Alicia Ault

Grassley Seeks Paxil Inquiry

Sen. Chuck Grassley (R-Iowa) is asking the Food and Drug Administration to investigate data it has from GlaxoSmithKline on paroxetine (Paxil), alleging that the company may have withheld knowledge of a risk of suicide and suicidal ideation. In a letter to FDA Commissioner Andrew von Eschenbach, Sen. Grassley cited a report by Harvard University psychiatry professor Dr. Joseph Glenmullen contending that GSK knew of Paxil's heightened suicide risk when it first sought FDA approval in 1989, but obscured the findings. Dr. Glenmullen's report was prepared for a plaintiffs' lawyer in August 2007 and was recently unsealed. Sen. Grassley also cited a recent report by the U.K. Medicines and Health Regulatory Authority, which determined in February that GSK knew of the risks in 1988. The company's responses to the senator so far “have been less than candid,” the senator said. In a lengthy statement, the company said it had requested a meeting with Sen. Grassley “to clarify some misunderstandings,” and also attacked Dr. Glenmullen, saying that his methodology is “scientifically flawed and unreliable.” “We remain firm in our belief that we acted properly and responsibly in the conduct of our clinical trials program for Paxil, documentation and submission of results from studies to regulators, and communication of important safety information to regulatory agencies, the scientific community, and the public,” the company said.

THC Levels Highest Ever

The federal government says that levels of tetrahydrocannabinol (THC) in marijuana are at the highest-ever recorded amounts, and that the potency may be contributing to increasing numbers of teenagers seeking treatment for dependence. The University of Mississippi's Potency Monitoring Project tests marijuana primarily taken during law enforcement seizures. The project is funded by the National Institute on Drug Abuse. A normal THC level is 1%–5%, but the average potency from the latest quarterly report was 9.6% for marijuana and 24% for hashish. The report is based on 1,248 marijuana samples and 33 hash samples. The highest recorded potency was 37% for marijuana and 66% for hashish. “The increases in marijuana potency are of concern since they increase the likelihood of acute toxicity, including mental impairment,” said Dr. Nora Volkow, NIDA director, in a statement. The federal Office of National Drug Control Policy said increasing potency might be linked to the increase in treatment admissions for marijuana abuse from 6% in 1992 to 16% in 2006.

DOD Improves on Mental Health

The Department of Defense is making some progress on screening troops for traumatic brain injury (TBI) and on screening for mental health issues before deployment, but there are still many gaps in the system, according to a report released last month by the Government Accountability Office. The GAO reviewed predeployment mental health screening, tracking of postdeployment mental health referrals, and implementation of screening for mild TBI. The agency determined that clinicians have received inconsistent instructions on predeployment screening. During visits to three sites, for instance, investigators found that physicians did not know they were supposed to review medical records as part of the predeployment screen. Tracking of referrals is often hampered by a lack of electronic record keeping, and the fact that National Guard and Reserve troops receive civilian care, said the agency. The military is doing better on TBI screening, said the GAO. Screening questions were added in January to postdeployment assessments, and, starting in July 2008, all troops will be assessed for mild TBI before they go overseas.

Drug Lobby Spending Is Up 32%

The pharmaceutical and medical device industries had yet another banner year for spending on lobbying in 2007, according to a new report by the Washington-based Center for Public Integrity. Last year, the pharmaceutical industry alone spent at least $168 million on lobbying members of Congress, a 32% increase from 2006, according to the report. Forty companies and three trade organizations–the Pharmaceutical Research and Manufacturers of America, the Biotechnology Industry Organization, and the Advanced Medical Technology Association–accounted for 90% of the spending. PhRMA led the way, spending $23 million in 2007. Amgen Inc. and Pfizer Inc. were the two biggest individual spenders, at $16 million and $13 million, respectively. Most efforts went into blocking drug reimportation, protecting patents, and on free-trade agreements. The industry also went to bat for reauthorization of the State Children's Health Insurance Program, and extensions of the Prescription Drug User Fee and Best Pharmaceuticals for Children acts, according to the center's analysis of lobbying records submitted to the Senate Office of Public Records.

Consumer Reports Rates Hospitals

Consumer Reports has begun grading hospitals and plans to eventually add ratings for other health care providers. The ratings, which include nearly 3,000 hospitals, are available at

www.consumerreportshealth.org

Grassley Seeks Paxil Inquiry

Sen. Chuck Grassley (R-Iowa) is asking the Food and Drug Administration to investigate data it has from GlaxoSmithKline on paroxetine (Paxil), alleging that the company may have withheld knowledge of a risk of suicide and suicidal ideation. In a letter to FDA Commissioner Andrew von Eschenbach, Sen. Grassley cited a report by Harvard University psychiatry professor Dr. Joseph Glenmullen contending that GSK knew of Paxil's heightened suicide risk when it first sought FDA approval in 1989, but obscured the findings. Dr. Glenmullen's report was prepared for a plaintiffs' lawyer in August 2007 and was recently unsealed. Sen. Grassley also cited a recent report by the U.K. Medicines and Health Regulatory Authority, which determined in February that GSK knew of the risks in 1988. The company's responses to the senator so far “have been less than candid,” the senator said. In a lengthy statement, the company said it had requested a meeting with Sen. Grassley “to clarify some misunderstandings,” and also attacked Dr. Glenmullen, saying that his methodology is “scientifically flawed and unreliable.” “We remain firm in our belief that we acted properly and responsibly in the conduct of our clinical trials program for Paxil, documentation and submission of results from studies to regulators, and communication of important safety information to regulatory agencies, the scientific community, and the public,” the company said.

THC Levels Highest Ever

The federal government says that levels of tetrahydrocannabinol (THC) in marijuana are at the highest-ever recorded amounts, and that the potency may be contributing to increasing numbers of teenagers seeking treatment for dependence. The University of Mississippi's Potency Monitoring Project tests marijuana primarily taken during law enforcement seizures. The project is funded by the National Institute on Drug Abuse. A normal THC level is 1%–5%, but the average potency from the latest quarterly report was 9.6% for marijuana and 24% for hashish. The report is based on 1,248 marijuana samples and 33 hash samples. The highest recorded potency was 37% for marijuana and 66% for hashish. “The increases in marijuana potency are of concern since they increase the likelihood of acute toxicity, including mental impairment,” said Dr. Nora Volkow, NIDA director, in a statement. The federal Office of National Drug Control Policy said increasing potency might be linked to the increase in treatment admissions for marijuana abuse from 6% in 1992 to 16% in 2006.

DOD Improves on Mental Health

The Department of Defense is making some progress on screening troops for traumatic brain injury (TBI) and on screening for mental health issues before deployment, but there are still many gaps in the system, according to a report released last month by the Government Accountability Office. The GAO reviewed predeployment mental health screening, tracking of postdeployment mental health referrals, and implementation of screening for mild TBI. The agency determined that clinicians have received inconsistent instructions on predeployment screening. During visits to three sites, for instance, investigators found that physicians did not know they were supposed to review medical records as part of the predeployment screen. Tracking of referrals is often hampered by a lack of electronic record keeping, and the fact that National Guard and Reserve troops receive civilian care, said the agency. The military is doing better on TBI screening, said the GAO. Screening questions were added in January to postdeployment assessments, and, starting in July 2008, all troops will be assessed for mild TBI before they go overseas.

Drug Lobby Spending Is Up 32%

The pharmaceutical and medical device industries had yet another banner year for spending on lobbying in 2007, according to a new report by the Washington-based Center for Public Integrity. Last year, the pharmaceutical industry alone spent at least $168 million on lobbying members of Congress, a 32% increase from 2006, according to the report. Forty companies and three trade organizations–the Pharmaceutical Research and Manufacturers of America, the Biotechnology Industry Organization, and the Advanced Medical Technology Association–accounted for 90% of the spending. PhRMA led the way, spending $23 million in 2007. Amgen Inc. and Pfizer Inc. were the two biggest individual spenders, at $16 million and $13 million, respectively. Most efforts went into blocking drug reimportation, protecting patents, and on free-trade agreements. The industry also went to bat for reauthorization of the State Children's Health Insurance Program, and extensions of the Prescription Drug User Fee and Best Pharmaceuticals for Children acts, according to the center's analysis of lobbying records submitted to the Senate Office of Public Records.

Consumer Reports Rates Hospitals

Consumer Reports has begun grading hospitals and plans to eventually add ratings for other health care providers. The ratings, which include nearly 3,000 hospitals, are available at

www.consumerreportshealth.org

Grassley Seeks Paxil Inquiry

Sen. Chuck Grassley (R-Iowa) is asking the Food and Drug Administration to investigate data it has from GlaxoSmithKline on paroxetine (Paxil), alleging that the company may have withheld knowledge of a risk of suicide and suicidal ideation. In a letter to FDA Commissioner Andrew von Eschenbach, Sen. Grassley cited a report by Harvard University psychiatry professor Dr. Joseph Glenmullen contending that GSK knew of Paxil's heightened suicide risk when it first sought FDA approval in 1989, but obscured the findings. Dr. Glenmullen's report was prepared for a plaintiffs' lawyer in August 2007 and was recently unsealed. Sen. Grassley also cited a recent report by the U.K. Medicines and Health Regulatory Authority, which determined in February that GSK knew of the risks in 1988. The company's responses to the senator so far “have been less than candid,” the senator said. In a lengthy statement, the company said it had requested a meeting with Sen. Grassley “to clarify some misunderstandings,” and also attacked Dr. Glenmullen, saying that his methodology is “scientifically flawed and unreliable.” “We remain firm in our belief that we acted properly and responsibly in the conduct of our clinical trials program for Paxil, documentation and submission of results from studies to regulators, and communication of important safety information to regulatory agencies, the scientific community, and the public,” the company said.

THC Levels Highest Ever

The federal government says that levels of tetrahydrocannabinol (THC) in marijuana are at the highest-ever recorded amounts, and that the potency may be contributing to increasing numbers of teenagers seeking treatment for dependence. The University of Mississippi's Potency Monitoring Project tests marijuana primarily taken during law enforcement seizures. The project is funded by the National Institute on Drug Abuse. A normal THC level is 1%–5%, but the average potency from the latest quarterly report was 9.6% for marijuana and 24% for hashish. The report is based on 1,248 marijuana samples and 33 hash samples. The highest recorded potency was 37% for marijuana and 66% for hashish. “The increases in marijuana potency are of concern since they increase the likelihood of acute toxicity, including mental impairment,” said Dr. Nora Volkow, NIDA director, in a statement. The federal Office of National Drug Control Policy said increasing potency might be linked to the increase in treatment admissions for marijuana abuse from 6% in 1992 to 16% in 2006.

DOD Improves on Mental Health

The Department of Defense is making some progress on screening troops for traumatic brain injury (TBI) and on screening for mental health issues before deployment, but there are still many gaps in the system, according to a report released last month by the Government Accountability Office. The GAO reviewed predeployment mental health screening, tracking of postdeployment mental health referrals, and implementation of screening for mild TBI. The agency determined that clinicians have received inconsistent instructions on predeployment screening. During visits to three sites, for instance, investigators found that physicians did not know they were supposed to review medical records as part of the predeployment screen. Tracking of referrals is often hampered by a lack of electronic record keeping, and the fact that National Guard and Reserve troops receive civilian care, said the agency. The military is doing better on TBI screening, said the GAO. Screening questions were added in January to postdeployment assessments, and, starting in July 2008, all troops will be assessed for mild TBI before they go overseas.

Drug Lobby Spending Is Up 32%

The pharmaceutical and medical device industries had yet another banner year for spending on lobbying in 2007, according to a new report by the Washington-based Center for Public Integrity. Last year, the pharmaceutical industry alone spent at least $168 million on lobbying members of Congress, a 32% increase from 2006, according to the report. Forty companies and three trade organizations–the Pharmaceutical Research and Manufacturers of America, the Biotechnology Industry Organization, and the Advanced Medical Technology Association–accounted for 90% of the spending. PhRMA led the way, spending $23 million in 2007. Amgen Inc. and Pfizer Inc. were the two biggest individual spenders, at $16 million and $13 million, respectively. Most efforts went into blocking drug reimportation, protecting patents, and on free-trade agreements. The industry also went to bat for reauthorization of the State Children's Health Insurance Program, and extensions of the Prescription Drug User Fee and Best Pharmaceuticals for Children acts, according to the center's analysis of lobbying records submitted to the Senate Office of Public Records.

Consumer Reports Rates Hospitals

Consumer Reports has begun grading hospitals and plans to eventually add ratings for other health care providers. The ratings, which include nearly 3,000 hospitals, are available at

www.consumerreportshealth.org

Preventable surgical errors are likely costing insurers more than $1 billion a year, according to a new study by the Agency for Healthcare Research and Quality.

The report provides a fuller accounting of the true cost of potentially preventable errors than had been previously published, according to the authors, William E. Encinosa, Ph.D., and Fred J. Hellinger, Ph.D., both with AHRQ's Center for Delivery, Organization, and Markets.

They looked at the comprehensive, per-episode cost of medical errors, including payments to hospitals for the initial admission and readmission, as well as payments for physicians, for outpatient services, and for prescription drugs. All cost data were included for 90 days after surgical admission.

The authors drew their analysis from the 2001-2002 MarketScan Commercial Claims and Encounter Database, which covers 5.6 million enrollees in private, employer-sponsored plans (Health Serv. Res. 2008 July 25 [doi: 10.1111/j.1475-6773.2008.00882.x

“Most papers that estimate the cost of medical errors only examine the initial hospitalization in which the medical error occurred,” they wrote. But, they added, “we find that the death rate increases by 50% over 90 days once the patient leaves the hospital.”

Postdischarge costs also are often higher than those for the initial admission, they noted. For infections, the excess payments during a 90-day episode were 28% higher.

By looking at an entire episode of care over 90 days, the researchers make a strong argument in favor of spending money on quality, Dr. Darrell A. Campbell, professor of surgery at the University of Michigan, Ann Arbor, said in an interview. “Complications and adverse events are expensive, and if you can avoid them, not only does quality go up, but costs go down.”

The case-control study examined 14 potentially preventable adverse medical events, defined by AHRQ as patient safety indicators. In all 161,004 adult, nonelderly, major surgeries were analyzed; 2.6% (4,140) of cases had at least one of the 14 preventable events, and 5.6% of those cases had additional errors.

Acute respiratory failure was the most common preventable event, which occurred in 0.9% (1,392) of all surgeries. That also was the most expensive event, at $106,000 per instance, and patients who had respiratory failure also had the highest death rate, at about 12% over the 90-day period tracked.

For all patients who had at least one preventable event, the 90-day death rate was higher at 6%, compared with 0.6% for patients who did not have a preventable event. The 90-day readmission rate was 15% for patients with a preventable event, compared with 5.5% for those without.

Overall 23% of patients who experienced potentially preventable events were readmitted, compared with 10% of those without an event. Not surprisingly, overall costs were higher for those patients with events. The 90-day cost for a surgery that included a potentially preventable event was $66,800, compared with $18,200 for a procedure that did not involve such an event.

Lengths of stay were longer, as well, at 22 days for patients with events, compared with 5 days for those without.

By extrapolating the results to the entire population of insured nonelderly adults in the United States, the authors report that 11% of 90-day postdischarge deaths and 2% of 90-day readmissions are due to the 14 potentially preventable adverse events, as are 2% ($1.5 billion) of all 90-day expenses after surgery.

This estimate might be conservative, because there are many costs that could be incurred outside of the 14 preventable errors that were assessed in the report, Dr. Campbell noted.

Going forward, it will be possible to collect stronger data on errors because hospitals are now recording whether certain preventable conditions are present on admission, he said.

ELSEVIER GLOBAL MEDICAL NEWS

Preventable surgical errors are likely costing insurers more than $1 billion a year, according to a new study by the Agency for Healthcare Research and Quality.

The report provides a fuller accounting of the true cost of potentially preventable errors than had been previously published, according to the authors, William E. Encinosa, Ph.D., and Fred J. Hellinger, Ph.D., both with AHRQ's Center for Delivery, Organization, and Markets.

They looked at the comprehensive, per-episode cost of medical errors, including payments to hospitals for the initial admission and readmission, as well as payments for physicians, for outpatient services, and for prescription drugs. All cost data were included for 90 days after surgical admission.

The authors drew their analysis from the 2001-2002 MarketScan Commercial Claims and Encounter Database, which covers 5.6 million enrollees in private, employer-sponsored plans (Health Serv. Res. 2008 July 25 [doi: 10.1111/j.1475-6773.2008.00882.x

“Most papers that estimate the cost of medical errors only examine the initial hospitalization in which the medical error occurred,” they wrote. But, they added, “we find that the death rate increases by 50% over 90 days once the patient leaves the hospital.”

Postdischarge costs also are often higher than those for the initial admission, they noted. For infections, the excess payments during a 90-day episode were 28% higher.

By looking at an entire episode of care over 90 days, the researchers make a strong argument in favor of spending money on quality, Dr. Darrell A. Campbell, professor of surgery at the University of Michigan, Ann Arbor, said in an interview. “Complications and adverse events are expensive, and if you can avoid them, not only does quality go up, but costs go down.”

The case-control study examined 14 potentially preventable adverse medical events, defined by AHRQ as patient safety indicators. In all 161,004 adult, nonelderly, major surgeries were analyzed; 2.6% (4,140) of cases had at least one of the 14 preventable events, and 5.6% of those cases had additional errors.

Acute respiratory failure was the most common preventable event, which occurred in 0.9% (1,392) of all surgeries. That also was the most expensive event, at $106,000 per instance, and patients who had respiratory failure also had the highest death rate, at about 12% over the 90-day period tracked.

For all patients who had at least one preventable event, the 90-day death rate was higher at 6%, compared with 0.6% for patients who did not have a preventable event. The 90-day readmission rate was 15% for patients with a preventable event, compared with 5.5% for those without.

Overall 23% of patients who experienced potentially preventable events were readmitted, compared with 10% of those without an event. Not surprisingly, overall costs were higher for those patients with events. The 90-day cost for a surgery that included a potentially preventable event was $66,800, compared with $18,200 for a procedure that did not involve such an event.

Lengths of stay were longer, as well, at 22 days for patients with events, compared with 5 days for those without.

By extrapolating the results to the entire population of insured nonelderly adults in the United States, the authors report that 11% of 90-day postdischarge deaths and 2% of 90-day readmissions are due to the 14 potentially preventable adverse events, as are 2% ($1.5 billion) of all 90-day expenses after surgery.

This estimate might be conservative, because there are many costs that could be incurred outside of the 14 preventable errors that were assessed in the report, Dr. Campbell noted.

Going forward, it will be possible to collect stronger data on errors because hospitals are now recording whether certain preventable conditions are present on admission, he said.

ELSEVIER GLOBAL MEDICAL NEWS

Preventable surgical errors are likely costing insurers more than $1 billion a year, according to a new study by the Agency for Healthcare Research and Quality.

The report provides a fuller accounting of the true cost of potentially preventable errors than had been previously published, according to the authors, William E. Encinosa, Ph.D., and Fred J. Hellinger, Ph.D., both with AHRQ's Center for Delivery, Organization, and Markets.

They looked at the comprehensive, per-episode cost of medical errors, including payments to hospitals for the initial admission and readmission, as well as payments for physicians, for outpatient services, and for prescription drugs. All cost data were included for 90 days after surgical admission.

The authors drew their analysis from the 2001-2002 MarketScan Commercial Claims and Encounter Database, which covers 5.6 million enrollees in private, employer-sponsored plans (Health Serv. Res. 2008 July 25 [doi: 10.1111/j.1475-6773.2008.00882.x

“Most papers that estimate the cost of medical errors only examine the initial hospitalization in which the medical error occurred,” they wrote. But, they added, “we find that the death rate increases by 50% over 90 days once the patient leaves the hospital.”

Postdischarge costs also are often higher than those for the initial admission, they noted. For infections, the excess payments during a 90-day episode were 28% higher.

By looking at an entire episode of care over 90 days, the researchers make a strong argument in favor of spending money on quality, Dr. Darrell A. Campbell, professor of surgery at the University of Michigan, Ann Arbor, said in an interview. “Complications and adverse events are expensive, and if you can avoid them, not only does quality go up, but costs go down.”

The case-control study examined 14 potentially preventable adverse medical events, defined by AHRQ as patient safety indicators. In all 161,004 adult, nonelderly, major surgeries were analyzed; 2.6% (4,140) of cases had at least one of the 14 preventable events, and 5.6% of those cases had additional errors.

Acute respiratory failure was the most common preventable event, which occurred in 0.9% (1,392) of all surgeries. That also was the most expensive event, at $106,000 per instance, and patients who had respiratory failure also had the highest death rate, at about 12% over the 90-day period tracked.

For all patients who had at least one preventable event, the 90-day death rate was higher at 6%, compared with 0.6% for patients who did not have a preventable event. The 90-day readmission rate was 15% for patients with a preventable event, compared with 5.5% for those without.

Overall 23% of patients who experienced potentially preventable events were readmitted, compared with 10% of those without an event. Not surprisingly, overall costs were higher for those patients with events. The 90-day cost for a surgery that included a potentially preventable event was $66,800, compared with $18,200 for a procedure that did not involve such an event.

Lengths of stay were longer, as well, at 22 days for patients with events, compared with 5 days for those without.

By extrapolating the results to the entire population of insured nonelderly adults in the United States, the authors report that 11% of 90-day postdischarge deaths and 2% of 90-day readmissions are due to the 14 potentially preventable adverse events, as are 2% ($1.5 billion) of all 90-day expenses after surgery.

This estimate might be conservative, because there are many costs that could be incurred outside of the 14 preventable errors that were assessed in the report, Dr. Campbell noted.

Going forward, it will be possible to collect stronger data on errors because hospitals are now recording whether certain preventable conditions are present on admission, he said.

ELSEVIER GLOBAL MEDICAL NEWS

New PQRI Melanoma Measures

The Centers for Medicare and Medicaid Services is seeking voluntary submission of data on 11 new measures under the Physician Quality Reporting Initiative (PQRI), including three new measures related to melanoma. The measures have been adopted by the AQA Alliance, and have CPT II codes that allow claims-based reporting, according to the CMS. Data submission started July 1. Reporting is voluntary; there is no bonus available for these new measures yet. For melanoma, physicians are asked to report on follow-up care given to patients with a new diagnosis; on whether those with an existing diagnosis are called back for a complete exam within a year; and whether a treatment plan is developed for a new melanoma occurrence and communicated to a treating physician within a month. Also new are three ophthalmic measures, two radiology measures, one oncology measure, a measure assessing influenza vaccination for kidney disease patients, and a measure on whether arthritis patients are assessed for use of over-the-counter medications.

Allergan Seeks Eyelash Drug OK

Allergan Inc. reported early last month that it is seeking Food and Drug Administration approval for its drug bimatoprost, to stimulate eyelash growth. Bimatoprost is the active ingredient in Lumigan, the company's glaucoma drug and a synthetic prostaglandin analog. The company said it expects FDA approval some time in 2009, and sales of the eyelash-lengthening product to reach at least $500 million a year. That would put it on par with Lumigan, which will have an estimated $450 million in sales in 2008. Allergan said the mascara market produces about $4 billion a year. The company had not previously disclosed it was developing an eyelash lengthener, but was not shy about suing companies it said infringed on the bimatoprost patent in November. A month later, the FDA seized thousands of tubes of an eyelash-lengthener made by Jan Marini Skin Research. That company stopped selling its eyelash products in January.

FDA Accepts Reloxin Application

Medicis and Ipsen announced that the FDA has accepted their application for approval of Reloxin (type A botulinum toxin). Reloxin is already approved in 23 countries, and Ipsen is seeking approval in additional markets. Medicis is paying Ipsen $25 million for achieving the FDA acceptance, and will pay an additional $75 million when the drug is approved. Medicis will market Reloxin in the United States.

MDs Mum on Trial Participation

Nearly 95% of Americans in a recent survey said that their physicians have never spoken to them about participating in a medical research study. The survey results, released by the Society for Women's Health Research, also found that less than 10% of respondents had ever participated in such a study. Women were less likely than were men to know that research opportunities were available. About 73% of women were aware of research opportunities, compared with 83% of men who were surveyed. Women were also more likely to say that they were too old or too sick to participate in research, according to the study. For example, 7.2% of women said that their age made them hesitant to participate in clinical research, compared with 2.4% of men. "Women 65 and older are among the fastest growing segments of our population, and we have very little health research data on them," Sherry Marts, Ph.D., vice president of scientific affairs for the Society for Women's Health Research, said in a statement. The telephone survey included responses from 2,028 U.S. adults.

Report Casts Doubt on IT Savings

Health information technology, when coupled with other reforms, can help reduce health spending in certain settings, according to a report from the Congressional Budget Office. However, the adoption of health IT alone will not produce significant savings, the report concluded. For example, institutions that have successfully used health IT to lower costs are generally integrated health care systems such as Kaiser Permanente. "Office-based physicians in particular may see no benefit if they purchase [an electronic health record]—and may even suffer financial harm," the CBO report said. Recent studies by the Rand Corporation and the Center for Information Technology Leadership estimate savings from health IT at around $80 billion annually. However, the CBO takes issue with those estimates because the savings figures are derived by assuming a number of changes to the health care system. However, without changes to the current payment system, providers would not be incentivized to reduce costs to the system. CBO analysts also found that a subsidy to providers could increase adoption but would be costly to the government. On the other hand, a mandate for adoption or a penalty for lack of adoption would be effective but costly for providers. The full report is available online at

www.cbo.gov

Consumer Reports to Grade Hospitals

Consumer Reports has begun grading hospitals and plans to eventually add ratings for other health care providers. The ratings, which include nearly 3,000 hospitals, are available at

www.consumerreportshealth.org

New PQRI Melanoma Measures

The Centers for Medicare and Medicaid Services is seeking voluntary submission of data on 11 new measures under the Physician Quality Reporting Initiative (PQRI), including three new measures related to melanoma. The measures have been adopted by the AQA Alliance, and have CPT II codes that allow claims-based reporting, according to the CMS. Data submission started July 1. Reporting is voluntary; there is no bonus available for these new measures yet. For melanoma, physicians are asked to report on follow-up care given to patients with a new diagnosis; on whether those with an existing diagnosis are called back for a complete exam within a year; and whether a treatment plan is developed for a new melanoma occurrence and communicated to a treating physician within a month. Also new are three ophthalmic measures, two radiology measures, one oncology measure, a measure assessing influenza vaccination for kidney disease patients, and a measure on whether arthritis patients are assessed for use of over-the-counter medications.

Allergan Seeks Eyelash Drug OK

Allergan Inc. reported early last month that it is seeking Food and Drug Administration approval for its drug bimatoprost, to stimulate eyelash growth. Bimatoprost is the active ingredient in Lumigan, the company's glaucoma drug and a synthetic prostaglandin analog. The company said it expects FDA approval some time in 2009, and sales of the eyelash-lengthening product to reach at least $500 million a year. That would put it on par with Lumigan, which will have an estimated $450 million in sales in 2008. Allergan said the mascara market produces about $4 billion a year. The company had not previously disclosed it was developing an eyelash lengthener, but was not shy about suing companies it said infringed on the bimatoprost patent in November. A month later, the FDA seized thousands of tubes of an eyelash-lengthener made by Jan Marini Skin Research. That company stopped selling its eyelash products in January.

FDA Accepts Reloxin Application

Medicis and Ipsen announced that the FDA has accepted their application for approval of Reloxin (type A botulinum toxin). Reloxin is already approved in 23 countries, and Ipsen is seeking approval in additional markets. Medicis is paying Ipsen $25 million for achieving the FDA acceptance, and will pay an additional $75 million when the drug is approved. Medicis will market Reloxin in the United States.

MDs Mum on Trial Participation

Nearly 95% of Americans in a recent survey said that their physicians have never spoken to them about participating in a medical research study. The survey results, released by the Society for Women's Health Research, also found that less than 10% of respondents had ever participated in such a study. Women were less likely than were men to know that research opportunities were available. About 73% of women were aware of research opportunities, compared with 83% of men who were surveyed. Women were also more likely to say that they were too old or too sick to participate in research, according to the study. For example, 7.2% of women said that their age made them hesitant to participate in clinical research, compared with 2.4% of men. "Women 65 and older are among the fastest growing segments of our population, and we have very little health research data on them," Sherry Marts, Ph.D., vice president of scientific affairs for the Society for Women's Health Research, said in a statement. The telephone survey included responses from 2,028 U.S. adults.

Report Casts Doubt on IT Savings

Health information technology, when coupled with other reforms, can help reduce health spending in certain settings, according to a report from the Congressional Budget Office. However, the adoption of health IT alone will not produce significant savings, the report concluded. For example, institutions that have successfully used health IT to lower costs are generally integrated health care systems such as Kaiser Permanente. "Office-based physicians in particular may see no benefit if they purchase [an electronic health record]—and may even suffer financial harm," the CBO report said. Recent studies by the Rand Corporation and the Center for Information Technology Leadership estimate savings from health IT at around $80 billion annually. However, the CBO takes issue with those estimates because the savings figures are derived by assuming a number of changes to the health care system. However, without changes to the current payment system, providers would not be incentivized to reduce costs to the system. CBO analysts also found that a subsidy to providers could increase adoption but would be costly to the government. On the other hand, a mandate for adoption or a penalty for lack of adoption would be effective but costly for providers. The full report is available online at

www.cbo.gov

Consumer Reports to Grade Hospitals

Consumer Reports has begun grading hospitals and plans to eventually add ratings for other health care providers. The ratings, which include nearly 3,000 hospitals, are available at

www.consumerreportshealth.org

New PQRI Melanoma Measures

The Centers for Medicare and Medicaid Services is seeking voluntary submission of data on 11 new measures under the Physician Quality Reporting Initiative (PQRI), including three new measures related to melanoma. The measures have been adopted by the AQA Alliance, and have CPT II codes that allow claims-based reporting, according to the CMS. Data submission started July 1. Reporting is voluntary; there is no bonus available for these new measures yet. For melanoma, physicians are asked to report on follow-up care given to patients with a new diagnosis; on whether those with an existing diagnosis are called back for a complete exam within a year; and whether a treatment plan is developed for a new melanoma occurrence and communicated to a treating physician within a month. Also new are three ophthalmic measures, two radiology measures, one oncology measure, a measure assessing influenza vaccination for kidney disease patients, and a measure on whether arthritis patients are assessed for use of over-the-counter medications.

Allergan Seeks Eyelash Drug OK

Allergan Inc. reported early last month that it is seeking Food and Drug Administration approval for its drug bimatoprost, to stimulate eyelash growth. Bimatoprost is the active ingredient in Lumigan, the company's glaucoma drug and a synthetic prostaglandin analog. The company said it expects FDA approval some time in 2009, and sales of the eyelash-lengthening product to reach at least $500 million a year. That would put it on par with Lumigan, which will have an estimated $450 million in sales in 2008. Allergan said the mascara market produces about $4 billion a year. The company had not previously disclosed it was developing an eyelash lengthener, but was not shy about suing companies it said infringed on the bimatoprost patent in November. A month later, the FDA seized thousands of tubes of an eyelash-lengthener made by Jan Marini Skin Research. That company stopped selling its eyelash products in January.

FDA Accepts Reloxin Application

Medicis and Ipsen announced that the FDA has accepted their application for approval of Reloxin (type A botulinum toxin). Reloxin is already approved in 23 countries, and Ipsen is seeking approval in additional markets. Medicis is paying Ipsen $25 million for achieving the FDA acceptance, and will pay an additional $75 million when the drug is approved. Medicis will market Reloxin in the United States.

MDs Mum on Trial Participation

Nearly 95% of Americans in a recent survey said that their physicians have never spoken to them about participating in a medical research study. The survey results, released by the Society for Women's Health Research, also found that less than 10% of respondents had ever participated in such a study. Women were less likely than were men to know that research opportunities were available. About 73% of women were aware of research opportunities, compared with 83% of men who were surveyed. Women were also more likely to say that they were too old or too sick to participate in research, according to the study. For example, 7.2% of women said that their age made them hesitant to participate in clinical research, compared with 2.4% of men. "Women 65 and older are among the fastest growing segments of our population, and we have very little health research data on them," Sherry Marts, Ph.D., vice president of scientific affairs for the Society for Women's Health Research, said in a statement. The telephone survey included responses from 2,028 U.S. adults.

Report Casts Doubt on IT Savings

Health information technology, when coupled with other reforms, can help reduce health spending in certain settings, according to a report from the Congressional Budget Office. However, the adoption of health IT alone will not produce significant savings, the report concluded. For example, institutions that have successfully used health IT to lower costs are generally integrated health care systems such as Kaiser Permanente. "Office-based physicians in particular may see no benefit if they purchase [an electronic health record]—and may even suffer financial harm," the CBO report said. Recent studies by the Rand Corporation and the Center for Information Technology Leadership estimate savings from health IT at around $80 billion annually. However, the CBO takes issue with those estimates because the savings figures are derived by assuming a number of changes to the health care system. However, without changes to the current payment system, providers would not be incentivized to reduce costs to the system. CBO analysts also found that a subsidy to providers could increase adoption but would be costly to the government. On the other hand, a mandate for adoption or a penalty for lack of adoption would be effective but costly for providers. The full report is available online at

www.cbo.gov

Consumer Reports to Grade Hospitals

Consumer Reports has begun grading hospitals and plans to eventually add ratings for other health care providers. The ratings, which include nearly 3,000 hospitals, are available at

www.consumerreportshealth.org

WASHINGTON — The nation's health care system will be overhauled in a substantive fashion in the early days of the next administration, promised advisers to the presidential candidates at a forum sponsored by the journal Health Affairs.

Although the economy has replaced health care as the top issue for voters, there is still a hunger for change, and economic and health concerns are linked, said Democratic and Republican pollsters at the same forum.

Sen. Ron Wyden (D-Ore.), who has pushed for health reform for years, agreed that early 2009 will be the right time. "At this point you almost don't want to hope again," he said at the forum. But "this time, believe."

He said that he has visited with 80 of 100 senators in the last few months and that all were motivated to reduce the cost of health care and to increase coverage for the uninsured.

Sen. Wyden and Sen. Bob Bennett (R-Utah) have promoted their Healthy Americans Act (S. 334) as a solution, but Sen. Wyden acknowledged that no one piece of legislation was likely to be the be-all and end-all.

Democratic pollster Celinda Lake said that voters view health care as a right and that in particular, women regarded it as a value. Women are concerned that health care not cost too much and that cost constraints not lead to any shortages that result in long waits for appointments or less time with a physician. And women are likely to be the voting bloc that decides the 2008 presidential election, said Ms. Lake.

On the other hand, those currently without health insurance are the least likely constituency of concern, she said, noting that the strongest predictor of not voting is being uninsured.

When it comes to health care, Americans are consumers, "not altruists," she said. That means they want to know how much it's going to cost them to cover the uninsured. "There is a real desire for change and a dramatic concern about rising costs," said Ms. Lake.

Presidential candidate Sen. John McCain (R-Ariz.) seems to have tapped into these sentiments with his proposal to grant tax credits for health insurance plans, paying for wellness and eliminating waste in the system, Ms. Lake said.

Health care is inexorably linked with the economy—when the economy is bad, people worry about their health coverage, said William McInturff, a Republican pollster. In a poll his company conducted for the Robert Wood Johnson Foundation in April, the top two items cited to improve the economic situation for the average American were making health care more affordable and providing coverage for all Americans.

Sixty-seven percent of respondents to that survey said they thought the number of uninsured would increase in the next 6 months. That's the highest percentage since his firm began asking the question in 2001, Mr. McInturff said.

Candidates' proposals—such as mandates requiring individuals to have insurance, a focus on prevention, and repealing tax cuts to pay for coverage—resonated, with 35%-45% of survey respondents saying they'd heard or read about such ideas.

Mr. McInturff predicted that if Sen. McCain becomes president that the senator would remain committed to health reform.

"I'm not sure I understand how Sen. McCain would advance cost control," said Dr. David Blumenthal, a senior adviser to Sen. Barack Obama's (D-Ill.) campaign. The way to get affordability and value is to address cost and access, said Dr. Blumenthal, director of the Massachusetts General Hospital Institute for Health Policy, Boston. He is also professor of health care policy and Samuel O. Thier Professor of Medicine at Harvard Medical School in Boston.

It would be relatively easy to curb spending in Medicare through budgetary caps, but that was not a good solution because it would just push the costs elsewhere, said Dr. Blumenthal.

Douglas Holtz-Eakin, a senior policy adviser to Sen. McCain's campaign, said that offering options to employer-sponsored health insurance could make Americans better consumers, and thus help drive down costs.

Regardless of their choice for president, all the advisers agreed that reform was coming.

"The next president will have to do health care reform, period," said Mr. Holtz-Eakin.

WASHINGTON — The nation's health care system will be overhauled in a substantive fashion in the early days of the next administration, promised advisers to the presidential candidates at a forum sponsored by the journal Health Affairs.

Although the economy has replaced health care as the top issue for voters, there is still a hunger for change, and economic and health concerns are linked, said Democratic and Republican pollsters at the same forum.

Sen. Ron Wyden (D-Ore.), who has pushed for health reform for years, agreed that early 2009 will be the right time. "At this point you almost don't want to hope again," he said at the forum. But "this time, believe."

He said that he has visited with 80 of 100 senators in the last few months and that all were motivated to reduce the cost of health care and to increase coverage for the uninsured.

Sen. Wyden and Sen. Bob Bennett (R-Utah) have promoted their Healthy Americans Act (S. 334) as a solution, but Sen. Wyden acknowledged that no one piece of legislation was likely to be the be-all and end-all.

Democratic pollster Celinda Lake said that voters view health care as a right and that in particular, women regarded it as a value. Women are concerned that health care not cost too much and that cost constraints not lead to any shortages that result in long waits for appointments or less time with a physician. And women are likely to be the voting bloc that decides the 2008 presidential election, said Ms. Lake.

On the other hand, those currently without health insurance are the least likely constituency of concern, she said, noting that the strongest predictor of not voting is being uninsured.

When it comes to health care, Americans are consumers, "not altruists," she said. That means they want to know how much it's going to cost them to cover the uninsured. "There is a real desire for change and a dramatic concern about rising costs," said Ms. Lake.

Presidential candidate Sen. John McCain (R-Ariz.) seems to have tapped into these sentiments with his proposal to grant tax credits for health insurance plans, paying for wellness and eliminating waste in the system, Ms. Lake said.

Health care is inexorably linked with the economy—when the economy is bad, people worry about their health coverage, said William McInturff, a Republican pollster. In a poll his company conducted for the Robert Wood Johnson Foundation in April, the top two items cited to improve the economic situation for the average American were making health care more affordable and providing coverage for all Americans.

Sixty-seven percent of respondents to that survey said they thought the number of uninsured would increase in the next 6 months. That's the highest percentage since his firm began asking the question in 2001, Mr. McInturff said.

Candidates' proposals—such as mandates requiring individuals to have insurance, a focus on prevention, and repealing tax cuts to pay for coverage—resonated, with 35%-45% of survey respondents saying they'd heard or read about such ideas.

Mr. McInturff predicted that if Sen. McCain becomes president that the senator would remain committed to health reform.

"I'm not sure I understand how Sen. McCain would advance cost control," said Dr. David Blumenthal, a senior adviser to Sen. Barack Obama's (D-Ill.) campaign. The way to get affordability and value is to address cost and access, said Dr. Blumenthal, director of the Massachusetts General Hospital Institute for Health Policy, Boston. He is also professor of health care policy and Samuel O. Thier Professor of Medicine at Harvard Medical School in Boston.

It would be relatively easy to curb spending in Medicare through budgetary caps, but that was not a good solution because it would just push the costs elsewhere, said Dr. Blumenthal.

Douglas Holtz-Eakin, a senior policy adviser to Sen. McCain's campaign, said that offering options to employer-sponsored health insurance could make Americans better consumers, and thus help drive down costs.

Regardless of their choice for president, all the advisers agreed that reform was coming.

"The next president will have to do health care reform, period," said Mr. Holtz-Eakin.

WASHINGTON — The nation's health care system will be overhauled in a substantive fashion in the early days of the next administration, promised advisers to the presidential candidates at a forum sponsored by the journal Health Affairs.

Although the economy has replaced health care as the top issue for voters, there is still a hunger for change, and economic and health concerns are linked, said Democratic and Republican pollsters at the same forum.

Sen. Ron Wyden (D-Ore.), who has pushed for health reform for years, agreed that early 2009 will be the right time. "At this point you almost don't want to hope again," he said at the forum. But "this time, believe."

He said that he has visited with 80 of 100 senators in the last few months and that all were motivated to reduce the cost of health care and to increase coverage for the uninsured.

Sen. Wyden and Sen. Bob Bennett (R-Utah) have promoted their Healthy Americans Act (S. 334) as a solution, but Sen. Wyden acknowledged that no one piece of legislation was likely to be the be-all and end-all.

Democratic pollster Celinda Lake said that voters view health care as a right and that in particular, women regarded it as a value. Women are concerned that health care not cost too much and that cost constraints not lead to any shortages that result in long waits for appointments or less time with a physician. And women are likely to be the voting bloc that decides the 2008 presidential election, said Ms. Lake.

On the other hand, those currently without health insurance are the least likely constituency of concern, she said, noting that the strongest predictor of not voting is being uninsured.

When it comes to health care, Americans are consumers, "not altruists," she said. That means they want to know how much it's going to cost them to cover the uninsured. "There is a real desire for change and a dramatic concern about rising costs," said Ms. Lake.

Presidential candidate Sen. John McCain (R-Ariz.) seems to have tapped into these sentiments with his proposal to grant tax credits for health insurance plans, paying for wellness and eliminating waste in the system, Ms. Lake said.

Health care is inexorably linked with the economy—when the economy is bad, people worry about their health coverage, said William McInturff, a Republican pollster. In a poll his company conducted for the Robert Wood Johnson Foundation in April, the top two items cited to improve the economic situation for the average American were making health care more affordable and providing coverage for all Americans.

Sixty-seven percent of respondents to that survey said they thought the number of uninsured would increase in the next 6 months. That's the highest percentage since his firm began asking the question in 2001, Mr. McInturff said.

Candidates' proposals—such as mandates requiring individuals to have insurance, a focus on prevention, and repealing tax cuts to pay for coverage—resonated, with 35%-45% of survey respondents saying they'd heard or read about such ideas.

Mr. McInturff predicted that if Sen. McCain becomes president that the senator would remain committed to health reform.

"I'm not sure I understand how Sen. McCain would advance cost control," said Dr. David Blumenthal, a senior adviser to Sen. Barack Obama's (D-Ill.) campaign. The way to get affordability and value is to address cost and access, said Dr. Blumenthal, director of the Massachusetts General Hospital Institute for Health Policy, Boston. He is also professor of health care policy and Samuel O. Thier Professor of Medicine at Harvard Medical School in Boston.

It would be relatively easy to curb spending in Medicare through budgetary caps, but that was not a good solution because it would just push the costs elsewhere, said Dr. Blumenthal.

Douglas Holtz-Eakin, a senior policy adviser to Sen. McCain's campaign, said that offering options to employer-sponsored health insurance could make Americans better consumers, and thus help drive down costs.

Regardless of their choice for president, all the advisers agreed that reform was coming.

"The next president will have to do health care reform, period," said Mr. Holtz-Eakin.

NEW ORLEANS — Colpocleisis successfully resolves pelvic organ prolapse and patient satisfaction rates are extremely high 1 year after surgery, according to a cohort study of 153 patients.

Colpocleisis is a “time-honored procedure,” having been performed for a century, but fell out of favor for many years, partly because of concerns about its effects on women's body image and sexual function, said Dr. Mary P. FitzGerald of the Loyola University Medical Center in Maywood, Ill. The procedure has rarely been formally studied with validated scales or to record outcomes, she added.

Dr. FitzGerald presented an analysis of the study, which was part of the National Institutes of Health-sponsored Pelvic Floor Disorders Network, at the annual meeting of the American College of Obstetricians and Gynecologists.

The researchers had two aims—to determine how difficult it was to recruit and retain older women in such a trial, and to assess morbidity, outcomes, and patient satisfaction with colpocleisis, she said.

Dr. FitzGerald and her colleagues looked at 153 women who already were undergoing colpocleisis for pelvic organ prolapse at six clinical centers participating in the NIH collaborative. Prolapse severity, symptoms, and quality of life were measured at baseline. The Pelvic Floor Distress Inventory (which includes the Pelvic Organ Prolapse Distress Inventory) and Pelvic Floor Impact Questionnaires were used, along with the Short Form 36. The researchers also recorded results of incontinence complaints before surgery.

All of the measures were recorded again at 3 months and 1 year post surgery. Women were also asked how they felt, how they perceived their body, and how they rated their sexual function relative to before the colpocleisis.

Ninety-two percent of the participants were white, with an age range of 65-94 years. Sixty percent had had a hysterectomy before the colpocleisis; 62% had a stage 3 prolapse, with the remainder having stage 4. Thirteen women (8%) had a hysterectomy at the time of the colpocleisis.

Serious adverse events were uncommon during the initial hospital stay (mean of 1.6 days), but included one case of pneumonia, one of pulmonary edema, two transfusions, two cardiac arrhythmias, and one case of hyponatremia.

There was one death, due to heart failure at 5 months post surgery; 133 women completed follow-up out to 1 year. Success—defined as all vaginal points at 1 cm or less beyond the hymen—was 97% at 3 months and 93% at 1 year. At 3 months, 97% of women had stage 1 or 2 prolapse, and 82% had stage 0 or 1; that result persisted for 1 year, said Dr. FitzGerald.

Forty-five percent of patients (69) had a simultaneous procedure to restore continence. This was not randomized or controlled, but a matter of patient choice, she said. About half the patients reported bothersome stress incontinence at baseline. That was reduced to 19% at 3 months and 14% at 1 year.

At 1 year, 85% of those who had the procedure were continent, compared with 80% of those who did not.

New-onset bothersome stress incontinence was rare, affecting only about 4% of those who had a continence procedure, but a third of those who did not have a simultaneous surgery.

All prolapse symptoms improved at 3 months, and improvement was maintained at 1 year.

The mean Pelvic Organ Prolapse Distress Inventory score dropped from 113 to 26 at 1 year after surgery. At that time, 95% (126 of those who completed follow-up) said they were very satisfied or satisfied with their decision to have colpocleisis.

Ninety-eight percent said their body looked better, compared with before the surgery; 98% said it felt better, and 97% said their sexual function was the same or improved.

Dr. FitzGerald concluded that colpocleisis “is an excellent procedure for prolapse correction.” And, she added, “We found that body image and sexual function were not adversely affected.”

A limitation of the study is that it did not compare colpocleisis to other prolapse procedures, Dr. FitzGerald said, adding that that would be important information to have.

NEW ORLEANS — Colpocleisis successfully resolves pelvic organ prolapse and patient satisfaction rates are extremely high 1 year after surgery, according to a cohort study of 153 patients.

Colpocleisis is a “time-honored procedure,” having been performed for a century, but fell out of favor for many years, partly because of concerns about its effects on women's body image and sexual function, said Dr. Mary P. FitzGerald of the Loyola University Medical Center in Maywood, Ill. The procedure has rarely been formally studied with validated scales or to record outcomes, she added.

Dr. FitzGerald presented an analysis of the study, which was part of the National Institutes of Health-sponsored Pelvic Floor Disorders Network, at the annual meeting of the American College of Obstetricians and Gynecologists.

The researchers had two aims—to determine how difficult it was to recruit and retain older women in such a trial, and to assess morbidity, outcomes, and patient satisfaction with colpocleisis, she said.

Dr. FitzGerald and her colleagues looked at 153 women who already were undergoing colpocleisis for pelvic organ prolapse at six clinical centers participating in the NIH collaborative. Prolapse severity, symptoms, and quality of life were measured at baseline. The Pelvic Floor Distress Inventory (which includes the Pelvic Organ Prolapse Distress Inventory) and Pelvic Floor Impact Questionnaires were used, along with the Short Form 36. The researchers also recorded results of incontinence complaints before surgery.

All of the measures were recorded again at 3 months and 1 year post surgery. Women were also asked how they felt, how they perceived their body, and how they rated their sexual function relative to before the colpocleisis.

Ninety-two percent of the participants were white, with an age range of 65-94 years. Sixty percent had had a hysterectomy before the colpocleisis; 62% had a stage 3 prolapse, with the remainder having stage 4. Thirteen women (8%) had a hysterectomy at the time of the colpocleisis.

Serious adverse events were uncommon during the initial hospital stay (mean of 1.6 days), but included one case of pneumonia, one of pulmonary edema, two transfusions, two cardiac arrhythmias, and one case of hyponatremia.

There was one death, due to heart failure at 5 months post surgery; 133 women completed follow-up out to 1 year. Success—defined as all vaginal points at 1 cm or less beyond the hymen—was 97% at 3 months and 93% at 1 year. At 3 months, 97% of women had stage 1 or 2 prolapse, and 82% had stage 0 or 1; that result persisted for 1 year, said Dr. FitzGerald.

Forty-five percent of patients (69) had a simultaneous procedure to restore continence. This was not randomized or controlled, but a matter of patient choice, she said. About half the patients reported bothersome stress incontinence at baseline. That was reduced to 19% at 3 months and 14% at 1 year.

At 1 year, 85% of those who had the procedure were continent, compared with 80% of those who did not.

New-onset bothersome stress incontinence was rare, affecting only about 4% of those who had a continence procedure, but a third of those who did not have a simultaneous surgery.

All prolapse symptoms improved at 3 months, and improvement was maintained at 1 year.

The mean Pelvic Organ Prolapse Distress Inventory score dropped from 113 to 26 at 1 year after surgery. At that time, 95% (126 of those who completed follow-up) said they were very satisfied or satisfied with their decision to have colpocleisis.

Ninety-eight percent said their body looked better, compared with before the surgery; 98% said it felt better, and 97% said their sexual function was the same or improved.

Dr. FitzGerald concluded that colpocleisis “is an excellent procedure for prolapse correction.” And, she added, “We found that body image and sexual function were not adversely affected.”

A limitation of the study is that it did not compare colpocleisis to other prolapse procedures, Dr. FitzGerald said, adding that that would be important information to have.

NEW ORLEANS — Colpocleisis successfully resolves pelvic organ prolapse and patient satisfaction rates are extremely high 1 year after surgery, according to a cohort study of 153 patients.

Colpocleisis is a “time-honored procedure,” having been performed for a century, but fell out of favor for many years, partly because of concerns about its effects on women's body image and sexual function, said Dr. Mary P. FitzGerald of the Loyola University Medical Center in Maywood, Ill. The procedure has rarely been formally studied with validated scales or to record outcomes, she added.

Dr. FitzGerald presented an analysis of the study, which was part of the National Institutes of Health-sponsored Pelvic Floor Disorders Network, at the annual meeting of the American College of Obstetricians and Gynecologists.

The researchers had two aims—to determine how difficult it was to recruit and retain older women in such a trial, and to assess morbidity, outcomes, and patient satisfaction with colpocleisis, she said.

Dr. FitzGerald and her colleagues looked at 153 women who already were undergoing colpocleisis for pelvic organ prolapse at six clinical centers participating in the NIH collaborative. Prolapse severity, symptoms, and quality of life were measured at baseline. The Pelvic Floor Distress Inventory (which includes the Pelvic Organ Prolapse Distress Inventory) and Pelvic Floor Impact Questionnaires were used, along with the Short Form 36. The researchers also recorded results of incontinence complaints before surgery.

All of the measures were recorded again at 3 months and 1 year post surgery. Women were also asked how they felt, how they perceived their body, and how they rated their sexual function relative to before the colpocleisis.

Ninety-two percent of the participants were white, with an age range of 65-94 years. Sixty percent had had a hysterectomy before the colpocleisis; 62% had a stage 3 prolapse, with the remainder having stage 4. Thirteen women (8%) had a hysterectomy at the time of the colpocleisis.

Serious adverse events were uncommon during the initial hospital stay (mean of 1.6 days), but included one case of pneumonia, one of pulmonary edema, two transfusions, two cardiac arrhythmias, and one case of hyponatremia.

There was one death, due to heart failure at 5 months post surgery; 133 women completed follow-up out to 1 year. Success—defined as all vaginal points at 1 cm or less beyond the hymen—was 97% at 3 months and 93% at 1 year. At 3 months, 97% of women had stage 1 or 2 prolapse, and 82% had stage 0 or 1; that result persisted for 1 year, said Dr. FitzGerald.

Forty-five percent of patients (69) had a simultaneous procedure to restore continence. This was not randomized or controlled, but a matter of patient choice, she said. About half the patients reported bothersome stress incontinence at baseline. That was reduced to 19% at 3 months and 14% at 1 year.

At 1 year, 85% of those who had the procedure were continent, compared with 80% of those who did not.

New-onset bothersome stress incontinence was rare, affecting only about 4% of those who had a continence procedure, but a third of those who did not have a simultaneous surgery.

All prolapse symptoms improved at 3 months, and improvement was maintained at 1 year.

The mean Pelvic Organ Prolapse Distress Inventory score dropped from 113 to 26 at 1 year after surgery. At that time, 95% (126 of those who completed follow-up) said they were very satisfied or satisfied with their decision to have colpocleisis.

Ninety-eight percent said their body looked better, compared with before the surgery; 98% said it felt better, and 97% said their sexual function was the same or improved.

Dr. FitzGerald concluded that colpocleisis “is an excellent procedure for prolapse correction.” And, she added, “We found that body image and sexual function were not adversely affected.”

A limitation of the study is that it did not compare colpocleisis to other prolapse procedures, Dr. FitzGerald said, adding that that would be important information to have.

Computed tomographic colonography could get a boost, thanks to the Centers for Medicare and Medicaid Services' proposal to pay for the nascent colorectal cancer screening technology.

Colonoscopy is one of the most commonly performed medical procedures in the United States, with estimates of up to 14 million procedures performed in 2003, according to the American Cancer Society.

Computed tomographic colonography (CTC) is relatively new, but it was identified as a viable alternative to colonoscopy and other colorectal cancer screening methods in guidelines compiled by the American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology (http://caonline.amcancersoc.org/cgi/content/full/CA.2007.0018v1

Medicare currently covers colorectal screening for average-risk individuals aged 50 years and older through colonoscopy, fecal occult blood testing, sigmoidoscopy, and barium enema. The new screening guidelines prompted the CMS proposal.

The guidelines state that CTC screening of average-risk adults should start after age 50, but noted that the interval for repeat exams was uncertain. The guidelines urged a colonoscopy exam when polyps of 6 mm or greater were discovered with CTC.

The CMS will make a decision by Nov. 19, according to the agency.

Private insurers generally follow Medicare payment policy, said Dr. Joel V. Brill, a fellow of the American Gastroenterological Association and chair of the AGA Institute practice management and economics committee. “Commercial insurers are also poised to begin coverage of screening CTC this year,” he said, speaking at Digestive Disease Week in San Diego.

CTC has not been assigned a current procedural terminology code; that is not likely to happen until 2010, said Dr. Brill, who is also chief medical officer of Predictive Health LLC, a medical management company in Phoenix.

Computed tomographic colonography could get a boost, thanks to the Centers for Medicare and Medicaid Services' proposal to pay for the nascent colorectal cancer screening technology.

Colonoscopy is one of the most commonly performed medical procedures in the United States, with estimates of up to 14 million procedures performed in 2003, according to the American Cancer Society.

Computed tomographic colonography (CTC) is relatively new, but it was identified as a viable alternative to colonoscopy and other colorectal cancer screening methods in guidelines compiled by the American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology (http://caonline.amcancersoc.org/cgi/content/full/CA.2007.0018v1

Medicare currently covers colorectal screening for average-risk individuals aged 50 years and older through colonoscopy, fecal occult blood testing, sigmoidoscopy, and barium enema. The new screening guidelines prompted the CMS proposal.

The guidelines state that CTC screening of average-risk adults should start after age 50, but noted that the interval for repeat exams was uncertain. The guidelines urged a colonoscopy exam when polyps of 6 mm or greater were discovered with CTC.

The CMS will make a decision by Nov. 19, according to the agency.

Private insurers generally follow Medicare payment policy, said Dr. Joel V. Brill, a fellow of the American Gastroenterological Association and chair of the AGA Institute practice management and economics committee. “Commercial insurers are also poised to begin coverage of screening CTC this year,” he said, speaking at Digestive Disease Week in San Diego.

CTC has not been assigned a current procedural terminology code; that is not likely to happen until 2010, said Dr. Brill, who is also chief medical officer of Predictive Health LLC, a medical management company in Phoenix.

Computed tomographic colonography could get a boost, thanks to the Centers for Medicare and Medicaid Services' proposal to pay for the nascent colorectal cancer screening technology.

Colonoscopy is one of the most commonly performed medical procedures in the United States, with estimates of up to 14 million procedures performed in 2003, according to the American Cancer Society.

Computed tomographic colonography (CTC) is relatively new, but it was identified as a viable alternative to colonoscopy and other colorectal cancer screening methods in guidelines compiled by the American Cancer Society, the U.S. Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology (http://caonline.amcancersoc.org/cgi/content/full/CA.2007.0018v1

Medicare currently covers colorectal screening for average-risk individuals aged 50 years and older through colonoscopy, fecal occult blood testing, sigmoidoscopy, and barium enema. The new screening guidelines prompted the CMS proposal.

The guidelines state that CTC screening of average-risk adults should start after age 50, but noted that the interval for repeat exams was uncertain. The guidelines urged a colonoscopy exam when polyps of 6 mm or greater were discovered with CTC.

The CMS will make a decision by Nov. 19, according to the agency.

Private insurers generally follow Medicare payment policy, said Dr. Joel V. Brill, a fellow of the American Gastroenterological Association and chair of the AGA Institute practice management and economics committee. “Commercial insurers are also poised to begin coverage of screening CTC this year,” he said, speaking at Digestive Disease Week in San Diego.

CTC has not been assigned a current procedural terminology code; that is not likely to happen until 2010, said Dr. Brill, who is also chief medical officer of Predictive Health LLC, a medical management company in Phoenix.

SAN DIEGO — Two new therapeutic approaches to celiac disease modestly improved patients' gluten tolerance, based on the results of early studies reported at a press briefing at the annual Digestive Disease Week.

The results of a third trial suggested diagnostic criteria for the disease may be too strict, leaving many patients with early-stage disease undiagnosed and untreated.

Celiac disease is a T-cell-mediated autoimmune disorder that is characterized by small intestinal inflammation, injury, and intolerance to gluten found in wheat, rye, and barley products. It affects about 3 million people in the United States. The small intestine primarily is affected, but the disorder is associated with a range of other systemic effects including malnutrition, bone mineral loss, anemia, and delayed growth. Treatment is limited to a gluten-free diet, but dietary adherence is difficult and response to diet is poor in up to 30% of patients.

Results were presented from a phase IIb study of larazotide acetate (AT-1001), a novel oral drug that inhibits intestinal barrier dysfunction being developed by Alba Therapeutics Corp. in Baltimore.

Dr. Daniel Leffler and his colleagues—from Beth Israel Deaconess Medical Center, Boston; the Mayo Clinic, Rochester, Minn.; and the South Hills Endoscopy Center in Pittsburgh—reported on 86 patients who had biopsy-proven celiac disease and were in remission for at least 6 months. They were randomized to one of seven treatment arms, including placebo and various doses of the active drug, with or without a gluten challenge, for 14 days. The drug was taken three times daily.

The primary end point was intestinal permeability, as measured by the urinary lactulose/mannitol ratio. None of the the 69 patients who completed the study met the primary outcome in the 14-day study period. In ad hoc analyses, however, permeability was significantly improved by day 21, said Dr. Leffler of the divisions of clinical nutrition and gastroenterology.

Alba aims to launch a larger phase II study, and planning for phase III has already begun, he said. The drug was well tolerated and undetectable in serum, making it a potentially safe addition or alternative to a gluten-free diet.

Working with Alvine Pharmaceuticals Inc., Dr. Peter Watson, of the Belfast City (Ireland) Hospital Trust performed a double-blind crossover study of another therapeutic designed to aid gluten digestion. Twenty celiac disease patients were randomly assigned to receive 5 g of gluten pretreated with a combination of enzymes or 5 g of untreated enzymes. The enzymes, prolyl endopeptidase and endopeptidase-B2, were synthesized from microorganisms and barley. The enzymes hypothetically could help celiac disease patients fully digest gluten and so avoid inflammation and symptoms. After treatment, there was no significant difference in symptom profiles, but 10 patients had a decrease in fecal fat levels, indicating increased gluten tolerance.

Currently, the diagnosis of celiac disease is confirmed by a biopsy showing small bowel mucosal villous atrophy with crypt hyperplasia (Marsh III). But Dr. Markku Mäki of the University of Tampere (Finland) presented results of a randomized, prospective study indicating that celiac disease damage occurs gradually with clinical symptoms appearing well before histologic damage.

He and his colleagues at Tampere and the University of Helsinki identified 23 patients (out of 145 consecutive cases) who had only intraepithelial lymphocytosis with or without crypt hyperplasia and randomized them either to a gluten-free diet or a normal diet.

A year later, clinical, serologic, and histologic exams were repeated. Villous architecture had deteriorated, and symptoms and antibody titers were unchanged in the normal diet group, whereas symptoms, antigluten antibodies, and mucosal inflammation were all significantly reduced in those who restricted gluten.

He urged more studies before changing diagnostic criteria, but urged considering celiac disease in all symptomatic patients and a trial of dietary restriction.

SAN DIEGO — Two new therapeutic approaches to celiac disease modestly improved patients' gluten tolerance, based on the results of early studies reported at a press briefing at the annual Digestive Disease Week.

The results of a third trial suggested diagnostic criteria for the disease may be too strict, leaving many patients with early-stage disease undiagnosed and untreated.

Celiac disease is a T-cell-mediated autoimmune disorder that is characterized by small intestinal inflammation, injury, and intolerance to gluten found in wheat, rye, and barley products. It affects about 3 million people in the United States. The small intestine primarily is affected, but the disorder is associated with a range of other systemic effects including malnutrition, bone mineral loss, anemia, and delayed growth. Treatment is limited to a gluten-free diet, but dietary adherence is difficult and response to diet is poor in up to 30% of patients.

Results were presented from a phase IIb study of larazotide acetate (AT-1001), a novel oral drug that inhibits intestinal barrier dysfunction being developed by Alba Therapeutics Corp. in Baltimore.

Dr. Daniel Leffler and his colleagues—from Beth Israel Deaconess Medical Center, Boston; the Mayo Clinic, Rochester, Minn.; and the South Hills Endoscopy Center in Pittsburgh—reported on 86 patients who had biopsy-proven celiac disease and were in remission for at least 6 months. They were randomized to one of seven treatment arms, including placebo and various doses of the active drug, with or without a gluten challenge, for 14 days. The drug was taken three times daily.

The primary end point was intestinal permeability, as measured by the urinary lactulose/mannitol ratio. None of the the 69 patients who completed the study met the primary outcome in the 14-day study period. In ad hoc analyses, however, permeability was significantly improved by day 21, said Dr. Leffler of the divisions of clinical nutrition and gastroenterology.

Alba aims to launch a larger phase II study, and planning for phase III has already begun, he said. The drug was well tolerated and undetectable in serum, making it a potentially safe addition or alternative to a gluten-free diet.

Working with Alvine Pharmaceuticals Inc., Dr. Peter Watson, of the Belfast City (Ireland) Hospital Trust performed a double-blind crossover study of another therapeutic designed to aid gluten digestion. Twenty celiac disease patients were randomly assigned to receive 5 g of gluten pretreated with a combination of enzymes or 5 g of untreated enzymes. The enzymes, prolyl endopeptidase and endopeptidase-B2, were synthesized from microorganisms and barley. The enzymes hypothetically could help celiac disease patients fully digest gluten and so avoid inflammation and symptoms. After treatment, there was no significant difference in symptom profiles, but 10 patients had a decrease in fecal fat levels, indicating increased gluten tolerance.

Currently, the diagnosis of celiac disease is confirmed by a biopsy showing small bowel mucosal villous atrophy with crypt hyperplasia (Marsh III). But Dr. Markku Mäki of the University of Tampere (Finland) presented results of a randomized, prospective study indicating that celiac disease damage occurs gradually with clinical symptoms appearing well before histologic damage.

He and his colleagues at Tampere and the University of Helsinki identified 23 patients (out of 145 consecutive cases) who had only intraepithelial lymphocytosis with or without crypt hyperplasia and randomized them either to a gluten-free diet or a normal diet.

A year later, clinical, serologic, and histologic exams were repeated. Villous architecture had deteriorated, and symptoms and antibody titers were unchanged in the normal diet group, whereas symptoms, antigluten antibodies, and mucosal inflammation were all significantly reduced in those who restricted gluten.

He urged more studies before changing diagnostic criteria, but urged considering celiac disease in all symptomatic patients and a trial of dietary restriction.

SAN DIEGO — Two new therapeutic approaches to celiac disease modestly improved patients' gluten tolerance, based on the results of early studies reported at a press briefing at the annual Digestive Disease Week.

The results of a third trial suggested diagnostic criteria for the disease may be too strict, leaving many patients with early-stage disease undiagnosed and untreated.

Celiac disease is a T-cell-mediated autoimmune disorder that is characterized by small intestinal inflammation, injury, and intolerance to gluten found in wheat, rye, and barley products. It affects about 3 million people in the United States. The small intestine primarily is affected, but the disorder is associated with a range of other systemic effects including malnutrition, bone mineral loss, anemia, and delayed growth. Treatment is limited to a gluten-free diet, but dietary adherence is difficult and response to diet is poor in up to 30% of patients.

Results were presented from a phase IIb study of larazotide acetate (AT-1001), a novel oral drug that inhibits intestinal barrier dysfunction being developed by Alba Therapeutics Corp. in Baltimore.

Dr. Daniel Leffler and his colleagues—from Beth Israel Deaconess Medical Center, Boston; the Mayo Clinic, Rochester, Minn.; and the South Hills Endoscopy Center in Pittsburgh—reported on 86 patients who had biopsy-proven celiac disease and were in remission for at least 6 months. They were randomized to one of seven treatment arms, including placebo and various doses of the active drug, with or without a gluten challenge, for 14 days. The drug was taken three times daily.

The primary end point was intestinal permeability, as measured by the urinary lactulose/mannitol ratio. None of the the 69 patients who completed the study met the primary outcome in the 14-day study period. In ad hoc analyses, however, permeability was significantly improved by day 21, said Dr. Leffler of the divisions of clinical nutrition and gastroenterology.

Alba aims to launch a larger phase II study, and planning for phase III has already begun, he said. The drug was well tolerated and undetectable in serum, making it a potentially safe addition or alternative to a gluten-free diet.

Working with Alvine Pharmaceuticals Inc., Dr. Peter Watson, of the Belfast City (Ireland) Hospital Trust performed a double-blind crossover study of another therapeutic designed to aid gluten digestion. Twenty celiac disease patients were randomly assigned to receive 5 g of gluten pretreated with a combination of enzymes or 5 g of untreated enzymes. The enzymes, prolyl endopeptidase and endopeptidase-B2, were synthesized from microorganisms and barley. The enzymes hypothetically could help celiac disease patients fully digest gluten and so avoid inflammation and symptoms. After treatment, there was no significant difference in symptom profiles, but 10 patients had a decrease in fecal fat levels, indicating increased gluten tolerance.

Currently, the diagnosis of celiac disease is confirmed by a biopsy showing small bowel mucosal villous atrophy with crypt hyperplasia (Marsh III). But Dr. Markku Mäki of the University of Tampere (Finland) presented results of a randomized, prospective study indicating that celiac disease damage occurs gradually with clinical symptoms appearing well before histologic damage.

He and his colleagues at Tampere and the University of Helsinki identified 23 patients (out of 145 consecutive cases) who had only intraepithelial lymphocytosis with or without crypt hyperplasia and randomized them either to a gluten-free diet or a normal diet.

A year later, clinical, serologic, and histologic exams were repeated. Villous architecture had deteriorated, and symptoms and antibody titers were unchanged in the normal diet group, whereas symptoms, antigluten antibodies, and mucosal inflammation were all significantly reduced in those who restricted gluten.

He urged more studies before changing diagnostic criteria, but urged considering celiac disease in all symptomatic patients and a trial of dietary restriction.

SAN DIEGO — Two new therapeutic approaches to celiac disease modestly improved patients' gluten tolerance, based on the results of early studies reported at a press briefing at the annual Digestive Disease Week.

The results of a third small trial indicated that the diagnostic criteria for celiac disease may be too strict, leaving many patients with early-stage disease undiagnosed and untreated.

Celiac disease is a T-cell-mediated autoimmune disorder characterized by small intestinal inflammation, injury, and intolerance to gluten found in wheat, rye, and barley products. Celiac disease affects about 6.5 million people worldwide and 3 million people in the United States. The small intestine primarily is affected, but the disorder is associated with a wide range of other systemic effects including malnutrition, bone mineral loss, anemia, and delayed growth. Treatment is limited to a gluten-free diet, but dietary adherence is difficult and response to diet is poor in up to 30% of patients.

Results were presented from a phase IIb study of larazotide acetate (AT-1001), a novel oral drug that inhibits intestinal barrier dysfunction and is being developed by Baltimore-based Alba Therapeutics Corp. Dr. Daniel Leffler and his colleagues—from the Beth Israel Deaconess Medical Center, Boston; the Mayo Clinic, Rochester, Minn.; and the South Hills Endoscopy Center in Pittsburgh—reported on 86 patients who had biopsy-proven celiac disease and were in remission for at least 6 months. Subjects were randomized to one of seven treatment arms, including placebo and various doses of the active drug, with or without a gluten challenge, for 14 days. The drug was taken three times daily with meals.

The primary end point was intestinal permeability, as measured by the urinary lactulose/mannitol ratio. Among the 69 patients who completed the study, the primary outcome was not met in the 14-day study period. In ad hoc analyses, however, permeability was significantly improved by day 21, reported Dr. Leffler of the divisions of clinical nutrition and gastroenterology.

Alba aims to launch a larger phase II study, and planning for phase III has already begun, he said. The drug was well tolerated and undetectable in serum, making it a potentially safe addition or alternative to a gluten-free diet, said Dr. Leffler.

Working with Alvine Pharmaceuticals Inc., Dr. Peter Watson, of the Belfast City (Ireland) Hospital Trust performed a double-blind crossover study of another therapeutic designed to aid gluten digestion.

For the study, 20 celiac disease patients were randomly assigned to receive 5 g of gluten pretreated with a combination of enzymes or 5 g of untreated enzymes. The enzymes, prolyl endopeptidase and endopeptidase-B2, were synthesized from microorganisms and barley. The enzymes hypothetically could help celiac disease patients fully digest gluten and thus avoid inflammation and symptoms, said Dr. Watson.

After treatment, there was no significant difference in symptom profiles, but 10 patients had a decrease in fecal fat levels, indicating increased gluten tolerance.

Dr. Peter H. Green, director of the celiac disease center at Columbia University, New York, hailed the two studies, saying that they indicated a potential for patients to have a treatment besides diet, which is notoriously difficult to follow. “It's very exciting for [researchers] and patients that the pharmaceutical industry has started to study this,” he said.

Currently, the diagnosis of celiac disease is confirmed by a biopsy showing small bowel mucosal villous atrophy with crypt hyperplasia (Marsh III).

But Dr. Markku Mäki of the University of Tampere (Finland) presented results of a randomized, prospective study that indicate damage from celiac disease occurs gradually, with clinical symptoms appearing well before histologic damage.

Dr. Mäki and his colleagues at Tampere and the University of Helsinki identified 23 patients out of 145 consecutive cases who had only intraepithelial lymphocytosis with or without crypt hyperplasia. These 23 patients were randomized either to a gluten-free diet or a normal diet. A year later, clinical, serologic, and histologic exams were repeated. Villous architecture had deteriorated, and symptoms and antibody titers were unchanged in the normal diet group.

Symptoms, antigluten antibodies, and mucosal inflammation were all significantly reduced in those who restricted gluten, Dr. Mäki said.

Dr. Mäki urged more studies before changing diagnostic criteria, but recommended considering celiac disease in all symptomatic patients and a trial of dietary restriction.

Dr. Green said that until a serum-based diagnostic test was available, intestinal biopsies were likely to remain the diagnostic standard.

Fewer than 5% of Americans with celiac disease have been diagnosed, Dr. Green estimated. “We're all looking for an easier way [than biopsy] to diagnose this disorder.”

'It's very exciting for [researchers] and patients that the pharmaceutical industry has started to study this.' DR. GREEN

SAN DIEGO — Two new therapeutic approaches to celiac disease modestly improved patients' gluten tolerance, based on the results of early studies reported at a press briefing at the annual Digestive Disease Week.

The results of a third small trial indicated that the diagnostic criteria for celiac disease may be too strict, leaving many patients with early-stage disease undiagnosed and untreated.

Celiac disease is a T-cell-mediated autoimmune disorder characterized by small intestinal inflammation, injury, and intolerance to gluten found in wheat, rye, and barley products. Celiac disease affects about 6.5 million people worldwide and 3 million people in the United States. The small intestine primarily is affected, but the disorder is associated with a wide range of other systemic effects including malnutrition, bone mineral loss, anemia, and delayed growth. Treatment is limited to a gluten-free diet, but dietary adherence is difficult and response to diet is poor in up to 30% of patients.

Results were presented from a phase IIb study of larazotide acetate (AT-1001), a novel oral drug that inhibits intestinal barrier dysfunction and is being developed by Baltimore-based Alba Therapeutics Corp. Dr. Daniel Leffler and his colleagues—from the Beth Israel Deaconess Medical Center, Boston; the Mayo Clinic, Rochester, Minn.; and the South Hills Endoscopy Center in Pittsburgh—reported on 86 patients who had biopsy-proven celiac disease and were in remission for at least 6 months. Subjects were randomized to one of seven treatment arms, including placebo and various doses of the active drug, with or without a gluten challenge, for 14 days. The drug was taken three times daily with meals.

The primary end point was intestinal permeability, as measured by the urinary lactulose/mannitol ratio. Among the 69 patients who completed the study, the primary outcome was not met in the 14-day study period. In ad hoc analyses, however, permeability was significantly improved by day 21, reported Dr. Leffler of the divisions of clinical nutrition and gastroenterology.

Alba aims to launch a larger phase II study, and planning for phase III has already begun, he said. The drug was well tolerated and undetectable in serum, making it a potentially safe addition or alternative to a gluten-free diet, said Dr. Leffler.

Working with Alvine Pharmaceuticals Inc., Dr. Peter Watson, of the Belfast City (Ireland) Hospital Trust performed a double-blind crossover study of another therapeutic designed to aid gluten digestion.

For the study, 20 celiac disease patients were randomly assigned to receive 5 g of gluten pretreated with a combination of enzymes or 5 g of untreated enzymes. The enzymes, prolyl endopeptidase and endopeptidase-B2, were synthesized from microorganisms and barley. The enzymes hypothetically could help celiac disease patients fully digest gluten and thus avoid inflammation and symptoms, said Dr. Watson.

After treatment, there was no significant difference in symptom profiles, but 10 patients had a decrease in fecal fat levels, indicating increased gluten tolerance.

Dr. Peter H. Green, director of the celiac disease center at Columbia University, New York, hailed the two studies, saying that they indicated a potential for patients to have a treatment besides diet, which is notoriously difficult to follow. “It's very exciting for [researchers] and patients that the pharmaceutical industry has started to study this,” he said.

Currently, the diagnosis of celiac disease is confirmed by a biopsy showing small bowel mucosal villous atrophy with crypt hyperplasia (Marsh III).

But Dr. Markku Mäki of the University of Tampere (Finland) presented results of a randomized, prospective study that indicate damage from celiac disease occurs gradually, with clinical symptoms appearing well before histologic damage.

Dr. Mäki and his colleagues at Tampere and the University of Helsinki identified 23 patients out of 145 consecutive cases who had only intraepithelial lymphocytosis with or without crypt hyperplasia. These 23 patients were randomized either to a gluten-free diet or a normal diet. A year later, clinical, serologic, and histologic exams were repeated. Villous architecture had deteriorated, and symptoms and antibody titers were unchanged in the normal diet group.

Symptoms, antigluten antibodies, and mucosal inflammation were all significantly reduced in those who restricted gluten, Dr. Mäki said.

Dr. Mäki urged more studies before changing diagnostic criteria, but recommended considering celiac disease in all symptomatic patients and a trial of dietary restriction.

Dr. Green said that until a serum-based diagnostic test was available, intestinal biopsies were likely to remain the diagnostic standard.

Fewer than 5% of Americans with celiac disease have been diagnosed, Dr. Green estimated. “We're all looking for an easier way [than biopsy] to diagnose this disorder.”

'It's very exciting for [researchers] and patients that the pharmaceutical industry has started to study this.' DR. GREEN

SAN DIEGO — Two new therapeutic approaches to celiac disease modestly improved patients' gluten tolerance, based on the results of early studies reported at a press briefing at the annual Digestive Disease Week.

The results of a third small trial indicated that the diagnostic criteria for celiac disease may be too strict, leaving many patients with early-stage disease undiagnosed and untreated.

Celiac disease is a T-cell-mediated autoimmune disorder characterized by small intestinal inflammation, injury, and intolerance to gluten found in wheat, rye, and barley products. Celiac disease affects about 6.5 million people worldwide and 3 million people in the United States. The small intestine primarily is affected, but the disorder is associated with a wide range of other systemic effects including malnutrition, bone mineral loss, anemia, and delayed growth. Treatment is limited to a gluten-free diet, but dietary adherence is difficult and response to diet is poor in up to 30% of patients.

Results were presented from a phase IIb study of larazotide acetate (AT-1001), a novel oral drug that inhibits intestinal barrier dysfunction and is being developed by Baltimore-based Alba Therapeutics Corp. Dr. Daniel Leffler and his colleagues—from the Beth Israel Deaconess Medical Center, Boston; the Mayo Clinic, Rochester, Minn.; and the South Hills Endoscopy Center in Pittsburgh—reported on 86 patients who had biopsy-proven celiac disease and were in remission for at least 6 months. Subjects were randomized to one of seven treatment arms, including placebo and various doses of the active drug, with or without a gluten challenge, for 14 days. The drug was taken three times daily with meals.

The primary end point was intestinal permeability, as measured by the urinary lactulose/mannitol ratio. Among the 69 patients who completed the study, the primary outcome was not met in the 14-day study period. In ad hoc analyses, however, permeability was significantly improved by day 21, reported Dr. Leffler of the divisions of clinical nutrition and gastroenterology.

Alba aims to launch a larger phase II study, and planning for phase III has already begun, he said. The drug was well tolerated and undetectable in serum, making it a potentially safe addition or alternative to a gluten-free diet, said Dr. Leffler.

Working with Alvine Pharmaceuticals Inc., Dr. Peter Watson, of the Belfast City (Ireland) Hospital Trust performed a double-blind crossover study of another therapeutic designed to aid gluten digestion.

For the study, 20 celiac disease patients were randomly assigned to receive 5 g of gluten pretreated with a combination of enzymes or 5 g of untreated enzymes. The enzymes, prolyl endopeptidase and endopeptidase-B2, were synthesized from microorganisms and barley. The enzymes hypothetically could help celiac disease patients fully digest gluten and thus avoid inflammation and symptoms, said Dr. Watson.

After treatment, there was no significant difference in symptom profiles, but 10 patients had a decrease in fecal fat levels, indicating increased gluten tolerance.

Dr. Peter H. Green, director of the celiac disease center at Columbia University, New York, hailed the two studies, saying that they indicated a potential for patients to have a treatment besides diet, which is notoriously difficult to follow. “It's very exciting for [researchers] and patients that the pharmaceutical industry has started to study this,” he said.

Currently, the diagnosis of celiac disease is confirmed by a biopsy showing small bowel mucosal villous atrophy with crypt hyperplasia (Marsh III).

But Dr. Markku Mäki of the University of Tampere (Finland) presented results of a randomized, prospective study that indicate damage from celiac disease occurs gradually, with clinical symptoms appearing well before histologic damage.

Dr. Mäki and his colleagues at Tampere and the University of Helsinki identified 23 patients out of 145 consecutive cases who had only intraepithelial lymphocytosis with or without crypt hyperplasia. These 23 patients were randomized either to a gluten-free diet or a normal diet. A year later, clinical, serologic, and histologic exams were repeated. Villous architecture had deteriorated, and symptoms and antibody titers were unchanged in the normal diet group.

Symptoms, antigluten antibodies, and mucosal inflammation were all significantly reduced in those who restricted gluten, Dr. Mäki said.

Dr. Mäki urged more studies before changing diagnostic criteria, but recommended considering celiac disease in all symptomatic patients and a trial of dietary restriction.

Dr. Green said that until a serum-based diagnostic test was available, intestinal biopsies were likely to remain the diagnostic standard.

Fewer than 5% of Americans with celiac disease have been diagnosed, Dr. Green estimated. “We're all looking for an easier way [than biopsy] to diagnose this disorder.”

'It's very exciting for [researchers] and patients that the pharmaceutical industry has started to study this.' DR. GREEN

LAS VEGAS — As more of the agreements signed by several large insurers to settle a class action suit alleging inappropriate billing practices expire, the possibility is increasing that the companies will return to the same behavior, especially given that many are being accused of violating the terms already, reported a compliance expert at a physicians' meeting.

Several of the health plans have said they will continue to comply with the terms of their settlements once they expire, but “not all have said that,” said Edward R. Gaines III, vice president and chief compliance officer for Healthcare Business Resources in Durham, N.C., who spoke at a meeting on reimbursement sponsored by the American College of Emergency Physicians (ACEP).

Mr. Gaines said that noncompliance among all the plans that have settled has continued to be an issue, which is being dealt with in the courts and administratively. But, “the problem is, once the settlement agreement expires, I can't go back into federal court through an easy process to make my complaint heard,” he said.

The settlements were struck in response to Multidistrict Litigation 1334, which was certified as a class action in U.S. District Court for the Southern District of Florida in 2002 and named Aetna Inc., Anthem Insurance Cos. Inc., Cigna, Coventry Health Care Inc., Health Net Inc., Humana Inc., PacifiCare Health Systems Inc., Prudential Insurance Co. of America, United Healthcare, and WellPoint Health Networks Inc. as defendants.

The suits alleged that the insurers violated the federal Racketeer Influenced and Corrupt Organizations Act by engaging in fraud and extortion in a common scheme to wrongfully deny payment to physicians.

Several state and county medical societies filed the suits on behalf of virtually every physician in the nation—about 900,000 doctors.

United Healthcare and Coventry both were summarily released from the litigation. Their release has been upheld on appeal.

Aetna and Cigna struck agreements that entailed an immediate payout in response to claims filed by physicians, some changes in billing behavior, and an agreement to provide prospective relief—$300 million from Aetna and $400 million from Cigna.

Cigna's 4-year agreement has now expired, and Aetna's 4-year agreement expired in June 2007; but Aetna's agreement was extended through this month because of compliance disputes. After an investigation, the New Jersey insurance department fined Aetna $9.5 million in June 2007 for failing to properly pay for out-of-network providers. The insurer is paying nonparticipating physicians only 125% of Medicare rates and informing patients that they are not responsible for the difference.

The national-level ACEP, the North Carolina chapter of ACEP, Wake Emergency Physicians, and the North Carolina Medical Society all subsequently followed up with a complaint to the North Carolina insurance department in November, said Mr. Gaines. The North Carolina group is challenging bundling of 12-lead ECGs into evaluation and management codes, and bundling of other procedures that use the CPT-25 modifier codes.

“If we don't get prompt action from Aetna, we're going back to court [to] ask for an extension of the settlement agreement term,” he said.

The American Medical Association and Aetna recently announced that they are working together to resolve outstanding complaints.

Prudential's agreement expires in 2009, and agreements with three other insurers expire in 2010: HealthNet, Anthem/WellPoint, and Humana.

Agreements were reached with 90% of the nation's Blue Cross and Blue Shield plans. The Blues plans agreed to similar terms as did the other payers, with one exception: Anthem/WellPoint and the Blues plans refused to accept assignment of benefits. In fact, the Blues plans were willing to walk away from the settlement if they did not win that concession, said Mr. Gaines.

Mr. Gaines urged physicians to hold the health plans that settled accountable to their agreements.

Information on settlement terms and how to dispute claims can be found at www.hmosettlements.com

LAS VEGAS — As more of the agreements signed by several large insurers to settle a class action suit alleging inappropriate billing practices expire, the possibility is increasing that the companies will return to the same behavior, especially given that many are being accused of violating the terms already, reported a compliance expert at a physicians' meeting.

Several of the health plans have said they will continue to comply with the terms of their settlements once they expire, but “not all have said that,” said Edward R. Gaines III, vice president and chief compliance officer for Healthcare Business Resources in Durham, N.C., who spoke at a meeting on reimbursement sponsored by the American College of Emergency Physicians (ACEP).

Mr. Gaines said that noncompliance among all the plans that have settled has continued to be an issue, which is being dealt with in the courts and administratively. But, “the problem is, once the settlement agreement expires, I can't go back into federal court through an easy process to make my complaint heard,” he said.

The settlements were struck in response to Multidistrict Litigation 1334, which was certified as a class action in U.S. District Court for the Southern District of Florida in 2002 and named Aetna Inc., Anthem Insurance Cos. Inc., Cigna, Coventry Health Care Inc., Health Net Inc., Humana Inc., PacifiCare Health Systems Inc., Prudential Insurance Co. of America, United Healthcare, and WellPoint Health Networks Inc. as defendants.

The suits alleged that the insurers violated the federal Racketeer Influenced and Corrupt Organizations Act by engaging in fraud and extortion in a common scheme to wrongfully deny payment to physicians.

Several state and county medical societies filed the suits on behalf of virtually every physician in the nation—about 900,000 doctors.

United Healthcare and Coventry both were summarily released from the litigation. Their release has been upheld on appeal.

Aetna and Cigna struck agreements that entailed an immediate payout in response to claims filed by physicians, some changes in billing behavior, and an agreement to provide prospective relief—$300 million from Aetna and $400 million from Cigna.

Cigna's 4-year agreement has now expired, and Aetna's 4-year agreement expired in June 2007; but Aetna's agreement was extended through this month because of compliance disputes. After an investigation, the New Jersey insurance department fined Aetna $9.5 million in June 2007 for failing to properly pay for out-of-network providers. The insurer is paying nonparticipating physicians only 125% of Medicare rates and informing patients that they are not responsible for the difference.

The national-level ACEP, the North Carolina chapter of ACEP, Wake Emergency Physicians, and the North Carolina Medical Society all subsequently followed up with a complaint to the North Carolina insurance department in November, said Mr. Gaines. The North Carolina group is challenging bundling of 12-lead ECGs into evaluation and management codes, and bundling of other procedures that use the CPT-25 modifier codes.

“If we don't get prompt action from Aetna, we're going back to court [to] ask for an extension of the settlement agreement term,” he said.

The American Medical Association and Aetna recently announced that they are working together to resolve outstanding complaints.

Prudential's agreement expires in 2009, and agreements with three other insurers expire in 2010: HealthNet, Anthem/WellPoint, and Humana.

Agreements were reached with 90% of the nation's Blue Cross and Blue Shield plans. The Blues plans agreed to similar terms as did the other payers, with one exception: Anthem/WellPoint and the Blues plans refused to accept assignment of benefits. In fact, the Blues plans were willing to walk away from the settlement if they did not win that concession, said Mr. Gaines.

Mr. Gaines urged physicians to hold the health plans that settled accountable to their agreements.

Information on settlement terms and how to dispute claims can be found at www.hmosettlements.com

LAS VEGAS — As more of the agreements signed by several large insurers to settle a class action suit alleging inappropriate billing practices expire, the possibility is increasing that the companies will return to the same behavior, especially given that many are being accused of violating the terms already, reported a compliance expert at a physicians' meeting.

Several of the health plans have said they will continue to comply with the terms of their settlements once they expire, but “not all have said that,” said Edward R. Gaines III, vice president and chief compliance officer for Healthcare Business Resources in Durham, N.C., who spoke at a meeting on reimbursement sponsored by the American College of Emergency Physicians (ACEP).

Mr. Gaines said that noncompliance among all the plans that have settled has continued to be an issue, which is being dealt with in the courts and administratively. But, “the problem is, once the settlement agreement expires, I can't go back into federal court through an easy process to make my complaint heard,” he said.

The settlements were struck in response to Multidistrict Litigation 1334, which was certified as a class action in U.S. District Court for the Southern District of Florida in 2002 and named Aetna Inc., Anthem Insurance Cos. Inc., Cigna, Coventry Health Care Inc., Health Net Inc., Humana Inc., PacifiCare Health Systems Inc., Prudential Insurance Co. of America, United Healthcare, and WellPoint Health Networks Inc. as defendants.

The suits alleged that the insurers violated the federal Racketeer Influenced and Corrupt Organizations Act by engaging in fraud and extortion in a common scheme to wrongfully deny payment to physicians.

Several state and county medical societies filed the suits on behalf of virtually every physician in the nation—about 900,000 doctors.

United Healthcare and Coventry both were summarily released from the litigation. Their release has been upheld on appeal.

Aetna and Cigna struck agreements that entailed an immediate payout in response to claims filed by physicians, some changes in billing behavior, and an agreement to provide prospective relief—$300 million from Aetna and $400 million from Cigna.

Cigna's 4-year agreement has now expired, and Aetna's 4-year agreement expired in June 2007; but Aetna's agreement was extended through this month because of compliance disputes. After an investigation, the New Jersey insurance department fined Aetna $9.5 million in June 2007 for failing to properly pay for out-of-network providers. The insurer is paying nonparticipating physicians only 125% of Medicare rates and informing patients that they are not responsible for the difference.

The national-level ACEP, the North Carolina chapter of ACEP, Wake Emergency Physicians, and the North Carolina Medical Society all subsequently followed up with a complaint to the North Carolina insurance department in November, said Mr. Gaines. The North Carolina group is challenging bundling of 12-lead ECGs into evaluation and management codes, and bundling of other procedures that use the CPT-25 modifier codes.

“If we don't get prompt action from Aetna, we're going back to court [to] ask for an extension of the settlement agreement term,” he said.

The American Medical Association and Aetna recently announced that they are working together to resolve outstanding complaints.

Prudential's agreement expires in 2009, and agreements with three other insurers expire in 2010: HealthNet, Anthem/WellPoint, and Humana.

Agreements were reached with 90% of the nation's Blue Cross and Blue Shield plans. The Blues plans agreed to similar terms as did the other payers, with one exception: Anthem/WellPoint and the Blues plans refused to accept assignment of benefits. In fact, the Blues plans were willing to walk away from the settlement if they did not win that concession, said Mr. Gaines.

Mr. Gaines urged physicians to hold the health plans that settled accountable to their agreements.

Information on settlement terms and how to dispute claims can be found at www.hmosettlements.com

NEW ORLEANS — The American Society for Reproductive Medicine, in collaboration with the Society for Reproductive Endocrinology and Infertility, is revising its definition of infertility to encourage earlier evaluation of women aged over 35 years who have difficulty conceiving.

The new definition, along with a new definition of recurrent pregnancy loss, will be published in the June issue of Fertility and Sterility, Dr. Marc Fritz said at the annual meeting of the American College of Obstetricians and Gynecologists.

ASRM members requested the new definitions, in part because insurers were adhering strictly to the existing guidelines, leading to a denial of access to appropriate treatment, Dr. Fritz said in an interview.

Infertility specialists say that the changes give credence to what's been standard practice in their field. The real impact should come from the word getting out to general ob.gyns. and family physicians, Dr. Eric Surrey, medical director of the Colorado Center for Reproductive Medicine in Lonetree, said in an interview. “This message is meant for the generalist, not the reproductive endocrinologist,” Dr. Masood Khatamee of New York University said in an interview. “And it's a very, very appropriate statement,” he said.

Dr. Fritz agreed that the ASRM was aiming for a broader audience. He said the ASRM will urge early evaluation and treatment of all women based on natural history and physical findings after a failure to achieve pregnancy following at least 12 months of regular unprotected intercourse. Treatment and evaluation will be warranted after 6 months for women aged over 35 years.

The ASRM also for the first time is specifically defining recurrent pregnancy loss as a disease distinct from infertility, said Dr. Fritz, professor of obstetrics and gynecology and division chief of reproductive endocrinology and infertility at the University of North Carolina at Chapel Hill. It will be defined by two or more failed pregnancies; these pregnancies must be documented by ultrasound or pathologic examination. When the cause is unknown, each pregnancy loss merits careful review to determine whether specific evaluations may be appropriate, said Dr. Fritz. After three or more losses, a thorough evaluation is warranted, he said.

Dr. Charles Miller, an infertility specialist in Chicago, said the ASRM “has thrown [its] weight behind what we in the field have done for a while.”

The clear statements on both infertility and recurrent pregnancy loss may also help convince insurance companies to cover evaluation and treatment in instances where they haven't in the past, Dr. Miller said in an interview.

Dr. Surrey agreed that the statements could be helpful for reimbursement. For instance, insurers often consider recurrent pregnancy loss to be a form of infertility, which is inappropriate and untrue, he said in an interview.

He said he was encouraged by the statement on infertility, noting that it will heighten patient and physician awareness that earlier evaluation is important. He said women are often told they have plenty of time to conceive. “That's not what they want to hear,” he said.

The 6-month cut-off for women aged over 35 is a somewhat arbitrary figure, but is necessary to prompt quicker action, said Dr. Surrey. The earlier evaluations may result in more findings of no abnormalities, but at least women will be reassured that they aren't wasting their time if they are told to spend another 6 months trying to conceive, he said.

Dr. Khatamee said he tells other physicians and medical students that a woman's age is a key deciding factor when evaluating infertility. Women over age 35 should not be told to spend a year trying to conceive, he said.

The ASRM favors early evaluation and treatment based on natural history and physical findings. DR. FRITZ

NEW ORLEANS — The American Society for Reproductive Medicine, in collaboration with the Society for Reproductive Endocrinology and Infertility, is revising its definition of infertility to encourage earlier evaluation of women aged over 35 years who have difficulty conceiving.

The new definition, along with a new definition of recurrent pregnancy loss, will be published in the June issue of Fertility and Sterility, Dr. Marc Fritz said at the annual meeting of the American College of Obstetricians and Gynecologists.

ASRM members requested the new definitions, in part because insurers were adhering strictly to the existing guidelines, leading to a denial of access to appropriate treatment, Dr. Fritz said in an interview.

Infertility specialists say that the changes give credence to what's been standard practice in their field. The real impact should come from the word getting out to general ob.gyns. and family physicians, Dr. Eric Surrey, medical director of the Colorado Center for Reproductive Medicine in Lonetree, said in an interview. “This message is meant for the generalist, not the reproductive endocrinologist,” Dr. Masood Khatamee of New York University said in an interview. “And it's a very, very appropriate statement,” he said.

Dr. Fritz agreed that the ASRM was aiming for a broader audience. He said the ASRM will urge early evaluation and treatment of all women based on natural history and physical findings after a failure to achieve pregnancy following at least 12 months of regular unprotected intercourse. Treatment and evaluation will be warranted after 6 months for women aged over 35 years.

The ASRM also for the first time is specifically defining recurrent pregnancy loss as a disease distinct from infertility, said Dr. Fritz, professor of obstetrics and gynecology and division chief of reproductive endocrinology and infertility at the University of North Carolina at Chapel Hill. It will be defined by two or more failed pregnancies; these pregnancies must be documented by ultrasound or pathologic examination. When the cause is unknown, each pregnancy loss merits careful review to determine whether specific evaluations may be appropriate, said Dr. Fritz. After three or more losses, a thorough evaluation is warranted, he said.

Dr. Charles Miller, an infertility specialist in Chicago, said the ASRM “has thrown [its] weight behind what we in the field have done for a while.”

The clear statements on both infertility and recurrent pregnancy loss may also help convince insurance companies to cover evaluation and treatment in instances where they haven't in the past, Dr. Miller said in an interview.

Dr. Surrey agreed that the statements could be helpful for reimbursement. For instance, insurers often consider recurrent pregnancy loss to be a form of infertility, which is inappropriate and untrue, he said in an interview.

He said he was encouraged by the statement on infertility, noting that it will heighten patient and physician awareness that earlier evaluation is important. He said women are often told they have plenty of time to conceive. “That's not what they want to hear,” he said.

The 6-month cut-off for women aged over 35 is a somewhat arbitrary figure, but is necessary to prompt quicker action, said Dr. Surrey. The earlier evaluations may result in more findings of no abnormalities, but at least women will be reassured that they aren't wasting their time if they are told to spend another 6 months trying to conceive, he said.

Dr. Khatamee said he tells other physicians and medical students that a woman's age is a key deciding factor when evaluating infertility. Women over age 35 should not be told to spend a year trying to conceive, he said.

The ASRM favors early evaluation and treatment based on natural history and physical findings. DR. FRITZ

NEW ORLEANS — The American Society for Reproductive Medicine, in collaboration with the Society for Reproductive Endocrinology and Infertility, is revising its definition of infertility to encourage earlier evaluation of women aged over 35 years who have difficulty conceiving.

The new definition, along with a new definition of recurrent pregnancy loss, will be published in the June issue of Fertility and Sterility, Dr. Marc Fritz said at the annual meeting of the American College of Obstetricians and Gynecologists.

ASRM members requested the new definitions, in part because insurers were adhering strictly to the existing guidelines, leading to a denial of access to appropriate treatment, Dr. Fritz said in an interview.

Infertility specialists say that the changes give credence to what's been standard practice in their field. The real impact should come from the word getting out to general ob.gyns. and family physicians, Dr. Eric Surrey, medical director of the Colorado Center for Reproductive Medicine in Lonetree, said in an interview. “This message is meant for the generalist, not the reproductive endocrinologist,” Dr. Masood Khatamee of New York University said in an interview. “And it's a very, very appropriate statement,” he said.

Dr. Fritz agreed that the ASRM was aiming for a broader audience. He said the ASRM will urge early evaluation and treatment of all women based on natural history and physical findings after a failure to achieve pregnancy following at least 12 months of regular unprotected intercourse. Treatment and evaluation will be warranted after 6 months for women aged over 35 years.

The ASRM also for the first time is specifically defining recurrent pregnancy loss as a disease distinct from infertility, said Dr. Fritz, professor of obstetrics and gynecology and division chief of reproductive endocrinology and infertility at the University of North Carolina at Chapel Hill. It will be defined by two or more failed pregnancies; these pregnancies must be documented by ultrasound or pathologic examination. When the cause is unknown, each pregnancy loss merits careful review to determine whether specific evaluations may be appropriate, said Dr. Fritz. After three or more losses, a thorough evaluation is warranted, he said.

Dr. Charles Miller, an infertility specialist in Chicago, said the ASRM “has thrown [its] weight behind what we in the field have done for a while.”

The clear statements on both infertility and recurrent pregnancy loss may also help convince insurance companies to cover evaluation and treatment in instances where they haven't in the past, Dr. Miller said in an interview.

Dr. Surrey agreed that the statements could be helpful for reimbursement. For instance, insurers often consider recurrent pregnancy loss to be a form of infertility, which is inappropriate and untrue, he said in an interview.

He said he was encouraged by the statement on infertility, noting that it will heighten patient and physician awareness that earlier evaluation is important. He said women are often told they have plenty of time to conceive. “That's not what they want to hear,” he said.

The 6-month cut-off for women aged over 35 is a somewhat arbitrary figure, but is necessary to prompt quicker action, said Dr. Surrey. The earlier evaluations may result in more findings of no abnormalities, but at least women will be reassured that they aren't wasting their time if they are told to spend another 6 months trying to conceive, he said.

Dr. Khatamee said he tells other physicians and medical students that a woman's age is a key deciding factor when evaluating infertility. Women over age 35 should not be told to spend a year trying to conceive, he said.

The ASRM favors early evaluation and treatment based on natural history and physical findings. DR. FRITZ