Joyce Frieden

The Food and Drug Administration plans to hold off on issuing approval guidelines for generic insulin and human growth hormones, despite pressure from congressional leaders.

Instead, the agency will offer broader guidance on follow-on proteins in general, Patrick Rowan, FDA associate commissioner for legislation, wrote to Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.), in response to their letter.

“FDA expects that this approach will provide useful guidance to the industry, while ensuring that we do not stifle innovation and the utilization of state-of-the-art technologies,” Mr. Rowan wrote. “FDA's consideration of regulatory requirements for these products has not stalled and … we are moving ahead as quickly as resources will allow.” He pointed out that the agency already has approved several follow-on protein products that meet FDA criteria, including human recombinant hyaluronidase (Hylenex), calcitonin-salmon recombinant (Fortical Nasal Spray), and glucagon recombinant (GlucaGen).

In their letter, Sen. Hatch and Rep. Waxman noted that the agency has been working on guidance documents for generic insulin and human growth hormone for 4 years.

“In 2002, FDA officials drafted guidance documents providing the requirements for approval of generic forms of insulin and human growth hormone,” they wrote. “Since that time, the agency has held public workshops and public meetings on various issues pertaining to generic biologics, but it apparently decided to defer the release of the guidance documents for insulin and HGH until it had resolved issues pertaining to the entire class of biologics.

“Now, several years later, the effort to develop the appropriate regulatory requirements for generic biologics appears to be at a complete standstill,” the legislators wrote. “It is time for FDA to clarify what data it will require that manufacturers provide when seeking to market a generic insulin or HGH product.”

Rather than waiting for guidance on the broader category to emerge, Sen. Hatch and Rep. Waxman argue that generic insulin and human growth hormone are simpler than other follow-on protein products and therefore should have guidance documents issued for them now.

Insulin and human growth hormone “have relatively simple structures with a long history of safe use by millions of people,” they wrote. “Moreover, because both of these products currently are regulated under the federal Food, Drug, and Cosmetic Act, establishing the approval requirements for their generic forms does not raise the legal issues that exist with approval of generic forms of [other follow-on protein] products. The legal framework for such approval already exists.”

Dr. Bill Law Jr., president of the American Academy of Clinical Endocrinologists, said that waiting for more general guidance would not be such a bad idea.

“Obviously, having less expensive biologicals would make it easier for patients to afford to actually purchase and administer them when prescribed, so it would be good for both patients and their physicians,” Dr. Law said in an interview. “However, an inexpensive product that is either unsafe or ineffective is not a good bargain.”

He noted that he talks every day with patients who are concerned about difficulty in paying for biologicals and other medications.

“However, I'm sure that they would rather continue to pay for a branded product that has proved to be safe and effective in human clinical trials than to be included later as a subject in a scientific article documenting major safety and/or efficacy deficiency problems in a generic biological product that was approved for use in humans based on poorly thought-out requirements created urgently because of political pressure by well-intentioned but scientifically naïve legislators,” he said.

The Food and Drug Administration plans to hold off on issuing approval guidelines for generic insulin and human growth hormones, despite pressure from congressional leaders.

Instead, the agency will offer broader guidance on follow-on proteins in general, Patrick Rowan, FDA associate commissioner for legislation, wrote to Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.), in response to their letter.

“FDA expects that this approach will provide useful guidance to the industry, while ensuring that we do not stifle innovation and the utilization of state-of-the-art technologies,” Mr. Rowan wrote. “FDA's consideration of regulatory requirements for these products has not stalled and … we are moving ahead as quickly as resources will allow.” He pointed out that the agency already has approved several follow-on protein products that meet FDA criteria, including human recombinant hyaluronidase (Hylenex), calcitonin-salmon recombinant (Fortical Nasal Spray), and glucagon recombinant (GlucaGen).

In their letter, Sen. Hatch and Rep. Waxman noted that the agency has been working on guidance documents for generic insulin and human growth hormone for 4 years.

“In 2002, FDA officials drafted guidance documents providing the requirements for approval of generic forms of insulin and human growth hormone,” they wrote. “Since that time, the agency has held public workshops and public meetings on various issues pertaining to generic biologics, but it apparently decided to defer the release of the guidance documents for insulin and HGH until it had resolved issues pertaining to the entire class of biologics.

“Now, several years later, the effort to develop the appropriate regulatory requirements for generic biologics appears to be at a complete standstill,” the legislators wrote. “It is time for FDA to clarify what data it will require that manufacturers provide when seeking to market a generic insulin or HGH product.”

Rather than waiting for guidance on the broader category to emerge, Sen. Hatch and Rep. Waxman argue that generic insulin and human growth hormone are simpler than other follow-on protein products and therefore should have guidance documents issued for them now.

Insulin and human growth hormone “have relatively simple structures with a long history of safe use by millions of people,” they wrote. “Moreover, because both of these products currently are regulated under the federal Food, Drug, and Cosmetic Act, establishing the approval requirements for their generic forms does not raise the legal issues that exist with approval of generic forms of [other follow-on protein] products. The legal framework for such approval already exists.”

Dr. Bill Law Jr., president of the American Academy of Clinical Endocrinologists, said that waiting for more general guidance would not be such a bad idea.

“Obviously, having less expensive biologicals would make it easier for patients to afford to actually purchase and administer them when prescribed, so it would be good for both patients and their physicians,” Dr. Law said in an interview. “However, an inexpensive product that is either unsafe or ineffective is not a good bargain.”

He noted that he talks every day with patients who are concerned about difficulty in paying for biologicals and other medications.

“However, I'm sure that they would rather continue to pay for a branded product that has proved to be safe and effective in human clinical trials than to be included later as a subject in a scientific article documenting major safety and/or efficacy deficiency problems in a generic biological product that was approved for use in humans based on poorly thought-out requirements created urgently because of political pressure by well-intentioned but scientifically naïve legislators,” he said.

The Food and Drug Administration plans to hold off on issuing approval guidelines for generic insulin and human growth hormones, despite pressure from congressional leaders.

Instead, the agency will offer broader guidance on follow-on proteins in general, Patrick Rowan, FDA associate commissioner for legislation, wrote to Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.), in response to their letter.

“FDA expects that this approach will provide useful guidance to the industry, while ensuring that we do not stifle innovation and the utilization of state-of-the-art technologies,” Mr. Rowan wrote. “FDA's consideration of regulatory requirements for these products has not stalled and … we are moving ahead as quickly as resources will allow.” He pointed out that the agency already has approved several follow-on protein products that meet FDA criteria, including human recombinant hyaluronidase (Hylenex), calcitonin-salmon recombinant (Fortical Nasal Spray), and glucagon recombinant (GlucaGen).

In their letter, Sen. Hatch and Rep. Waxman noted that the agency has been working on guidance documents for generic insulin and human growth hormone for 4 years.

“In 2002, FDA officials drafted guidance documents providing the requirements for approval of generic forms of insulin and human growth hormone,” they wrote. “Since that time, the agency has held public workshops and public meetings on various issues pertaining to generic biologics, but it apparently decided to defer the release of the guidance documents for insulin and HGH until it had resolved issues pertaining to the entire class of biologics.

“Now, several years later, the effort to develop the appropriate regulatory requirements for generic biologics appears to be at a complete standstill,” the legislators wrote. “It is time for FDA to clarify what data it will require that manufacturers provide when seeking to market a generic insulin or HGH product.”

Rather than waiting for guidance on the broader category to emerge, Sen. Hatch and Rep. Waxman argue that generic insulin and human growth hormone are simpler than other follow-on protein products and therefore should have guidance documents issued for them now.

Insulin and human growth hormone “have relatively simple structures with a long history of safe use by millions of people,” they wrote. “Moreover, because both of these products currently are regulated under the federal Food, Drug, and Cosmetic Act, establishing the approval requirements for their generic forms does not raise the legal issues that exist with approval of generic forms of [other follow-on protein] products. The legal framework for such approval already exists.”

Dr. Bill Law Jr., president of the American Academy of Clinical Endocrinologists, said that waiting for more general guidance would not be such a bad idea.

“Obviously, having less expensive biologicals would make it easier for patients to afford to actually purchase and administer them when prescribed, so it would be good for both patients and their physicians,” Dr. Law said in an interview. “However, an inexpensive product that is either unsafe or ineffective is not a good bargain.”

He noted that he talks every day with patients who are concerned about difficulty in paying for biologicals and other medications.

“However, I'm sure that they would rather continue to pay for a branded product that has proved to be safe and effective in human clinical trials than to be included later as a subject in a scientific article documenting major safety and/or efficacy deficiency problems in a generic biological product that was approved for use in humans based on poorly thought-out requirements created urgently because of political pressure by well-intentioned but scientifically naïve legislators,” he said.

The Food and Drug Administration plans to hold off on issuing approval guidelines for generic insulin and human growth hormones, despite pressure from congressional leaders.

Instead, the agency will offer broader guidance on follow-on proteins in general, Patrick Rowan, FDA associate commissioner for legislation, wrote to Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.), in response to their letter.

“FDA expects that this approach will provide useful guidance to the industry, while ensuring that we do not stifle innovation and the utilization of state-of-the-art technologies,” Mr. Rowan wrote. “FDA's consideration of regulatory requirements for these products has not stalled and … we are moving ahead as quickly as resources will allow.” He pointed out that the agency already has approved several follow-on protein products that meet FDA criteria, including human recombinant hyaluronidase (Hylenex), calcitonin-salmon recombinant (Fortical Nasal Spray), and glucagon recombinant (GlucaGen).

In their letter, Sen. Hatch and Rep. Waxman noted that the agency has been working on guidance documents for generic insulin and human growth hormone for 4 years.

“In 2002, FDA officials drafted guidance documents providing the requirements for approval of generic forms of insulin and human growth hormone,” they wrote. “Since that time, the agency has held public workshops and public meetings on various issues pertaining to generic biologics, but it apparently decided to defer the release of the guidance documents for insulin and HGH until it had resolved issues pertaining to the entire class of biologics.

“Now, several years later, the effort to develop the appropriate regulatory requirements for generic biologics appears to be at a complete standstill,” the legislators wrote. “It is time for FDA to clarify what data it will require that manufacturers provide when seeking to market a generic insulin or HGH product.”

Rather than waiting for guidance on the broader category to emerge, Sen. Hatch and Rep. Waxman argue that generic insulin and human growth hormone are simpler than other follow-on protein products and therefore should have guidance documents issued for them now.

“[Insulin and human growth hormone] have relatively simple structures with a long history of safe use by millions of people,” they wrote. “Moreover, because both of these products currently are regulated under the federal Food, Drug, and Cosmetic Act, establishing the approval requirements for their generic forms does not raise the legal issues that exist with approval of generic forms of [other follow-on protein] products. The legal framework for such approval already exists.”

Dr. Bill Law Jr., president of the American Academy of Clinical Endocrinologists, said that waiting for more general guidance would not be such a bad idea.

“Obviously, having less expensive biologicals would make it easier for patients to afford to actually purchase and administer them when prescribed, so it would be good for both patients and their physicians,” Dr. Law said in an interview. “However, an inexpensive product that is either unsafe or ineffective is not a good bargain.”

He noted that he talks daily with patients who are concerned about difficulty in paying for biologicals and medications.

“However, I'm sure that they would rather continue to pay for a branded product that has proved to be safe and effective in human clinical trials than to be included later as a subject in a scientific article documenting major safety and/or efficacy deficiency problems in a generic biological product that was approved for use in humans based on poorly thought-out requirements created urgently because of political pressure by well-intentioned but scientifically naive legislators,” Dr. Law said.

The Food and Drug Administration plans to hold off on issuing approval guidelines for generic insulin and human growth hormones, despite pressure from congressional leaders.

Instead, the agency will offer broader guidance on follow-on proteins in general, Patrick Rowan, FDA associate commissioner for legislation, wrote to Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.), in response to their letter.

“FDA expects that this approach will provide useful guidance to the industry, while ensuring that we do not stifle innovation and the utilization of state-of-the-art technologies,” Mr. Rowan wrote. “FDA's consideration of regulatory requirements for these products has not stalled and … we are moving ahead as quickly as resources will allow.” He pointed out that the agency already has approved several follow-on protein products that meet FDA criteria, including human recombinant hyaluronidase (Hylenex), calcitonin-salmon recombinant (Fortical Nasal Spray), and glucagon recombinant (GlucaGen).

In their letter, Sen. Hatch and Rep. Waxman noted that the agency has been working on guidance documents for generic insulin and human growth hormone for 4 years.

“In 2002, FDA officials drafted guidance documents providing the requirements for approval of generic forms of insulin and human growth hormone,” they wrote. “Since that time, the agency has held public workshops and public meetings on various issues pertaining to generic biologics, but it apparently decided to defer the release of the guidance documents for insulin and HGH until it had resolved issues pertaining to the entire class of biologics.

“Now, several years later, the effort to develop the appropriate regulatory requirements for generic biologics appears to be at a complete standstill,” the legislators wrote. “It is time for FDA to clarify what data it will require that manufacturers provide when seeking to market a generic insulin or HGH product.”

Rather than waiting for guidance on the broader category to emerge, Sen. Hatch and Rep. Waxman argue that generic insulin and human growth hormone are simpler than other follow-on protein products and therefore should have guidance documents issued for them now.

“[Insulin and human growth hormone] have relatively simple structures with a long history of safe use by millions of people,” they wrote. “Moreover, because both of these products currently are regulated under the federal Food, Drug, and Cosmetic Act, establishing the approval requirements for their generic forms does not raise the legal issues that exist with approval of generic forms of [other follow-on protein] products. The legal framework for such approval already exists.”

Dr. Bill Law Jr., president of the American Academy of Clinical Endocrinologists, said that waiting for more general guidance would not be such a bad idea.

“Obviously, having less expensive biologicals would make it easier for patients to afford to actually purchase and administer them when prescribed, so it would be good for both patients and their physicians,” Dr. Law said in an interview. “However, an inexpensive product that is either unsafe or ineffective is not a good bargain.”

He noted that he talks daily with patients who are concerned about difficulty in paying for biologicals and medications.

“However, I'm sure that they would rather continue to pay for a branded product that has proved to be safe and effective in human clinical trials than to be included later as a subject in a scientific article documenting major safety and/or efficacy deficiency problems in a generic biological product that was approved for use in humans based on poorly thought-out requirements created urgently because of political pressure by well-intentioned but scientifically naive legislators,” Dr. Law said.

The Food and Drug Administration plans to hold off on issuing approval guidelines for generic insulin and human growth hormones, despite pressure from congressional leaders.

Instead, the agency will offer broader guidance on follow-on proteins in general, Patrick Rowan, FDA associate commissioner for legislation, wrote to Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.), in response to their letter.

“FDA expects that this approach will provide useful guidance to the industry, while ensuring that we do not stifle innovation and the utilization of state-of-the-art technologies,” Mr. Rowan wrote. “FDA's consideration of regulatory requirements for these products has not stalled and … we are moving ahead as quickly as resources will allow.” He pointed out that the agency already has approved several follow-on protein products that meet FDA criteria, including human recombinant hyaluronidase (Hylenex), calcitonin-salmon recombinant (Fortical Nasal Spray), and glucagon recombinant (GlucaGen).

In their letter, Sen. Hatch and Rep. Waxman noted that the agency has been working on guidance documents for generic insulin and human growth hormone for 4 years.

“In 2002, FDA officials drafted guidance documents providing the requirements for approval of generic forms of insulin and human growth hormone,” they wrote. “Since that time, the agency has held public workshops and public meetings on various issues pertaining to generic biologics, but it apparently decided to defer the release of the guidance documents for insulin and HGH until it had resolved issues pertaining to the entire class of biologics.

“Now, several years later, the effort to develop the appropriate regulatory requirements for generic biologics appears to be at a complete standstill,” the legislators wrote. “It is time for FDA to clarify what data it will require that manufacturers provide when seeking to market a generic insulin or HGH product.”

Rather than waiting for guidance on the broader category to emerge, Sen. Hatch and Rep. Waxman argue that generic insulin and human growth hormone are simpler than other follow-on protein products and therefore should have guidance documents issued for them now.

“[Insulin and human growth hormone] have relatively simple structures with a long history of safe use by millions of people,” they wrote. “Moreover, because both of these products currently are regulated under the federal Food, Drug, and Cosmetic Act, establishing the approval requirements for their generic forms does not raise the legal issues that exist with approval of generic forms of [other follow-on protein] products. The legal framework for such approval already exists.”

Dr. Bill Law Jr., president of the American Academy of Clinical Endocrinologists, said that waiting for more general guidance would not be such a bad idea.

“Obviously, having less expensive biologicals would make it easier for patients to afford to actually purchase and administer them when prescribed, so it would be good for both patients and their physicians,” Dr. Law said in an interview. “However, an inexpensive product that is either unsafe or ineffective is not a good bargain.”

He noted that he talks daily with patients who are concerned about difficulty in paying for biologicals and medications.

“However, I'm sure that they would rather continue to pay for a branded product that has proved to be safe and effective in human clinical trials than to be included later as a subject in a scientific article documenting major safety and/or efficacy deficiency problems in a generic biological product that was approved for use in humans based on poorly thought-out requirements created urgently because of political pressure by well-intentioned but scientifically naive legislators,” Dr. Law said.

Diabetes Management at Chrysler

A pilot program designed to improve the health of Chrysler employees with diabetes has been deemed a success. The company enrolled 126 employees in its Auburn, Mich., headquarters in the program, which consisted of individual coaching sessions with certified diabetes educators. More than three-quarters of enrollees completed at least four coaching sessions. After 6 months, 77% of enrollees had reduced their HbA_1c level to less than 7%. At the program's start, 68% had HbA_1c levels at or below 7%. Participants' cholesterol levels improved slightly, with 42% having LDL cholesterol values less than 100 mg/dL at the program's end, compared with 39.5% at the study's start. Knowledge of diabetes and its management improved by more than 18%. “We love the direction this program is taking us,” said Cyndy Parker, Chrysler's healthy people initiatives manager. No word yet on whether the program saved money.

Part D Formulary Override Form

A new one-page form allows physicians to request a prior authorization or coverage of a nonformulary drug under Medicare Part D. The form can “easily communicate to drug plans why a patient needs a specific drug when similar drugs are covered by the plan,” American Medical Association board member Dr. Edward Langston said in a statement. AMA led a coalition of groups that developed the form. The form, which is used to explain the need for an alternative drug or dose, or why the formulary drug is not acceptable, is available at the Centers for Medicare and Medicaid Services' site:

http://www.cms.hhs.gov/MLNProducts/Downloads/Form_Exceptions_final.pdf

Generics Boost Medicare D Savings

At least 14 brand name drugs are due to go off-patent in the next 5 years, representing $23 billion in potential savings to Medicare Part D, claims the Pharmaceutical Care Management Association in a new report. PCMA's members—managed drug benefit plans—negotiate discounts with drug makers on behalf of employers and insurers. The organization says that this year alone, $1.5 billion could be saved due to lost exclusivity on four drugs: Zoloft (sertraline), Zocor (simvastatin), Proscar (finasteride), and Pravachol (pravastatin). The savings assume that 90% of Medicare prescriptions would be switched to generics, and that the generic would cost 60% less than the brand. In 2007, Norvasc (amlodipine besylate), Ambien (zoldipem tartrate), Zyrtec (cetirizine), Lotrel (amlodipine/benazepril), Coreg (carvedilol), and Lamisil (terbinafine) are due to lose patent protection, which could lead to $700 million in savings that year.

Maryland Passes Stem Cell Bill

The Maryland legislature passed a bill establishing a $15 million fund to promote stem cell research in the state. The measure, which passed by a vote of 90–48 and was signed by Republican Gov. Robert Ehrlich, will establish procedures for reviewing research projects involving either adult or embryonic stem cells. An independent commission—including representatives from the patient advocate, biotechnology, and ethics communities—will administer grants to universities and private sector researchers.

FDA Names Drug Safety Spokesman

The Food and Drug Administration has appointed Dr. Paul Seligman as associate center director for safety policy and communication in the agency's Center for Drug Evaluation and Research (CDER). According to CDER director Dr. Steven Galson, “This step will help to provide a more standardized and predictable approach to ensuring drug safety and enhance the effectiveness and timeliness of the information we provide to the health care community and the public.” But Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in an interview that the appointment was just more window dressing. Dr. Seligman “will be reporting directly to Dr. Galson and will lack the independence necessary to free up the Office of Drug Safety from its second-class position in FDA.” At a telephone conference, Dr. Seligman said that he still works for FDA, but “there are many important policy questions that go well beyond the FDA” when deciding whether to change labeling or pull a drug from the market. “Those issues will continue to be with us and will be decided on a drug-by-drug basis.”

Report Critical of HRSA

The Health Resources and Services Administration needs to do a better job of making workforce projections, according to a report from the Government Accountability Office. “HRSA has in the past decade published national supply and demand projections for the nurse and pharmacist workforces but no national projections for the physician and dentist workforces,” the GAO said in its report. In its response, HRSA stated, “we believe that the legislated goal of providing 'health workforce information and analysis, … such as shortages of registered nurses, shortages of pharmacists, and the distribution of health care workers in underserved areas,' is broader than what GAO's exclusive focus on supply and demand projections for physicians, nurses, and dentists would allow.”

Welfare Reform? More Uninsured

The welfare reform act passed in 1996 has resulted in more rural citizens becoming uninsured, according to a report from the National Rural Health Association. The report also found that people were more likely to become uninsured if they got jobs after leaving welfare, compared with those who remained unemployed (28% vs. 20%).

Diabetes Management at Chrysler

A pilot program designed to improve the health of Chrysler employees with diabetes has been deemed a success. The company enrolled 126 employees in its Auburn, Mich., headquarters in the program, which consisted of individual coaching sessions with certified diabetes educators. More than three-quarters of enrollees completed at least four coaching sessions. After 6 months, 77% of enrollees had reduced their HbA_1c level to less than 7%. At the program's start, 68% had HbA_1c levels at or below 7%. Participants' cholesterol levels improved slightly, with 42% having LDL cholesterol values less than 100 mg/dL at the program's end, compared with 39.5% at the study's start. Knowledge of diabetes and its management improved by more than 18%. “We love the direction this program is taking us,” said Cyndy Parker, Chrysler's healthy people initiatives manager. No word yet on whether the program saved money.

Part D Formulary Override Form

A new one-page form allows physicians to request a prior authorization or coverage of a nonformulary drug under Medicare Part D. The form can “easily communicate to drug plans why a patient needs a specific drug when similar drugs are covered by the plan,” American Medical Association board member Dr. Edward Langston said in a statement. AMA led a coalition of groups that developed the form. The form, which is used to explain the need for an alternative drug or dose, or why the formulary drug is not acceptable, is available at the Centers for Medicare and Medicaid Services' site:

http://www.cms.hhs.gov/MLNProducts/Downloads/Form_Exceptions_final.pdf

Generics Boost Medicare D Savings

At least 14 brand name drugs are due to go off-patent in the next 5 years, representing $23 billion in potential savings to Medicare Part D, claims the Pharmaceutical Care Management Association in a new report. PCMA's members—managed drug benefit plans—negotiate discounts with drug makers on behalf of employers and insurers. The organization says that this year alone, $1.5 billion could be saved due to lost exclusivity on four drugs: Zoloft (sertraline), Zocor (simvastatin), Proscar (finasteride), and Pravachol (pravastatin). The savings assume that 90% of Medicare prescriptions would be switched to generics, and that the generic would cost 60% less than the brand. In 2007, Norvasc (amlodipine besylate), Ambien (zoldipem tartrate), Zyrtec (cetirizine), Lotrel (amlodipine/benazepril), Coreg (carvedilol), and Lamisil (terbinafine) are due to lose patent protection, which could lead to $700 million in savings that year.

Maryland Passes Stem Cell Bill

The Maryland legislature passed a bill establishing a $15 million fund to promote stem cell research in the state. The measure, which passed by a vote of 90–48 and was signed by Republican Gov. Robert Ehrlich, will establish procedures for reviewing research projects involving either adult or embryonic stem cells. An independent commission—including representatives from the patient advocate, biotechnology, and ethics communities—will administer grants to universities and private sector researchers.

FDA Names Drug Safety Spokesman

The Food and Drug Administration has appointed Dr. Paul Seligman as associate center director for safety policy and communication in the agency's Center for Drug Evaluation and Research (CDER). According to CDER director Dr. Steven Galson, “This step will help to provide a more standardized and predictable approach to ensuring drug safety and enhance the effectiveness and timeliness of the information we provide to the health care community and the public.” But Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in an interview that the appointment was just more window dressing. Dr. Seligman “will be reporting directly to Dr. Galson and will lack the independence necessary to free up the Office of Drug Safety from its second-class position in FDA.” At a telephone conference, Dr. Seligman said that he still works for FDA, but “there are many important policy questions that go well beyond the FDA” when deciding whether to change labeling or pull a drug from the market. “Those issues will continue to be with us and will be decided on a drug-by-drug basis.”

Report Critical of HRSA

The Health Resources and Services Administration needs to do a better job of making workforce projections, according to a report from the Government Accountability Office. “HRSA has in the past decade published national supply and demand projections for the nurse and pharmacist workforces but no national projections for the physician and dentist workforces,” the GAO said in its report. In its response, HRSA stated, “we believe that the legislated goal of providing 'health workforce information and analysis, … such as shortages of registered nurses, shortages of pharmacists, and the distribution of health care workers in underserved areas,' is broader than what GAO's exclusive focus on supply and demand projections for physicians, nurses, and dentists would allow.”

Welfare Reform? More Uninsured

The welfare reform act passed in 1996 has resulted in more rural citizens becoming uninsured, according to a report from the National Rural Health Association. The report also found that people were more likely to become uninsured if they got jobs after leaving welfare, compared with those who remained unemployed (28% vs. 20%).

Diabetes Management at Chrysler

A pilot program designed to improve the health of Chrysler employees with diabetes has been deemed a success. The company enrolled 126 employees in its Auburn, Mich., headquarters in the program, which consisted of individual coaching sessions with certified diabetes educators. More than three-quarters of enrollees completed at least four coaching sessions. After 6 months, 77% of enrollees had reduced their HbA_1c level to less than 7%. At the program's start, 68% had HbA_1c levels at or below 7%. Participants' cholesterol levels improved slightly, with 42% having LDL cholesterol values less than 100 mg/dL at the program's end, compared with 39.5% at the study's start. Knowledge of diabetes and its management improved by more than 18%. “We love the direction this program is taking us,” said Cyndy Parker, Chrysler's healthy people initiatives manager. No word yet on whether the program saved money.

Part D Formulary Override Form

A new one-page form allows physicians to request a prior authorization or coverage of a nonformulary drug under Medicare Part D. The form can “easily communicate to drug plans why a patient needs a specific drug when similar drugs are covered by the plan,” American Medical Association board member Dr. Edward Langston said in a statement. AMA led a coalition of groups that developed the form. The form, which is used to explain the need for an alternative drug or dose, or why the formulary drug is not acceptable, is available at the Centers for Medicare and Medicaid Services' site:

http://www.cms.hhs.gov/MLNProducts/Downloads/Form_Exceptions_final.pdf

Generics Boost Medicare D Savings

At least 14 brand name drugs are due to go off-patent in the next 5 years, representing $23 billion in potential savings to Medicare Part D, claims the Pharmaceutical Care Management Association in a new report. PCMA's members—managed drug benefit plans—negotiate discounts with drug makers on behalf of employers and insurers. The organization says that this year alone, $1.5 billion could be saved due to lost exclusivity on four drugs: Zoloft (sertraline), Zocor (simvastatin), Proscar (finasteride), and Pravachol (pravastatin). The savings assume that 90% of Medicare prescriptions would be switched to generics, and that the generic would cost 60% less than the brand. In 2007, Norvasc (amlodipine besylate), Ambien (zoldipem tartrate), Zyrtec (cetirizine), Lotrel (amlodipine/benazepril), Coreg (carvedilol), and Lamisil (terbinafine) are due to lose patent protection, which could lead to $700 million in savings that year.

Maryland Passes Stem Cell Bill

The Maryland legislature passed a bill establishing a $15 million fund to promote stem cell research in the state. The measure, which passed by a vote of 90–48 and was signed by Republican Gov. Robert Ehrlich, will establish procedures for reviewing research projects involving either adult or embryonic stem cells. An independent commission—including representatives from the patient advocate, biotechnology, and ethics communities—will administer grants to universities and private sector researchers.

FDA Names Drug Safety Spokesman

The Food and Drug Administration has appointed Dr. Paul Seligman as associate center director for safety policy and communication in the agency's Center for Drug Evaluation and Research (CDER). According to CDER director Dr. Steven Galson, “This step will help to provide a more standardized and predictable approach to ensuring drug safety and enhance the effectiveness and timeliness of the information we provide to the health care community and the public.” But Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in an interview that the appointment was just more window dressing. Dr. Seligman “will be reporting directly to Dr. Galson and will lack the independence necessary to free up the Office of Drug Safety from its second-class position in FDA.” At a telephone conference, Dr. Seligman said that he still works for FDA, but “there are many important policy questions that go well beyond the FDA” when deciding whether to change labeling or pull a drug from the market. “Those issues will continue to be with us and will be decided on a drug-by-drug basis.”

Report Critical of HRSA

The Health Resources and Services Administration needs to do a better job of making workforce projections, according to a report from the Government Accountability Office. “HRSA has in the past decade published national supply and demand projections for the nurse and pharmacist workforces but no national projections for the physician and dentist workforces,” the GAO said in its report. In its response, HRSA stated, “we believe that the legislated goal of providing 'health workforce information and analysis, … such as shortages of registered nurses, shortages of pharmacists, and the distribution of health care workers in underserved areas,' is broader than what GAO's exclusive focus on supply and demand projections for physicians, nurses, and dentists would allow.”

Welfare Reform? More Uninsured

The welfare reform act passed in 1996 has resulted in more rural citizens becoming uninsured, according to a report from the National Rural Health Association. The report also found that people were more likely to become uninsured if they got jobs after leaving welfare, compared with those who remained unemployed (28% vs. 20%).

Over-the-counter drugs containing pseudoephedrine will go behind the counter beginning in late September under a new law passed by Congress and signed by President Bush.

The Combat Methamphetamine Epidemic Act of 2005—passed as part of the reauthorization of the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA PATRIOT) Improvement and Reauthorization Act of 2005—requires consumers who wish to purchase pseudoephedrine-containing over-the-counter medicines to show photo identification and sign a log book. It also limits the amount of pseudoephedrine-containing products that can be purchased to 3.6 g per day and 9 g within a 30-day period.

Rep. Roy Blunt (R-Mo.), one of the supporters of the legislation, said the new law will help combat methamphetamine abuse. “Easy access to common cold medicine is a meth cook's dream come true,” Rep. Blunt said in a statement. “The most effective way to fight the meth epidemic is to make it harder for criminals to get the key ingredient in the production of this deadly drug.”

Dr. Punyamurtula S. Kishore, an addiction medicine specialist in Chestnut Hill, Mass., agreed, although he noted that it wouldn't solve the problem completely. “[Pseudoephedrine] is the chief ingredient in the whole cooking process,” said Dr. Kishore. “Any controls are good controls.”

Dr. Maurice Ramirez, an emergency physician in Orlando, Fla., and a drug-testing professional for the Nuclear Regulatory Commission regulated industries, said that one reason cold medicines are being put behind the counter is to reduce the number of addicts who buy raw materials for their suppliers. “When you're taking meth, you look like you have a cold anyway, so the addicts buy a cartload of cold medicines and credit it against their account at the pusher,” he said. “It's foolish for [manufacturers] to go to the store and get their own pseudoephedrine, because they know that's where people are watching.”

Dr. Ramirez noted that the law also applies to sales of cold medicines on the Internet, which is one way many suppliers get them. “Many can just buy it over the Internet in large bulk amounts if they have a solid address and can generate the appropriate fake paperwork. It's harder to get the ammonia you need than it is to get cold medicine components. That part [of the law] is to counter crime and I think that's appropriate,” although it doesn't solve the problem of demand for meth.

Not everyone was as supportive. “This will not solve the problem,” said Dr. Akikur R. Mohammad of the psychiatry and behavioral sciences department at the University of Southern California, in Los Angeles. “It's easier to make meth with ephedrine and pseudoephedrine; if you take those medicines off the shelf, it makes [addicts'] lives harder but it doesn't mean they can't make it.”

Instead, said Dr. Mohammad, who is also medical director of Malibu Horizon, a residential substance abuse treatment facility, “We have to educate people that addiction is a disease, that it can cause problems with health. And when people are addicted, we have to aggressively treat them.”

Bill Piper, director of national affairs for the Drug Policy Alliance, a Washington-based group that emphasizes treatment over criminal prosecution for drug addicts, agreed. “I don't think it's going to have any impact,” he said. “It's not going to reduce the availability of methamphetamine, nor is it going to reduce the number of people addicted to meth. At the most, all it's going to do is reduce homemade meth.”

Laws similar to the Combat Methamphetamine Epidemic Act have previously been enacted in several states. In response to the reduction in available homemade methamphetamine, “Mexican-based drug cartels moved in,” Mr. Piper added. “As long as demand is there, there is going to be a supply.”

If addicts don't buy the meth directly from a cartel, there are ways to cook it without using cold medicines, although it is more complicated without the ephedrine or pseudoephedrine, Dr. Mohammad said. “Now they will have to turn to people who are more educated and have more knowledge in chemistry.”

The Combat Methamphetamine Epidemic Act also included other provisions related to helping meth addicts and their families. Mr. Piper pointed to one provision sponsored by Rep. Sheila Jackson Lee (D-Tex.) that creates grant programs to establish treatment centers for parenting and pregnant women.

“Generally speaking, most drug users tend to be men, but when it comes to meth, about 50% are women,” he said. “There is a huge lack of resources for drug treatment for women, especially women with children. If you are [being treated] in-house, you can't bring your child with you, and if you are an outpatient and you don't have child care, it's much more difficult.”

Over-the-counter drugs containing pseudoephedrine will go behind the counter beginning in late September under a new law passed by Congress and signed by President Bush.

The Combat Methamphetamine Epidemic Act of 2005—passed as part of the reauthorization of the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA PATRIOT) Improvement and Reauthorization Act of 2005—requires consumers who wish to purchase pseudoephedrine-containing over-the-counter medicines to show photo identification and sign a log book. It also limits the amount of pseudoephedrine-containing products that can be purchased to 3.6 g per day and 9 g within a 30-day period.

Rep. Roy Blunt (R-Mo.), one of the supporters of the legislation, said the new law will help combat methamphetamine abuse. “Easy access to common cold medicine is a meth cook's dream come true,” Rep. Blunt said in a statement. “The most effective way to fight the meth epidemic is to make it harder for criminals to get the key ingredient in the production of this deadly drug.”

Dr. Punyamurtula S. Kishore, an addiction medicine specialist in Chestnut Hill, Mass., agreed, although he noted that it wouldn't solve the problem completely. “[Pseudoephedrine] is the chief ingredient in the whole cooking process,” said Dr. Kishore. “Any controls are good controls.”

Dr. Maurice Ramirez, an emergency physician in Orlando, Fla., and a drug-testing professional for the Nuclear Regulatory Commission regulated industries, said that one reason cold medicines are being put behind the counter is to reduce the number of addicts who buy raw materials for their suppliers. “When you're taking meth, you look like you have a cold anyway, so the addicts buy a cartload of cold medicines and credit it against their account at the pusher,” he said. “It's foolish for [manufacturers] to go to the store and get their own pseudoephedrine, because they know that's where people are watching.”

Dr. Ramirez noted that the law also applies to sales of cold medicines on the Internet, which is one way many suppliers get them. “Many can just buy it over the Internet in large bulk amounts if they have a solid address and can generate the appropriate fake paperwork. It's harder to get the ammonia you need than it is to get cold medicine components. That part [of the law] is to counter crime and I think that's appropriate,” although it doesn't solve the problem of demand for meth.

Not everyone was as supportive. “This will not solve the problem,” said Dr. Akikur R. Mohammad of the psychiatry and behavioral sciences department at the University of Southern California, in Los Angeles. “It's easier to make meth with ephedrine and pseudoephedrine; if you take those medicines off the shelf, it makes [addicts'] lives harder but it doesn't mean they can't make it.”

Instead, said Dr. Mohammad, who is also medical director of Malibu Horizon, a residential substance abuse treatment facility, “We have to educate people that addiction is a disease, that it can cause problems with health. And when people are addicted, we have to aggressively treat them.”

Bill Piper, director of national affairs for the Drug Policy Alliance, a Washington-based group that emphasizes treatment over criminal prosecution for drug addicts, agreed. “I don't think it's going to have any impact,” he said. “It's not going to reduce the availability of methamphetamine, nor is it going to reduce the number of people addicted to meth. At the most, all it's going to do is reduce homemade meth.”

Laws similar to the Combat Methamphetamine Epidemic Act have previously been enacted in several states. In response to the reduction in available homemade methamphetamine, “Mexican-based drug cartels moved in,” Mr. Piper added. “As long as demand is there, there is going to be a supply.”

If addicts don't buy the meth directly from a cartel, there are ways to cook it without using cold medicines, although it is more complicated without the ephedrine or pseudoephedrine, Dr. Mohammad said. “Now they will have to turn to people who are more educated and have more knowledge in chemistry.”

The Combat Methamphetamine Epidemic Act also included other provisions related to helping meth addicts and their families. Mr. Piper pointed to one provision sponsored by Rep. Sheila Jackson Lee (D-Tex.) that creates grant programs to establish treatment centers for parenting and pregnant women.

“Generally speaking, most drug users tend to be men, but when it comes to meth, about 50% are women,” he said. “There is a huge lack of resources for drug treatment for women, especially women with children. If you are [being treated] in-house, you can't bring your child with you, and if you are an outpatient and you don't have child care, it's much more difficult.”

Over-the-counter drugs containing pseudoephedrine will go behind the counter beginning in late September under a new law passed by Congress and signed by President Bush.

The Combat Methamphetamine Epidemic Act of 2005—passed as part of the reauthorization of the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA PATRIOT) Improvement and Reauthorization Act of 2005—requires consumers who wish to purchase pseudoephedrine-containing over-the-counter medicines to show photo identification and sign a log book. It also limits the amount of pseudoephedrine-containing products that can be purchased to 3.6 g per day and 9 g within a 30-day period.

Rep. Roy Blunt (R-Mo.), one of the supporters of the legislation, said the new law will help combat methamphetamine abuse. “Easy access to common cold medicine is a meth cook's dream come true,” Rep. Blunt said in a statement. “The most effective way to fight the meth epidemic is to make it harder for criminals to get the key ingredient in the production of this deadly drug.”

Dr. Punyamurtula S. Kishore, an addiction medicine specialist in Chestnut Hill, Mass., agreed, although he noted that it wouldn't solve the problem completely. “[Pseudoephedrine] is the chief ingredient in the whole cooking process,” said Dr. Kishore. “Any controls are good controls.”

Dr. Maurice Ramirez, an emergency physician in Orlando, Fla., and a drug-testing professional for the Nuclear Regulatory Commission regulated industries, said that one reason cold medicines are being put behind the counter is to reduce the number of addicts who buy raw materials for their suppliers. “When you're taking meth, you look like you have a cold anyway, so the addicts buy a cartload of cold medicines and credit it against their account at the pusher,” he said. “It's foolish for [manufacturers] to go to the store and get their own pseudoephedrine, because they know that's where people are watching.”

Dr. Ramirez noted that the law also applies to sales of cold medicines on the Internet, which is one way many suppliers get them. “Many can just buy it over the Internet in large bulk amounts if they have a solid address and can generate the appropriate fake paperwork. It's harder to get the ammonia you need than it is to get cold medicine components. That part [of the law] is to counter crime and I think that's appropriate,” although it doesn't solve the problem of demand for meth.

Not everyone was as supportive. “This will not solve the problem,” said Dr. Akikur R. Mohammad of the psychiatry and behavioral sciences department at the University of Southern California, in Los Angeles. “It's easier to make meth with ephedrine and pseudoephedrine; if you take those medicines off the shelf, it makes [addicts'] lives harder but it doesn't mean they can't make it.”

Instead, said Dr. Mohammad, who is also medical director of Malibu Horizon, a residential substance abuse treatment facility, “We have to educate people that addiction is a disease, that it can cause problems with health. And when people are addicted, we have to aggressively treat them.”

Bill Piper, director of national affairs for the Drug Policy Alliance, a Washington-based group that emphasizes treatment over criminal prosecution for drug addicts, agreed. “I don't think it's going to have any impact,” he said. “It's not going to reduce the availability of methamphetamine, nor is it going to reduce the number of people addicted to meth. At the most, all it's going to do is reduce homemade meth.”

Laws similar to the Combat Methamphetamine Epidemic Act have previously been enacted in several states. In response to the reduction in available homemade methamphetamine, “Mexican-based drug cartels moved in,” Mr. Piper added. “As long as demand is there, there is going to be a supply.”

If addicts don't buy the meth directly from a cartel, there are ways to cook it without using cold medicines, although it is more complicated without the ephedrine or pseudoephedrine, Dr. Mohammad said. “Now they will have to turn to people who are more educated and have more knowledge in chemistry.”

The Combat Methamphetamine Epidemic Act also included other provisions related to helping meth addicts and their families. Mr. Piper pointed to one provision sponsored by Rep. Sheila Jackson Lee (D-Tex.) that creates grant programs to establish treatment centers for parenting and pregnant women.

“Generally speaking, most drug users tend to be men, but when it comes to meth, about 50% are women,” he said. “There is a huge lack of resources for drug treatment for women, especially women with children. If you are [being treated] in-house, you can't bring your child with you, and if you are an outpatient and you don't have child care, it's much more difficult.”

Stem Cell Committee Named

The Institute of Medicine and the National Research Council, two divisions of the National Academies, have appointed a committee to “monitor and revise” voluntary guidelines on the conduct of human embryonic stem cell research. The committee will provide updates to the voluntary guidelines issued last year by the National Academies; it is currently seeking comments on the guidelines. It also will have workshops to keep informed about developments in the field. The 14-member committee will be cochaired by R. Alta Charo, professor of law and bioethics at the University of Wisconsin, Madison, and Richard O. Hynes, Ph.D., investigator at the Howard Hughes Medical Institute and professor of cancer research at the Massachusetts Institute of Technology, Cambridge. The Ellison Medical Foundation, the Greenwall Foundation, and the Howard Hughes Medical Institute will provide funding for the committee.

Medicare Trustees Report

The federal Hospital Insurance Trust Fund—better known as Medicare Part A—is not adequately funded to meet the needs of future beneficiaries, according to the annual report of the Social Security and Medicare trustees. “The Hospital Insurance Trust Fund is not adequately financed over the next 10 years,” the report said. “From the beginning of 2006 to the end of 2015, the assets of the Hospital Insurance Trust Fund are projected to decrease from $286 billion to $197 billion, which would be less than the recommended minimum level of 1 year's expenditures.” The trustees added that “the financial outlook for the Medicare program continues to raise serious concerns.” Total expenditures under Medicare were $336 billion in 2005 and are expected to grow faster than the economy, the trustees' report said. They added that “growth of this magnitude, if realized, would still substantially increase the strain on the nation's workers, Medicare beneficiaries, and the federal budget.” Senate Majority Leader Dr. Bill Frist (R-Tenn.) took an upbeat approach to the report, pointing out that it showed that the costs of the new Medicare prescription drug benefit are significantly lower than cited in previous reports. “However, the trustees also make it clear that much work remains to be done to address the growth of Medicare spending,” he said in a statement. The American Medical Association focused on the report's projected “steep long-term cuts” in Medicare payments to physicians. “[This] report on the dire future of Medicare cries out for reforms to ensure that Medicare will be there for future generations,” Dr. Duane Cady, chair of the AMA board of trustees, said in a statement. “Congress must take an immediate step to preserve seniors' access to physicians by tying Medicare physician payments to the cost of caring for seniors.”

Uninsured Get Inefficient Care

The uninsured not only face a “downward spiral” in health, they also experience inefficiencies in care, a new report from the Commonwealth Fund found. Uninsured persons are more likely to go without the care or screening tests that could prevent more serious health problems, according to the report. They also are less likely to have a regular doctor (41% vs. 86% of insured adults) and are more likely to face fragmented care. “Nearly one-quarter (23%) of adults who are currently uninsured or had a time uninsured reported that test results of records were not available at the time of a doctor's appointment, compared with 15% of insured adults. Nearly one-fifth (19%) of uninsured adults had duplicate tests ordered, compared with 10% of insured adults,” the study said. Researchers found that an “alarmingly high proportion (59%) of adults” with chronic illnesses such as diabetes and asthma who were uninsured for a time in the past year went without their medications because they couldn't afford them. The findings come from the Commonwealth Fund Biennial Health Insurance Survey, a nationally representative sample of 4,350 U.S. adults aged 19 years and older, which was conducted via phone in August 2005-January 2006. This analysis focuses on the population aged 19–64 years.

Maryland Passes Stem Cell Bill

The Maryland legislature passed a bill establishing a $15 million fund to promote stem cell research in the state. The measure, which passed by a vote of 90–48 and was signed by Republican Gov. Robert Ehrlich last month, will establish procedures for reviewing research projects involving either adult or embryonic stem cells. An independent commission—including representatives from the patient advocate, biotechnology, and ethics communities—will administer grants to universities and private sector researchers. This law will make Maryland a leader in medical research, Gov. Ehrlich said.

Stem Cell Committee Named

The Institute of Medicine and the National Research Council, two divisions of the National Academies, have appointed a committee to “monitor and revise” voluntary guidelines on the conduct of human embryonic stem cell research. The committee will provide updates to the voluntary guidelines issued last year by the National Academies; it is currently seeking comments on the guidelines. It also will have workshops to keep informed about developments in the field. The 14-member committee will be cochaired by R. Alta Charo, professor of law and bioethics at the University of Wisconsin, Madison, and Richard O. Hynes, Ph.D., investigator at the Howard Hughes Medical Institute and professor of cancer research at the Massachusetts Institute of Technology, Cambridge. The Ellison Medical Foundation, the Greenwall Foundation, and the Howard Hughes Medical Institute will provide funding for the committee.

Medicare Trustees Report

The federal Hospital Insurance Trust Fund—better known as Medicare Part A—is not adequately funded to meet the needs of future beneficiaries, according to the annual report of the Social Security and Medicare trustees. “The Hospital Insurance Trust Fund is not adequately financed over the next 10 years,” the report said. “From the beginning of 2006 to the end of 2015, the assets of the Hospital Insurance Trust Fund are projected to decrease from $286 billion to $197 billion, which would be less than the recommended minimum level of 1 year's expenditures.” The trustees added that “the financial outlook for the Medicare program continues to raise serious concerns.” Total expenditures under Medicare were $336 billion in 2005 and are expected to grow faster than the economy, the trustees' report said. They added that “growth of this magnitude, if realized, would still substantially increase the strain on the nation's workers, Medicare beneficiaries, and the federal budget.” Senate Majority Leader Dr. Bill Frist (R-Tenn.) took an upbeat approach to the report, pointing out that it showed that the costs of the new Medicare prescription drug benefit are significantly lower than cited in previous reports. “However, the trustees also make it clear that much work remains to be done to address the growth of Medicare spending,” he said in a statement. The American Medical Association focused on the report's projected “steep long-term cuts” in Medicare payments to physicians. “[This] report on the dire future of Medicare cries out for reforms to ensure that Medicare will be there for future generations,” Dr. Duane Cady, chair of the AMA board of trustees, said in a statement. “Congress must take an immediate step to preserve seniors' access to physicians by tying Medicare physician payments to the cost of caring for seniors.”

Uninsured Get Inefficient Care

The uninsured not only face a “downward spiral” in health, they also experience inefficiencies in care, a new report from the Commonwealth Fund found. Uninsured persons are more likely to go without the care or screening tests that could prevent more serious health problems, according to the report. They also are less likely to have a regular doctor (41% vs. 86% of insured adults) and are more likely to face fragmented care. “Nearly one-quarter (23%) of adults who are currently uninsured or had a time uninsured reported that test results of records were not available at the time of a doctor's appointment, compared with 15% of insured adults. Nearly one-fifth (19%) of uninsured adults had duplicate tests ordered, compared with 10% of insured adults,” the study said. Researchers found that an “alarmingly high proportion (59%) of adults” with chronic illnesses such as diabetes and asthma who were uninsured for a time in the past year went without their medications because they couldn't afford them. The findings come from the Commonwealth Fund Biennial Health Insurance Survey, a nationally representative sample of 4,350 U.S. adults aged 19 years and older, which was conducted via phone in August 2005-January 2006. This analysis focuses on the population aged 19–64 years.

Maryland Passes Stem Cell Bill

The Maryland legislature passed a bill establishing a $15 million fund to promote stem cell research in the state. The measure, which passed by a vote of 90–48 and was signed by Republican Gov. Robert Ehrlich last month, will establish procedures for reviewing research projects involving either adult or embryonic stem cells. An independent commission—including representatives from the patient advocate, biotechnology, and ethics communities—will administer grants to universities and private sector researchers. This law will make Maryland a leader in medical research, Gov. Ehrlich said.

Stem Cell Committee Named

The Institute of Medicine and the National Research Council, two divisions of the National Academies, have appointed a committee to “monitor and revise” voluntary guidelines on the conduct of human embryonic stem cell research. The committee will provide updates to the voluntary guidelines issued last year by the National Academies; it is currently seeking comments on the guidelines. It also will have workshops to keep informed about developments in the field. The 14-member committee will be cochaired by R. Alta Charo, professor of law and bioethics at the University of Wisconsin, Madison, and Richard O. Hynes, Ph.D., investigator at the Howard Hughes Medical Institute and professor of cancer research at the Massachusetts Institute of Technology, Cambridge. The Ellison Medical Foundation, the Greenwall Foundation, and the Howard Hughes Medical Institute will provide funding for the committee.

Medicare Trustees Report

The federal Hospital Insurance Trust Fund—better known as Medicare Part A—is not adequately funded to meet the needs of future beneficiaries, according to the annual report of the Social Security and Medicare trustees. “The Hospital Insurance Trust Fund is not adequately financed over the next 10 years,” the report said. “From the beginning of 2006 to the end of 2015, the assets of the Hospital Insurance Trust Fund are projected to decrease from $286 billion to $197 billion, which would be less than the recommended minimum level of 1 year's expenditures.” The trustees added that “the financial outlook for the Medicare program continues to raise serious concerns.” Total expenditures under Medicare were $336 billion in 2005 and are expected to grow faster than the economy, the trustees' report said. They added that “growth of this magnitude, if realized, would still substantially increase the strain on the nation's workers, Medicare beneficiaries, and the federal budget.” Senate Majority Leader Dr. Bill Frist (R-Tenn.) took an upbeat approach to the report, pointing out that it showed that the costs of the new Medicare prescription drug benefit are significantly lower than cited in previous reports. “However, the trustees also make it clear that much work remains to be done to address the growth of Medicare spending,” he said in a statement. The American Medical Association focused on the report's projected “steep long-term cuts” in Medicare payments to physicians. “[This] report on the dire future of Medicare cries out for reforms to ensure that Medicare will be there for future generations,” Dr. Duane Cady, chair of the AMA board of trustees, said in a statement. “Congress must take an immediate step to preserve seniors' access to physicians by tying Medicare physician payments to the cost of caring for seniors.”

Uninsured Get Inefficient Care

The uninsured not only face a “downward spiral” in health, they also experience inefficiencies in care, a new report from the Commonwealth Fund found. Uninsured persons are more likely to go without the care or screening tests that could prevent more serious health problems, according to the report. They also are less likely to have a regular doctor (41% vs. 86% of insured adults) and are more likely to face fragmented care. “Nearly one-quarter (23%) of adults who are currently uninsured or had a time uninsured reported that test results of records were not available at the time of a doctor's appointment, compared with 15% of insured adults. Nearly one-fifth (19%) of uninsured adults had duplicate tests ordered, compared with 10% of insured adults,” the study said. Researchers found that an “alarmingly high proportion (59%) of adults” with chronic illnesses such as diabetes and asthma who were uninsured for a time in the past year went without their medications because they couldn't afford them. The findings come from the Commonwealth Fund Biennial Health Insurance Survey, a nationally representative sample of 4,350 U.S. adults aged 19 years and older, which was conducted via phone in August 2005-January 2006. This analysis focuses on the population aged 19–64 years.

Maryland Passes Stem Cell Bill

The Maryland legislature passed a bill establishing a $15 million fund to promote stem cell research in the state. The measure, which passed by a vote of 90–48 and was signed by Republican Gov. Robert Ehrlich last month, will establish procedures for reviewing research projects involving either adult or embryonic stem cells. An independent commission—including representatives from the patient advocate, biotechnology, and ethics communities—will administer grants to universities and private sector researchers. This law will make Maryland a leader in medical research, Gov. Ehrlich said.

WASHINGTON — Two programs sponsored by the National Hispanic Medical Association aim to train more Hispanics to become physicians and to help them become leaders in the health care system.

First, the association has partnered with Meharry Medical College in Nashville, Tenn., a historically black medical school, to recruit Hispanic students for the college.

“We are all communities of color and we have to band together,” John Maupin Jr., D.D.S., president of Meharry, said at a meeting sponsored by the National Hispanic Medical Association (NHMA). “We need to be for individuals of color and individuals from poor communities of all races.”

At the meeting, representatives from Meharry and NHMA signed a memorandum of understanding, which establishes a relationship between the two organizations to expand outreach to Hispanic students. The project involves creating a model joint mentoring program, offering a summer research opportunity to a select number of potential students, and establishing a regional interview program that provides an opportunity for NHMA medical volunteers to interview students—through teleconferencing or other means—who have applied to Meharry.

“Together we ought to be able to help any number of individuals who have the opportunity to go to Meharry,” said Dr. Maupin. “I want to reach out, Meharry wants to reach out. If we come together and execute this endeavor, we'll be able to find these students.”

NHMA President Elena Rios called the memorandum “historic.” “The historically black colleges and universities of this country and the black professional world are light years ahead of the Hispanics,” Dr. Rios said. “We have Hispanics serving all professions; we just don't have the boards of trustees and boards of directors that are Hispanic at our universities in this country. For the [historically black colleges and universities] to take their vision and include us, and for us to say we want to work together, this is history in the making.”

The second program is a 2-year initiative with the U.S. Department of Health and Human Services office of minority health to develop leadership training, education, and outreach programs to improve Hispanic health.

The initiative's goals include recruiting Hispanics for senior-level positions at HHS and developing a national leadership training program for Hispanic doctors and public health professionals.

“We believe in developing the leadership of [Hispanic] doctors so they understand how to talk to their congressmen and policymakers in their states,” Dr. Rios said at a press conference announcing the initiative.

The association currently has two leadership-related fellowship programs, she explained. One, the NHMA leadership fellowship, trains mid-career doctors on how to be better advocates.

The other one, the NHMA public health leadership fellowship, involves training Hispanic public health managers to be better leaders for the country. NHMA board member Dr. Luis Estevez said the association's overall goals go beyond just recruiting Hispanic physicians.

“We are [also] forming partnerships to try to build a pipeline to high schools and colleges to not only have more Latinos enter medical school, but also enter health professions in general, be it nursing, technological fields, or medicine,” he said.

Another place more Latinos are needed is in the health care system, especially in the top ranks, Dr. Estevez continued. “One study done at hospital systems in New York found that [in] some of the hospitals that had up to 96 persons [at] the level of vice-president and above, including the board of directors, there was not a single Hispanic, despite the fact that these hospitals—which receive federal funds, by the way—are located in Latino communities. You're not going to change the culture of the hospital unless you also affect the governance,” he said.

WASHINGTON — Two programs sponsored by the National Hispanic Medical Association aim to train more Hispanics to become physicians and to help them become leaders in the health care system.

First, the association has partnered with Meharry Medical College in Nashville, Tenn., a historically black medical school, to recruit Hispanic students for the college.

“We are all communities of color and we have to band together,” John Maupin Jr., D.D.S., president of Meharry, said at a meeting sponsored by the National Hispanic Medical Association (NHMA). “We need to be for individuals of color and individuals from poor communities of all races.”

At the meeting, representatives from Meharry and NHMA signed a memorandum of understanding, which establishes a relationship between the two organizations to expand outreach to Hispanic students. The project involves creating a model joint mentoring program, offering a summer research opportunity to a select number of potential students, and establishing a regional interview program that provides an opportunity for NHMA medical volunteers to interview students—through teleconferencing or other means—who have applied to Meharry.

“Together we ought to be able to help any number of individuals who have the opportunity to go to Meharry,” said Dr. Maupin. “I want to reach out, Meharry wants to reach out. If we come together and execute this endeavor, we'll be able to find these students.”

NHMA President Elena Rios called the memorandum “historic.” “The historically black colleges and universities of this country and the black professional world are light years ahead of the Hispanics,” Dr. Rios said. “We have Hispanics serving all professions; we just don't have the boards of trustees and boards of directors that are Hispanic at our universities in this country. For the [historically black colleges and universities] to take their vision and include us, and for us to say we want to work together, this is history in the making.”

The second program is a 2-year initiative with the U.S. Department of Health and Human Services office of minority health to develop leadership training, education, and outreach programs to improve Hispanic health.

The initiative's goals include recruiting Hispanics for senior-level positions at HHS and developing a national leadership training program for Hispanic doctors and public health professionals.

“We believe in developing the leadership of [Hispanic] doctors so they understand how to talk to their congressmen and policymakers in their states,” Dr. Rios said at a press conference announcing the initiative.

The association currently has two leadership-related fellowship programs, she explained. One, the NHMA leadership fellowship, trains mid-career doctors on how to be better advocates.

The other one, the NHMA public health leadership fellowship, involves training Hispanic public health managers to be better leaders for the country. NHMA board member Dr. Luis Estevez said the association's overall goals go beyond just recruiting Hispanic physicians.

“We are [also] forming partnerships to try to build a pipeline to high schools and colleges to not only have more Latinos enter medical school, but also enter health professions in general, be it nursing, technological fields, or medicine,” he said.

Another place more Latinos are needed is in the health care system, especially in the top ranks, Dr. Estevez continued. “One study done at hospital systems in New York found that [in] some of the hospitals that had up to 96 persons [at] the level of vice-president and above, including the board of directors, there was not a single Hispanic, despite the fact that these hospitals—which receive federal funds, by the way—are located in Latino communities. You're not going to change the culture of the hospital unless you also affect the governance,” he said.

WASHINGTON — Two programs sponsored by the National Hispanic Medical Association aim to train more Hispanics to become physicians and to help them become leaders in the health care system.

First, the association has partnered with Meharry Medical College in Nashville, Tenn., a historically black medical school, to recruit Hispanic students for the college.

“We are all communities of color and we have to band together,” John Maupin Jr., D.D.S., president of Meharry, said at a meeting sponsored by the National Hispanic Medical Association (NHMA). “We need to be for individuals of color and individuals from poor communities of all races.”

At the meeting, representatives from Meharry and NHMA signed a memorandum of understanding, which establishes a relationship between the two organizations to expand outreach to Hispanic students. The project involves creating a model joint mentoring program, offering a summer research opportunity to a select number of potential students, and establishing a regional interview program that provides an opportunity for NHMA medical volunteers to interview students—through teleconferencing or other means—who have applied to Meharry.

“Together we ought to be able to help any number of individuals who have the opportunity to go to Meharry,” said Dr. Maupin. “I want to reach out, Meharry wants to reach out. If we come together and execute this endeavor, we'll be able to find these students.”

NHMA President Elena Rios called the memorandum “historic.” “The historically black colleges and universities of this country and the black professional world are light years ahead of the Hispanics,” Dr. Rios said. “We have Hispanics serving all professions; we just don't have the boards of trustees and boards of directors that are Hispanic at our universities in this country. For the [historically black colleges and universities] to take their vision and include us, and for us to say we want to work together, this is history in the making.”

The second program is a 2-year initiative with the U.S. Department of Health and Human Services office of minority health to develop leadership training, education, and outreach programs to improve Hispanic health.

The initiative's goals include recruiting Hispanics for senior-level positions at HHS and developing a national leadership training program for Hispanic doctors and public health professionals.

“We believe in developing the leadership of [Hispanic] doctors so they understand how to talk to their congressmen and policymakers in their states,” Dr. Rios said at a press conference announcing the initiative.

The association currently has two leadership-related fellowship programs, she explained. One, the NHMA leadership fellowship, trains mid-career doctors on how to be better advocates.

The other one, the NHMA public health leadership fellowship, involves training Hispanic public health managers to be better leaders for the country. NHMA board member Dr. Luis Estevez said the association's overall goals go beyond just recruiting Hispanic physicians.

“We are [also] forming partnerships to try to build a pipeline to high schools and colleges to not only have more Latinos enter medical school, but also enter health professions in general, be it nursing, technological fields, or medicine,” he said.

Another place more Latinos are needed is in the health care system, especially in the top ranks, Dr. Estevez continued. “One study done at hospital systems in New York found that [in] some of the hospitals that had up to 96 persons [at] the level of vice-president and above, including the board of directors, there was not a single Hispanic, despite the fact that these hospitals—which receive federal funds, by the way—are located in Latino communities. You're not going to change the culture of the hospital unless you also affect the governance,” he said.

WASHINGTON — The costs of malpractice insurance and defensive medicine account for about 10 cents of every dollar spent on health care premiums, several speakers said at a press briefing sponsored by America's Health Insurance Plans.

Medical liability and defensive medicine represented the “lion's share” of cost increases in the physician and outpatient areas, Michael Thompson, principal at the New York office of PricewaterhouseCoopers, said at the briefing.

Litigation and defensive medicine also accounted for about a third of the costs associated with poor-quality health care, said Mr. Thompson, noting that the cost of poor-quality care was spread throughout the health care system.

According to AHIP President Karen Ignagni, efforts must be made to reduce the amount of poor-quality care being given. “We have a system where 45% of what's being done is not best practice,” she said. “No public or private entity could operate at that rate.”

Overall, the rate of increase in health care premiums was 8.8% in 2004–2005, down significantly from 13.7% in 2001–2002, noted Jack Rodgers, managing director at PricewaterhouseCoopers. One factor contributing to the slowdown was a decrease in the rate of cost increases for prescription drugs, according to Mr. Thompson. “It's now trending in line with overall premiums,” he said.

Part of the reason for that decrease is employers' increasing use of three-tiered or four-tiered drug programs, in which patients pay a larger share for brand-name drugs, especially if there are generic equivalents. In 2000, only 27% of patients were in drug plans with three or more tiers; in 2004, the figure was 68%, he said.

In addition, cost trends were helped by a drop in the number of state mandates that are being added each year, from 80 in 2000 to less than 40 in 2004, Mr. Thompson said.

Outpatient costs rose significantly last year, Mr. Rodgers said. “Those are the services that are really growing rapidly.” The increase in outpatient services accounted for more than a third of the 8.8% increase in premiums, he noted.

Despite these problems, Mr. Thompson said in an interview that he did not expect premium increases to go higher next year. “We're looking at the same number or maybe a little lower,” he predicted.

WASHINGTON — The costs of malpractice insurance and defensive medicine account for about 10 cents of every dollar spent on health care premiums, several speakers said at a press briefing sponsored by America's Health Insurance Plans.

Medical liability and defensive medicine represented the “lion's share” of cost increases in the physician and outpatient areas, Michael Thompson, principal at the New York office of PricewaterhouseCoopers, said at the briefing.

Litigation and defensive medicine also accounted for about a third of the costs associated with poor-quality health care, said Mr. Thompson, noting that the cost of poor-quality care was spread throughout the health care system.

According to AHIP President Karen Ignagni, efforts must be made to reduce the amount of poor-quality care being given. “We have a system where 45% of what's being done is not best practice,” she said. “No public or private entity could operate at that rate.”

Overall, the rate of increase in health care premiums was 8.8% in 2004–2005, down significantly from 13.7% in 2001–2002, noted Jack Rodgers, managing director at PricewaterhouseCoopers. One factor contributing to the slowdown was a decrease in the rate of cost increases for prescription drugs, according to Mr. Thompson. “It's now trending in line with overall premiums,” he said.

Part of the reason for that decrease is employers' increasing use of three-tiered or four-tiered drug programs, in which patients pay a larger share for brand-name drugs, especially if there are generic equivalents. In 2000, only 27% of patients were in drug plans with three or more tiers; in 2004, the figure was 68%, he said.

In addition, cost trends were helped by a drop in the number of state mandates that are being added each year, from 80 in 2000 to less than 40 in 2004, Mr. Thompson said.

Outpatient costs rose significantly last year, Mr. Rodgers said. “Those are the services that are really growing rapidly.” The increase in outpatient services accounted for more than a third of the 8.8% increase in premiums, he noted.

Despite these problems, Mr. Thompson said in an interview that he did not expect premium increases to go higher next year. “We're looking at the same number or maybe a little lower,” he predicted.

WASHINGTON — The costs of malpractice insurance and defensive medicine account for about 10 cents of every dollar spent on health care premiums, several speakers said at a press briefing sponsored by America's Health Insurance Plans.

Medical liability and defensive medicine represented the “lion's share” of cost increases in the physician and outpatient areas, Michael Thompson, principal at the New York office of PricewaterhouseCoopers, said at the briefing.

Litigation and defensive medicine also accounted for about a third of the costs associated with poor-quality health care, said Mr. Thompson, noting that the cost of poor-quality care was spread throughout the health care system.

According to AHIP President Karen Ignagni, efforts must be made to reduce the amount of poor-quality care being given. “We have a system where 45% of what's being done is not best practice,” she said. “No public or private entity could operate at that rate.”

Overall, the rate of increase in health care premiums was 8.8% in 2004–2005, down significantly from 13.7% in 2001–2002, noted Jack Rodgers, managing director at PricewaterhouseCoopers. One factor contributing to the slowdown was a decrease in the rate of cost increases for prescription drugs, according to Mr. Thompson. “It's now trending in line with overall premiums,” he said.

Part of the reason for that decrease is employers' increasing use of three-tiered or four-tiered drug programs, in which patients pay a larger share for brand-name drugs, especially if there are generic equivalents. In 2000, only 27% of patients were in drug plans with three or more tiers; in 2004, the figure was 68%, he said.

In addition, cost trends were helped by a drop in the number of state mandates that are being added each year, from 80 in 2000 to less than 40 in 2004, Mr. Thompson said.

Outpatient costs rose significantly last year, Mr. Rodgers said. “Those are the services that are really growing rapidly.” The increase in outpatient services accounted for more than a third of the 8.8% increase in premiums, he noted.

Despite these problems, Mr. Thompson said in an interview that he did not expect premium increases to go higher next year. “We're looking at the same number or maybe a little lower,” he predicted.

WASHINGTON – Two programs sponsored by the National Hispanic Medical Association aim to train more Hispanics to become physicians and to help them become leaders in the health care system.

First, the association has partnered with Meharry Medical College in Nashville, Tenn., a historically black medical school, to recruit Hispanic students for the college.

“We are all communities of color and we have to band together,” John Maupin Jr., D.D.S., president of Meharry, said at a meeting sponsored by the National Hispanic Medical Association (NHMA).

“We need to be for individuals of color and individuals from poor communities of all races,” he said.

At the meeting, representatives from Meharry and NHMA signed a memorandum of understanding, which establishes a relationship between the two organizations to expand outreach to Hispanic students. The project involves creating a model joint mentoring program, offering a summer research opportunity to a select number of potential students, and establishing a regional interview program that provides an opportunity for NHMA medical volunteers to interview students–through teleconferencing or other means–who have applied to Meharry.

“Together we ought to be able to help any number of individuals who have the opportunity to go to Meharry,” said Dr. Maupin. “I want to reach out, Meharry wants to reach out. If we come together and execute this endeavor, we'll be able to find these students.”

NHMA President Elena Rios called the memorandum “historic.” “The historically black colleges and universities of this country and the black professional world are light-years ahead of the Hispanics,” Dr. Rios said. “We have Hispanics serving all professions. We just don't have the boards of trustees and boards of directors that are Hispanic at our universities in this country. For the [historically black colleges and universities] to take their vision and include us, and for us to say we want to work together, this is history in the making.”

The second program is a 2-year initiative with the U.S. Department of Health and Human Services office of minority health to develop leadership training, education, and outreach programs to improve Hispanic health. The initiative's goals include recruiting Hispanics for senior-level positions at HHS and developing a national leadership training program for Hispanic doctors and public health professionals.

“We believe in developing the leadership of [Hispanic] doctors so they understand how to talk to their congressmen and policymakers in their states,” Dr. Rios said at a press conference announcing the initiative.

The association currently has two leadership-related fellowship programs, she explained. One, the NHMA leadership fellowship, trains midcareer doctors on how to be better advocates. The other one, the NHMA public health leadership fellowship, involves training Hispanic public health managers to be better leaders for the country.

NHMA board member Dr. Luis Estevez said the association's overall goals go beyond just recruiting Hispanic physicians. “We are [also] forming partnerships to try to build a pipeline to high schools and colleges to not only have more Latinos enter medical school, but also enter health professions in general, be it nursing, technological fields, or medicine,” he said.

Another place more Latinos are needed is in the health care system, especially in the top ranks, Dr. Estevez continued. “One study done at hospital systems in New York found that [in] some of the hospitals that had up to 96 persons [at] the level of vice president and above, including the board of directors, there was not a single Hispanic, despite the fact that these hospitals–which receive federal funds, by the way–are located in Latino communities. You're not going to change the culture of the hospital unless you also affect the governance.”

WASHINGTON – Two programs sponsored by the National Hispanic Medical Association aim to train more Hispanics to become physicians and to help them become leaders in the health care system.

First, the association has partnered with Meharry Medical College in Nashville, Tenn., a historically black medical school, to recruit Hispanic students for the college.

“We are all communities of color and we have to band together,” John Maupin Jr., D.D.S., president of Meharry, said at a meeting sponsored by the National Hispanic Medical Association (NHMA).

“We need to be for individuals of color and individuals from poor communities of all races,” he said.

At the meeting, representatives from Meharry and NHMA signed a memorandum of understanding, which establishes a relationship between the two organizations to expand outreach to Hispanic students. The project involves creating a model joint mentoring program, offering a summer research opportunity to a select number of potential students, and establishing a regional interview program that provides an opportunity for NHMA medical volunteers to interview students–through teleconferencing or other means–who have applied to Meharry.

“Together we ought to be able to help any number of individuals who have the opportunity to go to Meharry,” said Dr. Maupin. “I want to reach out, Meharry wants to reach out. If we come together and execute this endeavor, we'll be able to find these students.”

NHMA President Elena Rios called the memorandum “historic.” “The historically black colleges and universities of this country and the black professional world are light-years ahead of the Hispanics,” Dr. Rios said. “We have Hispanics serving all professions. We just don't have the boards of trustees and boards of directors that are Hispanic at our universities in this country. For the [historically black colleges and universities] to take their vision and include us, and for us to say we want to work together, this is history in the making.”

The second program is a 2-year initiative with the U.S. Department of Health and Human Services office of minority health to develop leadership training, education, and outreach programs to improve Hispanic health. The initiative's goals include recruiting Hispanics for senior-level positions at HHS and developing a national leadership training program for Hispanic doctors and public health professionals.

“We believe in developing the leadership of [Hispanic] doctors so they understand how to talk to their congressmen and policymakers in their states,” Dr. Rios said at a press conference announcing the initiative.

The association currently has two leadership-related fellowship programs, she explained. One, the NHMA leadership fellowship, trains midcareer doctors on how to be better advocates. The other one, the NHMA public health leadership fellowship, involves training Hispanic public health managers to be better leaders for the country.

NHMA board member Dr. Luis Estevez said the association's overall goals go beyond just recruiting Hispanic physicians. “We are [also] forming partnerships to try to build a pipeline to high schools and colleges to not only have more Latinos enter medical school, but also enter health professions in general, be it nursing, technological fields, or medicine,” he said.

Another place more Latinos are needed is in the health care system, especially in the top ranks, Dr. Estevez continued. “One study done at hospital systems in New York found that [in] some of the hospitals that had up to 96 persons [at] the level of vice president and above, including the board of directors, there was not a single Hispanic, despite the fact that these hospitals–which receive federal funds, by the way–are located in Latino communities. You're not going to change the culture of the hospital unless you also affect the governance.”

WASHINGTON – Two programs sponsored by the National Hispanic Medical Association aim to train more Hispanics to become physicians and to help them become leaders in the health care system.

First, the association has partnered with Meharry Medical College in Nashville, Tenn., a historically black medical school, to recruit Hispanic students for the college.

“We are all communities of color and we have to band together,” John Maupin Jr., D.D.S., president of Meharry, said at a meeting sponsored by the National Hispanic Medical Association (NHMA).

“We need to be for individuals of color and individuals from poor communities of all races,” he said.

At the meeting, representatives from Meharry and NHMA signed a memorandum of understanding, which establishes a relationship between the two organizations to expand outreach to Hispanic students. The project involves creating a model joint mentoring program, offering a summer research opportunity to a select number of potential students, and establishing a regional interview program that provides an opportunity for NHMA medical volunteers to interview students–through teleconferencing or other means–who have applied to Meharry.

“Together we ought to be able to help any number of individuals who have the opportunity to go to Meharry,” said Dr. Maupin. “I want to reach out, Meharry wants to reach out. If we come together and execute this endeavor, we'll be able to find these students.”

NHMA President Elena Rios called the memorandum “historic.” “The historically black colleges and universities of this country and the black professional world are light-years ahead of the Hispanics,” Dr. Rios said. “We have Hispanics serving all professions. We just don't have the boards of trustees and boards of directors that are Hispanic at our universities in this country. For the [historically black colleges and universities] to take their vision and include us, and for us to say we want to work together, this is history in the making.”

The second program is a 2-year initiative with the U.S. Department of Health and Human Services office of minority health to develop leadership training, education, and outreach programs to improve Hispanic health. The initiative's goals include recruiting Hispanics for senior-level positions at HHS and developing a national leadership training program for Hispanic doctors and public health professionals.

“We believe in developing the leadership of [Hispanic] doctors so they understand how to talk to their congressmen and policymakers in their states,” Dr. Rios said at a press conference announcing the initiative.

The association currently has two leadership-related fellowship programs, she explained. One, the NHMA leadership fellowship, trains midcareer doctors on how to be better advocates. The other one, the NHMA public health leadership fellowship, involves training Hispanic public health managers to be better leaders for the country.

NHMA board member Dr. Luis Estevez said the association's overall goals go beyond just recruiting Hispanic physicians. “We are [also] forming partnerships to try to build a pipeline to high schools and colleges to not only have more Latinos enter medical school, but also enter health professions in general, be it nursing, technological fields, or medicine,” he said.

Another place more Latinos are needed is in the health care system, especially in the top ranks, Dr. Estevez continued. “One study done at hospital systems in New York found that [in] some of the hospitals that had up to 96 persons [at] the level of vice president and above, including the board of directors, there was not a single Hispanic, despite the fact that these hospitals–which receive federal funds, by the way–are located in Latino communities. You're not going to change the culture of the hospital unless you also affect the governance.”

Underage Drinking

Underage alcohol use was up in California and Wisconsin in 2003–2004, compared with a year earlier, but down in Michigan and South Carolina, according to a new report from the Substance Abuse and Mental Health Services Administration. The survey found that the percentage of 12- to 20-year-olds using alcohol within the past month increased from 24.7% to 26.3% in California, and from 34.7% to 38.3% in Wisconsin. On the other hand, the rate of underage drinking decreased in Michigan, from 31.8% to 30.2%, and in South Carolina, from 27.3% to 24.1%. “While we are making progress on drug and tobacco use among youth, underage drinking continues as a stubbornly persistent problem,” said SAMHSA Administrator Charles Curie. “It's time to change attitudes toward teen drinking from acceptance to abstinence.” Eight states were in the top fifth for both underage use of alcohol and underage binge use of alcohol: Iowa, Massachusetts, Montana, New Hampshire, North Dakota, Rhode Island, South Dakota, and Wisconsin.

ADHD Drugs Prescribed Too Often?

Nearly two-thirds (61%) of adults think that drugs are prescribed too often to treat children under age 13 with attention-deficit hyperactivity disorder, according to a poll of 2,200 adults by Wall Street Journal Online/Harris Interactive. Only 2% said the drugs were not prescribed often enough, while 7% said they were prescribed as often as they should be, and 30% were not sure. In addition, 68% of respondents agreed that stronger warnings should be required on the drugs' labels; 6% disagreed. Respondents were slightly less concerned about ADHD drugs being prescribed to teens; 51% thought they were prescribed too often while 4% said they weren't prescribed often enough. “This [poll] suggests that the public would rather see the FDA err on the side of caution when it comes to labeling for prescription drugs,” said Katherine Binns, senior vice president of Harris Interactive.

FDA Names Drug Safety Spokesman

The Food and Drug Administration has appointed Dr. Paul Seligman as associate center director for safety policy and communication in the agency's Center for Drug Evaluation and Research (CDER). In this position, Dr. Seligman will coordinate drug safety policy and risk communications, according to CDER director Dr. Steven Galson. “We anticipate that this step will help to provide a more standardized and predictable approach to ensuring drug safety and enhance the effectiveness and timeliness of the information we provide to the health care community and the public.” But Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said the appointment was just more window dressing. “It's very parallel to the way in which they originally dealt with this problem of poor decision making as far as drug safety,” he said in an interview. When Congress was considering legislation to separate the Office of Drug Safety from CDER, the FDA responded with a safety advisory board–but one that was made up largely of agency employees. Now, in the case of Dr. Seligman, “he will be reporting directly to Dr. Galson and will lack the independence necessary to free up the Office of Drug Safety from its second-class position in FDA,” Dr. Wolfe said. At a telephone press conference, Dr. Seligman said that although he still works for FDA, “there are many important policy questions that go well beyond the FDA” when it comes to deciding whether to change drug labeling or pull a drug from the market.

Part D Costs Up for 2007

The Centers for Medicare and Medicaid Services reports that Medicare recipients enrolled in Part D drug coverage will be paying 7% more for their benefits in 2007. Deductibles will rise from the current $250 to $265; Medicare will stop coverage when the program has paid out $2,400 (up from $2,250), and will resume when the beneficiary has incurred $3,850 in medication costs (up from $3,600). This is the so-called “doughnut hole.” Putting a positive spin on the increase, a spokesperson from the CMS Office of the Actuary said in a statement that “the actuarial value of the drug benefit increases along with any increase in drug expenses, and the standard Part D benefit continues to cover a constant share of drug expenses from year to year.”

Report Critical of HRSA

The Health Resources and Services Administration needs to do a better job of making health workforce projections, according to a report from the Government Accountability Office. “Although HRSA is responsible for providing health professions workforce information to policymakers, HRSA has in the past decade published national supply and demand projections for the nurse and pharmacist workforces but no national projections for the physician and dentist workforces,” the GAO said in its report. HRSA should “develop a strategy and time frames to regularly update and publish national health professions workforce projections.” In response, HRSA noted that the GAO mainly focused its criticisms on publications from the agency's National Center for Workforce Information and Analysis and did not include “the considerable body of work produced by the regional workforce centers that receive … funding from HRSA.” The agency stated “that the legislated goal of providing 'health workforce information and analysis, … such as shortages of registered nurses, shortages of pharmacists, and the distribution of health care workers in underserved areas,' is broader than what GAO's exclusive focus on supply and demand projections for physicians, nurses, and dentists would allow.”

Underage Drinking

Underage alcohol use was up in California and Wisconsin in 2003–2004, compared with a year earlier, but down in Michigan and South Carolina, according to a new report from the Substance Abuse and Mental Health Services Administration. The survey found that the percentage of 12- to 20-year-olds using alcohol within the past month increased from 24.7% to 26.3% in California, and from 34.7% to 38.3% in Wisconsin. On the other hand, the rate of underage drinking decreased in Michigan, from 31.8% to 30.2%, and in South Carolina, from 27.3% to 24.1%. “While we are making progress on drug and tobacco use among youth, underage drinking continues as a stubbornly persistent problem,” said SAMHSA Administrator Charles Curie. “It's time to change attitudes toward teen drinking from acceptance to abstinence.” Eight states were in the top fifth for both underage use of alcohol and underage binge use of alcohol: Iowa, Massachusetts, Montana, New Hampshire, North Dakota, Rhode Island, South Dakota, and Wisconsin.

ADHD Drugs Prescribed Too Often?

Nearly two-thirds (61%) of adults think that drugs are prescribed too often to treat children under age 13 with attention-deficit hyperactivity disorder, according to a poll of 2,200 adults by Wall Street Journal Online/Harris Interactive. Only 2% said the drugs were not prescribed often enough, while 7% said they were prescribed as often as they should be, and 30% were not sure. In addition, 68% of respondents agreed that stronger warnings should be required on the drugs' labels; 6% disagreed. Respondents were slightly less concerned about ADHD drugs being prescribed to teens; 51% thought they were prescribed too often while 4% said they weren't prescribed often enough. “This [poll] suggests that the public would rather see the FDA err on the side of caution when it comes to labeling for prescription drugs,” said Katherine Binns, senior vice president of Harris Interactive.

FDA Names Drug Safety Spokesman

The Food and Drug Administration has appointed Dr. Paul Seligman as associate center director for safety policy and communication in the agency's Center for Drug Evaluation and Research (CDER). In this position, Dr. Seligman will coordinate drug safety policy and risk communications, according to CDER director Dr. Steven Galson. “We anticipate that this step will help to provide a more standardized and predictable approach to ensuring drug safety and enhance the effectiveness and timeliness of the information we provide to the health care community and the public.” But Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said the appointment was just more window dressing. “It's very parallel to the way in which they originally dealt with this problem of poor decision making as far as drug safety,” he said in an interview. When Congress was considering legislation to separate the Office of Drug Safety from CDER, the FDA responded with a safety advisory board–but one that was made up largely of agency employees. Now, in the case of Dr. Seligman, “he will be reporting directly to Dr. Galson and will lack the independence necessary to free up the Office of Drug Safety from its second-class position in FDA,” Dr. Wolfe said. At a telephone press conference, Dr. Seligman said that although he still works for FDA, “there are many important policy questions that go well beyond the FDA” when it comes to deciding whether to change drug labeling or pull a drug from the market.

Part D Costs Up for 2007

The Centers for Medicare and Medicaid Services reports that Medicare recipients enrolled in Part D drug coverage will be paying 7% more for their benefits in 2007. Deductibles will rise from the current $250 to $265; Medicare will stop coverage when the program has paid out $2,400 (up from $2,250), and will resume when the beneficiary has incurred $3,850 in medication costs (up from $3,600). This is the so-called “doughnut hole.” Putting a positive spin on the increase, a spokesperson from the CMS Office of the Actuary said in a statement that “the actuarial value of the drug benefit increases along with any increase in drug expenses, and the standard Part D benefit continues to cover a constant share of drug expenses from year to year.”

Report Critical of HRSA

The Health Resources and Services Administration needs to do a better job of making health workforce projections, according to a report from the Government Accountability Office. “Although HRSA is responsible for providing health professions workforce information to policymakers, HRSA has in the past decade published national supply and demand projections for the nurse and pharmacist workforces but no national projections for the physician and dentist workforces,” the GAO said in its report. HRSA should “develop a strategy and time frames to regularly update and publish national health professions workforce projections.” In response, HRSA noted that the GAO mainly focused its criticisms on publications from the agency's National Center for Workforce Information and Analysis and did not include “the considerable body of work produced by the regional workforce centers that receive … funding from HRSA.” The agency stated “that the legislated goal of providing 'health workforce information and analysis, … such as shortages of registered nurses, shortages of pharmacists, and the distribution of health care workers in underserved areas,' is broader than what GAO's exclusive focus on supply and demand projections for physicians, nurses, and dentists would allow.”

Underage Drinking

Underage alcohol use was up in California and Wisconsin in 2003–2004, compared with a year earlier, but down in Michigan and South Carolina, according to a new report from the Substance Abuse and Mental Health Services Administration. The survey found that the percentage of 12- to 20-year-olds using alcohol within the past month increased from 24.7% to 26.3% in California, and from 34.7% to 38.3% in Wisconsin. On the other hand, the rate of underage drinking decreased in Michigan, from 31.8% to 30.2%, and in South Carolina, from 27.3% to 24.1%. “While we are making progress on drug and tobacco use among youth, underage drinking continues as a stubbornly persistent problem,” said SAMHSA Administrator Charles Curie. “It's time to change attitudes toward teen drinking from acceptance to abstinence.” Eight states were in the top fifth for both underage use of alcohol and underage binge use of alcohol: Iowa, Massachusetts, Montana, New Hampshire, North Dakota, Rhode Island, South Dakota, and Wisconsin.

ADHD Drugs Prescribed Too Often?

Nearly two-thirds (61%) of adults think that drugs are prescribed too often to treat children under age 13 with attention-deficit hyperactivity disorder, according to a poll of 2,200 adults by Wall Street Journal Online/Harris Interactive. Only 2% said the drugs were not prescribed often enough, while 7% said they were prescribed as often as they should be, and 30% were not sure. In addition, 68% of respondents agreed that stronger warnings should be required on the drugs' labels; 6% disagreed. Respondents were slightly less concerned about ADHD drugs being prescribed to teens; 51% thought they were prescribed too often while 4% said they weren't prescribed often enough. “This [poll] suggests that the public would rather see the FDA err on the side of caution when it comes to labeling for prescription drugs,” said Katherine Binns, senior vice president of Harris Interactive.

FDA Names Drug Safety Spokesman

The Food and Drug Administration has appointed Dr. Paul Seligman as associate center director for safety policy and communication in the agency's Center for Drug Evaluation and Research (CDER). In this position, Dr. Seligman will coordinate drug safety policy and risk communications, according to CDER director Dr. Steven Galson. “We anticipate that this step will help to provide a more standardized and predictable approach to ensuring drug safety and enhance the effectiveness and timeliness of the information we provide to the health care community and the public.” But Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said the appointment was just more window dressing. “It's very parallel to the way in which they originally dealt with this problem of poor decision making as far as drug safety,” he said in an interview. When Congress was considering legislation to separate the Office of Drug Safety from CDER, the FDA responded with a safety advisory board–but one that was made up largely of agency employees. Now, in the case of Dr. Seligman, “he will be reporting directly to Dr. Galson and will lack the independence necessary to free up the Office of Drug Safety from its second-class position in FDA,” Dr. Wolfe said. At a telephone press conference, Dr. Seligman said that although he still works for FDA, “there are many important policy questions that go well beyond the FDA” when it comes to deciding whether to change drug labeling or pull a drug from the market.

Part D Costs Up for 2007

The Centers for Medicare and Medicaid Services reports that Medicare recipients enrolled in Part D drug coverage will be paying 7% more for their benefits in 2007. Deductibles will rise from the current $250 to $265; Medicare will stop coverage when the program has paid out $2,400 (up from $2,250), and will resume when the beneficiary has incurred $3,850 in medication costs (up from $3,600). This is the so-called “doughnut hole.” Putting a positive spin on the increase, a spokesperson from the CMS Office of the Actuary said in a statement that “the actuarial value of the drug benefit increases along with any increase in drug expenses, and the standard Part D benefit continues to cover a constant share of drug expenses from year to year.”

Report Critical of HRSA

The Health Resources and Services Administration needs to do a better job of making health workforce projections, according to a report from the Government Accountability Office. “Although HRSA is responsible for providing health professions workforce information to policymakers, HRSA has in the past decade published national supply and demand projections for the nurse and pharmacist workforces but no national projections for the physician and dentist workforces,” the GAO said in its report. HRSA should “develop a strategy and time frames to regularly update and publish national health professions workforce projections.” In response, HRSA noted that the GAO mainly focused its criticisms on publications from the agency's National Center for Workforce Information and Analysis and did not include “the considerable body of work produced by the regional workforce centers that receive … funding from HRSA.” The agency stated “that the legislated goal of providing 'health workforce information and analysis, … such as shortages of registered nurses, shortages of pharmacists, and the distribution of health care workers in underserved areas,' is broader than what GAO's exclusive focus on supply and demand projections for physicians, nurses, and dentists would allow.”

WASHINGTON — In spite of poor Medicare reimbursement, physicians who use infusion therapy can take steps to make their practices more profitable, Steven M. Coplon said at a conference sponsored by Elsevier Oncology.

Under Medicare's system for infusion-drug reimbursement, “essential services are underreimbursed or not reimbursed at all,” said Mr. Coplon, chief executive officer of The West Clinic, a Memphis, Tenn., oncology practice. “But the cost of drugs, staff, facilities, and malpractice insurance all continue to increase.”

To stay in business, practices must look more closely at the revenue they get for their services, he said. For example, “on one drug regimen [given frequently to Medicare patients], we're making $24 on $7,061 worth of investment. Even Sam Walton, when he started Wal-Mart, worked on a higher margin than that.”

One way to boost revenue is to raise the amount the practice brings in from private payers, he continued. “Negotiate it to the best of your ability; go for every code you can possibly think of. Get creative,” he advised. “If they're willing to say yes, you can make up for a lot of these margins you're losing on the Medicare book of business.”

Another strategy: Diversify. Instead of just providing drug, chemotherapy, administrative, and laboratory services at an oncology practice, why not add radiology, pain management, palliative care, gynecologic oncology, and hospitalist care? Within each service, of course, are different subsets—radiation oncology can include CT, PET, PET/CT, and MRI, he noted.

Roberta L. Buell, vice president of provider services and reimbursement at P4 Healthcare, Sausalito, Calif., said practices should consider if their billing procedures are “optimal.” In an optimal practice, “80% of receivables should be less than 90 days overdue,” Ms. Buell said. “And if your practice is more than 50% Medicare, you should be doing much better than that.” Also, be aware of your practice's “chair turn” per day and see if it can improve.

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

WASHINGTON — In spite of poor Medicare reimbursement, physicians who use infusion therapy can take steps to make their practices more profitable, Steven M. Coplon said at a conference sponsored by Elsevier Oncology.

Under Medicare's system for infusion-drug reimbursement, “essential services are underreimbursed or not reimbursed at all,” said Mr. Coplon, chief executive officer of The West Clinic, a Memphis, Tenn., oncology practice. “But the cost of drugs, staff, facilities, and malpractice insurance all continue to increase.”

To stay in business, practices must look more closely at the revenue they get for their services, he said. For example, “on one drug regimen [given frequently to Medicare patients], we're making $24 on $7,061 worth of investment. Even Sam Walton, when he started Wal-Mart, worked on a higher margin than that.”

One way to boost revenue is to raise the amount the practice brings in from private payers, he continued. “Negotiate it to the best of your ability; go for every code you can possibly think of. Get creative,” he advised. “If they're willing to say yes, you can make up for a lot of these margins you're losing on the Medicare book of business.”

Another strategy: Diversify. Instead of just providing drug, chemotherapy, administrative, and laboratory services at an oncology practice, why not add radiology, pain management, palliative care, gynecologic oncology, and hospitalist care? Within each service, of course, are different subsets—radiation oncology can include CT, PET, PET/CT, and MRI, he noted.

Roberta L. Buell, vice president of provider services and reimbursement at P4 Healthcare, Sausalito, Calif., said practices should consider if their billing procedures are “optimal.” In an optimal practice, “80% of receivables should be less than 90 days overdue,” Ms. Buell said. “And if your practice is more than 50% Medicare, you should be doing much better than that.” Also, be aware of your practice's “chair turn” per day and see if it can improve.

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.

WASHINGTON — In spite of poor Medicare reimbursement, physicians who use infusion therapy can take steps to make their practices more profitable, Steven M. Coplon said at a conference sponsored by Elsevier Oncology.

Under Medicare's system for infusion-drug reimbursement, “essential services are underreimbursed or not reimbursed at all,” said Mr. Coplon, chief executive officer of The West Clinic, a Memphis, Tenn., oncology practice. “But the cost of drugs, staff, facilities, and malpractice insurance all continue to increase.”

To stay in business, practices must look more closely at the revenue they get for their services, he said. For example, “on one drug regimen [given frequently to Medicare patients], we're making $24 on $7,061 worth of investment. Even Sam Walton, when he started Wal-Mart, worked on a higher margin than that.”

One way to boost revenue is to raise the amount the practice brings in from private payers, he continued. “Negotiate it to the best of your ability; go for every code you can possibly think of. Get creative,” he advised. “If they're willing to say yes, you can make up for a lot of these margins you're losing on the Medicare book of business.”

Another strategy: Diversify. Instead of just providing drug, chemotherapy, administrative, and laboratory services at an oncology practice, why not add radiology, pain management, palliative care, gynecologic oncology, and hospitalist care? Within each service, of course, are different subsets—radiation oncology can include CT, PET, PET/CT, and MRI, he noted.

Roberta L. Buell, vice president of provider services and reimbursement at P4 Healthcare, Sausalito, Calif., said practices should consider if their billing procedures are “optimal.” In an optimal practice, “80% of receivables should be less than 90 days overdue,” Ms. Buell said. “And if your practice is more than 50% Medicare, you should be doing much better than that.” Also, be aware of your practice's “chair turn” per day and see if it can improve.

Elsevier Oncology and this news organization are wholly owned subsidiaries of Elsevier.