Alicia Ault

GAITHERSBURG, MD. — The 2007–2008 trivalent influenza vaccine should retain two strains from the current vaccine and change one strain, a Food and Drug Administration advisory panel voted on Feb. 28.

The Vaccines and Related Biological Products Advisory Committee followed the lead of the World Health Organization, which made its recommendations for a Northern Hemisphere winter vaccine a week earlier. The FDA usually follows its panel's advice.

The decision gives the green light to manufacturers to go ahead with production. It generally takes until July or August for vaccine makers to complete testing, acquire FDA approval, and begin packaging their product. Distribution usually starts in September and ends by Nov. 1.

The WHO recommended keeping the current H3N2 strain, which is the A/Wisconsin/67/2005-like virus. The 2006–2007 flu season had been dominated mostly by influenza A (H1N1) strains, said Nancy J. Cox, Ph.D., director of the Centers for Disease Control and Prevention's influenza division. But in February, it appeared that H3N2 strains were starting to dominate. It wasn't clear yet which of those might be the predominant H3 strain, she said.

Even though panelists were concerned about the emergence of a new H3N2 subtype, 11 of 13 members voted to keep the current H3 strain. “At this point, I feel like we don't have any choice,” said Dr. Melinda Wharton, deputy director of the CDC's National Immunization Program and a temporary voting member of the committee. She noted that manufacturers already had started production on the current H3 strain.

Two committee members said they wanted to defer a decision until more surveillance data were available.

The panel voted unanimously to change the current H1N1 strain from A/New Caledonia/20/99-like virus with A/Solomon Islands/3/2006. The WHO had recommended that change. The FDA committee also voted unanimously to retain the current B strain—B/Malaysia/2506/2004-like virus—mirroring the WHO recommendation.

The 2006–2007 season has been fairly mild, said Ms. Cox. As of Feb. 17, widespread flu activity was reported in 24 states, 14 states reported regional activity, 10 reported local activity, and 2 reported sporadic activity. There were 3 pediatric deaths during that week, bringing the total to 15 deaths since the season began Oct. 1, 2006.

GAITHERSBURG, MD. — The 2007–2008 trivalent influenza vaccine should retain two strains from the current vaccine and change one strain, a Food and Drug Administration advisory panel voted on Feb. 28.

The Vaccines and Related Biological Products Advisory Committee followed the lead of the World Health Organization, which made its recommendations for a Northern Hemisphere winter vaccine a week earlier. The FDA usually follows its panel's advice.

The decision gives the green light to manufacturers to go ahead with production. It generally takes until July or August for vaccine makers to complete testing, acquire FDA approval, and begin packaging their product. Distribution usually starts in September and ends by Nov. 1.

The WHO recommended keeping the current H3N2 strain, which is the A/Wisconsin/67/2005-like virus. The 2006–2007 flu season had been dominated mostly by influenza A (H1N1) strains, said Nancy J. Cox, Ph.D., director of the Centers for Disease Control and Prevention's influenza division. But in February, it appeared that H3N2 strains were starting to dominate. It wasn't clear yet which of those might be the predominant H3 strain, she said.

Even though panelists were concerned about the emergence of a new H3N2 subtype, 11 of 13 members voted to keep the current H3 strain. “At this point, I feel like we don't have any choice,” said Dr. Melinda Wharton, deputy director of the CDC's National Immunization Program and a temporary voting member of the committee. She noted that manufacturers already had started production on the current H3 strain.

Two committee members said they wanted to defer a decision until more surveillance data were available.

The panel voted unanimously to change the current H1N1 strain from A/New Caledonia/20/99-like virus with A/Solomon Islands/3/2006. The WHO had recommended that change. The FDA committee also voted unanimously to retain the current B strain—B/Malaysia/2506/2004-like virus—mirroring the WHO recommendation.

The 2006–2007 season has been fairly mild, said Ms. Cox. As of Feb. 17, widespread flu activity was reported in 24 states, 14 states reported regional activity, 10 reported local activity, and 2 reported sporadic activity. There were 3 pediatric deaths during that week, bringing the total to 15 deaths since the season began Oct. 1, 2006.

GAITHERSBURG, MD. — The 2007–2008 trivalent influenza vaccine should retain two strains from the current vaccine and change one strain, a Food and Drug Administration advisory panel voted on Feb. 28.

The Vaccines and Related Biological Products Advisory Committee followed the lead of the World Health Organization, which made its recommendations for a Northern Hemisphere winter vaccine a week earlier. The FDA usually follows its panel's advice.

The decision gives the green light to manufacturers to go ahead with production. It generally takes until July or August for vaccine makers to complete testing, acquire FDA approval, and begin packaging their product. Distribution usually starts in September and ends by Nov. 1.

The WHO recommended keeping the current H3N2 strain, which is the A/Wisconsin/67/2005-like virus. The 2006–2007 flu season had been dominated mostly by influenza A (H1N1) strains, said Nancy J. Cox, Ph.D., director of the Centers for Disease Control and Prevention's influenza division. But in February, it appeared that H3N2 strains were starting to dominate. It wasn't clear yet which of those might be the predominant H3 strain, she said.

Even though panelists were concerned about the emergence of a new H3N2 subtype, 11 of 13 members voted to keep the current H3 strain. “At this point, I feel like we don't have any choice,” said Dr. Melinda Wharton, deputy director of the CDC's National Immunization Program and a temporary voting member of the committee. She noted that manufacturers already had started production on the current H3 strain.

Two committee members said they wanted to defer a decision until more surveillance data were available.

The panel voted unanimously to change the current H1N1 strain from A/New Caledonia/20/99-like virus with A/Solomon Islands/3/2006. The WHO had recommended that change. The FDA committee also voted unanimously to retain the current B strain—B/Malaysia/2506/2004-like virus—mirroring the WHO recommendation.

The 2006–2007 season has been fairly mild, said Ms. Cox. As of Feb. 17, widespread flu activity was reported in 24 states, 14 states reported regional activity, 10 reported local activity, and 2 reported sporadic activity. There were 3 pediatric deaths during that week, bringing the total to 15 deaths since the season began Oct. 1, 2006.

The Food and Drug Administration has issued a final rule that would require medical glove makers to improve their products' ability to serve as a barrier against pathogens.

Manufacturers are being given 2 years to comply with the new regulations.

The goal is to reduce the risk of transmission of bloodborne pathogens such as HIV and hepatitis B, according to the FDA. While the agency can't quantify how many cases might be prevented with better barriers, it estimated that approximately 2.4 HIV infections occur each year due to “problems with the barrier protection properties of gloves used in health-care settings.”

The FDA estimates that 140 health care workers are infected with the hepatitis B virus (HBV) on the job each year, primarily from percutaneous injuries. About a third, or 40 cases, may be due to glove defects, according to the agency.

There is less evidence that glove defects are associated with hepatitis C, said the agency, noting that most occupational exposures are from needle sticks.

The agency has inspected gloves—used for patient examinations and surgical procedures—since 1990. At that time, the International Organization for Standardization (ISO), ASTM International, and the FDA had the same standards for glove quality. A few years later, the ISO and ASTM began requiring higher standards.

The agency has allowed a defect rate of 4% for gloves used during patient exams and 2.5% for gloves used in surgery.

With more and more brands of gloves being marketed and sold, the agency hopes to maintain that defect rate. To do so means increasing the quality standards, said the agency.

The FDA estimates that about 2% of the 39.2 billion gloves currently marketed are defective—some 940 million gloves. There are more than 400 manufacturers, but the number of gloves made and sold is expected to vastly increase in the next 10 years. If standards were left at their current level, 10 years from now, some 1.2 billion defective gloves would be sold.

The agency said the benefits of higher standards will outweigh the costs. It will cost about $6.6 million a year, but will result in savings of about $15 million due to reduced need for blood screens and fewer infected health care workers.

The Food and Drug Administration has issued a final rule that would require medical glove makers to improve their products' ability to serve as a barrier against pathogens.

Manufacturers are being given 2 years to comply with the new regulations.

The goal is to reduce the risk of transmission of bloodborne pathogens such as HIV and hepatitis B, according to the FDA. While the agency can't quantify how many cases might be prevented with better barriers, it estimated that approximately 2.4 HIV infections occur each year due to “problems with the barrier protection properties of gloves used in health-care settings.”

The FDA estimates that 140 health care workers are infected with the hepatitis B virus (HBV) on the job each year, primarily from percutaneous injuries. About a third, or 40 cases, may be due to glove defects, according to the agency.

There is less evidence that glove defects are associated with hepatitis C, said the agency, noting that most occupational exposures are from needle sticks.

The agency has inspected gloves—used for patient examinations and surgical procedures—since 1990. At that time, the International Organization for Standardization (ISO), ASTM International, and the FDA had the same standards for glove quality. A few years later, the ISO and ASTM began requiring higher standards.

The agency has allowed a defect rate of 4% for gloves used during patient exams and 2.5% for gloves used in surgery.

With more and more brands of gloves being marketed and sold, the agency hopes to maintain that defect rate. To do so means increasing the quality standards, said the agency.

The FDA estimates that about 2% of the 39.2 billion gloves currently marketed are defective—some 940 million gloves. There are more than 400 manufacturers, but the number of gloves made and sold is expected to vastly increase in the next 10 years. If standards were left at their current level, 10 years from now, some 1.2 billion defective gloves would be sold.

The agency said the benefits of higher standards will outweigh the costs. It will cost about $6.6 million a year, but will result in savings of about $15 million due to reduced need for blood screens and fewer infected health care workers.

The Food and Drug Administration has issued a final rule that would require medical glove makers to improve their products' ability to serve as a barrier against pathogens.

Manufacturers are being given 2 years to comply with the new regulations.

The goal is to reduce the risk of transmission of bloodborne pathogens such as HIV and hepatitis B, according to the FDA. While the agency can't quantify how many cases might be prevented with better barriers, it estimated that approximately 2.4 HIV infections occur each year due to “problems with the barrier protection properties of gloves used in health-care settings.”

The FDA estimates that 140 health care workers are infected with the hepatitis B virus (HBV) on the job each year, primarily from percutaneous injuries. About a third, or 40 cases, may be due to glove defects, according to the agency.

There is less evidence that glove defects are associated with hepatitis C, said the agency, noting that most occupational exposures are from needle sticks.

The agency has inspected gloves—used for patient examinations and surgical procedures—since 1990. At that time, the International Organization for Standardization (ISO), ASTM International, and the FDA had the same standards for glove quality. A few years later, the ISO and ASTM began requiring higher standards.

The agency has allowed a defect rate of 4% for gloves used during patient exams and 2.5% for gloves used in surgery.

With more and more brands of gloves being marketed and sold, the agency hopes to maintain that defect rate. To do so means increasing the quality standards, said the agency.

The FDA estimates that about 2% of the 39.2 billion gloves currently marketed are defective—some 940 million gloves. There are more than 400 manufacturers, but the number of gloves made and sold is expected to vastly increase in the next 10 years. If standards were left at their current level, 10 years from now, some 1.2 billion defective gloves would be sold.

The agency said the benefits of higher standards will outweigh the costs. It will cost about $6.6 million a year, but will result in savings of about $15 million due to reduced need for blood screens and fewer infected health care workers.

WASHINGTON — As a Senate panel opened debate on reauthorization of the State Children's Health Insurance Program, legislators had doubts about expanding coverage to an estimated 9 million children who are eligible but who have not yet been enrolled.

SCHIP is due to expire on Sept. 30, but most states have been straining in the last few years to pay for children already covered by the program, several witnesses said at a meeting of the Senate Finance Committee.

Members of the committee also acknowledged that reality.

“Congress has simply not given [SCHIP] enough funds to meet the current demand for services,” said committee chair Max Baucus (D-Mont.), who estimated that the program would need $12 billion-$15 billion over the next 5 years to maintain current coverage and $45 billion to bring all eligible children into SCHIP.

A last-minute deal signed into law at the end of 2006 allocated $271 million to cover anticipated shortfalls for a dozen or so states, but at least 14 more states will run out of SCHIP funds for fiscal 2007 if Congress does not enact another bailout by mid-May, said Sen. Baucus.

In 2007, states will spend an estimated $6.3 billion on SCHIP, but only $5 billion has been allotted, said Cindy Mann, executive director of the Georgetown University Center for Children and Families. Without an influx of federal cash, 37 states will run out of funds this year, she testified.

As of fiscal 2005, SCHIP had 6 million enrollees, according to a Government Accountability Office (GAO) report released at the Finance Committee hearing. Enrollment grew fast during the early years of the program but recently leveled off.

Georgia Gov. Sonny Perdue testified that there has been no slowing of enrollment in his state, with an average 19% per month increase since June 2005. About 273,000 children are covered in Georgia, making it the fourth-largest SCHIP program in the country, he said. The Centers for Medicare and Medicaid Services had projected that only 130,000 children were eligible in Georgia, he said.

But, because of SCHIP rules, states that cover more children end up receiving a smaller allotment for the following year. “The successful implementation of SCHIP in any state automatically undermines maintaining funding to keep these kids enrolled in the program,” Gov. Perdue testified, arguing for a change in the SCHIP funding formula.

Some senators questioned whether states' flexibility should be reined in, saying that some initiatives might be diluting the program's intent—to cover low-income children. Generally, federal law allows states to cover children in families with incomes up to 200% of the poverty level or 50 percentage points above the Medicaid eligibility standard as of 1997. According to the GAO report, seven states were covering families with incomes at 300% of the poverty level or higher. Thirty-nine states require some cost sharing by families, but 11 states charge no premiums or copayments.

Fifteen states cover adults—generally parents of Medicaid- or SCHIP-eligible children, pregnant women, or childless adults. The Health and Human Services department has granted waivers for those states, said Kathryn G. Allen, director of health care at the GAO.

Sen. Charles Grassley (R-Iowa), ranking minority member of the Finance Committee, said he was interested in giving states flexibility but not in extending coverage to adults.

“The issue is whether SCHIP funds used to cover adults has drained resources targeted by Congress for kids,” he said.

Ms. Mann counseled senators to keep adult coverage in perspective, noting that only 600,000 of the 6 million SCHIP enrollees are adults. She added that it has been shown that when parents and children have health insurance, the whole family benefits.

WASHINGTON — As a Senate panel opened debate on reauthorization of the State Children's Health Insurance Program, legislators had doubts about expanding coverage to an estimated 9 million children who are eligible but who have not yet been enrolled.

SCHIP is due to expire on Sept. 30, but most states have been straining in the last few years to pay for children already covered by the program, several witnesses said at a meeting of the Senate Finance Committee.

Members of the committee also acknowledged that reality.

“Congress has simply not given [SCHIP] enough funds to meet the current demand for services,” said committee chair Max Baucus (D-Mont.), who estimated that the program would need $12 billion-$15 billion over the next 5 years to maintain current coverage and $45 billion to bring all eligible children into SCHIP.

A last-minute deal signed into law at the end of 2006 allocated $271 million to cover anticipated shortfalls for a dozen or so states, but at least 14 more states will run out of SCHIP funds for fiscal 2007 if Congress does not enact another bailout by mid-May, said Sen. Baucus.

In 2007, states will spend an estimated $6.3 billion on SCHIP, but only $5 billion has been allotted, said Cindy Mann, executive director of the Georgetown University Center for Children and Families. Without an influx of federal cash, 37 states will run out of funds this year, she testified.

As of fiscal 2005, SCHIP had 6 million enrollees, according to a Government Accountability Office (GAO) report released at the Finance Committee hearing. Enrollment grew fast during the early years of the program but recently leveled off.

Georgia Gov. Sonny Perdue testified that there has been no slowing of enrollment in his state, with an average 19% per month increase since June 2005. About 273,000 children are covered in Georgia, making it the fourth-largest SCHIP program in the country, he said. The Centers for Medicare and Medicaid Services had projected that only 130,000 children were eligible in Georgia, he said.

But, because of SCHIP rules, states that cover more children end up receiving a smaller allotment for the following year. “The successful implementation of SCHIP in any state automatically undermines maintaining funding to keep these kids enrolled in the program,” Gov. Perdue testified, arguing for a change in the SCHIP funding formula.

Some senators questioned whether states' flexibility should be reined in, saying that some initiatives might be diluting the program's intent—to cover low-income children. Generally, federal law allows states to cover children in families with incomes up to 200% of the poverty level or 50 percentage points above the Medicaid eligibility standard as of 1997. According to the GAO report, seven states were covering families with incomes at 300% of the poverty level or higher. Thirty-nine states require some cost sharing by families, but 11 states charge no premiums or copayments.

Fifteen states cover adults—generally parents of Medicaid- or SCHIP-eligible children, pregnant women, or childless adults. The Health and Human Services department has granted waivers for those states, said Kathryn G. Allen, director of health care at the GAO.

Sen. Charles Grassley (R-Iowa), ranking minority member of the Finance Committee, said he was interested in giving states flexibility but not in extending coverage to adults.

“The issue is whether SCHIP funds used to cover adults has drained resources targeted by Congress for kids,” he said.

Ms. Mann counseled senators to keep adult coverage in perspective, noting that only 600,000 of the 6 million SCHIP enrollees are adults. She added that it has been shown that when parents and children have health insurance, the whole family benefits.

WASHINGTON — As a Senate panel opened debate on reauthorization of the State Children's Health Insurance Program, legislators had doubts about expanding coverage to an estimated 9 million children who are eligible but who have not yet been enrolled.

SCHIP is due to expire on Sept. 30, but most states have been straining in the last few years to pay for children already covered by the program, several witnesses said at a meeting of the Senate Finance Committee.

Members of the committee also acknowledged that reality.

“Congress has simply not given [SCHIP] enough funds to meet the current demand for services,” said committee chair Max Baucus (D-Mont.), who estimated that the program would need $12 billion-$15 billion over the next 5 years to maintain current coverage and $45 billion to bring all eligible children into SCHIP.

A last-minute deal signed into law at the end of 2006 allocated $271 million to cover anticipated shortfalls for a dozen or so states, but at least 14 more states will run out of SCHIP funds for fiscal 2007 if Congress does not enact another bailout by mid-May, said Sen. Baucus.

In 2007, states will spend an estimated $6.3 billion on SCHIP, but only $5 billion has been allotted, said Cindy Mann, executive director of the Georgetown University Center for Children and Families. Without an influx of federal cash, 37 states will run out of funds this year, she testified.

As of fiscal 2005, SCHIP had 6 million enrollees, according to a Government Accountability Office (GAO) report released at the Finance Committee hearing. Enrollment grew fast during the early years of the program but recently leveled off.

Georgia Gov. Sonny Perdue testified that there has been no slowing of enrollment in his state, with an average 19% per month increase since June 2005. About 273,000 children are covered in Georgia, making it the fourth-largest SCHIP program in the country, he said. The Centers for Medicare and Medicaid Services had projected that only 130,000 children were eligible in Georgia, he said.

But, because of SCHIP rules, states that cover more children end up receiving a smaller allotment for the following year. “The successful implementation of SCHIP in any state automatically undermines maintaining funding to keep these kids enrolled in the program,” Gov. Perdue testified, arguing for a change in the SCHIP funding formula.

Some senators questioned whether states' flexibility should be reined in, saying that some initiatives might be diluting the program's intent—to cover low-income children. Generally, federal law allows states to cover children in families with incomes up to 200% of the poverty level or 50 percentage points above the Medicaid eligibility standard as of 1997. According to the GAO report, seven states were covering families with incomes at 300% of the poverty level or higher. Thirty-nine states require some cost sharing by families, but 11 states charge no premiums or copayments.

Fifteen states cover adults—generally parents of Medicaid- or SCHIP-eligible children, pregnant women, or childless adults. The Health and Human Services department has granted waivers for those states, said Kathryn G. Allen, director of health care at the GAO.

Sen. Charles Grassley (R-Iowa), ranking minority member of the Finance Committee, said he was interested in giving states flexibility but not in extending coverage to adults.

“The issue is whether SCHIP funds used to cover adults has drained resources targeted by Congress for kids,” he said.

Ms. Mann counseled senators to keep adult coverage in perspective, noting that only 600,000 of the 6 million SCHIP enrollees are adults. She added that it has been shown that when parents and children have health insurance, the whole family benefits.

WASHINGTON — The American Academy of Dermatology will soon start giving its official imprimatur to sunscreen products that it deems worthy, outgoing AAD President Stephen Stone said at the academy's annual meeting.

Two sunscreens, both made by Johnson & Johnson's consumer products division, will bear the AAD logo, with the words “Seal of Recognition” underneath, Dr. Stone said in a plenary session address to AAD members.

According to a company spokeswoman, the products are Aveeno Continuous Protection Sunblock Lotion, SPF 55, and Aveeno Baby Continuous Protection Sunblock Lotion, SPF 55.

Johnson & Johnson and other manufacturers that meet the AAD's selection criteria also will be allowed to use one of two statements.

The first statement says: “The American Academy of Dermatology recognizes this product for its sun-protection benefit.”

The second statement is somewhat longer: “The American Academy of Dermatology (AAD) recognizes that proper and regular use of sunscreens with Sun Protection Factor (SPF) 15 or higher and broad-spectrum (UVA/UVB) protection, along with wearing sun-protective clothing and seeking shade, will help protect against sunburn and may reduce long-term damage to the skin caused by sun exposure.”

To receive both the seal and the statement of support, sunscreen makers will pay a $10,000 application fee and a $10,000 annual fee to the AAD. The sunscreens must offer broad-spectrum (UVA/UVB) protection and a sun protection factor of 15 or higher.

They also have to provide evidence of water and sweat resistance and phototoxicity/stability.

The AAD Web site will include a list of products that have received the seal of recognition. Sunscreen makers can link their product's Web page to the AAD page that gives all the details on the program.

Dr. Stone said the program “will help consumers make educated choices when purchasing sunscreen products and help maintain the public perception of dermatologists as the leading experts in skin cancer prevention.”

The seal of recognition program came into being after surveys showed that 86% of AAD members believe it would help consumers make better choices, said an AAD spokeswoman.

It was approved by the AAD board at its summer meeting in July.

Any funds that are left over after administration of the program will be applied to the academy's Skin Cancer Reduction: Intervention Plan for Tomorrow (SCRIPT), said Dr. Stone. The program aims to markedly reduce skin cancer incidence and mortality over the next 10–30 years.

WASHINGTON — The American Academy of Dermatology will soon start giving its official imprimatur to sunscreen products that it deems worthy, outgoing AAD President Stephen Stone said at the academy's annual meeting.

Two sunscreens, both made by Johnson & Johnson's consumer products division, will bear the AAD logo, with the words “Seal of Recognition” underneath, Dr. Stone said in a plenary session address to AAD members.

According to a company spokeswoman, the products are Aveeno Continuous Protection Sunblock Lotion, SPF 55, and Aveeno Baby Continuous Protection Sunblock Lotion, SPF 55.

Johnson & Johnson and other manufacturers that meet the AAD's selection criteria also will be allowed to use one of two statements.

The first statement says: “The American Academy of Dermatology recognizes this product for its sun-protection benefit.”

The second statement is somewhat longer: “The American Academy of Dermatology (AAD) recognizes that proper and regular use of sunscreens with Sun Protection Factor (SPF) 15 or higher and broad-spectrum (UVA/UVB) protection, along with wearing sun-protective clothing and seeking shade, will help protect against sunburn and may reduce long-term damage to the skin caused by sun exposure.”

To receive both the seal and the statement of support, sunscreen makers will pay a $10,000 application fee and a $10,000 annual fee to the AAD. The sunscreens must offer broad-spectrum (UVA/UVB) protection and a sun protection factor of 15 or higher.

They also have to provide evidence of water and sweat resistance and phototoxicity/stability.

The AAD Web site will include a list of products that have received the seal of recognition. Sunscreen makers can link their product's Web page to the AAD page that gives all the details on the program.

Dr. Stone said the program “will help consumers make educated choices when purchasing sunscreen products and help maintain the public perception of dermatologists as the leading experts in skin cancer prevention.”

The seal of recognition program came into being after surveys showed that 86% of AAD members believe it would help consumers make better choices, said an AAD spokeswoman.

It was approved by the AAD board at its summer meeting in July.

Any funds that are left over after administration of the program will be applied to the academy's Skin Cancer Reduction: Intervention Plan for Tomorrow (SCRIPT), said Dr. Stone. The program aims to markedly reduce skin cancer incidence and mortality over the next 10–30 years.

WASHINGTON — The American Academy of Dermatology will soon start giving its official imprimatur to sunscreen products that it deems worthy, outgoing AAD President Stephen Stone said at the academy's annual meeting.

Two sunscreens, both made by Johnson & Johnson's consumer products division, will bear the AAD logo, with the words “Seal of Recognition” underneath, Dr. Stone said in a plenary session address to AAD members.

According to a company spokeswoman, the products are Aveeno Continuous Protection Sunblock Lotion, SPF 55, and Aveeno Baby Continuous Protection Sunblock Lotion, SPF 55.

Johnson & Johnson and other manufacturers that meet the AAD's selection criteria also will be allowed to use one of two statements.

The first statement says: “The American Academy of Dermatology recognizes this product for its sun-protection benefit.”

The second statement is somewhat longer: “The American Academy of Dermatology (AAD) recognizes that proper and regular use of sunscreens with Sun Protection Factor (SPF) 15 or higher and broad-spectrum (UVA/UVB) protection, along with wearing sun-protective clothing and seeking shade, will help protect against sunburn and may reduce long-term damage to the skin caused by sun exposure.”

To receive both the seal and the statement of support, sunscreen makers will pay a $10,000 application fee and a $10,000 annual fee to the AAD. The sunscreens must offer broad-spectrum (UVA/UVB) protection and a sun protection factor of 15 or higher.

They also have to provide evidence of water and sweat resistance and phototoxicity/stability.

The AAD Web site will include a list of products that have received the seal of recognition. Sunscreen makers can link their product's Web page to the AAD page that gives all the details on the program.

Dr. Stone said the program “will help consumers make educated choices when purchasing sunscreen products and help maintain the public perception of dermatologists as the leading experts in skin cancer prevention.”

The seal of recognition program came into being after surveys showed that 86% of AAD members believe it would help consumers make better choices, said an AAD spokeswoman.

It was approved by the AAD board at its summer meeting in July.

Any funds that are left over after administration of the program will be applied to the academy's Skin Cancer Reduction: Intervention Plan for Tomorrow (SCRIPT), said Dr. Stone. The program aims to markedly reduce skin cancer incidence and mortality over the next 10–30 years.

TORONTO — Thyroidectomy can be safely and effectively done on an outpatient basis and at a lower cost than in the hospital, according to results from a prospective, nonrandomized trial presented at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery Foundation.

Dr. David J. Terris of the Medical College of Georgia, Augusta, presented the results of the 91-patient study. He noted that while minimally invasive techniques have made it possible to perform thyroid removal on an outpatient basis, most surgeons have continued to keep patients at least overnight for observation for complications such as laryngeal nerve damage, airway compromise, and hypoparathyroidism.

Dr. Terris and his colleagues at the medical college enrolled consecutive patients who had thyroidectomy from 2004 to 2005. Patients either had conventional surgery using a Kocher incision, minimally invasive surgery, or endoscopic thyroidectomy.

Overall, 42 patients had a hemithyroidectomy, 38 a total thyroidectomy, and 11 a completion thyroidectomy. Of the 91 patients, 76 were women and 15 were men; the mean age was 46 years. The surgery was performed on an outpatient basis in 52 of the cases and as an inpatient procedure in 39. A procedure was considered inpatient if the patient was observed for at least 23 hours. If a patient had significant comorbidities or required a surgical drain (for a large lesion), he or she was offered an inpatient procedure. Patients who requested admission also were placed into the inpatient arm.

Outpatients were discharged as soon as they were ambulatory and could manage the pain. They were told to seek medical help if they had symptoms such as respiratory compromise or hypocalcemia, and were seen for follow-up 1–2 weeks after thyroid removal.

To deter hypocalcemia, every patient was given a prophylactic regimen of oral calcium carbonate for 3 weeks before the surgery. They took 600 mg three times daily for the first week, 600 mg twice daily in the second week, and 600 mg once a day in the third week.

There was no significant difference in age or gender between the inpatients and outpatients. But the operating room time was shorter for outpatients—102 minutes, compared with 144 minutes for inpatients. Mean estimated blood loss was lower in the outpatient group, at 18 mL, compared with 29 mL for the inpatient arm.

Two patients in the hospital group had complications, including hypocalcemia. One outpatient was anxious after being discharged and returned to the hospital where she was admitted. There were no hemorrhages or expanding hematomas.

Surgeons often argue that thyroidectomy must be done on an inpatient basis so drains can be placed postsurgically to prevent hematomas that might block the airway, Dr. Terris said. But new ultrasonic technology that creates an almost bloodless surgical field reduces the risk of expanding hematomas and makes it possible to decrease reliance on surgical drains. That makes outpatient surgery more feasible, as the Georgia study demonstrated, he said.

The study also showed that giving patients calcium before surgery also curbs the risk of hypocalcemia, he added.

Another argument favors outpatient thyroidectomy. The mean charge was lower: $7,800 for outpatient surgery, compared with $10,200 for inpatient surgery.

TORONTO — Thyroidectomy can be safely and effectively done on an outpatient basis and at a lower cost than in the hospital, according to results from a prospective, nonrandomized trial presented at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery Foundation.

Dr. David J. Terris of the Medical College of Georgia, Augusta, presented the results of the 91-patient study. He noted that while minimally invasive techniques have made it possible to perform thyroid removal on an outpatient basis, most surgeons have continued to keep patients at least overnight for observation for complications such as laryngeal nerve damage, airway compromise, and hypoparathyroidism.

Dr. Terris and his colleagues at the medical college enrolled consecutive patients who had thyroidectomy from 2004 to 2005. Patients either had conventional surgery using a Kocher incision, minimally invasive surgery, or endoscopic thyroidectomy.

Overall, 42 patients had a hemithyroidectomy, 38 a total thyroidectomy, and 11 a completion thyroidectomy. Of the 91 patients, 76 were women and 15 were men; the mean age was 46 years. The surgery was performed on an outpatient basis in 52 of the cases and as an inpatient procedure in 39. A procedure was considered inpatient if the patient was observed for at least 23 hours. If a patient had significant comorbidities or required a surgical drain (for a large lesion), he or she was offered an inpatient procedure. Patients who requested admission also were placed into the inpatient arm.

Outpatients were discharged as soon as they were ambulatory and could manage the pain. They were told to seek medical help if they had symptoms such as respiratory compromise or hypocalcemia, and were seen for follow-up 1–2 weeks after thyroid removal.

To deter hypocalcemia, every patient was given a prophylactic regimen of oral calcium carbonate for 3 weeks before the surgery. They took 600 mg three times daily for the first week, 600 mg twice daily in the second week, and 600 mg once a day in the third week.

There was no significant difference in age or gender between the inpatients and outpatients. But the operating room time was shorter for outpatients—102 minutes, compared with 144 minutes for inpatients. Mean estimated blood loss was lower in the outpatient group, at 18 mL, compared with 29 mL for the inpatient arm.

Two patients in the hospital group had complications, including hypocalcemia. One outpatient was anxious after being discharged and returned to the hospital where she was admitted. There were no hemorrhages or expanding hematomas.

Surgeons often argue that thyroidectomy must be done on an inpatient basis so drains can be placed postsurgically to prevent hematomas that might block the airway, Dr. Terris said. But new ultrasonic technology that creates an almost bloodless surgical field reduces the risk of expanding hematomas and makes it possible to decrease reliance on surgical drains. That makes outpatient surgery more feasible, as the Georgia study demonstrated, he said.

The study also showed that giving patients calcium before surgery also curbs the risk of hypocalcemia, he added.

Another argument favors outpatient thyroidectomy. The mean charge was lower: $7,800 for outpatient surgery, compared with $10,200 for inpatient surgery.

TORONTO — Thyroidectomy can be safely and effectively done on an outpatient basis and at a lower cost than in the hospital, according to results from a prospective, nonrandomized trial presented at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery Foundation.

Dr. David J. Terris of the Medical College of Georgia, Augusta, presented the results of the 91-patient study. He noted that while minimally invasive techniques have made it possible to perform thyroid removal on an outpatient basis, most surgeons have continued to keep patients at least overnight for observation for complications such as laryngeal nerve damage, airway compromise, and hypoparathyroidism.

Dr. Terris and his colleagues at the medical college enrolled consecutive patients who had thyroidectomy from 2004 to 2005. Patients either had conventional surgery using a Kocher incision, minimally invasive surgery, or endoscopic thyroidectomy.

Overall, 42 patients had a hemithyroidectomy, 38 a total thyroidectomy, and 11 a completion thyroidectomy. Of the 91 patients, 76 were women and 15 were men; the mean age was 46 years. The surgery was performed on an outpatient basis in 52 of the cases and as an inpatient procedure in 39. A procedure was considered inpatient if the patient was observed for at least 23 hours. If a patient had significant comorbidities or required a surgical drain (for a large lesion), he or she was offered an inpatient procedure. Patients who requested admission also were placed into the inpatient arm.

Outpatients were discharged as soon as they were ambulatory and could manage the pain. They were told to seek medical help if they had symptoms such as respiratory compromise or hypocalcemia, and were seen for follow-up 1–2 weeks after thyroid removal.

To deter hypocalcemia, every patient was given a prophylactic regimen of oral calcium carbonate for 3 weeks before the surgery. They took 600 mg three times daily for the first week, 600 mg twice daily in the second week, and 600 mg once a day in the third week.

There was no significant difference in age or gender between the inpatients and outpatients. But the operating room time was shorter for outpatients—102 minutes, compared with 144 minutes for inpatients. Mean estimated blood loss was lower in the outpatient group, at 18 mL, compared with 29 mL for the inpatient arm.

Two patients in the hospital group had complications, including hypocalcemia. One outpatient was anxious after being discharged and returned to the hospital where she was admitted. There were no hemorrhages or expanding hematomas.

Surgeons often argue that thyroidectomy must be done on an inpatient basis so drains can be placed postsurgically to prevent hematomas that might block the airway, Dr. Terris said. But new ultrasonic technology that creates an almost bloodless surgical field reduces the risk of expanding hematomas and makes it possible to decrease reliance on surgical drains. That makes outpatient surgery more feasible, as the Georgia study demonstrated, he said.

The study also showed that giving patients calcium before surgery also curbs the risk of hypocalcemia, he added.

Another argument favors outpatient thyroidectomy. The mean charge was lower: $7,800 for outpatient surgery, compared with $10,200 for inpatient surgery.

WASHINGTON – As a Senate panel opened debate on reauthorization of the State Children's Health Insurance Program, legislators had doubts about expanding coverage to an estimated 9 million children who are eligible but who have not yet been enrolled.

SCHIP is due to expire on Sept. 30, but most states have been straining in the last few years to pay for children already covered by the program, several witnesses said at a meeting of the Senate Finance Committee.

Members of the committee also acknowledged that reality.

“Congress has simply not given [SCHIP] enough funds to meet the current demand for services,” said committee chair Max Baucus (D-Mont.), who estimated that the program would need $12 billion-$15 billion over the next 5 years to maintain current coverage and $45 billion to bring all eligible children into SCHIP.

A last-minute deal signed into law at the end of 2006 allocated $271 million to cover anticipated shortfalls for a dozen or so states, but at least 14 more states will run out of SCHIP funds for fiscal 2007 if Congress does not enact another bailout by mid-May, Sen. Baucus said.

In 2007, states will spend an estimated $6.3 billion on SCHIP, but only $5 billion has been allotted, said Cindy Mann, executive director of the Georgetown University Center for Children and Families. Without an influx of federal cash, 37 states will run out of money this year, Ms. Mann testified to the Finance Committee.

As of fiscal 2005, SCHIP had 6 million enrollees, according to a Government Accountability Office (GAO) report released at the Finance Committee hearing. Enrollment grew fastest during the early years of the program and leveled off more recently.

Georgia Gov. Sonny Perdue testified that enrollment in his state increased by an average of 19% per month since June 2005. About 273,000 children are covered in Georgia, making it the country's fourth-largest SCHIP program, he said. The Centers for Medicare and Medicaid Services had projected that only 130,000 children would be eligible in Georgia, he said.

Some senators questioned whether states' flexibility should be reined in, saying that some initiatives might be diluting the program's intent. Generally, federal law allows states to cover children in families with incomes up to 200% of the poverty level or 50 percentage points above the Medicaid eligibility standard as of 1997. According to the GAO report, seven states were covering families with incomes at 300% of the poverty level or higher. Thirty-nine states require some cost sharing by families, but 11 states charge no premiums or copayments.

Fifteen states cover adults–generally parents of Medicaid- or SCHIP-eligible children, pregnant women, or childless adults. The Health and Human Services department has granted waivers for those states, said Kathryn G. Allen, director of health care at the GAO.

Sen. Charles Grassley (R-Iowa), ranking minority member of the Finance Committee, said he was interested in giving states more flexibility but questioned the legitimacy of extending coverage to adults. “The issue is whether SCHIP funds used to cover adults has drained resources targeted by Congress for kids,” said Sen. Grassley. “The 'C' stands for children. There is no 'A' in SCHIP.”

Ms. Mann counseled the senators to keep adult coverage in perspective, noting that only 600,000 of the 6 million SCHIP enrollees are adults, and that it has been shown that when parents and children have health insurance, the whole family benefits.

WASHINGTON – As a Senate panel opened debate on reauthorization of the State Children's Health Insurance Program, legislators had doubts about expanding coverage to an estimated 9 million children who are eligible but who have not yet been enrolled.

SCHIP is due to expire on Sept. 30, but most states have been straining in the last few years to pay for children already covered by the program, several witnesses said at a meeting of the Senate Finance Committee.

Members of the committee also acknowledged that reality.

“Congress has simply not given [SCHIP] enough funds to meet the current demand for services,” said committee chair Max Baucus (D-Mont.), who estimated that the program would need $12 billion-$15 billion over the next 5 years to maintain current coverage and $45 billion to bring all eligible children into SCHIP.

A last-minute deal signed into law at the end of 2006 allocated $271 million to cover anticipated shortfalls for a dozen or so states, but at least 14 more states will run out of SCHIP funds for fiscal 2007 if Congress does not enact another bailout by mid-May, Sen. Baucus said.

In 2007, states will spend an estimated $6.3 billion on SCHIP, but only $5 billion has been allotted, said Cindy Mann, executive director of the Georgetown University Center for Children and Families. Without an influx of federal cash, 37 states will run out of money this year, Ms. Mann testified to the Finance Committee.

As of fiscal 2005, SCHIP had 6 million enrollees, according to a Government Accountability Office (GAO) report released at the Finance Committee hearing. Enrollment grew fastest during the early years of the program and leveled off more recently.

Georgia Gov. Sonny Perdue testified that enrollment in his state increased by an average of 19% per month since June 2005. About 273,000 children are covered in Georgia, making it the country's fourth-largest SCHIP program, he said. The Centers for Medicare and Medicaid Services had projected that only 130,000 children would be eligible in Georgia, he said.

Some senators questioned whether states' flexibility should be reined in, saying that some initiatives might be diluting the program's intent. Generally, federal law allows states to cover children in families with incomes up to 200% of the poverty level or 50 percentage points above the Medicaid eligibility standard as of 1997. According to the GAO report, seven states were covering families with incomes at 300% of the poverty level or higher. Thirty-nine states require some cost sharing by families, but 11 states charge no premiums or copayments.

Fifteen states cover adults–generally parents of Medicaid- or SCHIP-eligible children, pregnant women, or childless adults. The Health and Human Services department has granted waivers for those states, said Kathryn G. Allen, director of health care at the GAO.

Sen. Charles Grassley (R-Iowa), ranking minority member of the Finance Committee, said he was interested in giving states more flexibility but questioned the legitimacy of extending coverage to adults. “The issue is whether SCHIP funds used to cover adults has drained resources targeted by Congress for kids,” said Sen. Grassley. “The 'C' stands for children. There is no 'A' in SCHIP.”

Ms. Mann counseled the senators to keep adult coverage in perspective, noting that only 600,000 of the 6 million SCHIP enrollees are adults, and that it has been shown that when parents and children have health insurance, the whole family benefits.

WASHINGTON – As a Senate panel opened debate on reauthorization of the State Children's Health Insurance Program, legislators had doubts about expanding coverage to an estimated 9 million children who are eligible but who have not yet been enrolled.

SCHIP is due to expire on Sept. 30, but most states have been straining in the last few years to pay for children already covered by the program, several witnesses said at a meeting of the Senate Finance Committee.

Members of the committee also acknowledged that reality.

“Congress has simply not given [SCHIP] enough funds to meet the current demand for services,” said committee chair Max Baucus (D-Mont.), who estimated that the program would need $12 billion-$15 billion over the next 5 years to maintain current coverage and $45 billion to bring all eligible children into SCHIP.

A last-minute deal signed into law at the end of 2006 allocated $271 million to cover anticipated shortfalls for a dozen or so states, but at least 14 more states will run out of SCHIP funds for fiscal 2007 if Congress does not enact another bailout by mid-May, Sen. Baucus said.

In 2007, states will spend an estimated $6.3 billion on SCHIP, but only $5 billion has been allotted, said Cindy Mann, executive director of the Georgetown University Center for Children and Families. Without an influx of federal cash, 37 states will run out of money this year, Ms. Mann testified to the Finance Committee.

As of fiscal 2005, SCHIP had 6 million enrollees, according to a Government Accountability Office (GAO) report released at the Finance Committee hearing. Enrollment grew fastest during the early years of the program and leveled off more recently.

Georgia Gov. Sonny Perdue testified that enrollment in his state increased by an average of 19% per month since June 2005. About 273,000 children are covered in Georgia, making it the country's fourth-largest SCHIP program, he said. The Centers for Medicare and Medicaid Services had projected that only 130,000 children would be eligible in Georgia, he said.

Some senators questioned whether states' flexibility should be reined in, saying that some initiatives might be diluting the program's intent. Generally, federal law allows states to cover children in families with incomes up to 200% of the poverty level or 50 percentage points above the Medicaid eligibility standard as of 1997. According to the GAO report, seven states were covering families with incomes at 300% of the poverty level or higher. Thirty-nine states require some cost sharing by families, but 11 states charge no premiums or copayments.

Fifteen states cover adults–generally parents of Medicaid- or SCHIP-eligible children, pregnant women, or childless adults. The Health and Human Services department has granted waivers for those states, said Kathryn G. Allen, director of health care at the GAO.

Sen. Charles Grassley (R-Iowa), ranking minority member of the Finance Committee, said he was interested in giving states more flexibility but questioned the legitimacy of extending coverage to adults. “The issue is whether SCHIP funds used to cover adults has drained resources targeted by Congress for kids,” said Sen. Grassley. “The 'C' stands for children. There is no 'A' in SCHIP.”

Ms. Mann counseled the senators to keep adult coverage in perspective, noting that only 600,000 of the 6 million SCHIP enrollees are adults, and that it has been shown that when parents and children have health insurance, the whole family benefits.

The Food and Drug Administration said it will beef up oversight of prescription drug safety, with a focus on risks and benefits once a product has been launched into the marketplace.

The initiatives were announced in January in a long-awaited response to September's Institute of Medicine critique of the agency's pharmaceutic safety monitoring.

The FDA said it had taken a close look at the IOM's 25 recommendations, and that it would focus its efforts on three major areas:

1. Strengthening the science used during product reviews and finding new tools to detect safety issues from preclinical testing through postmarketing.

2. Improving communications, especially about risk, to patients, physicians, and other interested parties.

3. Improving management practices.

The IOM criticized an agency culture that it saw as too concentrated on drug approval at the expense of product safety.

Some of the FDA initiatives are underway. Others were published in the Federal Register as part of recommendations for the reauthorization of the Prescription Drug User Fee Act. Under the next PDUFA law, which if enacted would begin in fiscal 2008, the FDA aims to collect $29 million from drug makers over 5 years specifically for postmarketing safety programs.

Key among the initiatives announced in late January is a “report card” on the postmarketing safety of new molecular entities. FDA has proposed a pilot feasibility study this year. These regularly scheduled reports would encompass data from the Adverse Events Reporting System, epidemiologic studies, postmarketing clinical trials, and “mining” of various other databases. The first report would come 18 months after a drug's launch. The goal of this effort is “to identify potential safety concerns early in the product life cycle,” according to the FDA.

The FDA also proposed sharing data more often with other agencies, and said it was already collaborating with the Agency for Health Care Quality and Research, the Centers for Disease Control and Prevention, and the Veterans Affairs department. The VA will provide real-world data on how its patients use pharmaceuticals and medical devices.

To address criticism that the FDA has not done a good job of communicating what it knows about a drug's risks on a timely basis, the agency said it could--and would--move quickly to establish a new advisory committee.

The FDA also said it would hold a public meeting in early March to explore the creation of a nationwide public-private medical product safety network. The agency envisions a network that would let both health care providers and regulators rapidly collect and exchange information about adverse events--and would do so at the point of care to help providers make better-informed treatment decisions.

American Medical Association board member Dr. Edward Langston said the AMA generally supported FDA's proposals. “The AMA agrees that the approaches used to communicate information to patients about the risks associated with drug products need significant improvement,” Dr. Langston said in a statement.

Long-time FDA critics in Congress, however, said the agency had not gone far enough.

“Today's report is thoughtful, and provides important recommendations for administrative action, but only legislation can give FDA the tools it needs to ensure that the agency is the gold standard for safety,” said Sen. Edward M. Kennedy (D-Mass.), who, along with Sen. Michael Enzi (R-Wyo.) soon will introduce a bill to further overhaul FDA's postmarketing safety program.

Sen. Christopher J. Dodd (D-Conn.) said that he and Sen. Chuck Grassley (R-Iowa) were also introducing a bill that would “revamp and prioritize the postmarket surveillance process within the Food and Drug Administration.”

That bill, called the Food and Drug Administration Safety Act, would establish a Center for Postmarket Evaluation and Research for Drugs and Biologics. The Center would report directly to the FDA commissioner.

“Congress will act on FDA-related legislation this year, and meaningful structural reforms to the agency need to be a part of what Congress does with regard to drug safety,” Sen. Grassley said.

The Food and Drug Administration said it will beef up oversight of prescription drug safety, with a focus on risks and benefits once a product has been launched into the marketplace.

The initiatives were announced in January in a long-awaited response to September's Institute of Medicine critique of the agency's pharmaceutic safety monitoring.

The FDA said it had taken a close look at the IOM's 25 recommendations, and that it would focus its efforts on three major areas:

1. Strengthening the science used during product reviews and finding new tools to detect safety issues from preclinical testing through postmarketing.

2. Improving communications, especially about risk, to patients, physicians, and other interested parties.

3. Improving management practices.

The IOM criticized an agency culture that it saw as too concentrated on drug approval at the expense of product safety.

Some of the FDA initiatives are underway. Others were published in the Federal Register as part of recommendations for the reauthorization of the Prescription Drug User Fee Act. Under the next PDUFA law, which if enacted would begin in fiscal 2008, the FDA aims to collect $29 million from drug makers over 5 years specifically for postmarketing safety programs.

Key among the initiatives announced in late January is a “report card” on the postmarketing safety of new molecular entities. FDA has proposed a pilot feasibility study this year. These regularly scheduled reports would encompass data from the Adverse Events Reporting System, epidemiologic studies, postmarketing clinical trials, and “mining” of various other databases. The first report would come 18 months after a drug's launch. The goal of this effort is “to identify potential safety concerns early in the product life cycle,” according to the FDA.

The FDA also proposed sharing data more often with other agencies, and said it was already collaborating with the Agency for Health Care Quality and Research, the Centers for Disease Control and Prevention, and the Veterans Affairs department. The VA will provide real-world data on how its patients use pharmaceuticals and medical devices.

To address criticism that the FDA has not done a good job of communicating what it knows about a drug's risks on a timely basis, the agency said it could--and would--move quickly to establish a new advisory committee.

The FDA also said it would hold a public meeting in early March to explore the creation of a nationwide public-private medical product safety network. The agency envisions a network that would let both health care providers and regulators rapidly collect and exchange information about adverse events--and would do so at the point of care to help providers make better-informed treatment decisions.

American Medical Association board member Dr. Edward Langston said the AMA generally supported FDA's proposals. “The AMA agrees that the approaches used to communicate information to patients about the risks associated with drug products need significant improvement,” Dr. Langston said in a statement.

Long-time FDA critics in Congress, however, said the agency had not gone far enough.

“Today's report is thoughtful, and provides important recommendations for administrative action, but only legislation can give FDA the tools it needs to ensure that the agency is the gold standard for safety,” said Sen. Edward M. Kennedy (D-Mass.), who, along with Sen. Michael Enzi (R-Wyo.) soon will introduce a bill to further overhaul FDA's postmarketing safety program.

Sen. Christopher J. Dodd (D-Conn.) said that he and Sen. Chuck Grassley (R-Iowa) were also introducing a bill that would “revamp and prioritize the postmarket surveillance process within the Food and Drug Administration.”

That bill, called the Food and Drug Administration Safety Act, would establish a Center for Postmarket Evaluation and Research for Drugs and Biologics. The Center would report directly to the FDA commissioner.

“Congress will act on FDA-related legislation this year, and meaningful structural reforms to the agency need to be a part of what Congress does with regard to drug safety,” Sen. Grassley said.

The Food and Drug Administration said it will beef up oversight of prescription drug safety, with a focus on risks and benefits once a product has been launched into the marketplace.

The initiatives were announced in January in a long-awaited response to September's Institute of Medicine critique of the agency's pharmaceutic safety monitoring.

The FDA said it had taken a close look at the IOM's 25 recommendations, and that it would focus its efforts on three major areas:

1. Strengthening the science used during product reviews and finding new tools to detect safety issues from preclinical testing through postmarketing.

2. Improving communications, especially about risk, to patients, physicians, and other interested parties.

3. Improving management practices.

The IOM criticized an agency culture that it saw as too concentrated on drug approval at the expense of product safety.

Some of the FDA initiatives are underway. Others were published in the Federal Register as part of recommendations for the reauthorization of the Prescription Drug User Fee Act. Under the next PDUFA law, which if enacted would begin in fiscal 2008, the FDA aims to collect $29 million from drug makers over 5 years specifically for postmarketing safety programs.

Key among the initiatives announced in late January is a “report card” on the postmarketing safety of new molecular entities. FDA has proposed a pilot feasibility study this year. These regularly scheduled reports would encompass data from the Adverse Events Reporting System, epidemiologic studies, postmarketing clinical trials, and “mining” of various other databases. The first report would come 18 months after a drug's launch. The goal of this effort is “to identify potential safety concerns early in the product life cycle,” according to the FDA.

The FDA also proposed sharing data more often with other agencies, and said it was already collaborating with the Agency for Health Care Quality and Research, the Centers for Disease Control and Prevention, and the Veterans Affairs department. The VA will provide real-world data on how its patients use pharmaceuticals and medical devices.

To address criticism that the FDA has not done a good job of communicating what it knows about a drug's risks on a timely basis, the agency said it could--and would--move quickly to establish a new advisory committee.

The FDA also said it would hold a public meeting in early March to explore the creation of a nationwide public-private medical product safety network. The agency envisions a network that would let both health care providers and regulators rapidly collect and exchange information about adverse events--and would do so at the point of care to help providers make better-informed treatment decisions.

American Medical Association board member Dr. Edward Langston said the AMA generally supported FDA's proposals. “The AMA agrees that the approaches used to communicate information to patients about the risks associated with drug products need significant improvement,” Dr. Langston said in a statement.

Long-time FDA critics in Congress, however, said the agency had not gone far enough.

“Today's report is thoughtful, and provides important recommendations for administrative action, but only legislation can give FDA the tools it needs to ensure that the agency is the gold standard for safety,” said Sen. Edward M. Kennedy (D-Mass.), who, along with Sen. Michael Enzi (R-Wyo.) soon will introduce a bill to further overhaul FDA's postmarketing safety program.

Sen. Christopher J. Dodd (D-Conn.) said that he and Sen. Chuck Grassley (R-Iowa) were also introducing a bill that would “revamp and prioritize the postmarket surveillance process within the Food and Drug Administration.”

That bill, called the Food and Drug Administration Safety Act, would establish a Center for Postmarket Evaluation and Research for Drugs and Biologics. The Center would report directly to the FDA commissioner.

“Congress will act on FDA-related legislation this year, and meaningful structural reforms to the agency need to be a part of what Congress does with regard to drug safety,” Sen. Grassley said.

A Medicare advisory panel has concluded that it has low confidence in spinal fusion as a treatment for lower-back pain, but for now, the federal insurance program has no plans to deny coverage for the procedure.

The Medicare Coverage Advisory Committee met in late 2006 to weigh the available evidence on spinal fusion, and voted on six questions. It said that the available data provide an intermediate level of confidence in addressing the outcomes needed to determine whether fusion is effective for low-back pain resulting from degenerative disk disease.

For all the other questions posed, which all pertained to degenerative disk disease, MCAC found that the evidence fell below the intermediate level of confidence for determining improved outcomes-- compared with conservative treatment--for both the first 2 years post surgery and beyond 2 years. They said the data were similarly lacking for fusions both with and without instrumentation. The panel said the results in the literature are reasonably likely to apply to the Medicare population.

The Centers for Medicare and Medicaid Services decided to hold a meeting to explore fusions after it denied coverage for the Charité artificial disk, according to an agency spokesman.

“It was also to identify where the holes are so that medical societies and industry and others could start to develop better data on those areas,” said Eric Muehlbauer, executive director of the North American Spine Society, in an interview.

Mr. Muehlbauer said that CMS is essentially wielding its clout to spur better data collection.

The North American Spine Society is considering three proposals on how to improve the evidence base on fusion, he said. There is an especially glaring need for data specific to the Medicare population, partly because fusions are rarer in that age group, Mr. Muehlbauer said.

Medical device makers, represented by the Advanced Medical Technology Association (AdvaMed), said that access should not be restricted during the evidence-gathering process.

“We encourage [CMS] to allow Medicare patients access to spinal fusion surgery as a treatment option as the body of clinical evidence develops over time,” said AdvaMed president and CEO Stephen J. Ubl in a statement.

The American Academy of Neurological Surgeons and the Congress of Neurological Surgeons are starting the second year of a pilot program to collect outcomes data on patients who have operations for lumbar stenosis at 15 practices, said Dr. Daniel Resnick, of the department of neurological surgery at the University of Wisconsin, Madison, in an interview.

There are several obstacles to getting good data, Dr. Resnick said. “We're hampered by an imperfect understanding of the physiology of pain in many patients,” he noted. And most patients will not enroll in a study in which there's a 50% chance they would get conservative treatment instead of surgery, he said, as most U.S. patients have already tried many therapies before they undergo fusion.

Both he and Mr. Muehlbauer said there is evidence that fusions work in the right patient. But they said they weren't surprised that CMS is examining the procedure, given the increase in fusions since the introduction of instrumentation.

A study on trends estimated that lumbar fusion increased 250% from 1992 to 2003 (Spine 2006;31:2707-14). Medicare payments for fusion rose from $75 million in 1992 to $482 million in 2003, estimated the authors, who are affiliated with Dartmouth Medical School and Dartmouth-Hitchcock Medical Center, Hanover, N.H. They also found huge geographic variations.

Dr. Resnick said fusions have increased because there are new technologies and techniques and because surgeons want to help patients who previously were not thought to be surgical candidates.

A Medicare advisory panel has concluded that it has low confidence in spinal fusion as a treatment for lower-back pain, but for now, the federal insurance program has no plans to deny coverage for the procedure.

The Medicare Coverage Advisory Committee met in late 2006 to weigh the available evidence on spinal fusion, and voted on six questions. It said that the available data provide an intermediate level of confidence in addressing the outcomes needed to determine whether fusion is effective for low-back pain resulting from degenerative disk disease.

For all the other questions posed, which all pertained to degenerative disk disease, MCAC found that the evidence fell below the intermediate level of confidence for determining improved outcomes-- compared with conservative treatment--for both the first 2 years post surgery and beyond 2 years. They said the data were similarly lacking for fusions both with and without instrumentation. The panel said the results in the literature are reasonably likely to apply to the Medicare population.

The Centers for Medicare and Medicaid Services decided to hold a meeting to explore fusions after it denied coverage for the Charité artificial disk, according to an agency spokesman.

“It was also to identify where the holes are so that medical societies and industry and others could start to develop better data on those areas,” said Eric Muehlbauer, executive director of the North American Spine Society, in an interview.

Mr. Muehlbauer said that CMS is essentially wielding its clout to spur better data collection.

The North American Spine Society is considering three proposals on how to improve the evidence base on fusion, he said. There is an especially glaring need for data specific to the Medicare population, partly because fusions are rarer in that age group, Mr. Muehlbauer said.

Medical device makers, represented by the Advanced Medical Technology Association (AdvaMed), said that access should not be restricted during the evidence-gathering process.

“We encourage [CMS] to allow Medicare patients access to spinal fusion surgery as a treatment option as the body of clinical evidence develops over time,” said AdvaMed president and CEO Stephen J. Ubl in a statement.

The American Academy of Neurological Surgeons and the Congress of Neurological Surgeons are starting the second year of a pilot program to collect outcomes data on patients who have operations for lumbar stenosis at 15 practices, said Dr. Daniel Resnick, of the department of neurological surgery at the University of Wisconsin, Madison, in an interview.

There are several obstacles to getting good data, Dr. Resnick said. “We're hampered by an imperfect understanding of the physiology of pain in many patients,” he noted. And most patients will not enroll in a study in which there's a 50% chance they would get conservative treatment instead of surgery, he said, as most U.S. patients have already tried many therapies before they undergo fusion.

Both he and Mr. Muehlbauer said there is evidence that fusions work in the right patient. But they said they weren't surprised that CMS is examining the procedure, given the increase in fusions since the introduction of instrumentation.

A study on trends estimated that lumbar fusion increased 250% from 1992 to 2003 (Spine 2006;31:2707-14). Medicare payments for fusion rose from $75 million in 1992 to $482 million in 2003, estimated the authors, who are affiliated with Dartmouth Medical School and Dartmouth-Hitchcock Medical Center, Hanover, N.H. They also found huge geographic variations.

Dr. Resnick said fusions have increased because there are new technologies and techniques and because surgeons want to help patients who previously were not thought to be surgical candidates.

A Medicare advisory panel has concluded that it has low confidence in spinal fusion as a treatment for lower-back pain, but for now, the federal insurance program has no plans to deny coverage for the procedure.

The Medicare Coverage Advisory Committee met in late 2006 to weigh the available evidence on spinal fusion, and voted on six questions. It said that the available data provide an intermediate level of confidence in addressing the outcomes needed to determine whether fusion is effective for low-back pain resulting from degenerative disk disease.

For all the other questions posed, which all pertained to degenerative disk disease, MCAC found that the evidence fell below the intermediate level of confidence for determining improved outcomes-- compared with conservative treatment--for both the first 2 years post surgery and beyond 2 years. They said the data were similarly lacking for fusions both with and without instrumentation. The panel said the results in the literature are reasonably likely to apply to the Medicare population.

The Centers for Medicare and Medicaid Services decided to hold a meeting to explore fusions after it denied coverage for the Charité artificial disk, according to an agency spokesman.

“It was also to identify where the holes are so that medical societies and industry and others could start to develop better data on those areas,” said Eric Muehlbauer, executive director of the North American Spine Society, in an interview.

Mr. Muehlbauer said that CMS is essentially wielding its clout to spur better data collection.

The North American Spine Society is considering three proposals on how to improve the evidence base on fusion, he said. There is an especially glaring need for data specific to the Medicare population, partly because fusions are rarer in that age group, Mr. Muehlbauer said.

Medical device makers, represented by the Advanced Medical Technology Association (AdvaMed), said that access should not be restricted during the evidence-gathering process.

“We encourage [CMS] to allow Medicare patients access to spinal fusion surgery as a treatment option as the body of clinical evidence develops over time,” said AdvaMed president and CEO Stephen J. Ubl in a statement.

The American Academy of Neurological Surgeons and the Congress of Neurological Surgeons are starting the second year of a pilot program to collect outcomes data on patients who have operations for lumbar stenosis at 15 practices, said Dr. Daniel Resnick, of the department of neurological surgery at the University of Wisconsin, Madison, in an interview.

There are several obstacles to getting good data, Dr. Resnick said. “We're hampered by an imperfect understanding of the physiology of pain in many patients,” he noted. And most patients will not enroll in a study in which there's a 50% chance they would get conservative treatment instead of surgery, he said, as most U.S. patients have already tried many therapies before they undergo fusion.

Both he and Mr. Muehlbauer said there is evidence that fusions work in the right patient. But they said they weren't surprised that CMS is examining the procedure, given the increase in fusions since the introduction of instrumentation.

A study on trends estimated that lumbar fusion increased 250% from 1992 to 2003 (Spine 2006;31:2707-14). Medicare payments for fusion rose from $75 million in 1992 to $482 million in 2003, estimated the authors, who are affiliated with Dartmouth Medical School and Dartmouth-Hitchcock Medical Center, Hanover, N.H. They also found huge geographic variations.

Dr. Resnick said fusions have increased because there are new technologies and techniques and because surgeons want to help patients who previously were not thought to be surgical candidates.

WASHINGTON — As a Senate panel opened debate on reauthorization of the State Children's Health Insurance Program, legislators had doubts about expanding coverage to an estimated 9 million children who are eligible but have not been enrolled.

SCHIP is due to expire on Sept. 30, but most states have been straining in the last few years to pay for children already covered by the program, several witnesses said at a meeting of the Senate Finance Committee.

Members of the committee also acknowledged that reality. “Congress has simply not given [SCHIP] enough funds to meet the current demand for services,” said committee chair Max Baucus (D-Mont.), who estimated that the program would need $12 billion-$15 billion over the next 5 years to maintain current coverage and $45 billion to bring all eligible children into SCHIP.

A last-minute deal signed into law at the end of 2006 allocated $271 million to cover anticipated shortfalls for a dozen or so states, but at least 14 more states will run out of SCHIP funds for fiscal 2007 if Congress does not enact another bailout by mid-May, Sen. Baucus said.

As of fiscal 2005, SCHIP had 6 million enrollees, according to a Government Accountability Office (GAO) report released at the Finance Committee hearing. Georgia Gov. Sonny Perdue testified that enrollment in his state has increased an average of 19% per month since June 2005. About 273,000 children are covered in Georgia, making it the fourth-largest SCHIP program in the country, he said. The Centers for Medicare and Medicaid Services had projected that only 130,000 children were eligible in Georgia, he said.

Some senators questioned whether states' flexibility should be reined in, saying that some initiatives might be diluting the program's intent—to cover low-income children. Federal law allows states to cover children in families with incomes up to 200% of the poverty level, but according to the GAO report, seven states were covering families with incomes at 300% of the poverty level or higher. Thirty-nine states require some cost sharing by families, but 11 states charge no premiums or copayments.

Fifteen states cover adults—generally parents of Medicaid- or SCHIP-eligible children, pregnant women, or childless adults. The Health and Human Services department has granted waivers for those states, said Kathryn G. Allen, director of health care at the GAO.

Sen. Charles Grassley (R-Iowa), ranking minority member of the Finance Committee, said he was interested in giving states more flexibility but was not happy about extending coverage to adults.

“The issue is whether SCHIP funds used to cover adults has drained resources targeted by Congress for kids,” said Sen. Grassley. Sen. Orrin Hatch (R-Utah) also questioned extending SCHIP benefits to adults.

WASHINGTON — As a Senate panel opened debate on reauthorization of the State Children's Health Insurance Program, legislators had doubts about expanding coverage to an estimated 9 million children who are eligible but have not been enrolled.

SCHIP is due to expire on Sept. 30, but most states have been straining in the last few years to pay for children already covered by the program, several witnesses said at a meeting of the Senate Finance Committee.

Members of the committee also acknowledged that reality. “Congress has simply not given [SCHIP] enough funds to meet the current demand for services,” said committee chair Max Baucus (D-Mont.), who estimated that the program would need $12 billion-$15 billion over the next 5 years to maintain current coverage and $45 billion to bring all eligible children into SCHIP.

A last-minute deal signed into law at the end of 2006 allocated $271 million to cover anticipated shortfalls for a dozen or so states, but at least 14 more states will run out of SCHIP funds for fiscal 2007 if Congress does not enact another bailout by mid-May, Sen. Baucus said.

As of fiscal 2005, SCHIP had 6 million enrollees, according to a Government Accountability Office (GAO) report released at the Finance Committee hearing. Georgia Gov. Sonny Perdue testified that enrollment in his state has increased an average of 19% per month since June 2005. About 273,000 children are covered in Georgia, making it the fourth-largest SCHIP program in the country, he said. The Centers for Medicare and Medicaid Services had projected that only 130,000 children were eligible in Georgia, he said.

Some senators questioned whether states' flexibility should be reined in, saying that some initiatives might be diluting the program's intent—to cover low-income children. Federal law allows states to cover children in families with incomes up to 200% of the poverty level, but according to the GAO report, seven states were covering families with incomes at 300% of the poverty level or higher. Thirty-nine states require some cost sharing by families, but 11 states charge no premiums or copayments.

Fifteen states cover adults—generally parents of Medicaid- or SCHIP-eligible children, pregnant women, or childless adults. The Health and Human Services department has granted waivers for those states, said Kathryn G. Allen, director of health care at the GAO.

Sen. Charles Grassley (R-Iowa), ranking minority member of the Finance Committee, said he was interested in giving states more flexibility but was not happy about extending coverage to adults.

“The issue is whether SCHIP funds used to cover adults has drained resources targeted by Congress for kids,” said Sen. Grassley. Sen. Orrin Hatch (R-Utah) also questioned extending SCHIP benefits to adults.

WASHINGTON — As a Senate panel opened debate on reauthorization of the State Children's Health Insurance Program, legislators had doubts about expanding coverage to an estimated 9 million children who are eligible but have not been enrolled.

SCHIP is due to expire on Sept. 30, but most states have been straining in the last few years to pay for children already covered by the program, several witnesses said at a meeting of the Senate Finance Committee.

Members of the committee also acknowledged that reality. “Congress has simply not given [SCHIP] enough funds to meet the current demand for services,” said committee chair Max Baucus (D-Mont.), who estimated that the program would need $12 billion-$15 billion over the next 5 years to maintain current coverage and $45 billion to bring all eligible children into SCHIP.

A last-minute deal signed into law at the end of 2006 allocated $271 million to cover anticipated shortfalls for a dozen or so states, but at least 14 more states will run out of SCHIP funds for fiscal 2007 if Congress does not enact another bailout by mid-May, Sen. Baucus said.

As of fiscal 2005, SCHIP had 6 million enrollees, according to a Government Accountability Office (GAO) report released at the Finance Committee hearing. Georgia Gov. Sonny Perdue testified that enrollment in his state has increased an average of 19% per month since June 2005. About 273,000 children are covered in Georgia, making it the fourth-largest SCHIP program in the country, he said. The Centers for Medicare and Medicaid Services had projected that only 130,000 children were eligible in Georgia, he said.

Some senators questioned whether states' flexibility should be reined in, saying that some initiatives might be diluting the program's intent—to cover low-income children. Federal law allows states to cover children in families with incomes up to 200% of the poverty level, but according to the GAO report, seven states were covering families with incomes at 300% of the poverty level or higher. Thirty-nine states require some cost sharing by families, but 11 states charge no premiums or copayments.

Fifteen states cover adults—generally parents of Medicaid- or SCHIP-eligible children, pregnant women, or childless adults. The Health and Human Services department has granted waivers for those states, said Kathryn G. Allen, director of health care at the GAO.

Sen. Charles Grassley (R-Iowa), ranking minority member of the Finance Committee, said he was interested in giving states more flexibility but was not happy about extending coverage to adults.

“The issue is whether SCHIP funds used to cover adults has drained resources targeted by Congress for kids,” said Sen. Grassley. Sen. Orrin Hatch (R-Utah) also questioned extending SCHIP benefits to adults.

The importance of keeping patients with drug-eluting stents on dual antiplatelet therapy has been vastly underestimated, according to new warnings about the risk of late thrombosis issued by the Food and Drug Administration and several professional societies.

In January, the FDA announced on its Web site that it had “made detection of DES [drug-eluting stent] thrombosis signals a priority because of the potential for serious harm to patients [even though] stent thrombosis occurs at low rates.” The agency summarized recommendations issued in December by its Circulatory System Devices Advisory Panel, including that the off-label use of DESs—estimated to be about 60% of device placements—is associated with an increased risk of thrombosis, death, or myocardial infarction (www.fda.gov/cdrh//010407.html

Shortly thereafter, the Society for Cardiovascular Angiography and Interventions (SCAI) issued a clinical alert on DESs (Cathet. Cardiovasc. Interv. 2007 Jan. 11 [Epub DOI:10.1002/ccd.21093

The alert is “a wake-up call,” said Dr. Hodgson, SCAI past president and chief of academic cardiology at St. Joseph's Hospital and Medical Center, Phoenix. “We've gotten a little sloppy about putting stents in and not thinking through the entire process,” he said.

Physicians should first determine if any procedure—whether surgery or stenting—is required, Dr. Hodgson said. If a DES is chosen, then intravascular ultrasound should be used to “document appropriate longitudinal lesion coverage and adequate stent expansion,” according to the alert.

All risks and benefits—and the importance of maintaining dual antiplatelet therapy for at least 3-6 months, and for 12 months when bleeding risk is low—should be discussed with the patient. Using a DES “can't be the default strategy,” he said, noting that many patients are not appropriate candidates for the devices.

Lastly, the American Heart Association, the American College of Cardiology, SCAI, the American College of Surgeons, and the American Dental Association issued a joint science advisory on the dangers of premature discontinuation of dual antiplatelet therapy after DES placement. The advisory was published in Circulation, the Journal of the American College of Cardiology, and Catheterization and Cardiovascular Interventions.

The recommendation has been to give 75 mg daily of Plavix (clopidogrel) and 325 mg daily of aspirin for 1 month after bare-metal stent implantation, for 3 months after sirolimus-coated DES implantation, for 6 months after paclitaxel-coated DES, and up to 12 months if there is a low risk for bleeding. “That's gone out the door,” said lead advisory author Dr. Cindy Grines, a cardiologist at William Beaumont Hospital, Royal Oak, Mich., in an interview.

The new recommendation is dual therapy for 12 months whenever possible, according to Dr. Grines. It has become clear that many patients and physicians—primarily those who are not cardiologists—are stopping dual therapy early, and that they may not understand the consequences, she said. Reasons for halting therapy include its expense (about $120 per month) and the perceived risk of bleeding during a subsequent surgical or dental procedure, Dr. Grines said.

The AHA advisory urges physicians to discuss with patients the pros and cons of dual therapy and the need to continue it for at least 12 months. The advisory cited numerous studies showing that early stoppage led to vastly higher rates of stent thrombosis, MI, and death.

Patients at particular risk for DES-related thrombosis—those who are older or have acute coronary syndrome, diabetes, low ejection fraction, or renal failure—should consider taking dual therapy for as long as possible, according to the advisory.

If 1 year is not possible, or if patients are required to have invasive surgery within 12 months of the catheterization, alternatives to DES—including a bare-metal stent or balloon angioplasty—should be weighed.

And cardiologists need to be consulted before a patient stops antiplatelet therapy, even if they are asked to do so by another physician.

There may be benefits to dual therapy beyond 12 months, but with few solid studies, it was harder to get a consensus on extending the duration, Dr. Grines said.

Drug-eluting stents are not overused, she said, adding that this is especially true given that they've been shown to have an edge in restenosis.

“Personally, I still use drug-eluting stents in most of my patients,” said Dr. Grines, noting that she makes exceptions for those who have had a recent MI, who have surgery scheduled, or who can't or aren't willing to maintain dual antiplatelet therapy for a year.

The FDA lauded the AHA document, saying it will raise awareness of the importance of dual therapy among all providers.

The importance of keeping patients with drug-eluting stents on dual antiplatelet therapy has been vastly underestimated, according to new warnings about the risk of late thrombosis issued by the Food and Drug Administration and several professional societies.

In January, the FDA announced on its Web site that it had “made detection of DES [drug-eluting stent] thrombosis signals a priority because of the potential for serious harm to patients [even though] stent thrombosis occurs at low rates.” The agency summarized recommendations issued in December by its Circulatory System Devices Advisory Panel, including that the off-label use of DESs—estimated to be about 60% of device placements—is associated with an increased risk of thrombosis, death, or myocardial infarction (www.fda.gov/cdrh//010407.html

Shortly thereafter, the Society for Cardiovascular Angiography and Interventions (SCAI) issued a clinical alert on DESs (Cathet. Cardiovasc. Interv. 2007 Jan. 11 [Epub DOI:10.1002/ccd.21093

The alert is “a wake-up call,” said Dr. Hodgson, SCAI past president and chief of academic cardiology at St. Joseph's Hospital and Medical Center, Phoenix. “We've gotten a little sloppy about putting stents in and not thinking through the entire process,” he said.

Physicians should first determine if any procedure—whether surgery or stenting—is required, Dr. Hodgson said. If a DES is chosen, then intravascular ultrasound should be used to “document appropriate longitudinal lesion coverage and adequate stent expansion,” according to the alert.

All risks and benefits—and the importance of maintaining dual antiplatelet therapy for at least 3-6 months, and for 12 months when bleeding risk is low—should be discussed with the patient. Using a DES “can't be the default strategy,” he said, noting that many patients are not appropriate candidates for the devices.

Lastly, the American Heart Association, the American College of Cardiology, SCAI, the American College of Surgeons, and the American Dental Association issued a joint science advisory on the dangers of premature discontinuation of dual antiplatelet therapy after DES placement. The advisory was published in Circulation, the Journal of the American College of Cardiology, and Catheterization and Cardiovascular Interventions.

The recommendation has been to give 75 mg daily of Plavix (clopidogrel) and 325 mg daily of aspirin for 1 month after bare-metal stent implantation, for 3 months after sirolimus-coated DES implantation, for 6 months after paclitaxel-coated DES, and up to 12 months if there is a low risk for bleeding. “That's gone out the door,” said lead advisory author Dr. Cindy Grines, a cardiologist at William Beaumont Hospital, Royal Oak, Mich., in an interview.

The new recommendation is dual therapy for 12 months whenever possible, according to Dr. Grines. It has become clear that many patients and physicians—primarily those who are not cardiologists—are stopping dual therapy early, and that they may not understand the consequences, she said. Reasons for halting therapy include its expense (about $120 per month) and the perceived risk of bleeding during a subsequent surgical or dental procedure, Dr. Grines said.

The AHA advisory urges physicians to discuss with patients the pros and cons of dual therapy and the need to continue it for at least 12 months. The advisory cited numerous studies showing that early stoppage led to vastly higher rates of stent thrombosis, MI, and death.

Patients at particular risk for DES-related thrombosis—those who are older or have acute coronary syndrome, diabetes, low ejection fraction, or renal failure—should consider taking dual therapy for as long as possible, according to the advisory.

If 1 year is not possible, or if patients are required to have invasive surgery within 12 months of the catheterization, alternatives to DES—including a bare-metal stent or balloon angioplasty—should be weighed.

And cardiologists need to be consulted before a patient stops antiplatelet therapy, even if they are asked to do so by another physician.

There may be benefits to dual therapy beyond 12 months, but with few solid studies, it was harder to get a consensus on extending the duration, Dr. Grines said.

Drug-eluting stents are not overused, she said, adding that this is especially true given that they've been shown to have an edge in restenosis.

“Personally, I still use drug-eluting stents in most of my patients,” said Dr. Grines, noting that she makes exceptions for those who have had a recent MI, who have surgery scheduled, or who can't or aren't willing to maintain dual antiplatelet therapy for a year.

The FDA lauded the AHA document, saying it will raise awareness of the importance of dual therapy among all providers.

The importance of keeping patients with drug-eluting stents on dual antiplatelet therapy has been vastly underestimated, according to new warnings about the risk of late thrombosis issued by the Food and Drug Administration and several professional societies.

In January, the FDA announced on its Web site that it had “made detection of DES [drug-eluting stent] thrombosis signals a priority because of the potential for serious harm to patients [even though] stent thrombosis occurs at low rates.” The agency summarized recommendations issued in December by its Circulatory System Devices Advisory Panel, including that the off-label use of DESs—estimated to be about 60% of device placements—is associated with an increased risk of thrombosis, death, or myocardial infarction (www.fda.gov/cdrh//010407.html

Shortly thereafter, the Society for Cardiovascular Angiography and Interventions (SCAI) issued a clinical alert on DESs (Cathet. Cardiovasc. Interv. 2007 Jan. 11 [Epub DOI:10.1002/ccd.21093

The alert is “a wake-up call,” said Dr. Hodgson, SCAI past president and chief of academic cardiology at St. Joseph's Hospital and Medical Center, Phoenix. “We've gotten a little sloppy about putting stents in and not thinking through the entire process,” he said.

Physicians should first determine if any procedure—whether surgery or stenting—is required, Dr. Hodgson said. If a DES is chosen, then intravascular ultrasound should be used to “document appropriate longitudinal lesion coverage and adequate stent expansion,” according to the alert.

All risks and benefits—and the importance of maintaining dual antiplatelet therapy for at least 3-6 months, and for 12 months when bleeding risk is low—should be discussed with the patient. Using a DES “can't be the default strategy,” he said, noting that many patients are not appropriate candidates for the devices.

Lastly, the American Heart Association, the American College of Cardiology, SCAI, the American College of Surgeons, and the American Dental Association issued a joint science advisory on the dangers of premature discontinuation of dual antiplatelet therapy after DES placement. The advisory was published in Circulation, the Journal of the American College of Cardiology, and Catheterization and Cardiovascular Interventions.

The recommendation has been to give 75 mg daily of Plavix (clopidogrel) and 325 mg daily of aspirin for 1 month after bare-metal stent implantation, for 3 months after sirolimus-coated DES implantation, for 6 months after paclitaxel-coated DES, and up to 12 months if there is a low risk for bleeding. “That's gone out the door,” said lead advisory author Dr. Cindy Grines, a cardiologist at William Beaumont Hospital, Royal Oak, Mich., in an interview.

The new recommendation is dual therapy for 12 months whenever possible, according to Dr. Grines. It has become clear that many patients and physicians—primarily those who are not cardiologists—are stopping dual therapy early, and that they may not understand the consequences, she said. Reasons for halting therapy include its expense (about $120 per month) and the perceived risk of bleeding during a subsequent surgical or dental procedure, Dr. Grines said.

The AHA advisory urges physicians to discuss with patients the pros and cons of dual therapy and the need to continue it for at least 12 months. The advisory cited numerous studies showing that early stoppage led to vastly higher rates of stent thrombosis, MI, and death.

Patients at particular risk for DES-related thrombosis—those who are older or have acute coronary syndrome, diabetes, low ejection fraction, or renal failure—should consider taking dual therapy for as long as possible, according to the advisory.

If 1 year is not possible, or if patients are required to have invasive surgery within 12 months of the catheterization, alternatives to DES—including a bare-metal stent or balloon angioplasty—should be weighed.

And cardiologists need to be consulted before a patient stops antiplatelet therapy, even if they are asked to do so by another physician.

There may be benefits to dual therapy beyond 12 months, but with few solid studies, it was harder to get a consensus on extending the duration, Dr. Grines said.

Drug-eluting stents are not overused, she said, adding that this is especially true given that they've been shown to have an edge in restenosis.

“Personally, I still use drug-eluting stents in most of my patients,” said Dr. Grines, noting that she makes exceptions for those who have had a recent MI, who have surgery scheduled, or who can't or aren't willing to maintain dual antiplatelet therapy for a year.

The FDA lauded the AHA document, saying it will raise awareness of the importance of dual therapy among all providers.