Alicia Ault

WASHINGTON — Almost nothing has been done in the year since the Institute of Medicine called on Congress to help enact a comprehensive overhaul of the nation's emergency medicine system, two emergency physicians and a trauma surgeon told a U.S. House committee.

“I'm absolutely shocked that more hasn't been done to fix this in the last year,” Dr. William Schwab, chief of the division of trauma and surgical critical care at the University of Pennsylvania Medical Center in Philadelphia, testified at a House Committee on Oversight and Government Reform hearing.

Dr. Schwab was a member of the IOM's Committee on the Future of Emergency Care in the U.S. Health System, which issued its report in June 2006.

So far, the only congressional action has been the introduction of the Access to Emergency Medical Services Act (H.R. 882), which would increase payments to physicians through an emergency medicine-specific trust fund and create a commission to study potential solutions. A companion bill has been introduced in the Senate (S. 1003).

Dr. Schwab and his colleagues told House committee members that if anything, emergency departments have become more crowded and overburdened, and that it is becoming increasingly difficult to find specialists such as orthopedic surgeons or neurosurgeons who will accept on-call assignments.

Leaving his written testimony behind, Dr. Schwab told the committee members that a recent experience at his hospital more fully revealed the crisis. On one of his days off, a partner in his practice called and said he was needed to help attend to a department bursting at the seams from a multivehicle accident. Upon arrival, Dr. Schwab instead was diverted to a gunshot victim. He performed an emergency thoracotomy, and when he was done, he looked up and realized that the accident patients had been watching from just 40 feet away because the trauma bay was so crowded.

The burden is not limited to big-city facilities, said Dr. Schwab, noting that his brother-in-law, a transplant patient on dialysis who had become very ill, recently had been refused initial admittance through the ED at Rodney Strong Hospital in Rochester because of overcrowding. Eventually, he was seen.

Dr. Ramon Johnson, director of emergency medicine at Mission Hospital Regional Medical Center in Mission Viejo, Calif., agreed that the crisis did not respect demographic boundaries. “Even in my sleepy suburban community,” the emergency department is “understaffed, underfunded, overworked, and overcrowded,” said Dr. Johnson, who also related anecdotes in place of his written testimony. He spoke of having to scramble to find an open bed for a child who was brought in—blue and choking—by his mother. Staff removed a less-ill patient from a bed, which was quickly occupied by the choking child. Dr. Johnson then reached into the child's trachea to fish out the offending apricot pit. But he had a moment where he thought he'd have to tend to the child on the floor.

“We have state-of-the-art technology, and yet we're practicing in a non-state-of-the-art environment,” echoed Dr. Robert E. O'Connor, incoming chair of emergency medicine at the University of Virginia, Charlottesville.

At the hearing, the physicians were well received by Democrats and Republicans.

“The fact of the matter is that we have a crisis in emergency care, and it is nationwide,” said acting panel chairman Elijah Cummings (D-Md.). “This begs the question: With a national emergency and trauma care system as fragile as ours, how would we manage the very real threats of a terrorist bombing, a natural disaster, or an outbreak of pandemic flu? Where is the surge capacity?”

Rep. Tom Davis (R-Va.) also questioned whether many of the nation's emergency departments are ready to handle a surge from a multiple-casualty highway crash, much less a terrorist event. The crisis has many roots, said Rep. Davis. “Legal, financial, and demographic trends have converged to punish the success of hospital emergency departments transformed by federal law into the de facto primary care provider for millions of the under- and uninsured,” he said.

Several committee members asked whether the 2006 Pandemic and All Hazards Preparedness Act had benefited emergency care. The answer: a resounding no.

“I don't think we could track a dime to actual practice at the bedside,” said Dr. Schwab.

But he and the other physicians emphasized that just throwing more money at emergency medicine would not be a panacea. “There's no way a simple solution can fix this,” said Dr. Schwab.

Rep. Cummings and other committee members took the Department of Health and Human Services to task for not ensuring that more of the Pandemic law's money made it directly to hospitals.

Dr. Kevin Yeskey, director of the Office of Preparedness and Emergency Operations at HHS, defended the agency, saying that federal money had been distributed to states, not directly to hospitals. But, he agreed that there should be more accountability for how the almost $3 billion in funds has been and will be distributed.

'We have state-of-the-art technology, and yet we're practicing in a non-state-of-the-art environment.' DR. O'CONNOR

WASHINGTON — Almost nothing has been done in the year since the Institute of Medicine called on Congress to help enact a comprehensive overhaul of the nation's emergency medicine system, two emergency physicians and a trauma surgeon told a U.S. House committee.

“I'm absolutely shocked that more hasn't been done to fix this in the last year,” Dr. William Schwab, chief of the division of trauma and surgical critical care at the University of Pennsylvania Medical Center in Philadelphia, testified at a House Committee on Oversight and Government Reform hearing.

Dr. Schwab was a member of the IOM's Committee on the Future of Emergency Care in the U.S. Health System, which issued its report in June 2006.

So far, the only congressional action has been the introduction of the Access to Emergency Medical Services Act (H.R. 882), which would increase payments to physicians through an emergency medicine-specific trust fund and create a commission to study potential solutions. A companion bill has been introduced in the Senate (S. 1003).

Dr. Schwab and his colleagues told House committee members that if anything, emergency departments have become more crowded and overburdened, and that it is becoming increasingly difficult to find specialists such as orthopedic surgeons or neurosurgeons who will accept on-call assignments.

Leaving his written testimony behind, Dr. Schwab told the committee members that a recent experience at his hospital more fully revealed the crisis. On one of his days off, a partner in his practice called and said he was needed to help attend to a department bursting at the seams from a multivehicle accident. Upon arrival, Dr. Schwab instead was diverted to a gunshot victim. He performed an emergency thoracotomy, and when he was done, he looked up and realized that the accident patients had been watching from just 40 feet away because the trauma bay was so crowded.

The burden is not limited to big-city facilities, said Dr. Schwab, noting that his brother-in-law, a transplant patient on dialysis who had become very ill, recently had been refused initial admittance through the ED at Rodney Strong Hospital in Rochester because of overcrowding. Eventually, he was seen.

Dr. Ramon Johnson, director of emergency medicine at Mission Hospital Regional Medical Center in Mission Viejo, Calif., agreed that the crisis did not respect demographic boundaries. “Even in my sleepy suburban community,” the emergency department is “understaffed, underfunded, overworked, and overcrowded,” said Dr. Johnson, who also related anecdotes in place of his written testimony. He spoke of having to scramble to find an open bed for a child who was brought in—blue and choking—by his mother. Staff removed a less-ill patient from a bed, which was quickly occupied by the choking child. Dr. Johnson then reached into the child's trachea to fish out the offending apricot pit. But he had a moment where he thought he'd have to tend to the child on the floor.

“We have state-of-the-art technology, and yet we're practicing in a non-state-of-the-art environment,” echoed Dr. Robert E. O'Connor, incoming chair of emergency medicine at the University of Virginia, Charlottesville.

At the hearing, the physicians were well received by Democrats and Republicans.

“The fact of the matter is that we have a crisis in emergency care, and it is nationwide,” said acting panel chairman Elijah Cummings (D-Md.). “This begs the question: With a national emergency and trauma care system as fragile as ours, how would we manage the very real threats of a terrorist bombing, a natural disaster, or an outbreak of pandemic flu? Where is the surge capacity?”

Rep. Tom Davis (R-Va.) also questioned whether many of the nation's emergency departments are ready to handle a surge from a multiple-casualty highway crash, much less a terrorist event. The crisis has many roots, said Rep. Davis. “Legal, financial, and demographic trends have converged to punish the success of hospital emergency departments transformed by federal law into the de facto primary care provider for millions of the under- and uninsured,” he said.

Several committee members asked whether the 2006 Pandemic and All Hazards Preparedness Act had benefited emergency care. The answer: a resounding no.

“I don't think we could track a dime to actual practice at the bedside,” said Dr. Schwab.

But he and the other physicians emphasized that just throwing more money at emergency medicine would not be a panacea. “There's no way a simple solution can fix this,” said Dr. Schwab.

Rep. Cummings and other committee members took the Department of Health and Human Services to task for not ensuring that more of the Pandemic law's money made it directly to hospitals.

Dr. Kevin Yeskey, director of the Office of Preparedness and Emergency Operations at HHS, defended the agency, saying that federal money had been distributed to states, not directly to hospitals. But, he agreed that there should be more accountability for how the almost $3 billion in funds has been and will be distributed.

'We have state-of-the-art technology, and yet we're practicing in a non-state-of-the-art environment.' DR. O'CONNOR

WASHINGTON — Almost nothing has been done in the year since the Institute of Medicine called on Congress to help enact a comprehensive overhaul of the nation's emergency medicine system, two emergency physicians and a trauma surgeon told a U.S. House committee.

“I'm absolutely shocked that more hasn't been done to fix this in the last year,” Dr. William Schwab, chief of the division of trauma and surgical critical care at the University of Pennsylvania Medical Center in Philadelphia, testified at a House Committee on Oversight and Government Reform hearing.

Dr. Schwab was a member of the IOM's Committee on the Future of Emergency Care in the U.S. Health System, which issued its report in June 2006.

So far, the only congressional action has been the introduction of the Access to Emergency Medical Services Act (H.R. 882), which would increase payments to physicians through an emergency medicine-specific trust fund and create a commission to study potential solutions. A companion bill has been introduced in the Senate (S. 1003).

Dr. Schwab and his colleagues told House committee members that if anything, emergency departments have become more crowded and overburdened, and that it is becoming increasingly difficult to find specialists such as orthopedic surgeons or neurosurgeons who will accept on-call assignments.

Leaving his written testimony behind, Dr. Schwab told the committee members that a recent experience at his hospital more fully revealed the crisis. On one of his days off, a partner in his practice called and said he was needed to help attend to a department bursting at the seams from a multivehicle accident. Upon arrival, Dr. Schwab instead was diverted to a gunshot victim. He performed an emergency thoracotomy, and when he was done, he looked up and realized that the accident patients had been watching from just 40 feet away because the trauma bay was so crowded.

The burden is not limited to big-city facilities, said Dr. Schwab, noting that his brother-in-law, a transplant patient on dialysis who had become very ill, recently had been refused initial admittance through the ED at Rodney Strong Hospital in Rochester because of overcrowding. Eventually, he was seen.

Dr. Ramon Johnson, director of emergency medicine at Mission Hospital Regional Medical Center in Mission Viejo, Calif., agreed that the crisis did not respect demographic boundaries. “Even in my sleepy suburban community,” the emergency department is “understaffed, underfunded, overworked, and overcrowded,” said Dr. Johnson, who also related anecdotes in place of his written testimony. He spoke of having to scramble to find an open bed for a child who was brought in—blue and choking—by his mother. Staff removed a less-ill patient from a bed, which was quickly occupied by the choking child. Dr. Johnson then reached into the child's trachea to fish out the offending apricot pit. But he had a moment where he thought he'd have to tend to the child on the floor.

“We have state-of-the-art technology, and yet we're practicing in a non-state-of-the-art environment,” echoed Dr. Robert E. O'Connor, incoming chair of emergency medicine at the University of Virginia, Charlottesville.

At the hearing, the physicians were well received by Democrats and Republicans.

“The fact of the matter is that we have a crisis in emergency care, and it is nationwide,” said acting panel chairman Elijah Cummings (D-Md.). “This begs the question: With a national emergency and trauma care system as fragile as ours, how would we manage the very real threats of a terrorist bombing, a natural disaster, or an outbreak of pandemic flu? Where is the surge capacity?”

Rep. Tom Davis (R-Va.) also questioned whether many of the nation's emergency departments are ready to handle a surge from a multiple-casualty highway crash, much less a terrorist event. The crisis has many roots, said Rep. Davis. “Legal, financial, and demographic trends have converged to punish the success of hospital emergency departments transformed by federal law into the de facto primary care provider for millions of the under- and uninsured,” he said.

Several committee members asked whether the 2006 Pandemic and All Hazards Preparedness Act had benefited emergency care. The answer: a resounding no.

“I don't think we could track a dime to actual practice at the bedside,” said Dr. Schwab.

But he and the other physicians emphasized that just throwing more money at emergency medicine would not be a panacea. “There's no way a simple solution can fix this,” said Dr. Schwab.

Rep. Cummings and other committee members took the Department of Health and Human Services to task for not ensuring that more of the Pandemic law's money made it directly to hospitals.

Dr. Kevin Yeskey, director of the Office of Preparedness and Emergency Operations at HHS, defended the agency, saying that federal money had been distributed to states, not directly to hospitals. But, he agreed that there should be more accountability for how the almost $3 billion in funds has been and will be distributed.

'We have state-of-the-art technology, and yet we're practicing in a non-state-of-the-art environment.' DR. O'CONNOR

WASHINGTON — Patients who are sicker, who are taking warfarin, and whose polyps are removed by snare with cautery are at higher risk for complications following screening or surveillance colonoscopy, according to an analysis presented at the annual Digestive Disease Week.

Overall, the incidence of serious complications after screening was 2.2 of every 1,000 exams, and it was 1.7/1,000 for potential related events, according to Dr. Cynthia Ko of the University of Washington, Seattle.

Dr. Ko and her colleagues prospectivelyassessed colonoscopies performed on 18,271 patients aged 40 years and older who were referred for average risk screening, surveillance of prior polyps or cancer, a family history of polyps or cancer, or follow-up after another diagnostic procedure, such as a positive result on a fecal occult blood test.

Patients were excluded if they had a history of recent gastrointestinal bleeding or of inflammatory bowel disease, or had an incomplete colonoscopy because of poor bowel preparation.

The researchers identified the study patients through the Clinical Outcomes Research Initiative, a database maintained by the Oregon Health and Science University, Portland.

Complication rates for surveillance and screening aren't well defined, Dr. Ko said. In the Washington study, patients were queried at 7 and 30 days after colonoscopy about new symptoms, physician visits, hospitalizations, and unplanned surgeries.

Related events included colon perforation, GI bleeding, diverticulitis, and postpolypectomy syndrome. Potentially related complications included cardiac and neurologic events.

The 18,271 patients came from 19 sites and received colonoscopies from 89 endoscopists. Related complication rates were 1.3/1,000 for GI bleeding requiring hospitalization, 0.8/1,000 for GI bleeding requiring transfusion, 0.9/1,000 for diverticulitis, 0.3/1,000 for diverticulitis requiring hospitalization, 0.1/1,000 for postpolypectomy syndrome, and 0.2/1,000 for perforation.

The authors also calculated an overall complication rate of 2.2/1,000, which included GI bleeding with transfusion, diverticulitis with hospitalization, perforation, or postpolypectomy syndrome. The serious complication rate was 1.4/1,000; serious complications included GI bleeding with hospitalization, diverticulitis with hospitalization, perforation, or postpolypectomy syndrome.

Potentially related events included angina or myocardial infarction (0.6/1,000), stroke or transient ischemic attack (0.4/1,000), and other events, including hospitalization for intravenous catheter site infections, abdominal pain, arrythmia, gallstones, kidney stones, and drug reactions (0.7/1,000).

Complications were higher for patients undergoing a surveillance or follow-up exam, and for those who were older. There were no complications among the 40- to 49-year-olds, compared with 4.4/1,000 among patients aged 80 and older.

There was a threefold increase in complications in patients who were American Society of Anesthesiologists class III, compared with class I or II patients; a fivefold increase in patients who took warfarin, compared with those who used aspirin or NSAIDs; and a fivefold increase for a polyp removed with cautery. If more than one polyp was removed, there was a 13-fold increase in complications, Dr. Ko said.

The study was supported by the National Institutes of Health and the Centers for Disease Control and Prevention.

WASHINGTON — Patients who are sicker, who are taking warfarin, and whose polyps are removed by snare with cautery are at higher risk for complications following screening or surveillance colonoscopy, according to an analysis presented at the annual Digestive Disease Week.

Overall, the incidence of serious complications after screening was 2.2 of every 1,000 exams, and it was 1.7/1,000 for potential related events, according to Dr. Cynthia Ko of the University of Washington, Seattle.

Dr. Ko and her colleagues prospectivelyassessed colonoscopies performed on 18,271 patients aged 40 years and older who were referred for average risk screening, surveillance of prior polyps or cancer, a family history of polyps or cancer, or follow-up after another diagnostic procedure, such as a positive result on a fecal occult blood test.

Patients were excluded if they had a history of recent gastrointestinal bleeding or of inflammatory bowel disease, or had an incomplete colonoscopy because of poor bowel preparation.

The researchers identified the study patients through the Clinical Outcomes Research Initiative, a database maintained by the Oregon Health and Science University, Portland.

Complication rates for surveillance and screening aren't well defined, Dr. Ko said. In the Washington study, patients were queried at 7 and 30 days after colonoscopy about new symptoms, physician visits, hospitalizations, and unplanned surgeries.

Related events included colon perforation, GI bleeding, diverticulitis, and postpolypectomy syndrome. Potentially related complications included cardiac and neurologic events.

The 18,271 patients came from 19 sites and received colonoscopies from 89 endoscopists. Related complication rates were 1.3/1,000 for GI bleeding requiring hospitalization, 0.8/1,000 for GI bleeding requiring transfusion, 0.9/1,000 for diverticulitis, 0.3/1,000 for diverticulitis requiring hospitalization, 0.1/1,000 for postpolypectomy syndrome, and 0.2/1,000 for perforation.

The authors also calculated an overall complication rate of 2.2/1,000, which included GI bleeding with transfusion, diverticulitis with hospitalization, perforation, or postpolypectomy syndrome. The serious complication rate was 1.4/1,000; serious complications included GI bleeding with hospitalization, diverticulitis with hospitalization, perforation, or postpolypectomy syndrome.

Potentially related events included angina or myocardial infarction (0.6/1,000), stroke or transient ischemic attack (0.4/1,000), and other events, including hospitalization for intravenous catheter site infections, abdominal pain, arrythmia, gallstones, kidney stones, and drug reactions (0.7/1,000).

Complications were higher for patients undergoing a surveillance or follow-up exam, and for those who were older. There were no complications among the 40- to 49-year-olds, compared with 4.4/1,000 among patients aged 80 and older.

There was a threefold increase in complications in patients who were American Society of Anesthesiologists class III, compared with class I or II patients; a fivefold increase in patients who took warfarin, compared with those who used aspirin or NSAIDs; and a fivefold increase for a polyp removed with cautery. If more than one polyp was removed, there was a 13-fold increase in complications, Dr. Ko said.

The study was supported by the National Institutes of Health and the Centers for Disease Control and Prevention.

WASHINGTON — Patients who are sicker, who are taking warfarin, and whose polyps are removed by snare with cautery are at higher risk for complications following screening or surveillance colonoscopy, according to an analysis presented at the annual Digestive Disease Week.

Overall, the incidence of serious complications after screening was 2.2 of every 1,000 exams, and it was 1.7/1,000 for potential related events, according to Dr. Cynthia Ko of the University of Washington, Seattle.

Dr. Ko and her colleagues prospectivelyassessed colonoscopies performed on 18,271 patients aged 40 years and older who were referred for average risk screening, surveillance of prior polyps or cancer, a family history of polyps or cancer, or follow-up after another diagnostic procedure, such as a positive result on a fecal occult blood test.

Patients were excluded if they had a history of recent gastrointestinal bleeding or of inflammatory bowel disease, or had an incomplete colonoscopy because of poor bowel preparation.

The researchers identified the study patients through the Clinical Outcomes Research Initiative, a database maintained by the Oregon Health and Science University, Portland.

Complication rates for surveillance and screening aren't well defined, Dr. Ko said. In the Washington study, patients were queried at 7 and 30 days after colonoscopy about new symptoms, physician visits, hospitalizations, and unplanned surgeries.

Related events included colon perforation, GI bleeding, diverticulitis, and postpolypectomy syndrome. Potentially related complications included cardiac and neurologic events.

The 18,271 patients came from 19 sites and received colonoscopies from 89 endoscopists. Related complication rates were 1.3/1,000 for GI bleeding requiring hospitalization, 0.8/1,000 for GI bleeding requiring transfusion, 0.9/1,000 for diverticulitis, 0.3/1,000 for diverticulitis requiring hospitalization, 0.1/1,000 for postpolypectomy syndrome, and 0.2/1,000 for perforation.

The authors also calculated an overall complication rate of 2.2/1,000, which included GI bleeding with transfusion, diverticulitis with hospitalization, perforation, or postpolypectomy syndrome. The serious complication rate was 1.4/1,000; serious complications included GI bleeding with hospitalization, diverticulitis with hospitalization, perforation, or postpolypectomy syndrome.

Potentially related events included angina or myocardial infarction (0.6/1,000), stroke or transient ischemic attack (0.4/1,000), and other events, including hospitalization for intravenous catheter site infections, abdominal pain, arrythmia, gallstones, kidney stones, and drug reactions (0.7/1,000).

Complications were higher for patients undergoing a surveillance or follow-up exam, and for those who were older. There were no complications among the 40- to 49-year-olds, compared with 4.4/1,000 among patients aged 80 and older.

There was a threefold increase in complications in patients who were American Society of Anesthesiologists class III, compared with class I or II patients; a fivefold increase in patients who took warfarin, compared with those who used aspirin or NSAIDs; and a fivefold increase for a polyp removed with cautery. If more than one polyp was removed, there was a 13-fold increase in complications, Dr. Ko said.

The study was supported by the National Institutes of Health and the Centers for Disease Control and Prevention.

Patients should avoid injection treatments to dissolve fat—known as mesotherapy or lipolysis—as they are neither safe nor effective, according to a warning from the American Society for Aesthetic Plastic Surgery.

An ASAPS spokeswoman said the organization issued the warning in the wake of concerns expressed by its membership at the annual meeting.

“The bottom line for patients is this: Don't allow yourself to be injected with an unknown and untested substance,” Dr. Foad Nahai, president of ASAPS, said in the statement.

Mesotherapy is not approved by the Food and Drug Administration. First practiced in France in the 1950s, the procedure involves multiple injections into the mesoderm of vitamins, plant extracts, minerals, homeopathic preparations, or traditional pharmaceuticals, depending on the condition targeted.

Practitioners claim there are few side effects, mainly burning, swelling and minor irritation.

But dermatologists note that there have been reports of serious infections and severely localized inflammation with mesotherapy.

“The bottom line is, long on hype, short on science,” said Dr. Richard G. Glogau, a dermatologist in private practice in San Francisco.

Dr. Robert A. Weiss of Johns Hopkins University, Baltimore, agreed on the potential dangers, and added, “I certainly warn my patients that it's unproven and could lead to the area possibly looking worse.”

The Aesthetic Surgery Education and Research Foundation is seeking Food and Drug Administration approval for a pilot study of lipolysis. In the 20-patient, 46-week placebo-controlled, double-blinded trial, patients will receive sham injections or injections of phosphatidylcholine/sodium deoxycholate, the most popular drug combination for lipolysis, Dr. Alan Gold, ASERF president, said in an interview. Evaluations will include histochemical and biochemical data and tissue scans. If the pilot is promising, the ASERF will conduct a multicenter trial, he said.

Patients should avoid injection treatments to dissolve fat—known as mesotherapy or lipolysis—as they are neither safe nor effective, according to a warning from the American Society for Aesthetic Plastic Surgery.

An ASAPS spokeswoman said the organization issued the warning in the wake of concerns expressed by its membership at the annual meeting.

“The bottom line for patients is this: Don't allow yourself to be injected with an unknown and untested substance,” Dr. Foad Nahai, president of ASAPS, said in the statement.

Mesotherapy is not approved by the Food and Drug Administration. First practiced in France in the 1950s, the procedure involves multiple injections into the mesoderm of vitamins, plant extracts, minerals, homeopathic preparations, or traditional pharmaceuticals, depending on the condition targeted.

Practitioners claim there are few side effects, mainly burning, swelling and minor irritation.

But dermatologists note that there have been reports of serious infections and severely localized inflammation with mesotherapy.

“The bottom line is, long on hype, short on science,” said Dr. Richard G. Glogau, a dermatologist in private practice in San Francisco.

Dr. Robert A. Weiss of Johns Hopkins University, Baltimore, agreed on the potential dangers, and added, “I certainly warn my patients that it's unproven and could lead to the area possibly looking worse.”

The Aesthetic Surgery Education and Research Foundation is seeking Food and Drug Administration approval for a pilot study of lipolysis. In the 20-patient, 46-week placebo-controlled, double-blinded trial, patients will receive sham injections or injections of phosphatidylcholine/sodium deoxycholate, the most popular drug combination for lipolysis, Dr. Alan Gold, ASERF president, said in an interview. Evaluations will include histochemical and biochemical data and tissue scans. If the pilot is promising, the ASERF will conduct a multicenter trial, he said.

Patients should avoid injection treatments to dissolve fat—known as mesotherapy or lipolysis—as they are neither safe nor effective, according to a warning from the American Society for Aesthetic Plastic Surgery.

An ASAPS spokeswoman said the organization issued the warning in the wake of concerns expressed by its membership at the annual meeting.

“The bottom line for patients is this: Don't allow yourself to be injected with an unknown and untested substance,” Dr. Foad Nahai, president of ASAPS, said in the statement.

Mesotherapy is not approved by the Food and Drug Administration. First practiced in France in the 1950s, the procedure involves multiple injections into the mesoderm of vitamins, plant extracts, minerals, homeopathic preparations, or traditional pharmaceuticals, depending on the condition targeted.

Practitioners claim there are few side effects, mainly burning, swelling and minor irritation.

But dermatologists note that there have been reports of serious infections and severely localized inflammation with mesotherapy.

“The bottom line is, long on hype, short on science,” said Dr. Richard G. Glogau, a dermatologist in private practice in San Francisco.

Dr. Robert A. Weiss of Johns Hopkins University, Baltimore, agreed on the potential dangers, and added, “I certainly warn my patients that it's unproven and could lead to the area possibly looking worse.”

The Aesthetic Surgery Education and Research Foundation is seeking Food and Drug Administration approval for a pilot study of lipolysis. In the 20-patient, 46-week placebo-controlled, double-blinded trial, patients will receive sham injections or injections of phosphatidylcholine/sodium deoxycholate, the most popular drug combination for lipolysis, Dr. Alan Gold, ASERF president, said in an interview. Evaluations will include histochemical and biochemical data and tissue scans. If the pilot is promising, the ASERF will conduct a multicenter trial, he said.

In 2006, Cigna Healthcare moved from fifth place to top ranking among national payers, and Aetna moved from fourth place to second, according to the second annual assessment of overall payment performance conducted by one of the nation's largest physician revenue management companies.

Not surprisingly, near the bottom of the list were state Medicaid programs.

The performance rankings were compiled for the second year in a row by AthenaHealth, a company based in Watertown, Mass., that collects about $2 billion a year on behalf of medical providers.

AthenaHealth used claims data from 8,000 providers, representing 28 million “charge lines,” or line items. The medical services were billed in 33 states. The ranking included national payers that had at least 120,000 charge lines as well as regional payers with at least 20,000 charge lines.

In 2005, Humana was the top-ranked payer, followed by Medicare. A year later, Medicare held the third position, while Humana dropped to fourth. Rounding out the top eight national payers were UnitedHealth Group, WellPoint, Coventry Health Care, and CHAMPUS/Tricare.

According to AthenaHealth, there were several trends observed from year to year. In 2006, days in accounts receivable (DAR) dropped by 5%, from 36.2 days to 34.4 days. Blue Cross & Blue Shield of Rhode Island had the lowest DAR at 16.8 days. New York's Medicaid plan had the highest, at 111 days.

Payers are also asking patients to pay more up front, which places a greater collections burden on physicians. Last year, there was a 19% increase in the amount of billed charges transferred to patients, according to AthenaHealth.

The overall ranking was based on how often claims were resolved on the first pass, the denial rate, denial transparency, percentage of noncompliance with national coding standards, and percentage of claims requiring medical documentation.

Denial rates ranged from a low of 4% at Cigna's southern plan to a high of 48% at Louisiana's Medicaid program. The Medicaid programs were laggards on all performance measures.

The Illinois Medicaid program paid medical claims on the first attempt only about 30% of the time, and was the second slowest payer overall, with an average 103 days to pay a claim. In Texas, physicians resubmitted denied claims at least twice 47% of the time, according to AthenaHealth.

“We are seeing disturbing administrative process breakdowns with some state Medicaid plans that are resulting in a growing number of physicians no longer accepting new Medicaid patients,” said Jonathan Bush, who is chairman and CEO of AthenaHealth.

The company said that some states have experimented with managed care as a solution to Medicaid's administrative difficulties. But in Georgia, that may have backfired.

A year after patients were moved into managed care, the Medical Association of Georgia “has had to troubleshoot more than 500 complaints from physicians, most of which should have been eliminated by the Care Management Organizations shortly after the start-up,” said Dr. S. William Clark, III.

The performance rankings are posted at www.athenapayerview.com

In 2006, Cigna Healthcare moved from fifth place to top ranking among national payers, and Aetna moved from fourth place to second, according to the second annual assessment of overall payment performance conducted by one of the nation's largest physician revenue management companies.

Not surprisingly, near the bottom of the list were state Medicaid programs.

The performance rankings were compiled for the second year in a row by AthenaHealth, a company based in Watertown, Mass., that collects about $2 billion a year on behalf of medical providers.

AthenaHealth used claims data from 8,000 providers, representing 28 million “charge lines,” or line items. The medical services were billed in 33 states. The ranking included national payers that had at least 120,000 charge lines as well as regional payers with at least 20,000 charge lines.

In 2005, Humana was the top-ranked payer, followed by Medicare. A year later, Medicare held the third position, while Humana dropped to fourth. Rounding out the top eight national payers were UnitedHealth Group, WellPoint, Coventry Health Care, and CHAMPUS/Tricare.

According to AthenaHealth, there were several trends observed from year to year. In 2006, days in accounts receivable (DAR) dropped by 5%, from 36.2 days to 34.4 days. Blue Cross & Blue Shield of Rhode Island had the lowest DAR at 16.8 days. New York's Medicaid plan had the highest, at 111 days.

Payers are also asking patients to pay more up front, which places a greater collections burden on physicians. Last year, there was a 19% increase in the amount of billed charges transferred to patients, according to AthenaHealth.

The overall ranking was based on how often claims were resolved on the first pass, the denial rate, denial transparency, percentage of noncompliance with national coding standards, and percentage of claims requiring medical documentation.

Denial rates ranged from a low of 4% at Cigna's southern plan to a high of 48% at Louisiana's Medicaid program. The Medicaid programs were laggards on all performance measures.

The Illinois Medicaid program paid medical claims on the first attempt only about 30% of the time, and was the second slowest payer overall, with an average 103 days to pay a claim. In Texas, physicians resubmitted denied claims at least twice 47% of the time, according to AthenaHealth.

“We are seeing disturbing administrative process breakdowns with some state Medicaid plans that are resulting in a growing number of physicians no longer accepting new Medicaid patients,” said Jonathan Bush, who is chairman and CEO of AthenaHealth.

The company said that some states have experimented with managed care as a solution to Medicaid's administrative difficulties. But in Georgia, that may have backfired.

A year after patients were moved into managed care, the Medical Association of Georgia “has had to troubleshoot more than 500 complaints from physicians, most of which should have been eliminated by the Care Management Organizations shortly after the start-up,” said Dr. S. William Clark, III.

The performance rankings are posted at www.athenapayerview.com

In 2006, Cigna Healthcare moved from fifth place to top ranking among national payers, and Aetna moved from fourth place to second, according to the second annual assessment of overall payment performance conducted by one of the nation's largest physician revenue management companies.

Not surprisingly, near the bottom of the list were state Medicaid programs.

The performance rankings were compiled for the second year in a row by AthenaHealth, a company based in Watertown, Mass., that collects about $2 billion a year on behalf of medical providers.

AthenaHealth used claims data from 8,000 providers, representing 28 million “charge lines,” or line items. The medical services were billed in 33 states. The ranking included national payers that had at least 120,000 charge lines as well as regional payers with at least 20,000 charge lines.

In 2005, Humana was the top-ranked payer, followed by Medicare. A year later, Medicare held the third position, while Humana dropped to fourth. Rounding out the top eight national payers were UnitedHealth Group, WellPoint, Coventry Health Care, and CHAMPUS/Tricare.

According to AthenaHealth, there were several trends observed from year to year. In 2006, days in accounts receivable (DAR) dropped by 5%, from 36.2 days to 34.4 days. Blue Cross & Blue Shield of Rhode Island had the lowest DAR at 16.8 days. New York's Medicaid plan had the highest, at 111 days.

Payers are also asking patients to pay more up front, which places a greater collections burden on physicians. Last year, there was a 19% increase in the amount of billed charges transferred to patients, according to AthenaHealth.

The overall ranking was based on how often claims were resolved on the first pass, the denial rate, denial transparency, percentage of noncompliance with national coding standards, and percentage of claims requiring medical documentation.

Denial rates ranged from a low of 4% at Cigna's southern plan to a high of 48% at Louisiana's Medicaid program. The Medicaid programs were laggards on all performance measures.

The Illinois Medicaid program paid medical claims on the first attempt only about 30% of the time, and was the second slowest payer overall, with an average 103 days to pay a claim. In Texas, physicians resubmitted denied claims at least twice 47% of the time, according to AthenaHealth.

“We are seeing disturbing administrative process breakdowns with some state Medicaid plans that are resulting in a growing number of physicians no longer accepting new Medicaid patients,” said Jonathan Bush, who is chairman and CEO of AthenaHealth.

The company said that some states have experimented with managed care as a solution to Medicaid's administrative difficulties. But in Georgia, that may have backfired.

A year after patients were moved into managed care, the Medical Association of Georgia “has had to troubleshoot more than 500 complaints from physicians, most of which should have been eliminated by the Care Management Organizations shortly after the start-up,” said Dr. S. William Clark, III.

The performance rankings are posted at www.athenapayerview.com

Under the Medicare final inpatient payment rule for fiscal 2008, many procedures to implant medical devices would see substantial payment increases, a development that has physicians and surgeons cautiously applauding.

A year ago, when the Centers for Medicare and Medicaid Services unveiled its inpatient payment proposal for fiscal 2007, it was met with dire predictions that access to crucial technologies would be diminished.

Interested parties argued that the agency's reliance on outdated cost data would end up chopping reimbursement for some procedures by as much as 30%.

The deep cuts disappeared in the final rule, however, and more recent data were used to calculate 2007 payments. For next fiscal year, CMS is still using a cost-based method, but with updated data, and is proposing to adjust payments based on illness severity with a new set of Medicare Severity diagnosis-related groups (MS-DRGs). Those 745 new DRGs—which have three levels of severity—replace the 538 current DRGs, which have only two levels.

As a result, payments for some procedures will rise if the rule is adopted.

To prevent hospitals from upcoding, CMS proposed about a 2% reduction in overall payments.

The bottom line: Hospitals will receive a 3.3% payment increase. To receive the full increase, hospitals must report to CMS on 27 quality measures, 6 more than last year. Some of the new measures are:

▸ Whether venous thromboembolism (VTE) prophylaxis was ordered for a surgery patient.

▸ Whether VTE prophylaxis was given within 24 hours before or after surgery.

▸ Whether antibiotics were given prophylactically for surgery patients.

▸ 30-day mortality for AMI patients.

▸ 30-day mortality for heart failure patients.

Under the proposed rule, hospitals will also now have a way to account for the receipt of free replacement devices sent by manufacturers after a recall. In the past, Medicare has paid for the devices because there was no way to cull them from the DRG for the replacement procedure. The new accounting method will also require hospitals to keep closer track of how often recalled devices are replaced.

In addition, hospitals will have to report secondary diagnoses present when patients are admitted. This is to fuel an effort to stop paying for conditions that develop in the hospital as a result of poor quality care, such as surgical infections. Beginning in fiscal 2009, CMS will not pay for some of these conditions under a higher DRG rate unless they were present at admission.

AdvaMed, a trade group for the medical device industry, said it was generally happy with the proposed final rule.

“The MS-DRGs maintain improvements to the patient classification system that have been made over the last few years to acknowledge rapid advancements in medical technology while improving the ability of the system to more precisely reflect the costs of more severely ill patients,” said AdvaMed President and CEO Stephen J. Ubl in a statement.

In a briefing with reporters, Mr. Ubl said that CMS's proposal still creates “charge compression,” by which the cost of low-technology devices is overstated and high technology, understated. The organization is also uncertain how hospitals will compensate when payments are reduced in some areas—a concern echoed by a spokesman for one surgeons' group and by the Heart Rhythm Society.

“On the face of it, it does make sense to pay hospitals more for patients who are sicker,” added Amy Melnick, vice president of health policy for HRS. The group is pleased with what it has seen so far, but is still reading through the proposal to analyze its potential impact, said Ms. Melnick.

CMS will publish a final rule before Oct. 1.

Under the Medicare final inpatient payment rule for fiscal 2008, many procedures to implant medical devices would see substantial payment increases, a development that has physicians and surgeons cautiously applauding.

A year ago, when the Centers for Medicare and Medicaid Services unveiled its inpatient payment proposal for fiscal 2007, it was met with dire predictions that access to crucial technologies would be diminished.

Interested parties argued that the agency's reliance on outdated cost data would end up chopping reimbursement for some procedures by as much as 30%.

The deep cuts disappeared in the final rule, however, and more recent data were used to calculate 2007 payments. For next fiscal year, CMS is still using a cost-based method, but with updated data, and is proposing to adjust payments based on illness severity with a new set of Medicare Severity diagnosis-related groups (MS-DRGs). Those 745 new DRGs—which have three levels of severity—replace the 538 current DRGs, which have only two levels.

As a result, payments for some procedures will rise if the rule is adopted.

To prevent hospitals from upcoding, CMS proposed about a 2% reduction in overall payments.

The bottom line: Hospitals will receive a 3.3% payment increase. To receive the full increase, hospitals must report to CMS on 27 quality measures, 6 more than last year. Some of the new measures are:

▸ Whether venous thromboembolism (VTE) prophylaxis was ordered for a surgery patient.

▸ Whether VTE prophylaxis was given within 24 hours before or after surgery.

▸ Whether antibiotics were given prophylactically for surgery patients.

▸ 30-day mortality for AMI patients.

▸ 30-day mortality for heart failure patients.

Under the proposed rule, hospitals will also now have a way to account for the receipt of free replacement devices sent by manufacturers after a recall. In the past, Medicare has paid for the devices because there was no way to cull them from the DRG for the replacement procedure. The new accounting method will also require hospitals to keep closer track of how often recalled devices are replaced.

In addition, hospitals will have to report secondary diagnoses present when patients are admitted. This is to fuel an effort to stop paying for conditions that develop in the hospital as a result of poor quality care, such as surgical infections. Beginning in fiscal 2009, CMS will not pay for some of these conditions under a higher DRG rate unless they were present at admission.

AdvaMed, a trade group for the medical device industry, said it was generally happy with the proposed final rule.

“The MS-DRGs maintain improvements to the patient classification system that have been made over the last few years to acknowledge rapid advancements in medical technology while improving the ability of the system to more precisely reflect the costs of more severely ill patients,” said AdvaMed President and CEO Stephen J. Ubl in a statement.

In a briefing with reporters, Mr. Ubl said that CMS's proposal still creates “charge compression,” by which the cost of low-technology devices is overstated and high technology, understated. The organization is also uncertain how hospitals will compensate when payments are reduced in some areas—a concern echoed by a spokesman for one surgeons' group and by the Heart Rhythm Society.

“On the face of it, it does make sense to pay hospitals more for patients who are sicker,” added Amy Melnick, vice president of health policy for HRS. The group is pleased with what it has seen so far, but is still reading through the proposal to analyze its potential impact, said Ms. Melnick.

CMS will publish a final rule before Oct. 1.

Under the Medicare final inpatient payment rule for fiscal 2008, many procedures to implant medical devices would see substantial payment increases, a development that has physicians and surgeons cautiously applauding.

A year ago, when the Centers for Medicare and Medicaid Services unveiled its inpatient payment proposal for fiscal 2007, it was met with dire predictions that access to crucial technologies would be diminished.

Interested parties argued that the agency's reliance on outdated cost data would end up chopping reimbursement for some procedures by as much as 30%.

The deep cuts disappeared in the final rule, however, and more recent data were used to calculate 2007 payments. For next fiscal year, CMS is still using a cost-based method, but with updated data, and is proposing to adjust payments based on illness severity with a new set of Medicare Severity diagnosis-related groups (MS-DRGs). Those 745 new DRGs—which have three levels of severity—replace the 538 current DRGs, which have only two levels.

As a result, payments for some procedures will rise if the rule is adopted.

To prevent hospitals from upcoding, CMS proposed about a 2% reduction in overall payments.

The bottom line: Hospitals will receive a 3.3% payment increase. To receive the full increase, hospitals must report to CMS on 27 quality measures, 6 more than last year. Some of the new measures are:

▸ Whether venous thromboembolism (VTE) prophylaxis was ordered for a surgery patient.

▸ Whether VTE prophylaxis was given within 24 hours before or after surgery.

▸ Whether antibiotics were given prophylactically for surgery patients.

▸ 30-day mortality for AMI patients.

▸ 30-day mortality for heart failure patients.

Under the proposed rule, hospitals will also now have a way to account for the receipt of free replacement devices sent by manufacturers after a recall. In the past, Medicare has paid for the devices because there was no way to cull them from the DRG for the replacement procedure. The new accounting method will also require hospitals to keep closer track of how often recalled devices are replaced.

In addition, hospitals will have to report secondary diagnoses present when patients are admitted. This is to fuel an effort to stop paying for conditions that develop in the hospital as a result of poor quality care, such as surgical infections. Beginning in fiscal 2009, CMS will not pay for some of these conditions under a higher DRG rate unless they were present at admission.

AdvaMed, a trade group for the medical device industry, said it was generally happy with the proposed final rule.

“The MS-DRGs maintain improvements to the patient classification system that have been made over the last few years to acknowledge rapid advancements in medical technology while improving the ability of the system to more precisely reflect the costs of more severely ill patients,” said AdvaMed President and CEO Stephen J. Ubl in a statement.

In a briefing with reporters, Mr. Ubl said that CMS's proposal still creates “charge compression,” by which the cost of low-technology devices is overstated and high technology, understated. The organization is also uncertain how hospitals will compensate when payments are reduced in some areas—a concern echoed by a spokesman for one surgeons' group and by the Heart Rhythm Society.

“On the face of it, it does make sense to pay hospitals more for patients who are sicker,” added Amy Melnick, vice president of health policy for HRS. The group is pleased with what it has seen so far, but is still reading through the proposal to analyze its potential impact, said Ms. Melnick.

CMS will publish a final rule before Oct. 1.

Penn. Publishes Surgery Data

The Pennsylvania Health Care Cost Containment Council has published data on 17,331 coronary artery bypass grafts (CABGs) and/or valve surgeries performed in the state in 2005. The data include in-hospital and 30-day mortality rates, 7- and 30-day readmission rates, and hospital- and surgeon-specific postsurgical lengths of stay. Inpatient mortality for CABG dropped from 1.98% in 2004 to 1.9% in 2005, but 7- and 30-day readmission rates increased slightly. The in-hospital death rate for those without infections was 2.4%, compared with 13.5% for those with infection. Overall mortality was 1.9% for CABG without valve; 3% for valve without CABG; and 7.5% for valve with CABG. Charges averaged $330,000 for those cases; on average, Medicare reimbursed about $57,000, and private insurers reimbursed about $65,000. The report also found that the amount paid by commercial payers and Medicare to each individual facility varied wildly, from a low of about $18,000 to a high of $106,000. Every hospital and surgeon in the state was given an opportunity to comment on the report. The Hospital of the University of Pennsylvania, for instance, noted that the majority of the 13 patients who died at its facility after a combined valve-CABG procedure were “at exceptionally high risk for perioperative death.” The report and associated comments can be found at

www.ph4c.org

Guidant Defib Suits Move Ahead

A U.S. District Court Judge in Minneapolis has ruled that a number of suits brought against Guidant Corp. can proceed. Guidant, now part of Boston Scientific Corp., was sued by 1,660 plaintiffs who allege that the company did not properly warn physicians and patients that its Model 1861 defibrillator had a design flaw. The model was recalled in 2005, but the suit contends that the company knew about the flaw in 2002. Boston Scientific has argued that the complaints should not be allowed to go forward because none of the plaintiffs were injured. However, Judge Donovan Frank said that the company should not be able to shirk liability just because the people alleging harm had their devices explanted. The first case is due to go to trial in late July. “We are fully prepared to take the bellwether cases to trial and remain confident that when juries look into the individual facts, they will side with us,” said Boston Scientific spokesman Paul Donovan in an interview.

Avandia-Related Suits Start

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

New FDA Risk Panel

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

DTC Ads Still Fall Short

Direct-to-consumer (DTC) advertisements emphasize individual drugs over conditions, don't do enough to emphasize risk, and minimize the importance of underlying health issues, according to a panel that reviewed such advertisements for the Pharmaceutical Research and Manufacturers of America. The review was undertaken to determine if consumer-directed marketing is meeting PhRMA's voluntary guiding principles, adopted in 2005 to address “many of the concerns publicly expressed about DTC advertising.” The four volunteer panelists–a pharmacist, a nurse, and two family physicians–also urged drug makers to include more information in their ads about assistance programs that provide low-cost or free medications. In a separate report, PhRMA said that comments it received from consumers on DTC ads indicated that many were confused about the ads' contents and thought they did not present a balance of risks and benefits. The organization received 458 comments from July to December 2006, mostly from consumers; 10% were from health professionals. The comments go to PhRMA's Office of Accountability, which forwards them for responses from individual drug makers.

Penn. Publishes Surgery Data

The Pennsylvania Health Care Cost Containment Council has published data on 17,331 coronary artery bypass grafts (CABGs) and/or valve surgeries performed in the state in 2005. The data include in-hospital and 30-day mortality rates, 7- and 30-day readmission rates, and hospital- and surgeon-specific postsurgical lengths of stay. Inpatient mortality for CABG dropped from 1.98% in 2004 to 1.9% in 2005, but 7- and 30-day readmission rates increased slightly. The in-hospital death rate for those without infections was 2.4%, compared with 13.5% for those with infection. Overall mortality was 1.9% for CABG without valve; 3% for valve without CABG; and 7.5% for valve with CABG. Charges averaged $330,000 for those cases; on average, Medicare reimbursed about $57,000, and private insurers reimbursed about $65,000. The report also found that the amount paid by commercial payers and Medicare to each individual facility varied wildly, from a low of about $18,000 to a high of $106,000. Every hospital and surgeon in the state was given an opportunity to comment on the report. The Hospital of the University of Pennsylvania, for instance, noted that the majority of the 13 patients who died at its facility after a combined valve-CABG procedure were “at exceptionally high risk for perioperative death.” The report and associated comments can be found at

www.ph4c.org

Guidant Defib Suits Move Ahead

A U.S. District Court Judge in Minneapolis has ruled that a number of suits brought against Guidant Corp. can proceed. Guidant, now part of Boston Scientific Corp., was sued by 1,660 plaintiffs who allege that the company did not properly warn physicians and patients that its Model 1861 defibrillator had a design flaw. The model was recalled in 2005, but the suit contends that the company knew about the flaw in 2002. Boston Scientific has argued that the complaints should not be allowed to go forward because none of the plaintiffs were injured. However, Judge Donovan Frank said that the company should not be able to shirk liability just because the people alleging harm had their devices explanted. The first case is due to go to trial in late July. “We are fully prepared to take the bellwether cases to trial and remain confident that when juries look into the individual facts, they will side with us,” said Boston Scientific spokesman Paul Donovan in an interview.

Avandia-Related Suits Start

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

New FDA Risk Panel

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

DTC Ads Still Fall Short

Direct-to-consumer (DTC) advertisements emphasize individual drugs over conditions, don't do enough to emphasize risk, and minimize the importance of underlying health issues, according to a panel that reviewed such advertisements for the Pharmaceutical Research and Manufacturers of America. The review was undertaken to determine if consumer-directed marketing is meeting PhRMA's voluntary guiding principles, adopted in 2005 to address “many of the concerns publicly expressed about DTC advertising.” The four volunteer panelists–a pharmacist, a nurse, and two family physicians–also urged drug makers to include more information in their ads about assistance programs that provide low-cost or free medications. In a separate report, PhRMA said that comments it received from consumers on DTC ads indicated that many were confused about the ads' contents and thought they did not present a balance of risks and benefits. The organization received 458 comments from July to December 2006, mostly from consumers; 10% were from health professionals. The comments go to PhRMA's Office of Accountability, which forwards them for responses from individual drug makers.

Penn. Publishes Surgery Data

The Pennsylvania Health Care Cost Containment Council has published data on 17,331 coronary artery bypass grafts (CABGs) and/or valve surgeries performed in the state in 2005. The data include in-hospital and 30-day mortality rates, 7- and 30-day readmission rates, and hospital- and surgeon-specific postsurgical lengths of stay. Inpatient mortality for CABG dropped from 1.98% in 2004 to 1.9% in 2005, but 7- and 30-day readmission rates increased slightly. The in-hospital death rate for those without infections was 2.4%, compared with 13.5% for those with infection. Overall mortality was 1.9% for CABG without valve; 3% for valve without CABG; and 7.5% for valve with CABG. Charges averaged $330,000 for those cases; on average, Medicare reimbursed about $57,000, and private insurers reimbursed about $65,000. The report also found that the amount paid by commercial payers and Medicare to each individual facility varied wildly, from a low of about $18,000 to a high of $106,000. Every hospital and surgeon in the state was given an opportunity to comment on the report. The Hospital of the University of Pennsylvania, for instance, noted that the majority of the 13 patients who died at its facility after a combined valve-CABG procedure were “at exceptionally high risk for perioperative death.” The report and associated comments can be found at

www.ph4c.org

Guidant Defib Suits Move Ahead

A U.S. District Court Judge in Minneapolis has ruled that a number of suits brought against Guidant Corp. can proceed. Guidant, now part of Boston Scientific Corp., was sued by 1,660 plaintiffs who allege that the company did not properly warn physicians and patients that its Model 1861 defibrillator had a design flaw. The model was recalled in 2005, but the suit contends that the company knew about the flaw in 2002. Boston Scientific has argued that the complaints should not be allowed to go forward because none of the plaintiffs were injured. However, Judge Donovan Frank said that the company should not be able to shirk liability just because the people alleging harm had their devices explanted. The first case is due to go to trial in late July. “We are fully prepared to take the bellwether cases to trial and remain confident that when juries look into the individual facts, they will side with us,” said Boston Scientific spokesman Paul Donovan in an interview.

Avandia-Related Suits Start

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

New FDA Risk Panel

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

DTC Ads Still Fall Short

Direct-to-consumer (DTC) advertisements emphasize individual drugs over conditions, don't do enough to emphasize risk, and minimize the importance of underlying health issues, according to a panel that reviewed such advertisements for the Pharmaceutical Research and Manufacturers of America. The review was undertaken to determine if consumer-directed marketing is meeting PhRMA's voluntary guiding principles, adopted in 2005 to address “many of the concerns publicly expressed about DTC advertising.” The four volunteer panelists–a pharmacist, a nurse, and two family physicians–also urged drug makers to include more information in their ads about assistance programs that provide low-cost or free medications. In a separate report, PhRMA said that comments it received from consumers on DTC ads indicated that many were confused about the ads' contents and thought they did not present a balance of risks and benefits. The organization received 458 comments from July to December 2006, mostly from consumers; 10% were from health professionals. The comments go to PhRMA's Office of Accountability, which forwards them for responses from individual drug makers.

CHICAGO — Major depressive disorder, bipolar disorder, panic disorder, and social phobia were diagnosed twice as often in those with migraine as in those without headache in a major Canadian population survey, Dr. Nathalie Jette said at the American Headache Society meeting.

The data came from the Canadian Community Health Survey, which was conducted in 2002, said Dr. Jette, of the clinical neurosciences department at the University of Calgary, Alta.

Some 36,984 Canadian residents were randomly selected for the survey. Of these, 70% agreed to participate; all the subjects were interviewed at home by trained interviewers, she said.

In the survey, 15% of women and 6% of men self-reported that they had physician-diagnosed migraine. Mental health was assessed using the World Health Mental Composite International Diagnostic Interview.

Psychiatric comorbidities were twice as common in those with migraine than in those without headache. But, after assessing the data, the researchers found that the higher prevalence of psychiatric disorders in migraineurs was not related to sociodemographics.

Major depression and bipolar disorder were more common among migraineurs. Middle- and higher-income respondents were less likely to have either condition, regardless of headache status, Dr. Jette said.

The authors also analyzed survey data on health-related outcomes, including 2-week disability, restrictions on activities, quality of life, and use of mental health care. They found that patients with a combination of migraine and major depressive disorder, bipolar disorder, panic disorder or social phobia had a reduced likelihood of a good health outcome, said Dr. Jette, who reported no conflicts of interest.

CHICAGO — Major depressive disorder, bipolar disorder, panic disorder, and social phobia were diagnosed twice as often in those with migraine as in those without headache in a major Canadian population survey, Dr. Nathalie Jette said at the American Headache Society meeting.

The data came from the Canadian Community Health Survey, which was conducted in 2002, said Dr. Jette, of the clinical neurosciences department at the University of Calgary, Alta.

Some 36,984 Canadian residents were randomly selected for the survey. Of these, 70% agreed to participate; all the subjects were interviewed at home by trained interviewers, she said.

In the survey, 15% of women and 6% of men self-reported that they had physician-diagnosed migraine. Mental health was assessed using the World Health Mental Composite International Diagnostic Interview.

Psychiatric comorbidities were twice as common in those with migraine than in those without headache. But, after assessing the data, the researchers found that the higher prevalence of psychiatric disorders in migraineurs was not related to sociodemographics.

Major depression and bipolar disorder were more common among migraineurs. Middle- and higher-income respondents were less likely to have either condition, regardless of headache status, Dr. Jette said.

The authors also analyzed survey data on health-related outcomes, including 2-week disability, restrictions on activities, quality of life, and use of mental health care. They found that patients with a combination of migraine and major depressive disorder, bipolar disorder, panic disorder or social phobia had a reduced likelihood of a good health outcome, said Dr. Jette, who reported no conflicts of interest.

CHICAGO — Major depressive disorder, bipolar disorder, panic disorder, and social phobia were diagnosed twice as often in those with migraine as in those without headache in a major Canadian population survey, Dr. Nathalie Jette said at the American Headache Society meeting.

The data came from the Canadian Community Health Survey, which was conducted in 2002, said Dr. Jette, of the clinical neurosciences department at the University of Calgary, Alta.

Some 36,984 Canadian residents were randomly selected for the survey. Of these, 70% agreed to participate; all the subjects were interviewed at home by trained interviewers, she said.

In the survey, 15% of women and 6% of men self-reported that they had physician-diagnosed migraine. Mental health was assessed using the World Health Mental Composite International Diagnostic Interview.

Psychiatric comorbidities were twice as common in those with migraine than in those without headache. But, after assessing the data, the researchers found that the higher prevalence of psychiatric disorders in migraineurs was not related to sociodemographics.

Major depression and bipolar disorder were more common among migraineurs. Middle- and higher-income respondents were less likely to have either condition, regardless of headache status, Dr. Jette said.

The authors also analyzed survey data on health-related outcomes, including 2-week disability, restrictions on activities, quality of life, and use of mental health care. They found that patients with a combination of migraine and major depressive disorder, bipolar disorder, panic disorder or social phobia had a reduced likelihood of a good health outcome, said Dr. Jette, who reported no conflicts of interest.

The Food and Drug Administration is proposing to beef up its conflict-of-interest guidelines for experts who serve on its advisory committees, the agency announced in a teleconference.

Proposed guidelines would bar experts with stock or other financial interests worth more than $50,000 in a particular company from reviewing that manufacturer's product and ban voting by those who receive or own less than $50,000.

The $50,000 rule would be applied to any holdings or interest within 12 months of an advisory panel meeting.

The proposal was billed by FDA officials as an upgrade of guidelines that have been in effect since 2000 and were made partly in response to public demands for more accountability, according to Randall Lutter, FDA acting deputy commissioner for policy.

“[The] FDA is committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees,” said Mr. Lutter in a statement issued by the agency.

However, in the briefing, he said the FDA “was not aware of any instances where decision making has been adversely affected by conflicts members might have.” The new guidance attempts to balance the quest for transparency with the need for qualified experts, Mr. Lutter said.

As in the past, the guidelines are not legally binding. They are offered as suggestions to staff evaluating potential conflicts of interest by both government and nongovernment employees. It is rare for staff to make decisions that fall outside of the guidance, though, and waivers will likely only rarely be granted, Mr. Lutter said. For instance, if a panel member has received an individual grant or other fee of less than $50,000 from a company for work in the hematology area, but is reviewing the company's cardiology drug or device, that person might be allowed to participate in the panel meeting.

Mr. Lutter and other agency officials would not say how they came up with the $50,000 threshold or how many current advisory panel members might be disqualified based on that figure. However, said Mr. Lutter, “our judgment is, it is a significant number.”

The proposed restriction would apply to stocks and investments, primary employment, consulting work, contracts and grants, royalties, expert witness work, and speaking and writing fees. It would not apply to mutual funds. The $50,000 figure would be increased each year in line with the consumer price index, according to the proposal.

A critic of the FDA's conflict-of-interest policies said the new guidance is a significant step forward in part because it would bar participants from voting if they had a financial conflict.

They “will be identified as committee members with a taint,” said Peter Lurie, deputy director of Public Citizen's Health Research Group. In the past, even nonvoting members could influence a panel's decision, he said, adding that the new proposal will act as a “countermeasure.”

The proposed rules also could “drive the conflict rate lower,” said Mr. Lurie, noting that when it comes to recruiting new advisory committee members, “there's going to be a premium on finding those who don't have conflicts.”

To submit electronic comments on the draft guidance, visit www.regulations.govwww.fda.gov/dockets/ecomments

The Food and Drug Administration is proposing to beef up its conflict-of-interest guidelines for experts who serve on its advisory committees, the agency announced in a teleconference.

Proposed guidelines would bar experts with stock or other financial interests worth more than $50,000 in a particular company from reviewing that manufacturer's product and ban voting by those who receive or own less than $50,000.

The $50,000 rule would be applied to any holdings or interest within 12 months of an advisory panel meeting.

The proposal was billed by FDA officials as an upgrade of guidelines that have been in effect since 2000 and were made partly in response to public demands for more accountability, according to Randall Lutter, FDA acting deputy commissioner for policy.

“[The] FDA is committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees,” said Mr. Lutter in a statement issued by the agency.

However, in the briefing, he said the FDA “was not aware of any instances where decision making has been adversely affected by conflicts members might have.” The new guidance attempts to balance the quest for transparency with the need for qualified experts, Mr. Lutter said.

As in the past, the guidelines are not legally binding. They are offered as suggestions to staff evaluating potential conflicts of interest by both government and nongovernment employees. It is rare for staff to make decisions that fall outside of the guidance, though, and waivers will likely only rarely be granted, Mr. Lutter said. For instance, if a panel member has received an individual grant or other fee of less than $50,000 from a company for work in the hematology area, but is reviewing the company's cardiology drug or device, that person might be allowed to participate in the panel meeting.

Mr. Lutter and other agency officials would not say how they came up with the $50,000 threshold or how many current advisory panel members might be disqualified based on that figure. However, said Mr. Lutter, “our judgment is, it is a significant number.”

The proposed restriction would apply to stocks and investments, primary employment, consulting work, contracts and grants, royalties, expert witness work, and speaking and writing fees. It would not apply to mutual funds. The $50,000 figure would be increased each year in line with the consumer price index, according to the proposal.

A critic of the FDA's conflict-of-interest policies said the new guidance is a significant step forward in part because it would bar participants from voting if they had a financial conflict.

They “will be identified as committee members with a taint,” said Peter Lurie, deputy director of Public Citizen's Health Research Group. In the past, even nonvoting members could influence a panel's decision, he said, adding that the new proposal will act as a “countermeasure.”

The proposed rules also could “drive the conflict rate lower,” said Mr. Lurie, noting that when it comes to recruiting new advisory committee members, “there's going to be a premium on finding those who don't have conflicts.”

To submit electronic comments on the draft guidance, visit www.regulations.govwww.fda.gov/dockets/ecomments

The Food and Drug Administration is proposing to beef up its conflict-of-interest guidelines for experts who serve on its advisory committees, the agency announced in a teleconference.

Proposed guidelines would bar experts with stock or other financial interests worth more than $50,000 in a particular company from reviewing that manufacturer's product and ban voting by those who receive or own less than $50,000.

The $50,000 rule would be applied to any holdings or interest within 12 months of an advisory panel meeting.

The proposal was billed by FDA officials as an upgrade of guidelines that have been in effect since 2000 and were made partly in response to public demands for more accountability, according to Randall Lutter, FDA acting deputy commissioner for policy.

“[The] FDA is committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees,” said Mr. Lutter in a statement issued by the agency.

However, in the briefing, he said the FDA “was not aware of any instances where decision making has been adversely affected by conflicts members might have.” The new guidance attempts to balance the quest for transparency with the need for qualified experts, Mr. Lutter said.

As in the past, the guidelines are not legally binding. They are offered as suggestions to staff evaluating potential conflicts of interest by both government and nongovernment employees. It is rare for staff to make decisions that fall outside of the guidance, though, and waivers will likely only rarely be granted, Mr. Lutter said. For instance, if a panel member has received an individual grant or other fee of less than $50,000 from a company for work in the hematology area, but is reviewing the company's cardiology drug or device, that person might be allowed to participate in the panel meeting.

Mr. Lutter and other agency officials would not say how they came up with the $50,000 threshold or how many current advisory panel members might be disqualified based on that figure. However, said Mr. Lutter, “our judgment is, it is a significant number.”

The proposed restriction would apply to stocks and investments, primary employment, consulting work, contracts and grants, royalties, expert witness work, and speaking and writing fees. It would not apply to mutual funds. The $50,000 figure would be increased each year in line with the consumer price index, according to the proposal.

A critic of the FDA's conflict-of-interest policies said the new guidance is a significant step forward in part because it would bar participants from voting if they had a financial conflict.

They “will be identified as committee members with a taint,” said Peter Lurie, deputy director of Public Citizen's Health Research Group. In the past, even nonvoting members could influence a panel's decision, he said, adding that the new proposal will act as a “countermeasure.”

The proposed rules also could “drive the conflict rate lower,” said Mr. Lurie, noting that when it comes to recruiting new advisory committee members, “there's going to be a premium on finding those who don't have conflicts.”

To submit electronic comments on the draft guidance, visit www.regulations.govwww.fda.gov/dockets/ecomments

Soon after the Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee voted unanimously against recommending approval of the weight-loss drug Zimulti, Sanofi-Aventis withdrew its new drug application, saying it needed time to discuss the panel's findings with the FDA.

The agency had been required to act on the Zimulti (rimonabant) application by July 26, and the likely result would have been a “nonapprovable” letter. The committee's recommendations are not binding, but the FDA generally follows its advice.

The panel members said at their June 13 meeting in Silver Spring, Md., that although they believed that the drug effectively helped patients lose about 5% of body weight, questions about psychiatric and neurologic side effects were too numerous. The advisory committee also expressed concerns about a high number of drop-outs in the company's four pivotal studies and about whether Zimulti was safe for long-term use.

Sanofi said Zimulti would have to be taken daily for a lifetime to combat what it called a chronic condition.

“There's much good about rimonabant,” said obesity expert Dr. Jules Hirsch of the Rockefeller University in New York, a temporary member of the FDA panel. He lauded the drug's ability to help patients lose weight and to improve triglyceride, HDL-cholesterol, and hemoglobin A_1c levels. “But I wouldn't in any way suggest that it be approved at the present time for use,” he added, citing safety concerns.

Sanofi repeatedly told the panel it would insist that Zimulti only be prescribed to patients who were prepared to comply with diet and exercise counseling, and who did not have a history of depression or epilepsy and were not currently receiving therapy for either of those conditions. The company also said it would ask physicians to administer a two-question depression screen to patients before prescribing Zimulti, and that it would monitor doctors' prescribing habits through regular surveys that would tell the company if depressed or epileptic patients were getting the drug.

Panelists were impressed but not swayed. “This is a real quandary for me,” said Dr. Wayne Goodman, chairman of psychiatry department at the University of Florida, Gainesville. “There are very few effective treatments for obesity out there … I don't want to deny this option.” However, Dr. Goodman said he could not vote for approval because of concerns about higher rates of depression, anxiety, and suicidality among Zimulti patients.

Zimulti is approved in 37 countries, but is currently only marketed in 18, according to Sanofi. It is indicated as an adjunct to diet and exercise for obese patients (those with a body mass index greater than 30 kg/m

Sanofi initially sought the same indication in the United States, along with using it in combination with metformin or a sulfonylurea to improve glycemic control and reduce weight in type 2 diabetes. The company later dropped the diabetes indication.

Although it voted against recommending approval, the advisory committee said it was willing to reconsider the issue after Sanofi completes the 17,000-patient Comprehensive Rimonabant Evaluation Study of Cardiovascular Endpoints and Outcomes (CRESCENDO) in 2010; that study will have 5-year follow-up data on patients.

In announcing its NDAwithdrawal, Sanofi did not say whether it would wait until those results are in. But the company did acknowledge that duration of treatment was a major concern of the panel. The reason for withdrawal was “our difficulty [in understanding] some points raised by the advisory panel and written in the minutes of the advisory committee from the FDA, such as the duration of treatment requested for a chronic disease like obesity,” said Marc Cluzel, Sanofi's senior vice president of scientific and medical affairs, in a June 29 conference call. “We thought that we have not enough time up to the [Prescription Drug User Fee Act] date to discuss this point with the FDA.”

The company will continue with its clinical program in rimonabant and will “quickly approach the FDAin order to determine together the most suitable label for Zimulti and the activities to be performed in order to resubmit,” he said.

The pivotal data came from four international multicenter studies that were part of the Rimonabant in Obesity and Related Metabolic Disorders (RIO) trials: RIO-North America, which involved 3,040 obese or overweight patients without comorbidities who were randomized to drug (5 mg or 20 mg) or placebo for a year, followed by having half of each group randomized to placebo for another year; RIO-Europe, a 2-year study with 1,507 patients similar to those in RIO-North America; RIO-Lipids, a 1-year trial involving 1,033 obese patients with untreated dyslipidemia; and RIO-Diabetes, a 1-year trial involving 1,045 obese or overweight patients with type 2 diabetes who were taking either metformin or a sulfonylurea.

Patients had a mean BMI of 34–37 in those studies, and a mean age of 45–55. Overall, they lost 9–12 pounds, or about 5% of baseline weight, though there was a trend toward a plateauing and then weight increase at the 2-year mark. In RIO-Lipids, patients taking the 20-mg dose saw an increase in HDL cholesterol of about 8% and a decrease in triglycerides of 12%.

Neither the panel nor the FDA questioned Zimulti's effectiveness; instead, safety was the big concern.

Sanofi classified rimonabant as a selective and neutral antagonist of the cannabinoid-1 receptor. But some panelists questioned whether some of the psychiatric and neurologic side effects with Zimulti might indicate that it was acting as an inverse agonist on the endocannabinoid system, meaning the drug would lock the receptors into inactivity and lead to negative consequences.

The FDA estimated that the relative risk for psychiatric adverse events in patients taking Zimulti in the four trials was 1.9, compared with placebo, and for neurologic adverse events the relative risk was 1.7. Four completed suicides have been reported for all of the company's completed and ongoing trials, said Dr. Amy G. Egan of the FDA's division of metabolic and endocrine products.

Because of the high drop-out rate seen in the trials–32%–49% in the first year, and 23%–58% in the second year–the relative risk may be underestimated, said Dr. Egan.

Zimulti appeared to double the risk of psychiatric adverse events, increased a variety of neurologic events, and increased nausea and vomiting, said Dr. Egan, adding that many of the risks “appear to be more pronounced in diabetics.”

The depression-obesity interrelationship gave pause to Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. “The evidence for increased suicidality and depression is of particular concern for a drug targeted towards the obese, a population that has been shown to have a significantly higher incidence of depression,” he told the advisory committee.

Soon after the Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee voted unanimously against recommending approval of the weight-loss drug Zimulti, Sanofi-Aventis withdrew its new drug application, saying it needed time to discuss the panel's findings with the FDA.

The agency had been required to act on the Zimulti (rimonabant) application by July 26, and the likely result would have been a “nonapprovable” letter. The committee's recommendations are not binding, but the FDA generally follows its advice.

The panel members said at their June 13 meeting in Silver Spring, Md., that although they believed that the drug effectively helped patients lose about 5% of body weight, questions about psychiatric and neurologic side effects were too numerous. The advisory committee also expressed concerns about a high number of drop-outs in the company's four pivotal studies and about whether Zimulti was safe for long-term use.

Sanofi said Zimulti would have to be taken daily for a lifetime to combat what it called a chronic condition.

“There's much good about rimonabant,” said obesity expert Dr. Jules Hirsch of the Rockefeller University in New York, a temporary member of the FDA panel. He lauded the drug's ability to help patients lose weight and to improve triglyceride, HDL-cholesterol, and hemoglobin A_1c levels. “But I wouldn't in any way suggest that it be approved at the present time for use,” he added, citing safety concerns.

Sanofi repeatedly told the panel it would insist that Zimulti only be prescribed to patients who were prepared to comply with diet and exercise counseling, and who did not have a history of depression or epilepsy and were not currently receiving therapy for either of those conditions. The company also said it would ask physicians to administer a two-question depression screen to patients before prescribing Zimulti, and that it would monitor doctors' prescribing habits through regular surveys that would tell the company if depressed or epileptic patients were getting the drug.

Panelists were impressed but not swayed. “This is a real quandary for me,” said Dr. Wayne Goodman, chairman of psychiatry department at the University of Florida, Gainesville. “There are very few effective treatments for obesity out there … I don't want to deny this option.” However, Dr. Goodman said he could not vote for approval because of concerns about higher rates of depression, anxiety, and suicidality among Zimulti patients.

Zimulti is approved in 37 countries, but is currently only marketed in 18, according to Sanofi. It is indicated as an adjunct to diet and exercise for obese patients (those with a body mass index greater than 30 kg/m

Sanofi initially sought the same indication in the United States, along with using it in combination with metformin or a sulfonylurea to improve glycemic control and reduce weight in type 2 diabetes. The company later dropped the diabetes indication.

Although it voted against recommending approval, the advisory committee said it was willing to reconsider the issue after Sanofi completes the 17,000-patient Comprehensive Rimonabant Evaluation Study of Cardiovascular Endpoints and Outcomes (CRESCENDO) in 2010; that study will have 5-year follow-up data on patients.

In announcing its NDAwithdrawal, Sanofi did not say whether it would wait until those results are in. But the company did acknowledge that duration of treatment was a major concern of the panel. The reason for withdrawal was “our difficulty [in understanding] some points raised by the advisory panel and written in the minutes of the advisory committee from the FDA, such as the duration of treatment requested for a chronic disease like obesity,” said Marc Cluzel, Sanofi's senior vice president of scientific and medical affairs, in a June 29 conference call. “We thought that we have not enough time up to the [Prescription Drug User Fee Act] date to discuss this point with the FDA.”

The company will continue with its clinical program in rimonabant and will “quickly approach the FDAin order to determine together the most suitable label for Zimulti and the activities to be performed in order to resubmit,” he said.

The pivotal data came from four international multicenter studies that were part of the Rimonabant in Obesity and Related Metabolic Disorders (RIO) trials: RIO-North America, which involved 3,040 obese or overweight patients without comorbidities who were randomized to drug (5 mg or 20 mg) or placebo for a year, followed by having half of each group randomized to placebo for another year; RIO-Europe, a 2-year study with 1,507 patients similar to those in RIO-North America; RIO-Lipids, a 1-year trial involving 1,033 obese patients with untreated dyslipidemia; and RIO-Diabetes, a 1-year trial involving 1,045 obese or overweight patients with type 2 diabetes who were taking either metformin or a sulfonylurea.

Patients had a mean BMI of 34–37 in those studies, and a mean age of 45–55. Overall, they lost 9–12 pounds, or about 5% of baseline weight, though there was a trend toward a plateauing and then weight increase at the 2-year mark. In RIO-Lipids, patients taking the 20-mg dose saw an increase in HDL cholesterol of about 8% and a decrease in triglycerides of 12%.

Neither the panel nor the FDA questioned Zimulti's effectiveness; instead, safety was the big concern.

Sanofi classified rimonabant as a selective and neutral antagonist of the cannabinoid-1 receptor. But some panelists questioned whether some of the psychiatric and neurologic side effects with Zimulti might indicate that it was acting as an inverse agonist on the endocannabinoid system, meaning the drug would lock the receptors into inactivity and lead to negative consequences.

The FDA estimated that the relative risk for psychiatric adverse events in patients taking Zimulti in the four trials was 1.9, compared with placebo, and for neurologic adverse events the relative risk was 1.7. Four completed suicides have been reported for all of the company's completed and ongoing trials, said Dr. Amy G. Egan of the FDA's division of metabolic and endocrine products.

Because of the high drop-out rate seen in the trials–32%–49% in the first year, and 23%–58% in the second year–the relative risk may be underestimated, said Dr. Egan.

Zimulti appeared to double the risk of psychiatric adverse events, increased a variety of neurologic events, and increased nausea and vomiting, said Dr. Egan, adding that many of the risks “appear to be more pronounced in diabetics.”

The depression-obesity interrelationship gave pause to Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. “The evidence for increased suicidality and depression is of particular concern for a drug targeted towards the obese, a population that has been shown to have a significantly higher incidence of depression,” he told the advisory committee.

Soon after the Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee voted unanimously against recommending approval of the weight-loss drug Zimulti, Sanofi-Aventis withdrew its new drug application, saying it needed time to discuss the panel's findings with the FDA.

The agency had been required to act on the Zimulti (rimonabant) application by July 26, and the likely result would have been a “nonapprovable” letter. The committee's recommendations are not binding, but the FDA generally follows its advice.

The panel members said at their June 13 meeting in Silver Spring, Md., that although they believed that the drug effectively helped patients lose about 5% of body weight, questions about psychiatric and neurologic side effects were too numerous. The advisory committee also expressed concerns about a high number of drop-outs in the company's four pivotal studies and about whether Zimulti was safe for long-term use.

Sanofi said Zimulti would have to be taken daily for a lifetime to combat what it called a chronic condition.

“There's much good about rimonabant,” said obesity expert Dr. Jules Hirsch of the Rockefeller University in New York, a temporary member of the FDA panel. He lauded the drug's ability to help patients lose weight and to improve triglyceride, HDL-cholesterol, and hemoglobin A_1c levels. “But I wouldn't in any way suggest that it be approved at the present time for use,” he added, citing safety concerns.

Sanofi repeatedly told the panel it would insist that Zimulti only be prescribed to patients who were prepared to comply with diet and exercise counseling, and who did not have a history of depression or epilepsy and were not currently receiving therapy for either of those conditions. The company also said it would ask physicians to administer a two-question depression screen to patients before prescribing Zimulti, and that it would monitor doctors' prescribing habits through regular surveys that would tell the company if depressed or epileptic patients were getting the drug.

Panelists were impressed but not swayed. “This is a real quandary for me,” said Dr. Wayne Goodman, chairman of psychiatry department at the University of Florida, Gainesville. “There are very few effective treatments for obesity out there … I don't want to deny this option.” However, Dr. Goodman said he could not vote for approval because of concerns about higher rates of depression, anxiety, and suicidality among Zimulti patients.

Zimulti is approved in 37 countries, but is currently only marketed in 18, according to Sanofi. It is indicated as an adjunct to diet and exercise for obese patients (those with a body mass index greater than 30 kg/m

Sanofi initially sought the same indication in the United States, along with using it in combination with metformin or a sulfonylurea to improve glycemic control and reduce weight in type 2 diabetes. The company later dropped the diabetes indication.

Although it voted against recommending approval, the advisory committee said it was willing to reconsider the issue after Sanofi completes the 17,000-patient Comprehensive Rimonabant Evaluation Study of Cardiovascular Endpoints and Outcomes (CRESCENDO) in 2010; that study will have 5-year follow-up data on patients.

In announcing its NDAwithdrawal, Sanofi did not say whether it would wait until those results are in. But the company did acknowledge that duration of treatment was a major concern of the panel. The reason for withdrawal was “our difficulty [in understanding] some points raised by the advisory panel and written in the minutes of the advisory committee from the FDA, such as the duration of treatment requested for a chronic disease like obesity,” said Marc Cluzel, Sanofi's senior vice president of scientific and medical affairs, in a June 29 conference call. “We thought that we have not enough time up to the [Prescription Drug User Fee Act] date to discuss this point with the FDA.”

The company will continue with its clinical program in rimonabant and will “quickly approach the FDAin order to determine together the most suitable label for Zimulti and the activities to be performed in order to resubmit,” he said.

The pivotal data came from four international multicenter studies that were part of the Rimonabant in Obesity and Related Metabolic Disorders (RIO) trials: RIO-North America, which involved 3,040 obese or overweight patients without comorbidities who were randomized to drug (5 mg or 20 mg) or placebo for a year, followed by having half of each group randomized to placebo for another year; RIO-Europe, a 2-year study with 1,507 patients similar to those in RIO-North America; RIO-Lipids, a 1-year trial involving 1,033 obese patients with untreated dyslipidemia; and RIO-Diabetes, a 1-year trial involving 1,045 obese or overweight patients with type 2 diabetes who were taking either metformin or a sulfonylurea.

Patients had a mean BMI of 34–37 in those studies, and a mean age of 45–55. Overall, they lost 9–12 pounds, or about 5% of baseline weight, though there was a trend toward a plateauing and then weight increase at the 2-year mark. In RIO-Lipids, patients taking the 20-mg dose saw an increase in HDL cholesterol of about 8% and a decrease in triglycerides of 12%.

Neither the panel nor the FDA questioned Zimulti's effectiveness; instead, safety was the big concern.

Sanofi classified rimonabant as a selective and neutral antagonist of the cannabinoid-1 receptor. But some panelists questioned whether some of the psychiatric and neurologic side effects with Zimulti might indicate that it was acting as an inverse agonist on the endocannabinoid system, meaning the drug would lock the receptors into inactivity and lead to negative consequences.

The FDA estimated that the relative risk for psychiatric adverse events in patients taking Zimulti in the four trials was 1.9, compared with placebo, and for neurologic adverse events the relative risk was 1.7. Four completed suicides have been reported for all of the company's completed and ongoing trials, said Dr. Amy G. Egan of the FDA's division of metabolic and endocrine products.

Because of the high drop-out rate seen in the trials–32%–49% in the first year, and 23%–58% in the second year–the relative risk may be underestimated, said Dr. Egan.

Zimulti appeared to double the risk of psychiatric adverse events, increased a variety of neurologic events, and increased nausea and vomiting, said Dr. Egan, adding that many of the risks “appear to be more pronounced in diabetics.”

The depression-obesity interrelationship gave pause to Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. “The evidence for increased suicidality and depression is of particular concern for a drug targeted towards the obese, a population that has been shown to have a significantly higher incidence of depression,” he told the advisory committee.

Drug Side Effect Awareness Low

One-third of surveyed patients with bipolar disorder were not aware that some of their medications are associated with hypertension, hypercholesterolemia, and elevated blood glucose. Bipolar patients are at higher risk of cardiovascular disease, and yet fewer than half of those surveyed had regular cholesterol or glucose testing, according to the survey, which was conducted by Harris Interactive on behalf of an academic working group that included Dr. Gary Sachs of Harvard University, Dr. Paul Keck of the University of Cincinnati, and Dr. Andrea Fagiolini of the University of Pittsburgh. Side effects such as weight gain led 55% of patients to discontinue a therapy, according to the survey of 300 patients, 105 psychiatrists, and 101 primary care physicians. The vast majority of physicians surveyed said they discussed side effects with patients, but even so, 70% of patients said they wanted physicians to provide more information. The study was sponsored by Pfizer Inc.

Teen Drug Chatter Pervasive

A sampling of 10 million messages posted by teenagers on online forums such as MySpace.com, ym.com, and teenspot.com found that at least 160,000 of those conversations were about drugs or alcohol. Nielsen BuzzMetrics used proprietary software to eavesdrop on the teens' online conversations. The vast majority of the illicit discussions mentioned alcohol, marijuana, cocaine, and LSD. The top behavior discussed was having sex while drinking. More girls talked about sex with alcohol, while boys mostly shared drunken experiences. The analysis was conducted for Caron Treatment Centers, a nonprofit addiction treatment provider.

Failed Mental Health Mission

The Department of Defense Task Force on Mental Health has found that the military is failing to provide adequate mental health care to service members. The task force report, which was issued in June, will be used to “develop and implement a corrective action plan” within 6 months, according to a statement from the DoD. The report states that according to the most recent Post-Deployment Health Re-Assessment (PDHRA), given to service members 90–120 days after returning from deployment, 38% of soldiers and 31% of Marines report psychological symptoms. Almost half of National Guard members said they had such symptoms. The task force also found that: Many service members are afraid to reach out for assistance because of a perceived stigma; mental health professionals aren't accessible; and, the military does not have enough “resources, funding or personnel to adequately support the psychological health of service members and their families.” The report is available at

www.ha.osd.mil/dhb/mhtf/MHTF-Report-Final.pdf

Limiting DXM Abuse

A small congressional group is attempting again to keep dextromethorphan out of the hands of teenagers who abuse the ingredient, found mostly in over-the-counter cough and cold medicines. The Dextromethorphan Distribution Act was introduced in the Senate by Sen. Patty Murray (D-Wash.) and in the House by Rep. Fred Upton (R-Miss.). The House passed a similar bill in 2006, but the Senate never took action. The new proposal would make it illegal for anyone not registered with the Food and Drug Administration or a state regulatory authority to possess or distribute unfinished DXM.

New FDA Risk Panel

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

DTC Ads Still Fall Short

Direct-to-consumer (DTC) advertisements emphasize individual drugs over conditions, don't do enough to emphasize risk, and minimize the importance of underlying health issues, according to a panel that reviewed such advertisements for the Pharmaceutical Research and Manufacturers of America. The review was undertaken to determine if consumer-directed marketing is meeting PhRMA's voluntary guiding principles, adopted in 2005 to address “many of the concerns publicly expressed about DTC advertising.” The four volunteer panelists–a pharmacist, a nurse, and two family physicians–also urged drug makers to include more information in their ads about assistance programs that provide low-cost or free medications. In a separate report, PhRMA said that comments it received from consumers on DTC ads indicated that many were confused about the ads' contents and thought they did not present a balance of risks and benefits. The organization received 458 comments from July to December 2006, mostly from consumers; 10% were from health professionals. The comments go to PhRMA's Office of Accountability, which forwards them for responses from individual drug makers.

Drug Side Effect Awareness Low

One-third of surveyed patients with bipolar disorder were not aware that some of their medications are associated with hypertension, hypercholesterolemia, and elevated blood glucose. Bipolar patients are at higher risk of cardiovascular disease, and yet fewer than half of those surveyed had regular cholesterol or glucose testing, according to the survey, which was conducted by Harris Interactive on behalf of an academic working group that included Dr. Gary Sachs of Harvard University, Dr. Paul Keck of the University of Cincinnati, and Dr. Andrea Fagiolini of the University of Pittsburgh. Side effects such as weight gain led 55% of patients to discontinue a therapy, according to the survey of 300 patients, 105 psychiatrists, and 101 primary care physicians. The vast majority of physicians surveyed said they discussed side effects with patients, but even so, 70% of patients said they wanted physicians to provide more information. The study was sponsored by Pfizer Inc.

Teen Drug Chatter Pervasive

A sampling of 10 million messages posted by teenagers on online forums such as MySpace.com, ym.com, and teenspot.com found that at least 160,000 of those conversations were about drugs or alcohol. Nielsen BuzzMetrics used proprietary software to eavesdrop on the teens' online conversations. The vast majority of the illicit discussions mentioned alcohol, marijuana, cocaine, and LSD. The top behavior discussed was having sex while drinking. More girls talked about sex with alcohol, while boys mostly shared drunken experiences. The analysis was conducted for Caron Treatment Centers, a nonprofit addiction treatment provider.

Failed Mental Health Mission

The Department of Defense Task Force on Mental Health has found that the military is failing to provide adequate mental health care to service members. The task force report, which was issued in June, will be used to “develop and implement a corrective action plan” within 6 months, according to a statement from the DoD. The report states that according to the most recent Post-Deployment Health Re-Assessment (PDHRA), given to service members 90–120 days after returning from deployment, 38% of soldiers and 31% of Marines report psychological symptoms. Almost half of National Guard members said they had such symptoms. The task force also found that: Many service members are afraid to reach out for assistance because of a perceived stigma; mental health professionals aren't accessible; and, the military does not have enough “resources, funding or personnel to adequately support the psychological health of service members and their families.” The report is available at

www.ha.osd.mil/dhb/mhtf/MHTF-Report-Final.pdf

Limiting DXM Abuse

A small congressional group is attempting again to keep dextromethorphan out of the hands of teenagers who abuse the ingredient, found mostly in over-the-counter cough and cold medicines. The Dextromethorphan Distribution Act was introduced in the Senate by Sen. Patty Murray (D-Wash.) and in the House by Rep. Fred Upton (R-Miss.). The House passed a similar bill in 2006, but the Senate never took action. The new proposal would make it illegal for anyone not registered with the Food and Drug Administration or a state regulatory authority to possess or distribute unfinished DXM.

New FDA Risk Panel

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

DTC Ads Still Fall Short

Direct-to-consumer (DTC) advertisements emphasize individual drugs over conditions, don't do enough to emphasize risk, and minimize the importance of underlying health issues, according to a panel that reviewed such advertisements for the Pharmaceutical Research and Manufacturers of America. The review was undertaken to determine if consumer-directed marketing is meeting PhRMA's voluntary guiding principles, adopted in 2005 to address “many of the concerns publicly expressed about DTC advertising.” The four volunteer panelists–a pharmacist, a nurse, and two family physicians–also urged drug makers to include more information in their ads about assistance programs that provide low-cost or free medications. In a separate report, PhRMA said that comments it received from consumers on DTC ads indicated that many were confused about the ads' contents and thought they did not present a balance of risks and benefits. The organization received 458 comments from July to December 2006, mostly from consumers; 10% were from health professionals. The comments go to PhRMA's Office of Accountability, which forwards them for responses from individual drug makers.

Drug Side Effect Awareness Low

One-third of surveyed patients with bipolar disorder were not aware that some of their medications are associated with hypertension, hypercholesterolemia, and elevated blood glucose. Bipolar patients are at higher risk of cardiovascular disease, and yet fewer than half of those surveyed had regular cholesterol or glucose testing, according to the survey, which was conducted by Harris Interactive on behalf of an academic working group that included Dr. Gary Sachs of Harvard University, Dr. Paul Keck of the University of Cincinnati, and Dr. Andrea Fagiolini of the University of Pittsburgh. Side effects such as weight gain led 55% of patients to discontinue a therapy, according to the survey of 300 patients, 105 psychiatrists, and 101 primary care physicians. The vast majority of physicians surveyed said they discussed side effects with patients, but even so, 70% of patients said they wanted physicians to provide more information. The study was sponsored by Pfizer Inc.

Teen Drug Chatter Pervasive

A sampling of 10 million messages posted by teenagers on online forums such as MySpace.com, ym.com, and teenspot.com found that at least 160,000 of those conversations were about drugs or alcohol. Nielsen BuzzMetrics used proprietary software to eavesdrop on the teens' online conversations. The vast majority of the illicit discussions mentioned alcohol, marijuana, cocaine, and LSD. The top behavior discussed was having sex while drinking. More girls talked about sex with alcohol, while boys mostly shared drunken experiences. The analysis was conducted for Caron Treatment Centers, a nonprofit addiction treatment provider.

Failed Mental Health Mission

The Department of Defense Task Force on Mental Health has found that the military is failing to provide adequate mental health care to service members. The task force report, which was issued in June, will be used to “develop and implement a corrective action plan” within 6 months, according to a statement from the DoD. The report states that according to the most recent Post-Deployment Health Re-Assessment (PDHRA), given to service members 90–120 days after returning from deployment, 38% of soldiers and 31% of Marines report psychological symptoms. Almost half of National Guard members said they had such symptoms. The task force also found that: Many service members are afraid to reach out for assistance because of a perceived stigma; mental health professionals aren't accessible; and, the military does not have enough “resources, funding or personnel to adequately support the psychological health of service members and their families.” The report is available at

www.ha.osd.mil/dhb/mhtf/MHTF-Report-Final.pdf

Limiting DXM Abuse

A small congressional group is attempting again to keep dextromethorphan out of the hands of teenagers who abuse the ingredient, found mostly in over-the-counter cough and cold medicines. The Dextromethorphan Distribution Act was introduced in the Senate by Sen. Patty Murray (D-Wash.) and in the House by Rep. Fred Upton (R-Miss.). The House passed a similar bill in 2006, but the Senate never took action. The new proposal would make it illegal for anyone not registered with the Food and Drug Administration or a state regulatory authority to possess or distribute unfinished DXM.

New FDA Risk Panel

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

DTC Ads Still Fall Short

Direct-to-consumer (DTC) advertisements emphasize individual drugs over conditions, don't do enough to emphasize risk, and minimize the importance of underlying health issues, according to a panel that reviewed such advertisements for the Pharmaceutical Research and Manufacturers of America. The review was undertaken to determine if consumer-directed marketing is meeting PhRMA's voluntary guiding principles, adopted in 2005 to address “many of the concerns publicly expressed about DTC advertising.” The four volunteer panelists–a pharmacist, a nurse, and two family physicians–also urged drug makers to include more information in their ads about assistance programs that provide low-cost or free medications. In a separate report, PhRMA said that comments it received from consumers on DTC ads indicated that many were confused about the ads' contents and thought they did not present a balance of risks and benefits. The organization received 458 comments from July to December 2006, mostly from consumers; 10% were from health professionals. The comments go to PhRMA's Office of Accountability, which forwards them for responses from individual drug makers.