Alicia Ault

CHICAGO — In one of the first studies to examine the long-term endocrine effects of gastric bypass surgery, it appears that after a loss in the first year post procedure, bone mineral density recovers in succeeding years, researchers reported at the annual meeting of the Society for Surgery of the Alimentary Tract.

Surgeons at Virginia Commonwealth University in Richmond prospectively collected data on 233 patients who were undergoing gastric bypass surgery. Of those, 82% had a Roux-en-Y procedure, 12% laparoscopically. The average age was 40 years, and the average body mass index was 50 kg/m

Dr. Johnson and his colleagues obtained preoperative bone mineral density (BMD) scans and found that most patients were normal at baseline, and remained at normal levels, even after surgery. Fifteen patients were osteopenic at baseline. Three developed osteopenia at 1 year post procedure. One patient with preoperative osteopenia actually had an increase in BMD after surgery.

At 1 year, for all patients, total forearm BMD decreased by 0.55%, and radius BMD increased by 1.85%. Total hip and lumbar spine BMD declined by 9.27% and 4.53%, respectively. These seem like fairly large decreases, but none of the patients developed osteoporosis during this period, Dr. Johnson said in an interview. The figures suggest a decline in the first year after gastric bypass, but the clinical significance of this is not yet known, he added.

At 2 years, forearm BMD decreased by 3.62%, but radius BMD remained steady. Both total hip and lumbar spine BMD recovered somewhat in the second year after bypass surgery, bringing them to almost the same levels as preoperatively.

At 3 and 4 years after surgery, BMD trended up, but there were too few patients at those time points to determine if the increases were statistically significant, Dr. Johnson said.

About 50%–60% of patients had calcium, parathyroid hormone, and vitamin D levels taken before surgery; all had those elements measured annually thereafter.

The mean serum calcium decreased from 9.8 mg/dL at baseline to 9.2 mg/dL in the first year, and to 8.8 mg/dL in the second year.

The parathyroid hormone level increased after surgery, which was not unexpected, Dr. Johnson said. It rose from 59.7 pg/mL preoperatively to 63.1 pg/mL in the first year, and to 64.7 pg/mL in the second year.

Vitamin D did not show any significant difference from preoperative level to 2 years, though it trended up. All the patients were given vitamin D postoperatively as part of a multivitamin supplement.

Dr. Johnson told attendees that at Virginia Commonwealth University, physicians recommend giving patients 1–1.5 grams of vitamin C and 400 IU of vitamin D daily, and monitoring them for BMD, calcium, parathyroid hormone, and vitamin D on an annual basis.

Although the study backed other reports showing an initial decline in BMD, the clinical significance is unclear, Dr. Johnson said. “We have shown it's not an ongoing process,” he added.

CHICAGO — In one of the first studies to examine the long-term endocrine effects of gastric bypass surgery, it appears that after a loss in the first year post procedure, bone mineral density recovers in succeeding years, researchers reported at the annual meeting of the Society for Surgery of the Alimentary Tract.

Surgeons at Virginia Commonwealth University in Richmond prospectively collected data on 233 patients who were undergoing gastric bypass surgery. Of those, 82% had a Roux-en-Y procedure, 12% laparoscopically. The average age was 40 years, and the average body mass index was 50 kg/m

Dr. Johnson and his colleagues obtained preoperative bone mineral density (BMD) scans and found that most patients were normal at baseline, and remained at normal levels, even after surgery. Fifteen patients were osteopenic at baseline. Three developed osteopenia at 1 year post procedure. One patient with preoperative osteopenia actually had an increase in BMD after surgery.

At 1 year, for all patients, total forearm BMD decreased by 0.55%, and radius BMD increased by 1.85%. Total hip and lumbar spine BMD declined by 9.27% and 4.53%, respectively. These seem like fairly large decreases, but none of the patients developed osteoporosis during this period, Dr. Johnson said in an interview. The figures suggest a decline in the first year after gastric bypass, but the clinical significance of this is not yet known, he added.

At 2 years, forearm BMD decreased by 3.62%, but radius BMD remained steady. Both total hip and lumbar spine BMD recovered somewhat in the second year after bypass surgery, bringing them to almost the same levels as preoperatively.

At 3 and 4 years after surgery, BMD trended up, but there were too few patients at those time points to determine if the increases were statistically significant, Dr. Johnson said.

About 50%–60% of patients had calcium, parathyroid hormone, and vitamin D levels taken before surgery; all had those elements measured annually thereafter.

The mean serum calcium decreased from 9.8 mg/dL at baseline to 9.2 mg/dL in the first year, and to 8.8 mg/dL in the second year.

The parathyroid hormone level increased after surgery, which was not unexpected, Dr. Johnson said. It rose from 59.7 pg/mL preoperatively to 63.1 pg/mL in the first year, and to 64.7 pg/mL in the second year.

Vitamin D did not show any significant difference from preoperative level to 2 years, though it trended up. All the patients were given vitamin D postoperatively as part of a multivitamin supplement.

Dr. Johnson told attendees that at Virginia Commonwealth University, physicians recommend giving patients 1–1.5 grams of vitamin C and 400 IU of vitamin D daily, and monitoring them for BMD, calcium, parathyroid hormone, and vitamin D on an annual basis.

Although the study backed other reports showing an initial decline in BMD, the clinical significance is unclear, Dr. Johnson said. “We have shown it's not an ongoing process,” he added.

CHICAGO — In one of the first studies to examine the long-term endocrine effects of gastric bypass surgery, it appears that after a loss in the first year post procedure, bone mineral density recovers in succeeding years, researchers reported at the annual meeting of the Society for Surgery of the Alimentary Tract.

Surgeons at Virginia Commonwealth University in Richmond prospectively collected data on 233 patients who were undergoing gastric bypass surgery. Of those, 82% had a Roux-en-Y procedure, 12% laparoscopically. The average age was 40 years, and the average body mass index was 50 kg/m

Dr. Johnson and his colleagues obtained preoperative bone mineral density (BMD) scans and found that most patients were normal at baseline, and remained at normal levels, even after surgery. Fifteen patients were osteopenic at baseline. Three developed osteopenia at 1 year post procedure. One patient with preoperative osteopenia actually had an increase in BMD after surgery.

At 1 year, for all patients, total forearm BMD decreased by 0.55%, and radius BMD increased by 1.85%. Total hip and lumbar spine BMD declined by 9.27% and 4.53%, respectively. These seem like fairly large decreases, but none of the patients developed osteoporosis during this period, Dr. Johnson said in an interview. The figures suggest a decline in the first year after gastric bypass, but the clinical significance of this is not yet known, he added.

At 2 years, forearm BMD decreased by 3.62%, but radius BMD remained steady. Both total hip and lumbar spine BMD recovered somewhat in the second year after bypass surgery, bringing them to almost the same levels as preoperatively.

At 3 and 4 years after surgery, BMD trended up, but there were too few patients at those time points to determine if the increases were statistically significant, Dr. Johnson said.

About 50%–60% of patients had calcium, parathyroid hormone, and vitamin D levels taken before surgery; all had those elements measured annually thereafter.

The mean serum calcium decreased from 9.8 mg/dL at baseline to 9.2 mg/dL in the first year, and to 8.8 mg/dL in the second year.

The parathyroid hormone level increased after surgery, which was not unexpected, Dr. Johnson said. It rose from 59.7 pg/mL preoperatively to 63.1 pg/mL in the first year, and to 64.7 pg/mL in the second year.

Vitamin D did not show any significant difference from preoperative level to 2 years, though it trended up. All the patients were given vitamin D postoperatively as part of a multivitamin supplement.

Dr. Johnson told attendees that at Virginia Commonwealth University, physicians recommend giving patients 1–1.5 grams of vitamin C and 400 IU of vitamin D daily, and monitoring them for BMD, calcium, parathyroid hormone, and vitamin D on an annual basis.

Although the study backed other reports showing an initial decline in BMD, the clinical significance is unclear, Dr. Johnson said. “We have shown it's not an ongoing process,” he added.

NEW ORLEANS — Fluorescence-guided surgery with 5-aminolevulinic acid appears to increase progression-free survival in malignant glioma, according to interim results of a multicenter study conducted in Germany, Walter Stummer, M.D., reported at the annual meeting of the American Association of Neurological Surgeons.

Participants in an ongoing study are being randomized to receive 20 mg/kg of 5-aminolevulinic acid (5-ALA) with fluorescence-guided surgery or conventional microsurgery, aided by white light. The German manufacturer Medac GmbH, which makes 5-ALA, designed the study with the researchersd. Eighteen centers are participating in the ALA-Glioma Study Group, said Dr. Stummer, of the University of Düsseldorf, a participating center.

5-ALA causes the accumulation of fluorescent porphyrins in malignant gliomas, which may help surgeons better identify and resect tumors intraoperatively. It is not approved for this use in the United States.

Dr. Stummer reported on the first 270 patients in an intent-to-treat population. (A total of 350 will be in the final analysis.) All patients were given an MRI preoperatively, during surgery, and on days 103, day 7, week 6, and every 3 months after surgery.

The cumulative 6-month progression-free survival rate was 41% for the 5-ALA group, compared with 21% for the control group. The 5-ALA patients had a median survival of 15.2 months, compared with 13.5 months for patients in the control group; however, the trial was not powered to show any difference in overall survival.

Sixty-five percent of postoperative MRIs done on the 5-ALA patients were devoid of residual contrast-enhancing tumor, compared with 36% in the control group (P < .001).

Patients who had less contrast in their MRIs had longer median survival—16 months, compared with 12 months in the control group (P < .001). “This study addresses the basic controversy in neurosurgery on whether maximal cytoreductive therapy of malignant gliomas is of benefit to patients,” said Dr. Stummer in a statement.

Results of the study “demonstrate that fluorescence guidance using 5-ALA enhances resections of malignant gliomas, and that enhanced resections are beneficial by translating into longer progression-free survival,” Dr. Stummer added.

In discussing the study at the meeting, Peter Black, M.D., chief of neurosurgical oncology at Dana-Farber Cancer Institute in Boston, said it provided class I evidence of improved survival.

The study also demonstrated a successful collaboration by the 18 centers, he said.

But, noted Dr. Black, since 5-ALA is not yet approved for this use in the United States, there is still a continuing need for other therapies.

NEW ORLEANS — Fluorescence-guided surgery with 5-aminolevulinic acid appears to increase progression-free survival in malignant glioma, according to interim results of a multicenter study conducted in Germany, Walter Stummer, M.D., reported at the annual meeting of the American Association of Neurological Surgeons.

Participants in an ongoing study are being randomized to receive 20 mg/kg of 5-aminolevulinic acid (5-ALA) with fluorescence-guided surgery or conventional microsurgery, aided by white light. The German manufacturer Medac GmbH, which makes 5-ALA, designed the study with the researchersd. Eighteen centers are participating in the ALA-Glioma Study Group, said Dr. Stummer, of the University of Düsseldorf, a participating center.

5-ALA causes the accumulation of fluorescent porphyrins in malignant gliomas, which may help surgeons better identify and resect tumors intraoperatively. It is not approved for this use in the United States.

Dr. Stummer reported on the first 270 patients in an intent-to-treat population. (A total of 350 will be in the final analysis.) All patients were given an MRI preoperatively, during surgery, and on days 103, day 7, week 6, and every 3 months after surgery.

The cumulative 6-month progression-free survival rate was 41% for the 5-ALA group, compared with 21% for the control group. The 5-ALA patients had a median survival of 15.2 months, compared with 13.5 months for patients in the control group; however, the trial was not powered to show any difference in overall survival.

Sixty-five percent of postoperative MRIs done on the 5-ALA patients were devoid of residual contrast-enhancing tumor, compared with 36% in the control group (P < .001).

Patients who had less contrast in their MRIs had longer median survival—16 months, compared with 12 months in the control group (P < .001). “This study addresses the basic controversy in neurosurgery on whether maximal cytoreductive therapy of malignant gliomas is of benefit to patients,” said Dr. Stummer in a statement.

Results of the study “demonstrate that fluorescence guidance using 5-ALA enhances resections of malignant gliomas, and that enhanced resections are beneficial by translating into longer progression-free survival,” Dr. Stummer added.

In discussing the study at the meeting, Peter Black, M.D., chief of neurosurgical oncology at Dana-Farber Cancer Institute in Boston, said it provided class I evidence of improved survival.

The study also demonstrated a successful collaboration by the 18 centers, he said.

But, noted Dr. Black, since 5-ALA is not yet approved for this use in the United States, there is still a continuing need for other therapies.

NEW ORLEANS — Fluorescence-guided surgery with 5-aminolevulinic acid appears to increase progression-free survival in malignant glioma, according to interim results of a multicenter study conducted in Germany, Walter Stummer, M.D., reported at the annual meeting of the American Association of Neurological Surgeons.

Participants in an ongoing study are being randomized to receive 20 mg/kg of 5-aminolevulinic acid (5-ALA) with fluorescence-guided surgery or conventional microsurgery, aided by white light. The German manufacturer Medac GmbH, which makes 5-ALA, designed the study with the researchersd. Eighteen centers are participating in the ALA-Glioma Study Group, said Dr. Stummer, of the University of Düsseldorf, a participating center.

5-ALA causes the accumulation of fluorescent porphyrins in malignant gliomas, which may help surgeons better identify and resect tumors intraoperatively. It is not approved for this use in the United States.

Dr. Stummer reported on the first 270 patients in an intent-to-treat population. (A total of 350 will be in the final analysis.) All patients were given an MRI preoperatively, during surgery, and on days 103, day 7, week 6, and every 3 months after surgery.

The cumulative 6-month progression-free survival rate was 41% for the 5-ALA group, compared with 21% for the control group. The 5-ALA patients had a median survival of 15.2 months, compared with 13.5 months for patients in the control group; however, the trial was not powered to show any difference in overall survival.

Sixty-five percent of postoperative MRIs done on the 5-ALA patients were devoid of residual contrast-enhancing tumor, compared with 36% in the control group (P < .001).

Patients who had less contrast in their MRIs had longer median survival—16 months, compared with 12 months in the control group (P < .001). “This study addresses the basic controversy in neurosurgery on whether maximal cytoreductive therapy of malignant gliomas is of benefit to patients,” said Dr. Stummer in a statement.

Results of the study “demonstrate that fluorescence guidance using 5-ALA enhances resections of malignant gliomas, and that enhanced resections are beneficial by translating into longer progression-free survival,” Dr. Stummer added.

In discussing the study at the meeting, Peter Black, M.D., chief of neurosurgical oncology at Dana-Farber Cancer Institute in Boston, said it provided class I evidence of improved survival.

The study also demonstrated a successful collaboration by the 18 centers, he said.

But, noted Dr. Black, since 5-ALA is not yet approved for this use in the United States, there is still a continuing need for other therapies.

The Bush administration has focused on overhauling the Social Security program, but the nation's governors and health providers say the real crisis is in Medicaid.

The National Governors Association (NGA) has offered a reform proposal to Congress, which has begun considering what can be done to sustain the program that provides health care for some 53 million impoverished and disabled Americans.

In July, the administration named 13 voting members and 15 nonvoting members to its commission on Medicaid reform. By law, the commission had until Sept. 1 to outline recommendations for cutting &dollar;10 billion from the Medicaid program; a report on long-term solutions for the program is due at year's end.

Former Tennessee Gov. Don Sundquist (R) will chair the commission and former Maine Gov. Angus King (I) will serve as vice chair, the Health and Human Services department announced.

Both the state and federal governments are feeling the squeeze. The program will likely hit &dollar;350 billion overall in 2005.

Medicaid represents 22% of the average state budget, according to testimony given to Congress by Mark Warner, Democratic governor of Virginia and chairman of the NGA.

The problem: a skyrocketing caseload over the last 5 years, combined with rising health care costs, and an increasing number of sicker patients, Gov. Warner pointed out.

The number of enrollees has grown by 40% in that period—at a time when eligibility has often been restricted, except for pregnant women and children, who have made up some of the growth. But there has also been a huge increase in the number of seriously disabled and severely and chronically ill recipients. Although they make up only 25% of the total number of Medicaid recipients, the elderly and disabled account for more than 70% of the budget.

That lopsided spending is seen when the per capita annual expense for various recipients is broken out. According to the Kaiser Family Foundation, Medicaid spends an average of &dollar;1,700 per child, &dollar;1,900 per nondisabled adult under 65 years, &dollar;12,300 per disabled recipient, and &dollar;12,800 per elderly recipient. So-called dual eligibles—those who receive both Medicaid and Med-icare—also are an increasing burden, said Diane Rowland, executive vice president of the Kaiser Family Foundation.

Speaking at the Medicaid Managed Care Conference in Baltimore in June, Ms. Rowland said that dual eligibles make up 14% of the Medicaid population but account for 42% of the program's costs. Medicaid covers prescription drugs, long-term care, acute care, and Medicare premiums for this group.

States have been using a variety of tactics to reduce spending. Forty-eight states now have drug cost controls, 50 have reduced payments to providers, and 21 have begun restricting eligibility and benefits, Ms. Rowland said.

And states have increasingly looked to managed care to decrease costs and improve health, she said, adding that 13 states have 75% of Medicaid recipients in a managed care plan.

In mid-June testimony to the Senate Finance Committee, Gov. Warner outlined NGA's preliminary suggestions for improving Medicaid, mostly by giving states more options.

States would like the power to get increased drug rebates and to encourage the use of more generic drugs.

In a departure, Gov. Warner said that states would also seek to create a tiered system of copays for pharmaceuticals. Asset transfers, designed to “impoverish” people so they can receive Medicaid, should be more widely restricted, Gov. Warner testified.

NGA is also proposing to start requiring recipients to pay a portion of their costs through premiums, deductibles, or copays.

The Bush administration has focused on overhauling the Social Security program, but the nation's governors and health providers say the real crisis is in Medicaid.

The National Governors Association (NGA) has offered a reform proposal to Congress, which has begun considering what can be done to sustain the program that provides health care for some 53 million impoverished and disabled Americans.

In July, the administration named 13 voting members and 15 nonvoting members to its commission on Medicaid reform. By law, the commission had until Sept. 1 to outline recommendations for cutting &dollar;10 billion from the Medicaid program; a report on long-term solutions for the program is due at year's end.

Former Tennessee Gov. Don Sundquist (R) will chair the commission and former Maine Gov. Angus King (I) will serve as vice chair, the Health and Human Services department announced.

Both the state and federal governments are feeling the squeeze. The program will likely hit &dollar;350 billion overall in 2005.

Medicaid represents 22% of the average state budget, according to testimony given to Congress by Mark Warner, Democratic governor of Virginia and chairman of the NGA.

The problem: a skyrocketing caseload over the last 5 years, combined with rising health care costs, and an increasing number of sicker patients, Gov. Warner pointed out.

The number of enrollees has grown by 40% in that period—at a time when eligibility has often been restricted, except for pregnant women and children, who have made up some of the growth. But there has also been a huge increase in the number of seriously disabled and severely and chronically ill recipients. Although they make up only 25% of the total number of Medicaid recipients, the elderly and disabled account for more than 70% of the budget.

That lopsided spending is seen when the per capita annual expense for various recipients is broken out. According to the Kaiser Family Foundation, Medicaid spends an average of &dollar;1,700 per child, &dollar;1,900 per nondisabled adult under 65 years, &dollar;12,300 per disabled recipient, and &dollar;12,800 per elderly recipient. So-called dual eligibles—those who receive both Medicaid and Med-icare—also are an increasing burden, said Diane Rowland, executive vice president of the Kaiser Family Foundation.

Speaking at the Medicaid Managed Care Conference in Baltimore in June, Ms. Rowland said that dual eligibles make up 14% of the Medicaid population but account for 42% of the program's costs. Medicaid covers prescription drugs, long-term care, acute care, and Medicare premiums for this group.

States have been using a variety of tactics to reduce spending. Forty-eight states now have drug cost controls, 50 have reduced payments to providers, and 21 have begun restricting eligibility and benefits, Ms. Rowland said.

And states have increasingly looked to managed care to decrease costs and improve health, she said, adding that 13 states have 75% of Medicaid recipients in a managed care plan.

In mid-June testimony to the Senate Finance Committee, Gov. Warner outlined NGA's preliminary suggestions for improving Medicaid, mostly by giving states more options.

States would like the power to get increased drug rebates and to encourage the use of more generic drugs.

In a departure, Gov. Warner said that states would also seek to create a tiered system of copays for pharmaceuticals. Asset transfers, designed to “impoverish” people so they can receive Medicaid, should be more widely restricted, Gov. Warner testified.

NGA is also proposing to start requiring recipients to pay a portion of their costs through premiums, deductibles, or copays.

The Bush administration has focused on overhauling the Social Security program, but the nation's governors and health providers say the real crisis is in Medicaid.

The National Governors Association (NGA) has offered a reform proposal to Congress, which has begun considering what can be done to sustain the program that provides health care for some 53 million impoverished and disabled Americans.

In July, the administration named 13 voting members and 15 nonvoting members to its commission on Medicaid reform. By law, the commission had until Sept. 1 to outline recommendations for cutting &dollar;10 billion from the Medicaid program; a report on long-term solutions for the program is due at year's end.

Former Tennessee Gov. Don Sundquist (R) will chair the commission and former Maine Gov. Angus King (I) will serve as vice chair, the Health and Human Services department announced.

Both the state and federal governments are feeling the squeeze. The program will likely hit &dollar;350 billion overall in 2005.

Medicaid represents 22% of the average state budget, according to testimony given to Congress by Mark Warner, Democratic governor of Virginia and chairman of the NGA.

The problem: a skyrocketing caseload over the last 5 years, combined with rising health care costs, and an increasing number of sicker patients, Gov. Warner pointed out.

The number of enrollees has grown by 40% in that period—at a time when eligibility has often been restricted, except for pregnant women and children, who have made up some of the growth. But there has also been a huge increase in the number of seriously disabled and severely and chronically ill recipients. Although they make up only 25% of the total number of Medicaid recipients, the elderly and disabled account for more than 70% of the budget.

That lopsided spending is seen when the per capita annual expense for various recipients is broken out. According to the Kaiser Family Foundation, Medicaid spends an average of &dollar;1,700 per child, &dollar;1,900 per nondisabled adult under 65 years, &dollar;12,300 per disabled recipient, and &dollar;12,800 per elderly recipient. So-called dual eligibles—those who receive both Medicaid and Med-icare—also are an increasing burden, said Diane Rowland, executive vice president of the Kaiser Family Foundation.

Speaking at the Medicaid Managed Care Conference in Baltimore in June, Ms. Rowland said that dual eligibles make up 14% of the Medicaid population but account for 42% of the program's costs. Medicaid covers prescription drugs, long-term care, acute care, and Medicare premiums for this group.

States have been using a variety of tactics to reduce spending. Forty-eight states now have drug cost controls, 50 have reduced payments to providers, and 21 have begun restricting eligibility and benefits, Ms. Rowland said.

And states have increasingly looked to managed care to decrease costs and improve health, she said, adding that 13 states have 75% of Medicaid recipients in a managed care plan.

In mid-June testimony to the Senate Finance Committee, Gov. Warner outlined NGA's preliminary suggestions for improving Medicaid, mostly by giving states more options.

States would like the power to get increased drug rebates and to encourage the use of more generic drugs.

In a departure, Gov. Warner said that states would also seek to create a tiered system of copays for pharmaceuticals. Asset transfers, designed to “impoverish” people so they can receive Medicaid, should be more widely restricted, Gov. Warner testified.

NGA is also proposing to start requiring recipients to pay a portion of their costs through premiums, deductibles, or copays.

Shortly after Purdue Pharma announced in July that it was taking its 24-hour opioid Palladone off the market because of a potentially fatal interaction with alcohol, the Food and Drug Administration said it was looking into the possibility that other sustained-release narcotics could pose the same danger.

The Palladone withdrawal (hydromorphone HCL extended release) came at the same time the FDA announced it was investigating whether the transdermal fentanyl patch marketed as Duragesic might be linked to a number of deaths.

“We are investigating 120 deaths that seemingly are related to overdose,” Robert Meyer, M.D., director of the Office of Drug Evaluation II at the Center for Drug Evaluation and Research (CDER), said in a statement.

The FDA actions throw yet another category of painkillers into an uncertain light.

Stamford, Conn.-based Purdue withdrew Palladone just 5 months after it was introduced to a limited number of prescribers. The FDA and the company agreed that testing showed that concomitant use of alcohol could cause a “dosage dump” of the hydromorphone. But there's a difference of opinion on what was known when.

Purdue, which also makes the oft-diverted and abused oxycodone (OxyContin) had conducted several tests to assess Palladone's susceptibility to tampering, spokesman James Heins said in an interview. In the lab, Purdue researchers used various means to cause an instantaneous release of Palladone's contents to produce euphoria. Dissolving capsules in alcohol did just that, Mr. Heins said.

A similar effect was observed when healthy volunteers were given 8 ounces of various proofs of alcohol (all the subjects were given naltrexone as a block).

Data from these studies were given to FDA in November, several months after the drug's approval in September 2004, but before it had been formally launched, he said.

The FDA, however, said those were “preliminary” data, and that a full report was not received until February 2005. With those full data in hand, CDER officials met with Purdue again in May to discuss strengthening Palladone's warnings. But the agency decided that the risk of death from inadvertent concomitant alcohol use was significant enough that even Palladone's strict risk management plan could not prevent potentially serious adverse events or deaths, according to an FDA spokesperson.

“CDER concluded that had it been aware of the alcohol interaction prior to approval, Palladone would not have been approved,” the spokesperson said in an interview.

The Purdue tests on Palladone led the agency to consider whether other sustained-release opioids might pose the same risk. Both FDA and the company conducted in vitro testing of currently marketed products. The agency won't say what those tests revealed, but the spokesperson said that based on the results, the FDA has asked “sponsors of certain products” to perform human studies to determine if there is any interaction with alcohol, and when it might occur.

Extended-release product labels already warn against using alcohol simultaneously.

The removal of Palladone does not leave a huge treatment gap, although the new drug was widely anticipated because of its ease of use, said B. Eliot Cole, M.D., executive director of the American Society of Pain Educators. “There are still plenty of other medications, not just opioids, that are useful for pain control, including antidepressants, anticonvulsants, anti-inflammatory agents, and more,” he told this newspaper.

Dr. Cole said warnings already contained in Palladone's label made it clear “that using alcohol with Palladone was a very bad idea.” But he did not disagree with the decision to remove the drug from the market. Dr. Cole participated on an advisory board for Palladone last fall and has been a speaker for Purdue.

Neither Purdue nor the FDA received any reports of serious adverse events or deaths related to Palladone and alcohol use, and Dr. Cole said that he had not heard of any anecdotally, either.

With Duragesic, however, there have been multiple reports of potential overdoses. In June, Janssen, the Johnson & Johnson division that makes and sells Duragesic, notified health professionals that concomitant use with cytochrome P450 3A4 inhibitors could lead to potentially fatal reactions. The company also issued stronger warnings against using Duragesic with alcohol or using patches that were torn.

The FDA issued a public health advisory in July stating that it was investigating deaths related to Duragesic. It urged physicians to educate patients about signs of overdose, proper patch application, and use of other medications while using the patch, as well as proper storage and disposal of the patch. The agency said that initial reviews indicated that unintentional overdoses might be related to use of multiple patches, application of heat to a patch (which might increase fentanyl absorption), injection or ingestion of the patch contents, leaking patches, and accidental exposure to the drug by coming into contact with a discarded patch.

Shortly after Purdue Pharma announced in July that it was taking its 24-hour opioid Palladone off the market because of a potentially fatal interaction with alcohol, the Food and Drug Administration said it was looking into the possibility that other sustained-release narcotics could pose the same danger.

The Palladone withdrawal (hydromorphone HCL extended release) came at the same time the FDA announced it was investigating whether the transdermal fentanyl patch marketed as Duragesic might be linked to a number of deaths.

“We are investigating 120 deaths that seemingly are related to overdose,” Robert Meyer, M.D., director of the Office of Drug Evaluation II at the Center for Drug Evaluation and Research (CDER), said in a statement.

The FDA actions throw yet another category of painkillers into an uncertain light.

Stamford, Conn.-based Purdue withdrew Palladone just 5 months after it was introduced to a limited number of prescribers. The FDA and the company agreed that testing showed that concomitant use of alcohol could cause a “dosage dump” of the hydromorphone. But there's a difference of opinion on what was known when.

Purdue, which also makes the oft-diverted and abused oxycodone (OxyContin) had conducted several tests to assess Palladone's susceptibility to tampering, spokesman James Heins said in an interview. In the lab, Purdue researchers used various means to cause an instantaneous release of Palladone's contents to produce euphoria. Dissolving capsules in alcohol did just that, Mr. Heins said.

A similar effect was observed when healthy volunteers were given 8 ounces of various proofs of alcohol (all the subjects were given naltrexone as a block).

Data from these studies were given to FDA in November, several months after the drug's approval in September 2004, but before it had been formally launched, he said.

The FDA, however, said those were “preliminary” data, and that a full report was not received until February 2005. With those full data in hand, CDER officials met with Purdue again in May to discuss strengthening Palladone's warnings. But the agency decided that the risk of death from inadvertent concomitant alcohol use was significant enough that even Palladone's strict risk management plan could not prevent potentially serious adverse events or deaths, according to an FDA spokesperson.

“CDER concluded that had it been aware of the alcohol interaction prior to approval, Palladone would not have been approved,” the spokesperson said in an interview.

The Purdue tests on Palladone led the agency to consider whether other sustained-release opioids might pose the same risk. Both FDA and the company conducted in vitro testing of currently marketed products. The agency won't say what those tests revealed, but the spokesperson said that based on the results, the FDA has asked “sponsors of certain products” to perform human studies to determine if there is any interaction with alcohol, and when it might occur.

Extended-release product labels already warn against using alcohol simultaneously.

The removal of Palladone does not leave a huge treatment gap, although the new drug was widely anticipated because of its ease of use, said B. Eliot Cole, M.D., executive director of the American Society of Pain Educators. “There are still plenty of other medications, not just opioids, that are useful for pain control, including antidepressants, anticonvulsants, anti-inflammatory agents, and more,” he told this newspaper.

Dr. Cole said warnings already contained in Palladone's label made it clear “that using alcohol with Palladone was a very bad idea.” But he did not disagree with the decision to remove the drug from the market. Dr. Cole participated on an advisory board for Palladone last fall and has been a speaker for Purdue.

Neither Purdue nor the FDA received any reports of serious adverse events or deaths related to Palladone and alcohol use, and Dr. Cole said that he had not heard of any anecdotally, either.

With Duragesic, however, there have been multiple reports of potential overdoses. In June, Janssen, the Johnson & Johnson division that makes and sells Duragesic, notified health professionals that concomitant use with cytochrome P450 3A4 inhibitors could lead to potentially fatal reactions. The company also issued stronger warnings against using Duragesic with alcohol or using patches that were torn.

The FDA issued a public health advisory in July stating that it was investigating deaths related to Duragesic. It urged physicians to educate patients about signs of overdose, proper patch application, and use of other medications while using the patch, as well as proper storage and disposal of the patch. The agency said that initial reviews indicated that unintentional overdoses might be related to use of multiple patches, application of heat to a patch (which might increase fentanyl absorption), injection or ingestion of the patch contents, leaking patches, and accidental exposure to the drug by coming into contact with a discarded patch.

Shortly after Purdue Pharma announced in July that it was taking its 24-hour opioid Palladone off the market because of a potentially fatal interaction with alcohol, the Food and Drug Administration said it was looking into the possibility that other sustained-release narcotics could pose the same danger.

The Palladone withdrawal (hydromorphone HCL extended release) came at the same time the FDA announced it was investigating whether the transdermal fentanyl patch marketed as Duragesic might be linked to a number of deaths.

“We are investigating 120 deaths that seemingly are related to overdose,” Robert Meyer, M.D., director of the Office of Drug Evaluation II at the Center for Drug Evaluation and Research (CDER), said in a statement.

The FDA actions throw yet another category of painkillers into an uncertain light.

Stamford, Conn.-based Purdue withdrew Palladone just 5 months after it was introduced to a limited number of prescribers. The FDA and the company agreed that testing showed that concomitant use of alcohol could cause a “dosage dump” of the hydromorphone. But there's a difference of opinion on what was known when.

Purdue, which also makes the oft-diverted and abused oxycodone (OxyContin) had conducted several tests to assess Palladone's susceptibility to tampering, spokesman James Heins said in an interview. In the lab, Purdue researchers used various means to cause an instantaneous release of Palladone's contents to produce euphoria. Dissolving capsules in alcohol did just that, Mr. Heins said.

A similar effect was observed when healthy volunteers were given 8 ounces of various proofs of alcohol (all the subjects were given naltrexone as a block).

Data from these studies were given to FDA in November, several months after the drug's approval in September 2004, but before it had been formally launched, he said.

The FDA, however, said those were “preliminary” data, and that a full report was not received until February 2005. With those full data in hand, CDER officials met with Purdue again in May to discuss strengthening Palladone's warnings. But the agency decided that the risk of death from inadvertent concomitant alcohol use was significant enough that even Palladone's strict risk management plan could not prevent potentially serious adverse events or deaths, according to an FDA spokesperson.

“CDER concluded that had it been aware of the alcohol interaction prior to approval, Palladone would not have been approved,” the spokesperson said in an interview.

The Purdue tests on Palladone led the agency to consider whether other sustained-release opioids might pose the same risk. Both FDA and the company conducted in vitro testing of currently marketed products. The agency won't say what those tests revealed, but the spokesperson said that based on the results, the FDA has asked “sponsors of certain products” to perform human studies to determine if there is any interaction with alcohol, and when it might occur.

Extended-release product labels already warn against using alcohol simultaneously.

The removal of Palladone does not leave a huge treatment gap, although the new drug was widely anticipated because of its ease of use, said B. Eliot Cole, M.D., executive director of the American Society of Pain Educators. “There are still plenty of other medications, not just opioids, that are useful for pain control, including antidepressants, anticonvulsants, anti-inflammatory agents, and more,” he told this newspaper.

Dr. Cole said warnings already contained in Palladone's label made it clear “that using alcohol with Palladone was a very bad idea.” But he did not disagree with the decision to remove the drug from the market. Dr. Cole participated on an advisory board for Palladone last fall and has been a speaker for Purdue.

Neither Purdue nor the FDA received any reports of serious adverse events or deaths related to Palladone and alcohol use, and Dr. Cole said that he had not heard of any anecdotally, either.

With Duragesic, however, there have been multiple reports of potential overdoses. In June, Janssen, the Johnson & Johnson division that makes and sells Duragesic, notified health professionals that concomitant use with cytochrome P450 3A4 inhibitors could lead to potentially fatal reactions. The company also issued stronger warnings against using Duragesic with alcohol or using patches that were torn.

The FDA issued a public health advisory in July stating that it was investigating deaths related to Duragesic. It urged physicians to educate patients about signs of overdose, proper patch application, and use of other medications while using the patch, as well as proper storage and disposal of the patch. The agency said that initial reviews indicated that unintentional overdoses might be related to use of multiple patches, application of heat to a patch (which might increase fentanyl absorption), injection or ingestion of the patch contents, leaking patches, and accidental exposure to the drug by coming into contact with a discarded patch.

CHICAGO — In one of the first studies to examine the long-term endocrine effects of gastric bypass surgery, it appears that after a loss in the first year post procedure, bone mineral density recovers in succeeding years, researchers reported at the annual meeting of the Society for Surgery of the Alimentary Tract.

Physicians at Virginia Commonwealth University in Richmond prospectively collected data on 233 patients who were undergoing gastric bypass surgery.

Of those, 82% had a Roux-en-Y procedure, 12% laparoscopically. The average age was 40 years, and the average body mass index was 50 kg/m

Dr. Johnson and his colleagues obtained preoperative bone mineral density (BMD) scans and found that most patients were normal at baseline, and remained at normal levels, even after surgery. Fifteen patients were osteopenic at baseline. Three developed osteopenia at 1 year post procedure. One patient with preoperative osteopenia actually had an increase in BMD after surgery.

At 1 year, for all patients, total forearm BMD decreased by 0.55%, and radius BMD increased by 1.85%. Total hip and lumbar spine BMD declined by 9.27% and 4.53%, respectively.

These seem like fairly large decreases, but none of the patients developed osteoporosis during this period, Dr. Johnson told FAMILY PRACTICE NEWS. The figures suggest a decline in the first year after gastric bypass, but the clinical significance of this is not yet known, he added.

At 2 years, forearm BMD decreased by 3.62%, but radius BMD remained steady. Both total hip and lumbar spine BMD recovered somewhat in the second year, bringing them to almost the same levels as preoperatively.

At 3 and 4 years after surgery, BMD trended up, but there were too few patients at those time points to determine if the increases were statistically significant, Dr. Johnson said.

About 50%–60% of patients had calcium, parathyroid hormone, and vitamin D levels taken before surgery; all had those elements measured annually thereafter.

The mean serum calcium decreased from 9.8 mg/dL at baseline to 9.2 mg/dL in the first year and to 8.8 mg/dL in the second year.

The parathyroid hormone level increased after surgery, which was not unexpected, Dr. Johnson said. It rose from 59.7 pg/mL preoperatively to 63.1 pg/mL in the first year and to 64.7 pg/mL in the second year.

Vitamin D showed no significant difference from preoperative level to 2 years, though it trended up. All the patients were given vitamin D postoperatively as part of a multivitamin supplement.

Dr. Johnson told attendees that at Virginia Commonwealth University, physicians recommend giving patients 1–1.5 grams of vitamin C and 400 IU of vitamin D daily, and monitoring them for BMD, calcium, parathyroid hormone, and vitamin D on an annual basis.

It's unclear what happens to bypass patients 5 or 10 years post procedure. So far, the university has not seen a lot of weight regain in its patients, but that could potentially have an impact on BMD, Dr. Johnson said at the meeting.

CHICAGO — In one of the first studies to examine the long-term endocrine effects of gastric bypass surgery, it appears that after a loss in the first year post procedure, bone mineral density recovers in succeeding years, researchers reported at the annual meeting of the Society for Surgery of the Alimentary Tract.

Physicians at Virginia Commonwealth University in Richmond prospectively collected data on 233 patients who were undergoing gastric bypass surgery.

Of those, 82% had a Roux-en-Y procedure, 12% laparoscopically. The average age was 40 years, and the average body mass index was 50 kg/m

Dr. Johnson and his colleagues obtained preoperative bone mineral density (BMD) scans and found that most patients were normal at baseline, and remained at normal levels, even after surgery. Fifteen patients were osteopenic at baseline. Three developed osteopenia at 1 year post procedure. One patient with preoperative osteopenia actually had an increase in BMD after surgery.

At 1 year, for all patients, total forearm BMD decreased by 0.55%, and radius BMD increased by 1.85%. Total hip and lumbar spine BMD declined by 9.27% and 4.53%, respectively.

These seem like fairly large decreases, but none of the patients developed osteoporosis during this period, Dr. Johnson told FAMILY PRACTICE NEWS. The figures suggest a decline in the first year after gastric bypass, but the clinical significance of this is not yet known, he added.

At 2 years, forearm BMD decreased by 3.62%, but radius BMD remained steady. Both total hip and lumbar spine BMD recovered somewhat in the second year, bringing them to almost the same levels as preoperatively.

At 3 and 4 years after surgery, BMD trended up, but there were too few patients at those time points to determine if the increases were statistically significant, Dr. Johnson said.

About 50%–60% of patients had calcium, parathyroid hormone, and vitamin D levels taken before surgery; all had those elements measured annually thereafter.

The mean serum calcium decreased from 9.8 mg/dL at baseline to 9.2 mg/dL in the first year and to 8.8 mg/dL in the second year.

The parathyroid hormone level increased after surgery, which was not unexpected, Dr. Johnson said. It rose from 59.7 pg/mL preoperatively to 63.1 pg/mL in the first year and to 64.7 pg/mL in the second year.

Vitamin D showed no significant difference from preoperative level to 2 years, though it trended up. All the patients were given vitamin D postoperatively as part of a multivitamin supplement.

Dr. Johnson told attendees that at Virginia Commonwealth University, physicians recommend giving patients 1–1.5 grams of vitamin C and 400 IU of vitamin D daily, and monitoring them for BMD, calcium, parathyroid hormone, and vitamin D on an annual basis.

It's unclear what happens to bypass patients 5 or 10 years post procedure. So far, the university has not seen a lot of weight regain in its patients, but that could potentially have an impact on BMD, Dr. Johnson said at the meeting.

CHICAGO — In one of the first studies to examine the long-term endocrine effects of gastric bypass surgery, it appears that after a loss in the first year post procedure, bone mineral density recovers in succeeding years, researchers reported at the annual meeting of the Society for Surgery of the Alimentary Tract.

Physicians at Virginia Commonwealth University in Richmond prospectively collected data on 233 patients who were undergoing gastric bypass surgery.

Of those, 82% had a Roux-en-Y procedure, 12% laparoscopically. The average age was 40 years, and the average body mass index was 50 kg/m

Dr. Johnson and his colleagues obtained preoperative bone mineral density (BMD) scans and found that most patients were normal at baseline, and remained at normal levels, even after surgery. Fifteen patients were osteopenic at baseline. Three developed osteopenia at 1 year post procedure. One patient with preoperative osteopenia actually had an increase in BMD after surgery.

At 1 year, for all patients, total forearm BMD decreased by 0.55%, and radius BMD increased by 1.85%. Total hip and lumbar spine BMD declined by 9.27% and 4.53%, respectively.

These seem like fairly large decreases, but none of the patients developed osteoporosis during this period, Dr. Johnson told FAMILY PRACTICE NEWS. The figures suggest a decline in the first year after gastric bypass, but the clinical significance of this is not yet known, he added.

At 2 years, forearm BMD decreased by 3.62%, but radius BMD remained steady. Both total hip and lumbar spine BMD recovered somewhat in the second year, bringing them to almost the same levels as preoperatively.

At 3 and 4 years after surgery, BMD trended up, but there were too few patients at those time points to determine if the increases were statistically significant, Dr. Johnson said.

About 50%–60% of patients had calcium, parathyroid hormone, and vitamin D levels taken before surgery; all had those elements measured annually thereafter.

The mean serum calcium decreased from 9.8 mg/dL at baseline to 9.2 mg/dL in the first year and to 8.8 mg/dL in the second year.

The parathyroid hormone level increased after surgery, which was not unexpected, Dr. Johnson said. It rose from 59.7 pg/mL preoperatively to 63.1 pg/mL in the first year and to 64.7 pg/mL in the second year.

Vitamin D showed no significant difference from preoperative level to 2 years, though it trended up. All the patients were given vitamin D postoperatively as part of a multivitamin supplement.

Dr. Johnson told attendees that at Virginia Commonwealth University, physicians recommend giving patients 1–1.5 grams of vitamin C and 400 IU of vitamin D daily, and monitoring them for BMD, calcium, parathyroid hormone, and vitamin D on an annual basis.

It's unclear what happens to bypass patients 5 or 10 years post procedure. So far, the university has not seen a lot of weight regain in its patients, but that could potentially have an impact on BMD, Dr. Johnson said at the meeting.

The Bush administration has focused on overhauling the Social Security program, but the nation's governors and health providers say the real crisis is in Medicaid.

The National Governors Association (NGA) has offered a reform proposal to Congress, which has begun considering what can be done to sustain the program that provides health care for some 53 million impoverished and disabled Americans.

In July, the administration named 13 voting members and 15 nonvoting members to its commission on Medicaid reform. By law, the commission has until Sept. 1 to outline recommendations for cutting &dollar;10 billion from the Medicaid program; a report on long-term solutions for the program is due at year's end.

Tennessee Gov. Don Sundquist (R) will chair the commission and former Maine Gov. Angus King (I) will serve as vice chair, the Health and Human Services department announced.

Both state and the federal governments are feeling the squeeze. The program will likely hit &dollar;350 billion overall in 2005.

Medicaid represents 22% of the average state budget, according to testimony given to Congress by Mark Warner, Democratic governor of Virginia and chairman of the NGA. The problem: a skyrocketing caseload over the last 5 years, combined with rising health care costs, and an increasing number of sicker patients, Gov. Warner said.

The number of enrollees has grown by 40% in that period—at a time when eligibility has often been restricted, except for pregnant women and children, who have made up some of the growth. But there has also been a huge increase in the number of seriously disabled and severely and chronically ill recipients. Though they make up only 25% of the total number of Medicaid recipients, the elderly and disabled account for more than 70% of the budget.

That lopsided spending is seen when the per capita annual expense for various recipients is broken out. According to the Kaiser Family Foundation, Medicaid spends an average of &dollar;1,700 per child, &dollar;1,900 per nondisabled adult under 65 years, &dollar;12,300 per disabled recipient, and &dollar;12,800 per elderly recipient. So-called dual eligibles—those who receive both Medicaid and Medicare—also are an increasing burden, said Diane Rowland, executive vice president of the Kaiser Family Foundation.

Speaking at the Medicaid Managed Care Conference in Baltimore in June, Ms. Rowland said that dual eligibles make up 14% of the Medicaid population but account for 42% of the program's costs. Medicaid covers prescription drugs, long-term care, acute care, and Medicare premiums for this group.

States have been using a variety of tactics to reduce spending. Forty-eight states now have drug cost controls, 50 have reduced payments to providers, and 21 have begun restricting eligibility and benefits, Ms. Rowland said. In addition, states have increasingly looked to managed care to decrease costs and improve health, she said, adding that 13 states have 75% of Medicaid recipients in a managed care plan.

In mid-June testimony to the Senate Finance Committee, Gov. Warner outlined NGA's preliminary suggestions for improving Medicaid, mostly by giving states more options. States would like the power to get increased drug rebates and to encourage the use of more generic drugs. In a departure, Gov. Warner said that states would also seek to create a tiered system of copays for pharmaceuticals. Asset transfers, designed to “impoverish” people so they can receive Medicaid, should be more widely restricted, Gov. Warner testified.

NGA also is proposing that recipients be required to pay a portion of their costs through premiums, deductibles, or copays.

The Bush administration has focused on overhauling the Social Security program, but the nation's governors and health providers say the real crisis is in Medicaid.

The National Governors Association (NGA) has offered a reform proposal to Congress, which has begun considering what can be done to sustain the program that provides health care for some 53 million impoverished and disabled Americans.

In July, the administration named 13 voting members and 15 nonvoting members to its commission on Medicaid reform. By law, the commission has until Sept. 1 to outline recommendations for cutting &dollar;10 billion from the Medicaid program; a report on long-term solutions for the program is due at year's end.

Tennessee Gov. Don Sundquist (R) will chair the commission and former Maine Gov. Angus King (I) will serve as vice chair, the Health and Human Services department announced.

Both state and the federal governments are feeling the squeeze. The program will likely hit &dollar;350 billion overall in 2005.

Medicaid represents 22% of the average state budget, according to testimony given to Congress by Mark Warner, Democratic governor of Virginia and chairman of the NGA. The problem: a skyrocketing caseload over the last 5 years, combined with rising health care costs, and an increasing number of sicker patients, Gov. Warner said.

The number of enrollees has grown by 40% in that period—at a time when eligibility has often been restricted, except for pregnant women and children, who have made up some of the growth. But there has also been a huge increase in the number of seriously disabled and severely and chronically ill recipients. Though they make up only 25% of the total number of Medicaid recipients, the elderly and disabled account for more than 70% of the budget.

That lopsided spending is seen when the per capita annual expense for various recipients is broken out. According to the Kaiser Family Foundation, Medicaid spends an average of &dollar;1,700 per child, &dollar;1,900 per nondisabled adult under 65 years, &dollar;12,300 per disabled recipient, and &dollar;12,800 per elderly recipient. So-called dual eligibles—those who receive both Medicaid and Medicare—also are an increasing burden, said Diane Rowland, executive vice president of the Kaiser Family Foundation.

Speaking at the Medicaid Managed Care Conference in Baltimore in June, Ms. Rowland said that dual eligibles make up 14% of the Medicaid population but account for 42% of the program's costs. Medicaid covers prescription drugs, long-term care, acute care, and Medicare premiums for this group.

States have been using a variety of tactics to reduce spending. Forty-eight states now have drug cost controls, 50 have reduced payments to providers, and 21 have begun restricting eligibility and benefits, Ms. Rowland said. In addition, states have increasingly looked to managed care to decrease costs and improve health, she said, adding that 13 states have 75% of Medicaid recipients in a managed care plan.

In mid-June testimony to the Senate Finance Committee, Gov. Warner outlined NGA's preliminary suggestions for improving Medicaid, mostly by giving states more options. States would like the power to get increased drug rebates and to encourage the use of more generic drugs. In a departure, Gov. Warner said that states would also seek to create a tiered system of copays for pharmaceuticals. Asset transfers, designed to “impoverish” people so they can receive Medicaid, should be more widely restricted, Gov. Warner testified.

NGA also is proposing that recipients be required to pay a portion of their costs through premiums, deductibles, or copays.

The Bush administration has focused on overhauling the Social Security program, but the nation's governors and health providers say the real crisis is in Medicaid.

The National Governors Association (NGA) has offered a reform proposal to Congress, which has begun considering what can be done to sustain the program that provides health care for some 53 million impoverished and disabled Americans.

In July, the administration named 13 voting members and 15 nonvoting members to its commission on Medicaid reform. By law, the commission has until Sept. 1 to outline recommendations for cutting &dollar;10 billion from the Medicaid program; a report on long-term solutions for the program is due at year's end.

Tennessee Gov. Don Sundquist (R) will chair the commission and former Maine Gov. Angus King (I) will serve as vice chair, the Health and Human Services department announced.

Both state and the federal governments are feeling the squeeze. The program will likely hit &dollar;350 billion overall in 2005.

Medicaid represents 22% of the average state budget, according to testimony given to Congress by Mark Warner, Democratic governor of Virginia and chairman of the NGA. The problem: a skyrocketing caseload over the last 5 years, combined with rising health care costs, and an increasing number of sicker patients, Gov. Warner said.

The number of enrollees has grown by 40% in that period—at a time when eligibility has often been restricted, except for pregnant women and children, who have made up some of the growth. But there has also been a huge increase in the number of seriously disabled and severely and chronically ill recipients. Though they make up only 25% of the total number of Medicaid recipients, the elderly and disabled account for more than 70% of the budget.

That lopsided spending is seen when the per capita annual expense for various recipients is broken out. According to the Kaiser Family Foundation, Medicaid spends an average of &dollar;1,700 per child, &dollar;1,900 per nondisabled adult under 65 years, &dollar;12,300 per disabled recipient, and &dollar;12,800 per elderly recipient. So-called dual eligibles—those who receive both Medicaid and Medicare—also are an increasing burden, said Diane Rowland, executive vice president of the Kaiser Family Foundation.

Speaking at the Medicaid Managed Care Conference in Baltimore in June, Ms. Rowland said that dual eligibles make up 14% of the Medicaid population but account for 42% of the program's costs. Medicaid covers prescription drugs, long-term care, acute care, and Medicare premiums for this group.

States have been using a variety of tactics to reduce spending. Forty-eight states now have drug cost controls, 50 have reduced payments to providers, and 21 have begun restricting eligibility and benefits, Ms. Rowland said. In addition, states have increasingly looked to managed care to decrease costs and improve health, she said, adding that 13 states have 75% of Medicaid recipients in a managed care plan.

In mid-June testimony to the Senate Finance Committee, Gov. Warner outlined NGA's preliminary suggestions for improving Medicaid, mostly by giving states more options. States would like the power to get increased drug rebates and to encourage the use of more generic drugs. In a departure, Gov. Warner said that states would also seek to create a tiered system of copays for pharmaceuticals. Asset transfers, designed to “impoverish” people so they can receive Medicaid, should be more widely restricted, Gov. Warner testified.

NGA also is proposing that recipients be required to pay a portion of their costs through premiums, deductibles, or copays.

The Bush administration has focused on overhauling the Social Security program, but the nation's governors and health providers say the real crisis is in Medicaid.

The National Governors Association (NGA) has offered a reform proposal to Congress, which has begun considering what can be done to sustain the program that provides health care for some 53 million impoverished and disabled Americans.

In July, the administration named 13 voting members and 15 nonvoting members to its commission on Medicaid reform. By law, the commission has until Sept. 1 to outline recommendations for cutting &dollar;10 billion from the Medicaid program; a report on long-term solutions for the program is due at year's end.

Tennessee Gov. Don Sundquist (R) will chair the commission and former Maine Gov. Angus King (I) will serve as vice chair, the Health and Human Services department announced.

Both state and the federal governments are feeling the squeeze. The program will likely hit &dollar;350 billion overall in 2005.

Medicaid represents 22% of the average state budget, according to testimony given to Congress by Mark Warner, Democratic governor of Virginia and chairman of the NGA. The problem: a skyrocketing caseload over the last 5 years, combined with rising health care costs, and an increasing number of sicker patients, Gov. Warner said.

The number of enrollees has grown by 40% in that period—at a time when eligibility has often been restricted, except for pregnant women and children, who have made up some of the growth. But there has also been a huge increase in the number of seriously disabled and severely and chronically ill recipients. Though they make up only 25% of the total number of Medicaid recipients, the elderly and disabled account for more than 70% of the budget.

That lopsided spending is seen when the per capita annual expense for various recipients is broken out. According to the Kaiser Family Foundation, Medicaid spends an average of &dollar;1,700 per child, &dollar;1,900 per nondisabled adult under 65 years, &dollar;12,300 per disabled recipient, and &dollar;12,800 per elderly recipient. So-called dual eligibles—those who receive both Medicaid and Medicare—also are an increasing burden, said Diane Rowland, executive vice president of the Kaiser Family Foundation.

Speaking at the Medicaid Managed Care Conference in Baltimore in June, Ms. Rowland said that dual eligibles make up 14% of the Medicaid population but account for 42% of the program's costs. Medicaid covers prescription drugs, long-term care, acute care, and Medicare premiums for this group.

States have been using a variety of tactics to reduce spending. Forty-eight states now have drug cost controls, 50 have reduced payments to providers, and 21 have begun restricting eligibility and benefits, Ms. Rowland said. And states have increasingly looked to managed care to decrease costs and improve health, she said, adding that 13 states have 75% of Medicaid recipients in a managed care plan.

In mid-June testimony to the Senate Finance Committee, Gov. Warner outlined NGA's preliminary suggestions for improving Medicaid, mostly by giving states more options. States would like the power to get increased drug rebates and to encourage the use of more generic drugs. In a departure, Gov. Warner said that states would also seek to create a tiered system of copays for pharmaceuticals. Asset transfers, designed to “impoverish” people so they can receive Medicaid, should be more widely restricted, Gov. Warner testified.

NGA is also proposing to start requiring recipients to pay a portion of their costs through premiums, deductibles, or copays.

The Bush administration has focused on overhauling the Social Security program, but the nation's governors and health providers say the real crisis is in Medicaid.

The National Governors Association (NGA) has offered a reform proposal to Congress, which has begun considering what can be done to sustain the program that provides health care for some 53 million impoverished and disabled Americans.

In July, the administration named 13 voting members and 15 nonvoting members to its commission on Medicaid reform. By law, the commission has until Sept. 1 to outline recommendations for cutting &dollar;10 billion from the Medicaid program; a report on long-term solutions for the program is due at year's end.

Tennessee Gov. Don Sundquist (R) will chair the commission and former Maine Gov. Angus King (I) will serve as vice chair, the Health and Human Services department announced.

Both state and the federal governments are feeling the squeeze. The program will likely hit &dollar;350 billion overall in 2005.

Medicaid represents 22% of the average state budget, according to testimony given to Congress by Mark Warner, Democratic governor of Virginia and chairman of the NGA. The problem: a skyrocketing caseload over the last 5 years, combined with rising health care costs, and an increasing number of sicker patients, Gov. Warner said.

The number of enrollees has grown by 40% in that period—at a time when eligibility has often been restricted, except for pregnant women and children, who have made up some of the growth. But there has also been a huge increase in the number of seriously disabled and severely and chronically ill recipients. Though they make up only 25% of the total number of Medicaid recipients, the elderly and disabled account for more than 70% of the budget.

That lopsided spending is seen when the per capita annual expense for various recipients is broken out. According to the Kaiser Family Foundation, Medicaid spends an average of &dollar;1,700 per child, &dollar;1,900 per nondisabled adult under 65 years, &dollar;12,300 per disabled recipient, and &dollar;12,800 per elderly recipient. So-called dual eligibles—those who receive both Medicaid and Medicare—also are an increasing burden, said Diane Rowland, executive vice president of the Kaiser Family Foundation.

Speaking at the Medicaid Managed Care Conference in Baltimore in June, Ms. Rowland said that dual eligibles make up 14% of the Medicaid population but account for 42% of the program's costs. Medicaid covers prescription drugs, long-term care, acute care, and Medicare premiums for this group.

States have been using a variety of tactics to reduce spending. Forty-eight states now have drug cost controls, 50 have reduced payments to providers, and 21 have begun restricting eligibility and benefits, Ms. Rowland said. And states have increasingly looked to managed care to decrease costs and improve health, she said, adding that 13 states have 75% of Medicaid recipients in a managed care plan.

In mid-June testimony to the Senate Finance Committee, Gov. Warner outlined NGA's preliminary suggestions for improving Medicaid, mostly by giving states more options. States would like the power to get increased drug rebates and to encourage the use of more generic drugs. In a departure, Gov. Warner said that states would also seek to create a tiered system of copays for pharmaceuticals. Asset transfers, designed to “impoverish” people so they can receive Medicaid, should be more widely restricted, Gov. Warner testified.

NGA is also proposing to start requiring recipients to pay a portion of their costs through premiums, deductibles, or copays.

The Bush administration has focused on overhauling the Social Security program, but the nation's governors and health providers say the real crisis is in Medicaid.

The National Governors Association (NGA) has offered a reform proposal to Congress, which has begun considering what can be done to sustain the program that provides health care for some 53 million impoverished and disabled Americans.

In July, the administration named 13 voting members and 15 nonvoting members to its commission on Medicaid reform. By law, the commission has until Sept. 1 to outline recommendations for cutting &dollar;10 billion from the Medicaid program; a report on long-term solutions for the program is due at year's end.

Tennessee Gov. Don Sundquist (R) will chair the commission and former Maine Gov. Angus King (I) will serve as vice chair, the Health and Human Services department announced.

Both state and the federal governments are feeling the squeeze. The program will likely hit &dollar;350 billion overall in 2005.

Medicaid represents 22% of the average state budget, according to testimony given to Congress by Mark Warner, Democratic governor of Virginia and chairman of the NGA. The problem: a skyrocketing caseload over the last 5 years, combined with rising health care costs, and an increasing number of sicker patients, Gov. Warner said.

The number of enrollees has grown by 40% in that period—at a time when eligibility has often been restricted, except for pregnant women and children, who have made up some of the growth. But there has also been a huge increase in the number of seriously disabled and severely and chronically ill recipients. Though they make up only 25% of the total number of Medicaid recipients, the elderly and disabled account for more than 70% of the budget.

That lopsided spending is seen when the per capita annual expense for various recipients is broken out. According to the Kaiser Family Foundation, Medicaid spends an average of &dollar;1,700 per child, &dollar;1,900 per nondisabled adult under 65 years, &dollar;12,300 per disabled recipient, and &dollar;12,800 per elderly recipient. So-called dual eligibles—those who receive both Medicaid and Medicare—also are an increasing burden, said Diane Rowland, executive vice president of the Kaiser Family Foundation.

Speaking at the Medicaid Managed Care Conference in Baltimore in June, Ms. Rowland said that dual eligibles make up 14% of the Medicaid population but account for 42% of the program's costs. Medicaid covers prescription drugs, long-term care, acute care, and Medicare premiums for this group.

States have been using a variety of tactics to reduce spending. Forty-eight states now have drug cost controls, 50 have reduced payments to providers, and 21 have begun restricting eligibility and benefits, Ms. Rowland said. And states have increasingly looked to managed care to decrease costs and improve health, she said, adding that 13 states have 75% of Medicaid recipients in a managed care plan.

In mid-June testimony to the Senate Finance Committee, Gov. Warner outlined NGA's preliminary suggestions for improving Medicaid, mostly by giving states more options. States would like the power to get increased drug rebates and to encourage the use of more generic drugs. In a departure, Gov. Warner said that states would also seek to create a tiered system of copays for pharmaceuticals. Asset transfers, designed to “impoverish” people so they can receive Medicaid, should be more widely restricted, Gov. Warner testified.

NGA is also proposing to start requiring recipients to pay a portion of their costs through premiums, deductibles, or copays.

WASHINGTON – Acknowledging that its drug safety system is inadequate, several Food and Drug Administration officials told an Institute of Medicine panel examining the issue that the agency is ready for recommendations on how to better protect the public's health.

The IOM committee was convened at FDA's request and has been charged with examining every aspect of the agency's drug safety program, including whether it needs new powers to mandate postmarketing safety studies by pharmaceutical companies.

At its first meeting in June, the panel heard from representatives of the FDA, the pharmaceutical industry, and consumers. Each had divergent views on how well the system works.

Janet Woodcock, M.D., acting deputy commissioner for FDA operations, said the agency had come a long way, but that it could improve on predicting, preventing, monitoring, and mitigating adverse drug events. Changes over the past decade have made it more difficult to ensure safety, Dr. Woodcock added.

Before, most drugs were marketed in other countries first, giving the agency a track record to evaluate, she said. Now, the United States is often the first avenue for sales. Huge drug company marketing campaigns aimed at physicians and consumers have led to a much quicker uptake of new drugs, which brings safety issues to a head even faster. Recalls are happening faster after a drug comes to market, but there has been no big increase in the number of withdrawals, Dr. Woodcock said.

She also said the agency was hamstrung by international agreements on how much premarket safety data could be requested; the agency can't force drug makers to conduct postmarketing safety studies.

MedWatch, FDA's postmarketing surveillance system is full of gaps, Dr. Woodcock added. Pharmaceutical makers are required to report adverse events to MedWatch, but reports from physicians, pharmacists, and other health care providers, and patients are voluntary. MedWatch receives 400,000 reports a year, but the FDA acknowledges it captures only a fraction of the events.

Alan Goldhammer, Ph.D., associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said, “simply increasing the number of spontaneous reports is not the answer” because it might just “increase the noise” instead of providing real signals about side effects.

He said the system was not broken. “We know more about safety profiles of drugs approved today than those approved 20 years ago,” Dr. Goldhammer said, adding that “FDA's current legal authorities over drug safety are robust and do not need to be changed.”

Bill Vaughan, a senior policy analyst with Consumers Union, vehemently disagreed, saying that the Washington-based nonprofit believes that “legislative action is essential to address the substantial problems in drug safety and oversight that have been highlighted over the last year.”

Mr. Vaughan urged the IOM panel to make interim recommendations to Congress as early as this summer, rather than waiting until its final report, due out next year. “It looks like the industry looks at the FDA like it's a paper tiger, and that needs to be addressed, and addressed soon,” Mr. Vaughan said.

Steven Galson, M.D., the acting director for FDA's Center for Drug Evaluation and Research touted the FDA's new Drug Safety Oversight Board, saying it would help provide “independent” oversight and advice. The board's first meeting was in late June.

Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, said he was skeptical of the board's capabilities, noting in a letter to FDA acting commissioner Lester Crawford, D.V.M., that it does not seem independent enough.

The next meeting of the panel is scheduled for Oct. 25.

WASHINGTON – Acknowledging that its drug safety system is inadequate, several Food and Drug Administration officials told an Institute of Medicine panel examining the issue that the agency is ready for recommendations on how to better protect the public's health.

The IOM committee was convened at FDA's request and has been charged with examining every aspect of the agency's drug safety program, including whether it needs new powers to mandate postmarketing safety studies by pharmaceutical companies.

At its first meeting in June, the panel heard from representatives of the FDA, the pharmaceutical industry, and consumers. Each had divergent views on how well the system works.

Janet Woodcock, M.D., acting deputy commissioner for FDA operations, said the agency had come a long way, but that it could improve on predicting, preventing, monitoring, and mitigating adverse drug events. Changes over the past decade have made it more difficult to ensure safety, Dr. Woodcock added.

Before, most drugs were marketed in other countries first, giving the agency a track record to evaluate, she said. Now, the United States is often the first avenue for sales. Huge drug company marketing campaigns aimed at physicians and consumers have led to a much quicker uptake of new drugs, which brings safety issues to a head even faster. Recalls are happening faster after a drug comes to market, but there has been no big increase in the number of withdrawals, Dr. Woodcock said.

She also said the agency was hamstrung by international agreements on how much premarket safety data could be requested; the agency can't force drug makers to conduct postmarketing safety studies.

MedWatch, FDA's postmarketing surveillance system is full of gaps, Dr. Woodcock added. Pharmaceutical makers are required to report adverse events to MedWatch, but reports from physicians, pharmacists, and other health care providers, and patients are voluntary. MedWatch receives 400,000 reports a year, but the FDA acknowledges it captures only a fraction of the events.

Alan Goldhammer, Ph.D., associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said, “simply increasing the number of spontaneous reports is not the answer” because it might just “increase the noise” instead of providing real signals about side effects.

He said the system was not broken. “We know more about safety profiles of drugs approved today than those approved 20 years ago,” Dr. Goldhammer said, adding that “FDA's current legal authorities over drug safety are robust and do not need to be changed.”

Bill Vaughan, a senior policy analyst with Consumers Union, vehemently disagreed, saying that the Washington-based nonprofit believes that “legislative action is essential to address the substantial problems in drug safety and oversight that have been highlighted over the last year.”

Mr. Vaughan urged the IOM panel to make interim recommendations to Congress as early as this summer, rather than waiting until its final report, due out next year. “It looks like the industry looks at the FDA like it's a paper tiger, and that needs to be addressed, and addressed soon,” Mr. Vaughan said.

Steven Galson, M.D., the acting director for FDA's Center for Drug Evaluation and Research touted the FDA's new Drug Safety Oversight Board, saying it would help provide “independent” oversight and advice. The board's first meeting was in late June.

Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, said he was skeptical of the board's capabilities, noting in a letter to FDA acting commissioner Lester Crawford, D.V.M., that it does not seem independent enough.

The next meeting of the panel is scheduled for Oct. 25.

WASHINGTON – Acknowledging that its drug safety system is inadequate, several Food and Drug Administration officials told an Institute of Medicine panel examining the issue that the agency is ready for recommendations on how to better protect the public's health.

The IOM committee was convened at FDA's request and has been charged with examining every aspect of the agency's drug safety program, including whether it needs new powers to mandate postmarketing safety studies by pharmaceutical companies.

At its first meeting in June, the panel heard from representatives of the FDA, the pharmaceutical industry, and consumers. Each had divergent views on how well the system works.

Janet Woodcock, M.D., acting deputy commissioner for FDA operations, said the agency had come a long way, but that it could improve on predicting, preventing, monitoring, and mitigating adverse drug events. Changes over the past decade have made it more difficult to ensure safety, Dr. Woodcock added.

Before, most drugs were marketed in other countries first, giving the agency a track record to evaluate, she said. Now, the United States is often the first avenue for sales. Huge drug company marketing campaigns aimed at physicians and consumers have led to a much quicker uptake of new drugs, which brings safety issues to a head even faster. Recalls are happening faster after a drug comes to market, but there has been no big increase in the number of withdrawals, Dr. Woodcock said.

She also said the agency was hamstrung by international agreements on how much premarket safety data could be requested; the agency can't force drug makers to conduct postmarketing safety studies.

MedWatch, FDA's postmarketing surveillance system is full of gaps, Dr. Woodcock added. Pharmaceutical makers are required to report adverse events to MedWatch, but reports from physicians, pharmacists, and other health care providers, and patients are voluntary. MedWatch receives 400,000 reports a year, but the FDA acknowledges it captures only a fraction of the events.

Alan Goldhammer, Ph.D., associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said, “simply increasing the number of spontaneous reports is not the answer” because it might just “increase the noise” instead of providing real signals about side effects.

He said the system was not broken. “We know more about safety profiles of drugs approved today than those approved 20 years ago,” Dr. Goldhammer said, adding that “FDA's current legal authorities over drug safety are robust and do not need to be changed.”

Bill Vaughan, a senior policy analyst with Consumers Union, vehemently disagreed, saying that the Washington-based nonprofit believes that “legislative action is essential to address the substantial problems in drug safety and oversight that have been highlighted over the last year.”

Mr. Vaughan urged the IOM panel to make interim recommendations to Congress as early as this summer, rather than waiting until its final report, due out next year. “It looks like the industry looks at the FDA like it's a paper tiger, and that needs to be addressed, and addressed soon,” Mr. Vaughan said.

Steven Galson, M.D., the acting director for FDA's Center for Drug Evaluation and Research touted the FDA's new Drug Safety Oversight Board, saying it would help provide “independent” oversight and advice. The board's first meeting was in late June.

Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, said he was skeptical of the board's capabilities, noting in a letter to FDA acting commissioner Lester Crawford, D.V.M., that it does not seem independent enough.

The next meeting of the panel is scheduled for Oct. 25.

The Bush administration has focused on overhauling the Social Security program, but the nation's governors and health providers say the real crisis is in Medicaid.

The National Governors Association (NGA) has offered a reform proposal to Congress, which has begun considering what can be done to sustain the program that provides health care for some 53 million impoverished and disabled Americans.

In July, the administration named 13 voting members and 15 nonvoting members to its commission on Medicaid reform. By law, the commission has until Sept. 1 to outline recommendations for cutting $10 billion from the Medicaid program; a report on long-term solutions for the program is due at year's end.

Tennessee Gov. Don Sundquist (R) will chair the commission and former Maine Gov. Angus King (I) will serve as vice chair, the Health and Human Services department announced.

Both the state and federal governments are feeling the squeeze. The program will likely hit $350 billion overall in 2005.

Medicaid represents 22% of the average state budget, according to testimony given to Congress by Mark Warner, Democratic governor of Virginia and chairman of the NGA. The problem: a skyrocketing caseload over the last 5 years, combined with rising health care costs, and an increasing number of sicker patients, Gov. Warner said.

The number of enrollees has grown by 40% in that period–at a time when eligibility has often been restricted, except for pregnant women and children, who have made up some of the growth. But there has also been a huge increase in the number of seriously disabled and severely and chronically ill recipients. Though they make up only 25% of the total number of Medicaid recipients, the elderly and disabled account for more than 70% of the budget.

That lopsided spending is seen when the per capita annual expense for various recipients is broken out. According to the Kaiser Family Foundation, Medicaid spends an average of $1,700 per child, $1,900 per nondisabled adult under 65 years, $12,300 per disabled recipient, and $12,800 per elderly recipient. So-called dual eligibles–those who receive both Medicaid and Medicare–also are an increasing burden, said Diane Rowland, executive vice president of the Kaiser Family Foundation.

Speaking at the Medicaid Managed Care Conference in Baltimore in June, Ms. Rowland said dual eligibles make up 14% of the Medicaid population but account for 42% of its costs. Medicaid covers prescription drugs, long-term care, acute care, and Medicare premiums for this group.

States have been using a variety of tactics to reduce spending. Forty-eight states now have drug cost controls, 50 have reduced payments to providers, and 21 have begun restricting eligibility and benefits, Ms. Rowland said. And states have increasingly looked to managed care to decrease costs and improve health, she said, adding that 13 states have 75% of Medicaid recipients in a managed care plan.

The Bush administration has focused on overhauling the Social Security program, but the nation's governors and health providers say the real crisis is in Medicaid.

The National Governors Association (NGA) has offered a reform proposal to Congress, which has begun considering what can be done to sustain the program that provides health care for some 53 million impoverished and disabled Americans.

In July, the administration named 13 voting members and 15 nonvoting members to its commission on Medicaid reform. By law, the commission has until Sept. 1 to outline recommendations for cutting $10 billion from the Medicaid program; a report on long-term solutions for the program is due at year's end.

Tennessee Gov. Don Sundquist (R) will chair the commission and former Maine Gov. Angus King (I) will serve as vice chair, the Health and Human Services department announced.

Both the state and federal governments are feeling the squeeze. The program will likely hit $350 billion overall in 2005.

Medicaid represents 22% of the average state budget, according to testimony given to Congress by Mark Warner, Democratic governor of Virginia and chairman of the NGA. The problem: a skyrocketing caseload over the last 5 years, combined with rising health care costs, and an increasing number of sicker patients, Gov. Warner said.

The number of enrollees has grown by 40% in that period–at a time when eligibility has often been restricted, except for pregnant women and children, who have made up some of the growth. But there has also been a huge increase in the number of seriously disabled and severely and chronically ill recipients. Though they make up only 25% of the total number of Medicaid recipients, the elderly and disabled account for more than 70% of the budget.

That lopsided spending is seen when the per capita annual expense for various recipients is broken out. According to the Kaiser Family Foundation, Medicaid spends an average of $1,700 per child, $1,900 per nondisabled adult under 65 years, $12,300 per disabled recipient, and $12,800 per elderly recipient. So-called dual eligibles–those who receive both Medicaid and Medicare–also are an increasing burden, said Diane Rowland, executive vice president of the Kaiser Family Foundation.

Speaking at the Medicaid Managed Care Conference in Baltimore in June, Ms. Rowland said dual eligibles make up 14% of the Medicaid population but account for 42% of its costs. Medicaid covers prescription drugs, long-term care, acute care, and Medicare premiums for this group.

States have been using a variety of tactics to reduce spending. Forty-eight states now have drug cost controls, 50 have reduced payments to providers, and 21 have begun restricting eligibility and benefits, Ms. Rowland said. And states have increasingly looked to managed care to decrease costs and improve health, she said, adding that 13 states have 75% of Medicaid recipients in a managed care plan.

The Bush administration has focused on overhauling the Social Security program, but the nation's governors and health providers say the real crisis is in Medicaid.

The National Governors Association (NGA) has offered a reform proposal to Congress, which has begun considering what can be done to sustain the program that provides health care for some 53 million impoverished and disabled Americans.

In July, the administration named 13 voting members and 15 nonvoting members to its commission on Medicaid reform. By law, the commission has until Sept. 1 to outline recommendations for cutting $10 billion from the Medicaid program; a report on long-term solutions for the program is due at year's end.

Tennessee Gov. Don Sundquist (R) will chair the commission and former Maine Gov. Angus King (I) will serve as vice chair, the Health and Human Services department announced.

Both the state and federal governments are feeling the squeeze. The program will likely hit $350 billion overall in 2005.

Medicaid represents 22% of the average state budget, according to testimony given to Congress by Mark Warner, Democratic governor of Virginia and chairman of the NGA. The problem: a skyrocketing caseload over the last 5 years, combined with rising health care costs, and an increasing number of sicker patients, Gov. Warner said.

The number of enrollees has grown by 40% in that period–at a time when eligibility has often been restricted, except for pregnant women and children, who have made up some of the growth. But there has also been a huge increase in the number of seriously disabled and severely and chronically ill recipients. Though they make up only 25% of the total number of Medicaid recipients, the elderly and disabled account for more than 70% of the budget.

That lopsided spending is seen when the per capita annual expense for various recipients is broken out. According to the Kaiser Family Foundation, Medicaid spends an average of $1,700 per child, $1,900 per nondisabled adult under 65 years, $12,300 per disabled recipient, and $12,800 per elderly recipient. So-called dual eligibles–those who receive both Medicaid and Medicare–also are an increasing burden, said Diane Rowland, executive vice president of the Kaiser Family Foundation.

Speaking at the Medicaid Managed Care Conference in Baltimore in June, Ms. Rowland said dual eligibles make up 14% of the Medicaid population but account for 42% of its costs. Medicaid covers prescription drugs, long-term care, acute care, and Medicare premiums for this group.

States have been using a variety of tactics to reduce spending. Forty-eight states now have drug cost controls, 50 have reduced payments to providers, and 21 have begun restricting eligibility and benefits, Ms. Rowland said. And states have increasingly looked to managed care to decrease costs and improve health, she said, adding that 13 states have 75% of Medicaid recipients in a managed care plan.

WASHINGTON — Acknowledging that its drug safety system is inadequate, several Food and Drug Administration officials told an Institute of Medicine panel examining the issue that the agency is ready for recommendations on how to better protect the public's health.

The IOM committee was convened at FDA's request and has been charged with examining every aspect of the agency's drug safety program, including whether it needs new powers to mandate postmarketing safety studies by pharmaceutical companies.

At its first meeting in June, the panel heard from representatives of the FDA, the pharmaceutical industry, and consumers. Each had divergent views on how well the system works.

Janet Woodcock, M.D., acting deputy commissioner for FDA operations, said the agency had come a long way, but that it could improve on predicting, preventing, monitoring, and mitigating adverse drug events.

Changes over the past decade have made it more difficult to ensure safety, Dr. Woodcock said.

Before, most drugs were marketed in other countries first, giving the agency a track record to evaluate, she said. Now, the United States is often the first avenue for sales.

Drug company marketing campaigns aimed at physicians and consumers have led to a quicker uptake of new drugs, which brings safety issues to a head even faster.

Recalls are happening faster after a drug comes to market, but there has been no big increase in the number of withdrawals, Dr. Woodcock said.

She also said the agency was hamstrung by international agreements on how much premarket safety data could be requested; the agency can't force drug makers to conduct postmarketing safety studies.

MedWatch, FDA's postmarketing surveillance system, is full of gaps, Dr. Woodcock added. Pharmaceutical makers are required to report adverse events to MedWatch, but reports from physicians, pharmacists, and other health care providers, and patients are voluntary.

MedWatch receives 400,000 reports a year, but the FDA acknowledges it captures only a fraction of the events.

Alan Goldhammer, Ph.D., associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said, "simply increasing the number of spontaneous reports is not the answer" because it might just "increase the noise" instead of providing real signals about side effects.

He said the system was not broken. "We know more about safety profiles of drugs approved today than those approved 20 years ago," Dr. Goldhammer said, adding that "FDA's current legal authorities over drug safety are robust and do not need to be changed."

Bill Vaughan, a senior policy analyst with Consumers Union, disagreed. "Legislative action is essential to address the substantial problems in drug safety and oversight that have been highlighted over the last year."

Mr. Vaughan urged the IOM panel to make interim recommendations to Congress before the panel issues its final report, due out next year.

Steven Galson, M.D., the acting director of the FDA's Center for Drug Evaluation and Research, touted the FDA's new Drug Safety Oversight Board, saying it would help provide "independent" oversight and advice. The board's first meeting was in June.

Sen. Chuck Grassley (R-Iowa) said he was skeptical of the board's capabilities, noting in a letter to FDA acting commissioner Lester Crawford, D.V.M., that it does not seem independent enough.

Dr. Woodcock told the panel, "one of the questions on the table really is how much uncertainty are we willing to tolerate," adding that patients and doctors should weigh benefits and risks.

The panel's next meeting is scheduled for October 25.

WASHINGTON — Acknowledging that its drug safety system is inadequate, several Food and Drug Administration officials told an Institute of Medicine panel examining the issue that the agency is ready for recommendations on how to better protect the public's health.

The IOM committee was convened at FDA's request and has been charged with examining every aspect of the agency's drug safety program, including whether it needs new powers to mandate postmarketing safety studies by pharmaceutical companies.

At its first meeting in June, the panel heard from representatives of the FDA, the pharmaceutical industry, and consumers. Each had divergent views on how well the system works.

Janet Woodcock, M.D., acting deputy commissioner for FDA operations, said the agency had come a long way, but that it could improve on predicting, preventing, monitoring, and mitigating adverse drug events.

Changes over the past decade have made it more difficult to ensure safety, Dr. Woodcock said.

Before, most drugs were marketed in other countries first, giving the agency a track record to evaluate, she said. Now, the United States is often the first avenue for sales.

Drug company marketing campaigns aimed at physicians and consumers have led to a quicker uptake of new drugs, which brings safety issues to a head even faster.

Recalls are happening faster after a drug comes to market, but there has been no big increase in the number of withdrawals, Dr. Woodcock said.

She also said the agency was hamstrung by international agreements on how much premarket safety data could be requested; the agency can't force drug makers to conduct postmarketing safety studies.

MedWatch, FDA's postmarketing surveillance system, is full of gaps, Dr. Woodcock added. Pharmaceutical makers are required to report adverse events to MedWatch, but reports from physicians, pharmacists, and other health care providers, and patients are voluntary.

MedWatch receives 400,000 reports a year, but the FDA acknowledges it captures only a fraction of the events.

Alan Goldhammer, Ph.D., associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said, "simply increasing the number of spontaneous reports is not the answer" because it might just "increase the noise" instead of providing real signals about side effects.

He said the system was not broken. "We know more about safety profiles of drugs approved today than those approved 20 years ago," Dr. Goldhammer said, adding that "FDA's current legal authorities over drug safety are robust and do not need to be changed."

Bill Vaughan, a senior policy analyst with Consumers Union, disagreed. "Legislative action is essential to address the substantial problems in drug safety and oversight that have been highlighted over the last year."

Mr. Vaughan urged the IOM panel to make interim recommendations to Congress before the panel issues its final report, due out next year.

Steven Galson, M.D., the acting director of the FDA's Center for Drug Evaluation and Research, touted the FDA's new Drug Safety Oversight Board, saying it would help provide "independent" oversight and advice. The board's first meeting was in June.

Sen. Chuck Grassley (R-Iowa) said he was skeptical of the board's capabilities, noting in a letter to FDA acting commissioner Lester Crawford, D.V.M., that it does not seem independent enough.

Dr. Woodcock told the panel, "one of the questions on the table really is how much uncertainty are we willing to tolerate," adding that patients and doctors should weigh benefits and risks.

The panel's next meeting is scheduled for October 25.

WASHINGTON — Acknowledging that its drug safety system is inadequate, several Food and Drug Administration officials told an Institute of Medicine panel examining the issue that the agency is ready for recommendations on how to better protect the public's health.

The IOM committee was convened at FDA's request and has been charged with examining every aspect of the agency's drug safety program, including whether it needs new powers to mandate postmarketing safety studies by pharmaceutical companies.

At its first meeting in June, the panel heard from representatives of the FDA, the pharmaceutical industry, and consumers. Each had divergent views on how well the system works.

Janet Woodcock, M.D., acting deputy commissioner for FDA operations, said the agency had come a long way, but that it could improve on predicting, preventing, monitoring, and mitigating adverse drug events.

Changes over the past decade have made it more difficult to ensure safety, Dr. Woodcock said.

Before, most drugs were marketed in other countries first, giving the agency a track record to evaluate, she said. Now, the United States is often the first avenue for sales.

Drug company marketing campaigns aimed at physicians and consumers have led to a quicker uptake of new drugs, which brings safety issues to a head even faster.

Recalls are happening faster after a drug comes to market, but there has been no big increase in the number of withdrawals, Dr. Woodcock said.

She also said the agency was hamstrung by international agreements on how much premarket safety data could be requested; the agency can't force drug makers to conduct postmarketing safety studies.

MedWatch, FDA's postmarketing surveillance system, is full of gaps, Dr. Woodcock added. Pharmaceutical makers are required to report adverse events to MedWatch, but reports from physicians, pharmacists, and other health care providers, and patients are voluntary.

MedWatch receives 400,000 reports a year, but the FDA acknowledges it captures only a fraction of the events.

Alan Goldhammer, Ph.D., associate vice president of regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said, "simply increasing the number of spontaneous reports is not the answer" because it might just "increase the noise" instead of providing real signals about side effects.

He said the system was not broken. "We know more about safety profiles of drugs approved today than those approved 20 years ago," Dr. Goldhammer said, adding that "FDA's current legal authorities over drug safety are robust and do not need to be changed."

Bill Vaughan, a senior policy analyst with Consumers Union, disagreed. "Legislative action is essential to address the substantial problems in drug safety and oversight that have been highlighted over the last year."

Mr. Vaughan urged the IOM panel to make interim recommendations to Congress before the panel issues its final report, due out next year.

Steven Galson, M.D., the acting director of the FDA's Center for Drug Evaluation and Research, touted the FDA's new Drug Safety Oversight Board, saying it would help provide "independent" oversight and advice. The board's first meeting was in June.

Sen. Chuck Grassley (R-Iowa) said he was skeptical of the board's capabilities, noting in a letter to FDA acting commissioner Lester Crawford, D.V.M., that it does not seem independent enough.

Dr. Woodcock told the panel, "one of the questions on the table really is how much uncertainty are we willing to tolerate," adding that patients and doctors should weigh benefits and risks.

The panel's next meeting is scheduled for October 25.