M. Alexander Otto

VANCOUVER, B.C. – Fluoroquinolone use increased the risk of B1-strain Clostridium difficile infection, a strain that is associated with severe disease and has caused outbreaks in hospitals throughout North America and Europe, according to a study at a Veterans Affairs hospital.

"We were able to demonstrate that patients in our hospital who developed CDI due to the epidemic B1 strain were more likely than patients infected with other strains to have been treated with fluoroquinolones prior to developing CDI," and that the B1 strain is highly resistant to fluoroquinolones, said Dr. Stuart Johnson, an infectious disease specialist at Loyola University, Chicago, and Hines (Ill.) VA Hospital, who presented the study at the annual meeting of the Infectious Diseases Society of America.

"We were using [the fluoroquinolone] ciprofloxacin for many years until we knew that this was a risk for C. difficile; all the fluoroquinolones have this particular risk," he said.

Dr. Johnson said the findings mimic those of the 1990s, when he and his colleagues found that the J strain of the pathogen was highly resistant to clindamycin and was associated with outbreaks in hospitals that used clindamycin heavily (N. Engl. J. Med. 1999;341:1645-51).

"In those instances, restriction of clindamycin was very effective in interrupting outbreaks," he said.

In general, "if you are having an outbreak or increased rates of C. difficile, you may be able to target antibiotic stewardship programs to those antibiotics that are leading to the outbreak," Dr. Johnson said.

In a case-control study funded by the Department of Veterans Affairs, stool samples from newly diagnosed CDI patients at the Hines VA Hospital were cultured and typed by restriction endonuclease analysis. Patients’ antibiotic exposures over the previous 6 weeks were then checked.

Fluoroquinolone use was more frequent in the 67 patients who developed B1-strain CDI, and greatly increased their risk for a B1 infection (odds ratio, 3.6; 95% confidence interval, 1.3-9.8; P = .01).

Clindamycin use was more frequent in the 30 patients who developed non–B1-strain CDI.

B1 isolates demonstrated high-level resistance to azithromycin and moxifloxacin, a newer generation fluoroquinolone. Non-B1 isolates demonstrated high-level clindamycin resistance. All strains were resistant to ceftriaxone, but none were resistant to piperacillin/tazobactam, Dr. Johnson said.

In a separate abstract presented at the meeting by Dr. Dimitri Drekonja, an infectious disease specialist at the Minneapolis VA Medical Center, 51 of 89 patients with CDI received at least one course of antibiotics within 30 days of completing CDI treatment.

"Roughly one-third of all antimicrobial use was judged to be inappropriate" in a preliminary analysis, he said. Pending additional investigation, however, Dr. Drekonja did not provide additional details.

Dr. Drekonja said he has no disclosures. Dr. Johnson said he is a consultant for Optimer Pharmaceuticals Inc., Viropharma Inc., Novartis, Cubist Pharmaceuticals Inc., and Bio-K+ International Inc.

VANCOUVER, B.C. – Fluoroquinolone use increased the risk of B1-strain Clostridium difficile infection, a strain that is associated with severe disease and has caused outbreaks in hospitals throughout North America and Europe, according to a study at a Veterans Affairs hospital.

"We were able to demonstrate that patients in our hospital who developed CDI due to the epidemic B1 strain were more likely than patients infected with other strains to have been treated with fluoroquinolones prior to developing CDI," and that the B1 strain is highly resistant to fluoroquinolones, said Dr. Stuart Johnson, an infectious disease specialist at Loyola University, Chicago, and Hines (Ill.) VA Hospital, who presented the study at the annual meeting of the Infectious Diseases Society of America.

"We were using [the fluoroquinolone] ciprofloxacin for many years until we knew that this was a risk for C. difficile; all the fluoroquinolones have this particular risk," he said.

Dr. Johnson said the findings mimic those of the 1990s, when he and his colleagues found that the J strain of the pathogen was highly resistant to clindamycin and was associated with outbreaks in hospitals that used clindamycin heavily (N. Engl. J. Med. 1999;341:1645-51).

"In those instances, restriction of clindamycin was very effective in interrupting outbreaks," he said.

In general, "if you are having an outbreak or increased rates of C. difficile, you may be able to target antibiotic stewardship programs to those antibiotics that are leading to the outbreak," Dr. Johnson said.

In a case-control study funded by the Department of Veterans Affairs, stool samples from newly diagnosed CDI patients at the Hines VA Hospital were cultured and typed by restriction endonuclease analysis. Patients’ antibiotic exposures over the previous 6 weeks were then checked.

Fluoroquinolone use was more frequent in the 67 patients who developed B1-strain CDI, and greatly increased their risk for a B1 infection (odds ratio, 3.6; 95% confidence interval, 1.3-9.8; P = .01).

Clindamycin use was more frequent in the 30 patients who developed non–B1-strain CDI.

B1 isolates demonstrated high-level resistance to azithromycin and moxifloxacin, a newer generation fluoroquinolone. Non-B1 isolates demonstrated high-level clindamycin resistance. All strains were resistant to ceftriaxone, but none were resistant to piperacillin/tazobactam, Dr. Johnson said.

In a separate abstract presented at the meeting by Dr. Dimitri Drekonja, an infectious disease specialist at the Minneapolis VA Medical Center, 51 of 89 patients with CDI received at least one course of antibiotics within 30 days of completing CDI treatment.

"Roughly one-third of all antimicrobial use was judged to be inappropriate" in a preliminary analysis, he said. Pending additional investigation, however, Dr. Drekonja did not provide additional details.

Dr. Drekonja said he has no disclosures. Dr. Johnson said he is a consultant for Optimer Pharmaceuticals Inc., Viropharma Inc., Novartis, Cubist Pharmaceuticals Inc., and Bio-K+ International Inc.

VANCOUVER, B.C. – Fluoroquinolone use increased the risk of B1-strain Clostridium difficile infection, a strain that is associated with severe disease and has caused outbreaks in hospitals throughout North America and Europe, according to a study at a Veterans Affairs hospital.

"We were able to demonstrate that patients in our hospital who developed CDI due to the epidemic B1 strain were more likely than patients infected with other strains to have been treated with fluoroquinolones prior to developing CDI," and that the B1 strain is highly resistant to fluoroquinolones, said Dr. Stuart Johnson, an infectious disease specialist at Loyola University, Chicago, and Hines (Ill.) VA Hospital, who presented the study at the annual meeting of the Infectious Diseases Society of America.

"We were using [the fluoroquinolone] ciprofloxacin for many years until we knew that this was a risk for C. difficile; all the fluoroquinolones have this particular risk," he said.

Dr. Johnson said the findings mimic those of the 1990s, when he and his colleagues found that the J strain of the pathogen was highly resistant to clindamycin and was associated with outbreaks in hospitals that used clindamycin heavily (N. Engl. J. Med. 1999;341:1645-51).

"In those instances, restriction of clindamycin was very effective in interrupting outbreaks," he said.

In general, "if you are having an outbreak or increased rates of C. difficile, you may be able to target antibiotic stewardship programs to those antibiotics that are leading to the outbreak," Dr. Johnson said.

In a case-control study funded by the Department of Veterans Affairs, stool samples from newly diagnosed CDI patients at the Hines VA Hospital were cultured and typed by restriction endonuclease analysis. Patients’ antibiotic exposures over the previous 6 weeks were then checked.

Fluoroquinolone use was more frequent in the 67 patients who developed B1-strain CDI, and greatly increased their risk for a B1 infection (odds ratio, 3.6; 95% confidence interval, 1.3-9.8; P = .01).

Clindamycin use was more frequent in the 30 patients who developed non–B1-strain CDI.

B1 isolates demonstrated high-level resistance to azithromycin and moxifloxacin, a newer generation fluoroquinolone. Non-B1 isolates demonstrated high-level clindamycin resistance. All strains were resistant to ceftriaxone, but none were resistant to piperacillin/tazobactam, Dr. Johnson said.

In a separate abstract presented at the meeting by Dr. Dimitri Drekonja, an infectious disease specialist at the Minneapolis VA Medical Center, 51 of 89 patients with CDI received at least one course of antibiotics within 30 days of completing CDI treatment.

"Roughly one-third of all antimicrobial use was judged to be inappropriate" in a preliminary analysis, he said. Pending additional investigation, however, Dr. Drekonja did not provide additional details.

Dr. Drekonja said he has no disclosures. Dr. Johnson said he is a consultant for Optimer Pharmaceuticals Inc., Viropharma Inc., Novartis, Cubist Pharmaceuticals Inc., and Bio-K+ International Inc.

VANCOUVER, B.C. – Fluoroquinolone use increased the risk of B1-strain Clostridium difficile infection, a strain that is associated with severe disease and has caused outbreaks in hospitals throughout North America and Europe, according to a study at a Veterans Affairs hospital.

"We were able to demonstrate that patients in our hospital who developed CDI due to the epidemic B1 strain were more likely than patients infected with other strains to have been treated with fluoroquinolones prior to developing CDI," and that the B1 strain is highly resistant to fluoroquinolones, said Dr. Stuart Johnson, an infectious disease specialist at Loyola University, Chicago, and Hines (Ill.) VA Hospital, who presented the study at the annual meeting of the Infectious Diseases Society of America.

"We were using [the fluoroquinolone] ciprofloxacin for many years until we knew that this was a risk for C. difficile; all the fluoroquinolones have this particular risk," he said.

Dr. Johnson said the findings mimic those of the 1990s, when he and his colleagues found that the J strain of the pathogen was highly resistant to clindamycin and was associated with outbreaks in hospitals that used clindamycin heavily (N. Engl. J. Med. 1999;341:1645-51).

"In those instances, restriction of clindamycin was very effective in interrupting outbreaks," he said.

In general, "if you are having an outbreak or increased rates of C. difficile, you may be able to target antibiotic stewardship programs to those antibiotics that are leading to the outbreak," Dr. Johnson said.

In a case-control study funded by the Department of Veterans Affairs, stool samples from newly diagnosed CDI patients at the Hines VA Hospital were cultured and typed by restriction endonuclease analysis. Patients’ antibiotic exposures over the previous 6 weeks were then checked.

Fluoroquinolone use was more frequent in the 67 patients who developed B1-strain CDI, and greatly increased their risk for a B1 infection (odds ratio, 3.6; 95% confidence interval, 1.3-9.8; P = .01).

Clindamycin use was more frequent in the 30 patients who developed non–B1-strain CDI.

B1 isolates demonstrated high-level resistance to azithromycin and moxifloxacin, a newer generation fluoroquinolone. Non-B1 isolates demonstrated high-level clindamycin resistance. All strains were resistant to ceftriaxone, but none were resistant to piperacillin/tazobactam, Dr. Johnson said.

In a separate abstract presented at the meeting by Dr. Dimitri Drekonja, an infectious disease specialist at the Minneapolis VA Medical Center, 51 of 89 patients with CDI received at least one course of antibiotics within 30 days of completing CDI treatment.

"Roughly one-third of all antimicrobial use was judged to be inappropriate" in a preliminary analysis, he said. Pending additional investigation, however, Dr. Drekonja did not provide additional details.

Dr. Drekonja said he has no disclosures. Dr. Johnson said he is a consultant for Optimer Pharmaceuticals Inc., Viropharma Inc., Novartis, Cubist Pharmaceuticals Inc., and Bio-K+ International Inc.

VANCOUVER, B.C. – Fluoroquinolone use increased the risk of B1-strain Clostridium difficile infection, a strain that is associated with severe disease and has caused outbreaks in hospitals throughout North America and Europe, according to a study at a Veterans Affairs hospital.

"We were able to demonstrate that patients in our hospital who developed CDI due to the epidemic B1 strain were more likely than patients infected with other strains to have been treated with fluoroquinolones prior to developing CDI," and that the B1 strain is highly resistant to fluoroquinolones, said Dr. Stuart Johnson, an infectious disease specialist at Loyola University, Chicago, and Hines (Ill.) VA Hospital, who presented the study at the annual meeting of the Infectious Diseases Society of America.

"We were using [the fluoroquinolone] ciprofloxacin for many years until we knew that this was a risk for C. difficile; all the fluoroquinolones have this particular risk," he said.

Dr. Johnson said the findings mimic those of the 1990s, when he and his colleagues found that the J strain of the pathogen was highly resistant to clindamycin and was associated with outbreaks in hospitals that used clindamycin heavily (N. Engl. J. Med. 1999;341:1645-51).

"In those instances, restriction of clindamycin was very effective in interrupting outbreaks," he said.

In general, "if you are having an outbreak or increased rates of C. difficile, you may be able to target antibiotic stewardship programs to those antibiotics that are leading to the outbreak," Dr. Johnson said.

In a case-control study funded by the Department of Veterans Affairs, stool samples from newly diagnosed CDI patients at the Hines VA Hospital were cultured and typed by restriction endonuclease analysis. Patients’ antibiotic exposures over the previous 6 weeks were then checked.

Fluoroquinolone use was more frequent in the 67 patients who developed B1-strain CDI, and greatly increased their risk for a B1 infection (odds ratio, 3.6; 95% confidence interval, 1.3-9.8; P = .01).

Clindamycin use was more frequent in the 30 patients who developed non–B1-strain CDI.

B1 isolates demonstrated high-level resistance to azithromycin and moxifloxacin, a newer generation fluoroquinolone. Non-B1 isolates demonstrated high-level clindamycin resistance. All strains were resistant to ceftriaxone, but none were resistant to piperacillin/tazobactam, Dr. Johnson said.

In a separate abstract presented at the meeting by Dr. Dimitri Drekonja, an infectious disease specialist at the Minneapolis VA Medical Center, 51 of 89 patients with CDI received at least one course of antibiotics within 30 days of completing CDI treatment.

"Roughly one-third of all antimicrobial use was judged to be inappropriate" in a preliminary analysis, he said. Pending additional investigation, however, Dr. Drekonja did not provide additional details.

Dr. Drekonja said he has no disclosures. Dr. Johnson said he is a consultant for Optimer Pharmaceuticals Inc., Viropharma Inc., Novartis, Cubist Pharmaceuticals Inc., and Bio-K+ International Inc.

VANCOUVER, B.C. – Fluoroquinolone use increased the risk of B1-strain Clostridium difficile infection, a strain that is associated with severe disease and has caused outbreaks in hospitals throughout North America and Europe, according to a study at a Veterans Affairs hospital.

"We were able to demonstrate that patients in our hospital who developed CDI due to the epidemic B1 strain were more likely than patients infected with other strains to have been treated with fluoroquinolones prior to developing CDI," and that the B1 strain is highly resistant to fluoroquinolones, said Dr. Stuart Johnson, an infectious disease specialist at Loyola University, Chicago, and Hines (Ill.) VA Hospital, who presented the study at the annual meeting of the Infectious Diseases Society of America.

"We were using [the fluoroquinolone] ciprofloxacin for many years until we knew that this was a risk for C. difficile; all the fluoroquinolones have this particular risk," he said.

Dr. Johnson said the findings mimic those of the 1990s, when he and his colleagues found that the J strain of the pathogen was highly resistant to clindamycin and was associated with outbreaks in hospitals that used clindamycin heavily (N. Engl. J. Med. 1999;341:1645-51).

"In those instances, restriction of clindamycin was very effective in interrupting outbreaks," he said.

In general, "if you are having an outbreak or increased rates of C. difficile, you may be able to target antibiotic stewardship programs to those antibiotics that are leading to the outbreak," Dr. Johnson said.

In a case-control study funded by the Department of Veterans Affairs, stool samples from newly diagnosed CDI patients at the Hines VA Hospital were cultured and typed by restriction endonuclease analysis. Patients’ antibiotic exposures over the previous 6 weeks were then checked.

Fluoroquinolone use was more frequent in the 67 patients who developed B1-strain CDI, and greatly increased their risk for a B1 infection (odds ratio, 3.6; 95% confidence interval, 1.3-9.8; P = .01).

Clindamycin use was more frequent in the 30 patients who developed non–B1-strain CDI.

B1 isolates demonstrated high-level resistance to azithromycin and moxifloxacin, a newer generation fluoroquinolone. Non-B1 isolates demonstrated high-level clindamycin resistance. All strains were resistant to ceftriaxone, but none were resistant to piperacillin/tazobactam, Dr. Johnson said.

In a separate abstract presented at the meeting by Dr. Dimitri Drekonja, an infectious disease specialist at the Minneapolis VA Medical Center, 51 of 89 patients with CDI received at least one course of antibiotics within 30 days of completing CDI treatment.

"Roughly one-third of all antimicrobial use was judged to be inappropriate" in a preliminary analysis, he said. Pending additional investigation, however, Dr. Drekonja did not provide additional details.

Dr. Drekonja said he has no disclosures. Dr. Johnson said he is a consultant for Optimer Pharmaceuticals Inc., Viropharma Inc., Novartis, Cubist Pharmaceuticals Inc., and Bio-K+ International Inc.

Many physicians have wondered how – and even if – they will be able to work together to form accountable care organizations without violating federal antitrust and fraud and abuse laws.

A federal regulatory meeting held earlier this fall offered possible answers to both questions. Federal regulators are considering exemptions to those laws that would allow providers who meet certain requirements to form ACOs.

"It is not easy to craft safe harbors that can replace an antitrust review that analyzes the specific facts of each case and market. But we’re going to try to do this," said Jon Leibowitz, chairman of the Federal Trade Commission (FTC).

Similarly, Daniel Levinson, inspector general of the U.S. Department of Health and Human Services, noted that the Affordable Care Act gives the HHS secretary the authority to waive some fraud and abuse laws as needed to help ACO programs develop.

"We and our HHS colleagues are looking closely at how the secretary might exercise this authority most effectively," Levinson said, according to the meeting transcript.

The FTC, the HHS Office of Inspector General, and the Centers for Medicare and Medicaid Services conducted the workshop in Baltimore to hear the opinions of panelists and audience members on a variety of ACO issues.

However, much of the questioning focused on how antitrust and fraud and abuse exemptions could be applied to ACOs.

The Affordable Care Act promotes ACO creation to reduce health-care fragmentation, improve outcomes, and cut health spending by, for instance, keeping patients out of hospitals when possible.

The goal is for providers to come together and contract with the CMS to integrate and manage the care of at least 5,000 patients, and to share a portion of the savings their efforts generate for Medicare, so long as quality parameters are met.

Once formed, ACOs could pursue similar types of contracts with commercial insurance companies.

The catch is that encouraging independent providers to jointly negotiate contracts and payment rates with health plans raises concerns about joint price fixing, reduced competition, and other antitrust matters.

Likewise, the shared-savings provision, among others, raises antikickback, self-referral, and other fraud and abuse concerns, according to health care attorney Douglas Hastings, board chair of Epstein Becker & Green, Washington, and a meeting panelist who offered his insights during a later interview.

Regulators are interested in applying to ACOs antitrust protections that already exist for providers who are clinically integrated and jointly accept significant financial risk.

"In those cases, [collaboration is] not viewed as an antitrust matter, since they are behaving as an integrated organization," explained meeting panelist and health policy expert Harold Miller, executive director of the Center for Health Care Quality and Payment Reform, who also offered his insights during a later interview.

Defining the extent of integration required for protection, and the time frame to achieve it, remain key issues for regulators, as does the possible creation of additional antitrust safe harbors related to market share and other matters. Regulators also said that they want to foster multiple ACOs in a given market to increase competition.

Which providers would be covered under fraud and abuse waivers also remains an issue, as well as whether waivers should apply only to shared savings payments or to other financial relationships ACOs create, Troy Barsky, director of the CMS Division of Technical Payment Policy, explained during the meeting.

Overall, the hope is to spur "coordination [and] cooperation among the people and the entities that provide health care," while at the same time ensure "appropriate corporate behaviors," said Dr. Donald Berwick, CMS Administrator.

Proposed ACO regulations are expected from the CMS in late December.

In the meantime, Mr. Miller advised physicians, "If you want to be an ACO, you have to start looking at the data you have – or get access to data from payers, Medicare, and others – to identify opportunities for savings.

"Once you know where they are, figure out what programs to put in place to achieve those savings," he said.

One option among many is to hire a nurse to help chronically ill patients manage their diseases, Mr. Miller said. That’s been proven to help reduce emergency department visits and hospitalizations, he added (Arch. Intern. Med. 2003;163:585-91).

To make such programs cost effective, however, "a small practice will need to think about how to partner with other practices in order to have enough patients who can benefit," he said.

Mr. Miller added that he does not believe recent election results will derail ACO efforts or other aspects of the Affordable Care Act. Despite Republican victories, "I think it would be a near impossibility to pass a repeal by a veto-proof margin. And the ACO stuff is not really controversial – yet," he noted.

The meeting’s audio and transcript – as well as public comments on ACO concerns – are online at www.ftc.gov/opp/workshops/aco/index.shtml.

Many physicians have wondered how – and even if – they will be able to work together to form accountable care organizations without violating federal antitrust and fraud and abuse laws.

A federal regulatory meeting held earlier this fall offered possible answers to both questions. Federal regulators are considering exemptions to those laws that would allow providers who meet certain requirements to form ACOs.

"It is not easy to craft safe harbors that can replace an antitrust review that analyzes the specific facts of each case and market. But we’re going to try to do this," said Jon Leibowitz, chairman of the Federal Trade Commission (FTC).

Similarly, Daniel Levinson, inspector general of the U.S. Department of Health and Human Services, noted that the Affordable Care Act gives the HHS secretary the authority to waive some fraud and abuse laws as needed to help ACO programs develop.

"We and our HHS colleagues are looking closely at how the secretary might exercise this authority most effectively," Levinson said, according to the meeting transcript.

The FTC, the HHS Office of Inspector General, and the Centers for Medicare and Medicaid Services conducted the workshop in Baltimore to hear the opinions of panelists and audience members on a variety of ACO issues.

However, much of the questioning focused on how antitrust and fraud and abuse exemptions could be applied to ACOs.

The Affordable Care Act promotes ACO creation to reduce health-care fragmentation, improve outcomes, and cut health spending by, for instance, keeping patients out of hospitals when possible.

The goal is for providers to come together and contract with the CMS to integrate and manage the care of at least 5,000 patients, and to share a portion of the savings their efforts generate for Medicare, so long as quality parameters are met.

Once formed, ACOs could pursue similar types of contracts with commercial insurance companies.

The catch is that encouraging independent providers to jointly negotiate contracts and payment rates with health plans raises concerns about joint price fixing, reduced competition, and other antitrust matters.

Likewise, the shared-savings provision, among others, raises antikickback, self-referral, and other fraud and abuse concerns, according to health care attorney Douglas Hastings, board chair of Epstein Becker & Green, Washington, and a meeting panelist who offered his insights during a later interview.

Regulators are interested in applying to ACOs antitrust protections that already exist for providers who are clinically integrated and jointly accept significant financial risk.

"In those cases, [collaboration is] not viewed as an antitrust matter, since they are behaving as an integrated organization," explained meeting panelist and health policy expert Harold Miller, executive director of the Center for Health Care Quality and Payment Reform, who also offered his insights during a later interview.

Defining the extent of integration required for protection, and the time frame to achieve it, remain key issues for regulators, as does the possible creation of additional antitrust safe harbors related to market share and other matters. Regulators also said that they want to foster multiple ACOs in a given market to increase competition.

Which providers would be covered under fraud and abuse waivers also remains an issue, as well as whether waivers should apply only to shared savings payments or to other financial relationships ACOs create, Troy Barsky, director of the CMS Division of Technical Payment Policy, explained during the meeting.

Overall, the hope is to spur "coordination [and] cooperation among the people and the entities that provide health care," while at the same time ensure "appropriate corporate behaviors," said Dr. Donald Berwick, CMS Administrator.

Proposed ACO regulations are expected from the CMS in late December.

In the meantime, Mr. Miller advised physicians, "If you want to be an ACO, you have to start looking at the data you have – or get access to data from payers, Medicare, and others – to identify opportunities for savings.

"Once you know where they are, figure out what programs to put in place to achieve those savings," he said.

One option among many is to hire a nurse to help chronically ill patients manage their diseases, Mr. Miller said. That’s been proven to help reduce emergency department visits and hospitalizations, he added (Arch. Intern. Med. 2003;163:585-91).

To make such programs cost effective, however, "a small practice will need to think about how to partner with other practices in order to have enough patients who can benefit," he said.

Mr. Miller added that he does not believe recent election results will derail ACO efforts or other aspects of the Affordable Care Act. Despite Republican victories, "I think it would be a near impossibility to pass a repeal by a veto-proof margin. And the ACO stuff is not really controversial – yet," he noted.

The meeting’s audio and transcript – as well as public comments on ACO concerns – are online at www.ftc.gov/opp/workshops/aco/index.shtml.

Many physicians have wondered how – and even if – they will be able to work together to form accountable care organizations without violating federal antitrust and fraud and abuse laws.

A federal regulatory meeting held earlier this fall offered possible answers to both questions. Federal regulators are considering exemptions to those laws that would allow providers who meet certain requirements to form ACOs.

"It is not easy to craft safe harbors that can replace an antitrust review that analyzes the specific facts of each case and market. But we’re going to try to do this," said Jon Leibowitz, chairman of the Federal Trade Commission (FTC).

Similarly, Daniel Levinson, inspector general of the U.S. Department of Health and Human Services, noted that the Affordable Care Act gives the HHS secretary the authority to waive some fraud and abuse laws as needed to help ACO programs develop.

"We and our HHS colleagues are looking closely at how the secretary might exercise this authority most effectively," Levinson said, according to the meeting transcript.

The FTC, the HHS Office of Inspector General, and the Centers for Medicare and Medicaid Services conducted the workshop in Baltimore to hear the opinions of panelists and audience members on a variety of ACO issues.

However, much of the questioning focused on how antitrust and fraud and abuse exemptions could be applied to ACOs.

The Affordable Care Act promotes ACO creation to reduce health-care fragmentation, improve outcomes, and cut health spending by, for instance, keeping patients out of hospitals when possible.

The goal is for providers to come together and contract with the CMS to integrate and manage the care of at least 5,000 patients, and to share a portion of the savings their efforts generate for Medicare, so long as quality parameters are met.

Once formed, ACOs could pursue similar types of contracts with commercial insurance companies.

The catch is that encouraging independent providers to jointly negotiate contracts and payment rates with health plans raises concerns about joint price fixing, reduced competition, and other antitrust matters.

Likewise, the shared-savings provision, among others, raises antikickback, self-referral, and other fraud and abuse concerns, according to health care attorney Douglas Hastings, board chair of Epstein Becker & Green, Washington, and a meeting panelist who offered his insights during a later interview.

Regulators are interested in applying to ACOs antitrust protections that already exist for providers who are clinically integrated and jointly accept significant financial risk.

"In those cases, [collaboration is] not viewed as an antitrust matter, since they are behaving as an integrated organization," explained meeting panelist and health policy expert Harold Miller, executive director of the Center for Health Care Quality and Payment Reform, who also offered his insights during a later interview.

Defining the extent of integration required for protection, and the time frame to achieve it, remain key issues for regulators, as does the possible creation of additional antitrust safe harbors related to market share and other matters. Regulators also said that they want to foster multiple ACOs in a given market to increase competition.

Which providers would be covered under fraud and abuse waivers also remains an issue, as well as whether waivers should apply only to shared savings payments or to other financial relationships ACOs create, Troy Barsky, director of the CMS Division of Technical Payment Policy, explained during the meeting.

Overall, the hope is to spur "coordination [and] cooperation among the people and the entities that provide health care," while at the same time ensure "appropriate corporate behaviors," said Dr. Donald Berwick, CMS Administrator.

Proposed ACO regulations are expected from the CMS in late December.

In the meantime, Mr. Miller advised physicians, "If you want to be an ACO, you have to start looking at the data you have – or get access to data from payers, Medicare, and others – to identify opportunities for savings.

"Once you know where they are, figure out what programs to put in place to achieve those savings," he said.

One option among many is to hire a nurse to help chronically ill patients manage their diseases, Mr. Miller said. That’s been proven to help reduce emergency department visits and hospitalizations, he added (Arch. Intern. Med. 2003;163:585-91).

To make such programs cost effective, however, "a small practice will need to think about how to partner with other practices in order to have enough patients who can benefit," he said.

Mr. Miller added that he does not believe recent election results will derail ACO efforts or other aspects of the Affordable Care Act. Despite Republican victories, "I think it would be a near impossibility to pass a repeal by a veto-proof margin. And the ACO stuff is not really controversial – yet," he noted.

The meeting’s audio and transcript – as well as public comments on ACO concerns – are online at www.ftc.gov/opp/workshops/aco/index.shtml.

Many physicians have wondered how – and even if – they will be able to work together to form accountable care organizations without violating federal antitrust and fraud and abuse laws.

A federal regulatory meeting held earlier this fall offered possible answers to both questions. Federal regulators are considering exemptions to those laws that would allow providers who meet certain requirements to form ACOs.

"It is not easy to craft safe harbors that can replace an antitrust review that analyzes the specific facts of each case and market. But we’re going to try to do this," said Jon Leibowitz, chairman of the Federal Trade Commission (FTC).

Similarly, Daniel Levinson, inspector general of the U.S. Department of Health and Human Services, noted that the Affordable Care Act gives the HHS secretary the authority to waive some fraud and abuse laws as needed to help ACO programs develop.

"We and our HHS colleagues are looking closely at how the secretary might exercise this authority most effectively," Levinson said, according to the meeting transcript.

The FTC, the HHS Office of Inspector General, and the Centers for Medicare and Medicaid Services conducted the workshop in Baltimore to hear the opinions of panelists and audience members on a variety of ACO issues.

However, much of the questioning focused on how antitrust and fraud and abuse exemptions could be applied to ACOs.

The Affordable Care Act promotes ACO creation to reduce health-care fragmentation, improve outcomes, and cut health spending by, for instance, keeping patients out of hospitals when possible.

The goal is for providers to come together and contract with the CMS to integrate and manage the care of at least 5,000 patients, and to share a portion of the savings their efforts generate for Medicare, so long as quality parameters are met.

Once formed, ACOs could pursue similar types of contracts with commercial insurance companies.

The catch is that encouraging independent providers to jointly negotiate contracts and payment rates with health plans raises concerns about joint price fixing, reduced competition, and other antitrust matters.

Likewise, the shared-savings provision, among others, raises antikickback, self-referral, and other fraud and abuse concerns, according to health care attorney Douglas Hastings, board chair of Epstein Becker & Green, Washington, and a meeting panelist who offered his insights during a later interview.

Regulators are interested in applying to ACOs antitrust protections that already exist for providers who are clinically integrated and jointly accept significant financial risk.

"In those cases, [collaboration is] not viewed as an antitrust matter, since they are behaving as an integrated organization," explained meeting panelist and health policy expert Harold Miller, executive director of the Center for Health Care Quality and Payment Reform, who also offered his insights during a later interview.

Defining the extent of integration required for protection, and the time frame to achieve it, remain key issues for regulators, as does the possible creation of additional antitrust safe harbors related to market share and other matters. Regulators also said that they want to foster multiple ACOs in a given market to increase competition.

Which providers would be covered under fraud and abuse waivers also remains an issue, as well as whether waivers should apply only to shared savings payments or to other financial relationships ACOs create, Troy Barsky, director of the CMS Division of Technical Payment Policy, explained during the meeting.

Overall, the hope is to spur "coordination [and] cooperation among the people and the entities that provide health care," while at the same time ensure "appropriate corporate behaviors," said Dr. Donald Berwick, CMS Administrator.

Proposed ACO regulations are expected from the CMS in late December.

In the meantime, Mr. Miller advised physicians, "If you want to be an ACO, you have to start looking at the data you have – or get access to data from payers, Medicare, and others – to identify opportunities for savings.

"Once you know where they are, figure out what programs to put in place to achieve those savings," he said.

One option among many is to hire a nurse to help chronically ill patients manage their diseases, Mr. Miller said. That’s been proven to help reduce emergency department visits and hospitalizations, he added (Arch. Intern. Med. 2003;163:585-91).

To make such programs cost effective, however, "a small practice will need to think about how to partner with other practices in order to have enough patients who can benefit," he said.

Mr. Miller added that he does not believe recent election results will derail ACO efforts or other aspects of the Affordable Care Act. Despite Republican victories, "I think it would be a near impossibility to pass a repeal by a veto-proof margin. And the ACO stuff is not really controversial – yet," he noted.

The meeting’s audio and transcript – as well as public comments on ACO concerns – are online at www.ftc.gov/opp/workshops/aco/index.shtml.

Many physicians have wondered how – and even if – they will be able to work together to form accountable care organizations without violating federal antitrust and fraud and abuse laws.

A federal regulatory meeting held earlier this fall offered possible answers to both questions. Federal regulators are considering exemptions to those laws that would allow providers who meet certain requirements to form ACOs.

"It is not easy to craft safe harbors that can replace an antitrust review that analyzes the specific facts of each case and market. But we’re going to try to do this," said Jon Leibowitz, chairman of the Federal Trade Commission (FTC).

Similarly, Daniel Levinson, inspector general of the U.S. Department of Health and Human Services, noted that the Affordable Care Act gives the HHS secretary the authority to waive some fraud and abuse laws as needed to help ACO programs develop.

"We and our HHS colleagues are looking closely at how the secretary might exercise this authority most effectively," Levinson said, according to the meeting transcript.

The FTC, the HHS Office of Inspector General, and the Centers for Medicare and Medicaid Services conducted the workshop in Baltimore to hear the opinions of panelists and audience members on a variety of ACO issues.

However, much of the questioning focused on how antitrust and fraud and abuse exemptions could be applied to ACOs.

The Affordable Care Act promotes ACO creation to reduce health-care fragmentation, improve outcomes, and cut health spending by, for instance, keeping patients out of hospitals when possible.

The goal is for providers to come together and contract with the CMS to integrate and manage the care of at least 5,000 patients, and to share a portion of the savings their efforts generate for Medicare, so long as quality parameters are met.

Once formed, ACOs could pursue similar types of contracts with commercial insurance companies.

The catch is that encouraging independent providers to jointly negotiate contracts and payment rates with health plans raises concerns about joint price fixing, reduced competition, and other antitrust matters.

Likewise, the shared-savings provision, among others, raises antikickback, self-referral, and other fraud and abuse concerns, according to health care attorney Douglas Hastings, board chair of Epstein Becker & Green, Washington, and a meeting panelist who offered his insights during a later interview.

Regulators are interested in applying to ACOs antitrust protections that already exist for providers who are clinically integrated and jointly accept significant financial risk.

"In those cases, [collaboration is] not viewed as an antitrust matter, since they are behaving as an integrated organization," explained meeting panelist and health policy expert Harold Miller, executive director of the Center for Health Care Quality and Payment Reform, who also offered his insights during a later interview.

Defining the extent of integration required for protection, and the time frame to achieve it, remain key issues for regulators, as does the possible creation of additional antitrust safe harbors related to market share and other matters. Regulators also said that they want to foster multiple ACOs in a given market to increase competition.

Which providers would be covered under fraud and abuse waivers also remains an issue, as well as whether waivers should apply only to shared savings payments or to other financial relationships ACOs create, Troy Barsky, director of the CMS Division of Technical Payment Policy, explained during the meeting.

Overall, the hope is to spur "coordination [and] cooperation among the people and the entities that provide health care," while at the same time ensure "appropriate corporate behaviors," said Dr. Donald Berwick, CMS Administrator.

Proposed ACO regulations are expected from the CMS in late December.

In the meantime, Mr. Miller advised physicians, "If you want to be an ACO, you have to start looking at the data you have – or get access to data from payers, Medicare, and others – to identify opportunities for savings.

"Once you know where they are, figure out what programs to put in place to achieve those savings," he said.

One option among many is to hire a nurse to help chronically ill patients manage their diseases, Mr. Miller said. That’s been proven to help reduce emergency department visits and hospitalizations, he added (Arch. Intern. Med. 2003;163:585-91).

To make such programs cost effective, however, "a small practice will need to think about how to partner with other practices in order to have enough patients who can benefit," he said.

Mr. Miller added that he does not believe recent election results will derail ACO efforts or other aspects of the Affordable Care Act. Despite Republican victories, "I think it would be a near impossibility to pass a repeal by a veto-proof margin. And the ACO stuff is not really controversial – yet," he noted.

The meeting’s audio and transcript – as well as public comments on ACO concerns – are online at www.ftc.gov/opp/workshops/aco/index.shtml.

Many physicians have wondered how – and even if – they will be able to work together to form accountable care organizations without violating federal antitrust and fraud and abuse laws.

A federal regulatory meeting held earlier this fall offered possible answers to both questions. Federal regulators are considering exemptions to those laws that would allow providers who meet certain requirements to form ACOs.

"It is not easy to craft safe harbors that can replace an antitrust review that analyzes the specific facts of each case and market. But we’re going to try to do this," said Jon Leibowitz, chairman of the Federal Trade Commission (FTC).

Similarly, Daniel Levinson, inspector general of the U.S. Department of Health and Human Services, noted that the Affordable Care Act gives the HHS secretary the authority to waive some fraud and abuse laws as needed to help ACO programs develop.

"We and our HHS colleagues are looking closely at how the secretary might exercise this authority most effectively," Levinson said, according to the meeting transcript.

The FTC, the HHS Office of Inspector General, and the Centers for Medicare and Medicaid Services conducted the workshop in Baltimore to hear the opinions of panelists and audience members on a variety of ACO issues.

However, much of the questioning focused on how antitrust and fraud and abuse exemptions could be applied to ACOs.

The Affordable Care Act promotes ACO creation to reduce health-care fragmentation, improve outcomes, and cut health spending by, for instance, keeping patients out of hospitals when possible.

The goal is for providers to come together and contract with the CMS to integrate and manage the care of at least 5,000 patients, and to share a portion of the savings their efforts generate for Medicare, so long as quality parameters are met.

Once formed, ACOs could pursue similar types of contracts with commercial insurance companies.

The catch is that encouraging independent providers to jointly negotiate contracts and payment rates with health plans raises concerns about joint price fixing, reduced competition, and other antitrust matters.

Likewise, the shared-savings provision, among others, raises antikickback, self-referral, and other fraud and abuse concerns, according to health care attorney Douglas Hastings, board chair of Epstein Becker & Green, Washington, and a meeting panelist who offered his insights during a later interview.

Regulators are interested in applying to ACOs antitrust protections that already exist for providers who are clinically integrated and jointly accept significant financial risk.

"In those cases, [collaboration is] not viewed as an antitrust matter, since they are behaving as an integrated organization," explained meeting panelist and health policy expert Harold Miller, executive director of the Center for Health Care Quality and Payment Reform, who also offered his insights during a later interview.

Defining the extent of integration required for protection, and the time frame to achieve it, remain key issues for regulators, as does the possible creation of additional antitrust safe harbors related to market share and other matters. Regulators also said that they want to foster multiple ACOs in a given market to increase competition.

Which providers would be covered under fraud and abuse waivers also remains an issue, as well as whether waivers should apply only to shared savings payments or to other financial relationships ACOs create, Troy Barsky, director of the CMS Division of Technical Payment Policy, explained during the meeting.

Overall, the hope is to spur "coordination [and] cooperation among the people and the entities that provide health care," while at the same time ensure "appropriate corporate behaviors," said Dr. Donald Berwick, CMS Administrator.

Proposed ACO regulations are expected from the CMS in late December.

In the meantime, Mr. Miller advised physicians, "If you want to be an ACO, you have to start looking at the data you have – or get access to data from payers, Medicare, and others – to identify opportunities for savings.

"Once you know where they are, figure out what programs to put in place to achieve those savings," he said.

One option among many is to hire a nurse to help chronically ill patients manage their diseases, Mr. Miller said. That’s been proven to help reduce emergency department visits and hospitalizations, he added (Arch. Intern. Med. 2003;163:585-91).

To make such programs cost effective, however, "a small practice will need to think about how to partner with other practices in order to have enough patients who can benefit," he said.

Mr. Miller added that he does not believe recent election results will derail ACO efforts or other aspects of the Affordable Care Act. Despite Republican victories, "I think it would be a near impossibility to pass a repeal by a veto-proof margin. And the ACO stuff is not really controversial – yet," he noted.

The meeting’s audio and transcript – as well as public comments on ACO concerns – are online at www.ftc.gov/opp/workshops/aco/index.shtml.

VANCOUVER, B.C. – Infants born to women who receive diphtheria-tetanus-acellular pertussis vaccine during pregnancy have higher pertussis antibody levels during their first few months of life than infants born to unvaccinated women, Dr. Abbey Hardy-Fairbanks reported.

The levels are sufficient to protect infants against pertussis prior to their first diphtheria-tetanus-acellular pertussis (DTaP) shot at around 2 months, a period of “significant pertussis morbidity and mortality,” said Dr. Hardy-Fairbanks, an ob.gyn. at the University of Iowa, Iowa City.

“This is the first evidence to document that pertussis immunization during pregnancy is likely to be beneficial to infants when they are most vulnerable to pertussis disease. [Physicians] should consider vaccination of women during pregnancy with DTaP,” she said at the meeting.

In the prospective cohort study, 16 (23%) of 70 pregnant women received DTaP vaccine; 54 (77%) pregnant women selected as controls did not and had not been vaccinated for at least 2 years.

Four of the women (25%) in the DTaP group were vaccinated in the first trimester, eight (50%) in the second, and four (25%) in the third. Vaccination did not cause any adverse pregnancy outcomes.

Maternal blood and cord blood were collected at delivery. Blood was also collected from children before and after their primary DTaP series and toddler booster doses at 12-18 months.

Blood samples were measured for pertussis antigens, including pertussis toxoid, filamentous hemagglutinin, pertactin, and fimbriae, by enzyme-linked immunosorbent assay.

Newborns in the DTaP group had higher pertussis antibody concentrations than their mothers, “showing efficient placental transfer of antibodies to the infant,” Dr. Hardy-Fairbanks explained.

They also had substantially higher concentrations than infants in the control group prior to the start of the primary DTaP series, and the differences were statistically significant.

However, at month 7, following completion of the DTaP series, infants born to vaccinated mothers had slightly lower antibody levels than infants in the control group.

The differences were not statistically significant, but “may represent some blunting of the infant immune response to the [vaccine],” Dr. Hardy-Fairbanks said.

By the time they got their toddler booster doses, however, antibody levels “were essentially equivalent” in the two groups, she said.

Dr. Hardy-Fairbanks said she had no conflicts of interest. The study was funded by Sanofi-Pasteur, maker of Daptacel DTaP vaccine.

VANCOUVER, B.C. – Infants born to women who receive diphtheria-tetanus-acellular pertussis vaccine during pregnancy have higher pertussis antibody levels during their first few months of life than infants born to unvaccinated women, Dr. Abbey Hardy-Fairbanks reported.

The levels are sufficient to protect infants against pertussis prior to their first diphtheria-tetanus-acellular pertussis (DTaP) shot at around 2 months, a period of “significant pertussis morbidity and mortality,” said Dr. Hardy-Fairbanks, an ob.gyn. at the University of Iowa, Iowa City.

“This is the first evidence to document that pertussis immunization during pregnancy is likely to be beneficial to infants when they are most vulnerable to pertussis disease. [Physicians] should consider vaccination of women during pregnancy with DTaP,” she said at the meeting.

In the prospective cohort study, 16 (23%) of 70 pregnant women received DTaP vaccine; 54 (77%) pregnant women selected as controls did not and had not been vaccinated for at least 2 years.

Four of the women (25%) in the DTaP group were vaccinated in the first trimester, eight (50%) in the second, and four (25%) in the third. Vaccination did not cause any adverse pregnancy outcomes.

Maternal blood and cord blood were collected at delivery. Blood was also collected from children before and after their primary DTaP series and toddler booster doses at 12-18 months.

Blood samples were measured for pertussis antigens, including pertussis toxoid, filamentous hemagglutinin, pertactin, and fimbriae, by enzyme-linked immunosorbent assay.

Newborns in the DTaP group had higher pertussis antibody concentrations than their mothers, “showing efficient placental transfer of antibodies to the infant,” Dr. Hardy-Fairbanks explained.

They also had substantially higher concentrations than infants in the control group prior to the start of the primary DTaP series, and the differences were statistically significant.

However, at month 7, following completion of the DTaP series, infants born to vaccinated mothers had slightly lower antibody levels than infants in the control group.

The differences were not statistically significant, but “may represent some blunting of the infant immune response to the [vaccine],” Dr. Hardy-Fairbanks said.

By the time they got their toddler booster doses, however, antibody levels “were essentially equivalent” in the two groups, she said.

Dr. Hardy-Fairbanks said she had no conflicts of interest. The study was funded by Sanofi-Pasteur, maker of Daptacel DTaP vaccine.

VANCOUVER, B.C. – Infants born to women who receive diphtheria-tetanus-acellular pertussis vaccine during pregnancy have higher pertussis antibody levels during their first few months of life than infants born to unvaccinated women, Dr. Abbey Hardy-Fairbanks reported.

The levels are sufficient to protect infants against pertussis prior to their first diphtheria-tetanus-acellular pertussis (DTaP) shot at around 2 months, a period of “significant pertussis morbidity and mortality,” said Dr. Hardy-Fairbanks, an ob.gyn. at the University of Iowa, Iowa City.

“This is the first evidence to document that pertussis immunization during pregnancy is likely to be beneficial to infants when they are most vulnerable to pertussis disease. [Physicians] should consider vaccination of women during pregnancy with DTaP,” she said at the meeting.

In the prospective cohort study, 16 (23%) of 70 pregnant women received DTaP vaccine; 54 (77%) pregnant women selected as controls did not and had not been vaccinated for at least 2 years.

Four of the women (25%) in the DTaP group were vaccinated in the first trimester, eight (50%) in the second, and four (25%) in the third. Vaccination did not cause any adverse pregnancy outcomes.

Maternal blood and cord blood were collected at delivery. Blood was also collected from children before and after their primary DTaP series and toddler booster doses at 12-18 months.

Blood samples were measured for pertussis antigens, including pertussis toxoid, filamentous hemagglutinin, pertactin, and fimbriae, by enzyme-linked immunosorbent assay.

Newborns in the DTaP group had higher pertussis antibody concentrations than their mothers, “showing efficient placental transfer of antibodies to the infant,” Dr. Hardy-Fairbanks explained.

They also had substantially higher concentrations than infants in the control group prior to the start of the primary DTaP series, and the differences were statistically significant.

However, at month 7, following completion of the DTaP series, infants born to vaccinated mothers had slightly lower antibody levels than infants in the control group.

The differences were not statistically significant, but “may represent some blunting of the infant immune response to the [vaccine],” Dr. Hardy-Fairbanks said.

By the time they got their toddler booster doses, however, antibody levels “were essentially equivalent” in the two groups, she said.

Dr. Hardy-Fairbanks said she had no conflicts of interest. The study was funded by Sanofi-Pasteur, maker of Daptacel DTaP vaccine.

VANCOUVER, B.C. – Infants born to women who receive diphtheria-tetanus-acellular pertussis vaccine during pregnancy have higher pertussis antibody levels during their first few months of life than infants born to unvaccinated women, Dr. Abbey Hardy-Fairbanks reported.

The levels are sufficient to protect infants against pertussis prior to their first diphtheria-tetanus-acellular pertussis (DTaP) shot at around 2 months, a period of “significant pertussis morbidity and mortality,” said Dr. Hardy-Fairbanks, an ob.gyn. at the University of Iowa, Iowa City.

“This is the first evidence to document that pertussis immunization during pregnancy is likely to be beneficial to infants when they are most vulnerable to pertussis disease. [Physicians] should consider vaccination of women during pregnancy with DTaP,” she said at the meeting.

In the prospective cohort study, 16 (23%) of 70 pregnant women received DTaP vaccine; 54 (77%) pregnant women selected as controls did not and had not been vaccinated for at least 2 years.

Four of the women (25%) in the DTaP group were vaccinated in the first trimester, eight (50%) in the second, and four (25%) in the third. Vaccination did not cause any adverse pregnancy outcomes.

Maternal blood and cord blood were collected at delivery. Blood was also collected from children before and after their primary DTaP series and toddler booster doses at 12-18 months.

Blood samples were measured for pertussis antigens, including pertussis toxoid, filamentous hemagglutinin, pertactin, and fimbriae, by enzyme-linked immunosorbent assay.

Newborns in the DTaP group had higher pertussis antibody concentrations than their mothers, “showing efficient placental transfer of antibodies to the infant,” Dr. Hardy-Fairbanks explained.

They also had substantially higher concentrations than infants in the control group prior to the start of the primary DTaP series, and the differences were statistically significant.

However, at month 7, following completion of the DTaP series, infants born to vaccinated mothers had slightly lower antibody levels than infants in the control group.

The differences were not statistically significant, but “may represent some blunting of the infant immune response to the [vaccine],” Dr. Hardy-Fairbanks said.

By the time they got their toddler booster doses, however, antibody levels “were essentially equivalent” in the two groups, she said.

Dr. Hardy-Fairbanks said she had no conflicts of interest. The study was funded by Sanofi-Pasteur, maker of Daptacel DTaP vaccine.

VANCOUVER, B.C. – Infants born to women who receive diphtheria-tetanus-acellular pertussis vaccine during pregnancy have higher pertussis antibody levels during their first few months of life than infants born to unvaccinated women, Dr. Abbey Hardy-Fairbanks reported.

The levels are sufficient to protect infants against pertussis prior to their first diphtheria-tetanus-acellular pertussis (DTaP) shot at around 2 months, a period of “significant pertussis morbidity and mortality,” said Dr. Hardy-Fairbanks, an ob.gyn. at the University of Iowa, Iowa City.

“This is the first evidence to document that pertussis immunization during pregnancy is likely to be beneficial to infants when they are most vulnerable to pertussis disease. [Physicians] should consider vaccination of women during pregnancy with DTaP,” she said at the meeting.

In the prospective cohort study, 16 (23%) of 70 pregnant women received DTaP vaccine; 54 (77%) pregnant women selected as controls did not and had not been vaccinated for at least 2 years.

Four of the women (25%) in the DTaP group were vaccinated in the first trimester, eight (50%) in the second, and four (25%) in the third. Vaccination did not cause any adverse pregnancy outcomes.

Maternal blood and cord blood were collected at delivery. Blood was also collected from children before and after their primary DTaP series and toddler booster doses at 12-18 months.

Blood samples were measured for pertussis antigens, including pertussis toxoid, filamentous hemagglutinin, pertactin, and fimbriae, by enzyme-linked immunosorbent assay.

Newborns in the DTaP group had higher pertussis antibody concentrations than their mothers, “showing efficient placental transfer of antibodies to the infant,” Dr. Hardy-Fairbanks explained.

They also had substantially higher concentrations than infants in the control group prior to the start of the primary DTaP series, and the differences were statistically significant.

However, at month 7, following completion of the DTaP series, infants born to vaccinated mothers had slightly lower antibody levels than infants in the control group.

The differences were not statistically significant, but “may represent some blunting of the infant immune response to the [vaccine],” Dr. Hardy-Fairbanks said.

By the time they got their toddler booster doses, however, antibody levels “were essentially equivalent” in the two groups, she said.

Dr. Hardy-Fairbanks said she had no conflicts of interest. The study was funded by Sanofi-Pasteur, maker of Daptacel DTaP vaccine.

VANCOUVER, B.C. – Infants born to women who receive diphtheria-tetanus-acellular pertussis vaccine during pregnancy have higher pertussis antibody levels during their first few months of life than infants born to unvaccinated women, Dr. Abbey Hardy-Fairbanks reported.

The levels are sufficient to protect infants against pertussis prior to their first diphtheria-tetanus-acellular pertussis (DTaP) shot at around 2 months, a period of “significant pertussis morbidity and mortality,” said Dr. Hardy-Fairbanks, an ob.gyn. at the University of Iowa, Iowa City.

“This is the first evidence to document that pertussis immunization during pregnancy is likely to be beneficial to infants when they are most vulnerable to pertussis disease. [Physicians] should consider vaccination of women during pregnancy with DTaP,” she said at the meeting.

In the prospective cohort study, 16 (23%) of 70 pregnant women received DTaP vaccine; 54 (77%) pregnant women selected as controls did not and had not been vaccinated for at least 2 years.

Four of the women (25%) in the DTaP group were vaccinated in the first trimester, eight (50%) in the second, and four (25%) in the third. Vaccination did not cause any adverse pregnancy outcomes.

Maternal blood and cord blood were collected at delivery. Blood was also collected from children before and after their primary DTaP series and toddler booster doses at 12-18 months.

Blood samples were measured for pertussis antigens, including pertussis toxoid, filamentous hemagglutinin, pertactin, and fimbriae, by enzyme-linked immunosorbent assay.

Newborns in the DTaP group had higher pertussis antibody concentrations than their mothers, “showing efficient placental transfer of antibodies to the infant,” Dr. Hardy-Fairbanks explained.

They also had substantially higher concentrations than infants in the control group prior to the start of the primary DTaP series, and the differences were statistically significant.

However, at month 7, following completion of the DTaP series, infants born to vaccinated mothers had slightly lower antibody levels than infants in the control group.

The differences were not statistically significant, but “may represent some blunting of the infant immune response to the [vaccine],” Dr. Hardy-Fairbanks said.

By the time they got their toddler booster doses, however, antibody levels “were essentially equivalent” in the two groups, she said.

Dr. Hardy-Fairbanks said she had no conflicts of interest. The study was funded by Sanofi-Pasteur, maker of Daptacel DTaP vaccine.

DENVER – The National Committee for Quality Assurance has improved its patient-centered medical home recognition process, making application submissions over the Web easier and decision times quicker, according to Patricia Barrett, the group's vice president for product development.

Since NCQA launched its recognition program about 2½ years ago, there have been complaints that the process is too cumbersome.

In September, the American Academy of Family Physicians' Congress of Delegates even passed a resolution calling for simpler assessment and documentation tools, and increased transparency and feedback.

“We have heard the criticism,” said Ms. Barrett. “We want the difficulty to be in becoming a medical home, not in applying” for recognition.

NCQA has hired additional staff to answer questions and provide feedback, she noted, and has updated its Web portal to make it more user friendly.

Applicants aren't required to mail or e-mail their applications anymore; they can be filled out directly on the Web site.

In addition, applicants can upload larger documents, and uploads are quicker, with documents appearing almost simultaneously at NCQA headquarters. The group now accepts electronic signatures on legal documents, Ms. Barrett said.

NCQA also has streamlined its document requirements to cut down on redundancy, she noted. And those renewing their recognitions don't have to start from scratch – document requirements have been eased for renewals.

In short, “We are meeting our target now” for 60-day decisions on recognition, Ms. Barrett said.

The changes sound good to Dr. Mary Campagnolo, a family physician in Lumberton, N.J., and a member of the state delegation that submitted the resolution at the Congress of Delegates.

The problem has been with the process, not the standards themselves, she said. Doctors at the AAFP meeting agree that the standards need to be rigorous in order to be meaningful, Dr. Campagnolo explained. “The documentation is voluminous,” she noted, adding that quicker uploads and other changes should reduce some of the hassle.

Many of the improvements are already in place just in time for NCQA's release of updated PCMH standards early next year.

Though the process is a bit easier, the standards will be tougher. “It will be a more rigorous program,” Ms. Barrett said. “We raised the bar significantly.” That's in part because NCQA has a better idea of what payers are likely to require for practices to qualify for additional reimbursements as medical homes, she said.

So far, NCQA has recognized about 1,000 PCMHs, and is fielding about 100 PCMH recognition applications per month.

The new standards haven't been finalized, however, so the group was short on details about the changes. But, in general, there will be greater emphasis on the full scope of a patient's health needs – reducing obesity, quitting smoking, and the like – not simply managing the problem that brought her into the clinic.

There also will be more emphasis on coordinating care with other practices, and ensuring records of what's done elsewhere make their way back to the medical home. In addition, meaningful use requirements have been added to electronic health records standards.

Scoring will get tougher, too. For instance, to achieve level 1 PCMH status, practices may have to earn 35 points on the group's 100-point scale – up from 25 under the current system.

The price – currently $1,280 for a three-physician practice, for example – is going up, too, though NCQA isn't certain yet how much. NCQA typically adjusts its program prices every other year, a spokeswoman said.

The changes to NCQA's program come as the Joint Commission and the Utilization Review Accreditation Commission both prepare to launch their own PCMH recognition programs next year.

DENVER – The National Committee for Quality Assurance has improved its patient-centered medical home recognition process, making application submissions over the Web easier and decision times quicker, according to Patricia Barrett, the group's vice president for product development.

Since NCQA launched its recognition program about 2½ years ago, there have been complaints that the process is too cumbersome.

In September, the American Academy of Family Physicians' Congress of Delegates even passed a resolution calling for simpler assessment and documentation tools, and increased transparency and feedback.

“We have heard the criticism,” said Ms. Barrett. “We want the difficulty to be in becoming a medical home, not in applying” for recognition.

NCQA has hired additional staff to answer questions and provide feedback, she noted, and has updated its Web portal to make it more user friendly.

Applicants aren't required to mail or e-mail their applications anymore; they can be filled out directly on the Web site.

In addition, applicants can upload larger documents, and uploads are quicker, with documents appearing almost simultaneously at NCQA headquarters. The group now accepts electronic signatures on legal documents, Ms. Barrett said.

NCQA also has streamlined its document requirements to cut down on redundancy, she noted. And those renewing their recognitions don't have to start from scratch – document requirements have been eased for renewals.

In short, “We are meeting our target now” for 60-day decisions on recognition, Ms. Barrett said.

The changes sound good to Dr. Mary Campagnolo, a family physician in Lumberton, N.J., and a member of the state delegation that submitted the resolution at the Congress of Delegates.

The problem has been with the process, not the standards themselves, she said. Doctors at the AAFP meeting agree that the standards need to be rigorous in order to be meaningful, Dr. Campagnolo explained. “The documentation is voluminous,” she noted, adding that quicker uploads and other changes should reduce some of the hassle.

Many of the improvements are already in place just in time for NCQA's release of updated PCMH standards early next year.

Though the process is a bit easier, the standards will be tougher. “It will be a more rigorous program,” Ms. Barrett said. “We raised the bar significantly.” That's in part because NCQA has a better idea of what payers are likely to require for practices to qualify for additional reimbursements as medical homes, she said.

So far, NCQA has recognized about 1,000 PCMHs, and is fielding about 100 PCMH recognition applications per month.

The new standards haven't been finalized, however, so the group was short on details about the changes. But, in general, there will be greater emphasis on the full scope of a patient's health needs – reducing obesity, quitting smoking, and the like – not simply managing the problem that brought her into the clinic.

There also will be more emphasis on coordinating care with other practices, and ensuring records of what's done elsewhere make their way back to the medical home. In addition, meaningful use requirements have been added to electronic health records standards.

Scoring will get tougher, too. For instance, to achieve level 1 PCMH status, practices may have to earn 35 points on the group's 100-point scale – up from 25 under the current system.

The price – currently $1,280 for a three-physician practice, for example – is going up, too, though NCQA isn't certain yet how much. NCQA typically adjusts its program prices every other year, a spokeswoman said.

The changes to NCQA's program come as the Joint Commission and the Utilization Review Accreditation Commission both prepare to launch their own PCMH recognition programs next year.

DENVER – The National Committee for Quality Assurance has improved its patient-centered medical home recognition process, making application submissions over the Web easier and decision times quicker, according to Patricia Barrett, the group's vice president for product development.

Since NCQA launched its recognition program about 2½ years ago, there have been complaints that the process is too cumbersome.

In September, the American Academy of Family Physicians' Congress of Delegates even passed a resolution calling for simpler assessment and documentation tools, and increased transparency and feedback.

“We have heard the criticism,” said Ms. Barrett. “We want the difficulty to be in becoming a medical home, not in applying” for recognition.

NCQA has hired additional staff to answer questions and provide feedback, she noted, and has updated its Web portal to make it more user friendly.

Applicants aren't required to mail or e-mail their applications anymore; they can be filled out directly on the Web site.

In addition, applicants can upload larger documents, and uploads are quicker, with documents appearing almost simultaneously at NCQA headquarters. The group now accepts electronic signatures on legal documents, Ms. Barrett said.

NCQA also has streamlined its document requirements to cut down on redundancy, she noted. And those renewing their recognitions don't have to start from scratch – document requirements have been eased for renewals.

In short, “We are meeting our target now” for 60-day decisions on recognition, Ms. Barrett said.

The changes sound good to Dr. Mary Campagnolo, a family physician in Lumberton, N.J., and a member of the state delegation that submitted the resolution at the Congress of Delegates.

The problem has been with the process, not the standards themselves, she said. Doctors at the AAFP meeting agree that the standards need to be rigorous in order to be meaningful, Dr. Campagnolo explained. “The documentation is voluminous,” she noted, adding that quicker uploads and other changes should reduce some of the hassle.

Many of the improvements are already in place just in time for NCQA's release of updated PCMH standards early next year.

Though the process is a bit easier, the standards will be tougher. “It will be a more rigorous program,” Ms. Barrett said. “We raised the bar significantly.” That's in part because NCQA has a better idea of what payers are likely to require for practices to qualify for additional reimbursements as medical homes, she said.

So far, NCQA has recognized about 1,000 PCMHs, and is fielding about 100 PCMH recognition applications per month.

The new standards haven't been finalized, however, so the group was short on details about the changes. But, in general, there will be greater emphasis on the full scope of a patient's health needs – reducing obesity, quitting smoking, and the like – not simply managing the problem that brought her into the clinic.

There also will be more emphasis on coordinating care with other practices, and ensuring records of what's done elsewhere make their way back to the medical home. In addition, meaningful use requirements have been added to electronic health records standards.

Scoring will get tougher, too. For instance, to achieve level 1 PCMH status, practices may have to earn 35 points on the group's 100-point scale – up from 25 under the current system.

The price – currently $1,280 for a three-physician practice, for example – is going up, too, though NCQA isn't certain yet how much. NCQA typically adjusts its program prices every other year, a spokeswoman said.

The changes to NCQA's program come as the Joint Commission and the Utilization Review Accreditation Commission both prepare to launch their own PCMH recognition programs next year.

VANCOUVER, B.C. – Two intranasal doses of an experimental norovirus vaccine led to a relative reduction of about 45% in the incidence of acute gastroenteritis in a randomized, placebo-controlled, phase I/II challenge study.

"The vaccine protected against illness. This is the first demonstration that an intranasally delivered vaccine can prevent human illness due to an enteric pathogen," said principal investigator Dr. Robert Atmar, a professor of molecular virology and microbiology at Baylor College of Medicine in Houston, who presented the findings.

The vaccine is a dry powder formulation of viruslike particles (VLP) that mimic the norovirus capsid. "From their first production in the early 90s, they were proposed as a candidate vaccine," Dr. Atmar said.

The trial initially included 98 healthy adults (aged 18-50 years) who were randomized to two vaccine doses – each dose containing 100 mcg of VLP and given 3 weeks apart – or placebo.

"Just under two-thirds of the subjects had a seroresponse" to the vaccine, and "the average total rise [in norovirus antibodies] was about fourfold after two doses," Dr. Atmar said.

About a month after the second dose, participants in the trial were administered approximately 10 human-infectious doses of norovirus and were put into a hospital setting for 4 days.

Subjects were checked daily for signs of infection, including stool virus shedding, and were monitored for signs of acute gastroenteritis. Stool was checked again at 1 and 3 weeks after the challenge.

The per-protocol analysis included 77 subjects. In all, 82% (32) in the placebo group and 61% (23) in the vaccine group developed infection, a relative reduction of 26% (P = .046); 69% (27) in the placebo arm and 37% (14) in the vaccine group developed acute gastritis, a relative reduction of 47% (P = .006).

The results were similar in the 84 subjects in the intent-to-treat analysis, with a relative reduction of acute gastroenteritis in the vaccine group of 44% (P = .005), and a nonsignificant relative reduction in infections of 22% in the vaccine group (P = .084).

"There were no severe adverse events or new onset of medically significant conditions," in the vaccine group, Dr. Atmar said.

However, 40% had mild to moderate nasal symptoms – including runny nose, congestion, itching, sneezing, and nasal discomfort – after the first dose, and 45% after the second.

"They usually lasted only a day or so after vaccination," Dr. Atmar said.

"Systemic symptoms were similar between the vaccine and the placebo group, and more frequently reported after the first [vaccine] dose than after the second dose. Symptoms we asked about included headache, nausea, fatigue/malaise, fever, anorexia, vomiting, and diarrhea," he said.

The vaccine continues to be studied. Among outstanding questions is whether it protects against strains other than norovirus genogroup 1, its target. The duration of protection is also unknown, Dr. Atmar said.

An intramuscular formulation is in clinical trials, but "a commercially available vaccine is still years away," he said.

The study was study sponsored by the vaccines maker, LigoCyte Pharmaceuticals Inc. Dr. Atmar disclosed that he is an investigator for, and receives research support from, LigoCyte.

VANCOUVER, B.C. – Two intranasal doses of an experimental norovirus vaccine led to a relative reduction of about 45% in the incidence of acute gastroenteritis in a randomized, placebo-controlled, phase I/II challenge study.

"The vaccine protected against illness. This is the first demonstration that an intranasally delivered vaccine can prevent human illness due to an enteric pathogen," said principal investigator Dr. Robert Atmar, a professor of molecular virology and microbiology at Baylor College of Medicine in Houston, who presented the findings.

The vaccine is a dry powder formulation of viruslike particles (VLP) that mimic the norovirus capsid. "From their first production in the early 90s, they were proposed as a candidate vaccine," Dr. Atmar said.

The trial initially included 98 healthy adults (aged 18-50 years) who were randomized to two vaccine doses – each dose containing 100 mcg of VLP and given 3 weeks apart – or placebo.

"Just under two-thirds of the subjects had a seroresponse" to the vaccine, and "the average total rise [in norovirus antibodies] was about fourfold after two doses," Dr. Atmar said.

About a month after the second dose, participants in the trial were administered approximately 10 human-infectious doses of norovirus and were put into a hospital setting for 4 days.

Subjects were checked daily for signs of infection, including stool virus shedding, and were monitored for signs of acute gastroenteritis. Stool was checked again at 1 and 3 weeks after the challenge.

The per-protocol analysis included 77 subjects. In all, 82% (32) in the placebo group and 61% (23) in the vaccine group developed infection, a relative reduction of 26% (P = .046); 69% (27) in the placebo arm and 37% (14) in the vaccine group developed acute gastritis, a relative reduction of 47% (P = .006).

The results were similar in the 84 subjects in the intent-to-treat analysis, with a relative reduction of acute gastroenteritis in the vaccine group of 44% (P = .005), and a nonsignificant relative reduction in infections of 22% in the vaccine group (P = .084).

"There were no severe adverse events or new onset of medically significant conditions," in the vaccine group, Dr. Atmar said.

However, 40% had mild to moderate nasal symptoms – including runny nose, congestion, itching, sneezing, and nasal discomfort – after the first dose, and 45% after the second.

"They usually lasted only a day or so after vaccination," Dr. Atmar said.

"Systemic symptoms were similar between the vaccine and the placebo group, and more frequently reported after the first [vaccine] dose than after the second dose. Symptoms we asked about included headache, nausea, fatigue/malaise, fever, anorexia, vomiting, and diarrhea," he said.

The vaccine continues to be studied. Among outstanding questions is whether it protects against strains other than norovirus genogroup 1, its target. The duration of protection is also unknown, Dr. Atmar said.

An intramuscular formulation is in clinical trials, but "a commercially available vaccine is still years away," he said.

The study was study sponsored by the vaccines maker, LigoCyte Pharmaceuticals Inc. Dr. Atmar disclosed that he is an investigator for, and receives research support from, LigoCyte.

VANCOUVER, B.C. – Two intranasal doses of an experimental norovirus vaccine led to a relative reduction of about 45% in the incidence of acute gastroenteritis in a randomized, placebo-controlled, phase I/II challenge study.

"The vaccine protected against illness. This is the first demonstration that an intranasally delivered vaccine can prevent human illness due to an enteric pathogen," said principal investigator Dr. Robert Atmar, a professor of molecular virology and microbiology at Baylor College of Medicine in Houston, who presented the findings.

The vaccine is a dry powder formulation of viruslike particles (VLP) that mimic the norovirus capsid. "From their first production in the early 90s, they were proposed as a candidate vaccine," Dr. Atmar said.

The trial initially included 98 healthy adults (aged 18-50 years) who were randomized to two vaccine doses – each dose containing 100 mcg of VLP and given 3 weeks apart – or placebo.

"Just under two-thirds of the subjects had a seroresponse" to the vaccine, and "the average total rise [in norovirus antibodies] was about fourfold after two doses," Dr. Atmar said.

About a month after the second dose, participants in the trial were administered approximately 10 human-infectious doses of norovirus and were put into a hospital setting for 4 days.

Subjects were checked daily for signs of infection, including stool virus shedding, and were monitored for signs of acute gastroenteritis. Stool was checked again at 1 and 3 weeks after the challenge.

The per-protocol analysis included 77 subjects. In all, 82% (32) in the placebo group and 61% (23) in the vaccine group developed infection, a relative reduction of 26% (P = .046); 69% (27) in the placebo arm and 37% (14) in the vaccine group developed acute gastritis, a relative reduction of 47% (P = .006).

The results were similar in the 84 subjects in the intent-to-treat analysis, with a relative reduction of acute gastroenteritis in the vaccine group of 44% (P = .005), and a nonsignificant relative reduction in infections of 22% in the vaccine group (P = .084).

"There were no severe adverse events or new onset of medically significant conditions," in the vaccine group, Dr. Atmar said.

However, 40% had mild to moderate nasal symptoms – including runny nose, congestion, itching, sneezing, and nasal discomfort – after the first dose, and 45% after the second.

"They usually lasted only a day or so after vaccination," Dr. Atmar said.

"Systemic symptoms were similar between the vaccine and the placebo group, and more frequently reported after the first [vaccine] dose than after the second dose. Symptoms we asked about included headache, nausea, fatigue/malaise, fever, anorexia, vomiting, and diarrhea," he said.

The vaccine continues to be studied. Among outstanding questions is whether it protects against strains other than norovirus genogroup 1, its target. The duration of protection is also unknown, Dr. Atmar said.

An intramuscular formulation is in clinical trials, but "a commercially available vaccine is still years away," he said.

The study was study sponsored by the vaccines maker, LigoCyte Pharmaceuticals Inc. Dr. Atmar disclosed that he is an investigator for, and receives research support from, LigoCyte.

VANCOUVER, B.C. – Two intranasal doses of an experimental norovirus vaccine led to a relative reduction of about 45% in the incidence of acute gastroenteritis in a randomized, placebo-controlled, phase I/II challenge study.

"The vaccine protected against illness. This is the first demonstration that an intranasally delivered vaccine can prevent human illness due to an enteric pathogen," said principal investigator Dr. Robert Atmar, a professor of molecular virology and microbiology at Baylor College of Medicine in Houston, who presented the findings.

The vaccine is a dry powder formulation of viruslike particles (VLP) that mimic the norovirus capsid. "From their first production in the early 90s, they were proposed as a candidate vaccine," Dr. Atmar said.

The trial initially included 98 healthy adults (aged 18-50 years) who were randomized to two vaccine doses – each dose containing 100 mcg of VLP and given 3 weeks apart – or placebo.

"Just under two-thirds of the subjects had a seroresponse" to the vaccine, and "the average total rise [in norovirus antibodies] was about fourfold after two doses," Dr. Atmar said.

About a month after the second dose, participants in the trial were administered approximately 10 human-infectious doses of norovirus and were put into a hospital setting for 4 days.

Subjects were checked daily for signs of infection, including stool virus shedding, and were monitored for signs of acute gastroenteritis. Stool was checked again at 1 and 3 weeks after the challenge.

The per-protocol analysis included 77 subjects. In all, 82% (32) in the placebo group and 61% (23) in the vaccine group developed infection, a relative reduction of 26% (P = .046); 69% (27) in the placebo arm and 37% (14) in the vaccine group developed acute gastritis, a relative reduction of 47% (P = .006).

The results were similar in the 84 subjects in the intent-to-treat analysis, with a relative reduction of acute gastroenteritis in the vaccine group of 44% (P = .005), and a nonsignificant relative reduction in infections of 22% in the vaccine group (P = .084).

"There were no severe adverse events or new onset of medically significant conditions," in the vaccine group, Dr. Atmar said.

However, 40% had mild to moderate nasal symptoms – including runny nose, congestion, itching, sneezing, and nasal discomfort – after the first dose, and 45% after the second.

"They usually lasted only a day or so after vaccination," Dr. Atmar said.

"Systemic symptoms were similar between the vaccine and the placebo group, and more frequently reported after the first [vaccine] dose than after the second dose. Symptoms we asked about included headache, nausea, fatigue/malaise, fever, anorexia, vomiting, and diarrhea," he said.

The vaccine continues to be studied. Among outstanding questions is whether it protects against strains other than norovirus genogroup 1, its target. The duration of protection is also unknown, Dr. Atmar said.

An intramuscular formulation is in clinical trials, but "a commercially available vaccine is still years away," he said.

The study was study sponsored by the vaccines maker, LigoCyte Pharmaceuticals Inc. Dr. Atmar disclosed that he is an investigator for, and receives research support from, LigoCyte.

VANCOUVER, B.C. – Two intranasal doses of an experimental norovirus vaccine led to a relative reduction of about 45% in the incidence of acute gastroenteritis in a randomized, placebo-controlled, phase I/II challenge study.

"The vaccine protected against illness. This is the first demonstration that an intranasally delivered vaccine can prevent human illness due to an enteric pathogen," said principal investigator Dr. Robert Atmar, a professor of molecular virology and microbiology at Baylor College of Medicine in Houston, who presented the findings.

The vaccine is a dry powder formulation of viruslike particles (VLP) that mimic the norovirus capsid. "From their first production in the early 90s, they were proposed as a candidate vaccine," Dr. Atmar said.

The trial initially included 98 healthy adults (aged 18-50 years) who were randomized to two vaccine doses – each dose containing 100 mcg of VLP and given 3 weeks apart – or placebo.

"Just under two-thirds of the subjects had a seroresponse" to the vaccine, and "the average total rise [in norovirus antibodies] was about fourfold after two doses," Dr. Atmar said.

About a month after the second dose, participants in the trial were administered approximately 10 human-infectious doses of norovirus and were put into a hospital setting for 4 days.

Subjects were checked daily for signs of infection, including stool virus shedding, and were monitored for signs of acute gastroenteritis. Stool was checked again at 1 and 3 weeks after the challenge.

The per-protocol analysis included 77 subjects. In all, 82% (32) in the placebo group and 61% (23) in the vaccine group developed infection, a relative reduction of 26% (P = .046); 69% (27) in the placebo arm and 37% (14) in the vaccine group developed acute gastritis, a relative reduction of 47% (P = .006).

The results were similar in the 84 subjects in the intent-to-treat analysis, with a relative reduction of acute gastroenteritis in the vaccine group of 44% (P = .005), and a nonsignificant relative reduction in infections of 22% in the vaccine group (P = .084).

"There were no severe adverse events or new onset of medically significant conditions," in the vaccine group, Dr. Atmar said.

However, 40% had mild to moderate nasal symptoms – including runny nose, congestion, itching, sneezing, and nasal discomfort – after the first dose, and 45% after the second.

"They usually lasted only a day or so after vaccination," Dr. Atmar said.

"Systemic symptoms were similar between the vaccine and the placebo group, and more frequently reported after the first [vaccine] dose than after the second dose. Symptoms we asked about included headache, nausea, fatigue/malaise, fever, anorexia, vomiting, and diarrhea," he said.

The vaccine continues to be studied. Among outstanding questions is whether it protects against strains other than norovirus genogroup 1, its target. The duration of protection is also unknown, Dr. Atmar said.

An intramuscular formulation is in clinical trials, but "a commercially available vaccine is still years away," he said.

The study was study sponsored by the vaccines maker, LigoCyte Pharmaceuticals Inc. Dr. Atmar disclosed that he is an investigator for, and receives research support from, LigoCyte.

VANCOUVER, B.C. – Two intranasal doses of an experimental norovirus vaccine led to a relative reduction of about 45% in the incidence of acute gastroenteritis in a randomized, placebo-controlled, phase I/II challenge study.

"The vaccine protected against illness. This is the first demonstration that an intranasally delivered vaccine can prevent human illness due to an enteric pathogen," said principal investigator Dr. Robert Atmar, a professor of molecular virology and microbiology at Baylor College of Medicine in Houston, who presented the findings.

The vaccine is a dry powder formulation of viruslike particles (VLP) that mimic the norovirus capsid. "From their first production in the early 90s, they were proposed as a candidate vaccine," Dr. Atmar said.

The trial initially included 98 healthy adults (aged 18-50 years) who were randomized to two vaccine doses – each dose containing 100 mcg of VLP and given 3 weeks apart – or placebo.

"Just under two-thirds of the subjects had a seroresponse" to the vaccine, and "the average total rise [in norovirus antibodies] was about fourfold after two doses," Dr. Atmar said.

About a month after the second dose, participants in the trial were administered approximately 10 human-infectious doses of norovirus and were put into a hospital setting for 4 days.

Subjects were checked daily for signs of infection, including stool virus shedding, and were monitored for signs of acute gastroenteritis. Stool was checked again at 1 and 3 weeks after the challenge.

The per-protocol analysis included 77 subjects. In all, 82% (32) in the placebo group and 61% (23) in the vaccine group developed infection, a relative reduction of 26% (P = .046); 69% (27) in the placebo arm and 37% (14) in the vaccine group developed acute gastritis, a relative reduction of 47% (P = .006).

The results were similar in the 84 subjects in the intent-to-treat analysis, with a relative reduction of acute gastroenteritis in the vaccine group of 44% (P = .005), and a nonsignificant relative reduction in infections of 22% in the vaccine group (P = .084).

"There were no severe adverse events or new onset of medically significant conditions," in the vaccine group, Dr. Atmar said.

However, 40% had mild to moderate nasal symptoms – including runny nose, congestion, itching, sneezing, and nasal discomfort – after the first dose, and 45% after the second.

"They usually lasted only a day or so after vaccination," Dr. Atmar said.

"Systemic symptoms were similar between the vaccine and the placebo group, and more frequently reported after the first [vaccine] dose than after the second dose. Symptoms we asked about included headache, nausea, fatigue/malaise, fever, anorexia, vomiting, and diarrhea," he said.

The vaccine continues to be studied. Among outstanding questions is whether it protects against strains other than norovirus genogroup 1, its target. The duration of protection is also unknown, Dr. Atmar said.

An intramuscular formulation is in clinical trials, but "a commercially available vaccine is still years away," he said.

The study was study sponsored by the vaccines maker, LigoCyte Pharmaceuticals Inc. Dr. Atmar disclosed that he is an investigator for, and receives research support from, LigoCyte.

VANCOUVER, B.C. – Infants born to women who receive diphtheria-tetanus-acellular pertussis vaccine during pregnancy have higher pertussis antibody levels during their first few months of life than infants born to unvaccinated women, Dr. Abbey Hardy-Fairbanks reported.

The levels are sufficient to protect infants against pertussis prior to their first diphtheria-tetanus-acellular pertussis (DTaP) shot at around 2 months, a period of "significant pertussis morbidity and mortality," said Dr. Hardy-Fairbanks, an ob.gyn. at the University of Iowa, Iowa City. "This is the first evidence to document that pertussis immunization during pregnancy is likely to be beneficial to infants when they are most vulnerable to pertussis disease. [Physicians] should consider vaccination of women during pregnancy with DTaP," she said at the annual meeting of the Infectious Diseases Society of America.

In the prospective cohort study, 16 (23%) of 70 pregnant women received DTaP vaccine; 54 (77%) pregnant women selected as controls did not and had not been vaccinated for at least 2 years.

Four of the women (25%) in the DTaP group were vaccinated in the first trimester, eight (50%) in the second, and four (25%) in the third. Vaccination did not cause any adverse pregnancy outcomes.

Maternal blood and cord blood were collected at delivery. Blood was also collected from children before and after their primary DTaP series and toddler booster doses at 12-18 months.

Blood samples were measured for pertussis antigens, including pertussis toxoid, filamentous hemagglutinin, pertactin, and fimbriae, by enzyme-linked immunosorbent assay.

Newborns in the DTaP group had higher pertussis antibody concentrations than their mothers, "showing efficient placental transfer of antibodies to the infant," Dr. Hardy-Fairbanks said.

They also had substantially higher concentrations than infants in the control group prior to the start of the primary DTaP series, and the differences were statistically significant.

However, at month 7, following completion of the DTaP series, infants born to vaccinated mothers had slightly lower antibody levels than infants in the control group. The differences were not statistically significant, but "may represent some blunting of the infant immune response to the [vaccine]," Dr. Hardy-Fairbanks said.

By the time they got their toddler booster doses, however, antibody levels "were essentially equivalent" in the two groups, she said.

Dr. Hardy-Fairbanks said the infants’ responses to polio, Haemophilus influenzae

type b, and hepatitis B vaccines are being analyzed.

Dr. Hardy-Fairbanks said she had no conflicts of interest. The study was funded by Sanofi-Pasteur, maker of Daptacel DTaP vaccine.

VANCOUVER, B.C. – Infants born to women who receive diphtheria-tetanus-acellular pertussis vaccine during pregnancy have higher pertussis antibody levels during their first few months of life than infants born to unvaccinated women, Dr. Abbey Hardy-Fairbanks reported.

The levels are sufficient to protect infants against pertussis prior to their first diphtheria-tetanus-acellular pertussis (DTaP) shot at around 2 months, a period of "significant pertussis morbidity and mortality," said Dr. Hardy-Fairbanks, an ob.gyn. at the University of Iowa, Iowa City. "This is the first evidence to document that pertussis immunization during pregnancy is likely to be beneficial to infants when they are most vulnerable to pertussis disease. [Physicians] should consider vaccination of women during pregnancy with DTaP," she said at the annual meeting of the Infectious Diseases Society of America.

In the prospective cohort study, 16 (23%) of 70 pregnant women received DTaP vaccine; 54 (77%) pregnant women selected as controls did not and had not been vaccinated for at least 2 years.

Four of the women (25%) in the DTaP group were vaccinated in the first trimester, eight (50%) in the second, and four (25%) in the third. Vaccination did not cause any adverse pregnancy outcomes.

Maternal blood and cord blood were collected at delivery. Blood was also collected from children before and after their primary DTaP series and toddler booster doses at 12-18 months.

Blood samples were measured for pertussis antigens, including pertussis toxoid, filamentous hemagglutinin, pertactin, and fimbriae, by enzyme-linked immunosorbent assay.

Newborns in the DTaP group had higher pertussis antibody concentrations than their mothers, "showing efficient placental transfer of antibodies to the infant," Dr. Hardy-Fairbanks said.

They also had substantially higher concentrations than infants in the control group prior to the start of the primary DTaP series, and the differences were statistically significant.

However, at month 7, following completion of the DTaP series, infants born to vaccinated mothers had slightly lower antibody levels than infants in the control group. The differences were not statistically significant, but "may represent some blunting of the infant immune response to the [vaccine]," Dr. Hardy-Fairbanks said.

By the time they got their toddler booster doses, however, antibody levels "were essentially equivalent" in the two groups, she said.

Dr. Hardy-Fairbanks said the infants’ responses to polio, Haemophilus influenzae

type b, and hepatitis B vaccines are being analyzed.

Dr. Hardy-Fairbanks said she had no conflicts of interest. The study was funded by Sanofi-Pasteur, maker of Daptacel DTaP vaccine.

VANCOUVER, B.C. – Infants born to women who receive diphtheria-tetanus-acellular pertussis vaccine during pregnancy have higher pertussis antibody levels during their first few months of life than infants born to unvaccinated women, Dr. Abbey Hardy-Fairbanks reported.

The levels are sufficient to protect infants against pertussis prior to their first diphtheria-tetanus-acellular pertussis (DTaP) shot at around 2 months, a period of "significant pertussis morbidity and mortality," said Dr. Hardy-Fairbanks, an ob.gyn. at the University of Iowa, Iowa City. "This is the first evidence to document that pertussis immunization during pregnancy is likely to be beneficial to infants when they are most vulnerable to pertussis disease. [Physicians] should consider vaccination of women during pregnancy with DTaP," she said at the annual meeting of the Infectious Diseases Society of America.

In the prospective cohort study, 16 (23%) of 70 pregnant women received DTaP vaccine; 54 (77%) pregnant women selected as controls did not and had not been vaccinated for at least 2 years.

Four of the women (25%) in the DTaP group were vaccinated in the first trimester, eight (50%) in the second, and four (25%) in the third. Vaccination did not cause any adverse pregnancy outcomes.

Maternal blood and cord blood were collected at delivery. Blood was also collected from children before and after their primary DTaP series and toddler booster doses at 12-18 months.

Blood samples were measured for pertussis antigens, including pertussis toxoid, filamentous hemagglutinin, pertactin, and fimbriae, by enzyme-linked immunosorbent assay.

Newborns in the DTaP group had higher pertussis antibody concentrations than their mothers, "showing efficient placental transfer of antibodies to the infant," Dr. Hardy-Fairbanks said.

They also had substantially higher concentrations than infants in the control group prior to the start of the primary DTaP series, and the differences were statistically significant.

However, at month 7, following completion of the DTaP series, infants born to vaccinated mothers had slightly lower antibody levels than infants in the control group. The differences were not statistically significant, but "may represent some blunting of the infant immune response to the [vaccine]," Dr. Hardy-Fairbanks said.

By the time they got their toddler booster doses, however, antibody levels "were essentially equivalent" in the two groups, she said.

Dr. Hardy-Fairbanks said the infants’ responses to polio, Haemophilus influenzae

type b, and hepatitis B vaccines are being analyzed.

Dr. Hardy-Fairbanks said she had no conflicts of interest. The study was funded by Sanofi-Pasteur, maker of Daptacel DTaP vaccine.