Alicia Ault

The number of students entering medical school this fall—17,759—is the largest ever, according to the Association of American Medical Colleges.

Although that number represents only a 2.3% increase from the previous year, there was an 8% increase in applicants, with 42,300 seeking to enter medical school in 2007. It was the fourth consecutive year in which the number of applicants was on the rise, after a 6-year decline.

In a press briefing, Darrell G. Kirch, AAMC president, said the increase in applicants and enrollees shows “the interest in medicine runs very strong in our country.”

Applicants and enrollees are more diverse than ever, according to the AAMC. Although the number of applicants who identified themselves as white or white combined with another ethnicity—26,916—still dwarfs other races, there was an increase in the number of minority applicants. There were 2,999 applicants who identified themselves as Latino or Hispanic alone or in combination with another race, 3,471 African American/combination applicants, and 9,225 Asian/combination applicants.

The number of black and Hispanic male applicants rose by 9.2%, which was larger than the growth of the overall applicant pool, according to the association. Black male acceptance and enrollment increased by 5.3%, and Hispanic male acceptance remained even with 2006 levels. There was an almost-even split among men and women applicants and enrollees. Men slightly edged out women, accounting for 51% of applicants and 51.7% of enrollees.

The AAMC and other groups have warned of looming physician shortages. Depending on the estimates used, there will be a shortfall of 55,000–90,000 physicians across all specialties by 2020. The AAMC has pushed for a 30% increase in enrollment by 2015, said Dr. Kirch.

The number of students entering medical school this fall—17,759—is the largest ever, according to the Association of American Medical Colleges.

Although that number represents only a 2.3% increase from the previous year, there was an 8% increase in applicants, with 42,300 seeking to enter medical school in 2007. It was the fourth consecutive year in which the number of applicants was on the rise, after a 6-year decline.

In a press briefing, Darrell G. Kirch, AAMC president, said the increase in applicants and enrollees shows “the interest in medicine runs very strong in our country.”

Applicants and enrollees are more diverse than ever, according to the AAMC. Although the number of applicants who identified themselves as white or white combined with another ethnicity—26,916—still dwarfs other races, there was an increase in the number of minority applicants. There were 2,999 applicants who identified themselves as Latino or Hispanic alone or in combination with another race, 3,471 African American/combination applicants, and 9,225 Asian/combination applicants.

The number of black and Hispanic male applicants rose by 9.2%, which was larger than the growth of the overall applicant pool, according to the association. Black male acceptance and enrollment increased by 5.3%, and Hispanic male acceptance remained even with 2006 levels. There was an almost-even split among men and women applicants and enrollees. Men slightly edged out women, accounting for 51% of applicants and 51.7% of enrollees.

The AAMC and other groups have warned of looming physician shortages. Depending on the estimates used, there will be a shortfall of 55,000–90,000 physicians across all specialties by 2020. The AAMC has pushed for a 30% increase in enrollment by 2015, said Dr. Kirch.

The number of students entering medical school this fall—17,759—is the largest ever, according to the Association of American Medical Colleges.

Although that number represents only a 2.3% increase from the previous year, there was an 8% increase in applicants, with 42,300 seeking to enter medical school in 2007. It was the fourth consecutive year in which the number of applicants was on the rise, after a 6-year decline.

In a press briefing, Darrell G. Kirch, AAMC president, said the increase in applicants and enrollees shows “the interest in medicine runs very strong in our country.”

Applicants and enrollees are more diverse than ever, according to the AAMC. Although the number of applicants who identified themselves as white or white combined with another ethnicity—26,916—still dwarfs other races, there was an increase in the number of minority applicants. There were 2,999 applicants who identified themselves as Latino or Hispanic alone or in combination with another race, 3,471 African American/combination applicants, and 9,225 Asian/combination applicants.

The number of black and Hispanic male applicants rose by 9.2%, which was larger than the growth of the overall applicant pool, according to the association. Black male acceptance and enrollment increased by 5.3%, and Hispanic male acceptance remained even with 2006 levels. There was an almost-even split among men and women applicants and enrollees. Men slightly edged out women, accounting for 51% of applicants and 51.7% of enrollees.

The AAMC and other groups have warned of looming physician shortages. Depending on the estimates used, there will be a shortfall of 55,000–90,000 physicians across all specialties by 2020. The AAMC has pushed for a 30% increase in enrollment by 2015, said Dr. Kirch.

WASHINGTON — Thousands of lives are being saved each year as health plans and physicians more closely follow quality measures such as giving β-blockers after a heart attack, managing hypertension and hypercholesterolemia, and controlling hemoglobin A_1c levels, according to the latest report card from the National Committee for Quality Assurance.

And, plans that report publicly on these measures deliver higher quality care, said NCQA president Margaret O'Kane in a briefing.

The NCQA's recently released report card shows that commercial and Medicaid plans that publicly disclose NCQA-tracked quality measures perform anywhere from half a percent to 16% better than plans that do not disclose their data.

However, even with some notable successes, some of the gains—such as in controlling blood sugar—are starting to plateau, said Ms. O'Kane. And, there are still gaps in quality between top-performing and average health plans. Thousands more lives could be saved if the laggards did as well as the top-performers in the NCQA database, she said.

The report is based on data that are voluntarily submitted to the NCQA, which also accredits health plans. In 2006, 767 organizations—626 managed care plans covering private patients and Medicare and Medicaid enrollees, and 83 commercial and 58 Medicare PPO plans—submitted data using the NCQA's Healthcare Effectiveness Data and Information Set (HEDIS).

Much of the data come from claims, but some also come from chart reviews. None of it is adjusted for severity of illness, socioeconomic, or other factors.

Approximately 84 million Americans were enrolled in plans that used HEDIS measures to report to the NCQA in 2006. Although that is a big number, at least 100 million Americans are in health plans that do not report quality data, and some 47 million have no insurance, said Ms. O'Kane. The quality picture is completely dark for the uninsured, she said.

But for those plans that did report, the news was good. Overall, commercial plans improved performance in 30 of 44 HEDIS measures where a trend could be discerned, Medicaid plans notched increases in 34 of 43 “trendable” measures, and Medicare plans achieved increase only on 7 of 21 trendable measures.

Among the biggest successes was that 98% of commercial plans, 94% of Medicare, and 88% of Medicaid plans reported prescribing a β-blocker upon discharge after acute myocardial infarction. Over the last 6 years, β-blocker treatment has saved an estimated 4,400–5,600 lives, said Ms. O'Kane.

Given the high prescribing rates, the NCQA will no longer track this measure. Instead, the organization will collect data on how many patients still receive β-blockers 6 months after discharge—currently, only about 74% in commercial plans and 70% for Medicare and Medicaid.

Childhood immunization rates are also at all-time highs, at about 80% for commercial plans and 73% for Medicaid plans for the recommended series of vaccinations.

There has been “stalling” in some of the older HEDIS measures, however, said Ms. O'Kane. Baseline screening for HbA_1c has plateaued at 88% in commercial plans and is down slightly for Medicare and Medicaid, at 87% and 78%, respectively.

Cholesterol screening and control of total cholesterol are also trending flat or down. The NCQA has no explanation for the leveling off, said Ms. O'Kane.

Adherence to mental health measures—which are already abysmally low—has also been flat for almost a decade. For instance, only 20% of commercial, 21% of Medicaid, and 11% of Medicare plans are meeting the benchmark of treating newly diagnosed depression patients with an antidepressant and following up with at least three visits within the 12-week acute treatment phase. These rates have stayed virtually the same since 1998.

Similarly, patients who have been hospitalized for a mental illness are not getting quality care, said Ms. O'Kane. Only 57% of patients in commercial, 37% of those in a Medicare, and 39% of those in a Medicaid plan had a follow-up within a week of hospitalization. Rates improved somewhat a month out, to 75%, 55%, and 58%. Studies have shown that follow-up care decreases the risk of repeat hospitalizations and improves adherence, according to the NCQA.

The low follow-up rates are “a national disgrace,” said Ms. O'Kane, adding that for anyone to be “out 30 days with no one checking on you is unacceptable.”

Several new HEDIS measures are in place for 2007, including tracking of potentially harmful drug-disease interactions in the elderly.

And, for the first time, health plans are being asked to report on their use of resources in treating various conditions. In 2007, they are diabetes, asthma, and low back pain.

In 2008, chronic obstructive pulmonary disease, hypertension, and cardiovascular disease will be added. These conditions account for 60% of health care spending, said Ms. O'Kane. The data will be used to determine the variations in resource use among health plans.

Coupled with the HEDIS quality measures, the NCQA will eventually be able to rate which plans give the best quality care for the least amount of money, said Ms. O'Kane.

WASHINGTON — Thousands of lives are being saved each year as health plans and physicians more closely follow quality measures such as giving β-blockers after a heart attack, managing hypertension and hypercholesterolemia, and controlling hemoglobin A_1c levels, according to the latest report card from the National Committee for Quality Assurance.

And, plans that report publicly on these measures deliver higher quality care, said NCQA president Margaret O'Kane in a briefing.

The NCQA's recently released report card shows that commercial and Medicaid plans that publicly disclose NCQA-tracked quality measures perform anywhere from half a percent to 16% better than plans that do not disclose their data.

However, even with some notable successes, some of the gains—such as in controlling blood sugar—are starting to plateau, said Ms. O'Kane. And, there are still gaps in quality between top-performing and average health plans. Thousands more lives could be saved if the laggards did as well as the top-performers in the NCQA database, she said.

The report is based on data that are voluntarily submitted to the NCQA, which also accredits health plans. In 2006, 767 organizations—626 managed care plans covering private patients and Medicare and Medicaid enrollees, and 83 commercial and 58 Medicare PPO plans—submitted data using the NCQA's Healthcare Effectiveness Data and Information Set (HEDIS).

Much of the data come from claims, but some also come from chart reviews. None of it is adjusted for severity of illness, socioeconomic, or other factors.

Approximately 84 million Americans were enrolled in plans that used HEDIS measures to report to the NCQA in 2006. Although that is a big number, at least 100 million Americans are in health plans that do not report quality data, and some 47 million have no insurance, said Ms. O'Kane. The quality picture is completely dark for the uninsured, she said.

But for those plans that did report, the news was good. Overall, commercial plans improved performance in 30 of 44 HEDIS measures where a trend could be discerned, Medicaid plans notched increases in 34 of 43 “trendable” measures, and Medicare plans achieved increase only on 7 of 21 trendable measures.

Among the biggest successes was that 98% of commercial plans, 94% of Medicare, and 88% of Medicaid plans reported prescribing a β-blocker upon discharge after acute myocardial infarction. Over the last 6 years, β-blocker treatment has saved an estimated 4,400–5,600 lives, said Ms. O'Kane.

Given the high prescribing rates, the NCQA will no longer track this measure. Instead, the organization will collect data on how many patients still receive β-blockers 6 months after discharge—currently, only about 74% in commercial plans and 70% for Medicare and Medicaid.

Childhood immunization rates are also at all-time highs, at about 80% for commercial plans and 73% for Medicaid plans for the recommended series of vaccinations.

There has been “stalling” in some of the older HEDIS measures, however, said Ms. O'Kane. Baseline screening for HbA_1c has plateaued at 88% in commercial plans and is down slightly for Medicare and Medicaid, at 87% and 78%, respectively.

Cholesterol screening and control of total cholesterol are also trending flat or down. The NCQA has no explanation for the leveling off, said Ms. O'Kane.

Adherence to mental health measures—which are already abysmally low—has also been flat for almost a decade. For instance, only 20% of commercial, 21% of Medicaid, and 11% of Medicare plans are meeting the benchmark of treating newly diagnosed depression patients with an antidepressant and following up with at least three visits within the 12-week acute treatment phase. These rates have stayed virtually the same since 1998.

Similarly, patients who have been hospitalized for a mental illness are not getting quality care, said Ms. O'Kane. Only 57% of patients in commercial, 37% of those in a Medicare, and 39% of those in a Medicaid plan had a follow-up within a week of hospitalization. Rates improved somewhat a month out, to 75%, 55%, and 58%. Studies have shown that follow-up care decreases the risk of repeat hospitalizations and improves adherence, according to the NCQA.

The low follow-up rates are “a national disgrace,” said Ms. O'Kane, adding that for anyone to be “out 30 days with no one checking on you is unacceptable.”

Several new HEDIS measures are in place for 2007, including tracking of potentially harmful drug-disease interactions in the elderly.

And, for the first time, health plans are being asked to report on their use of resources in treating various conditions. In 2007, they are diabetes, asthma, and low back pain.

In 2008, chronic obstructive pulmonary disease, hypertension, and cardiovascular disease will be added. These conditions account for 60% of health care spending, said Ms. O'Kane. The data will be used to determine the variations in resource use among health plans.

Coupled with the HEDIS quality measures, the NCQA will eventually be able to rate which plans give the best quality care for the least amount of money, said Ms. O'Kane.

WASHINGTON — Thousands of lives are being saved each year as health plans and physicians more closely follow quality measures such as giving β-blockers after a heart attack, managing hypertension and hypercholesterolemia, and controlling hemoglobin A_1c levels, according to the latest report card from the National Committee for Quality Assurance.

And, plans that report publicly on these measures deliver higher quality care, said NCQA president Margaret O'Kane in a briefing.

The NCQA's recently released report card shows that commercial and Medicaid plans that publicly disclose NCQA-tracked quality measures perform anywhere from half a percent to 16% better than plans that do not disclose their data.

However, even with some notable successes, some of the gains—such as in controlling blood sugar—are starting to plateau, said Ms. O'Kane. And, there are still gaps in quality between top-performing and average health plans. Thousands more lives could be saved if the laggards did as well as the top-performers in the NCQA database, she said.

The report is based on data that are voluntarily submitted to the NCQA, which also accredits health plans. In 2006, 767 organizations—626 managed care plans covering private patients and Medicare and Medicaid enrollees, and 83 commercial and 58 Medicare PPO plans—submitted data using the NCQA's Healthcare Effectiveness Data and Information Set (HEDIS).

Much of the data come from claims, but some also come from chart reviews. None of it is adjusted for severity of illness, socioeconomic, or other factors.

Approximately 84 million Americans were enrolled in plans that used HEDIS measures to report to the NCQA in 2006. Although that is a big number, at least 100 million Americans are in health plans that do not report quality data, and some 47 million have no insurance, said Ms. O'Kane. The quality picture is completely dark for the uninsured, she said.

But for those plans that did report, the news was good. Overall, commercial plans improved performance in 30 of 44 HEDIS measures where a trend could be discerned, Medicaid plans notched increases in 34 of 43 “trendable” measures, and Medicare plans achieved increase only on 7 of 21 trendable measures.

Among the biggest successes was that 98% of commercial plans, 94% of Medicare, and 88% of Medicaid plans reported prescribing a β-blocker upon discharge after acute myocardial infarction. Over the last 6 years, β-blocker treatment has saved an estimated 4,400–5,600 lives, said Ms. O'Kane.

Given the high prescribing rates, the NCQA will no longer track this measure. Instead, the organization will collect data on how many patients still receive β-blockers 6 months after discharge—currently, only about 74% in commercial plans and 70% for Medicare and Medicaid.

Childhood immunization rates are also at all-time highs, at about 80% for commercial plans and 73% for Medicaid plans for the recommended series of vaccinations.

There has been “stalling” in some of the older HEDIS measures, however, said Ms. O'Kane. Baseline screening for HbA_1c has plateaued at 88% in commercial plans and is down slightly for Medicare and Medicaid, at 87% and 78%, respectively.

Cholesterol screening and control of total cholesterol are also trending flat or down. The NCQA has no explanation for the leveling off, said Ms. O'Kane.

Adherence to mental health measures—which are already abysmally low—has also been flat for almost a decade. For instance, only 20% of commercial, 21% of Medicaid, and 11% of Medicare plans are meeting the benchmark of treating newly diagnosed depression patients with an antidepressant and following up with at least three visits within the 12-week acute treatment phase. These rates have stayed virtually the same since 1998.

Similarly, patients who have been hospitalized for a mental illness are not getting quality care, said Ms. O'Kane. Only 57% of patients in commercial, 37% of those in a Medicare, and 39% of those in a Medicaid plan had a follow-up within a week of hospitalization. Rates improved somewhat a month out, to 75%, 55%, and 58%. Studies have shown that follow-up care decreases the risk of repeat hospitalizations and improves adherence, according to the NCQA.

The low follow-up rates are “a national disgrace,” said Ms. O'Kane, adding that for anyone to be “out 30 days with no one checking on you is unacceptable.”

Several new HEDIS measures are in place for 2007, including tracking of potentially harmful drug-disease interactions in the elderly.

And, for the first time, health plans are being asked to report on their use of resources in treating various conditions. In 2007, they are diabetes, asthma, and low back pain.

In 2008, chronic obstructive pulmonary disease, hypertension, and cardiovascular disease will be added. These conditions account for 60% of health care spending, said Ms. O'Kane. The data will be used to determine the variations in resource use among health plans.

Coupled with the HEDIS quality measures, the NCQA will eventually be able to rate which plans give the best quality care for the least amount of money, said Ms. O'Kane.

As expected, the Food and Drug Administration has relaxed some of the rules for prescribing the acne drug isotretinoin, including eliminating the 23-day lockout period for women of childbearing potential.

Women still must have their initial prescription filled within 7 days of their first office visit or they will be prevented from getting the drug for 23 days. But the restriction no longer will apply to succeeding prescriptions.

Dermatologists, drugmakers, and professional organizations such as the American Academy of Dermatology had encouraged the FDA to make that change to the iPLEDGE program that governs isotretinoin prescribing.

At a meeting in August, the FDA's Dermatologic and Ophthalmic Drugs and Drug Safety and Risk Management advisory committees voted unanimously in support of eliminating the 23-day lockout and several other changes, which the agency also approved. Those included:

▸ Starting the 7-day window for the initial prescription for those of childbearing potential from the date of pregnancy testing, instead of the date of the office visit.

▸ Extending the prescription window from 7 days to 30 days for men and for women not of childbearing potential.

▸ Modifying the list of acceptable secondary forms of contraception to include male condoms with or without spermicide.

The changes will be effective Dec. 2. Updated materials will be sent to pharmacies and prescribers before then, said Roche Laboratories Inc., one of the isotretinoin manufacturers. The others are Mylan Laboratories Inc., Ranbaxy Laboratories Ltd., and Barr Pharmaceuticals Inc.

The committee members said iPLEDGE seemed to be interfering with the doctor-patient relationship and had not, despite all its restrictions, eliminated pregnancies. From March 2006 to March 31, 2007, there were 122 pregnancies in 91,894 women of childbearing potential who received a prescription.

There were 37 pregnancies in April, May, and June 2007, and 19 pregnancies outside the iPLEDGE program, Roche officials noted at the meeting.

As expected, the Food and Drug Administration has relaxed some of the rules for prescribing the acne drug isotretinoin, including eliminating the 23-day lockout period for women of childbearing potential.

Women still must have their initial prescription filled within 7 days of their first office visit or they will be prevented from getting the drug for 23 days. But the restriction no longer will apply to succeeding prescriptions.

Dermatologists, drugmakers, and professional organizations such as the American Academy of Dermatology had encouraged the FDA to make that change to the iPLEDGE program that governs isotretinoin prescribing.

At a meeting in August, the FDA's Dermatologic and Ophthalmic Drugs and Drug Safety and Risk Management advisory committees voted unanimously in support of eliminating the 23-day lockout and several other changes, which the agency also approved. Those included:

▸ Starting the 7-day window for the initial prescription for those of childbearing potential from the date of pregnancy testing, instead of the date of the office visit.

▸ Extending the prescription window from 7 days to 30 days for men and for women not of childbearing potential.

▸ Modifying the list of acceptable secondary forms of contraception to include male condoms with or without spermicide.

The changes will be effective Dec. 2. Updated materials will be sent to pharmacies and prescribers before then, said Roche Laboratories Inc., one of the isotretinoin manufacturers. The others are Mylan Laboratories Inc., Ranbaxy Laboratories Ltd., and Barr Pharmaceuticals Inc.

The committee members said iPLEDGE seemed to be interfering with the doctor-patient relationship and had not, despite all its restrictions, eliminated pregnancies. From March 2006 to March 31, 2007, there were 122 pregnancies in 91,894 women of childbearing potential who received a prescription.

There were 37 pregnancies in April, May, and June 2007, and 19 pregnancies outside the iPLEDGE program, Roche officials noted at the meeting.

As expected, the Food and Drug Administration has relaxed some of the rules for prescribing the acne drug isotretinoin, including eliminating the 23-day lockout period for women of childbearing potential.

Women still must have their initial prescription filled within 7 days of their first office visit or they will be prevented from getting the drug for 23 days. But the restriction no longer will apply to succeeding prescriptions.

Dermatologists, drugmakers, and professional organizations such as the American Academy of Dermatology had encouraged the FDA to make that change to the iPLEDGE program that governs isotretinoin prescribing.

At a meeting in August, the FDA's Dermatologic and Ophthalmic Drugs and Drug Safety and Risk Management advisory committees voted unanimously in support of eliminating the 23-day lockout and several other changes, which the agency also approved. Those included:

▸ Starting the 7-day window for the initial prescription for those of childbearing potential from the date of pregnancy testing, instead of the date of the office visit.

▸ Extending the prescription window from 7 days to 30 days for men and for women not of childbearing potential.

▸ Modifying the list of acceptable secondary forms of contraception to include male condoms with or without spermicide.

The changes will be effective Dec. 2. Updated materials will be sent to pharmacies and prescribers before then, said Roche Laboratories Inc., one of the isotretinoin manufacturers. The others are Mylan Laboratories Inc., Ranbaxy Laboratories Ltd., and Barr Pharmaceuticals Inc.

The committee members said iPLEDGE seemed to be interfering with the doctor-patient relationship and had not, despite all its restrictions, eliminated pregnancies. From March 2006 to March 31, 2007, there were 122 pregnancies in 91,894 women of childbearing potential who received a prescription.

There were 37 pregnancies in April, May, and June 2007, and 19 pregnancies outside the iPLEDGE program, Roche officials noted at the meeting.

The number of students entering medical school this fall—17,759—is the largest ever, according to the Association of American Medical Colleges.

While that number represents only a 2.3% increase from the previous year, there was an 8% increase in applicants, with 42,300 seeking to enter medical school in 2007. It was the fourth consecutive year in which the number of applicants was on the rise, after a 6-year decline.

In a briefing with reporters, AAMC President Darrell G. Kirch said that the continuing increase in applicants and enrollees shows “that the interest in medicine runs very strong in our country.”

Applicants and enrollees are more diverse than ever, according to the AAMC. While the number of applicants who identified themselves as white or white combined with another ethnicity—26,916—still dwarfs other races, there was an increase in the number of minority applicants. There were 2,999 applicants who identified themselves as Latino or Hispanic alone or in combination with another race, 3,471 African American/combination applicants, and 9,225 Asian/combination applicants.

The number of black and Hispanic male applicants rose by 9.2%, which was larger than the growth of the overall applicant pool, according to the AAMC. Ultimately, black male acceptance and enrollment increased by 5.3%, and Hispanic male acceptance remained even with 2006 levels. There was an almost-even split among men and women applicants and enrollees. Men slightly edged out women, accounting for 51% of applicants and 51.7% of enrollees.

Eleven of the 126 medical schools increased class size by more than 10%: Michigan State University (47% increase), Texas A&M University System (24%), University of Arizona (22%), Florida State University (19%), Emory University (14%), Mount Sinai School of Medicine (14%), University of California, Davis (13%), Joan C. Edwards School of Medicine at Marshall University (12%), Drexel University (10%), and Howard University and University of Minnesota (10%). Some of the increase in enrollment came through added capacity—both Michigan State and Arizona opened additional campuses. Six universities are currently seeking accreditation for a medical school, Dr. Kirch said.

The rise in applicants and enrollment represents some light at the end of the tunnel, he said. The AAMC and other organizations have warned of looming physician shortages. Depending on the estimates used, there will be a shortfall of 55,000–90,000 physicians across all specialties by 2020.

The AAMC has pushed for a 30% increase in enrollment by 2015, Dr. Kirch said. He acknowledged that it can be difficult to accurately predict shortages, noting that medical school enrollment has waxed and waned over the years.

Even so, despite the many current challenges of being a physician—including a patchwork health care system and unpredictable reimbursement picture—it's still seen as an attractive career choice, Dr. Kirch said. “What I think is most striking here is to see the draw that medicine still has despite those environmental forces,” he said. “I personally view this as a reflection that there are few careers that can be as meaningful, as fulfilling as pursuing medicine,” he added.

ELSEVIER GLOBAL MEDICAL NEWS

The number of students entering medical school this fall—17,759—is the largest ever, according to the Association of American Medical Colleges.

While that number represents only a 2.3% increase from the previous year, there was an 8% increase in applicants, with 42,300 seeking to enter medical school in 2007. It was the fourth consecutive year in which the number of applicants was on the rise, after a 6-year decline.

In a briefing with reporters, AAMC President Darrell G. Kirch said that the continuing increase in applicants and enrollees shows “that the interest in medicine runs very strong in our country.”

Applicants and enrollees are more diverse than ever, according to the AAMC. While the number of applicants who identified themselves as white or white combined with another ethnicity—26,916—still dwarfs other races, there was an increase in the number of minority applicants. There were 2,999 applicants who identified themselves as Latino or Hispanic alone or in combination with another race, 3,471 African American/combination applicants, and 9,225 Asian/combination applicants.

The number of black and Hispanic male applicants rose by 9.2%, which was larger than the growth of the overall applicant pool, according to the AAMC. Ultimately, black male acceptance and enrollment increased by 5.3%, and Hispanic male acceptance remained even with 2006 levels. There was an almost-even split among men and women applicants and enrollees. Men slightly edged out women, accounting for 51% of applicants and 51.7% of enrollees.

Eleven of the 126 medical schools increased class size by more than 10%: Michigan State University (47% increase), Texas A&M University System (24%), University of Arizona (22%), Florida State University (19%), Emory University (14%), Mount Sinai School of Medicine (14%), University of California, Davis (13%), Joan C. Edwards School of Medicine at Marshall University (12%), Drexel University (10%), and Howard University and University of Minnesota (10%). Some of the increase in enrollment came through added capacity—both Michigan State and Arizona opened additional campuses. Six universities are currently seeking accreditation for a medical school, Dr. Kirch said.

The rise in applicants and enrollment represents some light at the end of the tunnel, he said. The AAMC and other organizations have warned of looming physician shortages. Depending on the estimates used, there will be a shortfall of 55,000–90,000 physicians across all specialties by 2020.

The AAMC has pushed for a 30% increase in enrollment by 2015, Dr. Kirch said. He acknowledged that it can be difficult to accurately predict shortages, noting that medical school enrollment has waxed and waned over the years.

Even so, despite the many current challenges of being a physician—including a patchwork health care system and unpredictable reimbursement picture—it's still seen as an attractive career choice, Dr. Kirch said. “What I think is most striking here is to see the draw that medicine still has despite those environmental forces,” he said. “I personally view this as a reflection that there are few careers that can be as meaningful, as fulfilling as pursuing medicine,” he added.

ELSEVIER GLOBAL MEDICAL NEWS

The number of students entering medical school this fall—17,759—is the largest ever, according to the Association of American Medical Colleges.

While that number represents only a 2.3% increase from the previous year, there was an 8% increase in applicants, with 42,300 seeking to enter medical school in 2007. It was the fourth consecutive year in which the number of applicants was on the rise, after a 6-year decline.

In a briefing with reporters, AAMC President Darrell G. Kirch said that the continuing increase in applicants and enrollees shows “that the interest in medicine runs very strong in our country.”

Applicants and enrollees are more diverse than ever, according to the AAMC. While the number of applicants who identified themselves as white or white combined with another ethnicity—26,916—still dwarfs other races, there was an increase in the number of minority applicants. There were 2,999 applicants who identified themselves as Latino or Hispanic alone or in combination with another race, 3,471 African American/combination applicants, and 9,225 Asian/combination applicants.

The number of black and Hispanic male applicants rose by 9.2%, which was larger than the growth of the overall applicant pool, according to the AAMC. Ultimately, black male acceptance and enrollment increased by 5.3%, and Hispanic male acceptance remained even with 2006 levels. There was an almost-even split among men and women applicants and enrollees. Men slightly edged out women, accounting for 51% of applicants and 51.7% of enrollees.

Eleven of the 126 medical schools increased class size by more than 10%: Michigan State University (47% increase), Texas A&M University System (24%), University of Arizona (22%), Florida State University (19%), Emory University (14%), Mount Sinai School of Medicine (14%), University of California, Davis (13%), Joan C. Edwards School of Medicine at Marshall University (12%), Drexel University (10%), and Howard University and University of Minnesota (10%). Some of the increase in enrollment came through added capacity—both Michigan State and Arizona opened additional campuses. Six universities are currently seeking accreditation for a medical school, Dr. Kirch said.

The rise in applicants and enrollment represents some light at the end of the tunnel, he said. The AAMC and other organizations have warned of looming physician shortages. Depending on the estimates used, there will be a shortfall of 55,000–90,000 physicians across all specialties by 2020.

The AAMC has pushed for a 30% increase in enrollment by 2015, Dr. Kirch said. He acknowledged that it can be difficult to accurately predict shortages, noting that medical school enrollment has waxed and waned over the years.

Even so, despite the many current challenges of being a physician—including a patchwork health care system and unpredictable reimbursement picture—it's still seen as an attractive career choice, Dr. Kirch said. “What I think is most striking here is to see the draw that medicine still has despite those environmental forces,” he said. “I personally view this as a reflection that there are few careers that can be as meaningful, as fulfilling as pursuing medicine,” he added.

ELSEVIER GLOBAL MEDICAL NEWS

The Food and Drug Administration soon will begin to scrutinize the warning labels on tanning beds, under a new federal law signed by the president in late September.

The Tanning Accountability and Notification Act was included in the Food and Drug Administration Amendments Act of 2007. Four members of Congress—Sen. Jack Reed (D-R.I.), Sen. Johnny Isakson (R-Ga.), Rep. Carolyn Maloney (D-N.Y.), and Rep. Ginny Brown-Waite (R-Fla.)—originally sponsored the TAN Act.

Under the new law, the FDA is being directed to determine if the label is positioned correctly, whether it gives sufficient risk data, whether alternative warnings would better communicate risks, or if there is no warning that could communicate the risk of using tanning beds adequately.

To reach those determinations, the law requires the FDA to conduct tests with consumers; the agency is to issue a report by September 2008.

The American Academy of Dermatology Association applauded the passage of the TAN Act.

“The current labeling on tanning equipment inadequately explains the serious risks associated with indoor tanning,” said AAD president Dr. Diane R. Baker in a statement. “The TAN Act is the first step to correct this and ultimately will help educate the millions of Americans who tan each day about the potential cancer risks associated with ultraviolet radiation.”

AAD estimates that 30 million Americans use tanning beds each year, and that 2.3 million are teenagers. The Indoor Tanning Association does not have exact figures, but said the industry estimates that at least 25 million Americans are indoor tanners.

John Overstreet, executive director of the association, said that requiring the FDA to study new warnings is not necessary.

The current warning—which was devised by the FDA—is very detailed and blunt, Mr. Overstreet said in an interview. “With all the challenges facing FDA and all they have to do, this seems a little unnecessary,” he said, adding that the industry believes that the AAD and other organizations exaggerate the dangers of UV radiation.

The American Medical Association has continued to support the strengthening of state and local laws to regulate indoor tanning more stringently, including toughening the warnings posted in salons and spas.

Dr. Jessica Krant, an AMA alternate delegate representing the American Society for Dermatologic Surgery, said that passage of the bill means that Congress recognizes that teenagers still are being exposed to unnecessary risks from tanning. “I think it's the first step and a very good and important change,” she said in an interview.

But the AMA and the ASDS both feel that the current warnings—created in the 1970s—need to be updated and placed more prominently in tanning beds, said Dr. Krant, also of State University of New York, Brooklyn.

It is estimated that 25–30 million Americans are indoor tanners, and 2.3 million of these are teenagers. ©Dragan Trifunovic/Fotolia.com

The Food and Drug Administration soon will begin to scrutinize the warning labels on tanning beds, under a new federal law signed by the president in late September.

The Tanning Accountability and Notification Act was included in the Food and Drug Administration Amendments Act of 2007. Four members of Congress—Sen. Jack Reed (D-R.I.), Sen. Johnny Isakson (R-Ga.), Rep. Carolyn Maloney (D-N.Y.), and Rep. Ginny Brown-Waite (R-Fla.)—originally sponsored the TAN Act.

Under the new law, the FDA is being directed to determine if the label is positioned correctly, whether it gives sufficient risk data, whether alternative warnings would better communicate risks, or if there is no warning that could communicate the risk of using tanning beds adequately.

To reach those determinations, the law requires the FDA to conduct tests with consumers; the agency is to issue a report by September 2008.

The American Academy of Dermatology Association applauded the passage of the TAN Act.

“The current labeling on tanning equipment inadequately explains the serious risks associated with indoor tanning,” said AAD president Dr. Diane R. Baker in a statement. “The TAN Act is the first step to correct this and ultimately will help educate the millions of Americans who tan each day about the potential cancer risks associated with ultraviolet radiation.”

AAD estimates that 30 million Americans use tanning beds each year, and that 2.3 million are teenagers. The Indoor Tanning Association does not have exact figures, but said the industry estimates that at least 25 million Americans are indoor tanners.

John Overstreet, executive director of the association, said that requiring the FDA to study new warnings is not necessary.

The current warning—which was devised by the FDA—is very detailed and blunt, Mr. Overstreet said in an interview. “With all the challenges facing FDA and all they have to do, this seems a little unnecessary,” he said, adding that the industry believes that the AAD and other organizations exaggerate the dangers of UV radiation.

The American Medical Association has continued to support the strengthening of state and local laws to regulate indoor tanning more stringently, including toughening the warnings posted in salons and spas.

Dr. Jessica Krant, an AMA alternate delegate representing the American Society for Dermatologic Surgery, said that passage of the bill means that Congress recognizes that teenagers still are being exposed to unnecessary risks from tanning. “I think it's the first step and a very good and important change,” she said in an interview.

But the AMA and the ASDS both feel that the current warnings—created in the 1970s—need to be updated and placed more prominently in tanning beds, said Dr. Krant, also of State University of New York, Brooklyn.

It is estimated that 25–30 million Americans are indoor tanners, and 2.3 million of these are teenagers. ©Dragan Trifunovic/Fotolia.com

The Food and Drug Administration soon will begin to scrutinize the warning labels on tanning beds, under a new federal law signed by the president in late September.

The Tanning Accountability and Notification Act was included in the Food and Drug Administration Amendments Act of 2007. Four members of Congress—Sen. Jack Reed (D-R.I.), Sen. Johnny Isakson (R-Ga.), Rep. Carolyn Maloney (D-N.Y.), and Rep. Ginny Brown-Waite (R-Fla.)—originally sponsored the TAN Act.

Under the new law, the FDA is being directed to determine if the label is positioned correctly, whether it gives sufficient risk data, whether alternative warnings would better communicate risks, or if there is no warning that could communicate the risk of using tanning beds adequately.

To reach those determinations, the law requires the FDA to conduct tests with consumers; the agency is to issue a report by September 2008.

The American Academy of Dermatology Association applauded the passage of the TAN Act.

“The current labeling on tanning equipment inadequately explains the serious risks associated with indoor tanning,” said AAD president Dr. Diane R. Baker in a statement. “The TAN Act is the first step to correct this and ultimately will help educate the millions of Americans who tan each day about the potential cancer risks associated with ultraviolet radiation.”

AAD estimates that 30 million Americans use tanning beds each year, and that 2.3 million are teenagers. The Indoor Tanning Association does not have exact figures, but said the industry estimates that at least 25 million Americans are indoor tanners.

John Overstreet, executive director of the association, said that requiring the FDA to study new warnings is not necessary.

The current warning—which was devised by the FDA—is very detailed and blunt, Mr. Overstreet said in an interview. “With all the challenges facing FDA and all they have to do, this seems a little unnecessary,” he said, adding that the industry believes that the AAD and other organizations exaggerate the dangers of UV radiation.

The American Medical Association has continued to support the strengthening of state and local laws to regulate indoor tanning more stringently, including toughening the warnings posted in salons and spas.

Dr. Jessica Krant, an AMA alternate delegate representing the American Society for Dermatologic Surgery, said that passage of the bill means that Congress recognizes that teenagers still are being exposed to unnecessary risks from tanning. “I think it's the first step and a very good and important change,” she said in an interview.

But the AMA and the ASDS both feel that the current warnings—created in the 1970s—need to be updated and placed more prominently in tanning beds, said Dr. Krant, also of State University of New York, Brooklyn.

It is estimated that 25–30 million Americans are indoor tanners, and 2.3 million of these are teenagers. ©Dragan Trifunovic/Fotolia.com

The number of students entering medical school this fall—17,759—is the largest ever, according to the Association of American Medical Colleges.

While that number represents only a 2.3% increase from the previous year, there was an 8% increase in applicants, with 42,300 seeking to enter medical school in 2007. It was the fourth consecutive year in which the number of applicants was on the rise, after a 6-year decline.

In a briefing with reporters, AAMC President Darrell G. Kirch said that the continuing increase in applicants and enrollees shows “that the interest in medicine runs very strong in our country.”

Applicants and enrollees are more diverse than ever, according to the AAMC. While the number of applicants who identified themselves as white or white combined with another ethnicity—26,916—still dwarfs other races, there was an increase in the number of minority applicants. There were 2,999 applicants who identified themselves as Latino or Hispanic alone or in combination with another race, 3,471 African American/combination applicants, and 9,225 Asian/combination applicants.

The number of black and Hispanic male applicants rose by 9.2%, which was larger than the growth of the overall applicant pool, according to the AAMC. Ultimately, black male acceptance and enrollment increased by 5.3%, and Hispanic male acceptance remained even with 2006 levels.

There was an almost-even split among men and women applicants and enrollees. Men slightly edged out women, accounting for 51% of applicants and 51.7% of enrollees.

Eleven of the 126 medical schools increased class size by more than 10%: Michigan State University (47% increase), Texas A&M University System (24%), University of Arizona (22%), Florida State University (19%), Emory University (14%), Mount Sinai School of Medicine (14%), University of California, Davis (13%), Joan C. Edwards School of Medicine at Marshall University (12%), and Drexel University, Howard University, and University of Minnesota (10% each). Some of the increase in enrollment came through added capacity—both Michigan State and Arizona opened additional campuses.

Six universities are currently seeking accreditation for a medical school, said Dr. Kirch.

The rise in applicants and enrollment represents some light at the end of the tunnel, he said. The AAMC and other organizations have warned of looming physician shortages. Depending on the estimates used, there will be a shortfall of 55,000-90,000 physicians across all specialties by 2020.

The AAMC has pushed for a 30% increase in enrollment by 2015, said Dr. Kirch. He acknowledged that it can be difficult to accurately predict shortages, noting that medical school enrollment has waxed and waned over the years.

Even so, despite the many current challenges of being a physician—including a patchwork health care system and unpredictable reimbursement picture—it's still seen as an attractive career choice, Dr. Kirch said. “What I think is most striking here is to see the draw that medicine still has despite those environmental forces,” he said. “I personally view this as a reflection that there are few careers that can be as meaningful, as fulfilling as pursuing medicine,” he added.

The number of students entering medical school this fall—17,759—is the largest ever, according to the Association of American Medical Colleges.

While that number represents only a 2.3% increase from the previous year, there was an 8% increase in applicants, with 42,300 seeking to enter medical school in 2007. It was the fourth consecutive year in which the number of applicants was on the rise, after a 6-year decline.

In a briefing with reporters, AAMC President Darrell G. Kirch said that the continuing increase in applicants and enrollees shows “that the interest in medicine runs very strong in our country.”

Applicants and enrollees are more diverse than ever, according to the AAMC. While the number of applicants who identified themselves as white or white combined with another ethnicity—26,916—still dwarfs other races, there was an increase in the number of minority applicants. There were 2,999 applicants who identified themselves as Latino or Hispanic alone or in combination with another race, 3,471 African American/combination applicants, and 9,225 Asian/combination applicants.

The number of black and Hispanic male applicants rose by 9.2%, which was larger than the growth of the overall applicant pool, according to the AAMC. Ultimately, black male acceptance and enrollment increased by 5.3%, and Hispanic male acceptance remained even with 2006 levels.

There was an almost-even split among men and women applicants and enrollees. Men slightly edged out women, accounting for 51% of applicants and 51.7% of enrollees.

Eleven of the 126 medical schools increased class size by more than 10%: Michigan State University (47% increase), Texas A&M University System (24%), University of Arizona (22%), Florida State University (19%), Emory University (14%), Mount Sinai School of Medicine (14%), University of California, Davis (13%), Joan C. Edwards School of Medicine at Marshall University (12%), and Drexel University, Howard University, and University of Minnesota (10% each). Some of the increase in enrollment came through added capacity—both Michigan State and Arizona opened additional campuses.

Six universities are currently seeking accreditation for a medical school, said Dr. Kirch.

The rise in applicants and enrollment represents some light at the end of the tunnel, he said. The AAMC and other organizations have warned of looming physician shortages. Depending on the estimates used, there will be a shortfall of 55,000-90,000 physicians across all specialties by 2020.

The AAMC has pushed for a 30% increase in enrollment by 2015, said Dr. Kirch. He acknowledged that it can be difficult to accurately predict shortages, noting that medical school enrollment has waxed and waned over the years.

Even so, despite the many current challenges of being a physician—including a patchwork health care system and unpredictable reimbursement picture—it's still seen as an attractive career choice, Dr. Kirch said. “What I think is most striking here is to see the draw that medicine still has despite those environmental forces,” he said. “I personally view this as a reflection that there are few careers that can be as meaningful, as fulfilling as pursuing medicine,” he added.

The number of students entering medical school this fall—17,759—is the largest ever, according to the Association of American Medical Colleges.

While that number represents only a 2.3% increase from the previous year, there was an 8% increase in applicants, with 42,300 seeking to enter medical school in 2007. It was the fourth consecutive year in which the number of applicants was on the rise, after a 6-year decline.

In a briefing with reporters, AAMC President Darrell G. Kirch said that the continuing increase in applicants and enrollees shows “that the interest in medicine runs very strong in our country.”

Applicants and enrollees are more diverse than ever, according to the AAMC. While the number of applicants who identified themselves as white or white combined with another ethnicity—26,916—still dwarfs other races, there was an increase in the number of minority applicants. There were 2,999 applicants who identified themselves as Latino or Hispanic alone or in combination with another race, 3,471 African American/combination applicants, and 9,225 Asian/combination applicants.

The number of black and Hispanic male applicants rose by 9.2%, which was larger than the growth of the overall applicant pool, according to the AAMC. Ultimately, black male acceptance and enrollment increased by 5.3%, and Hispanic male acceptance remained even with 2006 levels.

There was an almost-even split among men and women applicants and enrollees. Men slightly edged out women, accounting for 51% of applicants and 51.7% of enrollees.

Eleven of the 126 medical schools increased class size by more than 10%: Michigan State University (47% increase), Texas A&M University System (24%), University of Arizona (22%), Florida State University (19%), Emory University (14%), Mount Sinai School of Medicine (14%), University of California, Davis (13%), Joan C. Edwards School of Medicine at Marshall University (12%), and Drexel University, Howard University, and University of Minnesota (10% each). Some of the increase in enrollment came through added capacity—both Michigan State and Arizona opened additional campuses.

Six universities are currently seeking accreditation for a medical school, said Dr. Kirch.

The rise in applicants and enrollment represents some light at the end of the tunnel, he said. The AAMC and other organizations have warned of looming physician shortages. Depending on the estimates used, there will be a shortfall of 55,000-90,000 physicians across all specialties by 2020.

The AAMC has pushed for a 30% increase in enrollment by 2015, said Dr. Kirch. He acknowledged that it can be difficult to accurately predict shortages, noting that medical school enrollment has waxed and waned over the years.

Even so, despite the many current challenges of being a physician—including a patchwork health care system and unpredictable reimbursement picture—it's still seen as an attractive career choice, Dr. Kirch said. “What I think is most striking here is to see the draw that medicine still has despite those environmental forces,” he said. “I personally view this as a reflection that there are few careers that can be as meaningful, as fulfilling as pursuing medicine,” he added.

President Bush has signed into law legislation that reauthorizes the Food and Drug Administration's collection of product review fees from drug and device makers, and gives the agency new safety monitoring and enforcement powers.

The new law—which allows for collection of fees through 2012—will impact much of the agency's mission for years beyond that date.

The law “will clarify and strengthen the FDA's authority and give it new tools to take measured and appropriate steps to protect the health and safety of Americans when the agency's postmarket surveillance signals potential dangers from a drug or therapy,” said Sen. Mike Enzi (R-Wyo.) who helped steer the bill through its unanimous victory in the Senate.

The almost-500-page law—known as the Food and Drug Administration Amendments Act of 2007—covers far more than just user fees; it also gives the FDA new authority to ensure that drug and device makers study their products in children, to use a burgeoning collection of electronic data in the private sector to track adverse events, to monitor the content of direct-to-consumer advertising, to track recalls of medical devices, to ensure the safety of seafood and pet food, and to weed out conflict-of-interest among outside advisory committees.

The user fees have become central to the agency's operations, providing about 25% of the FDA's annual budget; thus, they “are vitally important to the agency and its continued ability to protect and promote the public health,” said FDA Commissioner Dr. Andrew von Eschenbach in a statement after the bill passed both the House and Senate.

The law would give the FDA almost $400 million in fiscal 2008 and in each of the next 4 years for review of medical devices and drugs, and at least $50 million for enhanced safety monitoring, according to Sen. Edward Kennedy (D-Mass.), who toiled with Sen. Enzi to craft a compromise with the House-passed legislation.

The agency has an “urgent need for these funds,” said Sen. Kennedy in a statement. “Since 1990, the number of adverse events submitted to the FDA has increased by over 1,300%, but the agency's resources have increased only 130%.”

The new law seeks to increase FDA accountability in many ways. In a much-anticipated move, Congress expanded the agency's authority to require drug and device makers to disclose clinical trial data to the public. The aim is for consumers to be able to search a clinical trials registry for basic information on the trial's purpose, where it's being conducted, and its outcomes goals, but also—if it is an FDA-approved product—on whether it succeeded or failed, and whether the intervention has been the subject of FDA safety inquiries or warnings, or any other public health advisories. The law also gives FDA the power to levy civil fines on manufacturers if they do not submit the data according to established deadlines.

The agency, working with the National Institutes of Health, will phase in the system, said Dr. Janet Woodcock, FDA Deputy Commissioner and Chief Medical Officer, in a briefing with reporters.

Some in Congress also had hoped to require a risk evaluation and mitigation strategy to be implemented for most newly approved drugs. Currently, only a handful of drugs are subject to these strictures, most notably isotretinoin and thalidomide.

Under the new law, the FDA will be given leeway to decide when such programs are necessary and what form they will take. Companies that do not comply can be fined up to $1 million. The agency also will have more power to order postmarketing clinical trials.

It is not clear yet whether FDA will have to issue rules to implement these new powers, FDA Deputy Commissioner for Policy Randall Lutter told reporters.

On the device side, in addition to user fees for product reviews, the law also directs Congress to appropriate $7–$8 million annually for collecting, developing, reviewing, and evaluating postmarket safety information.

For the first time, the FDA also will collect fees from drug or device makers who voluntarily submit direct-to-consumer television advertisements for prebroadcast review.

Finally, the new law seeks to prevent outside advisory committee members with conflicts of interest from participating in deliberations on drugs or devices. A panelist would be barred if he or she has a financial interest that would be affected. However, the FDA commissioner will have the power to grant waiver in a variety of situations.

President Bush has signed into law legislation that reauthorizes the Food and Drug Administration's collection of product review fees from drug and device makers, and gives the agency new safety monitoring and enforcement powers.

The new law—which allows for collection of fees through 2012—will impact much of the agency's mission for years beyond that date.

The law “will clarify and strengthen the FDA's authority and give it new tools to take measured and appropriate steps to protect the health and safety of Americans when the agency's postmarket surveillance signals potential dangers from a drug or therapy,” said Sen. Mike Enzi (R-Wyo.) who helped steer the bill through its unanimous victory in the Senate.

The almost-500-page law—known as the Food and Drug Administration Amendments Act of 2007—covers far more than just user fees; it also gives the FDA new authority to ensure that drug and device makers study their products in children, to use a burgeoning collection of electronic data in the private sector to track adverse events, to monitor the content of direct-to-consumer advertising, to track recalls of medical devices, to ensure the safety of seafood and pet food, and to weed out conflict-of-interest among outside advisory committees.

The user fees have become central to the agency's operations, providing about 25% of the FDA's annual budget; thus, they “are vitally important to the agency and its continued ability to protect and promote the public health,” said FDA Commissioner Dr. Andrew von Eschenbach in a statement after the bill passed both the House and Senate.

The law would give the FDA almost $400 million in fiscal 2008 and in each of the next 4 years for review of medical devices and drugs, and at least $50 million for enhanced safety monitoring, according to Sen. Edward Kennedy (D-Mass.), who toiled with Sen. Enzi to craft a compromise with the House-passed legislation.

The agency has an “urgent need for these funds,” said Sen. Kennedy in a statement. “Since 1990, the number of adverse events submitted to the FDA has increased by over 1,300%, but the agency's resources have increased only 130%.”

The new law seeks to increase FDA accountability in many ways. In a much-anticipated move, Congress expanded the agency's authority to require drug and device makers to disclose clinical trial data to the public. The aim is for consumers to be able to search a clinical trials registry for basic information on the trial's purpose, where it's being conducted, and its outcomes goals, but also—if it is an FDA-approved product—on whether it succeeded or failed, and whether the intervention has been the subject of FDA safety inquiries or warnings, or any other public health advisories. The law also gives FDA the power to levy civil fines on manufacturers if they do not submit the data according to established deadlines.

The agency, working with the National Institutes of Health, will phase in the system, said Dr. Janet Woodcock, FDA Deputy Commissioner and Chief Medical Officer, in a briefing with reporters.

Some in Congress also had hoped to require a risk evaluation and mitigation strategy to be implemented for most newly approved drugs. Currently, only a handful of drugs are subject to these strictures, most notably isotretinoin and thalidomide.

Under the new law, the FDA will be given leeway to decide when such programs are necessary and what form they will take. Companies that do not comply can be fined up to $1 million. The agency also will have more power to order postmarketing clinical trials.

It is not clear yet whether FDA will have to issue rules to implement these new powers, FDA Deputy Commissioner for Policy Randall Lutter told reporters.

On the device side, in addition to user fees for product reviews, the law also directs Congress to appropriate $7–$8 million annually for collecting, developing, reviewing, and evaluating postmarket safety information.

For the first time, the FDA also will collect fees from drug or device makers who voluntarily submit direct-to-consumer television advertisements for prebroadcast review.

Finally, the new law seeks to prevent outside advisory committee members with conflicts of interest from participating in deliberations on drugs or devices. A panelist would be barred if he or she has a financial interest that would be affected. However, the FDA commissioner will have the power to grant waiver in a variety of situations.

President Bush has signed into law legislation that reauthorizes the Food and Drug Administration's collection of product review fees from drug and device makers, and gives the agency new safety monitoring and enforcement powers.

The new law—which allows for collection of fees through 2012—will impact much of the agency's mission for years beyond that date.

The law “will clarify and strengthen the FDA's authority and give it new tools to take measured and appropriate steps to protect the health and safety of Americans when the agency's postmarket surveillance signals potential dangers from a drug or therapy,” said Sen. Mike Enzi (R-Wyo.) who helped steer the bill through its unanimous victory in the Senate.

The almost-500-page law—known as the Food and Drug Administration Amendments Act of 2007—covers far more than just user fees; it also gives the FDA new authority to ensure that drug and device makers study their products in children, to use a burgeoning collection of electronic data in the private sector to track adverse events, to monitor the content of direct-to-consumer advertising, to track recalls of medical devices, to ensure the safety of seafood and pet food, and to weed out conflict-of-interest among outside advisory committees.

The user fees have become central to the agency's operations, providing about 25% of the FDA's annual budget; thus, they “are vitally important to the agency and its continued ability to protect and promote the public health,” said FDA Commissioner Dr. Andrew von Eschenbach in a statement after the bill passed both the House and Senate.

The law would give the FDA almost $400 million in fiscal 2008 and in each of the next 4 years for review of medical devices and drugs, and at least $50 million for enhanced safety monitoring, according to Sen. Edward Kennedy (D-Mass.), who toiled with Sen. Enzi to craft a compromise with the House-passed legislation.

The agency has an “urgent need for these funds,” said Sen. Kennedy in a statement. “Since 1990, the number of adverse events submitted to the FDA has increased by over 1,300%, but the agency's resources have increased only 130%.”

The new law seeks to increase FDA accountability in many ways. In a much-anticipated move, Congress expanded the agency's authority to require drug and device makers to disclose clinical trial data to the public. The aim is for consumers to be able to search a clinical trials registry for basic information on the trial's purpose, where it's being conducted, and its outcomes goals, but also—if it is an FDA-approved product—on whether it succeeded or failed, and whether the intervention has been the subject of FDA safety inquiries or warnings, or any other public health advisories. The law also gives FDA the power to levy civil fines on manufacturers if they do not submit the data according to established deadlines.

The agency, working with the National Institutes of Health, will phase in the system, said Dr. Janet Woodcock, FDA Deputy Commissioner and Chief Medical Officer, in a briefing with reporters.

Some in Congress also had hoped to require a risk evaluation and mitigation strategy to be implemented for most newly approved drugs. Currently, only a handful of drugs are subject to these strictures, most notably isotretinoin and thalidomide.

Under the new law, the FDA will be given leeway to decide when such programs are necessary and what form they will take. Companies that do not comply can be fined up to $1 million. The agency also will have more power to order postmarketing clinical trials.

It is not clear yet whether FDA will have to issue rules to implement these new powers, FDA Deputy Commissioner for Policy Randall Lutter told reporters.

On the device side, in addition to user fees for product reviews, the law also directs Congress to appropriate $7–$8 million annually for collecting, developing, reviewing, and evaluating postmarket safety information.

For the first time, the FDA also will collect fees from drug or device makers who voluntarily submit direct-to-consumer television advertisements for prebroadcast review.

Finally, the new law seeks to prevent outside advisory committee members with conflicts of interest from participating in deliberations on drugs or devices. A panelist would be barred if he or she has a financial interest that would be affected. However, the FDA commissioner will have the power to grant waiver in a variety of situations.

The Centers for Medicare and Medicaid Services will increase payments for outpatient services by an average of 3.8% in 2008, with most of the neurologic, cardiac, and gynecologic procedures covered under the payment system being slated for small to moderate increases.

Overall, hospitals will be paid about $36 billion in 2008, a 10% increase from 2007, and $1 billion more than was estimated in the proposed outpatient rule, according to CMS.

Some neurologic device implant procedures will see a reimbursement increase. Neurostimulators, used primarily for lessening of symptoms of movement disorders such as Parkinson's disease and essential tremor, as well as control of epilepsy and pain, are slated for a 3.1% increase. The electrodes required with the devices will see a 3.4% rise in payment.

The changes aren't substantial enough to have any impact on the numbers of these procedures being done, said Dr. Rajesh Pahwa, director of the Parkinson's Disease and Movement Disorder Center at the University of Kansas, Kansas City, who called the increases “modest.” “My guess would be less than 5% of the patients with those conditions undergo stimulator implants,” he said.

Other neurological devices, which Dr. Pahwa said “might include shunts for hydrocephalus,” for example, will get a 37.4% rate increase, according to the document.

The 2008 Hospital Outpatient Prospective Payment System final rule also includes a revised method of paying for services in ambulatory surgical centers (ASCs). Starting in 2008, services performed in ASCs will be reimbursed at 65% of the rate paid for the same service in an outpatient hospital department. This rate is unchanged from the proposed rule.

“The revised system takes a major step toward eliminating financial incentives for choosing one care setting over another, thereby placing patients' needs first, increasing efficiencies, and leading to savings for both beneficiaries and the Medicare program,” said CMS Acting Administrator Kerry Weems.

Hospitals will be required to report on seven quality measures, including five emergency department measures pertaining to transfer of acute myocardial infarction patients, and two surgical care improvement measures. Under the proposed rule, hospitals were going to be required to report on 10 measures. Three were dropped in the final rule: administration of an ACE inhibitor to heart failure patients, empiric antibiotics for community-acquired pneumonia, and hemoglobin A1c control. Now, if hospitals do not report on the seven measures, they will get an automatic 2% reduction in inpatient pay in 2009, according to CMS.

CMS also said it was issuing three new composite ambulatory payment classification (APC) groups. The APC bundles frequently performed procedures together into a single payment, thus creating an episode-of-care-based payment. The new APCs in the final rule are for extended outpatient visits with observation, low dose-rate prostate brachytherapy, and cardiac electrophysiologic evaluation and ablation.

The agency is continuing its policy of bundling payments for certain ancillary services, to create efficiencies and to give hospitals more flexibility to manage costs. Among the services that will now be covered by a bundled payment: image processing services, intraoperative services, imaging supervision and interpretation services, diagnostic radiopharmaceuticals, contrast agents, and observation services.

Dr. Kim Allan Williams, nuclear cardiology director at the University of Chicago, said that bundled payments can often mean that a service is not properly reimbursed. But under the outpatient payment system, CMS has found a way to make sure that every service is appropriately covered, said Dr. Williams in an interview.

Most cardiac procedures are slated for an increase–from a modest 1.9% for pacemaker insertion or replacement, to 5.2% for bare metal stents, to 13.3% for drug-eluting stents. Implantation of left ventricular pacing leads (add-on) will be cut by 12.4%, but that comes on the heels of 3 years of 80%–180% increases.

And for gynecologic procedures, endometrial ablation will get a 17.9% increase in pay, and surgical hysteroscopy a 4.2% increase.

The Centers for Medicare and Medicaid Services will increase payments for outpatient services by an average of 3.8% in 2008, with most of the neurologic, cardiac, and gynecologic procedures covered under the payment system being slated for small to moderate increases.

Overall, hospitals will be paid about $36 billion in 2008, a 10% increase from 2007, and $1 billion more than was estimated in the proposed outpatient rule, according to CMS.

Some neurologic device implant procedures will see a reimbursement increase. Neurostimulators, used primarily for lessening of symptoms of movement disorders such as Parkinson's disease and essential tremor, as well as control of epilepsy and pain, are slated for a 3.1% increase. The electrodes required with the devices will see a 3.4% rise in payment.

The changes aren't substantial enough to have any impact on the numbers of these procedures being done, said Dr. Rajesh Pahwa, director of the Parkinson's Disease and Movement Disorder Center at the University of Kansas, Kansas City, who called the increases “modest.” “My guess would be less than 5% of the patients with those conditions undergo stimulator implants,” he said.

Other neurological devices, which Dr. Pahwa said “might include shunts for hydrocephalus,” for example, will get a 37.4% rate increase, according to the document.

The 2008 Hospital Outpatient Prospective Payment System final rule also includes a revised method of paying for services in ambulatory surgical centers (ASCs). Starting in 2008, services performed in ASCs will be reimbursed at 65% of the rate paid for the same service in an outpatient hospital department. This rate is unchanged from the proposed rule.

“The revised system takes a major step toward eliminating financial incentives for choosing one care setting over another, thereby placing patients' needs first, increasing efficiencies, and leading to savings for both beneficiaries and the Medicare program,” said CMS Acting Administrator Kerry Weems.

Hospitals will be required to report on seven quality measures, including five emergency department measures pertaining to transfer of acute myocardial infarction patients, and two surgical care improvement measures. Under the proposed rule, hospitals were going to be required to report on 10 measures. Three were dropped in the final rule: administration of an ACE inhibitor to heart failure patients, empiric antibiotics for community-acquired pneumonia, and hemoglobin A1c control. Now, if hospitals do not report on the seven measures, they will get an automatic 2% reduction in inpatient pay in 2009, according to CMS.

CMS also said it was issuing three new composite ambulatory payment classification (APC) groups. The APC bundles frequently performed procedures together into a single payment, thus creating an episode-of-care-based payment. The new APCs in the final rule are for extended outpatient visits with observation, low dose-rate prostate brachytherapy, and cardiac electrophysiologic evaluation and ablation.

The agency is continuing its policy of bundling payments for certain ancillary services, to create efficiencies and to give hospitals more flexibility to manage costs. Among the services that will now be covered by a bundled payment: image processing services, intraoperative services, imaging supervision and interpretation services, diagnostic radiopharmaceuticals, contrast agents, and observation services.

Dr. Kim Allan Williams, nuclear cardiology director at the University of Chicago, said that bundled payments can often mean that a service is not properly reimbursed. But under the outpatient payment system, CMS has found a way to make sure that every service is appropriately covered, said Dr. Williams in an interview.

Most cardiac procedures are slated for an increase–from a modest 1.9% for pacemaker insertion or replacement, to 5.2% for bare metal stents, to 13.3% for drug-eluting stents. Implantation of left ventricular pacing leads (add-on) will be cut by 12.4%, but that comes on the heels of 3 years of 80%–180% increases.

And for gynecologic procedures, endometrial ablation will get a 17.9% increase in pay, and surgical hysteroscopy a 4.2% increase.

The Centers for Medicare and Medicaid Services will increase payments for outpatient services by an average of 3.8% in 2008, with most of the neurologic, cardiac, and gynecologic procedures covered under the payment system being slated for small to moderate increases.

Overall, hospitals will be paid about $36 billion in 2008, a 10% increase from 2007, and $1 billion more than was estimated in the proposed outpatient rule, according to CMS.

Some neurologic device implant procedures will see a reimbursement increase. Neurostimulators, used primarily for lessening of symptoms of movement disorders such as Parkinson's disease and essential tremor, as well as control of epilepsy and pain, are slated for a 3.1% increase. The electrodes required with the devices will see a 3.4% rise in payment.

The changes aren't substantial enough to have any impact on the numbers of these procedures being done, said Dr. Rajesh Pahwa, director of the Parkinson's Disease and Movement Disorder Center at the University of Kansas, Kansas City, who called the increases “modest.” “My guess would be less than 5% of the patients with those conditions undergo stimulator implants,” he said.

Other neurological devices, which Dr. Pahwa said “might include shunts for hydrocephalus,” for example, will get a 37.4% rate increase, according to the document.

The 2008 Hospital Outpatient Prospective Payment System final rule also includes a revised method of paying for services in ambulatory surgical centers (ASCs). Starting in 2008, services performed in ASCs will be reimbursed at 65% of the rate paid for the same service in an outpatient hospital department. This rate is unchanged from the proposed rule.

“The revised system takes a major step toward eliminating financial incentives for choosing one care setting over another, thereby placing patients' needs first, increasing efficiencies, and leading to savings for both beneficiaries and the Medicare program,” said CMS Acting Administrator Kerry Weems.

Hospitals will be required to report on seven quality measures, including five emergency department measures pertaining to transfer of acute myocardial infarction patients, and two surgical care improvement measures. Under the proposed rule, hospitals were going to be required to report on 10 measures. Three were dropped in the final rule: administration of an ACE inhibitor to heart failure patients, empiric antibiotics for community-acquired pneumonia, and hemoglobin A1c control. Now, if hospitals do not report on the seven measures, they will get an automatic 2% reduction in inpatient pay in 2009, according to CMS.

CMS also said it was issuing three new composite ambulatory payment classification (APC) groups. The APC bundles frequently performed procedures together into a single payment, thus creating an episode-of-care-based payment. The new APCs in the final rule are for extended outpatient visits with observation, low dose-rate prostate brachytherapy, and cardiac electrophysiologic evaluation and ablation.

The agency is continuing its policy of bundling payments for certain ancillary services, to create efficiencies and to give hospitals more flexibility to manage costs. Among the services that will now be covered by a bundled payment: image processing services, intraoperative services, imaging supervision and interpretation services, diagnostic radiopharmaceuticals, contrast agents, and observation services.

Dr. Kim Allan Williams, nuclear cardiology director at the University of Chicago, said that bundled payments can often mean that a service is not properly reimbursed. But under the outpatient payment system, CMS has found a way to make sure that every service is appropriately covered, said Dr. Williams in an interview.

Most cardiac procedures are slated for an increase–from a modest 1.9% for pacemaker insertion or replacement, to 5.2% for bare metal stents, to 13.3% for drug-eluting stents. Implantation of left ventricular pacing leads (add-on) will be cut by 12.4%, but that comes on the heels of 3 years of 80%–180% increases.

And for gynecologic procedures, endometrial ablation will get a 17.9% increase in pay, and surgical hysteroscopy a 4.2% increase.

Congress and the Bush administration headed back to the negotiating table in October after the House of Representatives failed to override President Bush's veto of the State Children's Health Insurance Program reauthorization legislation.

The House voted 273–156 to override the President's SCHIP veto, but that was 10 votes short of the needed two-thirds majority. The vote was split down party lines, with 229 Democrats and 44 Republicans voting in favor of override, and 154 Republicans and 2 Democrats voting against.

With the failure to overturn the veto, the House took up a new SCHIP package on October 25, voting 265–142 in favor. However, there were no new Republican converts, making it doubtful that the bill would survive another presidential veto. At press time, the Senate was preparing to take up the legislation.

SCHIP expired on Sept. 30, but a continuing resolution ensures that the program is funded through Nov. 16.

Ron Pollack, executive director of Families USA, predicted that compromises would be crafted around the issues that concern the White House, which he calls “myths.” Among those: that the law would cover children in families earning up to $83,000 a year, and that illegal immigrants would be eligible for coverage. These issues led a majority of House Republicans to vote in line with President Bush, he said in an interview.

Dr. Jay E. Berkelhamer, president of the American Academy of Pediatrics, said in a statement that “the rhetoric of those who opposed the legislation to reauthorize SCHIP demonstrated a fundamental misunderstanding of the bill.” He noted that the legislation would have blocked enrollment of many adults and children the White House has considered not eligible, “while still providing states flexibility and financial support for enrollment of up to 4 million low-income eligible children.”

The White House claimed victory after the House failed to override his veto. “As it is clear that this legislation lacks sufficient support to become law, now is the time for Congress to stop playing politics and to join the President in finding common ground to reauthorize this vital program,” according to a statement.

Rep. Charles Rangel (D-N.Y.) said “It is appalling that the administration would declare victory after denying health care to 10 million of the neediest children in America,” he said in a statement.

The White House said it had appointed a team to negotiate with Congress to make sure at least 500,000 children who currently are eligible for SCHIP, but not receiving benefits, would be enrolled in the program.

“If enrolling these children requires more than the 20% funding increase proposed by the President, we will work with Congress to find the necessary money,” according to the White House.

About 6 million children are currently enrolled in SCHIP. The congressional proposal would have increased funding by about $7 billion a year, adding as many as 4 million children to the SCHIP rolls.

The American College of Physicians said it would push for passage of a new bill, but one that would ensure coverage for those additional children. “The current SCHIP formula does not go far enough,” said Dr. David C. Dale, ACP president, in a statement.

The American Medical Association said it was committed to expanding coverage. “The number of uninsured kids has increased by nearly 1 million over the past 2 years, and action must be taken to reverse this growing trend,” said Dr. Edward Langston, AMA board chair, in a statement.

Congress and the Bush administration headed back to the negotiating table in October after the House of Representatives failed to override President Bush's veto of the State Children's Health Insurance Program reauthorization legislation.

The House voted 273–156 to override the President's SCHIP veto, but that was 10 votes short of the needed two-thirds majority. The vote was split down party lines, with 229 Democrats and 44 Republicans voting in favor of override, and 154 Republicans and 2 Democrats voting against.

With the failure to overturn the veto, the House took up a new SCHIP package on October 25, voting 265–142 in favor. However, there were no new Republican converts, making it doubtful that the bill would survive another presidential veto. At press time, the Senate was preparing to take up the legislation.

SCHIP expired on Sept. 30, but a continuing resolution ensures that the program is funded through Nov. 16.

Ron Pollack, executive director of Families USA, predicted that compromises would be crafted around the issues that concern the White House, which he calls “myths.” Among those: that the law would cover children in families earning up to $83,000 a year, and that illegal immigrants would be eligible for coverage. These issues led a majority of House Republicans to vote in line with President Bush, he said in an interview.

Dr. Jay E. Berkelhamer, president of the American Academy of Pediatrics, said in a statement that “the rhetoric of those who opposed the legislation to reauthorize SCHIP demonstrated a fundamental misunderstanding of the bill.” He noted that the legislation would have blocked enrollment of many adults and children the White House has considered not eligible, “while still providing states flexibility and financial support for enrollment of up to 4 million low-income eligible children.”

The White House claimed victory after the House failed to override his veto. “As it is clear that this legislation lacks sufficient support to become law, now is the time for Congress to stop playing politics and to join the President in finding common ground to reauthorize this vital program,” according to a statement.

Rep. Charles Rangel (D-N.Y.) said “It is appalling that the administration would declare victory after denying health care to 10 million of the neediest children in America,” he said in a statement.

The White House said it had appointed a team to negotiate with Congress to make sure at least 500,000 children who currently are eligible for SCHIP, but not receiving benefits, would be enrolled in the program.

“If enrolling these children requires more than the 20% funding increase proposed by the President, we will work with Congress to find the necessary money,” according to the White House.

About 6 million children are currently enrolled in SCHIP. The congressional proposal would have increased funding by about $7 billion a year, adding as many as 4 million children to the SCHIP rolls.

The American College of Physicians said it would push for passage of a new bill, but one that would ensure coverage for those additional children. “The current SCHIP formula does not go far enough,” said Dr. David C. Dale, ACP president, in a statement.

The American Medical Association said it was committed to expanding coverage. “The number of uninsured kids has increased by nearly 1 million over the past 2 years, and action must be taken to reverse this growing trend,” said Dr. Edward Langston, AMA board chair, in a statement.

Congress and the Bush administration headed back to the negotiating table in October after the House of Representatives failed to override President Bush's veto of the State Children's Health Insurance Program reauthorization legislation.

The House voted 273–156 to override the President's SCHIP veto, but that was 10 votes short of the needed two-thirds majority. The vote was split down party lines, with 229 Democrats and 44 Republicans voting in favor of override, and 154 Republicans and 2 Democrats voting against.

With the failure to overturn the veto, the House took up a new SCHIP package on October 25, voting 265–142 in favor. However, there were no new Republican converts, making it doubtful that the bill would survive another presidential veto. At press time, the Senate was preparing to take up the legislation.

SCHIP expired on Sept. 30, but a continuing resolution ensures that the program is funded through Nov. 16.

Ron Pollack, executive director of Families USA, predicted that compromises would be crafted around the issues that concern the White House, which he calls “myths.” Among those: that the law would cover children in families earning up to $83,000 a year, and that illegal immigrants would be eligible for coverage. These issues led a majority of House Republicans to vote in line with President Bush, he said in an interview.

Dr. Jay E. Berkelhamer, president of the American Academy of Pediatrics, said in a statement that “the rhetoric of those who opposed the legislation to reauthorize SCHIP demonstrated a fundamental misunderstanding of the bill.” He noted that the legislation would have blocked enrollment of many adults and children the White House has considered not eligible, “while still providing states flexibility and financial support for enrollment of up to 4 million low-income eligible children.”

The White House claimed victory after the House failed to override his veto. “As it is clear that this legislation lacks sufficient support to become law, now is the time for Congress to stop playing politics and to join the President in finding common ground to reauthorize this vital program,” according to a statement.

Rep. Charles Rangel (D-N.Y.) said “It is appalling that the administration would declare victory after denying health care to 10 million of the neediest children in America,” he said in a statement.

The White House said it had appointed a team to negotiate with Congress to make sure at least 500,000 children who currently are eligible for SCHIP, but not receiving benefits, would be enrolled in the program.

“If enrolling these children requires more than the 20% funding increase proposed by the President, we will work with Congress to find the necessary money,” according to the White House.

About 6 million children are currently enrolled in SCHIP. The congressional proposal would have increased funding by about $7 billion a year, adding as many as 4 million children to the SCHIP rolls.

The American College of Physicians said it would push for passage of a new bill, but one that would ensure coverage for those additional children. “The current SCHIP formula does not go far enough,” said Dr. David C. Dale, ACP president, in a statement.

The American Medical Association said it was committed to expanding coverage. “The number of uninsured kids has increased by nearly 1 million over the past 2 years, and action must be taken to reverse this growing trend,” said Dr. Edward Langston, AMA board chair, in a statement.

Medtronic Sued on ICD Leads

Within a day of Medtronic Inc.'s announcement that it was recalling Sprint Fidelis leads for implantable cardioverter defibrillators, a group of plaintiffs attorneys had filed suit in federal courts in Minneapolis and Puerto Rico on behalf of two patients. But the suit is seeking class action certification and relief for an estimated 100,000 patients. The filing alleges that Medtronic gave false assurances of safety and failed to properly warn physicians, among other claims. The defects in the leads were evident as early as the spring of 2007, according to the filing, which also said that as of July 2007, the Food and Drug Administration had received 1,000 adverse event reports on the Sprint Fidelis leads. More suits are being filed in Florida and California federal courts and in Minnesota state court, although those will be on behalf of individual plaintiffs only, said Hunter J. Shkolnik of Rheingold, Valet, Rheingold, Shkolnik & McCartney LLP in New York, whose firm is one of seven that are party to the initial federal cases against Medtronic. The seven firms—already representing plaintiffs in ICD-related suits—had been investigating reports of faulty leads for 6 months, Mr. Shkolnik said in an interview. Their filings were ready to go before the recall was announced, he said. Medtronic estimates that as many as 280,000 patients have had a Sprint Fidelis lead implanted since its 2004 approval. It has been used with ICDs made by Medtronic, St. Jude Medical Inc., Boston Scientific Corp., and Guidant Corp. (now a division of Boston Scientific). In response to the suits, a company spokesman said that Medtronic had conducted a “very substantial quality evaluation of the product.” And, he added, “no matter how responsibly a manufacturer acts in the course of a product field action, litigation is likely to be filed.”

Framingham Data Opened

The National Institutes of Health are opening up the database from the Framingham Heart Study. The Framingham information is the first to be made available freely to researchers worldwide through the National Heart, Lung, and Blood Institute-funded SHARe database. The database is designed to help researchers make a quicker connection between genetics and disease. “As one of the most comprehensive studies ever undertaken, the Framingham Heart Study will play a vital role in laying the foundation for this vast dataset to help researchers link genes and disease,” said Dr. Elizabeth G. Nabel, NHLBI director, in a statement. The Framingham study began in 1948 and contains data on 9,300 participants over three generations. It includes deidentified clinical and demographic data and results from testing for 550,000 genetic variations, or single nucleotide polymorphisms (SNPs). SHARe (SNP Health Association Resource) will continue to receive new information from Framingham as it is accumulated, and it will also incorporate data from other large studies, according to the NHLBI. Researchers can access SHARe at

http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?id=phs000007

No Cholesterol Tests for 36 Million

About 36 million Americans have never had their cholesterol tested, according to the Agency for Healthcare Research and Quality. Not surprisingly, the uninsured are most likely not to have had a cholesterol check. About one-third of those without insurance aged 20–64 years have never checked their lipid levels. That drops to 22% for people with public insurance and 16% for those with private insurance. The young are least likely to have had a cholesterol check; about 40% of those aged 20–34 years had never had a test, compared with only 2% of those older than age 65. The data come from AHRQ's Medical Expenditure Panel Survey for 2005.

Wal-Mart Expands $4 Generics

Wal-Mart has added 24 medications to its growing list of generic prescription drug products that patients can receive for $4 for a 30-day supply. The prescriptions can be filled at 4,005 Wal-Mart, Sam's Club, and Neighborhood Market pharmacies in the United States. Among the 24 new medications are carvedilol, timolol, and terbinafine. The company also expanded its reproductive drugs offerings. Wal-Mart claims that since its $4 generic program began in the fall of 2006, customers have saved $613 million. The generics represent 40% of all prescriptions filled in the last year. Because of state laws, some of the drugs cost more than $4 in California, Colorado, Hawaii, Minnesota, Montana, Pennsylvania, Tennessee, Wisconsin, and Wyoming.

Chronic Disease: $1 Trillion a Year

Seven chronic diseases—cancer, diabetes, hypertension, stroke, heart disease, pulmonary conditions, and mental illness—have a total impact on the economy of $1.3 trillion annually, including $1.1 trillion in lost productivity, according to a study by the Milken Institute. That figure could be nearly $6 trillion by midcentury, the report said. “By investing in good health, we can add billions of dollars in economic growth in the coming decades,” said Ross C. DeVol, the institute's director of regional economics and principal author of the report. He noted that much of this cost was avoidable. “With moderate improvements in prevention and early intervention, such as reducing the rate of obesity, the savings to the economy would be enormous.” West Virginia, Tennessee, Arkansas, Kentucky, and Mississippi have the highest rates of chronic disease. Utah, Alaska, Colorado, New Mexico, and Arizona have the lowest.

Medtronic Sued on ICD Leads

Within a day of Medtronic Inc.'s announcement that it was recalling Sprint Fidelis leads for implantable cardioverter defibrillators, a group of plaintiffs attorneys had filed suit in federal courts in Minneapolis and Puerto Rico on behalf of two patients. But the suit is seeking class action certification and relief for an estimated 100,000 patients. The filing alleges that Medtronic gave false assurances of safety and failed to properly warn physicians, among other claims. The defects in the leads were evident as early as the spring of 2007, according to the filing, which also said that as of July 2007, the Food and Drug Administration had received 1,000 adverse event reports on the Sprint Fidelis leads. More suits are being filed in Florida and California federal courts and in Minnesota state court, although those will be on behalf of individual plaintiffs only, said Hunter J. Shkolnik of Rheingold, Valet, Rheingold, Shkolnik & McCartney LLP in New York, whose firm is one of seven that are party to the initial federal cases against Medtronic. The seven firms—already representing plaintiffs in ICD-related suits—had been investigating reports of faulty leads for 6 months, Mr. Shkolnik said in an interview. Their filings were ready to go before the recall was announced, he said. Medtronic estimates that as many as 280,000 patients have had a Sprint Fidelis lead implanted since its 2004 approval. It has been used with ICDs made by Medtronic, St. Jude Medical Inc., Boston Scientific Corp., and Guidant Corp. (now a division of Boston Scientific). In response to the suits, a company spokesman said that Medtronic had conducted a “very substantial quality evaluation of the product.” And, he added, “no matter how responsibly a manufacturer acts in the course of a product field action, litigation is likely to be filed.”

Framingham Data Opened

The National Institutes of Health are opening up the database from the Framingham Heart Study. The Framingham information is the first to be made available freely to researchers worldwide through the National Heart, Lung, and Blood Institute-funded SHARe database. The database is designed to help researchers make a quicker connection between genetics and disease. “As one of the most comprehensive studies ever undertaken, the Framingham Heart Study will play a vital role in laying the foundation for this vast dataset to help researchers link genes and disease,” said Dr. Elizabeth G. Nabel, NHLBI director, in a statement. The Framingham study began in 1948 and contains data on 9,300 participants over three generations. It includes deidentified clinical and demographic data and results from testing for 550,000 genetic variations, or single nucleotide polymorphisms (SNPs). SHARe (SNP Health Association Resource) will continue to receive new information from Framingham as it is accumulated, and it will also incorporate data from other large studies, according to the NHLBI. Researchers can access SHARe at

http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?id=phs000007

No Cholesterol Tests for 36 Million

About 36 million Americans have never had their cholesterol tested, according to the Agency for Healthcare Research and Quality. Not surprisingly, the uninsured are most likely not to have had a cholesterol check. About one-third of those without insurance aged 20–64 years have never checked their lipid levels. That drops to 22% for people with public insurance and 16% for those with private insurance. The young are least likely to have had a cholesterol check; about 40% of those aged 20–34 years had never had a test, compared with only 2% of those older than age 65. The data come from AHRQ's Medical Expenditure Panel Survey for 2005.

Wal-Mart Expands $4 Generics

Wal-Mart has added 24 medications to its growing list of generic prescription drug products that patients can receive for $4 for a 30-day supply. The prescriptions can be filled at 4,005 Wal-Mart, Sam's Club, and Neighborhood Market pharmacies in the United States. Among the 24 new medications are carvedilol, timolol, and terbinafine. The company also expanded its reproductive drugs offerings. Wal-Mart claims that since its $4 generic program began in the fall of 2006, customers have saved $613 million. The generics represent 40% of all prescriptions filled in the last year. Because of state laws, some of the drugs cost more than $4 in California, Colorado, Hawaii, Minnesota, Montana, Pennsylvania, Tennessee, Wisconsin, and Wyoming.

Chronic Disease: $1 Trillion a Year

Seven chronic diseases—cancer, diabetes, hypertension, stroke, heart disease, pulmonary conditions, and mental illness—have a total impact on the economy of $1.3 trillion annually, including $1.1 trillion in lost productivity, according to a study by the Milken Institute. That figure could be nearly $6 trillion by midcentury, the report said. “By investing in good health, we can add billions of dollars in economic growth in the coming decades,” said Ross C. DeVol, the institute's director of regional economics and principal author of the report. He noted that much of this cost was avoidable. “With moderate improvements in prevention and early intervention, such as reducing the rate of obesity, the savings to the economy would be enormous.” West Virginia, Tennessee, Arkansas, Kentucky, and Mississippi have the highest rates of chronic disease. Utah, Alaska, Colorado, New Mexico, and Arizona have the lowest.

Medtronic Sued on ICD Leads

Within a day of Medtronic Inc.'s announcement that it was recalling Sprint Fidelis leads for implantable cardioverter defibrillators, a group of plaintiffs attorneys had filed suit in federal courts in Minneapolis and Puerto Rico on behalf of two patients. But the suit is seeking class action certification and relief for an estimated 100,000 patients. The filing alleges that Medtronic gave false assurances of safety and failed to properly warn physicians, among other claims. The defects in the leads were evident as early as the spring of 2007, according to the filing, which also said that as of July 2007, the Food and Drug Administration had received 1,000 adverse event reports on the Sprint Fidelis leads. More suits are being filed in Florida and California federal courts and in Minnesota state court, although those will be on behalf of individual plaintiffs only, said Hunter J. Shkolnik of Rheingold, Valet, Rheingold, Shkolnik & McCartney LLP in New York, whose firm is one of seven that are party to the initial federal cases against Medtronic. The seven firms—already representing plaintiffs in ICD-related suits—had been investigating reports of faulty leads for 6 months, Mr. Shkolnik said in an interview. Their filings were ready to go before the recall was announced, he said. Medtronic estimates that as many as 280,000 patients have had a Sprint Fidelis lead implanted since its 2004 approval. It has been used with ICDs made by Medtronic, St. Jude Medical Inc., Boston Scientific Corp., and Guidant Corp. (now a division of Boston Scientific). In response to the suits, a company spokesman said that Medtronic had conducted a “very substantial quality evaluation of the product.” And, he added, “no matter how responsibly a manufacturer acts in the course of a product field action, litigation is likely to be filed.”

Framingham Data Opened

The National Institutes of Health are opening up the database from the Framingham Heart Study. The Framingham information is the first to be made available freely to researchers worldwide through the National Heart, Lung, and Blood Institute-funded SHARe database. The database is designed to help researchers make a quicker connection between genetics and disease. “As one of the most comprehensive studies ever undertaken, the Framingham Heart Study will play a vital role in laying the foundation for this vast dataset to help researchers link genes and disease,” said Dr. Elizabeth G. Nabel, NHLBI director, in a statement. The Framingham study began in 1948 and contains data on 9,300 participants over three generations. It includes deidentified clinical and demographic data and results from testing for 550,000 genetic variations, or single nucleotide polymorphisms (SNPs). SHARe (SNP Health Association Resource) will continue to receive new information from Framingham as it is accumulated, and it will also incorporate data from other large studies, according to the NHLBI. Researchers can access SHARe at

http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?id=phs000007

No Cholesterol Tests for 36 Million

About 36 million Americans have never had their cholesterol tested, according to the Agency for Healthcare Research and Quality. Not surprisingly, the uninsured are most likely not to have had a cholesterol check. About one-third of those without insurance aged 20–64 years have never checked their lipid levels. That drops to 22% for people with public insurance and 16% for those with private insurance. The young are least likely to have had a cholesterol check; about 40% of those aged 20–34 years had never had a test, compared with only 2% of those older than age 65. The data come from AHRQ's Medical Expenditure Panel Survey for 2005.

Wal-Mart Expands $4 Generics

Wal-Mart has added 24 medications to its growing list of generic prescription drug products that patients can receive for $4 for a 30-day supply. The prescriptions can be filled at 4,005 Wal-Mart, Sam's Club, and Neighborhood Market pharmacies in the United States. Among the 24 new medications are carvedilol, timolol, and terbinafine. The company also expanded its reproductive drugs offerings. Wal-Mart claims that since its $4 generic program began in the fall of 2006, customers have saved $613 million. The generics represent 40% of all prescriptions filled in the last year. Because of state laws, some of the drugs cost more than $4 in California, Colorado, Hawaii, Minnesota, Montana, Pennsylvania, Tennessee, Wisconsin, and Wyoming.

Chronic Disease: $1 Trillion a Year

Seven chronic diseases—cancer, diabetes, hypertension, stroke, heart disease, pulmonary conditions, and mental illness—have a total impact on the economy of $1.3 trillion annually, including $1.1 trillion in lost productivity, according to a study by the Milken Institute. That figure could be nearly $6 trillion by midcentury, the report said. “By investing in good health, we can add billions of dollars in economic growth in the coming decades,” said Ross C. DeVol, the institute's director of regional economics and principal author of the report. He noted that much of this cost was avoidable. “With moderate improvements in prevention and early intervention, such as reducing the rate of obesity, the savings to the economy would be enormous.” West Virginia, Tennessee, Arkansas, Kentucky, and Mississippi have the highest rates of chronic disease. Utah, Alaska, Colorado, New Mexico, and Arizona have the lowest.