Joyce Frieden

Diabetes Impact on Federal Budget

One of every eight federal health care dollars is spent on treating patients with diabetes, according to a study released by the National Changing Diabetes Program (NCDP). The study, based on data from fiscal year 2005 and conducted by Mathematica Policy Research Inc., found that the federal government spent $79.7 billion more to provide health care services to people with diabetes than to those without the disease—a figure that represents 12% of the government's projected $645 billion health care spending for that year. The study also found coordination of diabetes spending to be insufficient. “We are spending as much on diabetes as we are on the entire Department of Education, but no one is leading the effort,” said Dana Haza, senior director of NCDP, a coalition of health care organizations aimed at advancing diabetes care that is funded by Novo Nordisk. “The staggering cost of treating diabetes and the number of diabetes-related programs highlight a need for a National Changing Diabetes Coordinator to ensure results,” said Ms. Haza. Rep. Diana DeGette (D-Colo.), cochair of the Congressional Diabetes Caucus, said the study “shines a spotlight on diabetes prevention and management. Too many people face the challenge of managing this disease daily, and I look forward to coordinating our federal diabetes efforts.”

Thyroid Disease in Pregnancy

A new clinical practice guideline from the Endocrine Society does not recommend universal screening of pregnant women for thyroid disease. But the guidelines do advise physicians to use a targeted case finding approach during early pregnancy. The guidelines recommend measuring thyroid stimulating hormone (TSH) among certain women who are at high risk for thyroid disease, including women with a history of hyperthyroid or hypothyroid disease, postpartum thyroiditis, or thyroid lobectomy; women with a family history of thyroid disease; women with a goiter; women with thyroid antibodies; and women with clinical signs that suggest either thyroid dysfunction. The high-risk groups also include those with type 1 diabetes, with other autoimmune disorders, with infertility, with previous therapeutic head or neck irradiation, and those with a history of miscarriage or preterm delivery. The guidelines, which were published online in June and are scheduled to appear in print in the August issue of the Journal of Clinical Endocrinology & Metabolism, are the result of 2 years' work by an international task force that included representatives from the Endocrine Society, American Thyroid Association, American Association of Clinical Endocrinologists, European Thyroid Association, Asia and Oceania Thyroid Association, and the Latin American Thyroid Society.

Overseas Drug Purchases Unabated

Two new reports suggest that despite multiple warnings, Americans are continuing to buy pharmaceuticals from overseas, mostly through the Internet. A new survey by the Pharmaceutical Research and Manufacturers of America (PhRMA) shows that more than 5 million adults—or more than 2% of the U.S. population—have recently purchased prescription drugs from another country, such as Canada or Mexico. The vast majority said they were looking for the best price, but about half decided to import because they didn't have a prescription. Overseas shoppers were more likely to be under age 35, Hispanic, live in a southern border state, and to spend more out-of-pocket money on prescription drugs than were nonimporters, PhRMA reported. Most of the products were for chronic ailments. Separately, the Food and Drug Administration said that consumers often can get the same products for less in the United States. New data from examinations of foreign mail shipments shows that 45% of the imports were available here as a generic, many for $4 each. Among the drugs being imported that were cheaper here, according to the FDA, were atenolol, hydrochlorothiazide, lisinopril, metformin, simvastatin, and warfarin.

CDC: 43 Million Lack Coverage

Nearly 15% of Americans-43.6 million—lacked health insurance in 2006, according to the Centers for Disease Control and Prevention. Among Americans aged 18 through 64, nearly 20% lacked health insurance in 2006, a slight increase from about 19% in 2005, the CDC said. About 9% of children did not have health coverage in 2006, a marked drop from 14% in 1997, the year the State Children's Health Insurance Program (SCHIP) was enacted. The CDC noted that the percentage of uninsured Americans in the 20 largest states varied from less than 8% in Michigan to nearly 24% in Texas. The CDC study was based on data collected from interviews in more than 100,000 households nationwide.

Diabetes Impact on Federal Budget

One of every eight federal health care dollars is spent on treating patients with diabetes, according to a study released by the National Changing Diabetes Program (NCDP). The study, based on data from fiscal year 2005 and conducted by Mathematica Policy Research Inc., found that the federal government spent $79.7 billion more to provide health care services to people with diabetes than to those without the disease—a figure that represents 12% of the government's projected $645 billion health care spending for that year. The study also found coordination of diabetes spending to be insufficient. “We are spending as much on diabetes as we are on the entire Department of Education, but no one is leading the effort,” said Dana Haza, senior director of NCDP, a coalition of health care organizations aimed at advancing diabetes care that is funded by Novo Nordisk. “The staggering cost of treating diabetes and the number of diabetes-related programs highlight a need for a National Changing Diabetes Coordinator to ensure results,” said Ms. Haza. Rep. Diana DeGette (D-Colo.), cochair of the Congressional Diabetes Caucus, said the study “shines a spotlight on diabetes prevention and management. Too many people face the challenge of managing this disease daily, and I look forward to coordinating our federal diabetes efforts.”

Thyroid Disease in Pregnancy

A new clinical practice guideline from the Endocrine Society does not recommend universal screening of pregnant women for thyroid disease. But the guidelines do advise physicians to use a targeted case finding approach during early pregnancy. The guidelines recommend measuring thyroid stimulating hormone (TSH) among certain women who are at high risk for thyroid disease, including women with a history of hyperthyroid or hypothyroid disease, postpartum thyroiditis, or thyroid lobectomy; women with a family history of thyroid disease; women with a goiter; women with thyroid antibodies; and women with clinical signs that suggest either thyroid dysfunction. The high-risk groups also include those with type 1 diabetes, with other autoimmune disorders, with infertility, with previous therapeutic head or neck irradiation, and those with a history of miscarriage or preterm delivery. The guidelines, which were published online in June and are scheduled to appear in print in the August issue of the Journal of Clinical Endocrinology & Metabolism, are the result of 2 years' work by an international task force that included representatives from the Endocrine Society, American Thyroid Association, American Association of Clinical Endocrinologists, European Thyroid Association, Asia and Oceania Thyroid Association, and the Latin American Thyroid Society.

Overseas Drug Purchases Unabated

Two new reports suggest that despite multiple warnings, Americans are continuing to buy pharmaceuticals from overseas, mostly through the Internet. A new survey by the Pharmaceutical Research and Manufacturers of America (PhRMA) shows that more than 5 million adults—or more than 2% of the U.S. population—have recently purchased prescription drugs from another country, such as Canada or Mexico. The vast majority said they were looking for the best price, but about half decided to import because they didn't have a prescription. Overseas shoppers were more likely to be under age 35, Hispanic, live in a southern border state, and to spend more out-of-pocket money on prescription drugs than were nonimporters, PhRMA reported. Most of the products were for chronic ailments. Separately, the Food and Drug Administration said that consumers often can get the same products for less in the United States. New data from examinations of foreign mail shipments shows that 45% of the imports were available here as a generic, many for $4 each. Among the drugs being imported that were cheaper here, according to the FDA, were atenolol, hydrochlorothiazide, lisinopril, metformin, simvastatin, and warfarin.

CDC: 43 Million Lack Coverage

Nearly 15% of Americans-43.6 million—lacked health insurance in 2006, according to the Centers for Disease Control and Prevention. Among Americans aged 18 through 64, nearly 20% lacked health insurance in 2006, a slight increase from about 19% in 2005, the CDC said. About 9% of children did not have health coverage in 2006, a marked drop from 14% in 1997, the year the State Children's Health Insurance Program (SCHIP) was enacted. The CDC noted that the percentage of uninsured Americans in the 20 largest states varied from less than 8% in Michigan to nearly 24% in Texas. The CDC study was based on data collected from interviews in more than 100,000 households nationwide.

Diabetes Impact on Federal Budget

One of every eight federal health care dollars is spent on treating patients with diabetes, according to a study released by the National Changing Diabetes Program (NCDP). The study, based on data from fiscal year 2005 and conducted by Mathematica Policy Research Inc., found that the federal government spent $79.7 billion more to provide health care services to people with diabetes than to those without the disease—a figure that represents 12% of the government's projected $645 billion health care spending for that year. The study also found coordination of diabetes spending to be insufficient. “We are spending as much on diabetes as we are on the entire Department of Education, but no one is leading the effort,” said Dana Haza, senior director of NCDP, a coalition of health care organizations aimed at advancing diabetes care that is funded by Novo Nordisk. “The staggering cost of treating diabetes and the number of diabetes-related programs highlight a need for a National Changing Diabetes Coordinator to ensure results,” said Ms. Haza. Rep. Diana DeGette (D-Colo.), cochair of the Congressional Diabetes Caucus, said the study “shines a spotlight on diabetes prevention and management. Too many people face the challenge of managing this disease daily, and I look forward to coordinating our federal diabetes efforts.”

Thyroid Disease in Pregnancy

A new clinical practice guideline from the Endocrine Society does not recommend universal screening of pregnant women for thyroid disease. But the guidelines do advise physicians to use a targeted case finding approach during early pregnancy. The guidelines recommend measuring thyroid stimulating hormone (TSH) among certain women who are at high risk for thyroid disease, including women with a history of hyperthyroid or hypothyroid disease, postpartum thyroiditis, or thyroid lobectomy; women with a family history of thyroid disease; women with a goiter; women with thyroid antibodies; and women with clinical signs that suggest either thyroid dysfunction. The high-risk groups also include those with type 1 diabetes, with other autoimmune disorders, with infertility, with previous therapeutic head or neck irradiation, and those with a history of miscarriage or preterm delivery. The guidelines, which were published online in June and are scheduled to appear in print in the August issue of the Journal of Clinical Endocrinology & Metabolism, are the result of 2 years' work by an international task force that included representatives from the Endocrine Society, American Thyroid Association, American Association of Clinical Endocrinologists, European Thyroid Association, Asia and Oceania Thyroid Association, and the Latin American Thyroid Society.

Overseas Drug Purchases Unabated

Two new reports suggest that despite multiple warnings, Americans are continuing to buy pharmaceuticals from overseas, mostly through the Internet. A new survey by the Pharmaceutical Research and Manufacturers of America (PhRMA) shows that more than 5 million adults—or more than 2% of the U.S. population—have recently purchased prescription drugs from another country, such as Canada or Mexico. The vast majority said they were looking for the best price, but about half decided to import because they didn't have a prescription. Overseas shoppers were more likely to be under age 35, Hispanic, live in a southern border state, and to spend more out-of-pocket money on prescription drugs than were nonimporters, PhRMA reported. Most of the products were for chronic ailments. Separately, the Food and Drug Administration said that consumers often can get the same products for less in the United States. New data from examinations of foreign mail shipments shows that 45% of the imports were available here as a generic, many for $4 each. Among the drugs being imported that were cheaper here, according to the FDA, were atenolol, hydrochlorothiazide, lisinopril, metformin, simvastatin, and warfarin.

CDC: 43 Million Lack Coverage

Nearly 15% of Americans-43.6 million—lacked health insurance in 2006, according to the Centers for Disease Control and Prevention. Among Americans aged 18 through 64, nearly 20% lacked health insurance in 2006, a slight increase from about 19% in 2005, the CDC said. About 9% of children did not have health coverage in 2006, a marked drop from 14% in 1997, the year the State Children's Health Insurance Program (SCHIP) was enacted. The CDC noted that the percentage of uninsured Americans in the 20 largest states varied from less than 8% in Michigan to nearly 24% in Texas. The CDC study was based on data collected from interviews in more than 100,000 households nationwide.

WASHINGTON — Thyroid disease screening has not yet been proved useful in the general population, but the issue of early detection of thyroid dysfunction deserves further exploration, Dr. Paul Ladenson explained at a meeting jointly sponsored by the American Thyroid Association and Johns Hopkins University.

Dr. Ladenson, director of the division of endocrinology and metabolism at Johns Hopkins University, Baltimore, said that in general, screening programs should be for diseases:

▸ With significant prevalence.

▸ With significant clinical consequence.

▸ For which clinical diagnosis often is inaccurate.

▸ For which delayed diagnosis and treatment have consequences that could be avoided by earlier diagnosis.

▸ For which there is an accurate, safe, and inexpensive diagnostic test.

▸ For which there is a safe, effective, inexpensive therapy.

At first glance, mild thyroid dysfunction—particularly mild thyrotoxicosis and mild hypothyroidism—would easily meet many of these criteria, Dr. Ladenson said. “These are disorders with highly significant prevalences, particularly subclinical hypothyroidism.”

In addition, data such as that from the Colorado Thyroid Disease Prevalence Study show that clinical diagnosis of these disorders lacks in specificity and sensitivity, “and certainly measurement of TSH and thyroxine therapy easily fulfill the final two criteria” of an accurate, safe, and inexpensive diagnostic test and having an effective, safe, and inexpensive therapy.

And thyroid testing has another thing going for it: It is relatively cheap in terms of cost effectiveness, according to Dr. Ladenson.

For example, studies have found that the cost of screening all women 35 years and older for thyroid dysfunction was $9,000 per each year of restoration to perfect health and life expectancy, which is inexpensive, compared with other interventions.

But Dr. Ladenson asked, “Are these disorders that have significant clinical consequences, and does it matter if we wait to diagnose and treat them [or] if we wait until patients come to us with complaints that might well be reversible?”

Various groups have tried to address the issue.

The American Thyroid Association looked at the issue in 2000 and determined that adults should be screened every 5 years beginning at age 35; those with symptoms and signs of a possible thyroid problem should be screened more frequently (Arch. Int. Med. 2000;160:1573–5). Dr. Ladenson, who said the conclusions were “aggressive in retrospect,” was the lead author of the guideline.

In 2003, a 13-member joint task force named by the American Thyroid Association, the Endocrine Society, and the American Association of Clinical Endocrinologists performed a structured literature review of 195 articles on thyroid disease screening; the group also attended a symposium on the topic with 12 expert presenters.

In its report, the task force concluded that there was insufficient evidence to support population-based thyroid disease screening, although they conceded that “aggressive case-finding” was recommended for pregnant women, women over 60 years, and others at high risk of thyroid dysfunction (JAMA 2004;291:228–38).

Just a month later, the U.S. Preventive Services Task Force published its recommendations on the issue—again using a literature review and deliberation by a panel of experts—and concluded that the evidence was insufficient to recommend for or against routine screening (Ann. Int. Med. 2004;140:125–7).

WASHINGTON — Thyroid disease screening has not yet been proved useful in the general population, but the issue of early detection of thyroid dysfunction deserves further exploration, Dr. Paul Ladenson explained at a meeting jointly sponsored by the American Thyroid Association and Johns Hopkins University.

Dr. Ladenson, director of the division of endocrinology and metabolism at Johns Hopkins University, Baltimore, said that in general, screening programs should be for diseases:

▸ With significant prevalence.

▸ With significant clinical consequence.

▸ For which clinical diagnosis often is inaccurate.

▸ For which delayed diagnosis and treatment have consequences that could be avoided by earlier diagnosis.

▸ For which there is an accurate, safe, and inexpensive diagnostic test.

▸ For which there is a safe, effective, inexpensive therapy.

At first glance, mild thyroid dysfunction—particularly mild thyrotoxicosis and mild hypothyroidism—would easily meet many of these criteria, Dr. Ladenson said. “These are disorders with highly significant prevalences, particularly subclinical hypothyroidism.”

In addition, data such as that from the Colorado Thyroid Disease Prevalence Study show that clinical diagnosis of these disorders lacks in specificity and sensitivity, “and certainly measurement of TSH and thyroxine therapy easily fulfill the final two criteria” of an accurate, safe, and inexpensive diagnostic test and having an effective, safe, and inexpensive therapy.

And thyroid testing has another thing going for it: It is relatively cheap in terms of cost effectiveness, according to Dr. Ladenson.

For example, studies have found that the cost of screening all women 35 years and older for thyroid dysfunction was $9,000 per each year of restoration to perfect health and life expectancy, which is inexpensive, compared with other interventions.

But Dr. Ladenson asked, “Are these disorders that have significant clinical consequences, and does it matter if we wait to diagnose and treat them [or] if we wait until patients come to us with complaints that might well be reversible?”

Various groups have tried to address the issue.

The American Thyroid Association looked at the issue in 2000 and determined that adults should be screened every 5 years beginning at age 35; those with symptoms and signs of a possible thyroid problem should be screened more frequently (Arch. Int. Med. 2000;160:1573–5). Dr. Ladenson, who said the conclusions were “aggressive in retrospect,” was the lead author of the guideline.

In 2003, a 13-member joint task force named by the American Thyroid Association, the Endocrine Society, and the American Association of Clinical Endocrinologists performed a structured literature review of 195 articles on thyroid disease screening; the group also attended a symposium on the topic with 12 expert presenters.

In its report, the task force concluded that there was insufficient evidence to support population-based thyroid disease screening, although they conceded that “aggressive case-finding” was recommended for pregnant women, women over 60 years, and others at high risk of thyroid dysfunction (JAMA 2004;291:228–38).

Just a month later, the U.S. Preventive Services Task Force published its recommendations on the issue—again using a literature review and deliberation by a panel of experts—and concluded that the evidence was insufficient to recommend for or against routine screening (Ann. Int. Med. 2004;140:125–7).

WASHINGTON — Thyroid disease screening has not yet been proved useful in the general population, but the issue of early detection of thyroid dysfunction deserves further exploration, Dr. Paul Ladenson explained at a meeting jointly sponsored by the American Thyroid Association and Johns Hopkins University.

Dr. Ladenson, director of the division of endocrinology and metabolism at Johns Hopkins University, Baltimore, said that in general, screening programs should be for diseases:

▸ With significant prevalence.

▸ With significant clinical consequence.

▸ For which clinical diagnosis often is inaccurate.

▸ For which delayed diagnosis and treatment have consequences that could be avoided by earlier diagnosis.

▸ For which there is an accurate, safe, and inexpensive diagnostic test.

▸ For which there is a safe, effective, inexpensive therapy.

At first glance, mild thyroid dysfunction—particularly mild thyrotoxicosis and mild hypothyroidism—would easily meet many of these criteria, Dr. Ladenson said. “These are disorders with highly significant prevalences, particularly subclinical hypothyroidism.”

In addition, data such as that from the Colorado Thyroid Disease Prevalence Study show that clinical diagnosis of these disorders lacks in specificity and sensitivity, “and certainly measurement of TSH and thyroxine therapy easily fulfill the final two criteria” of an accurate, safe, and inexpensive diagnostic test and having an effective, safe, and inexpensive therapy.

And thyroid testing has another thing going for it: It is relatively cheap in terms of cost effectiveness, according to Dr. Ladenson.

For example, studies have found that the cost of screening all women 35 years and older for thyroid dysfunction was $9,000 per each year of restoration to perfect health and life expectancy, which is inexpensive, compared with other interventions.

But Dr. Ladenson asked, “Are these disorders that have significant clinical consequences, and does it matter if we wait to diagnose and treat them [or] if we wait until patients come to us with complaints that might well be reversible?”

Various groups have tried to address the issue.

The American Thyroid Association looked at the issue in 2000 and determined that adults should be screened every 5 years beginning at age 35; those with symptoms and signs of a possible thyroid problem should be screened more frequently (Arch. Int. Med. 2000;160:1573–5). Dr. Ladenson, who said the conclusions were “aggressive in retrospect,” was the lead author of the guideline.

In 2003, a 13-member joint task force named by the American Thyroid Association, the Endocrine Society, and the American Association of Clinical Endocrinologists performed a structured literature review of 195 articles on thyroid disease screening; the group also attended a symposium on the topic with 12 expert presenters.

In its report, the task force concluded that there was insufficient evidence to support population-based thyroid disease screening, although they conceded that “aggressive case-finding” was recommended for pregnant women, women over 60 years, and others at high risk of thyroid dysfunction (JAMA 2004;291:228–38).

Just a month later, the U.S. Preventive Services Task Force published its recommendations on the issue—again using a literature review and deliberation by a panel of experts—and concluded that the evidence was insufficient to recommend for or against routine screening (Ann. Int. Med. 2004;140:125–7).

Patient Training From Medicare

Starting this month, Medicare will pay for self-management training for diabetes patients, the Centers for Medicare and Medicaid Services (CMS) announced. The program will pay for up to 10 hours of initial training, with an additional 2 hours of follow-up training every year after that. Training must be ordered by a physician or qualified nonphysician practitioner, and the must be provided by “a certified provider who meets certain quality standards,” according to CMS regulations. More information is available at

www.cms.hhs.gov/

FDA Forms Risk Communication Panel

Following an Institute of Medicine recommendation, the Food and Drug Administration has created a new advisory committee that will be charged with helping the agency better communicate the risks and benefits of pharmaceuticals and other products it regulates. In 2006, the IOM's report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public,” urged Congress to establish a new advisory panel that would weigh in on the FDA's communications about safety and efficacy to health care providers and the public. The agency found an administrative process that let it establish the committee without congressional action. The FDA is now seeking 15 members to serve on the Risk Communication Advisory Committee, including experts on risk communication, social marketing, health literacy, journalism, bioethics, and cultural competency.

AAPPO Launches Diabetes Initiative

The American Association of Preferred Provider Organizations (AAPPO) has started a new program to help PPOs provide high-quality diabetes care and encourage diabetes prevention efforts. The ACT on Diabetes Initiative provides tools and education for PPOs, physicians, and patients to help them use “best practices” in diabetes care. The association is also developing a tool kit that will include diabetes quality-improvement strategies for PPOs, links to consumer Web sites, and suggestions for talking with employers on health benefit designs that improve access to diabetes services. “With more than 158 million people enrolled in a PPO, our industry has a strong platform on which to reach a wide audience. As such, we are asking each of our members to take action to address diabetes,” said AAPPO President Karen Greenrose.

Investors Sue Over Avandia

GlaxoSmithKline Inc. is facing more headaches with its diabetes drug Avandia (rosiglitazone). A Texas man's relatives filed suit in the U.S. District Court for Eastern Texas in late June and claimed that the company failed to warn of cardiac risks. The 60-year-old, who was taking Avandamet (a combination of Avandia and metformin), died on May 21, the day a meta-analysis showing increased heart risks, by Dr. Steven Nissen of the Cleveland Clinic, was published in the New England Journal of Medicine. And Kaplan Fox & Kilsheimer LLP, a New York-based law firm, has filed a class-action lawsuit against the drugmaker on behalf of anyone who purchased shares between October 27, 2005, and May 21, 2007. The lawsuit alleges that although GlaxoSmithKline submitted partial data to the FDA in September 2005 and August 2006, it did not adequately disclose to the public that it had conducted a meta-analysis that showed an increased risk of heart attacks. When the results of Dr. Nissen's analysis were published on May 21, GlaxoSmithKline's share price dropped $4.53 (7.8%), according to the law firm.

Patient Training From Medicare

Starting this month, Medicare will pay for self-management training for diabetes patients, the Centers for Medicare and Medicaid Services (CMS) announced. The program will pay for up to 10 hours of initial training, with an additional 2 hours of follow-up training every year after that. Training must be ordered by a physician or qualified nonphysician practitioner, and the must be provided by “a certified provider who meets certain quality standards,” according to CMS regulations. More information is available at

www.cms.hhs.gov/

FDA Forms Risk Communication Panel

Following an Institute of Medicine recommendation, the Food and Drug Administration has created a new advisory committee that will be charged with helping the agency better communicate the risks and benefits of pharmaceuticals and other products it regulates. In 2006, the IOM's report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public,” urged Congress to establish a new advisory panel that would weigh in on the FDA's communications about safety and efficacy to health care providers and the public. The agency found an administrative process that let it establish the committee without congressional action. The FDA is now seeking 15 members to serve on the Risk Communication Advisory Committee, including experts on risk communication, social marketing, health literacy, journalism, bioethics, and cultural competency.

AAPPO Launches Diabetes Initiative

The American Association of Preferred Provider Organizations (AAPPO) has started a new program to help PPOs provide high-quality diabetes care and encourage diabetes prevention efforts. The ACT on Diabetes Initiative provides tools and education for PPOs, physicians, and patients to help them use “best practices” in diabetes care. The association is also developing a tool kit that will include diabetes quality-improvement strategies for PPOs, links to consumer Web sites, and suggestions for talking with employers on health benefit designs that improve access to diabetes services. “With more than 158 million people enrolled in a PPO, our industry has a strong platform on which to reach a wide audience. As such, we are asking each of our members to take action to address diabetes,” said AAPPO President Karen Greenrose.

Investors Sue Over Avandia

GlaxoSmithKline Inc. is facing more headaches with its diabetes drug Avandia (rosiglitazone). A Texas man's relatives filed suit in the U.S. District Court for Eastern Texas in late June and claimed that the company failed to warn of cardiac risks. The 60-year-old, who was taking Avandamet (a combination of Avandia and metformin), died on May 21, the day a meta-analysis showing increased heart risks, by Dr. Steven Nissen of the Cleveland Clinic, was published in the New England Journal of Medicine. And Kaplan Fox & Kilsheimer LLP, a New York-based law firm, has filed a class-action lawsuit against the drugmaker on behalf of anyone who purchased shares between October 27, 2005, and May 21, 2007. The lawsuit alleges that although GlaxoSmithKline submitted partial data to the FDA in September 2005 and August 2006, it did not adequately disclose to the public that it had conducted a meta-analysis that showed an increased risk of heart attacks. When the results of Dr. Nissen's analysis were published on May 21, GlaxoSmithKline's share price dropped $4.53 (7.8%), according to the law firm.

Patient Training From Medicare

Starting this month, Medicare will pay for self-management training for diabetes patients, the Centers for Medicare and Medicaid Services (CMS) announced. The program will pay for up to 10 hours of initial training, with an additional 2 hours of follow-up training every year after that. Training must be ordered by a physician or qualified nonphysician practitioner, and the must be provided by “a certified provider who meets certain quality standards,” according to CMS regulations. More information is available at

www.cms.hhs.gov/

FDA Forms Risk Communication Panel

Following an Institute of Medicine recommendation, the Food and Drug Administration has created a new advisory committee that will be charged with helping the agency better communicate the risks and benefits of pharmaceuticals and other products it regulates. In 2006, the IOM's report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public,” urged Congress to establish a new advisory panel that would weigh in on the FDA's communications about safety and efficacy to health care providers and the public. The agency found an administrative process that let it establish the committee without congressional action. The FDA is now seeking 15 members to serve on the Risk Communication Advisory Committee, including experts on risk communication, social marketing, health literacy, journalism, bioethics, and cultural competency.

AAPPO Launches Diabetes Initiative

The American Association of Preferred Provider Organizations (AAPPO) has started a new program to help PPOs provide high-quality diabetes care and encourage diabetes prevention efforts. The ACT on Diabetes Initiative provides tools and education for PPOs, physicians, and patients to help them use “best practices” in diabetes care. The association is also developing a tool kit that will include diabetes quality-improvement strategies for PPOs, links to consumer Web sites, and suggestions for talking with employers on health benefit designs that improve access to diabetes services. “With more than 158 million people enrolled in a PPO, our industry has a strong platform on which to reach a wide audience. As such, we are asking each of our members to take action to address diabetes,” said AAPPO President Karen Greenrose.

Investors Sue Over Avandia

GlaxoSmithKline Inc. is facing more headaches with its diabetes drug Avandia (rosiglitazone). A Texas man's relatives filed suit in the U.S. District Court for Eastern Texas in late June and claimed that the company failed to warn of cardiac risks. The 60-year-old, who was taking Avandamet (a combination of Avandia and metformin), died on May 21, the day a meta-analysis showing increased heart risks, by Dr. Steven Nissen of the Cleveland Clinic, was published in the New England Journal of Medicine. And Kaplan Fox & Kilsheimer LLP, a New York-based law firm, has filed a class-action lawsuit against the drugmaker on behalf of anyone who purchased shares between October 27, 2005, and May 21, 2007. The lawsuit alleges that although GlaxoSmithKline submitted partial data to the FDA in September 2005 and August 2006, it did not adequately disclose to the public that it had conducted a meta-analysis that showed an increased risk of heart attacks. When the results of Dr. Nissen's analysis were published on May 21, GlaxoSmithKline's share price dropped $4.53 (7.8%), according to the law firm.

WASHINGTON — The decision to perform fine-needle aspiration on a patient with a thyroid nodule depends on several factors, including nodule size, serum thyroid stimulating hormone level, and presenting symptoms, Dr. Erik Alexander said at a meeting jointly sponsored by the American Thyroid Association and Johns Hopkins University.

Dr. Alexander, who is with the division of endocrinology, diabetes, and hypertension at Brigham and Women's Hospital in Boston, outlined the algorithm he uses to evaluate a thyroid nodule.

Male gender, young age, and being symptomatic can increase the risk of a nodule being cancerous by about twofold, he said. But even if a nodule turns out to be cancerous, it doesn't necessarily mean that something has to be done about it.

“Do all thyroid cancers pose a danger? I think the answer likely is no,” said Dr. Alexander, who is also an assistant professor of medicine at Harvard Medical School, Boston. “Nodules that are over 1 cm are really the nodules and cancers that pose risk” because of their increased likelihood of distant metastasis.

One recent 10-year study of 650 patients with well-differentiated follicular or papillary thyroid carcinoma found that with papillary thyroid carcinoma, there was essentially a zero risk of extrathyroidal growth in cancers of 10 mm or less in diameter, further validating the idea of a 1-cm cutoff, Dr. Alexander said (Cancer 2005;103:2269–73).

Ultrasound imaging can help further determine the risk of a nodule being cancerous, but cannot rule out the need for fine-needle aspiration, Dr. Alexander noted. That's because several studies have shown that ultrasound identifies only about 80% of thyroid cancers. “Would any of us be willing to have a 20% false- negative rate? I don't think so.”

On the other hand, “Ultrasound is highly useful; it's most effective at assessing cancer risk,” he continued.

One study done at Dr. Alexander's hospital found that a woman who presents with a solitary nodule that is found on ultrasound to be completely solid with punctate calcifications has a 33% chance of that nodule being cancerous, while a woman who presents with a multiple nodules found on ultrasound to be mixed solid and cystic with rim or coarse calcifications has a much lower risk—about 6% (J. Clin. Endocrino. Metab. 2006;91:3411–7).

Dr. Alexander's approach to assessing thyroid nodules begins with a thyroid ultrasound. If no nodules greater than 1 cm are found, no more intervention is warranted. If a nodule greater than 1 cm is found, he orders a serum TSH test. If TSH is suppressed, he orders a thyroid scan to look for a toxic adenoma; if it is normal or elevated, he considers whether the patient is symptomatic or not.

In symptomatic patients, he performs fine-needle aspiration; for asymptomatic patients, he assesses their cancer risk—as determined by gender, ultrasound results, and serum TSH—as well as their comorbidities and, in an older population, estimated longevity, before deciding whether to proceed with aspiration.

He noted that 70% of nodules evaluated by fine-needle aspiration prove benign. And although Dr. Alexander's protocol puts the question of fine-needle aspiration at the end of the evaluation, “there are some individuals in which [an earlier] fine-needle aspiration would be helpful in giving you further data,” he said, adding that “fine-needle aspiration does not obligate you to further intervention,” even if suspicious or intermediate lesions are found.

WASHINGTON — The decision to perform fine-needle aspiration on a patient with a thyroid nodule depends on several factors, including nodule size, serum thyroid stimulating hormone level, and presenting symptoms, Dr. Erik Alexander said at a meeting jointly sponsored by the American Thyroid Association and Johns Hopkins University.

Dr. Alexander, who is with the division of endocrinology, diabetes, and hypertension at Brigham and Women's Hospital in Boston, outlined the algorithm he uses to evaluate a thyroid nodule.

Male gender, young age, and being symptomatic can increase the risk of a nodule being cancerous by about twofold, he said. But even if a nodule turns out to be cancerous, it doesn't necessarily mean that something has to be done about it.

“Do all thyroid cancers pose a danger? I think the answer likely is no,” said Dr. Alexander, who is also an assistant professor of medicine at Harvard Medical School, Boston. “Nodules that are over 1 cm are really the nodules and cancers that pose risk” because of their increased likelihood of distant metastasis.

One recent 10-year study of 650 patients with well-differentiated follicular or papillary thyroid carcinoma found that with papillary thyroid carcinoma, there was essentially a zero risk of extrathyroidal growth in cancers of 10 mm or less in diameter, further validating the idea of a 1-cm cutoff, Dr. Alexander said (Cancer 2005;103:2269–73).

Ultrasound imaging can help further determine the risk of a nodule being cancerous, but cannot rule out the need for fine-needle aspiration, Dr. Alexander noted. That's because several studies have shown that ultrasound identifies only about 80% of thyroid cancers. “Would any of us be willing to have a 20% false- negative rate? I don't think so.”

On the other hand, “Ultrasound is highly useful; it's most effective at assessing cancer risk,” he continued.

One study done at Dr. Alexander's hospital found that a woman who presents with a solitary nodule that is found on ultrasound to be completely solid with punctate calcifications has a 33% chance of that nodule being cancerous, while a woman who presents with a multiple nodules found on ultrasound to be mixed solid and cystic with rim or coarse calcifications has a much lower risk—about 6% (J. Clin. Endocrino. Metab. 2006;91:3411–7).

Dr. Alexander's approach to assessing thyroid nodules begins with a thyroid ultrasound. If no nodules greater than 1 cm are found, no more intervention is warranted. If a nodule greater than 1 cm is found, he orders a serum TSH test. If TSH is suppressed, he orders a thyroid scan to look for a toxic adenoma; if it is normal or elevated, he considers whether the patient is symptomatic or not.

In symptomatic patients, he performs fine-needle aspiration; for asymptomatic patients, he assesses their cancer risk—as determined by gender, ultrasound results, and serum TSH—as well as their comorbidities and, in an older population, estimated longevity, before deciding whether to proceed with aspiration.

He noted that 70% of nodules evaluated by fine-needle aspiration prove benign. And although Dr. Alexander's protocol puts the question of fine-needle aspiration at the end of the evaluation, “there are some individuals in which [an earlier] fine-needle aspiration would be helpful in giving you further data,” he said, adding that “fine-needle aspiration does not obligate you to further intervention,” even if suspicious or intermediate lesions are found.

WASHINGTON — The decision to perform fine-needle aspiration on a patient with a thyroid nodule depends on several factors, including nodule size, serum thyroid stimulating hormone level, and presenting symptoms, Dr. Erik Alexander said at a meeting jointly sponsored by the American Thyroid Association and Johns Hopkins University.

Dr. Alexander, who is with the division of endocrinology, diabetes, and hypertension at Brigham and Women's Hospital in Boston, outlined the algorithm he uses to evaluate a thyroid nodule.

Male gender, young age, and being symptomatic can increase the risk of a nodule being cancerous by about twofold, he said. But even if a nodule turns out to be cancerous, it doesn't necessarily mean that something has to be done about it.

“Do all thyroid cancers pose a danger? I think the answer likely is no,” said Dr. Alexander, who is also an assistant professor of medicine at Harvard Medical School, Boston. “Nodules that are over 1 cm are really the nodules and cancers that pose risk” because of their increased likelihood of distant metastasis.

One recent 10-year study of 650 patients with well-differentiated follicular or papillary thyroid carcinoma found that with papillary thyroid carcinoma, there was essentially a zero risk of extrathyroidal growth in cancers of 10 mm or less in diameter, further validating the idea of a 1-cm cutoff, Dr. Alexander said (Cancer 2005;103:2269–73).

Ultrasound imaging can help further determine the risk of a nodule being cancerous, but cannot rule out the need for fine-needle aspiration, Dr. Alexander noted. That's because several studies have shown that ultrasound identifies only about 80% of thyroid cancers. “Would any of us be willing to have a 20% false- negative rate? I don't think so.”

On the other hand, “Ultrasound is highly useful; it's most effective at assessing cancer risk,” he continued.

One study done at Dr. Alexander's hospital found that a woman who presents with a solitary nodule that is found on ultrasound to be completely solid with punctate calcifications has a 33% chance of that nodule being cancerous, while a woman who presents with a multiple nodules found on ultrasound to be mixed solid and cystic with rim or coarse calcifications has a much lower risk—about 6% (J. Clin. Endocrino. Metab. 2006;91:3411–7).

Dr. Alexander's approach to assessing thyroid nodules begins with a thyroid ultrasound. If no nodules greater than 1 cm are found, no more intervention is warranted. If a nodule greater than 1 cm is found, he orders a serum TSH test. If TSH is suppressed, he orders a thyroid scan to look for a toxic adenoma; if it is normal or elevated, he considers whether the patient is symptomatic or not.

In symptomatic patients, he performs fine-needle aspiration; for asymptomatic patients, he assesses their cancer risk—as determined by gender, ultrasound results, and serum TSH—as well as their comorbidities and, in an older population, estimated longevity, before deciding whether to proceed with aspiration.

He noted that 70% of nodules evaluated by fine-needle aspiration prove benign. And although Dr. Alexander's protocol puts the question of fine-needle aspiration at the end of the evaluation, “there are some individuals in which [an earlier] fine-needle aspiration would be helpful in giving you further data,” he said, adding that “fine-needle aspiration does not obligate you to further intervention,” even if suspicious or intermediate lesions are found.

Gender Disparities in Managed Care

Women with diabetes or heart disease who are in managed care plans are less likely to receive certain routine health services, compared with their male counterparts, according to a study by the Rand Corp. The study of more than 50,000 men and women enrolled in either a commercial or Medicare managed care plan in 1999 found that of 11 measures evaluated, women in commercial managed care plans were significantly less likely than men to receive the care in six measures; in Medicare managed care plans, they were less likely to receive care in four of the measures. For example, women with diabetes enrolled in a Medicare managed care plan were 19% less likely to have their cholesterol within recommended ranges; in commercial plans, they were 16% less likely to achieve that goal. Women also were less likely to be prescribed ACE inhibitors for chronic heart failure and to receive prescriptions for β-blockers following a heart attack. These disparities occurred even though women are generally more likely to see physicians more often, and even after researchers adjusted for socioeconomic factors that could affect care. The study appears in the May/June issue of the journal Women's Health Issues.

Drug Spending Expected to Surge

Spending on diabetes and endocrine drugs could increase nearly 70% over the next few years because of an increase in diabetes patients and more aggressive treatment of the disease, according to a study by Medco Health Solutions Inc., Franklin Lakes, N.J. The nation's aging population and rising incidence of obesity also will help fuel the trend, according to the company. Medco predicts annual spending growth rates on diabetes medications will rise upward of 16%–20% annually “as use increases each year by 8% to 10% and patients more frequently use new drug combinations to reach blood sugar targets.” Already, spending on diabetes treatments increased 14.5% from 2005 to 2006, second only to cholesterol-lowering medications. New treatments for diabetes also will contribute to future increases. Spending increases might be mitigated by several factors, including incentives to use generic drugs, greater use of mail-order pharmacies, and efforts to encourage more preventive care, the company notes.

Diabetes Bills Introduced

The American Diabetes Association has announced its support for two diabetes measures recently introduced in Congress. The Gestational Diabetes Act of 2007, sponsored by Sen. Hillary Clinton (D-N.Y.), Sen. Susan Collins (R-Maine), Rep. Eliot Engel (D-N.Y.), and Rep. Vito Fossella (R-N.Y.), aims to reduce the incidence of gestational diabetes by creating a government-led committee to develop multistate gestational diabetes research projects. The bill also provides money for demonstration projects that try to reduce the incidence of gestational diabetes, and provides for the tracking of women with the disease to prevent them from developing type 2 diabetes. The other bill, also introduced by the same members of Congress, is known as the Diabetes Treatment and Prevention Act of 2007. It would codify into law the Center for Disease Control and Prevention's division of diabetes translation and its work in diabetes surveillance and educational activities. It also would increase funding for state and local diabetes programs.

Medicare Chief Nominated

President Bush recently nominated Kerry N. Weems, a 24-year veteran of the Department of Health and Human Services, to lead the Centers for Medicare and Medicaid Services. Mr. Weems currently serves as deputy chief of staff to HHS Secretary Mike Leavitt. “He understands the large fiscal challenges facing Medicare and Medicaid and what it will take to strengthen and sustain those programs for the future,” Mr. Leavitt said in a statement. “Further, he has been a leader in this department's efforts to accelerate adoption of health information technology and better financial management systems.” If confirmed by the Senate, Mr. Weems will fill the vacancy left by Dr. Mark B. McClellan, who resigned from CMS last year.

Adults Disregard MDs' Orders

Forty-four percent of U.S. adults say they or an immediate family member have ignored a doctor's course of treatment or sought a second opinion because they felt the doctor's orders were unnecessary or overly aggressive, according to a survey. Most adults reported that they didn't view disregarding a doctor's recommendations as problematic or consequential. Only 1 in 10 adults who chose to disregard a physician's instructions at some time believes that he, she, or a family member experienced problems because of this decision. The survey was conducted by Harris Interactive for the Wall Street Journal Online's health industry edition.

Gender Disparities in Managed Care

Women with diabetes or heart disease who are in managed care plans are less likely to receive certain routine health services, compared with their male counterparts, according to a study by the Rand Corp. The study of more than 50,000 men and women enrolled in either a commercial or Medicare managed care plan in 1999 found that of 11 measures evaluated, women in commercial managed care plans were significantly less likely than men to receive the care in six measures; in Medicare managed care plans, they were less likely to receive care in four of the measures. For example, women with diabetes enrolled in a Medicare managed care plan were 19% less likely to have their cholesterol within recommended ranges; in commercial plans, they were 16% less likely to achieve that goal. Women also were less likely to be prescribed ACE inhibitors for chronic heart failure and to receive prescriptions for β-blockers following a heart attack. These disparities occurred even though women are generally more likely to see physicians more often, and even after researchers adjusted for socioeconomic factors that could affect care. The study appears in the May/June issue of the journal Women's Health Issues.

Drug Spending Expected to Surge

Spending on diabetes and endocrine drugs could increase nearly 70% over the next few years because of an increase in diabetes patients and more aggressive treatment of the disease, according to a study by Medco Health Solutions Inc., Franklin Lakes, N.J. The nation's aging population and rising incidence of obesity also will help fuel the trend, according to the company. Medco predicts annual spending growth rates on diabetes medications will rise upward of 16%–20% annually “as use increases each year by 8% to 10% and patients more frequently use new drug combinations to reach blood sugar targets.” Already, spending on diabetes treatments increased 14.5% from 2005 to 2006, second only to cholesterol-lowering medications. New treatments for diabetes also will contribute to future increases. Spending increases might be mitigated by several factors, including incentives to use generic drugs, greater use of mail-order pharmacies, and efforts to encourage more preventive care, the company notes.

Diabetes Bills Introduced

The American Diabetes Association has announced its support for two diabetes measures recently introduced in Congress. The Gestational Diabetes Act of 2007, sponsored by Sen. Hillary Clinton (D-N.Y.), Sen. Susan Collins (R-Maine), Rep. Eliot Engel (D-N.Y.), and Rep. Vito Fossella (R-N.Y.), aims to reduce the incidence of gestational diabetes by creating a government-led committee to develop multistate gestational diabetes research projects. The bill also provides money for demonstration projects that try to reduce the incidence of gestational diabetes, and provides for the tracking of women with the disease to prevent them from developing type 2 diabetes. The other bill, also introduced by the same members of Congress, is known as the Diabetes Treatment and Prevention Act of 2007. It would codify into law the Center for Disease Control and Prevention's division of diabetes translation and its work in diabetes surveillance and educational activities. It also would increase funding for state and local diabetes programs.

Medicare Chief Nominated

President Bush recently nominated Kerry N. Weems, a 24-year veteran of the Department of Health and Human Services, to lead the Centers for Medicare and Medicaid Services. Mr. Weems currently serves as deputy chief of staff to HHS Secretary Mike Leavitt. “He understands the large fiscal challenges facing Medicare and Medicaid and what it will take to strengthen and sustain those programs for the future,” Mr. Leavitt said in a statement. “Further, he has been a leader in this department's efforts to accelerate adoption of health information technology and better financial management systems.” If confirmed by the Senate, Mr. Weems will fill the vacancy left by Dr. Mark B. McClellan, who resigned from CMS last year.

Adults Disregard MDs' Orders

Forty-four percent of U.S. adults say they or an immediate family member have ignored a doctor's course of treatment or sought a second opinion because they felt the doctor's orders were unnecessary or overly aggressive, according to a survey. Most adults reported that they didn't view disregarding a doctor's recommendations as problematic or consequential. Only 1 in 10 adults who chose to disregard a physician's instructions at some time believes that he, she, or a family member experienced problems because of this decision. The survey was conducted by Harris Interactive for the Wall Street Journal Online's health industry edition.

Gender Disparities in Managed Care

Women with diabetes or heart disease who are in managed care plans are less likely to receive certain routine health services, compared with their male counterparts, according to a study by the Rand Corp. The study of more than 50,000 men and women enrolled in either a commercial or Medicare managed care plan in 1999 found that of 11 measures evaluated, women in commercial managed care plans were significantly less likely than men to receive the care in six measures; in Medicare managed care plans, they were less likely to receive care in four of the measures. For example, women with diabetes enrolled in a Medicare managed care plan were 19% less likely to have their cholesterol within recommended ranges; in commercial plans, they were 16% less likely to achieve that goal. Women also were less likely to be prescribed ACE inhibitors for chronic heart failure and to receive prescriptions for β-blockers following a heart attack. These disparities occurred even though women are generally more likely to see physicians more often, and even after researchers adjusted for socioeconomic factors that could affect care. The study appears in the May/June issue of the journal Women's Health Issues.

Drug Spending Expected to Surge

Spending on diabetes and endocrine drugs could increase nearly 70% over the next few years because of an increase in diabetes patients and more aggressive treatment of the disease, according to a study by Medco Health Solutions Inc., Franklin Lakes, N.J. The nation's aging population and rising incidence of obesity also will help fuel the trend, according to the company. Medco predicts annual spending growth rates on diabetes medications will rise upward of 16%–20% annually “as use increases each year by 8% to 10% and patients more frequently use new drug combinations to reach blood sugar targets.” Already, spending on diabetes treatments increased 14.5% from 2005 to 2006, second only to cholesterol-lowering medications. New treatments for diabetes also will contribute to future increases. Spending increases might be mitigated by several factors, including incentives to use generic drugs, greater use of mail-order pharmacies, and efforts to encourage more preventive care, the company notes.

Diabetes Bills Introduced

The American Diabetes Association has announced its support for two diabetes measures recently introduced in Congress. The Gestational Diabetes Act of 2007, sponsored by Sen. Hillary Clinton (D-N.Y.), Sen. Susan Collins (R-Maine), Rep. Eliot Engel (D-N.Y.), and Rep. Vito Fossella (R-N.Y.), aims to reduce the incidence of gestational diabetes by creating a government-led committee to develop multistate gestational diabetes research projects. The bill also provides money for demonstration projects that try to reduce the incidence of gestational diabetes, and provides for the tracking of women with the disease to prevent them from developing type 2 diabetes. The other bill, also introduced by the same members of Congress, is known as the Diabetes Treatment and Prevention Act of 2007. It would codify into law the Center for Disease Control and Prevention's division of diabetes translation and its work in diabetes surveillance and educational activities. It also would increase funding for state and local diabetes programs.

Medicare Chief Nominated

President Bush recently nominated Kerry N. Weems, a 24-year veteran of the Department of Health and Human Services, to lead the Centers for Medicare and Medicaid Services. Mr. Weems currently serves as deputy chief of staff to HHS Secretary Mike Leavitt. “He understands the large fiscal challenges facing Medicare and Medicaid and what it will take to strengthen and sustain those programs for the future,” Mr. Leavitt said in a statement. “Further, he has been a leader in this department's efforts to accelerate adoption of health information technology and better financial management systems.” If confirmed by the Senate, Mr. Weems will fill the vacancy left by Dr. Mark B. McClellan, who resigned from CMS last year.

Adults Disregard MDs' Orders

Forty-four percent of U.S. adults say they or an immediate family member have ignored a doctor's course of treatment or sought a second opinion because they felt the doctor's orders were unnecessary or overly aggressive, according to a survey. Most adults reported that they didn't view disregarding a doctor's recommendations as problematic or consequential. Only 1 in 10 adults who chose to disregard a physician's instructions at some time believes that he, she, or a family member experienced problems because of this decision. The survey was conducted by Harris Interactive for the Wall Street Journal Online's health industry edition.

WASHINGTON — A June 6 congressional hearing on the approval process and oversight of rosiglitazone found members of Congress pointing accusatory fingers at almost everyone who testified, including officials from the Food and Drug Administration, the company producing the drug, and the scientist who published a study expressing concerns about the drug's cardiovascular effects.

Rep. Henry Waxman (D-Calif.), chairman of the House Committee on Oversight and Government Reform, set the tone for the hearing in his opening statement. “It is not Congress' role to adjudicate these medical issues,” he declared. “But it is our role to ensure that the Food and Drug Administration is taking these concerns seriously and providing doctors and patients with the guidance they need to make informed decisions.”

Committee member Darryl Issa (R-Calif.) fired back, questioning the need for the hearing. “I'm concerned that we not tread too closely toward the hypocrisy this hearing begins to look like,” he said. “Politicizing science is what we could be doing here today.”

The hearing was held 3 weeks after Dr. Steven Nissen of the Cleveland Clinic and his colleague, Kathy Wolski, published a meta-analysis in the online edition of the New England Journal of Medicine suggesting that type 2 diabetes patients taking rosiglitazone had a 43% higher risk of myocardial infarction (MI) compared with patients on other drug treatments. (See story, p. 1.)

The day before the congressional hearing, the journal published interim results from the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD) trial, which looked at hospitalization or death from cardiovascular causes. The authors concluded that “the data were insufficient to determine whether the drug was associated with an increase in the risk of myocardial infarction” (Epub doi: 10.1056/NEJMoa073394). Three accompanying editorials all suggested that such a risk warranted careful consideration of the drug's use.

At the hearing, Rep. Waxman questioned FDA Commissioner Dr. Andrew von Eschenbach about why the agency did not take seriously the concerns of one of its own medical reviewers at the time the drug was approved.

Although the drug achieved the purpose of lowering blood sugar in patients with type 2 diabetes, “the increase in body weight and undesirable effects on serum lipids is cause for concern … It cannot be assumed that treatment with rosiglitazone will decrease the risk” of heart disease, according to the FDA's medical review dated April 1999. The reviewer recommended that a postmarketing study be done to address those concerns.

Dr. von Eschenbach defended the agency's actions, noting that the FDA has been monitoring cardiovascular adverse events, including edema and heart failure, since rosiglitazone was approved. He also said that rosiglitazone's label was updated in April 2006 to include new warnings about a potential increase in MIs in heart failure patients.

Dr. von Eschenbach noted that the agency was still analyzing follow-up data that it has received, and that it has scheduled an advisory committee meeting for July 30 to discuss whether additional action needs to be taken.

Rep. Issa admonished Dr. Nissen for his failure to share his findings with the FDA prior to publication. “You didn't even give them the benefit of the doubt,” Rep. Issa said.

Dr. Nissen responded that the FDA had access to all the data he had and added that submitting findings for peer review and publication was standard scientific practice.

Dr. John Buse, president-elect of the American Diabetes Association and director of the Diabetes Care Center at the University of North Carolina, Chapel Hill, testified that he first raised the issue of rosiglitazone's cardiovascular side effects in 1999. Dr. Buse said that officials at SmithKline Beecham—the predecessor to GlasxoSmithKline—then tried to intimidate him, implying that he could be held personally liable for the $4-billion drop in the company's value that occurred after his concerns became widely known.

In response to a question from Rep. Waxman about the “shocking” way Dr. Buse was treated, Moncef Slaoui, Ph.D., chairman of research and development at GSK, said that “there was a lot of passion on his side and on the side of the [company's] scientists” regarding the issue of rosiglitazone's safety. “We regret that Dr. Buse felt pressured.”

Dr. Steven Nissen of the Cleveland Clinic testifies at a congressional hearing on the oversight of Avandia. Jay Westcott/Elsevier Global Medical News

WASHINGTON — A June 6 congressional hearing on the approval process and oversight of rosiglitazone found members of Congress pointing accusatory fingers at almost everyone who testified, including officials from the Food and Drug Administration, the company producing the drug, and the scientist who published a study expressing concerns about the drug's cardiovascular effects.

Rep. Henry Waxman (D-Calif.), chairman of the House Committee on Oversight and Government Reform, set the tone for the hearing in his opening statement. “It is not Congress' role to adjudicate these medical issues,” he declared. “But it is our role to ensure that the Food and Drug Administration is taking these concerns seriously and providing doctors and patients with the guidance they need to make informed decisions.”

Committee member Darryl Issa (R-Calif.) fired back, questioning the need for the hearing. “I'm concerned that we not tread too closely toward the hypocrisy this hearing begins to look like,” he said. “Politicizing science is what we could be doing here today.”

The hearing was held 3 weeks after Dr. Steven Nissen of the Cleveland Clinic and his colleague, Kathy Wolski, published a meta-analysis in the online edition of the New England Journal of Medicine suggesting that type 2 diabetes patients taking rosiglitazone had a 43% higher risk of myocardial infarction (MI) compared with patients on other drug treatments. (See story, p. 1.)

The day before the congressional hearing, the journal published interim results from the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD) trial, which looked at hospitalization or death from cardiovascular causes. The authors concluded that “the data were insufficient to determine whether the drug was associated with an increase in the risk of myocardial infarction” (Epub doi: 10.1056/NEJMoa073394). Three accompanying editorials all suggested that such a risk warranted careful consideration of the drug's use.

At the hearing, Rep. Waxman questioned FDA Commissioner Dr. Andrew von Eschenbach about why the agency did not take seriously the concerns of one of its own medical reviewers at the time the drug was approved.

Although the drug achieved the purpose of lowering blood sugar in patients with type 2 diabetes, “the increase in body weight and undesirable effects on serum lipids is cause for concern … It cannot be assumed that treatment with rosiglitazone will decrease the risk” of heart disease, according to the FDA's medical review dated April 1999. The reviewer recommended that a postmarketing study be done to address those concerns.

Dr. von Eschenbach defended the agency's actions, noting that the FDA has been monitoring cardiovascular adverse events, including edema and heart failure, since rosiglitazone was approved. He also said that rosiglitazone's label was updated in April 2006 to include new warnings about a potential increase in MIs in heart failure patients.

Dr. von Eschenbach noted that the agency was still analyzing follow-up data that it has received, and that it has scheduled an advisory committee meeting for July 30 to discuss whether additional action needs to be taken.

Rep. Issa admonished Dr. Nissen for his failure to share his findings with the FDA prior to publication. “You didn't even give them the benefit of the doubt,” Rep. Issa said.

Dr. Nissen responded that the FDA had access to all the data he had and added that submitting findings for peer review and publication was standard scientific practice.

Dr. John Buse, president-elect of the American Diabetes Association and director of the Diabetes Care Center at the University of North Carolina, Chapel Hill, testified that he first raised the issue of rosiglitazone's cardiovascular side effects in 1999. Dr. Buse said that officials at SmithKline Beecham—the predecessor to GlasxoSmithKline—then tried to intimidate him, implying that he could be held personally liable for the $4-billion drop in the company's value that occurred after his concerns became widely known.

In response to a question from Rep. Waxman about the “shocking” way Dr. Buse was treated, Moncef Slaoui, Ph.D., chairman of research and development at GSK, said that “there was a lot of passion on his side and on the side of the [company's] scientists” regarding the issue of rosiglitazone's safety. “We regret that Dr. Buse felt pressured.”

Dr. Steven Nissen of the Cleveland Clinic testifies at a congressional hearing on the oversight of Avandia. Jay Westcott/Elsevier Global Medical News

WASHINGTON — A June 6 congressional hearing on the approval process and oversight of rosiglitazone found members of Congress pointing accusatory fingers at almost everyone who testified, including officials from the Food and Drug Administration, the company producing the drug, and the scientist who published a study expressing concerns about the drug's cardiovascular effects.

Rep. Henry Waxman (D-Calif.), chairman of the House Committee on Oversight and Government Reform, set the tone for the hearing in his opening statement. “It is not Congress' role to adjudicate these medical issues,” he declared. “But it is our role to ensure that the Food and Drug Administration is taking these concerns seriously and providing doctors and patients with the guidance they need to make informed decisions.”

Committee member Darryl Issa (R-Calif.) fired back, questioning the need for the hearing. “I'm concerned that we not tread too closely toward the hypocrisy this hearing begins to look like,” he said. “Politicizing science is what we could be doing here today.”

The hearing was held 3 weeks after Dr. Steven Nissen of the Cleveland Clinic and his colleague, Kathy Wolski, published a meta-analysis in the online edition of the New England Journal of Medicine suggesting that type 2 diabetes patients taking rosiglitazone had a 43% higher risk of myocardial infarction (MI) compared with patients on other drug treatments. (See story, p. 1.)

The day before the congressional hearing, the journal published interim results from the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD) trial, which looked at hospitalization or death from cardiovascular causes. The authors concluded that “the data were insufficient to determine whether the drug was associated with an increase in the risk of myocardial infarction” (Epub doi: 10.1056/NEJMoa073394). Three accompanying editorials all suggested that such a risk warranted careful consideration of the drug's use.

At the hearing, Rep. Waxman questioned FDA Commissioner Dr. Andrew von Eschenbach about why the agency did not take seriously the concerns of one of its own medical reviewers at the time the drug was approved.

Although the drug achieved the purpose of lowering blood sugar in patients with type 2 diabetes, “the increase in body weight and undesirable effects on serum lipids is cause for concern … It cannot be assumed that treatment with rosiglitazone will decrease the risk” of heart disease, according to the FDA's medical review dated April 1999. The reviewer recommended that a postmarketing study be done to address those concerns.

Dr. von Eschenbach defended the agency's actions, noting that the FDA has been monitoring cardiovascular adverse events, including edema and heart failure, since rosiglitazone was approved. He also said that rosiglitazone's label was updated in April 2006 to include new warnings about a potential increase in MIs in heart failure patients.

Dr. von Eschenbach noted that the agency was still analyzing follow-up data that it has received, and that it has scheduled an advisory committee meeting for July 30 to discuss whether additional action needs to be taken.

Rep. Issa admonished Dr. Nissen for his failure to share his findings with the FDA prior to publication. “You didn't even give them the benefit of the doubt,” Rep. Issa said.

Dr. Nissen responded that the FDA had access to all the data he had and added that submitting findings for peer review and publication was standard scientific practice.

Dr. John Buse, president-elect of the American Diabetes Association and director of the Diabetes Care Center at the University of North Carolina, Chapel Hill, testified that he first raised the issue of rosiglitazone's cardiovascular side effects in 1999. Dr. Buse said that officials at SmithKline Beecham—the predecessor to GlasxoSmithKline—then tried to intimidate him, implying that he could be held personally liable for the $4-billion drop in the company's value that occurred after his concerns became widely known.

In response to a question from Rep. Waxman about the “shocking” way Dr. Buse was treated, Moncef Slaoui, Ph.D., chairman of research and development at GSK, said that “there was a lot of passion on his side and on the side of the [company's] scientists” regarding the issue of rosiglitazone's safety. “We regret that Dr. Buse felt pressured.”

Dr. Steven Nissen of the Cleveland Clinic testifies at a congressional hearing on the oversight of Avandia. Jay Westcott/Elsevier Global Medical News

Obesity Ups Workers' Comp Costs

Obesity can have a negative effect on workers' compensation costs for employers, according to a study by Duke University researchers. The study looked at records of nearly 12,000 Duke employees over a 7-year period and found that obese workers filed twice as many workers' compensation claims and had medical costs seven times higher than those of nonobese workers. They also lost 13 times more work days because of work-related injuries and illnesses. “Given the strong link between obesity and workers' compensation, maintaining healthy weight is not only important to workers but should also be a high priority for employers,” said Dr. Truls Ostbye, professor of community and family medicine at the university and lead author of the study. “Work-based programs designed to target healthful eating and physical activity should be developed and then evaluated as part of a strategy to make all workplaces healthier and safer.” The study appeared in the April 23 issue of Archives of Internal Medicine.

Osteoporosis Audit in the Works

European experts are planning an audit to determine the status of osteoporosis in Europe. Current estimates are that in the European Union, an osteoporosis-related fracture occurs every 30 seconds, and with an aging population, the number of osteoporosis-related hip fractures is expected to double from about 500,000 to 1 million annually over the next 50 years, according to the International Osteoporosis Foundation (IOF). The IOF supports the EU Osteoporosis Consultation Panel, the group planning the audit. “We need this new [audit] to evaluate current standards of osteoporosis management in Europe,” said Juliet Compston, chair of the consultation panel. “This comprehensive snapshot will enable members to assess developments over the years, and identify areas that require more attention.”

ADA Launches 'CheckUp America'

The American Diabetes Association has launched a campaign to help Americans learn how to lower their risks of type 2 diabetes and heart disease. The “CheckUp America” campaign, which is funded by several pharmaceutical companies, includes an online risk assessment called My Health Advisor. Based on an individual's self-reported health status, the tool will assess the person's risk for type 2 diabetes, heart attack, stroke, and death, and will also suggest simple things the person can do to lower his or her risk. “Our major goal is to dispel the myth that disease prevention requires an extraordinary effort,” said Dr. John Buse, president-elect, medicine and science, at the ADA. “Helping individuals understand and apply this information could mean the difference between life and death.”

Group Receives $35 Million Grant

The Sumner M. Redstone Charitable Foundation has awarded a $35 million, 5-year grant to FasterCures/The Center for Accelerating Medical Solutions. FasterCures, founded 4 years ago, formed the Research Acceleration and Innovation Network to bring together disease research organizations that are focused on innovative research on diseases such as diabetes, heart disease, AIDS, and breast cancer. “One of our goals is to remove many of the bureaucratic and regulatory barriers that researchers face in pursuing better treatments and cures for all life-threatening conditions,” said FasterCures chairman Michael Milken. The grant also will be used to support FasterCures' Patients Helping Doctors program, which works to speed recruitment of patients for clinical trials.

Chicago Employers Tackle Diabetes

The Midwest Business Group on Health, a Chicago-based group of employers, has established an employer-based diabetes self-management program endorsed by the Institute of Medicine of Chicago. In the Taking Control of Your Health program, which is funded by Novo Nordisk Inc. and Novartis, employers will waive or lower copays for diabetes medications as an incentive to get patients to adhere to their medication regimens. Patients will also meet regularly with a pharmacist coach who is specially trained in diabetes education and monitoring. The program is modeled after several successful programs, including the Asheville Project in North Carolina. “The pharmacist's role is to be an educator and motivator, ensuring the patient follows their physician's orders and understands how to manage and monitor their diabetes and medications,” said MBGH president and CEO Larry Boress. MBGH is one of the groups participating in the Diabetes Ten-City Challenge, a national diabetes self-management program conducted by the American Pharmaceutical Association and funded by GlaxoSmithKline Inc.

Juries Side With MDs

Contrary to popular belief, juries in malpractice cases actually sympathize more with physicians and less with their patients, according to a law professor who performed an extensive review of studies involving malpractice cases from 1989 to 2006. Philip Peters, professor of law at the University of Missouri-Columbia, found that plaintiffs rarely win weak cases, although they have more success in cases viewed as a “toss-up” and better outcomes in cases with strong evidence of medical negligence. Mr. Peters, whose study appeared in the May edition of the Michigan Law Review, said that several factors systematically favor medical defendants in the courtroom, including the defendants' superior resources, physicians' social standing, social norms against “profiting” by injury, and the jury's willingness to give physicians the benefit of the doubt when evidence conflicts.

Obesity Ups Workers' Comp Costs

Obesity can have a negative effect on workers' compensation costs for employers, according to a study by Duke University researchers. The study looked at records of nearly 12,000 Duke employees over a 7-year period and found that obese workers filed twice as many workers' compensation claims and had medical costs seven times higher than those of nonobese workers. They also lost 13 times more work days because of work-related injuries and illnesses. “Given the strong link between obesity and workers' compensation, maintaining healthy weight is not only important to workers but should also be a high priority for employers,” said Dr. Truls Ostbye, professor of community and family medicine at the university and lead author of the study. “Work-based programs designed to target healthful eating and physical activity should be developed and then evaluated as part of a strategy to make all workplaces healthier and safer.” The study appeared in the April 23 issue of Archives of Internal Medicine.

Osteoporosis Audit in the Works

European experts are planning an audit to determine the status of osteoporosis in Europe. Current estimates are that in the European Union, an osteoporosis-related fracture occurs every 30 seconds, and with an aging population, the number of osteoporosis-related hip fractures is expected to double from about 500,000 to 1 million annually over the next 50 years, according to the International Osteoporosis Foundation (IOF). The IOF supports the EU Osteoporosis Consultation Panel, the group planning the audit. “We need this new [audit] to evaluate current standards of osteoporosis management in Europe,” said Juliet Compston, chair of the consultation panel. “This comprehensive snapshot will enable members to assess developments over the years, and identify areas that require more attention.”

ADA Launches 'CheckUp America'

The American Diabetes Association has launched a campaign to help Americans learn how to lower their risks of type 2 diabetes and heart disease. The “CheckUp America” campaign, which is funded by several pharmaceutical companies, includes an online risk assessment called My Health Advisor. Based on an individual's self-reported health status, the tool will assess the person's risk for type 2 diabetes, heart attack, stroke, and death, and will also suggest simple things the person can do to lower his or her risk. “Our major goal is to dispel the myth that disease prevention requires an extraordinary effort,” said Dr. John Buse, president-elect, medicine and science, at the ADA. “Helping individuals understand and apply this information could mean the difference between life and death.”

Group Receives $35 Million Grant

The Sumner M. Redstone Charitable Foundation has awarded a $35 million, 5-year grant to FasterCures/The Center for Accelerating Medical Solutions. FasterCures, founded 4 years ago, formed the Research Acceleration and Innovation Network to bring together disease research organizations that are focused on innovative research on diseases such as diabetes, heart disease, AIDS, and breast cancer. “One of our goals is to remove many of the bureaucratic and regulatory barriers that researchers face in pursuing better treatments and cures for all life-threatening conditions,” said FasterCures chairman Michael Milken. The grant also will be used to support FasterCures' Patients Helping Doctors program, which works to speed recruitment of patients for clinical trials.

Chicago Employers Tackle Diabetes

The Midwest Business Group on Health, a Chicago-based group of employers, has established an employer-based diabetes self-management program endorsed by the Institute of Medicine of Chicago. In the Taking Control of Your Health program, which is funded by Novo Nordisk Inc. and Novartis, employers will waive or lower copays for diabetes medications as an incentive to get patients to adhere to their medication regimens. Patients will also meet regularly with a pharmacist coach who is specially trained in diabetes education and monitoring. The program is modeled after several successful programs, including the Asheville Project in North Carolina. “The pharmacist's role is to be an educator and motivator, ensuring the patient follows their physician's orders and understands how to manage and monitor their diabetes and medications,” said MBGH president and CEO Larry Boress. MBGH is one of the groups participating in the Diabetes Ten-City Challenge, a national diabetes self-management program conducted by the American Pharmaceutical Association and funded by GlaxoSmithKline Inc.

Juries Side With MDs

Contrary to popular belief, juries in malpractice cases actually sympathize more with physicians and less with their patients, according to a law professor who performed an extensive review of studies involving malpractice cases from 1989 to 2006. Philip Peters, professor of law at the University of Missouri-Columbia, found that plaintiffs rarely win weak cases, although they have more success in cases viewed as a “toss-up” and better outcomes in cases with strong evidence of medical negligence. Mr. Peters, whose study appeared in the May edition of the Michigan Law Review, said that several factors systematically favor medical defendants in the courtroom, including the defendants' superior resources, physicians' social standing, social norms against “profiting” by injury, and the jury's willingness to give physicians the benefit of the doubt when evidence conflicts.

Obesity Ups Workers' Comp Costs

Obesity can have a negative effect on workers' compensation costs for employers, according to a study by Duke University researchers. The study looked at records of nearly 12,000 Duke employees over a 7-year period and found that obese workers filed twice as many workers' compensation claims and had medical costs seven times higher than those of nonobese workers. They also lost 13 times more work days because of work-related injuries and illnesses. “Given the strong link between obesity and workers' compensation, maintaining healthy weight is not only important to workers but should also be a high priority for employers,” said Dr. Truls Ostbye, professor of community and family medicine at the university and lead author of the study. “Work-based programs designed to target healthful eating and physical activity should be developed and then evaluated as part of a strategy to make all workplaces healthier and safer.” The study appeared in the April 23 issue of Archives of Internal Medicine.

Osteoporosis Audit in the Works

European experts are planning an audit to determine the status of osteoporosis in Europe. Current estimates are that in the European Union, an osteoporosis-related fracture occurs every 30 seconds, and with an aging population, the number of osteoporosis-related hip fractures is expected to double from about 500,000 to 1 million annually over the next 50 years, according to the International Osteoporosis Foundation (IOF). The IOF supports the EU Osteoporosis Consultation Panel, the group planning the audit. “We need this new [audit] to evaluate current standards of osteoporosis management in Europe,” said Juliet Compston, chair of the consultation panel. “This comprehensive snapshot will enable members to assess developments over the years, and identify areas that require more attention.”

ADA Launches 'CheckUp America'

The American Diabetes Association has launched a campaign to help Americans learn how to lower their risks of type 2 diabetes and heart disease. The “CheckUp America” campaign, which is funded by several pharmaceutical companies, includes an online risk assessment called My Health Advisor. Based on an individual's self-reported health status, the tool will assess the person's risk for type 2 diabetes, heart attack, stroke, and death, and will also suggest simple things the person can do to lower his or her risk. “Our major goal is to dispel the myth that disease prevention requires an extraordinary effort,” said Dr. John Buse, president-elect, medicine and science, at the ADA. “Helping individuals understand and apply this information could mean the difference between life and death.”

Group Receives $35 Million Grant

The Sumner M. Redstone Charitable Foundation has awarded a $35 million, 5-year grant to FasterCures/The Center for Accelerating Medical Solutions. FasterCures, founded 4 years ago, formed the Research Acceleration and Innovation Network to bring together disease research organizations that are focused on innovative research on diseases such as diabetes, heart disease, AIDS, and breast cancer. “One of our goals is to remove many of the bureaucratic and regulatory barriers that researchers face in pursuing better treatments and cures for all life-threatening conditions,” said FasterCures chairman Michael Milken. The grant also will be used to support FasterCures' Patients Helping Doctors program, which works to speed recruitment of patients for clinical trials.

Chicago Employers Tackle Diabetes

The Midwest Business Group on Health, a Chicago-based group of employers, has established an employer-based diabetes self-management program endorsed by the Institute of Medicine of Chicago. In the Taking Control of Your Health program, which is funded by Novo Nordisk Inc. and Novartis, employers will waive or lower copays for diabetes medications as an incentive to get patients to adhere to their medication regimens. Patients will also meet regularly with a pharmacist coach who is specially trained in diabetes education and monitoring. The program is modeled after several successful programs, including the Asheville Project in North Carolina. “The pharmacist's role is to be an educator and motivator, ensuring the patient follows their physician's orders and understands how to manage and monitor their diabetes and medications,” said MBGH president and CEO Larry Boress. MBGH is one of the groups participating in the Diabetes Ten-City Challenge, a national diabetes self-management program conducted by the American Pharmaceutical Association and funded by GlaxoSmithKline Inc.

Juries Side With MDs

Contrary to popular belief, juries in malpractice cases actually sympathize more with physicians and less with their patients, according to a law professor who performed an extensive review of studies involving malpractice cases from 1989 to 2006. Philip Peters, professor of law at the University of Missouri-Columbia, found that plaintiffs rarely win weak cases, although they have more success in cases viewed as a “toss-up” and better outcomes in cases with strong evidence of medical negligence. Mr. Peters, whose study appeared in the May edition of the Michigan Law Review, said that several factors systematically favor medical defendants in the courtroom, including the defendants' superior resources, physicians' social standing, social norms against “profiting” by injury, and the jury's willingness to give physicians the benefit of the doubt when evidence conflicts.

Increased Flu Vaccines Urged

The National Foundation for Infectious Diseases is asking providers and public health agencies to try to increase influenza vaccination rates for patients with diabetes. The foundation notes that more than 10 million Americans with diabetes do not receive an annual flu vaccination. “Complications from influenza can be serious and even fatal to those with diabetes,” NFID vice president Dr. William Schaffner said in statement. “Many health care professionals come in contact with these high-risk patients and all can play a role in increasing influenza vaccination rates.” Dr. Susan Rehm, the foundation's medical director, urged professional societies to get involved. “These groups should add annual influenza vaccination to their quality assurance checklists, which will help ensure their members offer adults and children with diabetes complete care according to longstanding national recommendations,” she said. Organizations supporting the NFID's initiative to get more diabetes patients vaccinated include the American Diabetes Association, the American Association of Diabetes Educators, and the American Medical Association.

Chicago Project Gets Donation

The Christopher Family Foundation has donated $1 million to the Chicago Project, an international consortium of researchers working on a cure for diabetes. The 3-year-old consortium, led by Dr. Jose Oberholzer of the University of Illinois at Chicago, is focusing on islet cell transplantation. “We believe in Dr. Oberholzer's research,” foundation board member Kelley Christopher Schueler said in a statement. “We hope other foundations and philanthropists will see our faith in the project and feel compelled to support this cause too.” Dr. Oberholzer said the gift “will allow us to continue our work in a number of crucial areas, including preclinical trials and technology for microcapsule formation and provisions for islet cell expansion.” The consortium includes researchers in Switzerland, France, Israel, Canada, and the United States.

Medicaid Diabetes Bill Introduced

Sen. Chuck Schumer (D-N.Y.) and Sen. Pete Domenici (R-N.M.) have introduced the “Diabetes Screening and Medicaid Savings Act.” The bill would require state Medicaid programs to cover screening for patients who are at risk for diabetes, and to cover insulin, diabetes education, and foot exams for diabetes patients. The bill also would ensure that these services would not be subject to cost-sharing; currently, coverage and cost-sharing rules for diabetes screening and treatment vary from state to state. Private insurance is also to blame, Sen. Schumer said in a statement, noting that many private insurers will often cover more than $11,000 for a prosthesis following a diabetes-related leg amputation, but will not cover preventive consultations with podiatrists that cost $100 and could save a patient's leg. “An ounce of prevention is worth a pound of cure,” he said. “It is essential we take a new approach toward diabetes care by focusing on early-age prevention rather than spending more on costly end-of-life care.” The American Diabetes Association endorsed the measure, noting that if more attention is not paid to covering diabetes screening and treatment, “we will be setting our health care system up for failure.”

CMS Extends Form Deadline

The Centers for Medicare and Medicaid Services has extended the deadline for filing Medicare claims using its new version of claims form CMS-1500, because of formatting errors on the revised form, CMS announced. The original deadline for switching to the new form—known as CMS-1500 (08/05)—was April 2. But CMS said last month that contractors have been directed to continue to accept the old form until the agency notifies them to stop. Additionally, the agency advised physicians who must use the form to use legacy provider numbers, since the form cannot accommodate a National Provider Identifier (NPI) number.

Uninsured Kids Fare Worse

Injured, uninsured children who are hospitalized were twice as likely to die of their injuries as were their insured counterparts, according to a new study from advocacy group Families USA. Among children admitted with traumatic brain injury, uninsured children were more than twice as likely to die while in the hospital as were insured children. Uninsured children also were less likely to get expensive treatment or rehabilitation, the report said. And among children admitted to the hospital with otitis media, uninsured children were less than half as likely to get ear tubes inserted than were insured children. “The clear implication of this ground-breaking data is that, when kids get hurt or sick, insurance matters,” Families USA executive director Ron Pollack said in a statement.

Increased Flu Vaccines Urged

The National Foundation for Infectious Diseases is asking providers and public health agencies to try to increase influenza vaccination rates for patients with diabetes. The foundation notes that more than 10 million Americans with diabetes do not receive an annual flu vaccination. “Complications from influenza can be serious and even fatal to those with diabetes,” NFID vice president Dr. William Schaffner said in statement. “Many health care professionals come in contact with these high-risk patients and all can play a role in increasing influenza vaccination rates.” Dr. Susan Rehm, the foundation's medical director, urged professional societies to get involved. “These groups should add annual influenza vaccination to their quality assurance checklists, which will help ensure their members offer adults and children with diabetes complete care according to longstanding national recommendations,” she said. Organizations supporting the NFID's initiative to get more diabetes patients vaccinated include the American Diabetes Association, the American Association of Diabetes Educators, and the American Medical Association.

Chicago Project Gets Donation

The Christopher Family Foundation has donated $1 million to the Chicago Project, an international consortium of researchers working on a cure for diabetes. The 3-year-old consortium, led by Dr. Jose Oberholzer of the University of Illinois at Chicago, is focusing on islet cell transplantation. “We believe in Dr. Oberholzer's research,” foundation board member Kelley Christopher Schueler said in a statement. “We hope other foundations and philanthropists will see our faith in the project and feel compelled to support this cause too.” Dr. Oberholzer said the gift “will allow us to continue our work in a number of crucial areas, including preclinical trials and technology for microcapsule formation and provisions for islet cell expansion.” The consortium includes researchers in Switzerland, France, Israel, Canada, and the United States.

Medicaid Diabetes Bill Introduced

Sen. Chuck Schumer (D-N.Y.) and Sen. Pete Domenici (R-N.M.) have introduced the “Diabetes Screening and Medicaid Savings Act.” The bill would require state Medicaid programs to cover screening for patients who are at risk for diabetes, and to cover insulin, diabetes education, and foot exams for diabetes patients. The bill also would ensure that these services would not be subject to cost-sharing; currently, coverage and cost-sharing rules for diabetes screening and treatment vary from state to state. Private insurance is also to blame, Sen. Schumer said in a statement, noting that many private insurers will often cover more than $11,000 for a prosthesis following a diabetes-related leg amputation, but will not cover preventive consultations with podiatrists that cost $100 and could save a patient's leg. “An ounce of prevention is worth a pound of cure,” he said. “It is essential we take a new approach toward diabetes care by focusing on early-age prevention rather than spending more on costly end-of-life care.” The American Diabetes Association endorsed the measure, noting that if more attention is not paid to covering diabetes screening and treatment, “we will be setting our health care system up for failure.”

CMS Extends Form Deadline

The Centers for Medicare and Medicaid Services has extended the deadline for filing Medicare claims using its new version of claims form CMS-1500, because of formatting errors on the revised form, CMS announced. The original deadline for switching to the new form—known as CMS-1500 (08/05)—was April 2. But CMS said last month that contractors have been directed to continue to accept the old form until the agency notifies them to stop. Additionally, the agency advised physicians who must use the form to use legacy provider numbers, since the form cannot accommodate a National Provider Identifier (NPI) number.

Uninsured Kids Fare Worse

Injured, uninsured children who are hospitalized were twice as likely to die of their injuries as were their insured counterparts, according to a new study from advocacy group Families USA. Among children admitted with traumatic brain injury, uninsured children were more than twice as likely to die while in the hospital as were insured children. Uninsured children also were less likely to get expensive treatment or rehabilitation, the report said. And among children admitted to the hospital with otitis media, uninsured children were less than half as likely to get ear tubes inserted than were insured children. “The clear implication of this ground-breaking data is that, when kids get hurt or sick, insurance matters,” Families USA executive director Ron Pollack said in a statement.

Increased Flu Vaccines Urged

The National Foundation for Infectious Diseases is asking providers and public health agencies to try to increase influenza vaccination rates for patients with diabetes. The foundation notes that more than 10 million Americans with diabetes do not receive an annual flu vaccination. “Complications from influenza can be serious and even fatal to those with diabetes,” NFID vice president Dr. William Schaffner said in statement. “Many health care professionals come in contact with these high-risk patients and all can play a role in increasing influenza vaccination rates.” Dr. Susan Rehm, the foundation's medical director, urged professional societies to get involved. “These groups should add annual influenza vaccination to their quality assurance checklists, which will help ensure their members offer adults and children with diabetes complete care according to longstanding national recommendations,” she said. Organizations supporting the NFID's initiative to get more diabetes patients vaccinated include the American Diabetes Association, the American Association of Diabetes Educators, and the American Medical Association.

Chicago Project Gets Donation

The Christopher Family Foundation has donated $1 million to the Chicago Project, an international consortium of researchers working on a cure for diabetes. The 3-year-old consortium, led by Dr. Jose Oberholzer of the University of Illinois at Chicago, is focusing on islet cell transplantation. “We believe in Dr. Oberholzer's research,” foundation board member Kelley Christopher Schueler said in a statement. “We hope other foundations and philanthropists will see our faith in the project and feel compelled to support this cause too.” Dr. Oberholzer said the gift “will allow us to continue our work in a number of crucial areas, including preclinical trials and technology for microcapsule formation and provisions for islet cell expansion.” The consortium includes researchers in Switzerland, France, Israel, Canada, and the United States.

Medicaid Diabetes Bill Introduced

Sen. Chuck Schumer (D-N.Y.) and Sen. Pete Domenici (R-N.M.) have introduced the “Diabetes Screening and Medicaid Savings Act.” The bill would require state Medicaid programs to cover screening for patients who are at risk for diabetes, and to cover insulin, diabetes education, and foot exams for diabetes patients. The bill also would ensure that these services would not be subject to cost-sharing; currently, coverage and cost-sharing rules for diabetes screening and treatment vary from state to state. Private insurance is also to blame, Sen. Schumer said in a statement, noting that many private insurers will often cover more than $11,000 for a prosthesis following a diabetes-related leg amputation, but will not cover preventive consultations with podiatrists that cost $100 and could save a patient's leg. “An ounce of prevention is worth a pound of cure,” he said. “It is essential we take a new approach toward diabetes care by focusing on early-age prevention rather than spending more on costly end-of-life care.” The American Diabetes Association endorsed the measure, noting that if more attention is not paid to covering diabetes screening and treatment, “we will be setting our health care system up for failure.”

CMS Extends Form Deadline

The Centers for Medicare and Medicaid Services has extended the deadline for filing Medicare claims using its new version of claims form CMS-1500, because of formatting errors on the revised form, CMS announced. The original deadline for switching to the new form—known as CMS-1500 (08/05)—was April 2. But CMS said last month that contractors have been directed to continue to accept the old form until the agency notifies them to stop. Additionally, the agency advised physicians who must use the form to use legacy provider numbers, since the form cannot accommodate a National Provider Identifier (NPI) number.

Uninsured Kids Fare Worse

Injured, uninsured children who are hospitalized were twice as likely to die of their injuries as were their insured counterparts, according to a new study from advocacy group Families USA. Among children admitted with traumatic brain injury, uninsured children were more than twice as likely to die while in the hospital as were insured children. Uninsured children also were less likely to get expensive treatment or rehabilitation, the report said. And among children admitted to the hospital with otitis media, uninsured children were less than half as likely to get ear tubes inserted than were insured children. “The clear implication of this ground-breaking data is that, when kids get hurt or sick, insurance matters,” Families USA executive director Ron Pollack said in a statement.

Generic Biologics Bill

Rep. Henry Waxman (D-Calif.), Sen. Charles Schumer (D-N.Y.), and Sen. Hillary Rodham Clinton (D-N.Y.) have reintroduced the “Access to Safe Medications Act,” which would require the FDA to establish a process for abbreviated approval of generic biologic drugs such as generic insulin. “Biologics treat some of the most devastating diseases around, and no one should be denied access to them because they're too expensive,” Sen. Schumer said in a statement. “Our legislation will allow all Americans to take advantage of these drugs by enabling competition in the market to lower the price and ending permanent monopolies over biologic products. It is high time for these vital treatments to become more affordable.” The Generic Pharmaceutical Association, which represents generic drug manufacturers, expressed “strong support” for the measure, which was first introduced last year. Critics of abbreviated approval contend that generic versions of biologic drugs are not as simple to make as other generic drugs and therefore should require more stringent approval processes than other generics, including additional clinical trials. The bill leaves it up to the Health and Human Services secretary to determine on a case-by-case basis how many additional trials will be required.

U.S. Gets Poor Marks in Prevention

Although the U.S. health care system is generally improving, providers have a long way to go in preventive care, according to the Agency for Healthcare Research and Quality. Two reports from AHRQ, the National Healthcare Quality Report and National Healthcare Disparities Report, found that, for example, only 48% of adults with diabetes received all three recommended screenings—glycosylated hemoglobin tests, foot exams, and eye exams—to prevent disease complications. AHRQ estimates about $2.5 billion could be saved each year by eliminating hospitalizations related to diabetes complications. The reports also found that fewer than half of obese adults reported being counseled about diet by a health care professional, despite the fact that the U.S. Preventive Services Task Force recommends “intensive counseling and behavioral interventions” for obese adults. “It's encouraging to learn that overall quality continues to improve,” said Dr. Carolyn M. Clancy, AHRQ director, in a statement. “At the same time, the message is clear: Much more can be done to prevent illness from occurring or progressing.”

More Americans Donating Organs

The percentage of Americans agreeing to become organ donors as indicated on driver's license or donor cards is increasing, the Health Resources and Services Administration announced. A Gallup Organization survey commissioned by HRSA, which directs federal efforts to promote organ donation, found that 53% of Americans listed themselves as donors in 2005, almost double the 28% who reported doing so in 1993. Nearly all (97%) of the 2,000 survey respondents said they would donate a family member's organs if they knew the person's wishes ahead of time. The 2005 survey also found that 71% of respondents had notified a family member about their donation wishes, up from 52% in 1993.

FDA's $2 Billion Budget

The Bush administration is requesting $2.1 billion for the Food and Drug Administration in fiscal 2008, a 5% increase from the previous year's request. The agency still has not received its final appropriation for fiscal 2007, so the exact amount it will receive for that year is not known yet. The budget includes $444 million in user fees from industry, including a new program to charge generic drug makers fees to review their products. The agency estimates that generic companies will contribute $16 million in fiscal 2008. In a statement, Generic Pharmaceutical Association CEO Kathleen Jaeger said the decision to seek user fees “will not bring generic medicines to consumers faster as long as brand companies are still permitted to use tactics that delay market entry.” The budget also includes $11 million for improving drug safety (this does not include user fee funds that will also go to that effort) and $7 million to boost medical device safety and to speed up device review. The agency also is requesting $13 million to move about 1,300 employees of the Center for Devices and Radiological Health to offices at the FDA's new White Oak, Md., campus. The FDA has been gradually moving its operations to the new facilities. The Washington-based consumer-, patient-, and industry-supported Coalition for a Stronger FDA said the budget did not go far enough. It is seeking at least $175 million more, including greater increases for food, drug, and medical device safety.

More EHRs Obtain Certification

The Certification Commission for Healthcare Information Technology (CCHIT) has given its stamp of approval to 18 more electronic health record products for office-based physicians, bringing the number of certified products to 55, or about 25% of companies in the market, according to a CCHIT estimate. Among the next steps at CCHIT is the expansion of EHR certification to products that cater specifically to certain professional specialties, care settings, and patient populations. “Electronic health record companies have stepped up to the plate, ensuring that their products meet CCHIT criteria,” Dr. Mark Leavitt, chairman of CCHIT, said in a statement. “The benefits of certification will increase as we continue to raise the standards of functionality, interoperability, and security.” A full list of certified products is available online at

www.cchit.org

Generic Biologics Bill

Rep. Henry Waxman (D-Calif.), Sen. Charles Schumer (D-N.Y.), and Sen. Hillary Rodham Clinton (D-N.Y.) have reintroduced the “Access to Safe Medications Act,” which would require the FDA to establish a process for abbreviated approval of generic biologic drugs such as generic insulin. “Biologics treat some of the most devastating diseases around, and no one should be denied access to them because they're too expensive,” Sen. Schumer said in a statement. “Our legislation will allow all Americans to take advantage of these drugs by enabling competition in the market to lower the price and ending permanent monopolies over biologic products. It is high time for these vital treatments to become more affordable.” The Generic Pharmaceutical Association, which represents generic drug manufacturers, expressed “strong support” for the measure, which was first introduced last year. Critics of abbreviated approval contend that generic versions of biologic drugs are not as simple to make as other generic drugs and therefore should require more stringent approval processes than other generics, including additional clinical trials. The bill leaves it up to the Health and Human Services secretary to determine on a case-by-case basis how many additional trials will be required.

U.S. Gets Poor Marks in Prevention

Although the U.S. health care system is generally improving, providers have a long way to go in preventive care, according to the Agency for Healthcare Research and Quality. Two reports from AHRQ, the National Healthcare Quality Report and National Healthcare Disparities Report, found that, for example, only 48% of adults with diabetes received all three recommended screenings—glycosylated hemoglobin tests, foot exams, and eye exams—to prevent disease complications. AHRQ estimates about $2.5 billion could be saved each year by eliminating hospitalizations related to diabetes complications. The reports also found that fewer than half of obese adults reported being counseled about diet by a health care professional, despite the fact that the U.S. Preventive Services Task Force recommends “intensive counseling and behavioral interventions” for obese adults. “It's encouraging to learn that overall quality continues to improve,” said Dr. Carolyn M. Clancy, AHRQ director, in a statement. “At the same time, the message is clear: Much more can be done to prevent illness from occurring or progressing.”

More Americans Donating Organs

The percentage of Americans agreeing to become organ donors as indicated on driver's license or donor cards is increasing, the Health Resources and Services Administration announced. A Gallup Organization survey commissioned by HRSA, which directs federal efforts to promote organ donation, found that 53% of Americans listed themselves as donors in 2005, almost double the 28% who reported doing so in 1993. Nearly all (97%) of the 2,000 survey respondents said they would donate a family member's organs if they knew the person's wishes ahead of time. The 2005 survey also found that 71% of respondents had notified a family member about their donation wishes, up from 52% in 1993.

FDA's $2 Billion Budget

The Bush administration is requesting $2.1 billion for the Food and Drug Administration in fiscal 2008, a 5% increase from the previous year's request. The agency still has not received its final appropriation for fiscal 2007, so the exact amount it will receive for that year is not known yet. The budget includes $444 million in user fees from industry, including a new program to charge generic drug makers fees to review their products. The agency estimates that generic companies will contribute $16 million in fiscal 2008. In a statement, Generic Pharmaceutical Association CEO Kathleen Jaeger said the decision to seek user fees “will not bring generic medicines to consumers faster as long as brand companies are still permitted to use tactics that delay market entry.” The budget also includes $11 million for improving drug safety (this does not include user fee funds that will also go to that effort) and $7 million to boost medical device safety and to speed up device review. The agency also is requesting $13 million to move about 1,300 employees of the Center for Devices and Radiological Health to offices at the FDA's new White Oak, Md., campus. The FDA has been gradually moving its operations to the new facilities. The Washington-based consumer-, patient-, and industry-supported Coalition for a Stronger FDA said the budget did not go far enough. It is seeking at least $175 million more, including greater increases for food, drug, and medical device safety.

More EHRs Obtain Certification

The Certification Commission for Healthcare Information Technology (CCHIT) has given its stamp of approval to 18 more electronic health record products for office-based physicians, bringing the number of certified products to 55, or about 25% of companies in the market, according to a CCHIT estimate. Among the next steps at CCHIT is the expansion of EHR certification to products that cater specifically to certain professional specialties, care settings, and patient populations. “Electronic health record companies have stepped up to the plate, ensuring that their products meet CCHIT criteria,” Dr. Mark Leavitt, chairman of CCHIT, said in a statement. “The benefits of certification will increase as we continue to raise the standards of functionality, interoperability, and security.” A full list of certified products is available online at

www.cchit.org

Generic Biologics Bill

Rep. Henry Waxman (D-Calif.), Sen. Charles Schumer (D-N.Y.), and Sen. Hillary Rodham Clinton (D-N.Y.) have reintroduced the “Access to Safe Medications Act,” which would require the FDA to establish a process for abbreviated approval of generic biologic drugs such as generic insulin. “Biologics treat some of the most devastating diseases around, and no one should be denied access to them because they're too expensive,” Sen. Schumer said in a statement. “Our legislation will allow all Americans to take advantage of these drugs by enabling competition in the market to lower the price and ending permanent monopolies over biologic products. It is high time for these vital treatments to become more affordable.” The Generic Pharmaceutical Association, which represents generic drug manufacturers, expressed “strong support” for the measure, which was first introduced last year. Critics of abbreviated approval contend that generic versions of biologic drugs are not as simple to make as other generic drugs and therefore should require more stringent approval processes than other generics, including additional clinical trials. The bill leaves it up to the Health and Human Services secretary to determine on a case-by-case basis how many additional trials will be required.

U.S. Gets Poor Marks in Prevention

Although the U.S. health care system is generally improving, providers have a long way to go in preventive care, according to the Agency for Healthcare Research and Quality. Two reports from AHRQ, the National Healthcare Quality Report and National Healthcare Disparities Report, found that, for example, only 48% of adults with diabetes received all three recommended screenings—glycosylated hemoglobin tests, foot exams, and eye exams—to prevent disease complications. AHRQ estimates about $2.5 billion could be saved each year by eliminating hospitalizations related to diabetes complications. The reports also found that fewer than half of obese adults reported being counseled about diet by a health care professional, despite the fact that the U.S. Preventive Services Task Force recommends “intensive counseling and behavioral interventions” for obese adults. “It's encouraging to learn that overall quality continues to improve,” said Dr. Carolyn M. Clancy, AHRQ director, in a statement. “At the same time, the message is clear: Much more can be done to prevent illness from occurring or progressing.”

More Americans Donating Organs

The percentage of Americans agreeing to become organ donors as indicated on driver's license or donor cards is increasing, the Health Resources and Services Administration announced. A Gallup Organization survey commissioned by HRSA, which directs federal efforts to promote organ donation, found that 53% of Americans listed themselves as donors in 2005, almost double the 28% who reported doing so in 1993. Nearly all (97%) of the 2,000 survey respondents said they would donate a family member's organs if they knew the person's wishes ahead of time. The 2005 survey also found that 71% of respondents had notified a family member about their donation wishes, up from 52% in 1993.

FDA's $2 Billion Budget

The Bush administration is requesting $2.1 billion for the Food and Drug Administration in fiscal 2008, a 5% increase from the previous year's request. The agency still has not received its final appropriation for fiscal 2007, so the exact amount it will receive for that year is not known yet. The budget includes $444 million in user fees from industry, including a new program to charge generic drug makers fees to review their products. The agency estimates that generic companies will contribute $16 million in fiscal 2008. In a statement, Generic Pharmaceutical Association CEO Kathleen Jaeger said the decision to seek user fees “will not bring generic medicines to consumers faster as long as brand companies are still permitted to use tactics that delay market entry.” The budget also includes $11 million for improving drug safety (this does not include user fee funds that will also go to that effort) and $7 million to boost medical device safety and to speed up device review. The agency also is requesting $13 million to move about 1,300 employees of the Center for Devices and Radiological Health to offices at the FDA's new White Oak, Md., campus. The FDA has been gradually moving its operations to the new facilities. The Washington-based consumer-, patient-, and industry-supported Coalition for a Stronger FDA said the budget did not go far enough. It is seeking at least $175 million more, including greater increases for food, drug, and medical device safety.

More EHRs Obtain Certification

The Certification Commission for Healthcare Information Technology (CCHIT) has given its stamp of approval to 18 more electronic health record products for office-based physicians, bringing the number of certified products to 55, or about 25% of companies in the market, according to a CCHIT estimate. Among the next steps at CCHIT is the expansion of EHR certification to products that cater specifically to certain professional specialties, care settings, and patient populations. “Electronic health record companies have stepped up to the plate, ensuring that their products meet CCHIT criteria,” Dr. Mark Leavitt, chairman of CCHIT, said in a statement. “The benefits of certification will increase as we continue to raise the standards of functionality, interoperability, and security.” A full list of certified products is available online at

www.cchit.org

The 24-year-old woman who came into the Oklahoma City Indian Clinic in early November 2005 was pretty depressed, and for good reason: She weighed 324 pounds, smoked, and had blood pressure of 158/114 mm Hg. She also had very poorly controlled blood sugar, with a hemoglobin A_1c reading of 10.5%. She had been diagnosed with diabetes at a previous health care provider but seemed not to be paying attention to the diagnosis.

The clinic staff enrolled her in its diabetes program, known as BRAID (Being Responsible American Indians with Diabetes). She was given prescriptions for twice-daily metformin and for insulin, and she was told to test her blood sugar three times a day. She also began a series of five diabetes education sessions.

Less than a year later, her picture had brightened considerably. Her weight had dropped to 282 pounds, she had quit smoking, and her blood pressure was down to 132/82 mm Hg.

But the most dramatic improvement was in her blood sugar: Her hemoglobin A_1c (HbA_1c) was 5.7%. Her daily metformin dose had decreased from 2,000 mg to 500 mg, and she was off of insulin completely.

Such success stories are often cited by backers of the federal government's Special Program for Diabetes in Indians (SPDI), of which BRAID is a part. SPDI, an Indian Health Service (IHS) initiative, was first authorized by Congress in 1997 and renewed in 2001 and for several years thereafter. The program gives money to Native American tribes and private contractors who provide diabetes treatment and prevention services. It is funded through fiscal year 2008, then it will come up for reauthorization.

But SPDI faces a stiff challenge. American Indians and Alaska Natives have an age-adjusted diabetes rate of 16.3%, the highest among all racial and ethnic groups in the United States. In some native communities, as many as 60% of adults have diabetes. Among Native Americans aged 15–19, the rate of diabetes increased 128% from 1990 to 2004, according to the IHS. Almost all of the cases are type 2 diabetes.

In February, the Senate Indian Affairs Committee held an oversight hearing on the SPDI program. Several witnesses testified to the great successes the program has had, especially in the areas of diabetes awareness, nutrition programs, and exercise.

But committee member Rep. Craig Thomas (R-Wyo.) was having none of it. He wanted to know only one thing.

“How effective have we been?” he asked Dr. Kelly Moore, clinical specialty consultant to the IHS division of diabetes treatment and prevention.

Dr. Moore cited improvements in blood pressure and blood sugar control, noting that the Native American community “has seen a decline during the SPDI program in A_1c levels from 8.9% to 7.9%.” (See box.) She admitted that data from 2004 indicated that diabetes has been increasing among Native American youth, “but we've had more efforts directed toward screening for diabetes, which would also increase our rates. And it will take decades to reverse the epidemic of type 2 diabetes we're seeing in our population.”

IHS director Charles Grim, D.D.S., also defended the increase. “We don't know what the rate of increase would have been if we didn't have this program,” he said. “We believe the rate would have been higher [without it].”

Dr. Biron Baker, a family physician who worked for the IHS in North Dakota for 3 years, testified that medication options for IHS diabetes patients were problematic. “In the IHS, we see older insulin preparations, older oral medication preparations, and things being done we don't think work any more,” he said.

Dr. Baker recommended to the committee that the IHS make it a priority to hire and retain competent administrators and medical staff. He also estimated that the IHS is currently funded at about 40% of the needed level.

“I don't usually advocate throwing money at a problem, but this is where I make an exception,” he said.

Dr. James Brosseau, director of the Altru's Diabetes Center in Grand Forks, N.D., testified about another problem: access to clinic care.

“Many patients are frustrated with a lack of service on evenings and weekends, long waits to see the doctor, and then the sense that you are just given a prescription and are sent out the door,” he said. “We have to change the way we deal with chronic disease. A 10-minute visit is not going to work for a person with diabetes.”

Despite these problems, many SPDI providers keep working to make a difference. Dr. Musarat Saeed, an internist at the Oklahoma City Indian Clinic, has been with the clinic for 12 years and spends 2 full days each week seeing diabetes patients.

The patients might not get the message about taking care of themselves if they hear it from just one provider, but by the time they are done talking to several people on the clinic's diabetes team, they often change their tune, Dr. Saeed said. “[After talking to] three or four people, the patient listens to somebody.”

Melissa Marks, a nurse on the diabetes team, has an extra incentive to be effective: She was diagnosed with diabetes in 1990. “We didn't choose to have diabetes, but we can choose to be responsible and take care of ourselves,” she said.

ELSEVIER GLOBAL MEDICAL NEWS

The 24-year-old woman who came into the Oklahoma City Indian Clinic in early November 2005 was pretty depressed, and for good reason: She weighed 324 pounds, smoked, and had blood pressure of 158/114 mm Hg. She also had very poorly controlled blood sugar, with a hemoglobin A_1c reading of 10.5%. She had been diagnosed with diabetes at a previous health care provider but seemed not to be paying attention to the diagnosis.

The clinic staff enrolled her in its diabetes program, known as BRAID (Being Responsible American Indians with Diabetes). She was given prescriptions for twice-daily metformin and for insulin, and she was told to test her blood sugar three times a day. She also began a series of five diabetes education sessions.

Less than a year later, her picture had brightened considerably. Her weight had dropped to 282 pounds, she had quit smoking, and her blood pressure was down to 132/82 mm Hg.

But the most dramatic improvement was in her blood sugar: Her hemoglobin A_1c (HbA_1c) was 5.7%. Her daily metformin dose had decreased from 2,000 mg to 500 mg, and she was off of insulin completely.

Such success stories are often cited by backers of the federal government's Special Program for Diabetes in Indians (SPDI), of which BRAID is a part. SPDI, an Indian Health Service (IHS) initiative, was first authorized by Congress in 1997 and renewed in 2001 and for several years thereafter. The program gives money to Native American tribes and private contractors who provide diabetes treatment and prevention services. It is funded through fiscal year 2008, then it will come up for reauthorization.

But SPDI faces a stiff challenge. American Indians and Alaska Natives have an age-adjusted diabetes rate of 16.3%, the highest among all racial and ethnic groups in the United States. In some native communities, as many as 60% of adults have diabetes. Among Native Americans aged 15–19, the rate of diabetes increased 128% from 1990 to 2004, according to the IHS. Almost all of the cases are type 2 diabetes.

In February, the Senate Indian Affairs Committee held an oversight hearing on the SPDI program. Several witnesses testified to the great successes the program has had, especially in the areas of diabetes awareness, nutrition programs, and exercise.

But committee member Rep. Craig Thomas (R-Wyo.) was having none of it. He wanted to know only one thing.

“How effective have we been?” he asked Dr. Kelly Moore, clinical specialty consultant to the IHS division of diabetes treatment and prevention.

Dr. Moore cited improvements in blood pressure and blood sugar control, noting that the Native American community “has seen a decline during the SPDI program in A_1c levels from 8.9% to 7.9%.” (See box.) She admitted that data from 2004 indicated that diabetes has been increasing among Native American youth, “but we've had more efforts directed toward screening for diabetes, which would also increase our rates. And it will take decades to reverse the epidemic of type 2 diabetes we're seeing in our population.”

IHS director Charles Grim, D.D.S., also defended the increase. “We don't know what the rate of increase would have been if we didn't have this program,” he said. “We believe the rate would have been higher [without it].”

Dr. Biron Baker, a family physician who worked for the IHS in North Dakota for 3 years, testified that medication options for IHS diabetes patients were problematic. “In the IHS, we see older insulin preparations, older oral medication preparations, and things being done we don't think work any more,” he said.

Dr. Baker recommended to the committee that the IHS make it a priority to hire and retain competent administrators and medical staff. He also estimated that the IHS is currently funded at about 40% of the needed level.

“I don't usually advocate throwing money at a problem, but this is where I make an exception,” he said.

Dr. James Brosseau, director of the Altru's Diabetes Center in Grand Forks, N.D., testified about another problem: access to clinic care.

“Many patients are frustrated with a lack of service on evenings and weekends, long waits to see the doctor, and then the sense that you are just given a prescription and are sent out the door,” he said. “We have to change the way we deal with chronic disease. A 10-minute visit is not going to work for a person with diabetes.”

Despite these problems, many SPDI providers keep working to make a difference. Dr. Musarat Saeed, an internist at the Oklahoma City Indian Clinic, has been with the clinic for 12 years and spends 2 full days each week seeing diabetes patients.

The patients might not get the message about taking care of themselves if they hear it from just one provider, but by the time they are done talking to several people on the clinic's diabetes team, they often change their tune, Dr. Saeed said. “[After talking to] three or four people, the patient listens to somebody.”

Melissa Marks, a nurse on the diabetes team, has an extra incentive to be effective: She was diagnosed with diabetes in 1990. “We didn't choose to have diabetes, but we can choose to be responsible and take care of ourselves,” she said.

ELSEVIER GLOBAL MEDICAL NEWS

The 24-year-old woman who came into the Oklahoma City Indian Clinic in early November 2005 was pretty depressed, and for good reason: She weighed 324 pounds, smoked, and had blood pressure of 158/114 mm Hg. She also had very poorly controlled blood sugar, with a hemoglobin A_1c reading of 10.5%. She had been diagnosed with diabetes at a previous health care provider but seemed not to be paying attention to the diagnosis.

The clinic staff enrolled her in its diabetes program, known as BRAID (Being Responsible American Indians with Diabetes). She was given prescriptions for twice-daily metformin and for insulin, and she was told to test her blood sugar three times a day. She also began a series of five diabetes education sessions.

Less than a year later, her picture had brightened considerably. Her weight had dropped to 282 pounds, she had quit smoking, and her blood pressure was down to 132/82 mm Hg.

But the most dramatic improvement was in her blood sugar: Her hemoglobin A_1c (HbA_1c) was 5.7%. Her daily metformin dose had decreased from 2,000 mg to 500 mg, and she was off of insulin completely.

Such success stories are often cited by backers of the federal government's Special Program for Diabetes in Indians (SPDI), of which BRAID is a part. SPDI, an Indian Health Service (IHS) initiative, was first authorized by Congress in 1997 and renewed in 2001 and for several years thereafter. The program gives money to Native American tribes and private contractors who provide diabetes treatment and prevention services. It is funded through fiscal year 2008, then it will come up for reauthorization.

But SPDI faces a stiff challenge. American Indians and Alaska Natives have an age-adjusted diabetes rate of 16.3%, the highest among all racial and ethnic groups in the United States. In some native communities, as many as 60% of adults have diabetes. Among Native Americans aged 15–19, the rate of diabetes increased 128% from 1990 to 2004, according to the IHS. Almost all of the cases are type 2 diabetes.

In February, the Senate Indian Affairs Committee held an oversight hearing on the SPDI program. Several witnesses testified to the great successes the program has had, especially in the areas of diabetes awareness, nutrition programs, and exercise.

But committee member Rep. Craig Thomas (R-Wyo.) was having none of it. He wanted to know only one thing.

“How effective have we been?” he asked Dr. Kelly Moore, clinical specialty consultant to the IHS division of diabetes treatment and prevention.

Dr. Moore cited improvements in blood pressure and blood sugar control, noting that the Native American community “has seen a decline during the SPDI program in A_1c levels from 8.9% to 7.9%.” (See box.) She admitted that data from 2004 indicated that diabetes has been increasing among Native American youth, “but we've had more efforts directed toward screening for diabetes, which would also increase our rates. And it will take decades to reverse the epidemic of type 2 diabetes we're seeing in our population.”

IHS director Charles Grim, D.D.S., also defended the increase. “We don't know what the rate of increase would have been if we didn't have this program,” he said. “We believe the rate would have been higher [without it].”

Dr. Biron Baker, a family physician who worked for the IHS in North Dakota for 3 years, testified that medication options for IHS diabetes patients were problematic. “In the IHS, we see older insulin preparations, older oral medication preparations, and things being done we don't think work any more,” he said.

Dr. Baker recommended to the committee that the IHS make it a priority to hire and retain competent administrators and medical staff. He also estimated that the IHS is currently funded at about 40% of the needed level.

“I don't usually advocate throwing money at a problem, but this is where I make an exception,” he said.

Dr. James Brosseau, director of the Altru's Diabetes Center in Grand Forks, N.D., testified about another problem: access to clinic care.

“Many patients are frustrated with a lack of service on evenings and weekends, long waits to see the doctor, and then the sense that you are just given a prescription and are sent out the door,” he said. “We have to change the way we deal with chronic disease. A 10-minute visit is not going to work for a person with diabetes.”

Despite these problems, many SPDI providers keep working to make a difference. Dr. Musarat Saeed, an internist at the Oklahoma City Indian Clinic, has been with the clinic for 12 years and spends 2 full days each week seeing diabetes patients.

The patients might not get the message about taking care of themselves if they hear it from just one provider, but by the time they are done talking to several people on the clinic's diabetes team, they often change their tune, Dr. Saeed said. “[After talking to] three or four people, the patient listens to somebody.”

Melissa Marks, a nurse on the diabetes team, has an extra incentive to be effective: She was diagnosed with diabetes in 1990. “We didn't choose to have diabetes, but we can choose to be responsible and take care of ourselves,” she said.

ELSEVIER GLOBAL MEDICAL NEWS