Jane Anderson

The Food and Drug Administration released draft guidance yesterday designed to provide more information on conflicts of interest involving members of its advisory committees and the waivers that allow them to participate in specific meetings.

The draft guidance is designed to bring agency policy in line with standard conflict of interest practice in the academic community, where medical journals require disclosures to be specific and thorough, Jill Hartzler Warner, acting associate commissioner for special medical programs at the FDA, said in a press briefing.

"When final, the guidance will increase transparency of the waiver process so that the public can understand the nature of the potential conflict," Ms. Warner said.

The FDA has 49 advisory committees with a total of more than 600 positions that provide advice on specific regulatory decisions, such as drug and device approvals, and general policy matters, such as regulations.

For highly technical subjects, the FDA often must choose from a small pool of potential advisors, and these people frequently have conflicts of interest, she said.

Federal law allows the FDA to grant waivers so that experts who have conflicts of interest can participate in advisory committee meetings; however, the waiver and disclosure process has been controversial, and the FDA acknowledged that its decisions could be viewed as tainted if it relies too heavily on experts with conflicts.

When a waiver is granted, federal law requires the FDA to disclose the type, nature, and magnitude of the conflict on its Web site. Ms. Warner said that the law limits the number of waivers to about 13% of all members participating in committee meetings, and in practice the agency grants waivers to fewer than 5%.

Currently, when the FDA decides to grant a waiver, the agency discloses whether the interest involved is associated with the sponsor, a competitor, or another affected firm. For example, the FDA might report the conflict as "holds $0-$5,000 of stock in a competitor company."

Under the draft guidance, the agency would expand the information disclosed about waivers so that the nature of the waiver granted and name of the company or institution involved also would be posted online prior to committee meetings.

"It's clearly better for the agency when advisory committee members have no conflict of interest, but many of the top authorities may have conflicts of interest," Ms. Warner said.

As a part of this effort, FDA Commissioner Dr. Margaret Hamburg told senior FDA staff in a letter yesterday that they should take three steps to minimize conflicts of interest among advisory committee members:

- Consider the nature of the conflict before granting a waiver. "An academic researcher whose institution receives grants from an affected company but who does not personally participate in the studies has a more tangential relationship to the conflict than the researcher who conducts studies for the company directly," Dr. Hamburg wrote.

- Look at what will be considered at the advisory committee meeting. Waivers may be more appropriate for meetings to consider broad policy issues and less appropriate for specific product considerations, according to the letter.

- Provide an explanation of why the individual's participation is needed despite the conflict of interest, as well as information on the search for equally expert advisors without conflicts.

The Food and Drug Administration released draft guidance yesterday designed to provide more information on conflicts of interest involving members of its advisory committees and the waivers that allow them to participate in specific meetings.

The draft guidance is designed to bring agency policy in line with standard conflict of interest practice in the academic community, where medical journals require disclosures to be specific and thorough, Jill Hartzler Warner, acting associate commissioner for special medical programs at the FDA, said in a press briefing.

"When final, the guidance will increase transparency of the waiver process so that the public can understand the nature of the potential conflict," Ms. Warner said.

The FDA has 49 advisory committees with a total of more than 600 positions that provide advice on specific regulatory decisions, such as drug and device approvals, and general policy matters, such as regulations.

For highly technical subjects, the FDA often must choose from a small pool of potential advisors, and these people frequently have conflicts of interest, she said.

Federal law allows the FDA to grant waivers so that experts who have conflicts of interest can participate in advisory committee meetings; however, the waiver and disclosure process has been controversial, and the FDA acknowledged that its decisions could be viewed as tainted if it relies too heavily on experts with conflicts.

When a waiver is granted, federal law requires the FDA to disclose the type, nature, and magnitude of the conflict on its Web site. Ms. Warner said that the law limits the number of waivers to about 13% of all members participating in committee meetings, and in practice the agency grants waivers to fewer than 5%.

Currently, when the FDA decides to grant a waiver, the agency discloses whether the interest involved is associated with the sponsor, a competitor, or another affected firm. For example, the FDA might report the conflict as "holds $0-$5,000 of stock in a competitor company."

Under the draft guidance, the agency would expand the information disclosed about waivers so that the nature of the waiver granted and name of the company or institution involved also would be posted online prior to committee meetings.

"It's clearly better for the agency when advisory committee members have no conflict of interest, but many of the top authorities may have conflicts of interest," Ms. Warner said.

As a part of this effort, FDA Commissioner Dr. Margaret Hamburg told senior FDA staff in a letter yesterday that they should take three steps to minimize conflicts of interest among advisory committee members:

- Consider the nature of the conflict before granting a waiver. "An academic researcher whose institution receives grants from an affected company but who does not personally participate in the studies has a more tangential relationship to the conflict than the researcher who conducts studies for the company directly," Dr. Hamburg wrote.

- Look at what will be considered at the advisory committee meeting. Waivers may be more appropriate for meetings to consider broad policy issues and less appropriate for specific product considerations, according to the letter.

- Provide an explanation of why the individual's participation is needed despite the conflict of interest, as well as information on the search for equally expert advisors without conflicts.

The Food and Drug Administration released draft guidance yesterday designed to provide more information on conflicts of interest involving members of its advisory committees and the waivers that allow them to participate in specific meetings.

The draft guidance is designed to bring agency policy in line with standard conflict of interest practice in the academic community, where medical journals require disclosures to be specific and thorough, Jill Hartzler Warner, acting associate commissioner for special medical programs at the FDA, said in a press briefing.

"When final, the guidance will increase transparency of the waiver process so that the public can understand the nature of the potential conflict," Ms. Warner said.

The FDA has 49 advisory committees with a total of more than 600 positions that provide advice on specific regulatory decisions, such as drug and device approvals, and general policy matters, such as regulations.

For highly technical subjects, the FDA often must choose from a small pool of potential advisors, and these people frequently have conflicts of interest, she said.

Federal law allows the FDA to grant waivers so that experts who have conflicts of interest can participate in advisory committee meetings; however, the waiver and disclosure process has been controversial, and the FDA acknowledged that its decisions could be viewed as tainted if it relies too heavily on experts with conflicts.

When a waiver is granted, federal law requires the FDA to disclose the type, nature, and magnitude of the conflict on its Web site. Ms. Warner said that the law limits the number of waivers to about 13% of all members participating in committee meetings, and in practice the agency grants waivers to fewer than 5%.

Currently, when the FDA decides to grant a waiver, the agency discloses whether the interest involved is associated with the sponsor, a competitor, or another affected firm. For example, the FDA might report the conflict as "holds $0-$5,000 of stock in a competitor company."

Under the draft guidance, the agency would expand the information disclosed about waivers so that the nature of the waiver granted and name of the company or institution involved also would be posted online prior to committee meetings.

"It's clearly better for the agency when advisory committee members have no conflict of interest, but many of the top authorities may have conflicts of interest," Ms. Warner said.

As a part of this effort, FDA Commissioner Dr. Margaret Hamburg told senior FDA staff in a letter yesterday that they should take three steps to minimize conflicts of interest among advisory committee members:

- Consider the nature of the conflict before granting a waiver. "An academic researcher whose institution receives grants from an affected company but who does not personally participate in the studies has a more tangential relationship to the conflict than the researcher who conducts studies for the company directly," Dr. Hamburg wrote.

- Look at what will be considered at the advisory committee meeting. Waivers may be more appropriate for meetings to consider broad policy issues and less appropriate for specific product considerations, according to the letter.

- Provide an explanation of why the individual's participation is needed despite the conflict of interest, as well as information on the search for equally expert advisors without conflicts.

FDA Proposes New Ad Rules

The Food and Drug Administration wants manufacturers to detail more of the contraindications and potential side effects of drugs in radio and television direct-to-consumer advertisements. The proposed rule would require that an ad's major statement on side effects and contraindications “be presented in a clear, conspicuous, and neutral manner.” The new rule would require manufacturers to present the information in both the audio and visual components of a video ad and make sure that it isn't overshadowed by other parts of either type of ad. The FDA will accept comments on the proposed rule until June 28.

Restaurants Must Post Calories

As part of the newly approved health care reform law, chain restaurants will be required to post the calorie content for their standard menu items along with information on daily suggested calorie intake from the Department of Agriculture. The provision in the Patient Protection and Affordable Care Act, signed into law last month by President Obama, will affect restaurants and other retail food establishments with 20 or more locations and the same menu items at each location. Restaurants also will need to have additional nutrition information, such as fat and sodium content, available for their menu items. Vending operators with more than 20 machines will be required to post calorie information on their food items. The law requires the FDA to issue proposed regulations by next March.

State Medical Board Actions Up

State medical boards took 5,721 actions against physicians in 2009, an increase of 342, or more than 6%, over 2008, according to a report from the Federation of State Medical Boards. Meanwhile, an analysis by the advocacy group Public Citizen found that the rate of serious disciplinary actions rose slightly in 2009 but still sits about 18% lower than the peak rate of 2004. Minnesota ranked last in disciplining physicians, Public Citizen said, and Maryland, South Carolina, and Wisconsin also consistently rank among the bottom 10. Arizona, Alaska, Kentucky, North Dakota, and Ohio discipline the most physicians, the group said. “There is considerable evidence that most boards are underdisciplining physicians,” Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a statement. “Most states are not living up to their obligations to protect patients from doctors who are practicing medicine in a substandard manner.”

Pfizer Paid $35M in 6 Months

Pfizer, the latest drug manufacturer to disclose payments to physicians, said that it paid approximately $20 million to 4,500 physicians and other health care professionals for consulting and speaking services between July and December 2009. Pfizer also said it paid $15.3 million to 250 academic medical centers and other researchers to fund clinical trials in the last 6 months of 2009. The Pfizer disclosures were required by an integrity agreement that the company signed last year to settle a federal investigation into promotion of off-label uses of drugs. Pfizer is the first major pharmaceutical company to disclose clinical trial payments, although drug maker GlaxoSmithKline has said that it will begin publishing the payments it makes to researchers in 2011.

Broadband Plan Adds Health Goals

As part of the Obama administration's overall National Broadband Plan to extend fast Internet service nationwide, the Federal Communications Commission said it wants to revamp the Rural Health Care Program to ensure that all health care providers have such access. The broadband plan, which contains seven specific recommendations on health care, would redistribute $400 million per year in the Rural Health Care Program to help health care providers purchase broadband services and expand broadband to more institutions. In addition, the new plan calls for states and other regulators to revise licensing, privileging, and credentialing standards to enable physicians to practice medicine remotely and across state lines.

Governor Signs Meth Law

Alabama Gov. Bob Riley (R) has signed a law intended to help law enforcement officials quickly track excessive purchases of pseudoephedrine, the chief ingredient used in the manufacture of methamphetamine. The law creates a new electronic database in an effort to modernize logs that already are kept on paper, making it possible to instantly track excessive purchases of pseudoephedrine. Every pharmacy or retailer selling ephedrine or pseudoephedrine products will be required to enter the purchaser's identifying information into an electronic database prior to any sale. The database then will notify the seller if the purchaser has exceeded the daily or monthly limit for such purchases. Law enforcement authorities also will have access to the database. “Our local law enforcement agencies tell us that in some Alabama counties, meth plays a role in almost every crime,” Gov. Riley said in a statement.

FDA Proposes New Ad Rules

The Food and Drug Administration wants manufacturers to detail more of the contraindications and potential side effects of drugs in radio and television direct-to-consumer advertisements. The proposed rule would require that an ad's major statement on side effects and contraindications “be presented in a clear, conspicuous, and neutral manner.” The new rule would require manufacturers to present the information in both the audio and visual components of a video ad and make sure that it isn't overshadowed by other parts of either type of ad. The FDA will accept comments on the proposed rule until June 28.

Restaurants Must Post Calories

As part of the newly approved health care reform law, chain restaurants will be required to post the calorie content for their standard menu items along with information on daily suggested calorie intake from the Department of Agriculture. The provision in the Patient Protection and Affordable Care Act, signed into law last month by President Obama, will affect restaurants and other retail food establishments with 20 or more locations and the same menu items at each location. Restaurants also will need to have additional nutrition information, such as fat and sodium content, available for their menu items. Vending operators with more than 20 machines will be required to post calorie information on their food items. The law requires the FDA to issue proposed regulations by next March.

State Medical Board Actions Up

State medical boards took 5,721 actions against physicians in 2009, an increase of 342, or more than 6%, over 2008, according to a report from the Federation of State Medical Boards. Meanwhile, an analysis by the advocacy group Public Citizen found that the rate of serious disciplinary actions rose slightly in 2009 but still sits about 18% lower than the peak rate of 2004. Minnesota ranked last in disciplining physicians, Public Citizen said, and Maryland, South Carolina, and Wisconsin also consistently rank among the bottom 10. Arizona, Alaska, Kentucky, North Dakota, and Ohio discipline the most physicians, the group said. “There is considerable evidence that most boards are underdisciplining physicians,” Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a statement. “Most states are not living up to their obligations to protect patients from doctors who are practicing medicine in a substandard manner.”

Pfizer Paid $35M in 6 Months

Pfizer, the latest drug manufacturer to disclose payments to physicians, said that it paid approximately $20 million to 4,500 physicians and other health care professionals for consulting and speaking services between July and December 2009. Pfizer also said it paid $15.3 million to 250 academic medical centers and other researchers to fund clinical trials in the last 6 months of 2009. The Pfizer disclosures were required by an integrity agreement that the company signed last year to settle a federal investigation into promotion of off-label uses of drugs. Pfizer is the first major pharmaceutical company to disclose clinical trial payments, although drug maker GlaxoSmithKline has said that it will begin publishing the payments it makes to researchers in 2011.

Broadband Plan Adds Health Goals

As part of the Obama administration's overall National Broadband Plan to extend fast Internet service nationwide, the Federal Communications Commission said it wants to revamp the Rural Health Care Program to ensure that all health care providers have such access. The broadband plan, which contains seven specific recommendations on health care, would redistribute $400 million per year in the Rural Health Care Program to help health care providers purchase broadband services and expand broadband to more institutions. In addition, the new plan calls for states and other regulators to revise licensing, privileging, and credentialing standards to enable physicians to practice medicine remotely and across state lines.

Governor Signs Meth Law

Alabama Gov. Bob Riley (R) has signed a law intended to help law enforcement officials quickly track excessive purchases of pseudoephedrine, the chief ingredient used in the manufacture of methamphetamine. The law creates a new electronic database in an effort to modernize logs that already are kept on paper, making it possible to instantly track excessive purchases of pseudoephedrine. Every pharmacy or retailer selling ephedrine or pseudoephedrine products will be required to enter the purchaser's identifying information into an electronic database prior to any sale. The database then will notify the seller if the purchaser has exceeded the daily or monthly limit for such purchases. Law enforcement authorities also will have access to the database. “Our local law enforcement agencies tell us that in some Alabama counties, meth plays a role in almost every crime,” Gov. Riley said in a statement.

FDA Proposes New Ad Rules

The Food and Drug Administration wants manufacturers to detail more of the contraindications and potential side effects of drugs in radio and television direct-to-consumer advertisements. The proposed rule would require that an ad's major statement on side effects and contraindications “be presented in a clear, conspicuous, and neutral manner.” The new rule would require manufacturers to present the information in both the audio and visual components of a video ad and make sure that it isn't overshadowed by other parts of either type of ad. The FDA will accept comments on the proposed rule until June 28.

Restaurants Must Post Calories

As part of the newly approved health care reform law, chain restaurants will be required to post the calorie content for their standard menu items along with information on daily suggested calorie intake from the Department of Agriculture. The provision in the Patient Protection and Affordable Care Act, signed into law last month by President Obama, will affect restaurants and other retail food establishments with 20 or more locations and the same menu items at each location. Restaurants also will need to have additional nutrition information, such as fat and sodium content, available for their menu items. Vending operators with more than 20 machines will be required to post calorie information on their food items. The law requires the FDA to issue proposed regulations by next March.

State Medical Board Actions Up

State medical boards took 5,721 actions against physicians in 2009, an increase of 342, or more than 6%, over 2008, according to a report from the Federation of State Medical Boards. Meanwhile, an analysis by the advocacy group Public Citizen found that the rate of serious disciplinary actions rose slightly in 2009 but still sits about 18% lower than the peak rate of 2004. Minnesota ranked last in disciplining physicians, Public Citizen said, and Maryland, South Carolina, and Wisconsin also consistently rank among the bottom 10. Arizona, Alaska, Kentucky, North Dakota, and Ohio discipline the most physicians, the group said. “There is considerable evidence that most boards are underdisciplining physicians,” Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a statement. “Most states are not living up to their obligations to protect patients from doctors who are practicing medicine in a substandard manner.”

Pfizer Paid $35M in 6 Months

Pfizer, the latest drug manufacturer to disclose payments to physicians, said that it paid approximately $20 million to 4,500 physicians and other health care professionals for consulting and speaking services between July and December 2009. Pfizer also said it paid $15.3 million to 250 academic medical centers and other researchers to fund clinical trials in the last 6 months of 2009. The Pfizer disclosures were required by an integrity agreement that the company signed last year to settle a federal investigation into promotion of off-label uses of drugs. Pfizer is the first major pharmaceutical company to disclose clinical trial payments, although drug maker GlaxoSmithKline has said that it will begin publishing the payments it makes to researchers in 2011.

Broadband Plan Adds Health Goals

As part of the Obama administration's overall National Broadband Plan to extend fast Internet service nationwide, the Federal Communications Commission said it wants to revamp the Rural Health Care Program to ensure that all health care providers have such access. The broadband plan, which contains seven specific recommendations on health care, would redistribute $400 million per year in the Rural Health Care Program to help health care providers purchase broadband services and expand broadband to more institutions. In addition, the new plan calls for states and other regulators to revise licensing, privileging, and credentialing standards to enable physicians to practice medicine remotely and across state lines.

Governor Signs Meth Law

Alabama Gov. Bob Riley (R) has signed a law intended to help law enforcement officials quickly track excessive purchases of pseudoephedrine, the chief ingredient used in the manufacture of methamphetamine. The law creates a new electronic database in an effort to modernize logs that already are kept on paper, making it possible to instantly track excessive purchases of pseudoephedrine. Every pharmacy or retailer selling ephedrine or pseudoephedrine products will be required to enter the purchaser's identifying information into an electronic database prior to any sale. The database then will notify the seller if the purchaser has exceeded the daily or monthly limit for such purchases. Law enforcement authorities also will have access to the database. “Our local law enforcement agencies tell us that in some Alabama counties, meth plays a role in almost every crime,” Gov. Riley said in a statement.

A new Open Government initiative unveiled by the Health and Human Services department aims to create more transparency at the giant federal health agency, improve accountability, and make large quantities of raw Medicare and public health data available to the public.

A separate transparency project at the Food and Drug Administration was announced during the same public webcast, as was a beta-test version of a new data dashboard for the Centers for Medicare and Medicaid Services (www.cms.gov/Dashboard

One of the biggest components of the HHS plan is the release of raw public health data.

The project will make various data sets public so that state and local governments, researchers, and others can use them to analyze public health trends and create novel applications, said Todd Park, HHS chief technology officer.

“We have a lot of data showing how we're doing on obesity, smoking, access to healthy foods,” Mr. Park said during a webcast launching the project.

Mr. Park said he is “100% confident” that users outside government will take the data and “come up with better ideas than we would ever have for it.”

For example, he said he could envision “social networking games to help advise a lot of folks on what's going on in community health and how to improve it.” He added that the agency is sponsoring the HHS Apps Challenge, which is a public competition for the best applications built using the data.

CMS plans to publish detailed Medicaid State Plan documents and amendments online at the CMS Web site by the end of 2010, and also will release never-before-published national, state, regional, and potentially county-level data on Medicare prevalence of disease, quality, costs, and service utilization as part of HHS's Community Health Data Initiative.

As part of the overall Open Government initiative, the FDA also launched a new dashboard, which when fully implemented, will allow the public to track some 300 performance measures and 80 key projects across more than 90 FDA program offices on an ongoing basis, Dr. Joshua Sharfstein, FDA principal deputy commissioner, said during the webcast.

The public will be able to use the dashboard, located at www.fda.gov/fda

A new Open Government initiative unveiled by the Health and Human Services department aims to create more transparency at the giant federal health agency, improve accountability, and make large quantities of raw Medicare and public health data available to the public.

A separate transparency project at the Food and Drug Administration was announced during the same public webcast, as was a beta-test version of a new data dashboard for the Centers for Medicare and Medicaid Services (www.cms.gov/Dashboard

One of the biggest components of the HHS plan is the release of raw public health data.

The project will make various data sets public so that state and local governments, researchers, and others can use them to analyze public health trends and create novel applications, said Todd Park, HHS chief technology officer.

“We have a lot of data showing how we're doing on obesity, smoking, access to healthy foods,” Mr. Park said during a webcast launching the project.

Mr. Park said he is “100% confident” that users outside government will take the data and “come up with better ideas than we would ever have for it.”

For example, he said he could envision “social networking games to help advise a lot of folks on what's going on in community health and how to improve it.” He added that the agency is sponsoring the HHS Apps Challenge, which is a public competition for the best applications built using the data.

CMS plans to publish detailed Medicaid State Plan documents and amendments online at the CMS Web site by the end of 2010, and also will release never-before-published national, state, regional, and potentially county-level data on Medicare prevalence of disease, quality, costs, and service utilization as part of HHS's Community Health Data Initiative.

As part of the overall Open Government initiative, the FDA also launched a new dashboard, which when fully implemented, will allow the public to track some 300 performance measures and 80 key projects across more than 90 FDA program offices on an ongoing basis, Dr. Joshua Sharfstein, FDA principal deputy commissioner, said during the webcast.

The public will be able to use the dashboard, located at www.fda.gov/fda

A new Open Government initiative unveiled by the Health and Human Services department aims to create more transparency at the giant federal health agency, improve accountability, and make large quantities of raw Medicare and public health data available to the public.

A separate transparency project at the Food and Drug Administration was announced during the same public webcast, as was a beta-test version of a new data dashboard for the Centers for Medicare and Medicaid Services (www.cms.gov/Dashboard

One of the biggest components of the HHS plan is the release of raw public health data.

The project will make various data sets public so that state and local governments, researchers, and others can use them to analyze public health trends and create novel applications, said Todd Park, HHS chief technology officer.

“We have a lot of data showing how we're doing on obesity, smoking, access to healthy foods,” Mr. Park said during a webcast launching the project.

Mr. Park said he is “100% confident” that users outside government will take the data and “come up with better ideas than we would ever have for it.”

For example, he said he could envision “social networking games to help advise a lot of folks on what's going on in community health and how to improve it.” He added that the agency is sponsoring the HHS Apps Challenge, which is a public competition for the best applications built using the data.

CMS plans to publish detailed Medicaid State Plan documents and amendments online at the CMS Web site by the end of 2010, and also will release never-before-published national, state, regional, and potentially county-level data on Medicare prevalence of disease, quality, costs, and service utilization as part of HHS's Community Health Data Initiative.

As part of the overall Open Government initiative, the FDA also launched a new dashboard, which when fully implemented, will allow the public to track some 300 performance measures and 80 key projects across more than 90 FDA program offices on an ongoing basis, Dr. Joshua Sharfstein, FDA principal deputy commissioner, said during the webcast.

The public will be able to use the dashboard, located at www.fda.gov/fda

More than 25% of medical interns have depression during their internships, and depressed interns are more likely to make medical errors, according to the largest prospective study of depression during medical internship to date.

In addition, interns who commit frequent medical errors may be more likely to become depressed than their colleagues who commit fewer, Dr. Srijan Sen of the University of Michigan, Ann Arbor, and colleagues wrote (Arch. Gen. Psychiatry 2010;67[doi:10.1001/archgenpsychiatry.2010.41

“Depressive symptoms that are present before internship predicted reported errors during internship, indicating that depression results in increased medical errors,” they said. “Controlling for the baseline level of depressive symptoms, a strong correlation between errors and depression persisted, indicating that errors may also cause depression and that the association between depression and reported medical errors is bidirectional.”

The authors assessed 740 interns for depressive symptoms and genetic risk prior to internship and then for symptoms and potential stressors at 3-month intervals throughout their internships.

There was a dramatic increase—from less than 4% prior to internship to an average of more than 25% during the internship year, according to Dr. Sen and associates.

Most subjects who met the criteria for depression were moderately depressed, and few subjects met the standards for moderately severe or severe depression, the investigators noted.

Women, and interns of either gender with history of depression, neuroticism, and a difficult early family environment, were more likely to suffer from depression, they found.

The study was funded by grants from the Donaghue Foundation, the Department of Veterans Affairs, the American Foundation for Suicide Prevention, and the Substance Abuse and Mental Health Services Administration. Two study authors reported consulting arrangements with a variety of pharmaceutical manufacturers, and one of these reported he also is a cosponsor on pending patents related to new drugs for psychiatric disorders, including depression.

My Take

System Needs to Build Resilience

This issue of depression among medical interns is not an individual problem, but a system one. If the 25% prevalence of depression among medical interns reported by Dr. Srijan Sen and colleagues is correct, there is something about our medical education system that is imbalanced. Medical training will always be stressful, which is why there needs to be a corresponding emphasis on building resilience and mental stability in the face of that distress.

One way to build resilience is to help physicians develop mindfulness skills. These skills fall into two categories. The first set emphasizes the development of self-awareness, so that the individual learns to be more attuned to the early stages of stress and so can attenuate the effects of that stress before it gets out of hand.

The second set of skills focuses on interpersonal mindfulness, that is, one's ability to read others, sense when they are in stress or reacting during the heat of the moment. This interpersonal mindfulness is at the heart of being able to be supportive.

In a before-after study, our mindful practice research group at the University of Rochester demonstrated that an intervention aimed at strengthening that sense of mindfulness among 70 primary care physicians successfully produced sustained improvements in well-being (JAMA. 2009;302:1284–93).

RONALD M. EPSTEIN, M.D., is professor of family medicine, psychiatry and oncology at the University of Rochester (N.Y.) School of Medicine and Dentistry.

Document

70512_fx1.sml

More than 25% of medical interns have depression during their internships, and depressed interns are more likely to make medical errors, according to the largest prospective study of depression during medical internship to date.

In addition, interns who commit frequent medical errors may be more likely to become depressed than their colleagues who commit fewer, Dr. Srijan Sen of the University of Michigan, Ann Arbor, and colleagues wrote (Arch. Gen. Psychiatry 2010;67[doi:10.1001/archgenpsychiatry.2010.41

“Depressive symptoms that are present before internship predicted reported errors during internship, indicating that depression results in increased medical errors,” they said. “Controlling for the baseline level of depressive symptoms, a strong correlation between errors and depression persisted, indicating that errors may also cause depression and that the association between depression and reported medical errors is bidirectional.”

The authors assessed 740 interns for depressive symptoms and genetic risk prior to internship and then for symptoms and potential stressors at 3-month intervals throughout their internships.

There was a dramatic increase—from less than 4% prior to internship to an average of more than 25% during the internship year, according to Dr. Sen and associates.

Most subjects who met the criteria for depression were moderately depressed, and few subjects met the standards for moderately severe or severe depression, the investigators noted.

Women, and interns of either gender with history of depression, neuroticism, and a difficult early family environment, were more likely to suffer from depression, they found.

The study was funded by grants from the Donaghue Foundation, the Department of Veterans Affairs, the American Foundation for Suicide Prevention, and the Substance Abuse and Mental Health Services Administration. Two study authors reported consulting arrangements with a variety of pharmaceutical manufacturers, and one of these reported he also is a cosponsor on pending patents related to new drugs for psychiatric disorders, including depression.

My Take

System Needs to Build Resilience

This issue of depression among medical interns is not an individual problem, but a system one. If the 25% prevalence of depression among medical interns reported by Dr. Srijan Sen and colleagues is correct, there is something about our medical education system that is imbalanced. Medical training will always be stressful, which is why there needs to be a corresponding emphasis on building resilience and mental stability in the face of that distress.

One way to build resilience is to help physicians develop mindfulness skills. These skills fall into two categories. The first set emphasizes the development of self-awareness, so that the individual learns to be more attuned to the early stages of stress and so can attenuate the effects of that stress before it gets out of hand.

The second set of skills focuses on interpersonal mindfulness, that is, one's ability to read others, sense when they are in stress or reacting during the heat of the moment. This interpersonal mindfulness is at the heart of being able to be supportive.

In a before-after study, our mindful practice research group at the University of Rochester demonstrated that an intervention aimed at strengthening that sense of mindfulness among 70 primary care physicians successfully produced sustained improvements in well-being (JAMA. 2009;302:1284–93).

RONALD M. EPSTEIN, M.D., is professor of family medicine, psychiatry and oncology at the University of Rochester (N.Y.) School of Medicine and Dentistry.

Document

70512_fx1.sml

More than 25% of medical interns have depression during their internships, and depressed interns are more likely to make medical errors, according to the largest prospective study of depression during medical internship to date.

In addition, interns who commit frequent medical errors may be more likely to become depressed than their colleagues who commit fewer, Dr. Srijan Sen of the University of Michigan, Ann Arbor, and colleagues wrote (Arch. Gen. Psychiatry 2010;67[doi:10.1001/archgenpsychiatry.2010.41

“Depressive symptoms that are present before internship predicted reported errors during internship, indicating that depression results in increased medical errors,” they said. “Controlling for the baseline level of depressive symptoms, a strong correlation between errors and depression persisted, indicating that errors may also cause depression and that the association between depression and reported medical errors is bidirectional.”

The authors assessed 740 interns for depressive symptoms and genetic risk prior to internship and then for symptoms and potential stressors at 3-month intervals throughout their internships.

There was a dramatic increase—from less than 4% prior to internship to an average of more than 25% during the internship year, according to Dr. Sen and associates.

Most subjects who met the criteria for depression were moderately depressed, and few subjects met the standards for moderately severe or severe depression, the investigators noted.

Women, and interns of either gender with history of depression, neuroticism, and a difficult early family environment, were more likely to suffer from depression, they found.

The study was funded by grants from the Donaghue Foundation, the Department of Veterans Affairs, the American Foundation for Suicide Prevention, and the Substance Abuse and Mental Health Services Administration. Two study authors reported consulting arrangements with a variety of pharmaceutical manufacturers, and one of these reported he also is a cosponsor on pending patents related to new drugs for psychiatric disorders, including depression.

My Take

System Needs to Build Resilience

This issue of depression among medical interns is not an individual problem, but a system one. If the 25% prevalence of depression among medical interns reported by Dr. Srijan Sen and colleagues is correct, there is something about our medical education system that is imbalanced. Medical training will always be stressful, which is why there needs to be a corresponding emphasis on building resilience and mental stability in the face of that distress.

One way to build resilience is to help physicians develop mindfulness skills. These skills fall into two categories. The first set emphasizes the development of self-awareness, so that the individual learns to be more attuned to the early stages of stress and so can attenuate the effects of that stress before it gets out of hand.

The second set of skills focuses on interpersonal mindfulness, that is, one's ability to read others, sense when they are in stress or reacting during the heat of the moment. This interpersonal mindfulness is at the heart of being able to be supportive.

In a before-after study, our mindful practice research group at the University of Rochester demonstrated that an intervention aimed at strengthening that sense of mindfulness among 70 primary care physicians successfully produced sustained improvements in well-being (JAMA. 2009;302:1284–93).

RONALD M. EPSTEIN, M.D., is professor of family medicine, psychiatry and oncology at the University of Rochester (N.Y.) School of Medicine and Dentistry.

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FDA Proposes New Ad Rules

The Food and Drug Administration wants manufacturers to detail more of the contraindications and potential side effects of drugs in radio and television direct-to-consumer advertisements. The proposed rule would require that an ad's major statement on side effects and contraindications “be presented in a clear, conspicuous, and neutral manner.” The new rule would require manufacturers to present the information in both the audio and visual components of a video ad and make sure that it isn't overshadowed by other parts of either type of ad. The FDA will accept comments on the proposed rule until June 28.

Restaurants Must Post Calories

As part of the newly approved health care reform law, chain restaurants will be required to post the calorie content for their standard menu items along with information on daily suggested calorie intake from the Department of Agriculture. The provision in the Patient Protection and Affordable Care Act, signed into law last month by President Obama, will affect restaurants and other retail food establishments with 20 or more locations and the same menu items at each location. Restaurants also will need to have additional nutrition information, such as fat and sodium content, available for their menu items. Vending operators with more than 20 machines will be required to post calorie information on their food items. The law requires the FDA to issue proposed regulations by next March.

Broadband Plan Adds Health Goals

As part of the Obama administration's overall National Broadband Plan to extend fast Internet service nationwide, the Federal Communications Commission said it wants to revamp the Rural Health Care Program to ensure that all health care providers have such access. The broadband plan, which contains seven specific recommendations on health care, would redistribute $400 million per year in the Rural Health Care Program to help health care providers purchase broadband services and expand broadband to more institutions. In addition, the new plan calls for states and other regulators to revise licensing, privileging, and credentialing standards to enable physicians to practice medicine remotely and across state lines.

Pfizer Paid $35M in 6 Months

Pfizer, the latest drug manufacturer to disclose physician payments, said it paid approximately $20 million to 4,500 physicians and other health care professionals for consulting and speaking services between July and December 2009. Pfizer also said it paid $15.3 million to 250 academic medical centers and other researchers to fund clinical trials in the last 6 months of 2009. The Pfizer disclosures were required by an integrity agreement that the company signed last year to settle a federal investigation into promotion of off-label uses of drugs. Pfizer is the first major pharmaceutical company to disclose clinical trial payments, although drug maker GlaxoSmith-Kline has said that it will begin publishing payments made to researchers in 2011.

State Medical Board Actions Up

State medical boards took 5,721 actions against physicians in 2009, an increase of 342, or more than 6%, over 2008, according to a report from the Federation of State Medical Boards. Meanwhile, an analysis by the advocacy group Public Citizen found that the rate of serious disciplinary actions rose slightly in 2009 but still sits about 18% lower than the peak rate of 2004. Minnesota ranked last in disciplining physicians, Public Citizen said, and Maryland, South Carolina, and Wisconsin also consistently rank among the bottom 10. Arizona, Alaska, Kentucky, North Dakota, and Ohio discipline the most physicians, the group said. “There is considerable evidence that most boards are underdisciplining physicians,” Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a statement. “Most states are not living up to their obligations to protect patients from doctors who are practicing medicine in a substandard manner.”

Governor Signs Meth Law

Alabama Gov. Bob Riley (R) has signed a law intended to help law enforcement officials quickly track excessive purchases of pseudoephedrine, which is the chief ingredient used in the manufacture of methamphetamine. The law creates a new electronic database in an effort to modernize logs that already are kept on paper, making it possible to instantly track excessive purchases of pseudoephedrine. Every pharmacy or retailer that sells ephedrine or pseudoephedrine products will be required to enter the purchaser's identifying information into an electronic database prior to any sale. The database then will notify the seller if the purchaser has exceeded the daily or monthly limit for such purchases. Law enforcement authorities also will have access to the database. “Our local law enforcement agencies tell us that in some Alabama counties, meth plays a role in almost every crime,” Gov. Riley said in a statement.

FDA Proposes New Ad Rules

The Food and Drug Administration wants manufacturers to detail more of the contraindications and potential side effects of drugs in radio and television direct-to-consumer advertisements. The proposed rule would require that an ad's major statement on side effects and contraindications “be presented in a clear, conspicuous, and neutral manner.” The new rule would require manufacturers to present the information in both the audio and visual components of a video ad and make sure that it isn't overshadowed by other parts of either type of ad. The FDA will accept comments on the proposed rule until June 28.

Restaurants Must Post Calories

As part of the newly approved health care reform law, chain restaurants will be required to post the calorie content for their standard menu items along with information on daily suggested calorie intake from the Department of Agriculture. The provision in the Patient Protection and Affordable Care Act, signed into law last month by President Obama, will affect restaurants and other retail food establishments with 20 or more locations and the same menu items at each location. Restaurants also will need to have additional nutrition information, such as fat and sodium content, available for their menu items. Vending operators with more than 20 machines will be required to post calorie information on their food items. The law requires the FDA to issue proposed regulations by next March.

Broadband Plan Adds Health Goals

As part of the Obama administration's overall National Broadband Plan to extend fast Internet service nationwide, the Federal Communications Commission said it wants to revamp the Rural Health Care Program to ensure that all health care providers have such access. The broadband plan, which contains seven specific recommendations on health care, would redistribute $400 million per year in the Rural Health Care Program to help health care providers purchase broadband services and expand broadband to more institutions. In addition, the new plan calls for states and other regulators to revise licensing, privileging, and credentialing standards to enable physicians to practice medicine remotely and across state lines.

Pfizer Paid $35M in 6 Months

Pfizer, the latest drug manufacturer to disclose physician payments, said it paid approximately $20 million to 4,500 physicians and other health care professionals for consulting and speaking services between July and December 2009. Pfizer also said it paid $15.3 million to 250 academic medical centers and other researchers to fund clinical trials in the last 6 months of 2009. The Pfizer disclosures were required by an integrity agreement that the company signed last year to settle a federal investigation into promotion of off-label uses of drugs. Pfizer is the first major pharmaceutical company to disclose clinical trial payments, although drug maker GlaxoSmith-Kline has said that it will begin publishing payments made to researchers in 2011.

State Medical Board Actions Up

State medical boards took 5,721 actions against physicians in 2009, an increase of 342, or more than 6%, over 2008, according to a report from the Federation of State Medical Boards. Meanwhile, an analysis by the advocacy group Public Citizen found that the rate of serious disciplinary actions rose slightly in 2009 but still sits about 18% lower than the peak rate of 2004. Minnesota ranked last in disciplining physicians, Public Citizen said, and Maryland, South Carolina, and Wisconsin also consistently rank among the bottom 10. Arizona, Alaska, Kentucky, North Dakota, and Ohio discipline the most physicians, the group said. “There is considerable evidence that most boards are underdisciplining physicians,” Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a statement. “Most states are not living up to their obligations to protect patients from doctors who are practicing medicine in a substandard manner.”

Governor Signs Meth Law

Alabama Gov. Bob Riley (R) has signed a law intended to help law enforcement officials quickly track excessive purchases of pseudoephedrine, which is the chief ingredient used in the manufacture of methamphetamine. The law creates a new electronic database in an effort to modernize logs that already are kept on paper, making it possible to instantly track excessive purchases of pseudoephedrine. Every pharmacy or retailer that sells ephedrine or pseudoephedrine products will be required to enter the purchaser's identifying information into an electronic database prior to any sale. The database then will notify the seller if the purchaser has exceeded the daily or monthly limit for such purchases. Law enforcement authorities also will have access to the database. “Our local law enforcement agencies tell us that in some Alabama counties, meth plays a role in almost every crime,” Gov. Riley said in a statement.

FDA Proposes New Ad Rules

The Food and Drug Administration wants manufacturers to detail more of the contraindications and potential side effects of drugs in radio and television direct-to-consumer advertisements. The proposed rule would require that an ad's major statement on side effects and contraindications “be presented in a clear, conspicuous, and neutral manner.” The new rule would require manufacturers to present the information in both the audio and visual components of a video ad and make sure that it isn't overshadowed by other parts of either type of ad. The FDA will accept comments on the proposed rule until June 28.

Restaurants Must Post Calories

As part of the newly approved health care reform law, chain restaurants will be required to post the calorie content for their standard menu items along with information on daily suggested calorie intake from the Department of Agriculture. The provision in the Patient Protection and Affordable Care Act, signed into law last month by President Obama, will affect restaurants and other retail food establishments with 20 or more locations and the same menu items at each location. Restaurants also will need to have additional nutrition information, such as fat and sodium content, available for their menu items. Vending operators with more than 20 machines will be required to post calorie information on their food items. The law requires the FDA to issue proposed regulations by next March.

Broadband Plan Adds Health Goals

As part of the Obama administration's overall National Broadband Plan to extend fast Internet service nationwide, the Federal Communications Commission said it wants to revamp the Rural Health Care Program to ensure that all health care providers have such access. The broadband plan, which contains seven specific recommendations on health care, would redistribute $400 million per year in the Rural Health Care Program to help health care providers purchase broadband services and expand broadband to more institutions. In addition, the new plan calls for states and other regulators to revise licensing, privileging, and credentialing standards to enable physicians to practice medicine remotely and across state lines.

Pfizer Paid $35M in 6 Months

Pfizer, the latest drug manufacturer to disclose physician payments, said it paid approximately $20 million to 4,500 physicians and other health care professionals for consulting and speaking services between July and December 2009. Pfizer also said it paid $15.3 million to 250 academic medical centers and other researchers to fund clinical trials in the last 6 months of 2009. The Pfizer disclosures were required by an integrity agreement that the company signed last year to settle a federal investigation into promotion of off-label uses of drugs. Pfizer is the first major pharmaceutical company to disclose clinical trial payments, although drug maker GlaxoSmith-Kline has said that it will begin publishing payments made to researchers in 2011.

State Medical Board Actions Up

State medical boards took 5,721 actions against physicians in 2009, an increase of 342, or more than 6%, over 2008, according to a report from the Federation of State Medical Boards. Meanwhile, an analysis by the advocacy group Public Citizen found that the rate of serious disciplinary actions rose slightly in 2009 but still sits about 18% lower than the peak rate of 2004. Minnesota ranked last in disciplining physicians, Public Citizen said, and Maryland, South Carolina, and Wisconsin also consistently rank among the bottom 10. Arizona, Alaska, Kentucky, North Dakota, and Ohio discipline the most physicians, the group said. “There is considerable evidence that most boards are underdisciplining physicians,” Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a statement. “Most states are not living up to their obligations to protect patients from doctors who are practicing medicine in a substandard manner.”

Governor Signs Meth Law

Alabama Gov. Bob Riley (R) has signed a law intended to help law enforcement officials quickly track excessive purchases of pseudoephedrine, which is the chief ingredient used in the manufacture of methamphetamine. The law creates a new electronic database in an effort to modernize logs that already are kept on paper, making it possible to instantly track excessive purchases of pseudoephedrine. Every pharmacy or retailer that sells ephedrine or pseudoephedrine products will be required to enter the purchaser's identifying information into an electronic database prior to any sale. The database then will notify the seller if the purchaser has exceeded the daily or monthly limit for such purchases. Law enforcement authorities also will have access to the database. “Our local law enforcement agencies tell us that in some Alabama counties, meth plays a role in almost every crime,” Gov. Riley said in a statement.

Almost all primary care physicians want to help obese patients lose weight, but they say that no one in their practice knows enough to adequately deal with weight-related issues, a survey revealed.

The survey of 290 primary care physicians, conducted by Harris Interactive late in 2009 and sponsored by the STOP (Strategies to Overcome and Prevent) Obesity Alliance, indicated physicians agree that a 5%-10% weight loss would help their obese patients.

But a companion survey of American adults released at the same time by the STOP Obesity Alliance found that only 39% of obese adults (those with a body mass index of 30 kg/m

Those adults whose physicians used the term obese also said that the physician recommended they lose weight. But about one in three of these said that their physicians never discussed the mechanics of how to go about losing weight, the survey of 1,002 adults reported.

This results in a disconnect between the information that obese patients need from their physicians and what physicians actually tell them about losing weight, according to presenters at a briefing on the results from the two surveys.

“Patients want more information about weight management. They're hungry for it, and they don't know what information to believe,” said Roz Pierson, Ph.D., Harris Interactive vice president of health policy research. “But a lot of primary care physicians said they or no one in their office had been trained to discuss weight issues. If you don't feel like you have the training to deal with weight issues, you can see why there is a lack of willingness to have a dialogue.”

Both physicians and patients agree that even a small amount of weight loss is beneficial, according to the surveys. In all, 80% of patients who consider themselves overweight or obese, along with 91% of physicians, agree that the risk of disease is reduced “a great deal” or “somewhat” following a weight loss of 5%-10%.

Physicians told surveyors that they recommended a variety of strategies to patients for weight loss, including improving their diets, counting calories, and reading a book or visiting a Web site. Physicians also said they recommended that their overweight or obese patients see a weight-loss specialist, enroll in community-based organizations, consider clinical programs for weight loss, or even have bariatric surgery.

However, physicians told surveyors that they didn't have the training or tools to properly counsel patients on weight, and they also lacked the time needed with those patients to do the job right.

Former U.S. Surgeon General Richard Carmona, who serves as health and wellness chairperson of the STOP Obesity Alliance, said at the briefing that solving the problem of time to deal with obesity and other preventive health issues would require a health system overhaul.

Still, he urged physicians to take the time if possible under the current system. “You can say, 'I'd like to take the time, but I don't have the time.' But would you say that if patient walked in with chest pains? In diabetic acidosis? With a broken arm?” Dr. Carmona asked.

Dr. William Bestermann Jr., medical director of Holston Medical Group Integrated Health Services in Houston, one of the most obese areas in the country, agreed that a health system overhaul would be needed to give physicians ample time to counsel patients on weight loss.

“The system produces the results it was designed to produce,” Dr. Bestermann said. “We do all this pricey stuff at the end of the game. We need to shift some of those resources from the end game” in order to help people lose weight and lower their risks of chronic and acute health issues from the beginning, he said.

The STOP Obesity Alliance recommended the following five strategies to improve the treatment of obesity within primary care:

▸ Monitor weight, health indicators, and risk.

▸ Assess patient motivation and readiness for change.

▸ Define success in terms of health improvement rather than looks.

▸ Increase integration and care coordination among providers.

▸ Implement electronic medical records.

Almost all primary care physicians want to help obese patients lose weight, but they say that no one in their practice knows enough to adequately deal with weight-related issues, a survey revealed.

The survey of 290 primary care physicians, conducted by Harris Interactive late in 2009 and sponsored by the STOP (Strategies to Overcome and Prevent) Obesity Alliance, indicated physicians agree that a 5%-10% weight loss would help their obese patients.

But a companion survey of American adults released at the same time by the STOP Obesity Alliance found that only 39% of obese adults (those with a body mass index of 30 kg/m

Those adults whose physicians used the term obese also said that the physician recommended they lose weight. But about one in three of these said that their physicians never discussed the mechanics of how to go about losing weight, the survey of 1,002 adults reported.

This results in a disconnect between the information that obese patients need from their physicians and what physicians actually tell them about losing weight, according to presenters at a briefing on the results from the two surveys.

“Patients want more information about weight management. They're hungry for it, and they don't know what information to believe,” said Roz Pierson, Ph.D., Harris Interactive vice president of health policy research. “But a lot of primary care physicians said they or no one in their office had been trained to discuss weight issues. If you don't feel like you have the training to deal with weight issues, you can see why there is a lack of willingness to have a dialogue.”

Both physicians and patients agree that even a small amount of weight loss is beneficial, according to the surveys. In all, 80% of patients who consider themselves overweight or obese, along with 91% of physicians, agree that the risk of disease is reduced “a great deal” or “somewhat” following a weight loss of 5%-10%.

Physicians told surveyors that they recommended a variety of strategies to patients for weight loss, including improving their diets, counting calories, and reading a book or visiting a Web site. Physicians also said they recommended that their overweight or obese patients see a weight-loss specialist, enroll in community-based organizations, consider clinical programs for weight loss, or even have bariatric surgery.

However, physicians told surveyors that they didn't have the training or tools to properly counsel patients on weight, and they also lacked the time needed with those patients to do the job right.

Former U.S. Surgeon General Richard Carmona, who serves as health and wellness chairperson of the STOP Obesity Alliance, said at the briefing that solving the problem of time to deal with obesity and other preventive health issues would require a health system overhaul.

Still, he urged physicians to take the time if possible under the current system. “You can say, 'I'd like to take the time, but I don't have the time.' But would you say that if patient walked in with chest pains? In diabetic acidosis? With a broken arm?” Dr. Carmona asked.

Dr. William Bestermann Jr., medical director of Holston Medical Group Integrated Health Services in Houston, one of the most obese areas in the country, agreed that a health system overhaul would be needed to give physicians ample time to counsel patients on weight loss.

“The system produces the results it was designed to produce,” Dr. Bestermann said. “We do all this pricey stuff at the end of the game. We need to shift some of those resources from the end game” in order to help people lose weight and lower their risks of chronic and acute health issues from the beginning, he said.

The STOP Obesity Alliance recommended the following five strategies to improve the treatment of obesity within primary care:

▸ Monitor weight, health indicators, and risk.

▸ Assess patient motivation and readiness for change.

▸ Define success in terms of health improvement rather than looks.

▸ Increase integration and care coordination among providers.

▸ Implement electronic medical records.

Almost all primary care physicians want to help obese patients lose weight, but they say that no one in their practice knows enough to adequately deal with weight-related issues, a survey revealed.

The survey of 290 primary care physicians, conducted by Harris Interactive late in 2009 and sponsored by the STOP (Strategies to Overcome and Prevent) Obesity Alliance, indicated physicians agree that a 5%-10% weight loss would help their obese patients.

But a companion survey of American adults released at the same time by the STOP Obesity Alliance found that only 39% of obese adults (those with a body mass index of 30 kg/m

Those adults whose physicians used the term obese also said that the physician recommended they lose weight. But about one in three of these said that their physicians never discussed the mechanics of how to go about losing weight, the survey of 1,002 adults reported.

This results in a disconnect between the information that obese patients need from their physicians and what physicians actually tell them about losing weight, according to presenters at a briefing on the results from the two surveys.

“Patients want more information about weight management. They're hungry for it, and they don't know what information to believe,” said Roz Pierson, Ph.D., Harris Interactive vice president of health policy research. “But a lot of primary care physicians said they or no one in their office had been trained to discuss weight issues. If you don't feel like you have the training to deal with weight issues, you can see why there is a lack of willingness to have a dialogue.”

Both physicians and patients agree that even a small amount of weight loss is beneficial, according to the surveys. In all, 80% of patients who consider themselves overweight or obese, along with 91% of physicians, agree that the risk of disease is reduced “a great deal” or “somewhat” following a weight loss of 5%-10%.

Physicians told surveyors that they recommended a variety of strategies to patients for weight loss, including improving their diets, counting calories, and reading a book or visiting a Web site. Physicians also said they recommended that their overweight or obese patients see a weight-loss specialist, enroll in community-based organizations, consider clinical programs for weight loss, or even have bariatric surgery.

However, physicians told surveyors that they didn't have the training or tools to properly counsel patients on weight, and they also lacked the time needed with those patients to do the job right.

Former U.S. Surgeon General Richard Carmona, who serves as health and wellness chairperson of the STOP Obesity Alliance, said at the briefing that solving the problem of time to deal with obesity and other preventive health issues would require a health system overhaul.

Still, he urged physicians to take the time if possible under the current system. “You can say, 'I'd like to take the time, but I don't have the time.' But would you say that if patient walked in with chest pains? In diabetic acidosis? With a broken arm?” Dr. Carmona asked.

Dr. William Bestermann Jr., medical director of Holston Medical Group Integrated Health Services in Houston, one of the most obese areas in the country, agreed that a health system overhaul would be needed to give physicians ample time to counsel patients on weight loss.

“The system produces the results it was designed to produce,” Dr. Bestermann said. “We do all this pricey stuff at the end of the game. We need to shift some of those resources from the end game” in order to help people lose weight and lower their risks of chronic and acute health issues from the beginning, he said.

The STOP Obesity Alliance recommended the following five strategies to improve the treatment of obesity within primary care:

▸ Monitor weight, health indicators, and risk.

▸ Assess patient motivation and readiness for change.

▸ Define success in terms of health improvement rather than looks.

▸ Increase integration and care coordination among providers.

▸ Implement electronic medical records.

Unhealthy behaviors such as a lack of exercise and a poor diet explain a substantial part of differences in mortality between the well off and those low on the socioeconomic ladder, a study suggested.

An assessment of smoking, alcohol consumption, diet, and physical activity among civil servants living in London over a 24-year period found “a clear social gradient in mortality, with lower socioeconomic position being associated with higher mortality,” the authors said (JAMA 2010;303:1159-66).

“Unhealthy behaviors such as smoking, unhealthy diet, and low levels of physical activity were strongly related to mortality, as well as nonconsumption of alcohol,” the authors wrote. Heavy alcohol consumption was more prevalent among participants in the highest socioeconomic bracket.

The researchers, led by Silvia Stringhini of the Centre for Research in Epidemiology and Population Health in Villejuif, France, and her associates, sought to examine unhealthy behaviors as they relate to the association between socioeconomic position and mortality. To do this accurately, they assessed behaviors in the 10,308 study participants five times: once at the beginning of the study and four times during the follow-up period.

The participants' socioeconomic position was determined from their civil service employment grades at the beginning of the study, when they were aged 35-55 years.

A total of 654 participants died during the study, and after adjustments for sex and age, the researchers determined that those with the lowest socioeconomic position had a risk of dying that was 1.6 times higher than those in the highest socioeconomic bracket.

Overall, unhealthy behaviors noted at the beginning of the study explained 29% of cardiovascular disease mortality, 61% of mortality not related to cardiovascular disease, and 42% of overall mortality.

By the end of the study, the researchers found these unhealthy behaviors explained 45% of cardiovascular disease deaths, 94% of mortality not related to cardiovascular disease, and 72% of deaths overall.

Smoking rates stayed fairly constant at around 32%-35% throughout the study. However, mortality risk rose in relation to diet (from 7% to 17% for all-cause mortality), physical activity (from 5% to 21% for all-cause mortality), and alcohol consumption (from 3% to 12% for all-cause mortality).

The authors noted that mortality risk for moderate drinkers was lower compared with both nondrinkers and heavy drinkers. Participants who abstained from alcohol completely were at higher risk for death from cardiovascular disease, while those who drank heavily had a higher cancer death risk.

The study results show that health behaviors explain more of socioeconomic differences in death rates than what has been observed in previous studies, James R. Dunn, Ph.D., of McMaster University in Hamilton, Ont., wrote in an editorial (JAMA 2010;303:1199-200).

However, the findings don't suggest that socioeconomic differences in health status can be reduced simply to socioeconomic differences in unhealthy behaviors, Dr. Dunn said. “Accordingly, it would be incorrect to infer that there is no need to be concerned with social and economic justice, only health behavior,” he said.

Evidence suggests that early childhood development involving stress management capabilities and health behavior may play a role in empowering adults to choose healthier behaviors, he said. Children with lower socioeconomic status are more likely to have deficits in these areas.

Disclosures: Neither Ms. Stringhini nor Dr. Dunn reported any financial disclosures. The study was supported by grants from the British Medical Research Council, the British Heart Foundation, the British Health and Safety Executive, and the British Department of Health; the National Heart, Lung, and Blood Institute; and the National Institute on Aging.

Unhealthy behaviors such as a lack of exercise and a poor diet explain a substantial part of differences in mortality between the well off and those low on the socioeconomic ladder, a study suggested.

An assessment of smoking, alcohol consumption, diet, and physical activity among civil servants living in London over a 24-year period found “a clear social gradient in mortality, with lower socioeconomic position being associated with higher mortality,” the authors said (JAMA 2010;303:1159-66).

“Unhealthy behaviors such as smoking, unhealthy diet, and low levels of physical activity were strongly related to mortality, as well as nonconsumption of alcohol,” the authors wrote. Heavy alcohol consumption was more prevalent among participants in the highest socioeconomic bracket.

The researchers, led by Silvia Stringhini of the Centre for Research in Epidemiology and Population Health in Villejuif, France, and her associates, sought to examine unhealthy behaviors as they relate to the association between socioeconomic position and mortality. To do this accurately, they assessed behaviors in the 10,308 study participants five times: once at the beginning of the study and four times during the follow-up period.

The participants' socioeconomic position was determined from their civil service employment grades at the beginning of the study, when they were aged 35-55 years.

A total of 654 participants died during the study, and after adjustments for sex and age, the researchers determined that those with the lowest socioeconomic position had a risk of dying that was 1.6 times higher than those in the highest socioeconomic bracket.

Overall, unhealthy behaviors noted at the beginning of the study explained 29% of cardiovascular disease mortality, 61% of mortality not related to cardiovascular disease, and 42% of overall mortality.

By the end of the study, the researchers found these unhealthy behaviors explained 45% of cardiovascular disease deaths, 94% of mortality not related to cardiovascular disease, and 72% of deaths overall.

Smoking rates stayed fairly constant at around 32%-35% throughout the study. However, mortality risk rose in relation to diet (from 7% to 17% for all-cause mortality), physical activity (from 5% to 21% for all-cause mortality), and alcohol consumption (from 3% to 12% for all-cause mortality).

The authors noted that mortality risk for moderate drinkers was lower compared with both nondrinkers and heavy drinkers. Participants who abstained from alcohol completely were at higher risk for death from cardiovascular disease, while those who drank heavily had a higher cancer death risk.

The study results show that health behaviors explain more of socioeconomic differences in death rates than what has been observed in previous studies, James R. Dunn, Ph.D., of McMaster University in Hamilton, Ont., wrote in an editorial (JAMA 2010;303:1199-200).

However, the findings don't suggest that socioeconomic differences in health status can be reduced simply to socioeconomic differences in unhealthy behaviors, Dr. Dunn said. “Accordingly, it would be incorrect to infer that there is no need to be concerned with social and economic justice, only health behavior,” he said.

Evidence suggests that early childhood development involving stress management capabilities and health behavior may play a role in empowering adults to choose healthier behaviors, he said. Children with lower socioeconomic status are more likely to have deficits in these areas.

Disclosures: Neither Ms. Stringhini nor Dr. Dunn reported any financial disclosures. The study was supported by grants from the British Medical Research Council, the British Heart Foundation, the British Health and Safety Executive, and the British Department of Health; the National Heart, Lung, and Blood Institute; and the National Institute on Aging.

Unhealthy behaviors such as a lack of exercise and a poor diet explain a substantial part of differences in mortality between the well off and those low on the socioeconomic ladder, a study suggested.

An assessment of smoking, alcohol consumption, diet, and physical activity among civil servants living in London over a 24-year period found “a clear social gradient in mortality, with lower socioeconomic position being associated with higher mortality,” the authors said (JAMA 2010;303:1159-66).

“Unhealthy behaviors such as smoking, unhealthy diet, and low levels of physical activity were strongly related to mortality, as well as nonconsumption of alcohol,” the authors wrote. Heavy alcohol consumption was more prevalent among participants in the highest socioeconomic bracket.

The researchers, led by Silvia Stringhini of the Centre for Research in Epidemiology and Population Health in Villejuif, France, and her associates, sought to examine unhealthy behaviors as they relate to the association between socioeconomic position and mortality. To do this accurately, they assessed behaviors in the 10,308 study participants five times: once at the beginning of the study and four times during the follow-up period.

The participants' socioeconomic position was determined from their civil service employment grades at the beginning of the study, when they were aged 35-55 years.

A total of 654 participants died during the study, and after adjustments for sex and age, the researchers determined that those with the lowest socioeconomic position had a risk of dying that was 1.6 times higher than those in the highest socioeconomic bracket.

Overall, unhealthy behaviors noted at the beginning of the study explained 29% of cardiovascular disease mortality, 61% of mortality not related to cardiovascular disease, and 42% of overall mortality.

By the end of the study, the researchers found these unhealthy behaviors explained 45% of cardiovascular disease deaths, 94% of mortality not related to cardiovascular disease, and 72% of deaths overall.

Smoking rates stayed fairly constant at around 32%-35% throughout the study. However, mortality risk rose in relation to diet (from 7% to 17% for all-cause mortality), physical activity (from 5% to 21% for all-cause mortality), and alcohol consumption (from 3% to 12% for all-cause mortality).

The authors noted that mortality risk for moderate drinkers was lower compared with both nondrinkers and heavy drinkers. Participants who abstained from alcohol completely were at higher risk for death from cardiovascular disease, while those who drank heavily had a higher cancer death risk.

The study results show that health behaviors explain more of socioeconomic differences in death rates than what has been observed in previous studies, James R. Dunn, Ph.D., of McMaster University in Hamilton, Ont., wrote in an editorial (JAMA 2010;303:1199-200).

However, the findings don't suggest that socioeconomic differences in health status can be reduced simply to socioeconomic differences in unhealthy behaviors, Dr. Dunn said. “Accordingly, it would be incorrect to infer that there is no need to be concerned with social and economic justice, only health behavior,” he said.

Evidence suggests that early childhood development involving stress management capabilities and health behavior may play a role in empowering adults to choose healthier behaviors, he said. Children with lower socioeconomic status are more likely to have deficits in these areas.

Disclosures: Neither Ms. Stringhini nor Dr. Dunn reported any financial disclosures. The study was supported by grants from the British Medical Research Council, the British Heart Foundation, the British Health and Safety Executive, and the British Department of Health; the National Heart, Lung, and Blood Institute; and the National Institute on Aging.

A new Open Government initiative unveiled by the Health and Human Services department April 7 aims to create more transparency at the giant federal health agency, improve accountability, and make large quantities of raw Medicare and public health data available to the public.

A separate transparency project at the Food and Drug Administration was announced during the same public webcast, as was a beta-test version of a new data dashboard for the Centers for Medicare and Medicaid Services (www.cms.gov/Dashboard).

One of the biggest components of the HHS plan is the release of raw public health data.

“HHS’s vast stores of data are a remarkable national resource which can be utilized to help citizens understand what we do and hold us accountable, help the public hold the private sector accountable, increase awareness of health and human services issues, generate insights into how to improve health and well-being, spark public and private sector innovation and action, and provide the basis for new products and services that can benefit the American people,” HHS officials wrote in the plan.

The project will make various data sets public so that state and local governments, researchers, and others can use it to analyze public health trends and create novel applications, said Todd Park, HHS chief technology officer.

“We have a lot of data showing how we’re doing on obesity, smoking, access to healthy foods,” Mr. Park said during a webcast launching the project. “We’re going to take all that data, make sure it doesn’t compromise patient privacy, and then release it.”

Mr. Park said he is “100% confident” that users outside government will take the data and “come up with better ideas than we would ever have for it.”

For example, he said he could envision “social networking games to help advise a lot of folks on what’s going on in community health and how to improve it.” He added that the agency is sponsoring the HHS Apps Challenge, which is a public competition for the best applications built using the data.

CMS already has uploaded an improved user interface and analytical tool for viewing existing CMS COMPARE data on quality performance for hospitals, nursing homes, home health agencies, and dialysis centers, HHS officials said during the webcast.

And, CMS plans to publish detailed Medicaid State Plan documents and amendments online at the CMS Web site by the end of 2010, and also will release never-before-published national, state, regional, and potentially county-level data on Medicare prevalence of disease, quality, costs, and service utilization as part of HHS’s Community Health Data Initiative.

As part of the overall Open Government initiative, the FDA also launched a new dashboard, which when fully implemented, will allow the public to track some 300 performance measures and 80 key projects across more than 90 FDA program offices on an ongoing basis, Dr. Joshua Sharfstein, FDA principal deputy commissioner, said during the webcast.

The public will be able to use the dashboard, located at www.fda.gov/fdatrack, to “see the progress that each office is making toward its goals,” he said. For example, measures might include how many generic drugs are waiting to be reviewed, and progress in tracking contaminated foods, he said.

“In the past, agencies had been measured by some broad overall measures,” Dr. Sharfstein said. “Our measures are monthly, there are many more of them, and they’re really targeted. People will be able to go online and see our progress.”

A new Open Government initiative unveiled by the Health and Human Services department April 7 aims to create more transparency at the giant federal health agency, improve accountability, and make large quantities of raw Medicare and public health data available to the public.

A separate transparency project at the Food and Drug Administration was announced during the same public webcast, as was a beta-test version of a new data dashboard for the Centers for Medicare and Medicaid Services (www.cms.gov/Dashboard).

One of the biggest components of the HHS plan is the release of raw public health data.

“HHS’s vast stores of data are a remarkable national resource which can be utilized to help citizens understand what we do and hold us accountable, help the public hold the private sector accountable, increase awareness of health and human services issues, generate insights into how to improve health and well-being, spark public and private sector innovation and action, and provide the basis for new products and services that can benefit the American people,” HHS officials wrote in the plan.

The project will make various data sets public so that state and local governments, researchers, and others can use it to analyze public health trends and create novel applications, said Todd Park, HHS chief technology officer.

“We have a lot of data showing how we’re doing on obesity, smoking, access to healthy foods,” Mr. Park said during a webcast launching the project. “We’re going to take all that data, make sure it doesn’t compromise patient privacy, and then release it.”

Mr. Park said he is “100% confident” that users outside government will take the data and “come up with better ideas than we would ever have for it.”

For example, he said he could envision “social networking games to help advise a lot of folks on what’s going on in community health and how to improve it.” He added that the agency is sponsoring the HHS Apps Challenge, which is a public competition for the best applications built using the data.

CMS already has uploaded an improved user interface and analytical tool for viewing existing CMS COMPARE data on quality performance for hospitals, nursing homes, home health agencies, and dialysis centers, HHS officials said during the webcast.

And, CMS plans to publish detailed Medicaid State Plan documents and amendments online at the CMS Web site by the end of 2010, and also will release never-before-published national, state, regional, and potentially county-level data on Medicare prevalence of disease, quality, costs, and service utilization as part of HHS’s Community Health Data Initiative.

As part of the overall Open Government initiative, the FDA also launched a new dashboard, which when fully implemented, will allow the public to track some 300 performance measures and 80 key projects across more than 90 FDA program offices on an ongoing basis, Dr. Joshua Sharfstein, FDA principal deputy commissioner, said during the webcast.

The public will be able to use the dashboard, located at www.fda.gov/fdatrack, to “see the progress that each office is making toward its goals,” he said. For example, measures might include how many generic drugs are waiting to be reviewed, and progress in tracking contaminated foods, he said.

“In the past, agencies had been measured by some broad overall measures,” Dr. Sharfstein said. “Our measures are monthly, there are many more of them, and they’re really targeted. People will be able to go online and see our progress.”

A new Open Government initiative unveiled by the Health and Human Services department April 7 aims to create more transparency at the giant federal health agency, improve accountability, and make large quantities of raw Medicare and public health data available to the public.

A separate transparency project at the Food and Drug Administration was announced during the same public webcast, as was a beta-test version of a new data dashboard for the Centers for Medicare and Medicaid Services (www.cms.gov/Dashboard).

One of the biggest components of the HHS plan is the release of raw public health data.

“HHS’s vast stores of data are a remarkable national resource which can be utilized to help citizens understand what we do and hold us accountable, help the public hold the private sector accountable, increase awareness of health and human services issues, generate insights into how to improve health and well-being, spark public and private sector innovation and action, and provide the basis for new products and services that can benefit the American people,” HHS officials wrote in the plan.

The project will make various data sets public so that state and local governments, researchers, and others can use it to analyze public health trends and create novel applications, said Todd Park, HHS chief technology officer.

“We have a lot of data showing how we’re doing on obesity, smoking, access to healthy foods,” Mr. Park said during a webcast launching the project. “We’re going to take all that data, make sure it doesn’t compromise patient privacy, and then release it.”

Mr. Park said he is “100% confident” that users outside government will take the data and “come up with better ideas than we would ever have for it.”

For example, he said he could envision “social networking games to help advise a lot of folks on what’s going on in community health and how to improve it.” He added that the agency is sponsoring the HHS Apps Challenge, which is a public competition for the best applications built using the data.

CMS already has uploaded an improved user interface and analytical tool for viewing existing CMS COMPARE data on quality performance for hospitals, nursing homes, home health agencies, and dialysis centers, HHS officials said during the webcast.

And, CMS plans to publish detailed Medicaid State Plan documents and amendments online at the CMS Web site by the end of 2010, and also will release never-before-published national, state, regional, and potentially county-level data on Medicare prevalence of disease, quality, costs, and service utilization as part of HHS’s Community Health Data Initiative.

As part of the overall Open Government initiative, the FDA also launched a new dashboard, which when fully implemented, will allow the public to track some 300 performance measures and 80 key projects across more than 90 FDA program offices on an ongoing basis, Dr. Joshua Sharfstein, FDA principal deputy commissioner, said during the webcast.

The public will be able to use the dashboard, located at www.fda.gov/fdatrack, to “see the progress that each office is making toward its goals,” he said. For example, measures might include how many generic drugs are waiting to be reviewed, and progress in tracking contaminated foods, he said.

“In the past, agencies had been measured by some broad overall measures,” Dr. Sharfstein said. “Our measures are monthly, there are many more of them, and they’re really targeted. People will be able to go online and see our progress.”

More than 25% of medical interns suffer from depression during their internships, and depressed interns are more likely to make medical errors, a study published online April 5 in the Archives of General Psychiatry reported.

In addition, interns who commit frequent medical errors may be more likely to become depressed than their colleagues who commit fewer, according to the study, the largest prospective study of depression during medical internship to date.

“Depressive symptoms that are present before internship predicted reported errors during internship, indicating that depression results in increased medical errors,” Dr. Srijan Sen of the University of Michigan, Ann Arbor, and colleagues wrote. “Controlling for the baseline level of depressive symptoms, a strong correlation between errors and depression persisted, indicating that errors may also cause depression and that the association between depression and reported medical errors is bidirectional.”

The authors followed 740 interns, assessing them for depressive symptoms and genetic risk prior to internship and then for symptoms and potential stressors at 3-month intervals throughout their internships.

They found a dramatic increase in depression between the last year of medical school and internship. The rate of depression rose from less than 4% prior to internship to an average of more than 25% during the internship year, according to the investigators (Arch. Gen. Psychiatry. 2010;67[doi:10.1001/archgenpsychiatry.2010.41]).

Most subjects who met the criteria for depression were moderately depressed, and few subjects met the standards for moderately severe or severe depression, the investigators wrote.

Women, and interns of either gender with history of depression, neuroticism, and a difficult early family environment, were more likely to suffer from depression, they found.

Depression during internship also was associated with a U.S. medical school education and with fewer depressive symptoms before the beginning of the internship, the investigators wrote. However, age and the medical specialty chosen had no effect on rates of depression during internship.

The data could be useful in preventing depressive symptoms among medical interns, they wrote.

“With effective interventions to help prevent the onset of depression now available, the predictive factors identified herein could allow at-risk interns to take steps before the onset of symptoms to lower their chances of developing depression,” according to Dr. Sen and colleagues.

The study was funded by grants from the Donaghue Foundation, the Department of Veterans Affairs, the American Foundation for Suicide Prevention, and the Substance Abuse and Mental Health Services Administration.

Two of the study authors reported consulting arrangements with a variety of pharmaceutical manufacturers, and one of these reported he also is a cosponsor on pending patents related to new drugs for psychiatric disorders, including depression.

_{Image above courtesy Flickr Creative Commons user "Psychedelic Tuna."}

More than 25% of medical interns suffer from depression during their internships, and depressed interns are more likely to make medical errors, a study published online April 5 in the Archives of General Psychiatry reported.

In addition, interns who commit frequent medical errors may be more likely to become depressed than their colleagues who commit fewer, according to the study, the largest prospective study of depression during medical internship to date.

“Depressive symptoms that are present before internship predicted reported errors during internship, indicating that depression results in increased medical errors,” Dr. Srijan Sen of the University of Michigan, Ann Arbor, and colleagues wrote. “Controlling for the baseline level of depressive symptoms, a strong correlation between errors and depression persisted, indicating that errors may also cause depression and that the association between depression and reported medical errors is bidirectional.”

The authors followed 740 interns, assessing them for depressive symptoms and genetic risk prior to internship and then for symptoms and potential stressors at 3-month intervals throughout their internships.

They found a dramatic increase in depression between the last year of medical school and internship. The rate of depression rose from less than 4% prior to internship to an average of more than 25% during the internship year, according to the investigators (Arch. Gen. Psychiatry. 2010;67[doi:10.1001/archgenpsychiatry.2010.41]).

Most subjects who met the criteria for depression were moderately depressed, and few subjects met the standards for moderately severe or severe depression, the investigators wrote.

Women, and interns of either gender with history of depression, neuroticism, and a difficult early family environment, were more likely to suffer from depression, they found.

Depression during internship also was associated with a U.S. medical school education and with fewer depressive symptoms before the beginning of the internship, the investigators wrote. However, age and the medical specialty chosen had no effect on rates of depression during internship.

The data could be useful in preventing depressive symptoms among medical interns, they wrote.

“With effective interventions to help prevent the onset of depression now available, the predictive factors identified herein could allow at-risk interns to take steps before the onset of symptoms to lower their chances of developing depression,” according to Dr. Sen and colleagues.

The study was funded by grants from the Donaghue Foundation, the Department of Veterans Affairs, the American Foundation for Suicide Prevention, and the Substance Abuse and Mental Health Services Administration.

Two of the study authors reported consulting arrangements with a variety of pharmaceutical manufacturers, and one of these reported he also is a cosponsor on pending patents related to new drugs for psychiatric disorders, including depression.

_{Image above courtesy Flickr Creative Commons user "Psychedelic Tuna."}

More than 25% of medical interns suffer from depression during their internships, and depressed interns are more likely to make medical errors, a study published online April 5 in the Archives of General Psychiatry reported.

In addition, interns who commit frequent medical errors may be more likely to become depressed than their colleagues who commit fewer, according to the study, the largest prospective study of depression during medical internship to date.

“Depressive symptoms that are present before internship predicted reported errors during internship, indicating that depression results in increased medical errors,” Dr. Srijan Sen of the University of Michigan, Ann Arbor, and colleagues wrote. “Controlling for the baseline level of depressive symptoms, a strong correlation between errors and depression persisted, indicating that errors may also cause depression and that the association between depression and reported medical errors is bidirectional.”

The authors followed 740 interns, assessing them for depressive symptoms and genetic risk prior to internship and then for symptoms and potential stressors at 3-month intervals throughout their internships.

They found a dramatic increase in depression between the last year of medical school and internship. The rate of depression rose from less than 4% prior to internship to an average of more than 25% during the internship year, according to the investigators (Arch. Gen. Psychiatry. 2010;67[doi:10.1001/archgenpsychiatry.2010.41]).

Most subjects who met the criteria for depression were moderately depressed, and few subjects met the standards for moderately severe or severe depression, the investigators wrote.

Women, and interns of either gender with history of depression, neuroticism, and a difficult early family environment, were more likely to suffer from depression, they found.

Depression during internship also was associated with a U.S. medical school education and with fewer depressive symptoms before the beginning of the internship, the investigators wrote. However, age and the medical specialty chosen had no effect on rates of depression during internship.

The data could be useful in preventing depressive symptoms among medical interns, they wrote.

“With effective interventions to help prevent the onset of depression now available, the predictive factors identified herein could allow at-risk interns to take steps before the onset of symptoms to lower their chances of developing depression,” according to Dr. Sen and colleagues.

The study was funded by grants from the Donaghue Foundation, the Department of Veterans Affairs, the American Foundation for Suicide Prevention, and the Substance Abuse and Mental Health Services Administration.

Two of the study authors reported consulting arrangements with a variety of pharmaceutical manufacturers, and one of these reported he also is a cosponsor on pending patents related to new drugs for psychiatric disorders, including depression.

_{Image above courtesy Flickr Creative Commons user "Psychedelic Tuna."}

Ads Misled on Metozolv ODT

Salix Pharmaceuticals Inc. misled physicians and consumers in promotional materials for its drug Metozolv ODT (metoclopramide), which was approved in September 2009 for diabetic gastroparesis and gastroesophageal reflux disease, the Food and Drug Administration said in a warning letter to the company. Metozolv ODT is approved for short-term therapy in adults with diabetic gastroparesis, and for short-term therapy in adults who have GERD that does not respond to other medications. The FDA warning letter said Salix downplayed and omitted risk information and broadened the indications for Metozolv ODT in advertising materials and in a display at a clinical meeting. Salix failed to submit some of the materials to the FDA, as required, at the time of their initial use. The FDA specifically flagged the term “ideal for all patients,” which it said was untrue due to Metozolv ODT's “numerous contraindications and limitations of indications for use.” The warning letter told Salix to immediately stop using the questionable promotional materials and to ensure that all other materials comply with FDA regulations.

Calif. County Sues Over Avandia

A California county has sued GlaxoSmithKline, saying the pharmaceutical giant falsely promoted its diabetes drug Avandia as safe and effective while suppressing evidence of serious cardiovascular problems. The complaint, filed by Santa Clara County in U.S. District Court for the Northern California District, asserts that GSK ignored or concealed early data and studies revealing Avandia's hazards. The company also engaged in “an aggressive and highly successful marketing strategy designed to persuade patients, doctors, and insurers to use Avandia instead of less expensive and far safer diabetes drugs already on the market,” the complaint said. The lawsuit seeks monetary restitution for all Avandia purchasers and users in California, and notes that Santa Clara County spent $2 million on Avandia purchases between 1999 and 2007.

GSK Ties Underreported

Many researchers who published articles supporting rosiglitazone (Avandia) after it was linked to cardiovascular disease in 2007 had financial ties to GlaxoSmithKline, an analysis published in the British Medical Journal found. The authors examined 202 articles, including 108 that contained a financial conflict-of-interest statement, and found that researchers who had a favorable view of Avandia's cardiovascular risks were more likely to have financial conflicts of interest. Disclosure rates overall were “unexpectedly low,” the BMJ analysis said. “There was a clear and strong link between the orientation of authors' expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies,” the analysis said, adding that although this does not prove cause and effect, it shows the need for better disclosure practices.

HbA_1c Test Sales Increasing

Hemoglobin A_1c testing will increase more than other tests performed at the point of care as a result of expert recommendations, new diabetes cases, and booming mail-in test sales, according to a report from marketing research company Kalorama Information. Kalorama estimated that the global market for point-of-care HbA_1c tests reached $230 million in 2009 and will rise to $350 million by 2013, a growth rate that is 50% higher than the average point-of-care testing product. The mail-in self-tests, performed by mail-in laboratory services, represents a small percentage of those revenues now, but is showing faster sales growth than lab-based tests and should grow at 25% annually over the next 5 years, Kalorama said. At least 30 companies offer HbA_1c assays for automated systems, the report said.

FDA Warns on Food Labels

The Food and Drug Administration has notified 17 food manufacturers, including Gorton's Inc. and Nestle, that labeling for some of their food products violates the Federal Food, Drug, and Cosmetic Act. Violations cited in the warning letters include unauthorized health claims, unauthorized nutrient-content claims, and the unauthorized use of terms such as “healthy.” Nestle, for example, was warned about using “100% juice” to describe a product that had added flavors, while the FDA told Gorton's in its letter that its fish fillet packages need to disclose high levels of sodium, saturated fat, and total fat to accompany the claim of zero trans fats.

Ads Misled on Metozolv ODT

Salix Pharmaceuticals Inc. misled physicians and consumers in promotional materials for its drug Metozolv ODT (metoclopramide), which was approved in September 2009 for diabetic gastroparesis and gastroesophageal reflux disease, the Food and Drug Administration said in a warning letter to the company. Metozolv ODT is approved for short-term therapy in adults with diabetic gastroparesis, and for short-term therapy in adults who have GERD that does not respond to other medications. The FDA warning letter said Salix downplayed and omitted risk information and broadened the indications for Metozolv ODT in advertising materials and in a display at a clinical meeting. Salix failed to submit some of the materials to the FDA, as required, at the time of their initial use. The FDA specifically flagged the term “ideal for all patients,” which it said was untrue due to Metozolv ODT's “numerous contraindications and limitations of indications for use.” The warning letter told Salix to immediately stop using the questionable promotional materials and to ensure that all other materials comply with FDA regulations.

Calif. County Sues Over Avandia

A California county has sued GlaxoSmithKline, saying the pharmaceutical giant falsely promoted its diabetes drug Avandia as safe and effective while suppressing evidence of serious cardiovascular problems. The complaint, filed by Santa Clara County in U.S. District Court for the Northern California District, asserts that GSK ignored or concealed early data and studies revealing Avandia's hazards. The company also engaged in “an aggressive and highly successful marketing strategy designed to persuade patients, doctors, and insurers to use Avandia instead of less expensive and far safer diabetes drugs already on the market,” the complaint said. The lawsuit seeks monetary restitution for all Avandia purchasers and users in California, and notes that Santa Clara County spent $2 million on Avandia purchases between 1999 and 2007.

GSK Ties Underreported

Many researchers who published articles supporting rosiglitazone (Avandia) after it was linked to cardiovascular disease in 2007 had financial ties to GlaxoSmithKline, an analysis published in the British Medical Journal found. The authors examined 202 articles, including 108 that contained a financial conflict-of-interest statement, and found that researchers who had a favorable view of Avandia's cardiovascular risks were more likely to have financial conflicts of interest. Disclosure rates overall were “unexpectedly low,” the BMJ analysis said. “There was a clear and strong link between the orientation of authors' expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies,” the analysis said, adding that although this does not prove cause and effect, it shows the need for better disclosure practices.

HbA_1c Test Sales Increasing

Hemoglobin A_1c testing will increase more than other tests performed at the point of care as a result of expert recommendations, new diabetes cases, and booming mail-in test sales, according to a report from marketing research company Kalorama Information. Kalorama estimated that the global market for point-of-care HbA_1c tests reached $230 million in 2009 and will rise to $350 million by 2013, a growth rate that is 50% higher than the average point-of-care testing product. The mail-in self-tests, performed by mail-in laboratory services, represents a small percentage of those revenues now, but is showing faster sales growth than lab-based tests and should grow at 25% annually over the next 5 years, Kalorama said. At least 30 companies offer HbA_1c assays for automated systems, the report said.

FDA Warns on Food Labels

The Food and Drug Administration has notified 17 food manufacturers, including Gorton's Inc. and Nestle, that labeling for some of their food products violates the Federal Food, Drug, and Cosmetic Act. Violations cited in the warning letters include unauthorized health claims, unauthorized nutrient-content claims, and the unauthorized use of terms such as “healthy.” Nestle, for example, was warned about using “100% juice” to describe a product that had added flavors, while the FDA told Gorton's in its letter that its fish fillet packages need to disclose high levels of sodium, saturated fat, and total fat to accompany the claim of zero trans fats.

Ads Misled on Metozolv ODT

Salix Pharmaceuticals Inc. misled physicians and consumers in promotional materials for its drug Metozolv ODT (metoclopramide), which was approved in September 2009 for diabetic gastroparesis and gastroesophageal reflux disease, the Food and Drug Administration said in a warning letter to the company. Metozolv ODT is approved for short-term therapy in adults with diabetic gastroparesis, and for short-term therapy in adults who have GERD that does not respond to other medications. The FDA warning letter said Salix downplayed and omitted risk information and broadened the indications for Metozolv ODT in advertising materials and in a display at a clinical meeting. Salix failed to submit some of the materials to the FDA, as required, at the time of their initial use. The FDA specifically flagged the term “ideal for all patients,” which it said was untrue due to Metozolv ODT's “numerous contraindications and limitations of indications for use.” The warning letter told Salix to immediately stop using the questionable promotional materials and to ensure that all other materials comply with FDA regulations.

Calif. County Sues Over Avandia

A California county has sued GlaxoSmithKline, saying the pharmaceutical giant falsely promoted its diabetes drug Avandia as safe and effective while suppressing evidence of serious cardiovascular problems. The complaint, filed by Santa Clara County in U.S. District Court for the Northern California District, asserts that GSK ignored or concealed early data and studies revealing Avandia's hazards. The company also engaged in “an aggressive and highly successful marketing strategy designed to persuade patients, doctors, and insurers to use Avandia instead of less expensive and far safer diabetes drugs already on the market,” the complaint said. The lawsuit seeks monetary restitution for all Avandia purchasers and users in California, and notes that Santa Clara County spent $2 million on Avandia purchases between 1999 and 2007.

GSK Ties Underreported

Many researchers who published articles supporting rosiglitazone (Avandia) after it was linked to cardiovascular disease in 2007 had financial ties to GlaxoSmithKline, an analysis published in the British Medical Journal found. The authors examined 202 articles, including 108 that contained a financial conflict-of-interest statement, and found that researchers who had a favorable view of Avandia's cardiovascular risks were more likely to have financial conflicts of interest. Disclosure rates overall were “unexpectedly low,” the BMJ analysis said. “There was a clear and strong link between the orientation of authors' expressed views on the rosiglitazone controversy and their financial conflicts of interest with pharmaceutical companies,” the analysis said, adding that although this does not prove cause and effect, it shows the need for better disclosure practices.

HbA_1c Test Sales Increasing

Hemoglobin A_1c testing will increase more than other tests performed at the point of care as a result of expert recommendations, new diabetes cases, and booming mail-in test sales, according to a report from marketing research company Kalorama Information. Kalorama estimated that the global market for point-of-care HbA_1c tests reached $230 million in 2009 and will rise to $350 million by 2013, a growth rate that is 50% higher than the average point-of-care testing product. The mail-in self-tests, performed by mail-in laboratory services, represents a small percentage of those revenues now, but is showing faster sales growth than lab-based tests and should grow at 25% annually over the next 5 years, Kalorama said. At least 30 companies offer HbA_1c assays for automated systems, the report said.

FDA Warns on Food Labels

The Food and Drug Administration has notified 17 food manufacturers, including Gorton's Inc. and Nestle, that labeling for some of their food products violates the Federal Food, Drug, and Cosmetic Act. Violations cited in the warning letters include unauthorized health claims, unauthorized nutrient-content claims, and the unauthorized use of terms such as “healthy.” Nestle, for example, was warned about using “100% juice” to describe a product that had added flavors, while the FDA told Gorton's in its letter that its fish fillet packages need to disclose high levels of sodium, saturated fat, and total fat to accompany the claim of zero trans fats.