attributed to chance alone or to the aspirin dosages. Differences in clinical practice in the United States were the more likely explanation, said several panelists.

Members of FDA advisory panels have been cleared of conflicts related to the topic under discussion.

The agency is due to make a decision on the application for approval by Sept. 18.

Psychiatrists in High Demand

The physician search firm Merritt Hawkins & Associates says that from April 2009 to March 2010, requests for psychiatrists jumped 47% over the previous year, and 121% from 3 years ago. The Irving, Tex.–based company said that the increased demand is attributable to the recession and its accompanying rise in stress-related conditions. And as the population ages and more Afghanistan and Iraq war veterans need mental health services, the supply of psychiatrists is dwindling, said Merritt Hawkins. “The shortage of psychiatrists may be a silent one, but it is real nonetheless,” said company president Mark Smith in a statement. The company also reported that more physicians are choosing to work as hospital employees. Four years ago, 23% of physician searches were for positions in hospitals, but in the latest survey, that portion jumped to 51%.

Prescription Narcotic Treatment Up

Almost 10% of substance abuse treatment admissions in 2008 involved prescription narcotic painkiller abuse, quadruple the proportion in 1998, according to the Substance Abuse and Mental Health Services Administration (SAMHSA). The increase touched all age groups, both sexes, and all levels of education and employment. However, slightly more prescription abuse occurred among women and people with higher-than–high school educations, with 13% and 12% of their abuse admissions involving prescription narcotics, respectively. “The nonmedical use of prescription pain relievers is now the second most prevalent form of illicit dug use in the nation,” said the agency's administrator, Pamela S. Hyde, in a statement. It is also the fastest-growing problem, according to the White House Office of National Drug Control Policy. A SAMHSA study released in June found that emergency department visits for nonmedical use of painkillers had doubled between 2004 and 2008.

Millions Get Urgent Mental Care

One in eight (or 12 million) of the nation's 95 million emergency department visits in 2007 was for a mental disorder, substance abuse problem, or both, according to the Agency for Healthcare Research and Quality. Of those 12 million visits, 43% were for depression, 26% for anxiety, and 23% for alcohol-related problems. Two-thirds were for a mental disorder alone, 25% for substance abuse alone, and the remainder for both issues, said the agency. Hospitalizations resulted from 41% of these visits, a rate that's 2.5 times higher than that for emergency department visits not related to mental disorders or substance abuse. The data are in the report “Mental Health and Substance Abuse–Related Emergency Department Visits Among Adults, 2007,” available at

www.hcup-us.ahrq.gov/reports/statbriefs/sb92.pdf

313 Drugs Are in the Pipeline

The Pharmaceutical Research and Manufacturers of America said that there are 313 medications in development to treat mental illness. Of these, 90 (the largest group) are being developed to treat dementias. Two of those–both in phase III testing–are imaging agents intended to be used to diagnose Alzheimer's disease. The next largest category of agents would treat depression, with 71 such products in development. Some 54 drugs are being investigated for schizophrenia, 33 for addiction disorders, 38 for anxiety disorders, 33 for eating disorders (primarily obesity, but also anorexia and bulimia), 21 for sleep disorders, and a handful of drugs for fragile X syndrome and autism. The manufacturers' trade group said that mental illness costs the United States more than $317 billion a year in lost wages, health costs, and disability benefits.

Teen Smoking Leveled Off

The long decline in teen smoking slowed from 2003 to 2009, according to data published in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report (2010;59:797-801). The CDC analyzed data from the biennial Youth Risk Behavior Survey for trends from 1991 to 2009, and found that the prevalence of teens who said they'd ever smoked cigarettes declined from 70% in 1991 to 58% in 2003, but had dropped no farther than 46% in 2009. The proportion that had smoked least 1 day of the 30 days before the survey declined from 36% in 1997 to 22% in 2003 and to 19% in 2009. Current frequent smokers dropped from 17% in 1999 to 10% in 2003 and to 7% in 2009. “The slow progress since 2003 tells us that much more needs to be done to reduce youth smoking,” said CDC Director Thomas R. Frieden in a statement.

Bill Seeks Federal Safety Net

A congressional proposal would establish a network of federally qualified behavioral health centers to provide mental health and substance abuse services to low-income Americans. The Community Mental Health and Addictions Safety Net Equity Act (H.R. 5636) was introduced by Rep. Doris Matsui (D-Calif.) and Rep. Eliot Engel (D-N.Y.). It would reimburse the federally qualified centers through Medicaid. “Investing in mental health and addictions treatment can save our economy the many billions we now spend” on emergency department visits, incarceration, and lost productivity, said Rep. Matsui in a statement. The legislation is supported by the National Alliance on Mental Illness and the National Council for Community Behavioral Healthcare, among other organizations.

Psychiatrists in High Demand

The physician search firm Merritt Hawkins & Associates says that from April 2009 to March 2010, requests for psychiatrists jumped 47% over the previous year, and 121% from 3 years ago. The Irving, Tex.–based company said that the increased demand is attributable to the recession and its accompanying rise in stress-related conditions. And as the population ages and more Afghanistan and Iraq war veterans need mental health services, the supply of psychiatrists is dwindling, said Merritt Hawkins. “The shortage of psychiatrists may be a silent one, but it is real nonetheless,” said company president Mark Smith in a statement. The company also reported that more physicians are choosing to work as hospital employees. Four years ago, 23% of physician searches were for positions in hospitals, but in the latest survey, that portion jumped to 51%.

Prescription Narcotic Treatment Up

Almost 10% of substance abuse treatment admissions in 2008 involved prescription narcotic painkiller abuse, quadruple the proportion in 1998, according to the Substance Abuse and Mental Health Services Administration (SAMHSA). The increase touched all age groups, both sexes, and all levels of education and employment. However, slightly more prescription abuse occurred among women and people with higher-than–high school educations, with 13% and 12% of their abuse admissions involving prescription narcotics, respectively. “The nonmedical use of prescription pain relievers is now the second most prevalent form of illicit dug use in the nation,” said the agency's administrator, Pamela S. Hyde, in a statement. It is also the fastest-growing problem, according to the White House Office of National Drug Control Policy. A SAMHSA study released in June found that emergency department visits for nonmedical use of painkillers had doubled between 2004 and 2008.

Millions Get Urgent Mental Care

One in eight (or 12 million) of the nation's 95 million emergency department visits in 2007 was for a mental disorder, substance abuse problem, or both, according to the Agency for Healthcare Research and Quality. Of those 12 million visits, 43% were for depression, 26% for anxiety, and 23% for alcohol-related problems. Two-thirds were for a mental disorder alone, 25% for substance abuse alone, and the remainder for both issues, said the agency. Hospitalizations resulted from 41% of these visits, a rate that's 2.5 times higher than that for emergency department visits not related to mental disorders or substance abuse. The data are in the report “Mental Health and Substance Abuse–Related Emergency Department Visits Among Adults, 2007,” available at

www.hcup-us.ahrq.gov/reports/statbriefs/sb92.pdf

313 Drugs Are in the Pipeline

The Pharmaceutical Research and Manufacturers of America said that there are 313 medications in development to treat mental illness. Of these, 90 (the largest group) are being developed to treat dementias. Two of those–both in phase III testing–are imaging agents intended to be used to diagnose Alzheimer's disease. The next largest category of agents would treat depression, with 71 such products in development. Some 54 drugs are being investigated for schizophrenia, 33 for addiction disorders, 38 for anxiety disorders, 33 for eating disorders (primarily obesity, but also anorexia and bulimia), 21 for sleep disorders, and a handful of drugs for fragile X syndrome and autism. The manufacturers' trade group said that mental illness costs the United States more than $317 billion a year in lost wages, health costs, and disability benefits.

Teen Smoking Leveled Off

The long decline in teen smoking slowed from 2003 to 2009, according to data published in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report (2010;59:797-801). The CDC analyzed data from the biennial Youth Risk Behavior Survey for trends from 1991 to 2009, and found that the prevalence of teens who said they'd ever smoked cigarettes declined from 70% in 1991 to 58% in 2003, but had dropped no farther than 46% in 2009. The proportion that had smoked least 1 day of the 30 days before the survey declined from 36% in 1997 to 22% in 2003 and to 19% in 2009. Current frequent smokers dropped from 17% in 1999 to 10% in 2003 and to 7% in 2009. “The slow progress since 2003 tells us that much more needs to be done to reduce youth smoking,” said CDC Director Thomas R. Frieden in a statement.

Bill Seeks Federal Safety Net

A congressional proposal would establish a network of federally qualified behavioral health centers to provide mental health and substance abuse services to low-income Americans. The Community Mental Health and Addictions Safety Net Equity Act (H.R. 5636) was introduced by Rep. Doris Matsui (D-Calif.) and Rep. Eliot Engel (D-N.Y.). It would reimburse the federally qualified centers through Medicaid. “Investing in mental health and addictions treatment can save our economy the many billions we now spend” on emergency department visits, incarceration, and lost productivity, said Rep. Matsui in a statement. The legislation is supported by the National Alliance on Mental Illness and the National Council for Community Behavioral Healthcare, among other organizations.

Psychiatrists in High Demand

The physician search firm Merritt Hawkins & Associates says that from April 2009 to March 2010, requests for psychiatrists jumped 47% over the previous year, and 121% from 3 years ago. The Irving, Tex.–based company said that the increased demand is attributable to the recession and its accompanying rise in stress-related conditions. And as the population ages and more Afghanistan and Iraq war veterans need mental health services, the supply of psychiatrists is dwindling, said Merritt Hawkins. “The shortage of psychiatrists may be a silent one, but it is real nonetheless,” said company president Mark Smith in a statement. The company also reported that more physicians are choosing to work as hospital employees. Four years ago, 23% of physician searches were for positions in hospitals, but in the latest survey, that portion jumped to 51%.

Prescription Narcotic Treatment Up

Almost 10% of substance abuse treatment admissions in 2008 involved prescription narcotic painkiller abuse, quadruple the proportion in 1998, according to the Substance Abuse and Mental Health Services Administration (SAMHSA). The increase touched all age groups, both sexes, and all levels of education and employment. However, slightly more prescription abuse occurred among women and people with higher-than–high school educations, with 13% and 12% of their abuse admissions involving prescription narcotics, respectively. “The nonmedical use of prescription pain relievers is now the second most prevalent form of illicit dug use in the nation,” said the agency's administrator, Pamela S. Hyde, in a statement. It is also the fastest-growing problem, according to the White House Office of National Drug Control Policy. A SAMHSA study released in June found that emergency department visits for nonmedical use of painkillers had doubled between 2004 and 2008.

Millions Get Urgent Mental Care

One in eight (or 12 million) of the nation's 95 million emergency department visits in 2007 was for a mental disorder, substance abuse problem, or both, according to the Agency for Healthcare Research and Quality. Of those 12 million visits, 43% were for depression, 26% for anxiety, and 23% for alcohol-related problems. Two-thirds were for a mental disorder alone, 25% for substance abuse alone, and the remainder for both issues, said the agency. Hospitalizations resulted from 41% of these visits, a rate that's 2.5 times higher than that for emergency department visits not related to mental disorders or substance abuse. The data are in the report “Mental Health and Substance Abuse–Related Emergency Department Visits Among Adults, 2007,” available at

www.hcup-us.ahrq.gov/reports/statbriefs/sb92.pdf

313 Drugs Are in the Pipeline

The Pharmaceutical Research and Manufacturers of America said that there are 313 medications in development to treat mental illness. Of these, 90 (the largest group) are being developed to treat dementias. Two of those–both in phase III testing–are imaging agents intended to be used to diagnose Alzheimer's disease. The next largest category of agents would treat depression, with 71 such products in development. Some 54 drugs are being investigated for schizophrenia, 33 for addiction disorders, 38 for anxiety disorders, 33 for eating disorders (primarily obesity, but also anorexia and bulimia), 21 for sleep disorders, and a handful of drugs for fragile X syndrome and autism. The manufacturers' trade group said that mental illness costs the United States more than $317 billion a year in lost wages, health costs, and disability benefits.

Teen Smoking Leveled Off

The long decline in teen smoking slowed from 2003 to 2009, according to data published in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report (2010;59:797-801). The CDC analyzed data from the biennial Youth Risk Behavior Survey for trends from 1991 to 2009, and found that the prevalence of teens who said they'd ever smoked cigarettes declined from 70% in 1991 to 58% in 2003, but had dropped no farther than 46% in 2009. The proportion that had smoked least 1 day of the 30 days before the survey declined from 36% in 1997 to 22% in 2003 and to 19% in 2009. Current frequent smokers dropped from 17% in 1999 to 10% in 2003 and to 7% in 2009. “The slow progress since 2003 tells us that much more needs to be done to reduce youth smoking,” said CDC Director Thomas R. Frieden in a statement.

Bill Seeks Federal Safety Net

A congressional proposal would establish a network of federally qualified behavioral health centers to provide mental health and substance abuse services to low-income Americans. The Community Mental Health and Addictions Safety Net Equity Act (H.R. 5636) was introduced by Rep. Doris Matsui (D-Calif.) and Rep. Eliot Engel (D-N.Y.). It would reimburse the federally qualified centers through Medicaid. “Investing in mental health and addictions treatment can save our economy the many billions we now spend” on emergency department visits, incarceration, and lost productivity, said Rep. Matsui in a statement. The legislation is supported by the National Alliance on Mental Illness and the National Council for Community Behavioral Healthcare, among other organizations.

WASHINGTON – The federal government is seeking to track acute and long-term health effects in individuals working to clean up the BP oil spill in the Gulf of Mexico and is enlisting health care providers to assist, the director of the National Institute for Occupational Safety and Health (NIOSH) testified at a hearing.

Dr. John Howard said at the June 16 hearing that the agency he leads had begun enrolling workers in what could end up becoming a formal registry. NIOSH is eager to have a full list of anyone involved in the clean-up, he said, noting that no such list was compiled for volunteers and others who helped at Ground Zero in the wake of Sept. 11, 2001. The lack of such a list made it difficult to go back and correlate either acute or long-term health complaints with exposure, he said.

NIOSH is “trying to keep all health care professionals alerted to our rostering effort,” so that all workers who are potentially exposed to any hazards are included in the database, Dr. Howard said. He called on Gulf region physicians to refer to NIOSH any patients they might see who have worked on the clean-up effort.

NIOSH employees have gone into the field and to BP-operated training centers to ask workers to complete a simple one-page questionnaire. The questionnaire seeks demographic data, whether the worker is a contractor, BP employee, or volunteer. It includes specific questions relating to the type of work being done, duration of the work, and whether the person smokes or has been vaccinated for tetanus. Federal officials hope to post the questionnaire online shortly, and are asking physicians who encounter workers to direct them to NIOSH to complete the survey.

So far, 13,000 workers have completed forms, said Dr. Howard, but he estimates that at least another 15,000-20,000 people are working on the clean-up. NIOSH asked for but has yet to receive a full list of BP workers involved, Dr. Howard said. “It's a simple request,” he said to reporters after the hearing. Dr. Howard expressed consternation that the oil company had yet to respond.

Clean-up workers will receive the most significant exposure to toxic substances, he said, adding that they would be the best group to study to determine long-term risks. Currently, there are few data on long-term health effects of exposures to oil and to the chemicals, such as dispersants, being used in the clean-up, Dr. Howard said.

The federal government also is attempting to track exposures in the general population. The American Association of Poison Control Centers has directed its 60 local centers in all 50 states to code any calls related to the oil spill so that the Centers for Disease Control and Prevention can track them, said Dr. Howard. As of May 27, there were 93 calls, mostly from Louisiana and Mississippi. In all, 34 callers had been exposed to oil and reported symptoms, including cough, nausea, headache, eye irritation, chest pain, and dizziness, according to data on the CDC's Web site.

Health issues are also being tracked through BioSense, an existing network of health facilities that track health changes in real time and report back to the CDC. There are 86 participating facilities in the five Gulf states. So far, there have been some spikes in skin irritation and asthma in two states; investigations are continuing.

State health departments in Alabama, Florida, Louisiana, and Mississippi are also soliciting reports and tracking illnesses. At press time, the Louisiana Department of Health and Hospitals reported 109 spill-related illnesses–74 from workers and 35 from the public. In all, 33 were reported through poison control centers; 43 through emergency departments; and others from urgent care centers, clinics, physician offices, and a hotline. Most of the complaints were of odors or inhalation issues. There were nine hospitalizations, all in workers.

Many lawmakers at the hearing said they were concerned that both workers and residents of the Gulf states were being given confusing messages about health and safety and where to report exposures or problems. In addition to the state health departments, the CDC, NIOSH, and BP are also taking exposure reports.

Dr. Howard said that was one reason he was pushing BP to correlate its list with NIOSH. He also said that he supports a centralized Web site for all the spill-related data.

The Environmental Protection Agency is also monitoring the air, water, and soil and issuing reports on its Web site; the Food and Drug Administration is tracking seafood safety.

WASHINGTON – The federal government is seeking to track acute and long-term health effects in individuals working to clean up the BP oil spill in the Gulf of Mexico and is enlisting health care providers to assist, the director of the National Institute for Occupational Safety and Health (NIOSH) testified at a hearing.

Dr. John Howard said at the June 16 hearing that the agency he leads had begun enrolling workers in what could end up becoming a formal registry. NIOSH is eager to have a full list of anyone involved in the clean-up, he said, noting that no such list was compiled for volunteers and others who helped at Ground Zero in the wake of Sept. 11, 2001. The lack of such a list made it difficult to go back and correlate either acute or long-term health complaints with exposure, he said.

NIOSH is “trying to keep all health care professionals alerted to our rostering effort,” so that all workers who are potentially exposed to any hazards are included in the database, Dr. Howard said. He called on Gulf region physicians to refer to NIOSH any patients they might see who have worked on the clean-up effort.

NIOSH employees have gone into the field and to BP-operated training centers to ask workers to complete a simple one-page questionnaire. The questionnaire seeks demographic data, whether the worker is a contractor, BP employee, or volunteer. It includes specific questions relating to the type of work being done, duration of the work, and whether the person smokes or has been vaccinated for tetanus. Federal officials hope to post the questionnaire online shortly, and are asking physicians who encounter workers to direct them to NIOSH to complete the survey.

So far, 13,000 workers have completed forms, said Dr. Howard, but he estimates that at least another 15,000-20,000 people are working on the clean-up. NIOSH asked for but has yet to receive a full list of BP workers involved, Dr. Howard said. “It's a simple request,” he said to reporters after the hearing. Dr. Howard expressed consternation that the oil company had yet to respond.

Clean-up workers will receive the most significant exposure to toxic substances, he said, adding that they would be the best group to study to determine long-term risks. Currently, there are few data on long-term health effects of exposures to oil and to the chemicals, such as dispersants, being used in the clean-up, Dr. Howard said.

The federal government also is attempting to track exposures in the general population. The American Association of Poison Control Centers has directed its 60 local centers in all 50 states to code any calls related to the oil spill so that the Centers for Disease Control and Prevention can track them, said Dr. Howard. As of May 27, there were 93 calls, mostly from Louisiana and Mississippi. In all, 34 callers had been exposed to oil and reported symptoms, including cough, nausea, headache, eye irritation, chest pain, and dizziness, according to data on the CDC's Web site.

Health issues are also being tracked through BioSense, an existing network of health facilities that track health changes in real time and report back to the CDC. There are 86 participating facilities in the five Gulf states. So far, there have been some spikes in skin irritation and asthma in two states; investigations are continuing.

State health departments in Alabama, Florida, Louisiana, and Mississippi are also soliciting reports and tracking illnesses. At press time, the Louisiana Department of Health and Hospitals reported 109 spill-related illnesses–74 from workers and 35 from the public. In all, 33 were reported through poison control centers; 43 through emergency departments; and others from urgent care centers, clinics, physician offices, and a hotline. Most of the complaints were of odors or inhalation issues. There were nine hospitalizations, all in workers.

Many lawmakers at the hearing said they were concerned that both workers and residents of the Gulf states were being given confusing messages about health and safety and where to report exposures or problems. In addition to the state health departments, the CDC, NIOSH, and BP are also taking exposure reports.

Dr. Howard said that was one reason he was pushing BP to correlate its list with NIOSH. He also said that he supports a centralized Web site for all the spill-related data.

The Environmental Protection Agency is also monitoring the air, water, and soil and issuing reports on its Web site; the Food and Drug Administration is tracking seafood safety.

WASHINGTON – The federal government is seeking to track acute and long-term health effects in individuals working to clean up the BP oil spill in the Gulf of Mexico and is enlisting health care providers to assist, the director of the National Institute for Occupational Safety and Health (NIOSH) testified at a hearing.

Dr. John Howard said at the June 16 hearing that the agency he leads had begun enrolling workers in what could end up becoming a formal registry. NIOSH is eager to have a full list of anyone involved in the clean-up, he said, noting that no such list was compiled for volunteers and others who helped at Ground Zero in the wake of Sept. 11, 2001. The lack of such a list made it difficult to go back and correlate either acute or long-term health complaints with exposure, he said.

NIOSH is “trying to keep all health care professionals alerted to our rostering effort,” so that all workers who are potentially exposed to any hazards are included in the database, Dr. Howard said. He called on Gulf region physicians to refer to NIOSH any patients they might see who have worked on the clean-up effort.

NIOSH employees have gone into the field and to BP-operated training centers to ask workers to complete a simple one-page questionnaire. The questionnaire seeks demographic data, whether the worker is a contractor, BP employee, or volunteer. It includes specific questions relating to the type of work being done, duration of the work, and whether the person smokes or has been vaccinated for tetanus. Federal officials hope to post the questionnaire online shortly, and are asking physicians who encounter workers to direct them to NIOSH to complete the survey.

So far, 13,000 workers have completed forms, said Dr. Howard, but he estimates that at least another 15,000-20,000 people are working on the clean-up. NIOSH asked for but has yet to receive a full list of BP workers involved, Dr. Howard said. “It's a simple request,” he said to reporters after the hearing. Dr. Howard expressed consternation that the oil company had yet to respond.

Clean-up workers will receive the most significant exposure to toxic substances, he said, adding that they would be the best group to study to determine long-term risks. Currently, there are few data on long-term health effects of exposures to oil and to the chemicals, such as dispersants, being used in the clean-up, Dr. Howard said.

The federal government also is attempting to track exposures in the general population. The American Association of Poison Control Centers has directed its 60 local centers in all 50 states to code any calls related to the oil spill so that the Centers for Disease Control and Prevention can track them, said Dr. Howard. As of May 27, there were 93 calls, mostly from Louisiana and Mississippi. In all, 34 callers had been exposed to oil and reported symptoms, including cough, nausea, headache, eye irritation, chest pain, and dizziness, according to data on the CDC's Web site.

Health issues are also being tracked through BioSense, an existing network of health facilities that track health changes in real time and report back to the CDC. There are 86 participating facilities in the five Gulf states. So far, there have been some spikes in skin irritation and asthma in two states; investigations are continuing.

State health departments in Alabama, Florida, Louisiana, and Mississippi are also soliciting reports and tracking illnesses. At press time, the Louisiana Department of Health and Hospitals reported 109 spill-related illnesses–74 from workers and 35 from the public. In all, 33 were reported through poison control centers; 43 through emergency departments; and others from urgent care centers, clinics, physician offices, and a hotline. Most of the complaints were of odors or inhalation issues. There were nine hospitalizations, all in workers.

Many lawmakers at the hearing said they were concerned that both workers and residents of the Gulf states were being given confusing messages about health and safety and where to report exposures or problems. In addition to the state health departments, the CDC, NIOSH, and BP are also taking exposure reports.

Dr. Howard said that was one reason he was pushing BP to correlate its list with NIOSH. He also said that he supports a centralized Web site for all the spill-related data.

The Environmental Protection Agency is also monitoring the air, water, and soil and issuing reports on its Web site; the Food and Drug Administration is tracking seafood safety.

The federal government published regulations that will allow for temporary certification of electronic health records—the first step in helping physicians and other providers get the software and hardware required to be eligible for bonus payments under federal health programs.

According to the Office of the National Coordinator for Health Information Technology (ONC), the rule “establishes processes that organizations will need to follow in order to be authorized by the National Coordinator to test and certify [electronic health record] technology.”

“We hope that all [health information technology] stakeholders view this rule as the federal government's commitment to reduce uncertainty in the health IT marketplace and advance the successful implementation of EHR incentive programs,” Dr. David Blumenthal, national coordinator for health information technology, said in a statement.

Certification means that the EHR package has been tested and includes the required capabilities to meet the “meaningful use” standards issued by ONC. Hospitals and physicians will have the assurance that the certified EHRs can help them improve the quality of care and qualify for bonus payments under Medicare or Medicaid.

By purchasing certified EHR technology, hospitals and eligible professionals will be able to make EHR purchasing decisions knowing that the technology will allow them to become meaningful users of electronic health records, qualify for the payment incentives, and begin to use EHRs in a way that will improve quality and efficiency in our health care system, Dr. Blumenthal said.

This rule is for a temporary program. A final rule on permanent certification of EHRs will be issued in the fall.

For more information about the temporary certification program and rule, please visit http://healthit.hhs.gov/certification

The federal government published regulations that will allow for temporary certification of electronic health records—the first step in helping physicians and other providers get the software and hardware required to be eligible for bonus payments under federal health programs.

According to the Office of the National Coordinator for Health Information Technology (ONC), the rule “establishes processes that organizations will need to follow in order to be authorized by the National Coordinator to test and certify [electronic health record] technology.”

“We hope that all [health information technology] stakeholders view this rule as the federal government's commitment to reduce uncertainty in the health IT marketplace and advance the successful implementation of EHR incentive programs,” Dr. David Blumenthal, national coordinator for health information technology, said in a statement.

Certification means that the EHR package has been tested and includes the required capabilities to meet the “meaningful use” standards issued by ONC. Hospitals and physicians will have the assurance that the certified EHRs can help them improve the quality of care and qualify for bonus payments under Medicare or Medicaid.

By purchasing certified EHR technology, hospitals and eligible professionals will be able to make EHR purchasing decisions knowing that the technology will allow them to become meaningful users of electronic health records, qualify for the payment incentives, and begin to use EHRs in a way that will improve quality and efficiency in our health care system, Dr. Blumenthal said.

This rule is for a temporary program. A final rule on permanent certification of EHRs will be issued in the fall.

For more information about the temporary certification program and rule, please visit http://healthit.hhs.gov/certification

The federal government published regulations that will allow for temporary certification of electronic health records—the first step in helping physicians and other providers get the software and hardware required to be eligible for bonus payments under federal health programs.

According to the Office of the National Coordinator for Health Information Technology (ONC), the rule “establishes processes that organizations will need to follow in order to be authorized by the National Coordinator to test and certify [electronic health record] technology.”

“We hope that all [health information technology] stakeholders view this rule as the federal government's commitment to reduce uncertainty in the health IT marketplace and advance the successful implementation of EHR incentive programs,” Dr. David Blumenthal, national coordinator for health information technology, said in a statement.

Certification means that the EHR package has been tested and includes the required capabilities to meet the “meaningful use” standards issued by ONC. Hospitals and physicians will have the assurance that the certified EHRs can help them improve the quality of care and qualify for bonus payments under Medicare or Medicaid.

By purchasing certified EHR technology, hospitals and eligible professionals will be able to make EHR purchasing decisions knowing that the technology will allow them to become meaningful users of electronic health records, qualify for the payment incentives, and begin to use EHRs in a way that will improve quality and efficiency in our health care system, Dr. Blumenthal said.

This rule is for a temporary program. A final rule on permanent certification of EHRs will be issued in the fall.

For more information about the temporary certification program and rule, please visit http://healthit.hhs.gov/certification

The Accreditation Council for Graduate Medical Education has revisited its standards for resident duty hours and determined that some modifications should be made, mostly for first-year residents. All other residents should still be subject to an 80-hour work week and up to 24 hours of continuous duty, according to an article published online.

The 16-member ACGME task force that wrote the standards will review public comments and make any modifications considered necessary before July 2011, when the new standards will go into effect.

The original ACGME standards, established in 2003, have been the subject of much consternation in the medical community, with opinions differing over whether they have been too restrictive or too loose to properly protect patients and ensure a good quality of life for residents.

According to the latest report, written by Dr. Thomas J. Nasca, Dr. Susan H. Day, and Dr. E. Stephen Amis Jr. on behalf of the ACGME task force, the 2003 standards had the following three “problematic” elements, as identified by the educational community and the public:

▸ The limits on duty hours may have created a shift mentality among residents, which tends to conflict with the duty to serve patients.

▸ Many academic programs began focusing on meeting the duty hour restrictions, perhaps at the expense of education.

▸ The 80-hour work week, with up to 24 hours of continuous duty, was seen by many as compromising patient safety.

In 2008, the Institute of Medicine took a hard look at the ACGME standards and, among other things, recommended that no residents should exceed 16 hours of continuous duty.

The ACGME convened the task force to consider the IOM recommendations. One of the biggest challenges, according to the authors, was to reconcile the IOM's suggestion for an across-the-board restriction on duty hours with the continuing plea from academic programs that duty hours needed to be tailored to each specialty (N. Engl. J. Med. 2010 [doi:10.1056/NEJMsb1005800]).

For surgery, in particular, it would be difficult—and contrary to learning—to have a resident leave in the midst of a procedure because his or her duty hours had been reached.

The ACGME panel also had to weigh whether there was sufficient evidence to show that working more than 16 hours or up to 30 hours continuously led to more medical errors, as has been suggested by many critics of the duty hour standards.

According to the ACGME panel, the data thus far indicate only that first-year residents are more prone to mistakes as a result of sleep deprivation. Therefore, the task force urged a new paradigm for the first year of residency, whereby residents cannot be on duty for longer than 16 hours continuously and should have 10 hours off and 8 hours free of duty between their scheduled duty periods. First-year residents are not allowed to moonlight, and they must have direct, in-house, attending-level supervision.

All residents are allowed to work up to an additional 4 hours to facilitate patient handoffs—an area of concern for patient safety.

The panel decided not to tailor duty hours to specialties “because studies have not shown that the safety effect of current standards varies with specialty,” said the authors.

The IOM had also criticized the ACGME for not properly enforcing the duty hours. The task force said that enforcement is an “inherent” challenge, partly because there are some 9,000 accredited programs.

However, the ACGME is now undertaking annual site visits and analyzing whether institutions can comply. Eventually, the organization will give each institution a report on its compliance status and recommendations for resolving problems. The reports will be made available to the public, said the authors.

Wake Up Doctor, a coalition of public interest and patient safety groups that has been pushing the ACGME to further restrict resident hours, said that the new standards don't go far enough. The group gave the ACGME an “F” for failing to comply with the IOM recommendation that continuous duty be restricted to 16 hours for all residents.

The coalition also gave a failing grade to the ACGME's plans for better monitoring compliance with the standards. However, the recommendation for greater supervision of first-year residents got higher marks.

The revised standards represent an important step, but “I think the acid test will be in the details,” said Helen Haskell, founder and president of Mothers Against Medical Error, and a coalition member, in a statement. “We need to be sure that residents of all levels have sufficient backup and reasonable limits on their workloads.”

The Accreditation Council for Graduate Medical Education has revisited its standards for resident duty hours and determined that some modifications should be made, mostly for first-year residents. All other residents should still be subject to an 80-hour work week and up to 24 hours of continuous duty, according to an article published online.

The 16-member ACGME task force that wrote the standards will review public comments and make any modifications considered necessary before July 2011, when the new standards will go into effect.

The original ACGME standards, established in 2003, have been the subject of much consternation in the medical community, with opinions differing over whether they have been too restrictive or too loose to properly protect patients and ensure a good quality of life for residents.

According to the latest report, written by Dr. Thomas J. Nasca, Dr. Susan H. Day, and Dr. E. Stephen Amis Jr. on behalf of the ACGME task force, the 2003 standards had the following three “problematic” elements, as identified by the educational community and the public:

▸ The limits on duty hours may have created a shift mentality among residents, which tends to conflict with the duty to serve patients.

▸ Many academic programs began focusing on meeting the duty hour restrictions, perhaps at the expense of education.

▸ The 80-hour work week, with up to 24 hours of continuous duty, was seen by many as compromising patient safety.

In 2008, the Institute of Medicine took a hard look at the ACGME standards and, among other things, recommended that no residents should exceed 16 hours of continuous duty.

The ACGME convened the task force to consider the IOM recommendations. One of the biggest challenges, according to the authors, was to reconcile the IOM's suggestion for an across-the-board restriction on duty hours with the continuing plea from academic programs that duty hours needed to be tailored to each specialty (N. Engl. J. Med. 2010 [doi:10.1056/NEJMsb1005800]).

For surgery, in particular, it would be difficult—and contrary to learning—to have a resident leave in the midst of a procedure because his or her duty hours had been reached.

The ACGME panel also had to weigh whether there was sufficient evidence to show that working more than 16 hours or up to 30 hours continuously led to more medical errors, as has been suggested by many critics of the duty hour standards.

According to the ACGME panel, the data thus far indicate only that first-year residents are more prone to mistakes as a result of sleep deprivation. Therefore, the task force urged a new paradigm for the first year of residency, whereby residents cannot be on duty for longer than 16 hours continuously and should have 10 hours off and 8 hours free of duty between their scheduled duty periods. First-year residents are not allowed to moonlight, and they must have direct, in-house, attending-level supervision.

All residents are allowed to work up to an additional 4 hours to facilitate patient handoffs—an area of concern for patient safety.

The panel decided not to tailor duty hours to specialties “because studies have not shown that the safety effect of current standards varies with specialty,” said the authors.

The IOM had also criticized the ACGME for not properly enforcing the duty hours. The task force said that enforcement is an “inherent” challenge, partly because there are some 9,000 accredited programs.

However, the ACGME is now undertaking annual site visits and analyzing whether institutions can comply. Eventually, the organization will give each institution a report on its compliance status and recommendations for resolving problems. The reports will be made available to the public, said the authors.

Wake Up Doctor, a coalition of public interest and patient safety groups that has been pushing the ACGME to further restrict resident hours, said that the new standards don't go far enough. The group gave the ACGME an “F” for failing to comply with the IOM recommendation that continuous duty be restricted to 16 hours for all residents.

The coalition also gave a failing grade to the ACGME's plans for better monitoring compliance with the standards. However, the recommendation for greater supervision of first-year residents got higher marks.

The revised standards represent an important step, but “I think the acid test will be in the details,” said Helen Haskell, founder and president of Mothers Against Medical Error, and a coalition member, in a statement. “We need to be sure that residents of all levels have sufficient backup and reasonable limits on their workloads.”

The Accreditation Council for Graduate Medical Education has revisited its standards for resident duty hours and determined that some modifications should be made, mostly for first-year residents. All other residents should still be subject to an 80-hour work week and up to 24 hours of continuous duty, according to an article published online.

The 16-member ACGME task force that wrote the standards will review public comments and make any modifications considered necessary before July 2011, when the new standards will go into effect.

The original ACGME standards, established in 2003, have been the subject of much consternation in the medical community, with opinions differing over whether they have been too restrictive or too loose to properly protect patients and ensure a good quality of life for residents.

According to the latest report, written by Dr. Thomas J. Nasca, Dr. Susan H. Day, and Dr. E. Stephen Amis Jr. on behalf of the ACGME task force, the 2003 standards had the following three “problematic” elements, as identified by the educational community and the public:

▸ The limits on duty hours may have created a shift mentality among residents, which tends to conflict with the duty to serve patients.

▸ Many academic programs began focusing on meeting the duty hour restrictions, perhaps at the expense of education.

▸ The 80-hour work week, with up to 24 hours of continuous duty, was seen by many as compromising patient safety.

In 2008, the Institute of Medicine took a hard look at the ACGME standards and, among other things, recommended that no residents should exceed 16 hours of continuous duty.

The ACGME convened the task force to consider the IOM recommendations. One of the biggest challenges, according to the authors, was to reconcile the IOM's suggestion for an across-the-board restriction on duty hours with the continuing plea from academic programs that duty hours needed to be tailored to each specialty (N. Engl. J. Med. 2010 [doi:10.1056/NEJMsb1005800]).

For surgery, in particular, it would be difficult—and contrary to learning—to have a resident leave in the midst of a procedure because his or her duty hours had been reached.

The ACGME panel also had to weigh whether there was sufficient evidence to show that working more than 16 hours or up to 30 hours continuously led to more medical errors, as has been suggested by many critics of the duty hour standards.

According to the ACGME panel, the data thus far indicate only that first-year residents are more prone to mistakes as a result of sleep deprivation. Therefore, the task force urged a new paradigm for the first year of residency, whereby residents cannot be on duty for longer than 16 hours continuously and should have 10 hours off and 8 hours free of duty between their scheduled duty periods. First-year residents are not allowed to moonlight, and they must have direct, in-house, attending-level supervision.

All residents are allowed to work up to an additional 4 hours to facilitate patient handoffs—an area of concern for patient safety.

The panel decided not to tailor duty hours to specialties “because studies have not shown that the safety effect of current standards varies with specialty,” said the authors.

The IOM had also criticized the ACGME for not properly enforcing the duty hours. The task force said that enforcement is an “inherent” challenge, partly because there are some 9,000 accredited programs.

However, the ACGME is now undertaking annual site visits and analyzing whether institutions can comply. Eventually, the organization will give each institution a report on its compliance status and recommendations for resolving problems. The reports will be made available to the public, said the authors.

Wake Up Doctor, a coalition of public interest and patient safety groups that has been pushing the ACGME to further restrict resident hours, said that the new standards don't go far enough. The group gave the ACGME an “F” for failing to comply with the IOM recommendation that continuous duty be restricted to 16 hours for all residents.

The coalition also gave a failing grade to the ACGME's plans for better monitoring compliance with the standards. However, the recommendation for greater supervision of first-year residents got higher marks.

The revised standards represent an important step, but “I think the acid test will be in the details,” said Helen Haskell, founder and president of Mothers Against Medical Error, and a coalition member, in a statement. “We need to be sure that residents of all levels have sufficient backup and reasonable limits on their workloads.”

WASHINGTON — A group of 19 health systems is taking the first steps toward becoming accountable care organizations, joining together to share best practices, coordinate care, and improve quality.

The health systems—which include Geisinger Health System, Baystate Health, and Bon Secours Health System—are all members of Premier Inc., a nonprofit health purchasing and quality improvement alliance. Premier will provide the expertise and databases necessary for the systems to build the accountable care organizations (ACOs).

According to Premier, members of the ACO Implementation Collaborative may be ready in 2012 to start contracting with the Centers for Medicare and Medicaid Services under the shared savings program mandated under the health reform law (Affordable Care Act). ACOs have been envisioned as the backbone of the new health care system, but they were not clearly defined in the law President Obama signed in March.

At the briefing, Sen. Max Baucus (D-Mont.), Rep. Earl Pomeroy (D-N.D.), and Rep. Charles Boustany (R-La.) praised the Premier effort, saying that it would help speed transformation of the health care system into one that values quality over quantity. Sen. Baucus said that the ACOs in the Premier alliance “put the new and innovative ideas in the health care reform law into practice to improve health care quality while reducing inefficient and wasteful spending.” Rep. Boustany, who is a cardiovascular surgeon, added that the reform law did not go far enough to align incentives among health providers or to foster care coordination.

The Premier alliance will address some of these issues, he said, but it still is not clear if the ACO model can work in rural areas where there may be great distances between facilities and disparate missions from urban or suburban counterparts.

According to Premier president and CEO Susan S. DeVore, all members of the ACO collaborative will build the “critical components of accountable care,” including a patient-centered foundation; medical homes that deliver primary care and wellness; incentives to reward coordination, efficiency, and productivity; tight integration among specialists, ancillary providers, and hospitals; reimbursement models that reward value over volume; and health information technology systems that can be used to coordinate care across networks.

The 19 systems already have some of these elements in place and can pursue accountability for a portion of their population, according to Premier. These hospitals and health systems have been participating in Premier's QUEST: High-Performing Hospitals collaborative. QUEST is a 3-year information and quality improvement sharing initiative involving 200 hospitals in 31 states. In the first year, hospitals reduced the cost of care by an average $343 per patient. The facilities delivered care according to evidence-based quality measures 86% of the time, according to Premier.

The ACO Implementation Collaborative aims to build on that success. The first step is to define value. According to Premier, the agreed-upon definition so far is to optimize patient outcomes, the patient care experience, and the total cost of care.

Dr. Nicholas Wolter, CEO of the Billings Clinic, which is part of the ACO collaborative, said although ACOs may seem to be a fad, much as managed care was in the early 1990s, more is known now about patient safety and delivering high-quality care. “In the ACO, patients are partners working with their care team to manage and improve their health. This is the real goal of health reform—the highest quality care at a more cost-effective price for patients and taxpayers.”

To watch a video interview of Dr. Wolter, go to http://www.youtube.com/watch?v=2OzuMyovRss

Members of the Premier Collaborative to Date

Aria Health, Philadelphia

AtlantiCare, Egg Harbor Township, N.J.

Baystate Health, Springfield, Mass.

Billings Clinic, Mont.

Bon Secours Health System Inc., Greenville, S.C., and Richmond, Va.

CaroMont Health, Gastonia, N.C.

Fairview Health Services, Minneapolis

Geisinger Health System, Danville, Pa.

Heartland Health, St. Joseph, Mo.

Methodist Medical Center of Illinois, Peoria

North Shore-LIJ Health System, Long Island, N.Y.

Presbyterian Healthcare Services, Albuquerque

Saint Francis Health System, Tulsa, Okla.

Southcoast Hospitals Group, Fall River, Mass.

SSM Health Care, St. Louis

Summa Health System, Akron, Ohio

Texas Health Resources, Arlington, Tex.

University Hospitals, Cleveland

WASHINGTON — A group of 19 health systems is taking the first steps toward becoming accountable care organizations, joining together to share best practices, coordinate care, and improve quality.

The health systems—which include Geisinger Health System, Baystate Health, and Bon Secours Health System—are all members of Premier Inc., a nonprofit health purchasing and quality improvement alliance. Premier will provide the expertise and databases necessary for the systems to build the accountable care organizations (ACOs).

According to Premier, members of the ACO Implementation Collaborative may be ready in 2012 to start contracting with the Centers for Medicare and Medicaid Services under the shared savings program mandated under the health reform law (Affordable Care Act). ACOs have been envisioned as the backbone of the new health care system, but they were not clearly defined in the law President Obama signed in March.

At the briefing, Sen. Max Baucus (D-Mont.), Rep. Earl Pomeroy (D-N.D.), and Rep. Charles Boustany (R-La.) praised the Premier effort, saying that it would help speed transformation of the health care system into one that values quality over quantity. Sen. Baucus said that the ACOs in the Premier alliance “put the new and innovative ideas in the health care reform law into practice to improve health care quality while reducing inefficient and wasteful spending.” Rep. Boustany, who is a cardiovascular surgeon, added that the reform law did not go far enough to align incentives among health providers or to foster care coordination.

The Premier alliance will address some of these issues, he said, but it still is not clear if the ACO model can work in rural areas where there may be great distances between facilities and disparate missions from urban or suburban counterparts.

According to Premier president and CEO Susan S. DeVore, all members of the ACO collaborative will build the “critical components of accountable care,” including a patient-centered foundation; medical homes that deliver primary care and wellness; incentives to reward coordination, efficiency, and productivity; tight integration among specialists, ancillary providers, and hospitals; reimbursement models that reward value over volume; and health information technology systems that can be used to coordinate care across networks.

The 19 systems already have some of these elements in place and can pursue accountability for a portion of their population, according to Premier. These hospitals and health systems have been participating in Premier's QUEST: High-Performing Hospitals collaborative. QUEST is a 3-year information and quality improvement sharing initiative involving 200 hospitals in 31 states. In the first year, hospitals reduced the cost of care by an average $343 per patient. The facilities delivered care according to evidence-based quality measures 86% of the time, according to Premier.

The ACO Implementation Collaborative aims to build on that success. The first step is to define value. According to Premier, the agreed-upon definition so far is to optimize patient outcomes, the patient care experience, and the total cost of care.

Dr. Nicholas Wolter, CEO of the Billings Clinic, which is part of the ACO collaborative, said although ACOs may seem to be a fad, much as managed care was in the early 1990s, more is known now about patient safety and delivering high-quality care. “In the ACO, patients are partners working with their care team to manage and improve their health. This is the real goal of health reform—the highest quality care at a more cost-effective price for patients and taxpayers.”

To watch a video interview of Dr. Wolter, go to http://www.youtube.com/watch?v=2OzuMyovRss

Members of the Premier Collaborative to Date

Aria Health, Philadelphia

AtlantiCare, Egg Harbor Township, N.J.

Baystate Health, Springfield, Mass.

Billings Clinic, Mont.

Bon Secours Health System Inc., Greenville, S.C., and Richmond, Va.

CaroMont Health, Gastonia, N.C.

Fairview Health Services, Minneapolis

Geisinger Health System, Danville, Pa.

Heartland Health, St. Joseph, Mo.

Methodist Medical Center of Illinois, Peoria

North Shore-LIJ Health System, Long Island, N.Y.

Presbyterian Healthcare Services, Albuquerque

Saint Francis Health System, Tulsa, Okla.

Southcoast Hospitals Group, Fall River, Mass.

SSM Health Care, St. Louis

Summa Health System, Akron, Ohio

Texas Health Resources, Arlington, Tex.

University Hospitals, Cleveland

WASHINGTON — A group of 19 health systems is taking the first steps toward becoming accountable care organizations, joining together to share best practices, coordinate care, and improve quality.

The health systems—which include Geisinger Health System, Baystate Health, and Bon Secours Health System—are all members of Premier Inc., a nonprofit health purchasing and quality improvement alliance. Premier will provide the expertise and databases necessary for the systems to build the accountable care organizations (ACOs).

According to Premier, members of the ACO Implementation Collaborative may be ready in 2012 to start contracting with the Centers for Medicare and Medicaid Services under the shared savings program mandated under the health reform law (Affordable Care Act). ACOs have been envisioned as the backbone of the new health care system, but they were not clearly defined in the law President Obama signed in March.

At the briefing, Sen. Max Baucus (D-Mont.), Rep. Earl Pomeroy (D-N.D.), and Rep. Charles Boustany (R-La.) praised the Premier effort, saying that it would help speed transformation of the health care system into one that values quality over quantity. Sen. Baucus said that the ACOs in the Premier alliance “put the new and innovative ideas in the health care reform law into practice to improve health care quality while reducing inefficient and wasteful spending.” Rep. Boustany, who is a cardiovascular surgeon, added that the reform law did not go far enough to align incentives among health providers or to foster care coordination.

The Premier alliance will address some of these issues, he said, but it still is not clear if the ACO model can work in rural areas where there may be great distances between facilities and disparate missions from urban or suburban counterparts.

According to Premier president and CEO Susan S. DeVore, all members of the ACO collaborative will build the “critical components of accountable care,” including a patient-centered foundation; medical homes that deliver primary care and wellness; incentives to reward coordination, efficiency, and productivity; tight integration among specialists, ancillary providers, and hospitals; reimbursement models that reward value over volume; and health information technology systems that can be used to coordinate care across networks.

The 19 systems already have some of these elements in place and can pursue accountability for a portion of their population, according to Premier. These hospitals and health systems have been participating in Premier's QUEST: High-Performing Hospitals collaborative. QUEST is a 3-year information and quality improvement sharing initiative involving 200 hospitals in 31 states. In the first year, hospitals reduced the cost of care by an average $343 per patient. The facilities delivered care according to evidence-based quality measures 86% of the time, according to Premier.

The ACO Implementation Collaborative aims to build on that success. The first step is to define value. According to Premier, the agreed-upon definition so far is to optimize patient outcomes, the patient care experience, and the total cost of care.

Dr. Nicholas Wolter, CEO of the Billings Clinic, which is part of the ACO collaborative, said although ACOs may seem to be a fad, much as managed care was in the early 1990s, more is known now about patient safety and delivering high-quality care. “In the ACO, patients are partners working with their care team to manage and improve their health. This is the real goal of health reform—the highest quality care at a more cost-effective price for patients and taxpayers.”

To watch a video interview of Dr. Wolter, go to http://www.youtube.com/watch?v=2OzuMyovRss

Members of the Premier Collaborative to Date

Aria Health, Philadelphia

AtlantiCare, Egg Harbor Township, N.J.

Baystate Health, Springfield, Mass.

Billings Clinic, Mont.

Bon Secours Health System Inc., Greenville, S.C., and Richmond, Va.

CaroMont Health, Gastonia, N.C.

Fairview Health Services, Minneapolis

Geisinger Health System, Danville, Pa.

Heartland Health, St. Joseph, Mo.

Methodist Medical Center of Illinois, Peoria

North Shore-LIJ Health System, Long Island, N.Y.

Presbyterian Healthcare Services, Albuquerque

Saint Francis Health System, Tulsa, Okla.

Southcoast Hospitals Group, Fall River, Mass.

SSM Health Care, St. Louis

Summa Health System, Akron, Ohio

Texas Health Resources, Arlington, Tex.

University Hospitals, Cleveland