Joyce Frieden

WASHINGTON — Regulating overseas drugmakers who export their products to the United States will become a bigger focus of the Food and Drug Administration, FDA Commissioner Margaret Hamburg said at the annual meeting of the Endocrine Society.

“Food and product safety is a very compelling concern to me,” said Dr. Hamburg, who was confirmed by the Senate on May 18. “For FDA to reenter our modern, global world is a high priority. … When you look at the number of facilities overseas all around the world that are manufacturing both drugs and food, it's a huge and growing challenge.”

Like Dr. Francis Collins, a possible candidate for the office of director of the National Institutes of Health, who addressed the meeting the previous day, Dr. Hamburg called for more collaboration between her agency and the pharmaceutical industry. “Regulatory science is an essential yet still underdeveloped field,” she said. “It's my hope to see expanded efforts in this area, including engaging academic scientists at research universities, along with industry, and [encouraging] more research aimed at addressing unmet scientific needs involving the safety and effectiveness of regulated products, as well as how to best leverage emergent science and technology to strengthen and streamline the drug and product review process.”

Dr. Hamburg also called for improving conditions for the agency's scientists. “We have extraordinary talent at the FDA, but over the years, important aspects of our scientific endeavor have been underresourced and underappreciated, and this must change,” she said. “We must be able to recruit and retain the best crop of scientists, and give them the facilities and opportunities they need to do their job.”

WASHINGTON — Regulating overseas drugmakers who export their products to the United States will become a bigger focus of the Food and Drug Administration, FDA Commissioner Margaret Hamburg said at the annual meeting of the Endocrine Society.

“Food and product safety is a very compelling concern to me,” said Dr. Hamburg, who was confirmed by the Senate on May 18. “For FDA to reenter our modern, global world is a high priority. … When you look at the number of facilities overseas all around the world that are manufacturing both drugs and food, it's a huge and growing challenge.”

Like Dr. Francis Collins, a possible candidate for the office of director of the National Institutes of Health, who addressed the meeting the previous day, Dr. Hamburg called for more collaboration between her agency and the pharmaceutical industry. “Regulatory science is an essential yet still underdeveloped field,” she said. “It's my hope to see expanded efforts in this area, including engaging academic scientists at research universities, along with industry, and [encouraging] more research aimed at addressing unmet scientific needs involving the safety and effectiveness of regulated products, as well as how to best leverage emergent science and technology to strengthen and streamline the drug and product review process.”

Dr. Hamburg also called for improving conditions for the agency's scientists. “We have extraordinary talent at the FDA, but over the years, important aspects of our scientific endeavor have been underresourced and underappreciated, and this must change,” she said. “We must be able to recruit and retain the best crop of scientists, and give them the facilities and opportunities they need to do their job.”

WASHINGTON — Regulating overseas drugmakers who export their products to the United States will become a bigger focus of the Food and Drug Administration, FDA Commissioner Margaret Hamburg said at the annual meeting of the Endocrine Society.

“Food and product safety is a very compelling concern to me,” said Dr. Hamburg, who was confirmed by the Senate on May 18. “For FDA to reenter our modern, global world is a high priority. … When you look at the number of facilities overseas all around the world that are manufacturing both drugs and food, it's a huge and growing challenge.”

Like Dr. Francis Collins, a possible candidate for the office of director of the National Institutes of Health, who addressed the meeting the previous day, Dr. Hamburg called for more collaboration between her agency and the pharmaceutical industry. “Regulatory science is an essential yet still underdeveloped field,” she said. “It's my hope to see expanded efforts in this area, including engaging academic scientists at research universities, along with industry, and [encouraging] more research aimed at addressing unmet scientific needs involving the safety and effectiveness of regulated products, as well as how to best leverage emergent science and technology to strengthen and streamline the drug and product review process.”

Dr. Hamburg also called for improving conditions for the agency's scientists. “We have extraordinary talent at the FDA, but over the years, important aspects of our scientific endeavor have been underresourced and underappreciated, and this must change,” she said. “We must be able to recruit and retain the best crop of scientists, and give them the facilities and opportunities they need to do their job.”

Diabetes Registry OK for PQRI

The National Committee for Quality Assurance's diabetes registry has been designated by the Centers for Medicare and Medicaid Services as a registry that can be used for quality reporting, NCQA has announced. Physicians who have earned recognition through the NCQA's Diabetes Recognition Program may now opt to have NCQA submit their clinical data to Medicare for use in the Physician Quality Reporting Initiative, which rewards physicians financially for collecting and reporting performance data. “Using NCQA data to qualify for the PQRI allows NCQA-recognized providers … to streamline their reporting and devote more resources to patient care,” NCQA said in a press release. Interested providers can submit data to NCQA for the 2009 PQRI registry through Jan. 31, 2010.

Vermont Bans Most Pharma Gifts

Vermont Gov. Jim Douglas (R) has signed into law a bill that prohibits manufacturers of drugs, medical devices, and biologics from providing free gifts, including meals and travel, to physicians and other health care providers. The toughest of its kind in the nation, the legislation also requires disclosure of any allowed gifts or payments, regardless of their value. In 2002, a Vermont law required disclosure of gifts or payments of $25 or more. Under the stronger law, manufacturers can give physicians only gifts such as samples intended for patients, “reasonable quantities” of medical device evaluation or demonstration units, and copies of peer-reviewed articles. Companies still can provide scholarships or other support for medical students, residents, and fellows to attend educational events held by professional associations, as long as the association selects the scholarship recipient.

Benefits of the Recession

More employees are saying that living a healthy lifestyle is a priority compared with a year ago, “in perhaps a nod to controlling their own health care costs,” according to the National Business Group on Health. The group surveyed 1,500 workers between the ages of 22 and 69; all worked at companies with at least 2,000 employees. The survey found that 34% of respondents reported exercising more, 46% said they were eating healthier, and 44% reported eating out less at fast-food restaurants. On the negative side, 27% of respondents reported forgoing health care treatment to save money on copayments or coinsurance costs. One in five respondents skipped taking their prescription drug medication dosage as prescribed by their doctor. “The National Business Group on Health believes the survey data provide a pathway for businesses to help their workers cope—and thrive—despite the bad economy, including offering financial incentives to motivate health behavior changes; disseminating more information about the costs and quality of services at a provider level … and providing more targeted communications based on specific health conditions,” the group said in a statement.

Bankruptcies, Illness Linked

Medical problems contributed to nearly two-thirds of all bankruptcies in the United States in 2007, according to a study in the American Journal of Medicine. Based on court-record reviews and interviews of more than 2,300 bankruptcy filers in 2007, the study found that 62% of filers cited medical debts and income lost to illness as reasons for seeking bankruptcy. Of these “medically bankrupt families,” 9 out of 10 said they had medical debts over $5,000, and the rest met criteria for medical bankruptcy because they had lost significant income because of illness or mortgaged a home to pay medical bills. Out-of-pocket medical costs averaged $17,943 for all medically bankrupt families, including the three-quarters of families that had insurance at the outset of their problems. Most medical debtors were well-educated, owned homes, and had middle-class occupations, the study found.

Obama: Give MedPAC More Clout

The Obama administration wants to give MedPAC greater influence. In a June 2 letter to Sen. Ted Kennedy (D-Mass.) and Sen. Max Baucus (D-Mont.), President Obama said he supported giving each MedPAC recommendation the force of law unless it is opposed by a joint resolution of Congress. This appeared to embrace the approach in the MedPAC Reform Act of 2009, which Sen. Jay Rockefeller (D-W.Va.) introduced in May. Currently, MedPAC advises Congress, which then decides whether to act on the recommendations. At a Brookings Institution conference in mid-June, White House Office of Management and Budget Director Peter Orszag reiterated support for giving MedPAC more teeth. Mr. Orszag said the administration wanted to “take the MedPAC recommendations and, rather than having them sit on a shelf somewhere, have them protected in a fast track procedure, voted up or down as a package, and considered within a limited period of time so they become much more relevant.”

Genetics Education Seen Lacking

The development of personalized medicine is hindered by doctors' lack of education about genetic screening tests, speakers at a Personalized Medicine Colloquium said last month. Education on interpretation of genetic tests in medical schools “is not adequate yet,” said Affymetrix Chief Medical Officer Rick Hockett. Joseph McInerney, executive director of the National Coalition for Health Professional Education in Genetics, agreed that medical schools may not be preparing new doctors to incorporate genetics research into clinical practice. McInerney said there is not much research data about genetics education in medical schools, but he did cite a 2007 study of 150 medical school educators that showed 62% of respondents offered between 20 and 40 hours of instruction in genetics, but only 11% of them taught practical applications of genetics in addition to general concepts of genetics.

Diabetes Registry OK for PQRI

The National Committee for Quality Assurance's diabetes registry has been designated by the Centers for Medicare and Medicaid Services as a registry that can be used for quality reporting, NCQA has announced. Physicians who have earned recognition through the NCQA's Diabetes Recognition Program may now opt to have NCQA submit their clinical data to Medicare for use in the Physician Quality Reporting Initiative, which rewards physicians financially for collecting and reporting performance data. “Using NCQA data to qualify for the PQRI allows NCQA-recognized providers … to streamline their reporting and devote more resources to patient care,” NCQA said in a press release. Interested providers can submit data to NCQA for the 2009 PQRI registry through Jan. 31, 2010.

Vermont Bans Most Pharma Gifts

Vermont Gov. Jim Douglas (R) has signed into law a bill that prohibits manufacturers of drugs, medical devices, and biologics from providing free gifts, including meals and travel, to physicians and other health care providers. The toughest of its kind in the nation, the legislation also requires disclosure of any allowed gifts or payments, regardless of their value. In 2002, a Vermont law required disclosure of gifts or payments of $25 or more. Under the stronger law, manufacturers can give physicians only gifts such as samples intended for patients, “reasonable quantities” of medical device evaluation or demonstration units, and copies of peer-reviewed articles. Companies still can provide scholarships or other support for medical students, residents, and fellows to attend educational events held by professional associations, as long as the association selects the scholarship recipient.

Benefits of the Recession

More employees are saying that living a healthy lifestyle is a priority compared with a year ago, “in perhaps a nod to controlling their own health care costs,” according to the National Business Group on Health. The group surveyed 1,500 workers between the ages of 22 and 69; all worked at companies with at least 2,000 employees. The survey found that 34% of respondents reported exercising more, 46% said they were eating healthier, and 44% reported eating out less at fast-food restaurants. On the negative side, 27% of respondents reported forgoing health care treatment to save money on copayments or coinsurance costs. One in five respondents skipped taking their prescription drug medication dosage as prescribed by their doctor. “The National Business Group on Health believes the survey data provide a pathway for businesses to help their workers cope—and thrive—despite the bad economy, including offering financial incentives to motivate health behavior changes; disseminating more information about the costs and quality of services at a provider level … and providing more targeted communications based on specific health conditions,” the group said in a statement.

Bankruptcies, Illness Linked

Medical problems contributed to nearly two-thirds of all bankruptcies in the United States in 2007, according to a study in the American Journal of Medicine. Based on court-record reviews and interviews of more than 2,300 bankruptcy filers in 2007, the study found that 62% of filers cited medical debts and income lost to illness as reasons for seeking bankruptcy. Of these “medically bankrupt families,” 9 out of 10 said they had medical debts over $5,000, and the rest met criteria for medical bankruptcy because they had lost significant income because of illness or mortgaged a home to pay medical bills. Out-of-pocket medical costs averaged $17,943 for all medically bankrupt families, including the three-quarters of families that had insurance at the outset of their problems. Most medical debtors were well-educated, owned homes, and had middle-class occupations, the study found.

Obama: Give MedPAC More Clout

The Obama administration wants to give MedPAC greater influence. In a June 2 letter to Sen. Ted Kennedy (D-Mass.) and Sen. Max Baucus (D-Mont.), President Obama said he supported giving each MedPAC recommendation the force of law unless it is opposed by a joint resolution of Congress. This appeared to embrace the approach in the MedPAC Reform Act of 2009, which Sen. Jay Rockefeller (D-W.Va.) introduced in May. Currently, MedPAC advises Congress, which then decides whether to act on the recommendations. At a Brookings Institution conference in mid-June, White House Office of Management and Budget Director Peter Orszag reiterated support for giving MedPAC more teeth. Mr. Orszag said the administration wanted to “take the MedPAC recommendations and, rather than having them sit on a shelf somewhere, have them protected in a fast track procedure, voted up or down as a package, and considered within a limited period of time so they become much more relevant.”

Genetics Education Seen Lacking

The development of personalized medicine is hindered by doctors' lack of education about genetic screening tests, speakers at a Personalized Medicine Colloquium said last month. Education on interpretation of genetic tests in medical schools “is not adequate yet,” said Affymetrix Chief Medical Officer Rick Hockett. Joseph McInerney, executive director of the National Coalition for Health Professional Education in Genetics, agreed that medical schools may not be preparing new doctors to incorporate genetics research into clinical practice. McInerney said there is not much research data about genetics education in medical schools, but he did cite a 2007 study of 150 medical school educators that showed 62% of respondents offered between 20 and 40 hours of instruction in genetics, but only 11% of them taught practical applications of genetics in addition to general concepts of genetics.

Diabetes Registry OK for PQRI

The National Committee for Quality Assurance's diabetes registry has been designated by the Centers for Medicare and Medicaid Services as a registry that can be used for quality reporting, NCQA has announced. Physicians who have earned recognition through the NCQA's Diabetes Recognition Program may now opt to have NCQA submit their clinical data to Medicare for use in the Physician Quality Reporting Initiative, which rewards physicians financially for collecting and reporting performance data. “Using NCQA data to qualify for the PQRI allows NCQA-recognized providers … to streamline their reporting and devote more resources to patient care,” NCQA said in a press release. Interested providers can submit data to NCQA for the 2009 PQRI registry through Jan. 31, 2010.

Vermont Bans Most Pharma Gifts

Vermont Gov. Jim Douglas (R) has signed into law a bill that prohibits manufacturers of drugs, medical devices, and biologics from providing free gifts, including meals and travel, to physicians and other health care providers. The toughest of its kind in the nation, the legislation also requires disclosure of any allowed gifts or payments, regardless of their value. In 2002, a Vermont law required disclosure of gifts or payments of $25 or more. Under the stronger law, manufacturers can give physicians only gifts such as samples intended for patients, “reasonable quantities” of medical device evaluation or demonstration units, and copies of peer-reviewed articles. Companies still can provide scholarships or other support for medical students, residents, and fellows to attend educational events held by professional associations, as long as the association selects the scholarship recipient.

Benefits of the Recession

More employees are saying that living a healthy lifestyle is a priority compared with a year ago, “in perhaps a nod to controlling their own health care costs,” according to the National Business Group on Health. The group surveyed 1,500 workers between the ages of 22 and 69; all worked at companies with at least 2,000 employees. The survey found that 34% of respondents reported exercising more, 46% said they were eating healthier, and 44% reported eating out less at fast-food restaurants. On the negative side, 27% of respondents reported forgoing health care treatment to save money on copayments or coinsurance costs. One in five respondents skipped taking their prescription drug medication dosage as prescribed by their doctor. “The National Business Group on Health believes the survey data provide a pathway for businesses to help their workers cope—and thrive—despite the bad economy, including offering financial incentives to motivate health behavior changes; disseminating more information about the costs and quality of services at a provider level … and providing more targeted communications based on specific health conditions,” the group said in a statement.

Bankruptcies, Illness Linked

Medical problems contributed to nearly two-thirds of all bankruptcies in the United States in 2007, according to a study in the American Journal of Medicine. Based on court-record reviews and interviews of more than 2,300 bankruptcy filers in 2007, the study found that 62% of filers cited medical debts and income lost to illness as reasons for seeking bankruptcy. Of these “medically bankrupt families,” 9 out of 10 said they had medical debts over $5,000, and the rest met criteria for medical bankruptcy because they had lost significant income because of illness or mortgaged a home to pay medical bills. Out-of-pocket medical costs averaged $17,943 for all medically bankrupt families, including the three-quarters of families that had insurance at the outset of their problems. Most medical debtors were well-educated, owned homes, and had middle-class occupations, the study found.

Obama: Give MedPAC More Clout

The Obama administration wants to give MedPAC greater influence. In a June 2 letter to Sen. Ted Kennedy (D-Mass.) and Sen. Max Baucus (D-Mont.), President Obama said he supported giving each MedPAC recommendation the force of law unless it is opposed by a joint resolution of Congress. This appeared to embrace the approach in the MedPAC Reform Act of 2009, which Sen. Jay Rockefeller (D-W.Va.) introduced in May. Currently, MedPAC advises Congress, which then decides whether to act on the recommendations. At a Brookings Institution conference in mid-June, White House Office of Management and Budget Director Peter Orszag reiterated support for giving MedPAC more teeth. Mr. Orszag said the administration wanted to “take the MedPAC recommendations and, rather than having them sit on a shelf somewhere, have them protected in a fast track procedure, voted up or down as a package, and considered within a limited period of time so they become much more relevant.”

Genetics Education Seen Lacking

The development of personalized medicine is hindered by doctors' lack of education about genetic screening tests, speakers at a Personalized Medicine Colloquium said last month. Education on interpretation of genetic tests in medical schools “is not adequate yet,” said Affymetrix Chief Medical Officer Rick Hockett. Joseph McInerney, executive director of the National Coalition for Health Professional Education in Genetics, agreed that medical schools may not be preparing new doctors to incorporate genetics research into clinical practice. McInerney said there is not much research data about genetics education in medical schools, but he did cite a 2007 study of 150 medical school educators that showed 62% of respondents offered between 20 and 40 hours of instruction in genetics, but only 11% of them taught practical applications of genetics in addition to general concepts of genetics.

WASHINGTON — Women with polycystic ovary syndrome who have a high body mass index or poor body self-esteem are more likely to be depressed, according to results from a study of 67 untreated PCOS patients.

Depression is very common in PCOS patients, with previous studies showing depression rates of 35%–50% in PCOS patients compared with 12%–14% in the general female population, said Lisa Pastore, Ph.D., of the department of obstetrics and gynecology at the University of Virginia, Charlottesville, at the annual meeting of the Androgen Excess and PCOS Society. Prior research also has shown neither the degree of hirsutism nor that of acne are related to body self-esteem in PCOS patients, she added.

Eligibility criteria for the current study included a diagnosis of PCOS using the National Institute of Child Health and Human Development criteria, age 18–43 years, weight less than 250 pounds, and at least one menses in the past 6 months but no more than eight periods in the most recent 12 months without hormonal intervention. Exclusion criteria included use of metformin or hormones in the prior 60 days, current pregnancy or breastfeeding in the prior 30 days, acupuncture treatment for ovulatory disorders in the prior 30 days, and any bleeding disorder.

The mean age of study participants was 27 years; 54% were single. Overall, 39% of participants were normal weight, 12% were overweight, and 49% were obese; 27% were of minority ethnicity.

Study participants were asked to rate each of 35 items, including body parts and functions, on a 5-point Likert scale with possible responses ranging from 1 (very negative feelings) to 5 (very positive feelings). A lower score indicated a worse body image.

Respondents also completed the Quick Inventory of Depressive Symptomatology-Self Report, which includes 16 items used to assess depressive episodes or major depressive disorders. Areas covered include sad mood, concentration, self-criticism, suicidal ideation, decreases or increases in appetite and weight, and sleep disturbances. Participants self-reported frequency and severity of symptoms over the previous 7 days, rating severity on a scale of 0–3.

Patients underwent chemiluminescent immunoassay of total testosterone and testing for dehydroepiandrosterone sulfate and sex hormone binding globulin (SHBG). In addition, mathematically derived free testosterone was calculated.

Respondents' total testosterone ranged from 19 ng/dL to 161 ng/dL with a mean of 62 ng/dL. SHBG ranged from 2 nmol/L to 86 nmol/L with a mean of 31 nmol/L. Free testosterone ranged from 3 pg/mL to 45 pg/mL with a mean of 13 pg/mL. Nearly half of the patients in the study were depressed; 70% of those had mild depression, according to Dr. Pastore, the study's lead author.

The study was consistent with an association between depression severity and body esteem among PCOS patients after the researchers controlled for age, education, and BMI. Higher BMI also was correlated with depression, although body self-esteem was an independent predictor of depression in both lean and obese women.

In addition, although none of the androgens were predictive of depression severity, “there was some curvilinear relationship,” with depression severity lowest among patients with very high or very low free testosterone levels, Dr. Pastore said.

The study was supported with funding by the National Center for Complementary and Alternative Medicine and the National Center for Research Resources. Dr. Pastore disclosed no conflicts of interest.

WASHINGTON — Women with polycystic ovary syndrome who have a high body mass index or poor body self-esteem are more likely to be depressed, according to results from a study of 67 untreated PCOS patients.

Depression is very common in PCOS patients, with previous studies showing depression rates of 35%–50% in PCOS patients compared with 12%–14% in the general female population, said Lisa Pastore, Ph.D., of the department of obstetrics and gynecology at the University of Virginia, Charlottesville, at the annual meeting of the Androgen Excess and PCOS Society. Prior research also has shown neither the degree of hirsutism nor that of acne are related to body self-esteem in PCOS patients, she added.

Eligibility criteria for the current study included a diagnosis of PCOS using the National Institute of Child Health and Human Development criteria, age 18–43 years, weight less than 250 pounds, and at least one menses in the past 6 months but no more than eight periods in the most recent 12 months without hormonal intervention. Exclusion criteria included use of metformin or hormones in the prior 60 days, current pregnancy or breastfeeding in the prior 30 days, acupuncture treatment for ovulatory disorders in the prior 30 days, and any bleeding disorder.

The mean age of study participants was 27 years; 54% were single. Overall, 39% of participants were normal weight, 12% were overweight, and 49% were obese; 27% were of minority ethnicity.

Study participants were asked to rate each of 35 items, including body parts and functions, on a 5-point Likert scale with possible responses ranging from 1 (very negative feelings) to 5 (very positive feelings). A lower score indicated a worse body image.

Respondents also completed the Quick Inventory of Depressive Symptomatology-Self Report, which includes 16 items used to assess depressive episodes or major depressive disorders. Areas covered include sad mood, concentration, self-criticism, suicidal ideation, decreases or increases in appetite and weight, and sleep disturbances. Participants self-reported frequency and severity of symptoms over the previous 7 days, rating severity on a scale of 0–3.

Patients underwent chemiluminescent immunoassay of total testosterone and testing for dehydroepiandrosterone sulfate and sex hormone binding globulin (SHBG). In addition, mathematically derived free testosterone was calculated.

Respondents' total testosterone ranged from 19 ng/dL to 161 ng/dL with a mean of 62 ng/dL. SHBG ranged from 2 nmol/L to 86 nmol/L with a mean of 31 nmol/L. Free testosterone ranged from 3 pg/mL to 45 pg/mL with a mean of 13 pg/mL. Nearly half of the patients in the study were depressed; 70% of those had mild depression, according to Dr. Pastore, the study's lead author.

The study was consistent with an association between depression severity and body esteem among PCOS patients after the researchers controlled for age, education, and BMI. Higher BMI also was correlated with depression, although body self-esteem was an independent predictor of depression in both lean and obese women.

In addition, although none of the androgens were predictive of depression severity, “there was some curvilinear relationship,” with depression severity lowest among patients with very high or very low free testosterone levels, Dr. Pastore said.

The study was supported with funding by the National Center for Complementary and Alternative Medicine and the National Center for Research Resources. Dr. Pastore disclosed no conflicts of interest.

WASHINGTON — Women with polycystic ovary syndrome who have a high body mass index or poor body self-esteem are more likely to be depressed, according to results from a study of 67 untreated PCOS patients.

Depression is very common in PCOS patients, with previous studies showing depression rates of 35%–50% in PCOS patients compared with 12%–14% in the general female population, said Lisa Pastore, Ph.D., of the department of obstetrics and gynecology at the University of Virginia, Charlottesville, at the annual meeting of the Androgen Excess and PCOS Society. Prior research also has shown neither the degree of hirsutism nor that of acne are related to body self-esteem in PCOS patients, she added.

Eligibility criteria for the current study included a diagnosis of PCOS using the National Institute of Child Health and Human Development criteria, age 18–43 years, weight less than 250 pounds, and at least one menses in the past 6 months but no more than eight periods in the most recent 12 months without hormonal intervention. Exclusion criteria included use of metformin or hormones in the prior 60 days, current pregnancy or breastfeeding in the prior 30 days, acupuncture treatment for ovulatory disorders in the prior 30 days, and any bleeding disorder.

The mean age of study participants was 27 years; 54% were single. Overall, 39% of participants were normal weight, 12% were overweight, and 49% were obese; 27% were of minority ethnicity.

Study participants were asked to rate each of 35 items, including body parts and functions, on a 5-point Likert scale with possible responses ranging from 1 (very negative feelings) to 5 (very positive feelings). A lower score indicated a worse body image.

Respondents also completed the Quick Inventory of Depressive Symptomatology-Self Report, which includes 16 items used to assess depressive episodes or major depressive disorders. Areas covered include sad mood, concentration, self-criticism, suicidal ideation, decreases or increases in appetite and weight, and sleep disturbances. Participants self-reported frequency and severity of symptoms over the previous 7 days, rating severity on a scale of 0–3.

Patients underwent chemiluminescent immunoassay of total testosterone and testing for dehydroepiandrosterone sulfate and sex hormone binding globulin (SHBG). In addition, mathematically derived free testosterone was calculated.

Respondents' total testosterone ranged from 19 ng/dL to 161 ng/dL with a mean of 62 ng/dL. SHBG ranged from 2 nmol/L to 86 nmol/L with a mean of 31 nmol/L. Free testosterone ranged from 3 pg/mL to 45 pg/mL with a mean of 13 pg/mL. Nearly half of the patients in the study were depressed; 70% of those had mild depression, according to Dr. Pastore, the study's lead author.

The study was consistent with an association between depression severity and body esteem among PCOS patients after the researchers controlled for age, education, and BMI. Higher BMI also was correlated with depression, although body self-esteem was an independent predictor of depression in both lean and obese women.

In addition, although none of the androgens were predictive of depression severity, “there was some curvilinear relationship,” with depression severity lowest among patients with very high or very low free testosterone levels, Dr. Pastore said.

The study was supported with funding by the National Center for Complementary and Alternative Medicine and the National Center for Research Resources. Dr. Pastore disclosed no conflicts of interest.

WASHINGTON — The National Institutes of Health needs to partner more with the pharmaceutical industry in order to create a better pipeline for new drugs, Dr. Francis Collins said at the annual meeting of the Endocrine Society.

Dr. Collins, former head of the National Human Genome Research Institute who is widely rumored to be President Obama's pick for NIH director, said that with all the developments now occurring in genomic research, “pharmaceutical companies are a little overwhelmed about where to start” when it comes to figuring out which genes would make good targets for drug therapy.

“Academic investigators should get more intentionally involved in the translational process of going from basic research to drug development,” Dr. Collins said. “There is an opportunity now, more than ever, to bring together academic investigators and the private sector to put together a really exciting version of a drug development pipeline.”

Such a collaboration “involves more of academics taking the front-end risk of developing promising compounds so they become attractive and licensable by the private sector.”

Dr. Collins noted that many academic researchers are identifying promising targets for drugs, “but relatively few are taking that information and turning it into an assay … to see if there is something promising that might turn out to become a therapeutic.”

Some targets start out looking promising, but when they get to a point where they need support for preclinical development, “that's where things often die,” he said.

“Congress just a few months ago put $24 million into the fiscal year 2009 budget to start this process in an NIH-funded way, and I hope the money will go up substantially in the next 5 years.”

With such a pipeline, conflicts of interest on the part of pharmaceutical companies “would have to be factored in,” Dr. Collins said in an interview.

Drugmakers' interests in commercialization would be a factor. “You want to start a project that is going to get somewhere,” he said.

“But there are companies across the board that are interested in almost any disease—even very rare ones—as long as it won't cost a fortune to get that drug approved. For the rare diseases, you may have to push things further down the pipeline with public money before the company says, 'Okay, I'll start with that one now,' but I don't know that that should discourage consideration of working on even a very rare disease in this pipeline,” he noted.

During a question-and-answer session, Dr. Collins was asked whether he would list his priorities for NIH “as a private citizen,” since he couldn't address any possible nomination for the head job, a question that won laughter from the audience.

“We have an opportunity to take [the new technologies] that have started to appear and apply them in a vigorous way to understand fundamentals of biology; that would include genomics and nanotechnology and a wide variety of approaches to epigenetics,” he said.

“I would also think we need to take seriously the charge coming from the Congress and the Administration to provide useful information to guide health care reform.

“That would mean, in some instances, comparative effectiveness research, but we need to be careful not to lose the personalized aspects of individual [health] along the way.” Global health should also be an NIH focus, Dr. Collins said, adding “The U.S. is in a position to spread more soft power instead of hard power around the world. NIH ought to be able to play a useful role in that. And we should encourage the research community, including young investigators, and increase the diversity of our workforce, to make it vigorous and effective.”

WASHINGTON — The National Institutes of Health needs to partner more with the pharmaceutical industry in order to create a better pipeline for new drugs, Dr. Francis Collins said at the annual meeting of the Endocrine Society.

Dr. Collins, former head of the National Human Genome Research Institute who is widely rumored to be President Obama's pick for NIH director, said that with all the developments now occurring in genomic research, “pharmaceutical companies are a little overwhelmed about where to start” when it comes to figuring out which genes would make good targets for drug therapy.

“Academic investigators should get more intentionally involved in the translational process of going from basic research to drug development,” Dr. Collins said. “There is an opportunity now, more than ever, to bring together academic investigators and the private sector to put together a really exciting version of a drug development pipeline.”

Such a collaboration “involves more of academics taking the front-end risk of developing promising compounds so they become attractive and licensable by the private sector.”

Dr. Collins noted that many academic researchers are identifying promising targets for drugs, “but relatively few are taking that information and turning it into an assay … to see if there is something promising that might turn out to become a therapeutic.”

Some targets start out looking promising, but when they get to a point where they need support for preclinical development, “that's where things often die,” he said.

“Congress just a few months ago put $24 million into the fiscal year 2009 budget to start this process in an NIH-funded way, and I hope the money will go up substantially in the next 5 years.”

With such a pipeline, conflicts of interest on the part of pharmaceutical companies “would have to be factored in,” Dr. Collins said in an interview.

Drugmakers' interests in commercialization would be a factor. “You want to start a project that is going to get somewhere,” he said.

“But there are companies across the board that are interested in almost any disease—even very rare ones—as long as it won't cost a fortune to get that drug approved. For the rare diseases, you may have to push things further down the pipeline with public money before the company says, 'Okay, I'll start with that one now,' but I don't know that that should discourage consideration of working on even a very rare disease in this pipeline,” he noted.

During a question-and-answer session, Dr. Collins was asked whether he would list his priorities for NIH “as a private citizen,” since he couldn't address any possible nomination for the head job, a question that won laughter from the audience.

“We have an opportunity to take [the new technologies] that have started to appear and apply them in a vigorous way to understand fundamentals of biology; that would include genomics and nanotechnology and a wide variety of approaches to epigenetics,” he said.

“I would also think we need to take seriously the charge coming from the Congress and the Administration to provide useful information to guide health care reform.

“That would mean, in some instances, comparative effectiveness research, but we need to be careful not to lose the personalized aspects of individual [health] along the way.” Global health should also be an NIH focus, Dr. Collins said, adding “The U.S. is in a position to spread more soft power instead of hard power around the world. NIH ought to be able to play a useful role in that. And we should encourage the research community, including young investigators, and increase the diversity of our workforce, to make it vigorous and effective.”

WASHINGTON — The National Institutes of Health needs to partner more with the pharmaceutical industry in order to create a better pipeline for new drugs, Dr. Francis Collins said at the annual meeting of the Endocrine Society.

Dr. Collins, former head of the National Human Genome Research Institute who is widely rumored to be President Obama's pick for NIH director, said that with all the developments now occurring in genomic research, “pharmaceutical companies are a little overwhelmed about where to start” when it comes to figuring out which genes would make good targets for drug therapy.

“Academic investigators should get more intentionally involved in the translational process of going from basic research to drug development,” Dr. Collins said. “There is an opportunity now, more than ever, to bring together academic investigators and the private sector to put together a really exciting version of a drug development pipeline.”

Such a collaboration “involves more of academics taking the front-end risk of developing promising compounds so they become attractive and licensable by the private sector.”

Dr. Collins noted that many academic researchers are identifying promising targets for drugs, “but relatively few are taking that information and turning it into an assay … to see if there is something promising that might turn out to become a therapeutic.”

Some targets start out looking promising, but when they get to a point where they need support for preclinical development, “that's where things often die,” he said.

“Congress just a few months ago put $24 million into the fiscal year 2009 budget to start this process in an NIH-funded way, and I hope the money will go up substantially in the next 5 years.”

With such a pipeline, conflicts of interest on the part of pharmaceutical companies “would have to be factored in,” Dr. Collins said in an interview.

Drugmakers' interests in commercialization would be a factor. “You want to start a project that is going to get somewhere,” he said.

“But there are companies across the board that are interested in almost any disease—even very rare ones—as long as it won't cost a fortune to get that drug approved. For the rare diseases, you may have to push things further down the pipeline with public money before the company says, 'Okay, I'll start with that one now,' but I don't know that that should discourage consideration of working on even a very rare disease in this pipeline,” he noted.

During a question-and-answer session, Dr. Collins was asked whether he would list his priorities for NIH “as a private citizen,” since he couldn't address any possible nomination for the head job, a question that won laughter from the audience.

“We have an opportunity to take [the new technologies] that have started to appear and apply them in a vigorous way to understand fundamentals of biology; that would include genomics and nanotechnology and a wide variety of approaches to epigenetics,” he said.

“I would also think we need to take seriously the charge coming from the Congress and the Administration to provide useful information to guide health care reform.

“That would mean, in some instances, comparative effectiveness research, but we need to be careful not to lose the personalized aspects of individual [health] along the way.” Global health should also be an NIH focus, Dr. Collins said, adding “The U.S. is in a position to spread more soft power instead of hard power around the world. NIH ought to be able to play a useful role in that. And we should encourage the research community, including young investigators, and increase the diversity of our workforce, to make it vigorous and effective.”

WASHINGTON — The National Institutes of Health needs to partner more with the pharmaceutical industry in order to create a better pipeline for new drugs, Dr. Francis Collins said at the annual meeting of the Endocrine Society.

Dr. Collins, the former head of the National Human Genome Research Institute who at press time was rumored to be President Obama's pick for NIH director, said that with all the genomic research developments, “pharmaceutical companies are a little overwhelmed about where to start” when it comes to figuring out which genes would make good targets for drug therapy.

“Academic investigators should get more intentionally involved in the translational process of going from basic research to drug development,” Dr. Collins said. “There is an opportunity now, more than ever, to bring together academic investigators and the private sector to put together a really exciting version of a drug development pipeline.” Such a collaboration “involves more of academics taking the front-end risk of developing promising compounds so they become attractive and licensable by the private sector.”

Dr. Collins noted that many academic researchers are identifying promising targets for drugs, “but relatively few are taking that information and turning it into an assay … to see if there is something promising that might turn out to become a therapeutic.”

Some targets start out looking promising, but when they get to a point where they need support for preclinical development, “that's where things often die,” he said. “Congress just a few months ago put $24 million into the fiscal year 2009 budget to start this process in an NIH-funded way, and I hope the money will go up substantially in the next 5 years.”

With such a pipeline, conflicts of interest on the part of pharmaceutical companies “would have to be factored in,” Dr. Collins said in an interview. Drugmakers' interest in commercialization would be a factor. “You want to start a project that is going to get somewhere,” he said. “But there are companies across the board that are interested in almost any disease—even very rare ones—as long as it won't cost a fortune to get that drug approved. For the rare diseases, you may have to push things further down the pipeline with public money before the company says, 'Okay, I'll start with that one now,' but I don't know that that should discourage consideration of working on even a very rare disease in this pipeline.”

During a question-and-answer session, Dr. Collins was asked whether he would list his priorities for NIH “as a private citizen,” since he couldn't address any possible nomination for the head job, a question that elicited laughter and applause from the audience.

“We have an opportunity to take [the new technologies] that have started to appear and apply them in a vigorous way to understand fundamentals of biology; that would include genomics and nanotechnology and a wide variety of approaches to epigenetics,” he said.

“I would also think we need to take seriously the charge coming from the Congress and the Administration to provide useful information to guide health care reform. That would mean, in some instances, comparative effectiveness research, but we need to be careful not to lose the personalized aspects of individual [health] along the way.”

“The U.S. is in a position to spread more soft power instead of hard power around the world; NIH ought to be able to play a useful role in that. And we should encourage the research community, including young investigators, and increase the diversity of our workforce, to make it vigorous and effective.”

WASHINGTON — The National Institutes of Health needs to partner more with the pharmaceutical industry in order to create a better pipeline for new drugs, Dr. Francis Collins said at the annual meeting of the Endocrine Society.

Dr. Collins, the former head of the National Human Genome Research Institute who at press time was rumored to be President Obama's pick for NIH director, said that with all the genomic research developments, “pharmaceutical companies are a little overwhelmed about where to start” when it comes to figuring out which genes would make good targets for drug therapy.

“Academic investigators should get more intentionally involved in the translational process of going from basic research to drug development,” Dr. Collins said. “There is an opportunity now, more than ever, to bring together academic investigators and the private sector to put together a really exciting version of a drug development pipeline.” Such a collaboration “involves more of academics taking the front-end risk of developing promising compounds so they become attractive and licensable by the private sector.”

Dr. Collins noted that many academic researchers are identifying promising targets for drugs, “but relatively few are taking that information and turning it into an assay … to see if there is something promising that might turn out to become a therapeutic.”

Some targets start out looking promising, but when they get to a point where they need support for preclinical development, “that's where things often die,” he said. “Congress just a few months ago put $24 million into the fiscal year 2009 budget to start this process in an NIH-funded way, and I hope the money will go up substantially in the next 5 years.”

With such a pipeline, conflicts of interest on the part of pharmaceutical companies “would have to be factored in,” Dr. Collins said in an interview. Drugmakers' interest in commercialization would be a factor. “You want to start a project that is going to get somewhere,” he said. “But there are companies across the board that are interested in almost any disease—even very rare ones—as long as it won't cost a fortune to get that drug approved. For the rare diseases, you may have to push things further down the pipeline with public money before the company says, 'Okay, I'll start with that one now,' but I don't know that that should discourage consideration of working on even a very rare disease in this pipeline.”

During a question-and-answer session, Dr. Collins was asked whether he would list his priorities for NIH “as a private citizen,” since he couldn't address any possible nomination for the head job, a question that elicited laughter and applause from the audience.

“We have an opportunity to take [the new technologies] that have started to appear and apply them in a vigorous way to understand fundamentals of biology; that would include genomics and nanotechnology and a wide variety of approaches to epigenetics,” he said.

“I would also think we need to take seriously the charge coming from the Congress and the Administration to provide useful information to guide health care reform. That would mean, in some instances, comparative effectiveness research, but we need to be careful not to lose the personalized aspects of individual [health] along the way.”

“The U.S. is in a position to spread more soft power instead of hard power around the world; NIH ought to be able to play a useful role in that. And we should encourage the research community, including young investigators, and increase the diversity of our workforce, to make it vigorous and effective.”

WASHINGTON — The National Institutes of Health needs to partner more with the pharmaceutical industry in order to create a better pipeline for new drugs, Dr. Francis Collins said at the annual meeting of the Endocrine Society.

Dr. Collins, the former head of the National Human Genome Research Institute who at press time was rumored to be President Obama's pick for NIH director, said that with all the genomic research developments, “pharmaceutical companies are a little overwhelmed about where to start” when it comes to figuring out which genes would make good targets for drug therapy.

“Academic investigators should get more intentionally involved in the translational process of going from basic research to drug development,” Dr. Collins said. “There is an opportunity now, more than ever, to bring together academic investigators and the private sector to put together a really exciting version of a drug development pipeline.” Such a collaboration “involves more of academics taking the front-end risk of developing promising compounds so they become attractive and licensable by the private sector.”

Dr. Collins noted that many academic researchers are identifying promising targets for drugs, “but relatively few are taking that information and turning it into an assay … to see if there is something promising that might turn out to become a therapeutic.”

Some targets start out looking promising, but when they get to a point where they need support for preclinical development, “that's where things often die,” he said. “Congress just a few months ago put $24 million into the fiscal year 2009 budget to start this process in an NIH-funded way, and I hope the money will go up substantially in the next 5 years.”

With such a pipeline, conflicts of interest on the part of pharmaceutical companies “would have to be factored in,” Dr. Collins said in an interview. Drugmakers' interest in commercialization would be a factor. “You want to start a project that is going to get somewhere,” he said. “But there are companies across the board that are interested in almost any disease—even very rare ones—as long as it won't cost a fortune to get that drug approved. For the rare diseases, you may have to push things further down the pipeline with public money before the company says, 'Okay, I'll start with that one now,' but I don't know that that should discourage consideration of working on even a very rare disease in this pipeline.”

During a question-and-answer session, Dr. Collins was asked whether he would list his priorities for NIH “as a private citizen,” since he couldn't address any possible nomination for the head job, a question that elicited laughter and applause from the audience.

“We have an opportunity to take [the new technologies] that have started to appear and apply them in a vigorous way to understand fundamentals of biology; that would include genomics and nanotechnology and a wide variety of approaches to epigenetics,” he said.

“I would also think we need to take seriously the charge coming from the Congress and the Administration to provide useful information to guide health care reform. That would mean, in some instances, comparative effectiveness research, but we need to be careful not to lose the personalized aspects of individual [health] along the way.”

“The U.S. is in a position to spread more soft power instead of hard power around the world; NIH ought to be able to play a useful role in that. And we should encourage the research community, including young investigators, and increase the diversity of our workforce, to make it vigorous and effective.”

Major pharmaceutical firms have agreed to offer drug discounts to Medicare beneficiaries trapped in the Part D “doughnut hole,” President Obama has announced.

The president endorsed an agreement reached between the Pharmaceutical Research and Manufacturers of America (PhRMA) and Sen. Max Baucus (D-Mont.), chairman of the Senate Finance Committee. Mr. Obama explained that “as part of the health care reform I expect Congress to enact this year, Medicare beneficiaries whose spending falls within this gap will now receive a discount on prescription drugs of at least 50% from the negotiated price their plan pays. It's a reform that will make prescription drugs more affordable for millions of seniors, and restore a measure of fairness to Medicare Part D.” The estimated cost of the discount program, which applies only to brand-name drugs, is $80 billion over the next decade.

Medicare Part D enrollees who are in the doughnut hole will receive their discounts at the pharmacy and will not have to fill out any additional paperwork. They also will receive credit for the full cost of a drug against their spending obligation in the doughnut hole, even though they are actually paying half that amount.

President Obama noted that under the Medicare Part D prescription drug benefit, “Medicare covers up to $2,700 in yearly prescription costs and then stops, and the coverage starts back up when the costs exceed $6,100. [That] means between $2,700 and $6,100, folks are out of luck. And this gap in coverage has placed a crushing burden on many older Americans who live on fixed incomes and can't afford thousands of dollars in out-of-pocket expenses.”

At the White House event, Barry Rand, CEO of AARP, which endorsed the agreement, called the deal “an early win for reform and a major step forward.”

Mr. Rand said, “Too many Americans who fall into the coverage gap stop taking their medications because they simply cannot afford them. They will now have a new opportunity to lead a healthier life.”

Billy Tauzin, president and CEO of PhRMA, noted in a statement that “even though we have had policy disagreements in the past [with AARP], this is an historic coming-together moment. AARP, the largest advocacy organization on behalf of American seniors, clearly recognizes the importance of innovative, cutting-edge medicines to the lives of patients everywhere.

Sen. Baucus noted in a statement that when it was created, the Part D benefit “helped address the problem of skyrocketing prescription drug prices for millions of seniors. [With this agreement] we helped fill the gap in coverage and finished the job. … This benefit is part of our continued commitment to seniors and our ongoing effort to reform health care by lowering health care costs and ensuring all Americans have access to the quality, affordable health care coverage they deserve.”

The Medicare Rights Center, a consumer group that advocates improved Medicare benefits, expressed cautious optimism about the agreement.“As always, the devil is in the details,” center president Joe Baker said in a statement. “We look forward to working with President Obama and the Congress to making the promised discount most useful.” He added that the discount complements the health reform proposal from the chairmen of three House committees to phase out the Part D doughnut hole. “Full coverage of both brand-name and generic drugs is the best way to ensure people with Medicare can afford the medicines they need,” Mr. Baker said.

Major pharmaceutical firms have agreed to offer drug discounts to Medicare beneficiaries trapped in the Part D “doughnut hole,” President Obama has announced.

The president endorsed an agreement reached between the Pharmaceutical Research and Manufacturers of America (PhRMA) and Sen. Max Baucus (D-Mont.), chairman of the Senate Finance Committee. Mr. Obama explained that “as part of the health care reform I expect Congress to enact this year, Medicare beneficiaries whose spending falls within this gap will now receive a discount on prescription drugs of at least 50% from the negotiated price their plan pays. It's a reform that will make prescription drugs more affordable for millions of seniors, and restore a measure of fairness to Medicare Part D.” The estimated cost of the discount program, which applies only to brand-name drugs, is $80 billion over the next decade.

Medicare Part D enrollees who are in the doughnut hole will receive their discounts at the pharmacy and will not have to fill out any additional paperwork. They also will receive credit for the full cost of a drug against their spending obligation in the doughnut hole, even though they are actually paying half that amount.

President Obama noted that under the Medicare Part D prescription drug benefit, “Medicare covers up to $2,700 in yearly prescription costs and then stops, and the coverage starts back up when the costs exceed $6,100. [That] means between $2,700 and $6,100, folks are out of luck. And this gap in coverage has placed a crushing burden on many older Americans who live on fixed incomes and can't afford thousands of dollars in out-of-pocket expenses.”

At the White House event, Barry Rand, CEO of AARP, which endorsed the agreement, called the deal “an early win for reform and a major step forward.”

Mr. Rand said, “Too many Americans who fall into the coverage gap stop taking their medications because they simply cannot afford them. They will now have a new opportunity to lead a healthier life.”

Billy Tauzin, president and CEO of PhRMA, noted in a statement that “even though we have had policy disagreements in the past [with AARP], this is an historic coming-together moment. AARP, the largest advocacy organization on behalf of American seniors, clearly recognizes the importance of innovative, cutting-edge medicines to the lives of patients everywhere.

Sen. Baucus noted in a statement that when it was created, the Part D benefit “helped address the problem of skyrocketing prescription drug prices for millions of seniors. [With this agreement] we helped fill the gap in coverage and finished the job. … This benefit is part of our continued commitment to seniors and our ongoing effort to reform health care by lowering health care costs and ensuring all Americans have access to the quality, affordable health care coverage they deserve.”

The Medicare Rights Center, a consumer group that advocates improved Medicare benefits, expressed cautious optimism about the agreement.“As always, the devil is in the details,” center president Joe Baker said in a statement. “We look forward to working with President Obama and the Congress to making the promised discount most useful.” He added that the discount complements the health reform proposal from the chairmen of three House committees to phase out the Part D doughnut hole. “Full coverage of both brand-name and generic drugs is the best way to ensure people with Medicare can afford the medicines they need,” Mr. Baker said.

Major pharmaceutical firms have agreed to offer drug discounts to Medicare beneficiaries trapped in the Part D “doughnut hole,” President Obama has announced.

The president endorsed an agreement reached between the Pharmaceutical Research and Manufacturers of America (PhRMA) and Sen. Max Baucus (D-Mont.), chairman of the Senate Finance Committee. Mr. Obama explained that “as part of the health care reform I expect Congress to enact this year, Medicare beneficiaries whose spending falls within this gap will now receive a discount on prescription drugs of at least 50% from the negotiated price their plan pays. It's a reform that will make prescription drugs more affordable for millions of seniors, and restore a measure of fairness to Medicare Part D.” The estimated cost of the discount program, which applies only to brand-name drugs, is $80 billion over the next decade.

Medicare Part D enrollees who are in the doughnut hole will receive their discounts at the pharmacy and will not have to fill out any additional paperwork. They also will receive credit for the full cost of a drug against their spending obligation in the doughnut hole, even though they are actually paying half that amount.

President Obama noted that under the Medicare Part D prescription drug benefit, “Medicare covers up to $2,700 in yearly prescription costs and then stops, and the coverage starts back up when the costs exceed $6,100. [That] means between $2,700 and $6,100, folks are out of luck. And this gap in coverage has placed a crushing burden on many older Americans who live on fixed incomes and can't afford thousands of dollars in out-of-pocket expenses.”

At the White House event, Barry Rand, CEO of AARP, which endorsed the agreement, called the deal “an early win for reform and a major step forward.”

Mr. Rand said, “Too many Americans who fall into the coverage gap stop taking their medications because they simply cannot afford them. They will now have a new opportunity to lead a healthier life.”

Billy Tauzin, president and CEO of PhRMA, noted in a statement that “even though we have had policy disagreements in the past [with AARP], this is an historic coming-together moment. AARP, the largest advocacy organization on behalf of American seniors, clearly recognizes the importance of innovative, cutting-edge medicines to the lives of patients everywhere.

Sen. Baucus noted in a statement that when it was created, the Part D benefit “helped address the problem of skyrocketing prescription drug prices for millions of seniors. [With this agreement] we helped fill the gap in coverage and finished the job. … This benefit is part of our continued commitment to seniors and our ongoing effort to reform health care by lowering health care costs and ensuring all Americans have access to the quality, affordable health care coverage they deserve.”

The Medicare Rights Center, a consumer group that advocates improved Medicare benefits, expressed cautious optimism about the agreement.“As always, the devil is in the details,” center president Joe Baker said in a statement. “We look forward to working with President Obama and the Congress to making the promised discount most useful.” He added that the discount complements the health reform proposal from the chairmen of three House committees to phase out the Part D doughnut hole. “Full coverage of both brand-name and generic drugs is the best way to ensure people with Medicare can afford the medicines they need,” Mr. Baker said.

Physicians and their staffs spend the equivalent of weeks–and $31 billion–each year processing health insurance paperwork, according to a study funded by the Commonwealth Fund and the Robert Wood Johnson Foundation.

The survey of 895 physicians and practice administrators nationwide asked respondents about the amount of time their practice's staff spent on various administrative activities, including prior authorization, drug formularies, claims and billing, credentialing, contracting, and collecting and reporting quality data.

The researchers found that physicians spent an average of 3 hours a week–or nearly 3 weeks a year–on administrative activities. Nursing staff spent more than 23 weeks per physician per year, and clerical staff spent 44 weeks per physician per year, interacting with health plans. More than three in four respondents said the costs of interacting with health plans have increased over the past 2 years (Health Affairs doi:10.1377/hlthaff.28.4.w533

“While there are benefits to physician offices' interactions with health plans–which may, for example, help to reduce unnecessary care or the inappropriate use of medication–it would be useful to explore the extent to which these benefits are large enough to justify spending 3 weeks annually of physician time … on physician practice-health plan interaction,” the study's lead author, Dr. Lawrence P. Casalino of Cornell University, said in a statement.

“It would also be useful to explore ways to make the interactions more efficient, both on the health plan side and in physician offices.”

Physicians in solo or two-person practices spent many more hours interacting with health plans than did those in practices with 10 or more physicians; this was especially true in primary care, the researchers found.

And all physicians and staff members spent much more time on authorization, formularies, claims and billing, and credentialing than they did on submitting quality data or on reviewing quality data provided by health plans.

“To get to a health care system that is high-quality and delivers better value for everyone, we have to address the skyrocketing price of health care's administrative costs,” Dr. Risa Lavizzo-Mourey, president and CEO of the Robert Wood Johnson Foundation, said in a statement.

“Administrative costs will never be zero, but we need to make sure that administrative interactions improve the quality of care by working to make care safer and more efficient, and rewarding health care providers who successfully reduce excessive care and provide the right treatment at the right time.

Physicians and their staffs spend the equivalent of weeks–and $31 billion–each year processing health insurance paperwork, according to a study funded by the Commonwealth Fund and the Robert Wood Johnson Foundation.

The survey of 895 physicians and practice administrators nationwide asked respondents about the amount of time their practice's staff spent on various administrative activities, including prior authorization, drug formularies, claims and billing, credentialing, contracting, and collecting and reporting quality data.

The researchers found that physicians spent an average of 3 hours a week–or nearly 3 weeks a year–on administrative activities. Nursing staff spent more than 23 weeks per physician per year, and clerical staff spent 44 weeks per physician per year, interacting with health plans. More than three in four respondents said the costs of interacting with health plans have increased over the past 2 years (Health Affairs doi:10.1377/hlthaff.28.4.w533

“While there are benefits to physician offices' interactions with health plans–which may, for example, help to reduce unnecessary care or the inappropriate use of medication–it would be useful to explore the extent to which these benefits are large enough to justify spending 3 weeks annually of physician time … on physician practice-health plan interaction,” the study's lead author, Dr. Lawrence P. Casalino of Cornell University, said in a statement.

“It would also be useful to explore ways to make the interactions more efficient, both on the health plan side and in physician offices.”

Physicians in solo or two-person practices spent many more hours interacting with health plans than did those in practices with 10 or more physicians; this was especially true in primary care, the researchers found.

And all physicians and staff members spent much more time on authorization, formularies, claims and billing, and credentialing than they did on submitting quality data or on reviewing quality data provided by health plans.

“To get to a health care system that is high-quality and delivers better value for everyone, we have to address the skyrocketing price of health care's administrative costs,” Dr. Risa Lavizzo-Mourey, president and CEO of the Robert Wood Johnson Foundation, said in a statement.

“Administrative costs will never be zero, but we need to make sure that administrative interactions improve the quality of care by working to make care safer and more efficient, and rewarding health care providers who successfully reduce excessive care and provide the right treatment at the right time.

Physicians and their staffs spend the equivalent of weeks–and $31 billion–each year processing health insurance paperwork, according to a study funded by the Commonwealth Fund and the Robert Wood Johnson Foundation.

The survey of 895 physicians and practice administrators nationwide asked respondents about the amount of time their practice's staff spent on various administrative activities, including prior authorization, drug formularies, claims and billing, credentialing, contracting, and collecting and reporting quality data.

The researchers found that physicians spent an average of 3 hours a week–or nearly 3 weeks a year–on administrative activities. Nursing staff spent more than 23 weeks per physician per year, and clerical staff spent 44 weeks per physician per year, interacting with health plans. More than three in four respondents said the costs of interacting with health plans have increased over the past 2 years (Health Affairs doi:10.1377/hlthaff.28.4.w533

“While there are benefits to physician offices' interactions with health plans–which may, for example, help to reduce unnecessary care or the inappropriate use of medication–it would be useful to explore the extent to which these benefits are large enough to justify spending 3 weeks annually of physician time … on physician practice-health plan interaction,” the study's lead author, Dr. Lawrence P. Casalino of Cornell University, said in a statement.

“It would also be useful to explore ways to make the interactions more efficient, both on the health plan side and in physician offices.”

Physicians in solo or two-person practices spent many more hours interacting with health plans than did those in practices with 10 or more physicians; this was especially true in primary care, the researchers found.

And all physicians and staff members spent much more time on authorization, formularies, claims and billing, and credentialing than they did on submitting quality data or on reviewing quality data provided by health plans.

“To get to a health care system that is high-quality and delivers better value for everyone, we have to address the skyrocketing price of health care's administrative costs,” Dr. Risa Lavizzo-Mourey, president and CEO of the Robert Wood Johnson Foundation, said in a statement.

“Administrative costs will never be zero, but we need to make sure that administrative interactions improve the quality of care by working to make care safer and more efficient, and rewarding health care providers who successfully reduce excessive care and provide the right treatment at the right time.

In one of her first public acts at the Food and Drug Administration, new commissioner Dr. Margaret Hamburg announced that the agency aims to be more transparent about its daily work and decision making process.

“Over the years, complaints have been made about FDA's lack of transparency,” Dr. Hamburg said in early June. “The agency has been referred to as a 'black box' that makes important decisions without disclosing them. The agency can and should communicate in a way that provides more transparency, not less.”

The commissioner said it was her goal that the public looks first to FDA for trustworthy and useful information about drugs and devices.

“On President Obama's first day in office, he pledged to strengthen democracy … by creating an unprecedented level of openness” in government,” Dr. Hamburg noted. “This will be an agency-wide effort charged with figuring out how to make the FDA and its processes more transparent to the public.”

The transparency task force will include the directors of all FDA centers as well as the agency's associate commissioner for regulatory affairs, its chief counsel, and its chief scientist. Its first meeting was held June 24; another will take place in the fall. All meetings will be open to the public. The task force “expects to submit a written report to the commissioner about 6 months from now,” according to FDA principal deputy commissioner and task force chair Dr. Joshua Sharfstein.

Being clearer about why the agency decides things a certain way is one area of interest for Dr. Sharfstein. “People don't understand why the FDA may have done something or not done something,” he said. “In many cases, the agency has an explanation, but you don't necessarily hear that explanation very clearly.”

Dr. Hamburg said she expects that a wide range of recommendations could emerge from the task force's work. Some recommendations “will be in areas that we can implement swiftly, but there may be other types of information that will take more time, and there may be some area where we have limitations within the current law and need to examine whether appropriate changes can and should be made,” she said.

Both Dr. Hamburg and Dr. Sharfstein emphasized, however, that a balance will need to be struck between providing more information and the appropriate use of confidentiality. “We recognize that there are other policy goals besides transparency, and one of the other questions is what information should remain confidential,” Dr. Sharfstein said. “The secret formula for how to make X pill may be legitimately confidential information.”

Another balancing act will come in terms of clinical trials, Dr. Sharfstein continued. “What is the argument for different amounts of data [being disclosed] at different points in the drug development process, and on the other side, what are the confidentiality concerns and the reasons for them?”

The call for transparency comes at a time when FDA already has a backlog of requests under the Freedom of Information Act. Asked how she planned to handle personnel needs at a time when the agency is behind in its work, Dr. Hamburg said: “When the recommendations come in, I will work with the task force and others on implementation. Some activity may result in more work, and some may result in decreased work. If we make more information available, there may be fewer Freedom of Information Act requests and citizen petitions.”

The Federal Register notice announcing the task force's formation is available online at www.federalregister.gov/OFRUpload/OFRData/2009-12902_PI.pdf

In one of her first public acts at the Food and Drug Administration, new commissioner Dr. Margaret Hamburg announced that the agency aims to be more transparent about its daily work and decision making process.

“Over the years, complaints have been made about FDA's lack of transparency,” Dr. Hamburg said in early June. “The agency has been referred to as a 'black box' that makes important decisions without disclosing them. The agency can and should communicate in a way that provides more transparency, not less.”

The commissioner said it was her goal that the public looks first to FDA for trustworthy and useful information about drugs and devices.

“On President Obama's first day in office, he pledged to strengthen democracy … by creating an unprecedented level of openness” in government,” Dr. Hamburg noted. “This will be an agency-wide effort charged with figuring out how to make the FDA and its processes more transparent to the public.”

The transparency task force will include the directors of all FDA centers as well as the agency's associate commissioner for regulatory affairs, its chief counsel, and its chief scientist. Its first meeting was held June 24; another will take place in the fall. All meetings will be open to the public. The task force “expects to submit a written report to the commissioner about 6 months from now,” according to FDA principal deputy commissioner and task force chair Dr. Joshua Sharfstein.

Being clearer about why the agency decides things a certain way is one area of interest for Dr. Sharfstein. “People don't understand why the FDA may have done something or not done something,” he said. “In many cases, the agency has an explanation, but you don't necessarily hear that explanation very clearly.”

Dr. Hamburg said she expects that a wide range of recommendations could emerge from the task force's work. Some recommendations “will be in areas that we can implement swiftly, but there may be other types of information that will take more time, and there may be some area where we have limitations within the current law and need to examine whether appropriate changes can and should be made,” she said.

Both Dr. Hamburg and Dr. Sharfstein emphasized, however, that a balance will need to be struck between providing more information and the appropriate use of confidentiality. “We recognize that there are other policy goals besides transparency, and one of the other questions is what information should remain confidential,” Dr. Sharfstein said. “The secret formula for how to make X pill may be legitimately confidential information.”

Another balancing act will come in terms of clinical trials, Dr. Sharfstein continued. “What is the argument for different amounts of data [being disclosed] at different points in the drug development process, and on the other side, what are the confidentiality concerns and the reasons for them?”

The call for transparency comes at a time when FDA already has a backlog of requests under the Freedom of Information Act. Asked how she planned to handle personnel needs at a time when the agency is behind in its work, Dr. Hamburg said: “When the recommendations come in, I will work with the task force and others on implementation. Some activity may result in more work, and some may result in decreased work. If we make more information available, there may be fewer Freedom of Information Act requests and citizen petitions.”

The Federal Register notice announcing the task force's formation is available online at www.federalregister.gov/OFRUpload/OFRData/2009-12902_PI.pdf

In one of her first public acts at the Food and Drug Administration, new commissioner Dr. Margaret Hamburg announced that the agency aims to be more transparent about its daily work and decision making process.

“Over the years, complaints have been made about FDA's lack of transparency,” Dr. Hamburg said in early June. “The agency has been referred to as a 'black box' that makes important decisions without disclosing them. The agency can and should communicate in a way that provides more transparency, not less.”

The commissioner said it was her goal that the public looks first to FDA for trustworthy and useful information about drugs and devices.

“On President Obama's first day in office, he pledged to strengthen democracy … by creating an unprecedented level of openness” in government,” Dr. Hamburg noted. “This will be an agency-wide effort charged with figuring out how to make the FDA and its processes more transparent to the public.”

The transparency task force will include the directors of all FDA centers as well as the agency's associate commissioner for regulatory affairs, its chief counsel, and its chief scientist. Its first meeting was held June 24; another will take place in the fall. All meetings will be open to the public. The task force “expects to submit a written report to the commissioner about 6 months from now,” according to FDA principal deputy commissioner and task force chair Dr. Joshua Sharfstein.

Being clearer about why the agency decides things a certain way is one area of interest for Dr. Sharfstein. “People don't understand why the FDA may have done something or not done something,” he said. “In many cases, the agency has an explanation, but you don't necessarily hear that explanation very clearly.”

Dr. Hamburg said she expects that a wide range of recommendations could emerge from the task force's work. Some recommendations “will be in areas that we can implement swiftly, but there may be other types of information that will take more time, and there may be some area where we have limitations within the current law and need to examine whether appropriate changes can and should be made,” she said.

Both Dr. Hamburg and Dr. Sharfstein emphasized, however, that a balance will need to be struck between providing more information and the appropriate use of confidentiality. “We recognize that there are other policy goals besides transparency, and one of the other questions is what information should remain confidential,” Dr. Sharfstein said. “The secret formula for how to make X pill may be legitimately confidential information.”

Another balancing act will come in terms of clinical trials, Dr. Sharfstein continued. “What is the argument for different amounts of data [being disclosed] at different points in the drug development process, and on the other side, what are the confidentiality concerns and the reasons for them?”

The call for transparency comes at a time when FDA already has a backlog of requests under the Freedom of Information Act. Asked how she planned to handle personnel needs at a time when the agency is behind in its work, Dr. Hamburg said: “When the recommendations come in, I will work with the task force and others on implementation. Some activity may result in more work, and some may result in decreased work. If we make more information available, there may be fewer Freedom of Information Act requests and citizen petitions.”

The Federal Register notice announcing the task force's formation is available online at www.federalregister.gov/OFRUpload/OFRData/2009-12902_PI.pdf

WASHINGTON – Regulating overseas drugmakers who export their products to the United States will become a bigger focus of the Food and Drug Administration, FDA Commissioner Margaret Hamburg said at the annual meeting of the Endocrine Society.

“Food and product safety is a very compelling concern to me,” said Dr. Hamburg, who was confirmed in mid-May by the Senate. “For FDA to re-enter our modern, global world is a high priority. … When you look at the number of facilities overseas all around the world that are manufacturing both drugs and food, it's a huge and growing challenge.”

Like Dr. Francis Collins, a possible candidate for the office of director of the National Institutes of Health, who addressed the meeting the previous day, Dr. Hamburg called for more collaboration between her agency and the pharmaceutical industry. “Regulatory science is an essential yet still underdeveloped field,” she said. “It's my hope to see expanded efforts in this area.”

Dr. Hamburg also called for improving conditions for the agency's scientists. “We must be able to recruit and retain the best crop of scientists, and give them the facilities and opportunities they need,” she said.

WASHINGTON – Regulating overseas drugmakers who export their products to the United States will become a bigger focus of the Food and Drug Administration, FDA Commissioner Margaret Hamburg said at the annual meeting of the Endocrine Society.

“Food and product safety is a very compelling concern to me,” said Dr. Hamburg, who was confirmed in mid-May by the Senate. “For FDA to re-enter our modern, global world is a high priority. … When you look at the number of facilities overseas all around the world that are manufacturing both drugs and food, it's a huge and growing challenge.”

Like Dr. Francis Collins, a possible candidate for the office of director of the National Institutes of Health, who addressed the meeting the previous day, Dr. Hamburg called for more collaboration between her agency and the pharmaceutical industry. “Regulatory science is an essential yet still underdeveloped field,” she said. “It's my hope to see expanded efforts in this area.”

Dr. Hamburg also called for improving conditions for the agency's scientists. “We must be able to recruit and retain the best crop of scientists, and give them the facilities and opportunities they need,” she said.

WASHINGTON – Regulating overseas drugmakers who export their products to the United States will become a bigger focus of the Food and Drug Administration, FDA Commissioner Margaret Hamburg said at the annual meeting of the Endocrine Society.

“Food and product safety is a very compelling concern to me,” said Dr. Hamburg, who was confirmed in mid-May by the Senate. “For FDA to re-enter our modern, global world is a high priority. … When you look at the number of facilities overseas all around the world that are manufacturing both drugs and food, it's a huge and growing challenge.”

Like Dr. Francis Collins, a possible candidate for the office of director of the National Institutes of Health, who addressed the meeting the previous day, Dr. Hamburg called for more collaboration between her agency and the pharmaceutical industry. “Regulatory science is an essential yet still underdeveloped field,” she said. “It's my hope to see expanded efforts in this area.”

Dr. Hamburg also called for improving conditions for the agency's scientists. “We must be able to recruit and retain the best crop of scientists, and give them the facilities and opportunities they need,” she said.

A new report from the Dartmouth Atlas of Health Care finds that, overall, the hospital bed supply per capita contracted from 1996 to 2006, while the numbers of hospital-based employees and registered nurses increased.

The number of staffed acute care beds dropped from 2.82 per 1,000 U.S. residents in 1996 to 2.46 per 1,000 in 2006, according to the report. However, there was great regional variation. For example, the Jackson, Miss., area had 4.44 beds per 1,000 in 2006, compared with 1.45 in San Mateo County, Calif. Not surprisingly, the areas with the most beds also had high numbers of hospital employees.

“As long ago as the 1960s, Milton Roemer described the phenomenon that a built bed was a filled bed,” noted the report authors. “Numerous studies since then have found that higher bed supply is associated with more hospital use for conditions where outpatient care is a viable alternative. This includes most medical causes of hospitalization.”

Physician supply continued to expand “modestly,” although numbers varied greatly by specialty, the report said. For example, the number of primary care physicians increased 11% over the study period, compared with 51% for infectious disease specialists and a whopping 198% for critical care specialists. Specialties that experienced declines included cardiothoracic surgery (-17%), pulmonology (-18%), and general surgery (-19%).

The authors made several suggestions for managing hospital capacity and physician workforce growth. To reduce “unwarranted” variations in hospital supply, “Congress could require the Centers for Medicare and Medicaid Services to use its capital payment policies to limit the further growth of hospital capacity in markets that are already overinvested,” they wrote. “Although Certificate of Need programs have generally not been effective, strengthening [such] programs or statewide prospective hospital budgeting processes could be used to more wisely target future hospital growth. Neither of these approaches, however, would help reduce capacity in regions that already have an oversupply.”

To better adjust the physician workforce, “a national workforce commission with representation from the clinical professions, public health, health care purchasers, and patients would provide badly needed analyses and research to better direct funds for health workforce training and for provision of care to the underserved,” the authors suggested.

Another alternative for getting both hospital bed capacity and the physician workforce to the right size would be a more market-oriented approach based on organized systems of care, according to the report.

“Consensus is emerging that integrated delivery systems that provide strong clinical support to clinicians and team-based care management for patients offer great promise for improving quality and lowering costs,” the authors wrote.

“Hospital and Physician Capacity Update: A Brief Report from the Dartmouth Atlas of Health Care” is available at www.dartmouthatlas.org/atlases/Capacity_Report_2009.pdf

A new report from the Dartmouth Atlas of Health Care finds that, overall, the hospital bed supply per capita contracted from 1996 to 2006, while the numbers of hospital-based employees and registered nurses increased.

The number of staffed acute care beds dropped from 2.82 per 1,000 U.S. residents in 1996 to 2.46 per 1,000 in 2006, according to the report. However, there was great regional variation. For example, the Jackson, Miss., area had 4.44 beds per 1,000 in 2006, compared with 1.45 in San Mateo County, Calif. Not surprisingly, the areas with the most beds also had high numbers of hospital employees.

“As long ago as the 1960s, Milton Roemer described the phenomenon that a built bed was a filled bed,” noted the report authors. “Numerous studies since then have found that higher bed supply is associated with more hospital use for conditions where outpatient care is a viable alternative. This includes most medical causes of hospitalization.”

Physician supply continued to expand “modestly,” although numbers varied greatly by specialty, the report said. For example, the number of primary care physicians increased 11% over the study period, compared with 51% for infectious disease specialists and a whopping 198% for critical care specialists. Specialties that experienced declines included cardiothoracic surgery (-17%), pulmonology (-18%), and general surgery (-19%).

The authors made several suggestions for managing hospital capacity and physician workforce growth. To reduce “unwarranted” variations in hospital supply, “Congress could require the Centers for Medicare and Medicaid Services to use its capital payment policies to limit the further growth of hospital capacity in markets that are already overinvested,” they wrote. “Although Certificate of Need programs have generally not been effective, strengthening [such] programs or statewide prospective hospital budgeting processes could be used to more wisely target future hospital growth. Neither of these approaches, however, would help reduce capacity in regions that already have an oversupply.”

To better adjust the physician workforce, “a national workforce commission with representation from the clinical professions, public health, health care purchasers, and patients would provide badly needed analyses and research to better direct funds for health workforce training and for provision of care to the underserved,” the authors suggested.

Another alternative for getting both hospital bed capacity and the physician workforce to the right size would be a more market-oriented approach based on organized systems of care, according to the report.

“Consensus is emerging that integrated delivery systems that provide strong clinical support to clinicians and team-based care management for patients offer great promise for improving quality and lowering costs,” the authors wrote.

“Hospital and Physician Capacity Update: A Brief Report from the Dartmouth Atlas of Health Care” is available at www.dartmouthatlas.org/atlases/Capacity_Report_2009.pdf

A new report from the Dartmouth Atlas of Health Care finds that, overall, the hospital bed supply per capita contracted from 1996 to 2006, while the numbers of hospital-based employees and registered nurses increased.

The number of staffed acute care beds dropped from 2.82 per 1,000 U.S. residents in 1996 to 2.46 per 1,000 in 2006, according to the report. However, there was great regional variation. For example, the Jackson, Miss., area had 4.44 beds per 1,000 in 2006, compared with 1.45 in San Mateo County, Calif. Not surprisingly, the areas with the most beds also had high numbers of hospital employees.

“As long ago as the 1960s, Milton Roemer described the phenomenon that a built bed was a filled bed,” noted the report authors. “Numerous studies since then have found that higher bed supply is associated with more hospital use for conditions where outpatient care is a viable alternative. This includes most medical causes of hospitalization.”

Physician supply continued to expand “modestly,” although numbers varied greatly by specialty, the report said. For example, the number of primary care physicians increased 11% over the study period, compared with 51% for infectious disease specialists and a whopping 198% for critical care specialists. Specialties that experienced declines included cardiothoracic surgery (-17%), pulmonology (-18%), and general surgery (-19%).

The authors made several suggestions for managing hospital capacity and physician workforce growth. To reduce “unwarranted” variations in hospital supply, “Congress could require the Centers for Medicare and Medicaid Services to use its capital payment policies to limit the further growth of hospital capacity in markets that are already overinvested,” they wrote. “Although Certificate of Need programs have generally not been effective, strengthening [such] programs or statewide prospective hospital budgeting processes could be used to more wisely target future hospital growth. Neither of these approaches, however, would help reduce capacity in regions that already have an oversupply.”

To better adjust the physician workforce, “a national workforce commission with representation from the clinical professions, public health, health care purchasers, and patients would provide badly needed analyses and research to better direct funds for health workforce training and for provision of care to the underserved,” the authors suggested.

Another alternative for getting both hospital bed capacity and the physician workforce to the right size would be a more market-oriented approach based on organized systems of care, according to the report.

“Consensus is emerging that integrated delivery systems that provide strong clinical support to clinicians and team-based care management for patients offer great promise for improving quality and lowering costs,” the authors wrote.

“Hospital and Physician Capacity Update: A Brief Report from the Dartmouth Atlas of Health Care” is available at www.dartmouthatlas.org/atlases/Capacity_Report_2009.pdf