Joyce Frieden

Avandia Comes Under Fire

Public Citizen has petitioned the Food and Drug Administration to remove GlaxoSmithKline's rosiglitazone (Avandia) from the market because of unacceptable safety risks. The public interest group cited 14 cases of liver failure—including 12 deaths—in patients on the drug as the main reason for its petition; the cases were reported to the FDA's MedWatch program. “The scientific consensus against Avandia is overwhelming,” said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. In response, GlaxoSmithKline issued a statement saying that as recently as July 2008, its external Hepatic Safety Board, which reviews adverse events, “continued to endorse a favorable hepatic safety profile for Avandia. … The record of safety and effectiveness of Avandia is backed by one of the largest clinical trial programs (including 52,000 patients) ever undertaken for any medicine.”

Diabetes Treatment Costs Rising …

The cost of drugs to treat type 2 diabetes rose from $6.7 billion to $12.5 billion from 2001 to 2007, according to a study in the Archives of Internal Medicine. Using data from the National Disease and Therapeutic Index as well as the National Prescription Audit, the researchers also found that the average cost of a diabetes prescription had risen from $56 in 2001 to $76 in 2007. The authors, led by Dr. G. Caleb Alexander of the University of Chicago, attributed much of the cost increase to the rising use of newer medications, such as glitazones, exenatide, and newer insulins. “Although many of these newer therapies have made therapy more convenient and may have potentially lowered the risk of treatment-associated complications, further research of their long-term benefits is needed,” the authors wrote, adding that “[s]ubstantial outcome differences would be needed to overcome the high cost of the newer drugs.”

… As Incidence Nearly Doubles

The rate of new diabetes cases increased by more than 90% over the last 10 years, according to a study by the Centers for Disease Control and Prevention. The CDC found that the incidence of diabetes among adults increased from 4.8 per 1,000 from 1995–1997 to 9.1 per 1,000 from 2005–2007. “This study demonstrates that we must continue to promote effective diabetes prevention efforts,” said lead author Karen Kirtland, Ph.D. The incidence of new cases was highest in Puerto Rico, at 12.8 per 1,000, and lowest in Minnesota, at 5 per 1,000.

New Leaders at ATA

The American Thyroid Association installed a new president at its annual meeting in Chicago last month. Dr. Kenneth Burman, chief of the endocrine section at Washington (D.C.) Hospital Center is the association's new president. “It has been a privilege to be a member of the ATA since 1975, my most valued and important society [membership],” Dr. Burman said in a statement. Chosen as president-elect was Dr. Terry Davies, professor of medicine at the Mount Sinai School of Medicine, New York.

Avandia Comes Under Fire

Public Citizen has petitioned the Food and Drug Administration to remove GlaxoSmithKline's rosiglitazone (Avandia) from the market because of unacceptable safety risks. The public interest group cited 14 cases of liver failure—including 12 deaths—in patients on the drug as the main reason for its petition; the cases were reported to the FDA's MedWatch program. “The scientific consensus against Avandia is overwhelming,” said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. In response, GlaxoSmithKline issued a statement saying that as recently as July 2008, its external Hepatic Safety Board, which reviews adverse events, “continued to endorse a favorable hepatic safety profile for Avandia. … The record of safety and effectiveness of Avandia is backed by one of the largest clinical trial programs (including 52,000 patients) ever undertaken for any medicine.”

Diabetes Treatment Costs Rising …

The cost of drugs to treat type 2 diabetes rose from $6.7 billion to $12.5 billion from 2001 to 2007, according to a study in the Archives of Internal Medicine. Using data from the National Disease and Therapeutic Index as well as the National Prescription Audit, the researchers also found that the average cost of a diabetes prescription had risen from $56 in 2001 to $76 in 2007. The authors, led by Dr. G. Caleb Alexander of the University of Chicago, attributed much of the cost increase to the rising use of newer medications, such as glitazones, exenatide, and newer insulins. “Although many of these newer therapies have made therapy more convenient and may have potentially lowered the risk of treatment-associated complications, further research of their long-term benefits is needed,” the authors wrote, adding that “[s]ubstantial outcome differences would be needed to overcome the high cost of the newer drugs.”

… As Incidence Nearly Doubles

The rate of new diabetes cases increased by more than 90% over the last 10 years, according to a study by the Centers for Disease Control and Prevention. The CDC found that the incidence of diabetes among adults increased from 4.8 per 1,000 from 1995–1997 to 9.1 per 1,000 from 2005–2007. “This study demonstrates that we must continue to promote effective diabetes prevention efforts,” said lead author Karen Kirtland, Ph.D. The incidence of new cases was highest in Puerto Rico, at 12.8 per 1,000, and lowest in Minnesota, at 5 per 1,000.

New Leaders at ATA

The American Thyroid Association installed a new president at its annual meeting in Chicago last month. Dr. Kenneth Burman, chief of the endocrine section at Washington (D.C.) Hospital Center is the association's new president. “It has been a privilege to be a member of the ATA since 1975, my most valued and important society [membership],” Dr. Burman said in a statement. Chosen as president-elect was Dr. Terry Davies, professor of medicine at the Mount Sinai School of Medicine, New York.

Avandia Comes Under Fire

Public Citizen has petitioned the Food and Drug Administration to remove GlaxoSmithKline's rosiglitazone (Avandia) from the market because of unacceptable safety risks. The public interest group cited 14 cases of liver failure—including 12 deaths—in patients on the drug as the main reason for its petition; the cases were reported to the FDA's MedWatch program. “The scientific consensus against Avandia is overwhelming,” said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. In response, GlaxoSmithKline issued a statement saying that as recently as July 2008, its external Hepatic Safety Board, which reviews adverse events, “continued to endorse a favorable hepatic safety profile for Avandia. … The record of safety and effectiveness of Avandia is backed by one of the largest clinical trial programs (including 52,000 patients) ever undertaken for any medicine.”

Diabetes Treatment Costs Rising …

The cost of drugs to treat type 2 diabetes rose from $6.7 billion to $12.5 billion from 2001 to 2007, according to a study in the Archives of Internal Medicine. Using data from the National Disease and Therapeutic Index as well as the National Prescription Audit, the researchers also found that the average cost of a diabetes prescription had risen from $56 in 2001 to $76 in 2007. The authors, led by Dr. G. Caleb Alexander of the University of Chicago, attributed much of the cost increase to the rising use of newer medications, such as glitazones, exenatide, and newer insulins. “Although many of these newer therapies have made therapy more convenient and may have potentially lowered the risk of treatment-associated complications, further research of their long-term benefits is needed,” the authors wrote, adding that “[s]ubstantial outcome differences would be needed to overcome the high cost of the newer drugs.”

… As Incidence Nearly Doubles

The rate of new diabetes cases increased by more than 90% over the last 10 years, according to a study by the Centers for Disease Control and Prevention. The CDC found that the incidence of diabetes among adults increased from 4.8 per 1,000 from 1995–1997 to 9.1 per 1,000 from 2005–2007. “This study demonstrates that we must continue to promote effective diabetes prevention efforts,” said lead author Karen Kirtland, Ph.D. The incidence of new cases was highest in Puerto Rico, at 12.8 per 1,000, and lowest in Minnesota, at 5 per 1,000.

New Leaders at ATA

The American Thyroid Association installed a new president at its annual meeting in Chicago last month. Dr. Kenneth Burman, chief of the endocrine section at Washington (D.C.) Hospital Center is the association's new president. “It has been a privilege to be a member of the ATA since 1975, my most valued and important society [membership],” Dr. Burman said in a statement. Chosen as president-elect was Dr. Terry Davies, professor of medicine at the Mount Sinai School of Medicine, New York.

Randall Osborne of Elsevier's “Pink Sheet Daily” contributed to this report.

Pharmaceutical manufacturer Merck & Co. has stopped developing taranabant, a weight-loss drug, because of concerns over psychiatric side effects, the company announced last month.

“Available phase III data showed that both efficacy and adverse events were dose related, with greater efficacy and more adverse events in the higher doses,” Dr. John Amatruda, senior vice president and research head, diabetes and obesity, at Merck Research Laboratories, said in a statement.

Interim results presented at the European Congress on Obesity in Geneva earlier this year from a 2-year study of taranabant in more than 1,200 overweight and obese patients showed average losses of 5.7 pounds, 14.5 pounds, and almost 18 pounds in patients who received placebo, taranabant 2 mg, and taranabant 4 mg, respectively.

However, psychiatric adverse events occurred in 20% of those on placebo, 28% of those on taranabant 2 mg, and 40% of those on taranabant 4 mg.

The company's decision “represents a major setback in the future development of agents for obesity,” Dr. Yehuda Handelsman, director of medical education management at the Metabolic Institute of America, in Tarzana, Calif., said in an interview. “The message drug companies got from the FDA is that they should not waste their money to study drugs for obesity and related diseases if they have some side effects, because the agency will not approve such drugs.”

Merck's decision to abandon taranabant is only the most recent in a series of setbacks for the cannabinoid-1 (CB-1) receptor antagonist class of obesity drugs. Last year, an FDA advisory panel recommended against approval of Sanofi-Aventis's CB-1 antagonist rimonabant (Zimulti); the company withdrew its new drug application for rimonabant a few weeks later.

But Sanofi is not completely through with rimonabant. A phase III trial of the drug, marketed in Europe as Acomplia, is expected to report data in the second half of 2009.

Pfizer's CP-945598, another CB-1 antagonist for obesity, also seems to be on its way out. Results from a 2,000-patient phase III trial were expected in the first quarter of 2009, but Pfizer recently said obesity programs will be dropped.

One CB-1 antagonist that is still being investigated is Bristol-Myers Squibb/ Solvay's CB-1 antagonist SLV-319. That compound is currently the subject of phase IIb trials.

Dr. Handelsman is on the speakers bureau for Merck & Co. and has received research support from Sanofi-Aventis.

Randall Osborne of Elsevier's “Pink Sheet Daily” contributed to this report.

Pharmaceutical manufacturer Merck & Co. has stopped developing taranabant, a weight-loss drug, because of concerns over psychiatric side effects, the company announced last month.

“Available phase III data showed that both efficacy and adverse events were dose related, with greater efficacy and more adverse events in the higher doses,” Dr. John Amatruda, senior vice president and research head, diabetes and obesity, at Merck Research Laboratories, said in a statement.

Interim results presented at the European Congress on Obesity in Geneva earlier this year from a 2-year study of taranabant in more than 1,200 overweight and obese patients showed average losses of 5.7 pounds, 14.5 pounds, and almost 18 pounds in patients who received placebo, taranabant 2 mg, and taranabant 4 mg, respectively.

However, psychiatric adverse events occurred in 20% of those on placebo, 28% of those on taranabant 2 mg, and 40% of those on taranabant 4 mg.

The company's decision “represents a major setback in the future development of agents for obesity,” Dr. Yehuda Handelsman, director of medical education management at the Metabolic Institute of America, in Tarzana, Calif., said in an interview. “The message drug companies got from the FDA is that they should not waste their money to study drugs for obesity and related diseases if they have some side effects, because the agency will not approve such drugs.”

Merck's decision to abandon taranabant is only the most recent in a series of setbacks for the cannabinoid-1 (CB-1) receptor antagonist class of obesity drugs. Last year, an FDA advisory panel recommended against approval of Sanofi-Aventis's CB-1 antagonist rimonabant (Zimulti); the company withdrew its new drug application for rimonabant a few weeks later.

But Sanofi is not completely through with rimonabant. A phase III trial of the drug, marketed in Europe as Acomplia, is expected to report data in the second half of 2009.

Pfizer's CP-945598, another CB-1 antagonist for obesity, also seems to be on its way out. Results from a 2,000-patient phase III trial were expected in the first quarter of 2009, but Pfizer recently said obesity programs will be dropped.

One CB-1 antagonist that is still being investigated is Bristol-Myers Squibb/ Solvay's CB-1 antagonist SLV-319. That compound is currently the subject of phase IIb trials.

Dr. Handelsman is on the speakers bureau for Merck & Co. and has received research support from Sanofi-Aventis.

Randall Osborne of Elsevier's “Pink Sheet Daily” contributed to this report.

Pharmaceutical manufacturer Merck & Co. has stopped developing taranabant, a weight-loss drug, because of concerns over psychiatric side effects, the company announced last month.

“Available phase III data showed that both efficacy and adverse events were dose related, with greater efficacy and more adverse events in the higher doses,” Dr. John Amatruda, senior vice president and research head, diabetes and obesity, at Merck Research Laboratories, said in a statement.

Interim results presented at the European Congress on Obesity in Geneva earlier this year from a 2-year study of taranabant in more than 1,200 overweight and obese patients showed average losses of 5.7 pounds, 14.5 pounds, and almost 18 pounds in patients who received placebo, taranabant 2 mg, and taranabant 4 mg, respectively.

However, psychiatric adverse events occurred in 20% of those on placebo, 28% of those on taranabant 2 mg, and 40% of those on taranabant 4 mg.

The company's decision “represents a major setback in the future development of agents for obesity,” Dr. Yehuda Handelsman, director of medical education management at the Metabolic Institute of America, in Tarzana, Calif., said in an interview. “The message drug companies got from the FDA is that they should not waste their money to study drugs for obesity and related diseases if they have some side effects, because the agency will not approve such drugs.”

Merck's decision to abandon taranabant is only the most recent in a series of setbacks for the cannabinoid-1 (CB-1) receptor antagonist class of obesity drugs. Last year, an FDA advisory panel recommended against approval of Sanofi-Aventis's CB-1 antagonist rimonabant (Zimulti); the company withdrew its new drug application for rimonabant a few weeks later.

But Sanofi is not completely through with rimonabant. A phase III trial of the drug, marketed in Europe as Acomplia, is expected to report data in the second half of 2009.

Pfizer's CP-945598, another CB-1 antagonist for obesity, also seems to be on its way out. Results from a 2,000-patient phase III trial were expected in the first quarter of 2009, but Pfizer recently said obesity programs will be dropped.

One CB-1 antagonist that is still being investigated is Bristol-Myers Squibb/ Solvay's CB-1 antagonist SLV-319. That compound is currently the subject of phase IIb trials.

Dr. Handelsman is on the speakers bureau for Merck & Co. and has received research support from Sanofi-Aventis.

Osteoporosis: Women's Disease?

Women aged 30 years and older are more likely to report being at risk for osteoporosis than are men and young adults, according to a study published in the October issue of Health Education & Behavior. In a study of 300 men and women across a range of age groups (18–25, 30–50, and 50-plus), the researchers used the Osteoporosis Health Belief Scale to gauge participants' perceptions about their susceptibility to osteoporosis, the seriousness of the condition, and their motivation to make changes to their health behaviors. The 35-item, self-report questionnaire grades responses on a 5-point scale. The responses revealed that women aged 30–50 years and women aged 50 and older had the highest susceptibility scores. Men aged 18–25 years had the lowest susceptibility scores, according to the study. However, the scores related to the seriousness of the condition and the motivation to change health behaviors were not significantly different among the various groups. The finding suggests that men and women of all ages may be unaware of the serious consequences of osteoporosis, the researchers wrote.

ADA Revisions Pass Congress

Both Houses of Congress have passed the Americans With Disabilities Act Amendments Act, which reverses three Supreme Court decisions that restricted the ADA's jurisdiction. The legislation, which President Bush was expected to sign at press time, prohibits the consideration of measures that reduce or mitigate the impact of impairment—such as medication, prosthetics, and assistive technology—in determining whether an individual has a disability; covers workers whose employers discriminate against them based on a perception that the worker is impaired, regardless of whether the worker has a disability; and makes it clear that the ADA provides broad coverage to protect anyone who faces discrimination on the basis of disability. The American Diabetes Association praised the bill's passage, noting that many people with chronic illnesses such as diabetes have found themselves no longer covered by the act. “Overwhelming majorities in both houses of Congress realized the merit of this historic legislation. They acknowledged that the proposed act strengthens fundamental protections for Americans with disabilities yet also has been recognized as manageable by prominent representatives of U.S. employers,” said Dan Kohrman, chair of the association's legal advocacy subcommittee.

Uninsured Spend $30B on Care

Americans who lack health insurance for any part of 2008 will spend $30 billion out of pocket for health services and also receive $56 billion in uncompensated care while uninsured, according to a study in Health Affairs. Government programs will pay for about $43 billion for the uncompensated care, the researchers reported. Compared with people who have full-year private health care coverage, people who are uninsured for a full year receive less than half as much care but pay a larger share out of pocket, the authors reported. Someone who is uninsured all year would pay 35%, or $583 on average, out of pocket toward average annual medical costs of $1,686, the study said. In contrast, annual medical costs of the privately insured average $3,915, with 17%, or $681 on average, paid out of pocket, according to the study.

HHS Privacy Efforts Lacking

The Health and Human Services department has taken some steps to safeguard patient privacy, but efforts in several areas are still lacking, according to a report from the Government Accountability Office. The report notes that although HHS has made progress in developing a confidentiality, security, and privacy framework for health records, it has looked at some areas only in a narrow view. For example, the agency's efforts at harmonizing certification and standards mostly address technical issues such as data encryption and password protections, while the recommendations submitted by the HHS's advisory committees are primarily aimed at policy and legal issues. In response, the report noted that “HHS agreed that more work remains to be done in the department's efforts to protect the privacy of electronic personal health information and stated that it is actively pursuing a two-phased process for assessing and prioritizing privacy-related initiatives intended to build public trust and confidence in health IT, particularly in electronic health information exchange.”

Part B Premiums Same for 2009

Medicare beneficiaries won't have to reach any deeper into their wallets to pay their Part B premiums and deductibles next year. Officials at the Centers for Medicare and Medicaid Services announced that the 2009 standard Part B monthly premiums will be the same as in 2008—$96.40. This is the first time since 2000 that the standard Part B premium has not increased over the previous year, according to the CMS.

Osteoporosis: Women's Disease?

Women aged 30 years and older are more likely to report being at risk for osteoporosis than are men and young adults, according to a study published in the October issue of Health Education & Behavior. In a study of 300 men and women across a range of age groups (18–25, 30–50, and 50-plus), the researchers used the Osteoporosis Health Belief Scale to gauge participants' perceptions about their susceptibility to osteoporosis, the seriousness of the condition, and their motivation to make changes to their health behaviors. The 35-item, self-report questionnaire grades responses on a 5-point scale. The responses revealed that women aged 30–50 years and women aged 50 and older had the highest susceptibility scores. Men aged 18–25 years had the lowest susceptibility scores, according to the study. However, the scores related to the seriousness of the condition and the motivation to change health behaviors were not significantly different among the various groups. The finding suggests that men and women of all ages may be unaware of the serious consequences of osteoporosis, the researchers wrote.

ADA Revisions Pass Congress

Both Houses of Congress have passed the Americans With Disabilities Act Amendments Act, which reverses three Supreme Court decisions that restricted the ADA's jurisdiction. The legislation, which President Bush was expected to sign at press time, prohibits the consideration of measures that reduce or mitigate the impact of impairment—such as medication, prosthetics, and assistive technology—in determining whether an individual has a disability; covers workers whose employers discriminate against them based on a perception that the worker is impaired, regardless of whether the worker has a disability; and makes it clear that the ADA provides broad coverage to protect anyone who faces discrimination on the basis of disability. The American Diabetes Association praised the bill's passage, noting that many people with chronic illnesses such as diabetes have found themselves no longer covered by the act. “Overwhelming majorities in both houses of Congress realized the merit of this historic legislation. They acknowledged that the proposed act strengthens fundamental protections for Americans with disabilities yet also has been recognized as manageable by prominent representatives of U.S. employers,” said Dan Kohrman, chair of the association's legal advocacy subcommittee.

Uninsured Spend $30B on Care

Americans who lack health insurance for any part of 2008 will spend $30 billion out of pocket for health services and also receive $56 billion in uncompensated care while uninsured, according to a study in Health Affairs. Government programs will pay for about $43 billion for the uncompensated care, the researchers reported. Compared with people who have full-year private health care coverage, people who are uninsured for a full year receive less than half as much care but pay a larger share out of pocket, the authors reported. Someone who is uninsured all year would pay 35%, or $583 on average, out of pocket toward average annual medical costs of $1,686, the study said. In contrast, annual medical costs of the privately insured average $3,915, with 17%, or $681 on average, paid out of pocket, according to the study.

HHS Privacy Efforts Lacking

The Health and Human Services department has taken some steps to safeguard patient privacy, but efforts in several areas are still lacking, according to a report from the Government Accountability Office. The report notes that although HHS has made progress in developing a confidentiality, security, and privacy framework for health records, it has looked at some areas only in a narrow view. For example, the agency's efforts at harmonizing certification and standards mostly address technical issues such as data encryption and password protections, while the recommendations submitted by the HHS's advisory committees are primarily aimed at policy and legal issues. In response, the report noted that “HHS agreed that more work remains to be done in the department's efforts to protect the privacy of electronic personal health information and stated that it is actively pursuing a two-phased process for assessing and prioritizing privacy-related initiatives intended to build public trust and confidence in health IT, particularly in electronic health information exchange.”

Part B Premiums Same for 2009

Medicare beneficiaries won't have to reach any deeper into their wallets to pay their Part B premiums and deductibles next year. Officials at the Centers for Medicare and Medicaid Services announced that the 2009 standard Part B monthly premiums will be the same as in 2008—$96.40. This is the first time since 2000 that the standard Part B premium has not increased over the previous year, according to the CMS.

Osteoporosis: Women's Disease?

Women aged 30 years and older are more likely to report being at risk for osteoporosis than are men and young adults, according to a study published in the October issue of Health Education & Behavior. In a study of 300 men and women across a range of age groups (18–25, 30–50, and 50-plus), the researchers used the Osteoporosis Health Belief Scale to gauge participants' perceptions about their susceptibility to osteoporosis, the seriousness of the condition, and their motivation to make changes to their health behaviors. The 35-item, self-report questionnaire grades responses on a 5-point scale. The responses revealed that women aged 30–50 years and women aged 50 and older had the highest susceptibility scores. Men aged 18–25 years had the lowest susceptibility scores, according to the study. However, the scores related to the seriousness of the condition and the motivation to change health behaviors were not significantly different among the various groups. The finding suggests that men and women of all ages may be unaware of the serious consequences of osteoporosis, the researchers wrote.

ADA Revisions Pass Congress

Both Houses of Congress have passed the Americans With Disabilities Act Amendments Act, which reverses three Supreme Court decisions that restricted the ADA's jurisdiction. The legislation, which President Bush was expected to sign at press time, prohibits the consideration of measures that reduce or mitigate the impact of impairment—such as medication, prosthetics, and assistive technology—in determining whether an individual has a disability; covers workers whose employers discriminate against them based on a perception that the worker is impaired, regardless of whether the worker has a disability; and makes it clear that the ADA provides broad coverage to protect anyone who faces discrimination on the basis of disability. The American Diabetes Association praised the bill's passage, noting that many people with chronic illnesses such as diabetes have found themselves no longer covered by the act. “Overwhelming majorities in both houses of Congress realized the merit of this historic legislation. They acknowledged that the proposed act strengthens fundamental protections for Americans with disabilities yet also has been recognized as manageable by prominent representatives of U.S. employers,” said Dan Kohrman, chair of the association's legal advocacy subcommittee.

Uninsured Spend $30B on Care

Americans who lack health insurance for any part of 2008 will spend $30 billion out of pocket for health services and also receive $56 billion in uncompensated care while uninsured, according to a study in Health Affairs. Government programs will pay for about $43 billion for the uncompensated care, the researchers reported. Compared with people who have full-year private health care coverage, people who are uninsured for a full year receive less than half as much care but pay a larger share out of pocket, the authors reported. Someone who is uninsured all year would pay 35%, or $583 on average, out of pocket toward average annual medical costs of $1,686, the study said. In contrast, annual medical costs of the privately insured average $3,915, with 17%, or $681 on average, paid out of pocket, according to the study.

HHS Privacy Efforts Lacking

The Health and Human Services department has taken some steps to safeguard patient privacy, but efforts in several areas are still lacking, according to a report from the Government Accountability Office. The report notes that although HHS has made progress in developing a confidentiality, security, and privacy framework for health records, it has looked at some areas only in a narrow view. For example, the agency's efforts at harmonizing certification and standards mostly address technical issues such as data encryption and password protections, while the recommendations submitted by the HHS's advisory committees are primarily aimed at policy and legal issues. In response, the report noted that “HHS agreed that more work remains to be done in the department's efforts to protect the privacy of electronic personal health information and stated that it is actively pursuing a two-phased process for assessing and prioritizing privacy-related initiatives intended to build public trust and confidence in health IT, particularly in electronic health information exchange.”

Part B Premiums Same for 2009

Medicare beneficiaries won't have to reach any deeper into their wallets to pay their Part B premiums and deductibles next year. Officials at the Centers for Medicare and Medicaid Services announced that the 2009 standard Part B monthly premiums will be the same as in 2008—$96.40. This is the first time since 2000 that the standard Part B premium has not increased over the previous year, according to the CMS.

WASHINGTON — Physicians and other health care providers who take care of diabetes patients can easily suffer from “clinical inertia,” but performance feedback might help improve their performance, according to one diabetes expert.

Clinical inertia is defined as “failure to institute or change therapy appropriately when more intensive management is indicated,” Catherine Barnes, Ph.D., said at the annual meeting of the American Association of Diabetes Educators.

This problem is usually not caused by unfamiliarity with practice guidelines or inadequate time for care, she noted. Instead, it usually occurs when providers use “soft” reasons to avoid intensifying therapy. For example, they tell the patient to “try the diet a little longer,” or they say that a particular study's results don't apply to their own patients. Such providers also usually don't have systems to encourage them to step up therapy, such as flow sheets or “stepped” care protocols, said Dr. Barnes, who is with the Grady Diabetes Clinic in Atlanta.

Both patients and providers are trained not to be really aggressive with diabetes therapy, she said. “Patients don't change their diet because they're used to high-fat [food], or because they say they can't afford sugar-free items,” said Dr. Barnes. “Socially, they complain about lack of family support. … Or they have trouble looking at food labels and at food exchanges.”

On the caregiver side, one likely cause of inertia is that the providers have no way of knowing how their patients are doing as a group. So the clinic conducted a study to see if giving feedback to providers would result in lower HbA_1c readings for patients. Because the Grady clinic is run by nurses, who provide most of the care, the researchers focused on six nurses who saw a total of 1,171 patients over a 2-year period.

The patients had a mean age of 61; 64% were female, and 94% were black. The mean body mass index was 33.9, average diabetes duration was 12 years, and average HbA_1c was 7.35%. A total of 7% of patients were being treated with diet alone; 33% were on oral medications alone or a combination of oral medications and diet therapy; 47% were on insulin alone, and 13% were on insulin plus diet therapy.

The first year of the study served as a comparison period; no feedback was given. By the end of the first year, the patients' average HbA_1c rose slightly to 7.36%, an insignificant difference.

Starting in the second year, the nurses had 5-minute feedback sessions with a diabetes specialist every 3 weeks. The specialists told the nurses how their particular patients were doing as a group in terms of HbA_1c levels and other tests, such as blood pressure and cholesterol. Feedback sessions were scripted and included some questions to help the nurses become active learners.

At the end of the 2 years, the average HbA_1c had dropped to 7.24%, a significant difference. “In every case, after these report cards, the HbA_1c of [each nurse's patients] had come down,” showing that they were more likely to intensify treatment if they were given feedback. The comments from the nurses were also positive, she added.

In addition to receiving feedback, physicians and other providers can take several steps to improve their care of diabetes patients, according to Dr. Barnes. “One thing you can do is [post] reminders of high values,” she said. “You can also give those numbers to patients, so the patient can become empowered to say, 'My A_1c is 8.5; what can we do about this?'”

WASHINGTON — Physicians and other health care providers who take care of diabetes patients can easily suffer from “clinical inertia,” but performance feedback might help improve their performance, according to one diabetes expert.

Clinical inertia is defined as “failure to institute or change therapy appropriately when more intensive management is indicated,” Catherine Barnes, Ph.D., said at the annual meeting of the American Association of Diabetes Educators.

This problem is usually not caused by unfamiliarity with practice guidelines or inadequate time for care, she noted. Instead, it usually occurs when providers use “soft” reasons to avoid intensifying therapy. For example, they tell the patient to “try the diet a little longer,” or they say that a particular study's results don't apply to their own patients. Such providers also usually don't have systems to encourage them to step up therapy, such as flow sheets or “stepped” care protocols, said Dr. Barnes, who is with the Grady Diabetes Clinic in Atlanta.

Both patients and providers are trained not to be really aggressive with diabetes therapy, she said. “Patients don't change their diet because they're used to high-fat [food], or because they say they can't afford sugar-free items,” said Dr. Barnes. “Socially, they complain about lack of family support. … Or they have trouble looking at food labels and at food exchanges.”

On the caregiver side, one likely cause of inertia is that the providers have no way of knowing how their patients are doing as a group. So the clinic conducted a study to see if giving feedback to providers would result in lower HbA_1c readings for patients. Because the Grady clinic is run by nurses, who provide most of the care, the researchers focused on six nurses who saw a total of 1,171 patients over a 2-year period.

The patients had a mean age of 61; 64% were female, and 94% were black. The mean body mass index was 33.9, average diabetes duration was 12 years, and average HbA_1c was 7.35%. A total of 7% of patients were being treated with diet alone; 33% were on oral medications alone or a combination of oral medications and diet therapy; 47% were on insulin alone, and 13% were on insulin plus diet therapy.

The first year of the study served as a comparison period; no feedback was given. By the end of the first year, the patients' average HbA_1c rose slightly to 7.36%, an insignificant difference.

Starting in the second year, the nurses had 5-minute feedback sessions with a diabetes specialist every 3 weeks. The specialists told the nurses how their particular patients were doing as a group in terms of HbA_1c levels and other tests, such as blood pressure and cholesterol. Feedback sessions were scripted and included some questions to help the nurses become active learners.

At the end of the 2 years, the average HbA_1c had dropped to 7.24%, a significant difference. “In every case, after these report cards, the HbA_1c of [each nurse's patients] had come down,” showing that they were more likely to intensify treatment if they were given feedback. The comments from the nurses were also positive, she added.

In addition to receiving feedback, physicians and other providers can take several steps to improve their care of diabetes patients, according to Dr. Barnes. “One thing you can do is [post] reminders of high values,” she said. “You can also give those numbers to patients, so the patient can become empowered to say, 'My A_1c is 8.5; what can we do about this?'”

WASHINGTON — Physicians and other health care providers who take care of diabetes patients can easily suffer from “clinical inertia,” but performance feedback might help improve their performance, according to one diabetes expert.

Clinical inertia is defined as “failure to institute or change therapy appropriately when more intensive management is indicated,” Catherine Barnes, Ph.D., said at the annual meeting of the American Association of Diabetes Educators.

This problem is usually not caused by unfamiliarity with practice guidelines or inadequate time for care, she noted. Instead, it usually occurs when providers use “soft” reasons to avoid intensifying therapy. For example, they tell the patient to “try the diet a little longer,” or they say that a particular study's results don't apply to their own patients. Such providers also usually don't have systems to encourage them to step up therapy, such as flow sheets or “stepped” care protocols, said Dr. Barnes, who is with the Grady Diabetes Clinic in Atlanta.

Both patients and providers are trained not to be really aggressive with diabetes therapy, she said. “Patients don't change their diet because they're used to high-fat [food], or because they say they can't afford sugar-free items,” said Dr. Barnes. “Socially, they complain about lack of family support. … Or they have trouble looking at food labels and at food exchanges.”

On the caregiver side, one likely cause of inertia is that the providers have no way of knowing how their patients are doing as a group. So the clinic conducted a study to see if giving feedback to providers would result in lower HbA_1c readings for patients. Because the Grady clinic is run by nurses, who provide most of the care, the researchers focused on six nurses who saw a total of 1,171 patients over a 2-year period.

The patients had a mean age of 61; 64% were female, and 94% were black. The mean body mass index was 33.9, average diabetes duration was 12 years, and average HbA_1c was 7.35%. A total of 7% of patients were being treated with diet alone; 33% were on oral medications alone or a combination of oral medications and diet therapy; 47% were on insulin alone, and 13% were on insulin plus diet therapy.

The first year of the study served as a comparison period; no feedback was given. By the end of the first year, the patients' average HbA_1c rose slightly to 7.36%, an insignificant difference.

Starting in the second year, the nurses had 5-minute feedback sessions with a diabetes specialist every 3 weeks. The specialists told the nurses how their particular patients were doing as a group in terms of HbA_1c levels and other tests, such as blood pressure and cholesterol. Feedback sessions were scripted and included some questions to help the nurses become active learners.

At the end of the 2 years, the average HbA_1c had dropped to 7.24%, a significant difference. “In every case, after these report cards, the HbA_1c of [each nurse's patients] had come down,” showing that they were more likely to intensify treatment if they were given feedback. The comments from the nurses were also positive, she added.

In addition to receiving feedback, physicians and other providers can take several steps to improve their care of diabetes patients, according to Dr. Barnes. “One thing you can do is [post] reminders of high values,” she said. “You can also give those numbers to patients, so the patient can become empowered to say, 'My A_1c is 8.5; what can we do about this?'”

PHILADELPHIA — The Food and Drug Administration needs to change the way it regulates promotion of off-label drug use, according to the chair of the department of health policy and public health at the University of the Sciences in Philadelphia.

This year, the FDA issued draft guidance regarding off-label promotion. The draft guidance states that although any materials promoting off-label use must be peer reviewed, approval by the agency is not required, and the pharmaceutical company does not need to prove its intent to submit a new drug application for the off-label use, Robert I. Field, J.D., Ph.D., said at a meeting of the American Society of Law, Medicine, and Ethics. “This is considered to be a significant loosening of the requirements, certainly of the FDA's enforcement attitude.”

However, the company must clearly disclose that the suggested use is off-label, and any published negative findings regarding the off-label use must be included in the materials. “The problem is, negative findings don't get published very often, so there's probably not going to be a whole lot of that,” he added.

The comment period on the FDA's draft guidance ended several months ago; final guidance has yet to be issued. But there are certainly reasonable arguments for promoting off-label use under certain circumstances, according to Dr. Field.

Medicine only advances when information is shared, “and there are good reasons to allow off-label uses and therefore to allow physicians to know about those off-label uses,” he said. “On the other hand, it is clear that lack of oversight will lead to overzealous, aggressive promotion of uses that have limited, if any, scientific substantiation. The big question [is whether the] average physician who's working 80 hours a week [is] really going to be able to evaluate this information, even if it has a disclosure written at the top.”

Although the ultimate goal should be to get approval for an off-label use, pharmaceutical companies don't have many good reasons to do so, Dr. Field noted. “The problem is that clinical trials take a lot of time and the FDA is an overburdened agency; its reviews are slow.”

Off-label use is abundant and has increased over the last 3 decades, Dr. Field said.

Before 1997, the FDA opposed all off-label promotion. The agency allowed limited distribution of peer-reviewed articles in direct response to physician requests.

In 1997, Congress passed the Food and Drug Administration Modernization Act, which allowed pharmaceutical companies to initiate distribution of articles promoting off-label use if they came from a legitimate peer-reviewed source, such as a journal or book chapter. Also, companies could sponsor continuing medical education if it was done through a third-party operation.

But there were restrictions on these uses—the material to be distributed first had to be given to the FDA for approval, and the company had to intend to submit a new drug application for the off-label use.

In 1998, the Washington Legal Foundation sued the FDA, arguing that the restrictions on article distribution were unconstitutional under the First Amendment. The court said the agency could limit article distribution but could not require prior submission of the materials for FDA approval or require that the company intend to submit a new drug application. A similar lawsuit in 1999 produced the same result.

These rulings “left questions as to what would and wouldn't be allowed” under the act, Dr. Field said.

Other challenges to off-label promotion rules were not as successful. In 2004, Pfizer Inc. was fined $430 million for paying physicians to promote the off-label use of gabapentin (Neurontin) with little evidence of benefit. And a psychiatrist was arrested in 2006 for accepting $100,000 to promote off-label uses for Jazz Pharmaceutical Inc.'s sodium oxybate (Xyrem).

PHILADELPHIA — The Food and Drug Administration needs to change the way it regulates promotion of off-label drug use, according to the chair of the department of health policy and public health at the University of the Sciences in Philadelphia.

This year, the FDA issued draft guidance regarding off-label promotion. The draft guidance states that although any materials promoting off-label use must be peer reviewed, approval by the agency is not required, and the pharmaceutical company does not need to prove its intent to submit a new drug application for the off-label use, Robert I. Field, J.D., Ph.D., said at a meeting of the American Society of Law, Medicine, and Ethics. “This is considered to be a significant loosening of the requirements, certainly of the FDA's enforcement attitude.”

However, the company must clearly disclose that the suggested use is off-label, and any published negative findings regarding the off-label use must be included in the materials. “The problem is, negative findings don't get published very often, so there's probably not going to be a whole lot of that,” he added.

The comment period on the FDA's draft guidance ended several months ago; final guidance has yet to be issued. But there are certainly reasonable arguments for promoting off-label use under certain circumstances, according to Dr. Field.

Medicine only advances when information is shared, “and there are good reasons to allow off-label uses and therefore to allow physicians to know about those off-label uses,” he said. “On the other hand, it is clear that lack of oversight will lead to overzealous, aggressive promotion of uses that have limited, if any, scientific substantiation. The big question [is whether the] average physician who's working 80 hours a week [is] really going to be able to evaluate this information, even if it has a disclosure written at the top.”

Although the ultimate goal should be to get approval for an off-label use, pharmaceutical companies don't have many good reasons to do so, Dr. Field noted. “The problem is that clinical trials take a lot of time and the FDA is an overburdened agency; its reviews are slow.”

Off-label use is abundant and has increased over the last 3 decades, Dr. Field said.

Before 1997, the FDA opposed all off-label promotion. The agency allowed limited distribution of peer-reviewed articles in direct response to physician requests.

In 1997, Congress passed the Food and Drug Administration Modernization Act, which allowed pharmaceutical companies to initiate distribution of articles promoting off-label use if they came from a legitimate peer-reviewed source, such as a journal or book chapter. Also, companies could sponsor continuing medical education if it was done through a third-party operation.

But there were restrictions on these uses—the material to be distributed first had to be given to the FDA for approval, and the company had to intend to submit a new drug application for the off-label use.

In 1998, the Washington Legal Foundation sued the FDA, arguing that the restrictions on article distribution were unconstitutional under the First Amendment. The court said the agency could limit article distribution but could not require prior submission of the materials for FDA approval or require that the company intend to submit a new drug application. A similar lawsuit in 1999 produced the same result.

These rulings “left questions as to what would and wouldn't be allowed” under the act, Dr. Field said.

Other challenges to off-label promotion rules were not as successful. In 2004, Pfizer Inc. was fined $430 million for paying physicians to promote the off-label use of gabapentin (Neurontin) with little evidence of benefit. And a psychiatrist was arrested in 2006 for accepting $100,000 to promote off-label uses for Jazz Pharmaceutical Inc.'s sodium oxybate (Xyrem).

PHILADELPHIA — The Food and Drug Administration needs to change the way it regulates promotion of off-label drug use, according to the chair of the department of health policy and public health at the University of the Sciences in Philadelphia.

This year, the FDA issued draft guidance regarding off-label promotion. The draft guidance states that although any materials promoting off-label use must be peer reviewed, approval by the agency is not required, and the pharmaceutical company does not need to prove its intent to submit a new drug application for the off-label use, Robert I. Field, J.D., Ph.D., said at a meeting of the American Society of Law, Medicine, and Ethics. “This is considered to be a significant loosening of the requirements, certainly of the FDA's enforcement attitude.”

However, the company must clearly disclose that the suggested use is off-label, and any published negative findings regarding the off-label use must be included in the materials. “The problem is, negative findings don't get published very often, so there's probably not going to be a whole lot of that,” he added.

The comment period on the FDA's draft guidance ended several months ago; final guidance has yet to be issued. But there are certainly reasonable arguments for promoting off-label use under certain circumstances, according to Dr. Field.

Medicine only advances when information is shared, “and there are good reasons to allow off-label uses and therefore to allow physicians to know about those off-label uses,” he said. “On the other hand, it is clear that lack of oversight will lead to overzealous, aggressive promotion of uses that have limited, if any, scientific substantiation. The big question [is whether the] average physician who's working 80 hours a week [is] really going to be able to evaluate this information, even if it has a disclosure written at the top.”

Although the ultimate goal should be to get approval for an off-label use, pharmaceutical companies don't have many good reasons to do so, Dr. Field noted. “The problem is that clinical trials take a lot of time and the FDA is an overburdened agency; its reviews are slow.”

Off-label use is abundant and has increased over the last 3 decades, Dr. Field said.

Before 1997, the FDA opposed all off-label promotion. The agency allowed limited distribution of peer-reviewed articles in direct response to physician requests.

In 1997, Congress passed the Food and Drug Administration Modernization Act, which allowed pharmaceutical companies to initiate distribution of articles promoting off-label use if they came from a legitimate peer-reviewed source, such as a journal or book chapter. Also, companies could sponsor continuing medical education if it was done through a third-party operation.

But there were restrictions on these uses—the material to be distributed first had to be given to the FDA for approval, and the company had to intend to submit a new drug application for the off-label use.

In 1998, the Washington Legal Foundation sued the FDA, arguing that the restrictions on article distribution were unconstitutional under the First Amendment. The court said the agency could limit article distribution but could not require prior submission of the materials for FDA approval or require that the company intend to submit a new drug application. A similar lawsuit in 1999 produced the same result.

These rulings “left questions as to what would and wouldn't be allowed” under the act, Dr. Field said.

Other challenges to off-label promotion rules were not as successful. In 2004, Pfizer Inc. was fined $430 million for paying physicians to promote the off-label use of gabapentin (Neurontin) with little evidence of benefit. And a psychiatrist was arrested in 2006 for accepting $100,000 to promote off-label uses for Jazz Pharmaceutical Inc.'s sodium oxybate (Xyrem).

PHILADELPHIA — The Food and Drug Administration needs to change the way it regulates promotion of off-label drug use, according to the chair of the department of health policy and public health at the University of the Sciences in Philadelphia.

This year, the FDA issued draft guidance regarding off-label promotion. The draft guidance states that although any materials promoting off-label use must be peer reviewed, approval by the agency is not required, and the pharmaceutical company does not need to prove its intent to submit a new drug application for the off-label use, Robert I. Field, J.D., Ph.D., said at a meeting of the American Society of Law, Medicine, and Ethics. “This is considered to be a significant loosening of the requirements, certainly of the FDA's enforcement attitude.”

However, the company must clearly disclose that the suggested use is off-label, and any published negative findings regarding the off-label use must be included in the materials. “The problem is, negative findings don't get published very often, so there's probably not going to be a whole lot of that,” he added.

The comment period on the FDA's draft guidance ended several months ago; final guidance has yet to be issued. But there are certainly reasonable arguments for promoting off-label use under certain circumstances, according to Dr. Field.

Medicine only advances when information is shared, “and there are good reasons to allow off-label uses and therefore to allow physicians to know about those off-label uses,” he said. “On the other hand, it is clear that lack of oversight will lead to overzealous, aggressive promotion of uses that have limited, if any, scientific substantiation. The big question [is whether the] average physician, who's working 80 hours a week [is] really going to be able to evaluate this information, even if it has a disclosure written at the top?”

Although the ultimate goal should be to get approval for an off-label use, pharmaceutical companies don't have many good reasons to do so, Dr. Field noted. “The problem is that clinical trials take a lot of time and the FDA is an overburdened agency; its reviews are slow.”

Off-label use is abundant and has grown over the last 3 decades, Dr. Field said.

Before 1997, the FDA opposed all off-label promotion. The agency allowed limited distribution of peer-reviewed articles in direct response to physician requests.

In 1997, Congress passed the Food and Drug Administration Modernization Act, which allowed pharmaceutical companies to initiate distribution of articles promoting off-label use if they came from a legitimate peer-reviewed source, such as a journal or book chapter, and they could sponsor continuing medical education if it was done through a third-party operation.

But there were restrictions on these uses—the material to be distributed first had to be given to the FDA for approval, and the company had to intend to submit a new drug application for the off-label use.

In 1998, the Washington Legal Foundation sued the FDA, arguing that the restrictions on article distribution were unconstitutional under the First Amendment. The court said the agency could limit article distribution but could not require prior submission of the materials for FDA approval or require that the company intend to submit a new drug application. A similar lawsuit in 1999 produced the same result.

These rulings “left questions as to what would and wouldn't be allowed” under the act, Dr. Field said. Other challenges to off-label promotion rules were not as successful. In 2004, Pfizer Inc. was fined $430 million for paying physicians to promote the off-label use of gabapentin (Neurontin) with little evidence of benefit. And a psychiatrist was arrested in 2006 for accepting $100,000 to promote off-label uses for Jazz Pharmaceutical Inc.'s sodium oxybate (Xyrem).

PHILADELPHIA — The Food and Drug Administration needs to change the way it regulates promotion of off-label drug use, according to the chair of the department of health policy and public health at the University of the Sciences in Philadelphia.

This year, the FDA issued draft guidance regarding off-label promotion. The draft guidance states that although any materials promoting off-label use must be peer reviewed, approval by the agency is not required, and the pharmaceutical company does not need to prove its intent to submit a new drug application for the off-label use, Robert I. Field, J.D., Ph.D., said at a meeting of the American Society of Law, Medicine, and Ethics. “This is considered to be a significant loosening of the requirements, certainly of the FDA's enforcement attitude.”

However, the company must clearly disclose that the suggested use is off-label, and any published negative findings regarding the off-label use must be included in the materials. “The problem is, negative findings don't get published very often, so there's probably not going to be a whole lot of that,” he added.

The comment period on the FDA's draft guidance ended several months ago; final guidance has yet to be issued. But there are certainly reasonable arguments for promoting off-label use under certain circumstances, according to Dr. Field.

Medicine only advances when information is shared, “and there are good reasons to allow off-label uses and therefore to allow physicians to know about those off-label uses,” he said. “On the other hand, it is clear that lack of oversight will lead to overzealous, aggressive promotion of uses that have limited, if any, scientific substantiation. The big question [is whether the] average physician, who's working 80 hours a week [is] really going to be able to evaluate this information, even if it has a disclosure written at the top?”

Although the ultimate goal should be to get approval for an off-label use, pharmaceutical companies don't have many good reasons to do so, Dr. Field noted. “The problem is that clinical trials take a lot of time and the FDA is an overburdened agency; its reviews are slow.”

Off-label use is abundant and has grown over the last 3 decades, Dr. Field said.

Before 1997, the FDA opposed all off-label promotion. The agency allowed limited distribution of peer-reviewed articles in direct response to physician requests.

In 1997, Congress passed the Food and Drug Administration Modernization Act, which allowed pharmaceutical companies to initiate distribution of articles promoting off-label use if they came from a legitimate peer-reviewed source, such as a journal or book chapter, and they could sponsor continuing medical education if it was done through a third-party operation.

But there were restrictions on these uses—the material to be distributed first had to be given to the FDA for approval, and the company had to intend to submit a new drug application for the off-label use.

In 1998, the Washington Legal Foundation sued the FDA, arguing that the restrictions on article distribution were unconstitutional under the First Amendment. The court said the agency could limit article distribution but could not require prior submission of the materials for FDA approval or require that the company intend to submit a new drug application. A similar lawsuit in 1999 produced the same result.

These rulings “left questions as to what would and wouldn't be allowed” under the act, Dr. Field said. Other challenges to off-label promotion rules were not as successful. In 2004, Pfizer Inc. was fined $430 million for paying physicians to promote the off-label use of gabapentin (Neurontin) with little evidence of benefit. And a psychiatrist was arrested in 2006 for accepting $100,000 to promote off-label uses for Jazz Pharmaceutical Inc.'s sodium oxybate (Xyrem).

PHILADELPHIA — The Food and Drug Administration needs to change the way it regulates promotion of off-label drug use, according to the chair of the department of health policy and public health at the University of the Sciences in Philadelphia.

This year, the FDA issued draft guidance regarding off-label promotion. The draft guidance states that although any materials promoting off-label use must be peer reviewed, approval by the agency is not required, and the pharmaceutical company does not need to prove its intent to submit a new drug application for the off-label use, Robert I. Field, J.D., Ph.D., said at a meeting of the American Society of Law, Medicine, and Ethics. “This is considered to be a significant loosening of the requirements, certainly of the FDA's enforcement attitude.”

However, the company must clearly disclose that the suggested use is off-label, and any published negative findings regarding the off-label use must be included in the materials. “The problem is, negative findings don't get published very often, so there's probably not going to be a whole lot of that,” he added.

The comment period on the FDA's draft guidance ended several months ago; final guidance has yet to be issued. But there are certainly reasonable arguments for promoting off-label use under certain circumstances, according to Dr. Field.

Medicine only advances when information is shared, “and there are good reasons to allow off-label uses and therefore to allow physicians to know about those off-label uses,” he said. “On the other hand, it is clear that lack of oversight will lead to overzealous, aggressive promotion of uses that have limited, if any, scientific substantiation. The big question [is whether the] average physician, who's working 80 hours a week [is] really going to be able to evaluate this information, even if it has a disclosure written at the top?”

Although the ultimate goal should be to get approval for an off-label use, pharmaceutical companies don't have many good reasons to do so, Dr. Field noted. “The problem is that clinical trials take a lot of time and the FDA is an overburdened agency; its reviews are slow.”

Off-label use is abundant and has grown over the last 3 decades, Dr. Field said.

Before 1997, the FDA opposed all off-label promotion. The agency allowed limited distribution of peer-reviewed articles in direct response to physician requests.

In 1997, Congress passed the Food and Drug Administration Modernization Act, which allowed pharmaceutical companies to initiate distribution of articles promoting off-label use if they came from a legitimate peer-reviewed source, such as a journal or book chapter, and they could sponsor continuing medical education if it was done through a third-party operation.

But there were restrictions on these uses—the material to be distributed first had to be given to the FDA for approval, and the company had to intend to submit a new drug application for the off-label use.

In 1998, the Washington Legal Foundation sued the FDA, arguing that the restrictions on article distribution were unconstitutional under the First Amendment. The court said the agency could limit article distribution but could not require prior submission of the materials for FDA approval or require that the company intend to submit a new drug application. A similar lawsuit in 1999 produced the same result.

These rulings “left questions as to what would and wouldn't be allowed” under the act, Dr. Field said. Other challenges to off-label promotion rules were not as successful. In 2004, Pfizer Inc. was fined $430 million for paying physicians to promote the off-label use of gabapentin (Neurontin) with little evidence of benefit. And a psychiatrist was arrested in 2006 for accepting $100,000 to promote off-label uses for Jazz Pharmaceutical Inc.'s sodium oxybate (Xyrem).

P4P Working, Says CMS

Providers that participated in a Medicare pay-for-performance demonstration program earned $16.7 million in incentive payments during the program's second year by improving the quality of care for patients with several chronic conditions, including heart failure, coronary artery disease, and diabetes, according to the Centers for Medicare and Medicaid Services. All 10 of the participating physician groups achieved benchmark or target performance on at least 25 out of 27 quality markers for patients with diabetes, coronary artery disease and heart failure. Five of the groups achieved benchmark quality performance on all 27 quality measures. The groups improved their performance by changing some of their office processes and investing in health information technology. “We are paying for better outcomes and we are getting higher quality and more value for the Medicare dollar,” said Kerry Weems, CMS acting administrator. “And these results show that by working in collaboration with the physician groups on new and innovative ways to reimburse for high quality care, we are on the right track to find a better way to pay physicians.” The demonstration project was originally scheduled to last 3 years but has since been extended to a fourth year.

Obesity as Dem. Platform Plank

The drafters of the Democratic Party Platform have included a section on obesity, marking what appears to be the first time the disorder has been mentioned in any national party platform. The document, which was approved by the full platform committee in early August, reads in part, “Our nation faces epidemics of obesity and chronic diseases as well as new threats like pandemic flu and bioterrorism. Yet despite all of this, less than 4 cents of every health care dollar is spent on prevention and public health. … We will ensure that Americans can benefit from healthy environments that allow them to pursue healthy choices. Additionally, as childhood obesity rates have more than doubled in the last 30 years, we will work to ensure healthy environments in our schools.” Gary Foster, Ph.D., president of the Obesity Society, applauded the action. “We are pleased to see a major political party recognize the importance of obesity to the health of Americans and to the health care system overall,” he said.

Feds Scrutinize Generic Maker

India's Ranbaxy Inc., 1 of the top 10 generic drug makers in the world, is being investigated by various arms of the federal government for allegedly introducing “adulterated or misbranded products” into the U.S. market. The company's auditor, Parexel Consulting, is also under scrutiny. According to a subpoena for documents filed in the U.S. District Court for the District of Maryland by the federal Department of Justice and the U.S. Attorney's Office in Maryland, Ranbaxy submitted false information to the Food and Drug Administration on sterility and bioequivalence, covered up violations of good manufacturing practice, and defrauded Medicare. Rep. John Dingell (D-Mich.) and Rep. Bart Stupak (D-Mich.) said that they will formally investigate the Ranbaxy situation. “If these allegations are true, Ranbaxy has imperiled the safety of Americans in a manner similar to the generic drug scandal we uncovered 20 years ago,” said Rep. Dingell. “I would like to know whether FDA officials knew about these allegations and what, if any, action was taken.”

Patients Cutting Health Care

To save money, many Americans are reducing the amount of medical care they receive, according to a survey of nearly 700 people by the National Association of Insurance Commissioners. Twenty-two percent of respondents to the July survey said they have reduced the number of times they see the doctor. In addition, 11% said they have cut back the number of prescription drugs they take, or reduced the dosage to make the prescription last longer. “Delaying medical treatment and regular physicals puts consumers at risk for potential health issues, and increases overall health insurance costs,” said Kansas Insurance Commissioner Sandy Praeger, president of the NAIC. The vast majority of respondents did not change their health insurance policies; of the 5% who did make changes, 2% reduced coverage, 1% fell behind on payments, and 2% canceled their policies.

Specialists' Incomes Vary Widely

Incomes vary widely among the four medical specialties—geriatrics, hematology-oncology, nephrology, and rheumatology—that derive more than half of their revenues from government-run health insurance programs, a study showed. For example, geriatricians' incomes averaged $165,000 annually, versus $504,000 for hematologists, even though the two specialties require a similar amount of training, according to the study by Harvard Medical School researchers at Cambridge (Mass.) Health Alliance, published online in the Journal of General Internal Medicine. The study analyzes data from the national Medical Expenditure Panel Survey. The income disparity fuels the shortage of primary care physicians, said Dr. Karen Lasser, the study's lead author. “It's no surprise that there is a shortage of primary care doctors when debt-burdened medical students have much more lucrative career options,” Dr. Lasser said in a statement. “What is surprising is that government fee schedules are behind much of this income discrepancy.” In total, Medicare accounts for about 21% of payments to doctors, whereas Medicaid and other government programs account for 10%, according to the study.

P4P Working, Says CMS

Providers that participated in a Medicare pay-for-performance demonstration program earned $16.7 million in incentive payments during the program's second year by improving the quality of care for patients with several chronic conditions, including heart failure, coronary artery disease, and diabetes, according to the Centers for Medicare and Medicaid Services. All 10 of the participating physician groups achieved benchmark or target performance on at least 25 out of 27 quality markers for patients with diabetes, coronary artery disease and heart failure. Five of the groups achieved benchmark quality performance on all 27 quality measures. The groups improved their performance by changing some of their office processes and investing in health information technology. “We are paying for better outcomes and we are getting higher quality and more value for the Medicare dollar,” said Kerry Weems, CMS acting administrator. “And these results show that by working in collaboration with the physician groups on new and innovative ways to reimburse for high quality care, we are on the right track to find a better way to pay physicians.” The demonstration project was originally scheduled to last 3 years but has since been extended to a fourth year.

Obesity as Dem. Platform Plank

The drafters of the Democratic Party Platform have included a section on obesity, marking what appears to be the first time the disorder has been mentioned in any national party platform. The document, which was approved by the full platform committee in early August, reads in part, “Our nation faces epidemics of obesity and chronic diseases as well as new threats like pandemic flu and bioterrorism. Yet despite all of this, less than 4 cents of every health care dollar is spent on prevention and public health. … We will ensure that Americans can benefit from healthy environments that allow them to pursue healthy choices. Additionally, as childhood obesity rates have more than doubled in the last 30 years, we will work to ensure healthy environments in our schools.” Gary Foster, Ph.D., president of the Obesity Society, applauded the action. “We are pleased to see a major political party recognize the importance of obesity to the health of Americans and to the health care system overall,” he said.

Feds Scrutinize Generic Maker

India's Ranbaxy Inc., 1 of the top 10 generic drug makers in the world, is being investigated by various arms of the federal government for allegedly introducing “adulterated or misbranded products” into the U.S. market. The company's auditor, Parexel Consulting, is also under scrutiny. According to a subpoena for documents filed in the U.S. District Court for the District of Maryland by the federal Department of Justice and the U.S. Attorney's Office in Maryland, Ranbaxy submitted false information to the Food and Drug Administration on sterility and bioequivalence, covered up violations of good manufacturing practice, and defrauded Medicare. Rep. John Dingell (D-Mich.) and Rep. Bart Stupak (D-Mich.) said that they will formally investigate the Ranbaxy situation. “If these allegations are true, Ranbaxy has imperiled the safety of Americans in a manner similar to the generic drug scandal we uncovered 20 years ago,” said Rep. Dingell. “I would like to know whether FDA officials knew about these allegations and what, if any, action was taken.”

Patients Cutting Health Care

To save money, many Americans are reducing the amount of medical care they receive, according to a survey of nearly 700 people by the National Association of Insurance Commissioners. Twenty-two percent of respondents to the July survey said they have reduced the number of times they see the doctor. In addition, 11% said they have cut back the number of prescription drugs they take, or reduced the dosage to make the prescription last longer. “Delaying medical treatment and regular physicals puts consumers at risk for potential health issues, and increases overall health insurance costs,” said Kansas Insurance Commissioner Sandy Praeger, president of the NAIC. The vast majority of respondents did not change their health insurance policies; of the 5% who did make changes, 2% reduced coverage, 1% fell behind on payments, and 2% canceled their policies.

Specialists' Incomes Vary Widely

Incomes vary widely among the four medical specialties—geriatrics, hematology-oncology, nephrology, and rheumatology—that derive more than half of their revenues from government-run health insurance programs, a study showed. For example, geriatricians' incomes averaged $165,000 annually, versus $504,000 for hematologists, even though the two specialties require a similar amount of training, according to the study by Harvard Medical School researchers at Cambridge (Mass.) Health Alliance, published online in the Journal of General Internal Medicine. The study analyzes data from the national Medical Expenditure Panel Survey. The income disparity fuels the shortage of primary care physicians, said Dr. Karen Lasser, the study's lead author. “It's no surprise that there is a shortage of primary care doctors when debt-burdened medical students have much more lucrative career options,” Dr. Lasser said in a statement. “What is surprising is that government fee schedules are behind much of this income discrepancy.” In total, Medicare accounts for about 21% of payments to doctors, whereas Medicaid and other government programs account for 10%, according to the study.

P4P Working, Says CMS

Providers that participated in a Medicare pay-for-performance demonstration program earned $16.7 million in incentive payments during the program's second year by improving the quality of care for patients with several chronic conditions, including heart failure, coronary artery disease, and diabetes, according to the Centers for Medicare and Medicaid Services. All 10 of the participating physician groups achieved benchmark or target performance on at least 25 out of 27 quality markers for patients with diabetes, coronary artery disease and heart failure. Five of the groups achieved benchmark quality performance on all 27 quality measures. The groups improved their performance by changing some of their office processes and investing in health information technology. “We are paying for better outcomes and we are getting higher quality and more value for the Medicare dollar,” said Kerry Weems, CMS acting administrator. “And these results show that by working in collaboration with the physician groups on new and innovative ways to reimburse for high quality care, we are on the right track to find a better way to pay physicians.” The demonstration project was originally scheduled to last 3 years but has since been extended to a fourth year.

Obesity as Dem. Platform Plank

The drafters of the Democratic Party Platform have included a section on obesity, marking what appears to be the first time the disorder has been mentioned in any national party platform. The document, which was approved by the full platform committee in early August, reads in part, “Our nation faces epidemics of obesity and chronic diseases as well as new threats like pandemic flu and bioterrorism. Yet despite all of this, less than 4 cents of every health care dollar is spent on prevention and public health. … We will ensure that Americans can benefit from healthy environments that allow them to pursue healthy choices. Additionally, as childhood obesity rates have more than doubled in the last 30 years, we will work to ensure healthy environments in our schools.” Gary Foster, Ph.D., president of the Obesity Society, applauded the action. “We are pleased to see a major political party recognize the importance of obesity to the health of Americans and to the health care system overall,” he said.

Feds Scrutinize Generic Maker

India's Ranbaxy Inc., 1 of the top 10 generic drug makers in the world, is being investigated by various arms of the federal government for allegedly introducing “adulterated or misbranded products” into the U.S. market. The company's auditor, Parexel Consulting, is also under scrutiny. According to a subpoena for documents filed in the U.S. District Court for the District of Maryland by the federal Department of Justice and the U.S. Attorney's Office in Maryland, Ranbaxy submitted false information to the Food and Drug Administration on sterility and bioequivalence, covered up violations of good manufacturing practice, and defrauded Medicare. Rep. John Dingell (D-Mich.) and Rep. Bart Stupak (D-Mich.) said that they will formally investigate the Ranbaxy situation. “If these allegations are true, Ranbaxy has imperiled the safety of Americans in a manner similar to the generic drug scandal we uncovered 20 years ago,” said Rep. Dingell. “I would like to know whether FDA officials knew about these allegations and what, if any, action was taken.”

Patients Cutting Health Care

To save money, many Americans are reducing the amount of medical care they receive, according to a survey of nearly 700 people by the National Association of Insurance Commissioners. Twenty-two percent of respondents to the July survey said they have reduced the number of times they see the doctor. In addition, 11% said they have cut back the number of prescription drugs they take, or reduced the dosage to make the prescription last longer. “Delaying medical treatment and regular physicals puts consumers at risk for potential health issues, and increases overall health insurance costs,” said Kansas Insurance Commissioner Sandy Praeger, president of the NAIC. The vast majority of respondents did not change their health insurance policies; of the 5% who did make changes, 2% reduced coverage, 1% fell behind on payments, and 2% canceled their policies.

Specialists' Incomes Vary Widely

Incomes vary widely among the four medical specialties—geriatrics, hematology-oncology, nephrology, and rheumatology—that derive more than half of their revenues from government-run health insurance programs, a study showed. For example, geriatricians' incomes averaged $165,000 annually, versus $504,000 for hematologists, even though the two specialties require a similar amount of training, according to the study by Harvard Medical School researchers at Cambridge (Mass.) Health Alliance, published online in the Journal of General Internal Medicine. The study analyzes data from the national Medical Expenditure Panel Survey. The income disparity fuels the shortage of primary care physicians, said Dr. Karen Lasser, the study's lead author. “It's no surprise that there is a shortage of primary care doctors when debt-burdened medical students have much more lucrative career options,” Dr. Lasser said in a statement. “What is surprising is that government fee schedules are behind much of this income discrepancy.” In total, Medicare accounts for about 21% of payments to doctors, whereas Medicaid and other government programs account for 10%, according to the study.

WASHINGTON — “It's almost as if [health care providers] have a secret strategy for discouraging people” from monitoring their blood glucose levels, according to William Polonsky, Ph.D.

To help his colleagues avoid these negative behaviors, Dr. Polonsky, a certified diabetes educator and founder of San Diego's Behavioral Diabetes Institute, listed six surefire ways to dissuade diabetes patients from regularly testing their blood sugar:

▸ Be vague about your testing recommendations. Just tell patients to “check every day or so.”

▸ Ignore blood glucose logs. If patients bring in the results of their blood glucose tests, don't look at the results or comment on them.

▸ Don't explain anything. Don't let patients know how to understand and use their test results.

▸ Hide your own discomfort. If you don't know what the glucose test results mean, just say the results are “very complex.”

▸ Be controlling. Explain how patients can use their results to limit and control their lives. Be punitive if you can.

▸ Use the “red circle” approach. If you do look at their test results, look at them quickly and draw a red circle around the highest number you can find; then say, “What happened here?”

“If you practice this with your next 10 patients, I guarantee you that none of them will check their blood sugars any more,” Dr. Polonsky said at the annual meeting of the American Association of Diabetes Educators.

For those who want to encourage patients to test their glucose regularly, Dr. Polonsky suggested the following strategies:

▸ Make it meaningful. Make sure the blood glucose data answer their questions, such as how exercise affects their blood sugar or why they feel tired at certain times, he said. (See box.)

▸ Use the “Noah's Ark” principle. The idea is to perform blood glucose tests in “before and after” pairs so that patients can see how their actions affect their glucose readings. This is probably the most important concept, he said.

▸ Look at the patient's testing results. “I know we're all so busy, but I'm pretty sure this might help,” he said. “I hear so much about my colleagues saying, 'Just fax me your results,' and then no one ever gets back to [the patient] or the fax gets misplaced.”

▸ Congratulate people on the effort, not the numbers. “I'm not going to critique [the patient] on what that number is,” said Dr. Polonsky. Instead, “I'm going to say, 'Hey, you checked your blood sugar. This is great. Thanks.'”

▸ Find better ways to help patients understand the information. “Help people to see patterns, because for many of our patients, it's not so clear.”

▸ Watch for patients who base their self-esteem on their results. “We need to challenge them. We need to say over and over again, in a really kind way, 'Wait; there are no good or bad numbers. This is just information, and all of it is valuable.'” Dr. Polonsky's institute gives patients tiny stickers that go right under the window of any blood glucose meter that say, “Hey, remember, it's just a number.”

That doesn't mean that patients don't still need to be counseled generally on what to do about too-high or too-low glucose readings, he noted during his session, which was sponsored by Roche Diagnostics, maker of blood glucose monitors. “Instead of using the word 'bad,' I use the words 'safe' and 'unsafe,' as in, 'This number tells me you're not in a safe place.'”

Although many providers think that diabetes patients don't understand how serious their disease is, that's not actually a problem, said Dr. Polonsky. “Most of our patients understand it's a serious disease; the problem is many of our patients don't believe this is an urgent disease. [They think], 'I can deal with this later.' Using the words safe and unsafe is my way of trying to say, 'You're not safe right now, so this is urgent.'”

It's also a way of not sounding condescending, “as opposed to, 'You've been bad again, I see,'” he added.

▸ Find better ways to promote action from patients. “What we should be always practicing saying and asking our patients to think out loud, is, 'What, if anything, can I do about this?'” Dr. Polonsky said. “We want to help our patients get into that kind of thinking so that the immediate thought is not, 'I can't believe I messed up again,' but [instead], 'It's just a piece of information; what can I do about this?'”

'We need to say over and over again … “This is just information, and all of it is valuable.”' DR. POLONSKY

Using Data to Answer Patient Questions

Dr. Polonsky discussed several patients for whom he designed “home experiments” using blood glucose monitoring to answer their diabetes questions.

One patient who previously hadn't been motivated to exercise wanted to know whether exercise affected his blood sugar, so Dr. Polonsky asked him to walk for 30 minutes each day for 1 week, and measure his blood sugar before and after the walk.

The patient's blood glucose level fell by an average of 34 mg/dL after walking. “But the kicker was, [the patient] showed up in my office with [the log] and said, 'I've discovered something that will shock you,'” Dr. Polonsky explained. “I said, 'What is it?' and he said, 'Look, exercise lowers blood sugar.'

“I said, 'We've been talking about this for a year! You sat through that diabetes education program twice, remember?' He said, 'Yeah, but I'm not kidding. I mean, it really works.'”

Because the patient “figured out that exercise was of value, he got excited about it. … And he wasn't just interested in exercise, he got interested in blood glucose monitoring because he realized it [helped him] learn something useful,” Dr. Polonsky said.

Another patient was curious about how breakfast affected her blood sugar. Dr. Polonsky asked her to perform a similar 1-week experiment in which she wrote down her blood sugar results right before and 2 hours after breakfast. Her average increase was 34 mg/dL. “I said, 'Whatever you're doing, generally speaking, looks like it's working. Congratulations!' And for [her], that was very exciting. Patients desperately need a sense of positive treatment efficacy. … It helps them become activated, engaged, and interested in doing more.”

WASHINGTON — “It's almost as if [health care providers] have a secret strategy for discouraging people” from monitoring their blood glucose levels, according to William Polonsky, Ph.D.

To help his colleagues avoid these negative behaviors, Dr. Polonsky, a certified diabetes educator and founder of San Diego's Behavioral Diabetes Institute, listed six surefire ways to dissuade diabetes patients from regularly testing their blood sugar:

▸ Be vague about your testing recommendations. Just tell patients to “check every day or so.”

▸ Ignore blood glucose logs. If patients bring in the results of their blood glucose tests, don't look at the results or comment on them.

▸ Don't explain anything. Don't let patients know how to understand and use their test results.

▸ Hide your own discomfort. If you don't know what the glucose test results mean, just say the results are “very complex.”

▸ Be controlling. Explain how patients can use their results to limit and control their lives. Be punitive if you can.

▸ Use the “red circle” approach. If you do look at their test results, look at them quickly and draw a red circle around the highest number you can find; then say, “What happened here?”

“If you practice this with your next 10 patients, I guarantee you that none of them will check their blood sugars any more,” Dr. Polonsky said at the annual meeting of the American Association of Diabetes Educators.

For those who want to encourage patients to test their glucose regularly, Dr. Polonsky suggested the following strategies:

▸ Make it meaningful. Make sure the blood glucose data answer their questions, such as how exercise affects their blood sugar or why they feel tired at certain times, he said. (See box.)

▸ Use the “Noah's Ark” principle. The idea is to perform blood glucose tests in “before and after” pairs so that patients can see how their actions affect their glucose readings. This is probably the most important concept, he said.

▸ Look at the patient's testing results. “I know we're all so busy, but I'm pretty sure this might help,” he said. “I hear so much about my colleagues saying, 'Just fax me your results,' and then no one ever gets back to [the patient] or the fax gets misplaced.”

▸ Congratulate people on the effort, not the numbers. “I'm not going to critique [the patient] on what that number is,” said Dr. Polonsky. Instead, “I'm going to say, 'Hey, you checked your blood sugar. This is great. Thanks.'”

▸ Find better ways to help patients understand the information. “Help people to see patterns, because for many of our patients, it's not so clear.”

▸ Watch for patients who base their self-esteem on their results. “We need to challenge them. We need to say over and over again, in a really kind way, 'Wait; there are no good or bad numbers. This is just information, and all of it is valuable.'” Dr. Polonsky's institute gives patients tiny stickers that go right under the window of any blood glucose meter that say, “Hey, remember, it's just a number.”

That doesn't mean that patients don't still need to be counseled generally on what to do about too-high or too-low glucose readings, he noted during his session, which was sponsored by Roche Diagnostics, maker of blood glucose monitors. “Instead of using the word 'bad,' I use the words 'safe' and 'unsafe,' as in, 'This number tells me you're not in a safe place.'”

Although many providers think that diabetes patients don't understand how serious their disease is, that's not actually a problem, said Dr. Polonsky. “Most of our patients understand it's a serious disease; the problem is many of our patients don't believe this is an urgent disease. [They think], 'I can deal with this later.' Using the words safe and unsafe is my way of trying to say, 'You're not safe right now, so this is urgent.'”

It's also a way of not sounding condescending, “as opposed to, 'You've been bad again, I see,'” he added.

▸ Find better ways to promote action from patients. “What we should be always practicing saying and asking our patients to think out loud, is, 'What, if anything, can I do about this?'” Dr. Polonsky said. “We want to help our patients get into that kind of thinking so that the immediate thought is not, 'I can't believe I messed up again,' but [instead], 'It's just a piece of information; what can I do about this?'”

'We need to say over and over again … “This is just information, and all of it is valuable.”' DR. POLONSKY

Using Data to Answer Patient Questions

Dr. Polonsky discussed several patients for whom he designed “home experiments” using blood glucose monitoring to answer their diabetes questions.

One patient who previously hadn't been motivated to exercise wanted to know whether exercise affected his blood sugar, so Dr. Polonsky asked him to walk for 30 minutes each day for 1 week, and measure his blood sugar before and after the walk.

The patient's blood glucose level fell by an average of 34 mg/dL after walking. “But the kicker was, [the patient] showed up in my office with [the log] and said, 'I've discovered something that will shock you,'” Dr. Polonsky explained. “I said, 'What is it?' and he said, 'Look, exercise lowers blood sugar.'

“I said, 'We've been talking about this for a year! You sat through that diabetes education program twice, remember?' He said, 'Yeah, but I'm not kidding. I mean, it really works.'”

Because the patient “figured out that exercise was of value, he got excited about it. … And he wasn't just interested in exercise, he got interested in blood glucose monitoring because he realized it [helped him] learn something useful,” Dr. Polonsky said.

Another patient was curious about how breakfast affected her blood sugar. Dr. Polonsky asked her to perform a similar 1-week experiment in which she wrote down her blood sugar results right before and 2 hours after breakfast. Her average increase was 34 mg/dL. “I said, 'Whatever you're doing, generally speaking, looks like it's working. Congratulations!' And for [her], that was very exciting. Patients desperately need a sense of positive treatment efficacy. … It helps them become activated, engaged, and interested in doing more.”

WASHINGTON — “It's almost as if [health care providers] have a secret strategy for discouraging people” from monitoring their blood glucose levels, according to William Polonsky, Ph.D.

To help his colleagues avoid these negative behaviors, Dr. Polonsky, a certified diabetes educator and founder of San Diego's Behavioral Diabetes Institute, listed six surefire ways to dissuade diabetes patients from regularly testing their blood sugar:

▸ Be vague about your testing recommendations. Just tell patients to “check every day or so.”

▸ Ignore blood glucose logs. If patients bring in the results of their blood glucose tests, don't look at the results or comment on them.

▸ Don't explain anything. Don't let patients know how to understand and use their test results.

▸ Hide your own discomfort. If you don't know what the glucose test results mean, just say the results are “very complex.”

▸ Be controlling. Explain how patients can use their results to limit and control their lives. Be punitive if you can.

▸ Use the “red circle” approach. If you do look at their test results, look at them quickly and draw a red circle around the highest number you can find; then say, “What happened here?”

“If you practice this with your next 10 patients, I guarantee you that none of them will check their blood sugars any more,” Dr. Polonsky said at the annual meeting of the American Association of Diabetes Educators.

For those who want to encourage patients to test their glucose regularly, Dr. Polonsky suggested the following strategies:

▸ Make it meaningful. Make sure the blood glucose data answer their questions, such as how exercise affects their blood sugar or why they feel tired at certain times, he said. (See box.)

▸ Use the “Noah's Ark” principle. The idea is to perform blood glucose tests in “before and after” pairs so that patients can see how their actions affect their glucose readings. This is probably the most important concept, he said.

▸ Look at the patient's testing results. “I know we're all so busy, but I'm pretty sure this might help,” he said. “I hear so much about my colleagues saying, 'Just fax me your results,' and then no one ever gets back to [the patient] or the fax gets misplaced.”

▸ Congratulate people on the effort, not the numbers. “I'm not going to critique [the patient] on what that number is,” said Dr. Polonsky. Instead, “I'm going to say, 'Hey, you checked your blood sugar. This is great. Thanks.'”

▸ Find better ways to help patients understand the information. “Help people to see patterns, because for many of our patients, it's not so clear.”

▸ Watch for patients who base their self-esteem on their results. “We need to challenge them. We need to say over and over again, in a really kind way, 'Wait; there are no good or bad numbers. This is just information, and all of it is valuable.'” Dr. Polonsky's institute gives patients tiny stickers that go right under the window of any blood glucose meter that say, “Hey, remember, it's just a number.”

That doesn't mean that patients don't still need to be counseled generally on what to do about too-high or too-low glucose readings, he noted during his session, which was sponsored by Roche Diagnostics, maker of blood glucose monitors. “Instead of using the word 'bad,' I use the words 'safe' and 'unsafe,' as in, 'This number tells me you're not in a safe place.'”

Although many providers think that diabetes patients don't understand how serious their disease is, that's not actually a problem, said Dr. Polonsky. “Most of our patients understand it's a serious disease; the problem is many of our patients don't believe this is an urgent disease. [They think], 'I can deal with this later.' Using the words safe and unsafe is my way of trying to say, 'You're not safe right now, so this is urgent.'”

It's also a way of not sounding condescending, “as opposed to, 'You've been bad again, I see,'” he added.

▸ Find better ways to promote action from patients. “What we should be always practicing saying and asking our patients to think out loud, is, 'What, if anything, can I do about this?'” Dr. Polonsky said. “We want to help our patients get into that kind of thinking so that the immediate thought is not, 'I can't believe I messed up again,' but [instead], 'It's just a piece of information; what can I do about this?'”

'We need to say over and over again … “This is just information, and all of it is valuable.”' DR. POLONSKY

Using Data to Answer Patient Questions

Dr. Polonsky discussed several patients for whom he designed “home experiments” using blood glucose monitoring to answer their diabetes questions.

One patient who previously hadn't been motivated to exercise wanted to know whether exercise affected his blood sugar, so Dr. Polonsky asked him to walk for 30 minutes each day for 1 week, and measure his blood sugar before and after the walk.

The patient's blood glucose level fell by an average of 34 mg/dL after walking. “But the kicker was, [the patient] showed up in my office with [the log] and said, 'I've discovered something that will shock you,'” Dr. Polonsky explained. “I said, 'What is it?' and he said, 'Look, exercise lowers blood sugar.'

“I said, 'We've been talking about this for a year! You sat through that diabetes education program twice, remember?' He said, 'Yeah, but I'm not kidding. I mean, it really works.'”

Because the patient “figured out that exercise was of value, he got excited about it. … And he wasn't just interested in exercise, he got interested in blood glucose monitoring because he realized it [helped him] learn something useful,” Dr. Polonsky said.

Another patient was curious about how breakfast affected her blood sugar. Dr. Polonsky asked her to perform a similar 1-week experiment in which she wrote down her blood sugar results right before and 2 hours after breakfast. Her average increase was 34 mg/dL. “I said, 'Whatever you're doing, generally speaking, looks like it's working. Congratulations!' And for [her], that was very exciting. Patients desperately need a sense of positive treatment efficacy. … It helps them become activated, engaged, and interested in doing more.”

ARLINGTON, VA. — International medical graduates have become an integral part of providing medical care in federally designated physician shortage areas, according to results from a recent study.

“Compared to U.S.-trained physicians, IMGs provide more primary care and more [overall] medical care to populations living in primary care shortage areas” as well as to minorities, immigrants, patients in poor areas, and Medicaid recipients, said Esther Hing of the National Center for Health Statistics, Hyattsville, Md. Ms. Hing and her colleague Susan Lin, Dr.P.H., studied 2005–2006 data from the National Ambulatory Medical Care Survey. The survey was nationally representative, and the data used by the researchers included information from 2,390 physicians in office-based practices. Surveyors performed a face-to-face interview and abstracted medical records for about 30 office visits. Ms. Hing presented the survey results at the 2008 Physician Workforce Research Conference.

The survey showed that IMGs make up 25% of office-based physicians. They tend to be a little older that U.S.-trained doctors, with an average age of 52 years, compared with 50 years for physicians trained in the United States. The racial and ethnic differences were more pronounced: 71% of U.S. medical graduates were non-Hispanic white vs. 26% of IMGs. Asian/Pacific Islanders made up 32% of IMGs, compared with 5% of U.S. medical graduates. Hispanic and Latino physicians accounted for 7% of IMGs, compared with 2% of U.S. graduates.

IMGs also practiced more often in counties that included primary care shortage areas than did U.S.-trained physicians—87% vs. 79%. And IMGs more often saw patients during evening and weekend hours than their U.S.-trained counterparts. IMGs were more likely to accept new patients and to accept Medicaid.

“This study illustrates how the U.S. health care system continues to rely on IMGs to address shortages in primary care,” Ms. Hing said at the conference, which was sponsored by the Association of American Medical Colleges and Harvard Medical School.

ARLINGTON, VA. — International medical graduates have become an integral part of providing medical care in federally designated physician shortage areas, according to results from a recent study.

“Compared to U.S.-trained physicians, IMGs provide more primary care and more [overall] medical care to populations living in primary care shortage areas” as well as to minorities, immigrants, patients in poor areas, and Medicaid recipients, said Esther Hing of the National Center for Health Statistics, Hyattsville, Md. Ms. Hing and her colleague Susan Lin, Dr.P.H., studied 2005–2006 data from the National Ambulatory Medical Care Survey. The survey was nationally representative, and the data used by the researchers included information from 2,390 physicians in office-based practices. Surveyors performed a face-to-face interview and abstracted medical records for about 30 office visits. Ms. Hing presented the survey results at the 2008 Physician Workforce Research Conference.

The survey showed that IMGs make up 25% of office-based physicians. They tend to be a little older that U.S.-trained doctors, with an average age of 52 years, compared with 50 years for physicians trained in the United States. The racial and ethnic differences were more pronounced: 71% of U.S. medical graduates were non-Hispanic white vs. 26% of IMGs. Asian/Pacific Islanders made up 32% of IMGs, compared with 5% of U.S. medical graduates. Hispanic and Latino physicians accounted for 7% of IMGs, compared with 2% of U.S. graduates.

IMGs also practiced more often in counties that included primary care shortage areas than did U.S.-trained physicians—87% vs. 79%. And IMGs more often saw patients during evening and weekend hours than their U.S.-trained counterparts. IMGs were more likely to accept new patients and to accept Medicaid.

“This study illustrates how the U.S. health care system continues to rely on IMGs to address shortages in primary care,” Ms. Hing said at the conference, which was sponsored by the Association of American Medical Colleges and Harvard Medical School.

ARLINGTON, VA. — International medical graduates have become an integral part of providing medical care in federally designated physician shortage areas, according to results from a recent study.

“Compared to U.S.-trained physicians, IMGs provide more primary care and more [overall] medical care to populations living in primary care shortage areas” as well as to minorities, immigrants, patients in poor areas, and Medicaid recipients, said Esther Hing of the National Center for Health Statistics, Hyattsville, Md. Ms. Hing and her colleague Susan Lin, Dr.P.H., studied 2005–2006 data from the National Ambulatory Medical Care Survey. The survey was nationally representative, and the data used by the researchers included information from 2,390 physicians in office-based practices. Surveyors performed a face-to-face interview and abstracted medical records for about 30 office visits. Ms. Hing presented the survey results at the 2008 Physician Workforce Research Conference.

The survey showed that IMGs make up 25% of office-based physicians. They tend to be a little older that U.S.-trained doctors, with an average age of 52 years, compared with 50 years for physicians trained in the United States. The racial and ethnic differences were more pronounced: 71% of U.S. medical graduates were non-Hispanic white vs. 26% of IMGs. Asian/Pacific Islanders made up 32% of IMGs, compared with 5% of U.S. medical graduates. Hispanic and Latino physicians accounted for 7% of IMGs, compared with 2% of U.S. graduates.

IMGs also practiced more often in counties that included primary care shortage areas than did U.S.-trained physicians—87% vs. 79%. And IMGs more often saw patients during evening and weekend hours than their U.S.-trained counterparts. IMGs were more likely to accept new patients and to accept Medicaid.

“This study illustrates how the U.S. health care system continues to rely on IMGs to address shortages in primary care,” Ms. Hing said at the conference, which was sponsored by the Association of American Medical Colleges and Harvard Medical School.

PHILADELPHIA — The Food and Drug Administration needs to change the way it regulates promotion of off-label drug use, according to the chair of the department of health policy and public health at the University of the Sciences in Philadelphia.

This year, the FDA issued draft guidance regarding off-label promotion. The draft guidance states that although any materials promoting off-label use must be peer reviewed, approval by the agency is not required, and the pharmaceutical company does not need to prove its intent to submit a new drug application for the off-label use, Robert I. Field, J.D., Ph.D. said at a meeting of the American Society of Law, Medicine, and Ethics. “This is considered to be a significant loosening of the requirements, certainly of the FDA's enforcement attitude.”

However, the company must clearly disclose that the suggested use is off-label, and any published negative findings regarding the off-label use must be included in the materials. “The problem is, negative findings don't get published very often, so there's probably not going to be a whole lot of that,” he added.

The comment period on the FDA's draft guidance ended several months ago; final guidance has yet to be issued. But there are certainly reasonable arguments for promoting off-label use under certain circumstances, according to Dr. Field.

Medicine only advances when information is shared, “and there are good reasons to allow off-label uses and therefore to allow physicians to know about those off-label uses,” he said. “On the other hand, it is clear that lack of oversight will lead to overzealous, aggressive promotion of uses that have limited, if any, scientific substantiation. The big question [is whether the] average physician, who's working 80 hours a week [is] really going to be able to evaluate this information, even if it has a disclosure written at the top?”

Although the ultimate goal should be to get approval for an off-label use, pharmaceutical companies don't have many good reasons to do so, Dr. Field noted. “The problem is that clinical trials take a lot of time and the FDA is an overburdened agency; its reviews are slow.”

Off-label use is abundant and has grown over the last 3 decades, Dr. Field said.

Before 1997, the FDA opposed all off-label promotion. The agency allowed limited distribution of peer-reviewed articles in direct response to physician requests.

In 1997, Congress passed the Food and Drug Administration Modernization Act, which allowed pharmaceutical companies to initiate distribution of articles promoting off-label use if they came from a legitimate peer-reviewed source, such as a journal or book chapter, and they could sponsor continuing medical education if it was done through a third-party operation.

But there were restrictions on these uses—the material to be distributed first had to be given to the FDA for approval, and the company had to intend to submit a new drug application for the off-label use.

In 1998, the Washington Legal Foundation sued the FDA, arguing that the restrictions on article distribution were unconstitutional under the First Amendment. The court said the agency could limit article distribution but could not require prior submission of the materials for FDA approval or require that the company intend to submit a new drug application. A similar lawsuit in 1999 produced the same result.

These rulings “left questions as to what would and wouldn't be allowed” under the act, Dr. Field said. Other challenges to off-label promotion rules were not as successful. In 2004, Pfizer Inc. was fined $430 million for paying physicians to promote the off-label use of gabapentin (Neurontin) with little evidence of benefit. And a psychiatrist was arrested in 2006 for accepting $100,000 to promote off-label uses for Jazz Pharmaceutical Inc.'s sodium oxybate (Xyrem).

PHILADELPHIA — The Food and Drug Administration needs to change the way it regulates promotion of off-label drug use, according to the chair of the department of health policy and public health at the University of the Sciences in Philadelphia.

This year, the FDA issued draft guidance regarding off-label promotion. The draft guidance states that although any materials promoting off-label use must be peer reviewed, approval by the agency is not required, and the pharmaceutical company does not need to prove its intent to submit a new drug application for the off-label use, Robert I. Field, J.D., Ph.D. said at a meeting of the American Society of Law, Medicine, and Ethics. “This is considered to be a significant loosening of the requirements, certainly of the FDA's enforcement attitude.”

However, the company must clearly disclose that the suggested use is off-label, and any published negative findings regarding the off-label use must be included in the materials. “The problem is, negative findings don't get published very often, so there's probably not going to be a whole lot of that,” he added.

The comment period on the FDA's draft guidance ended several months ago; final guidance has yet to be issued. But there are certainly reasonable arguments for promoting off-label use under certain circumstances, according to Dr. Field.

Medicine only advances when information is shared, “and there are good reasons to allow off-label uses and therefore to allow physicians to know about those off-label uses,” he said. “On the other hand, it is clear that lack of oversight will lead to overzealous, aggressive promotion of uses that have limited, if any, scientific substantiation. The big question [is whether the] average physician, who's working 80 hours a week [is] really going to be able to evaluate this information, even if it has a disclosure written at the top?”

Although the ultimate goal should be to get approval for an off-label use, pharmaceutical companies don't have many good reasons to do so, Dr. Field noted. “The problem is that clinical trials take a lot of time and the FDA is an overburdened agency; its reviews are slow.”

Off-label use is abundant and has grown over the last 3 decades, Dr. Field said.

Before 1997, the FDA opposed all off-label promotion. The agency allowed limited distribution of peer-reviewed articles in direct response to physician requests.

In 1997, Congress passed the Food and Drug Administration Modernization Act, which allowed pharmaceutical companies to initiate distribution of articles promoting off-label use if they came from a legitimate peer-reviewed source, such as a journal or book chapter, and they could sponsor continuing medical education if it was done through a third-party operation.

But there were restrictions on these uses—the material to be distributed first had to be given to the FDA for approval, and the company had to intend to submit a new drug application for the off-label use.

In 1998, the Washington Legal Foundation sued the FDA, arguing that the restrictions on article distribution were unconstitutional under the First Amendment. The court said the agency could limit article distribution but could not require prior submission of the materials for FDA approval or require that the company intend to submit a new drug application. A similar lawsuit in 1999 produced the same result.

These rulings “left questions as to what would and wouldn't be allowed” under the act, Dr. Field said. Other challenges to off-label promotion rules were not as successful. In 2004, Pfizer Inc. was fined $430 million for paying physicians to promote the off-label use of gabapentin (Neurontin) with little evidence of benefit. And a psychiatrist was arrested in 2006 for accepting $100,000 to promote off-label uses for Jazz Pharmaceutical Inc.'s sodium oxybate (Xyrem).

PHILADELPHIA — The Food and Drug Administration needs to change the way it regulates promotion of off-label drug use, according to the chair of the department of health policy and public health at the University of the Sciences in Philadelphia.

This year, the FDA issued draft guidance regarding off-label promotion. The draft guidance states that although any materials promoting off-label use must be peer reviewed, approval by the agency is not required, and the pharmaceutical company does not need to prove its intent to submit a new drug application for the off-label use, Robert I. Field, J.D., Ph.D. said at a meeting of the American Society of Law, Medicine, and Ethics. “This is considered to be a significant loosening of the requirements, certainly of the FDA's enforcement attitude.”

However, the company must clearly disclose that the suggested use is off-label, and any published negative findings regarding the off-label use must be included in the materials. “The problem is, negative findings don't get published very often, so there's probably not going to be a whole lot of that,” he added.

The comment period on the FDA's draft guidance ended several months ago; final guidance has yet to be issued. But there are certainly reasonable arguments for promoting off-label use under certain circumstances, according to Dr. Field.

Medicine only advances when information is shared, “and there are good reasons to allow off-label uses and therefore to allow physicians to know about those off-label uses,” he said. “On the other hand, it is clear that lack of oversight will lead to overzealous, aggressive promotion of uses that have limited, if any, scientific substantiation. The big question [is whether the] average physician, who's working 80 hours a week [is] really going to be able to evaluate this information, even if it has a disclosure written at the top?”

Although the ultimate goal should be to get approval for an off-label use, pharmaceutical companies don't have many good reasons to do so, Dr. Field noted. “The problem is that clinical trials take a lot of time and the FDA is an overburdened agency; its reviews are slow.”

Off-label use is abundant and has grown over the last 3 decades, Dr. Field said.

Before 1997, the FDA opposed all off-label promotion. The agency allowed limited distribution of peer-reviewed articles in direct response to physician requests.

In 1997, Congress passed the Food and Drug Administration Modernization Act, which allowed pharmaceutical companies to initiate distribution of articles promoting off-label use if they came from a legitimate peer-reviewed source, such as a journal or book chapter, and they could sponsor continuing medical education if it was done through a third-party operation.

But there were restrictions on these uses—the material to be distributed first had to be given to the FDA for approval, and the company had to intend to submit a new drug application for the off-label use.

In 1998, the Washington Legal Foundation sued the FDA, arguing that the restrictions on article distribution were unconstitutional under the First Amendment. The court said the agency could limit article distribution but could not require prior submission of the materials for FDA approval or require that the company intend to submit a new drug application. A similar lawsuit in 1999 produced the same result.

These rulings “left questions as to what would and wouldn't be allowed” under the act, Dr. Field said. Other challenges to off-label promotion rules were not as successful. In 2004, Pfizer Inc. was fined $430 million for paying physicians to promote the off-label use of gabapentin (Neurontin) with little evidence of benefit. And a psychiatrist was arrested in 2006 for accepting $100,000 to promote off-label uses for Jazz Pharmaceutical Inc.'s sodium oxybate (Xyrem).