Mary Ellen Schneider

DALLAS — Last year's Gulf Coast hurricanes and their devastating aftermath left many physicians wondering how they could help in future disasters, Dr. Joseph A. Scott, director of the division of prehospital and emergency health care at the University of Miami, said at the annual meeting of the National Medical Association.

There are a number of federal disaster response teams for which physicians can volunteer, Dr. Scott said.

The National Disaster Medical System (NDMS) is a public-private partnership, based primarily in the Department of Homeland Security, which coordinates teams of medical providers to respond to storms, floods, airplane crashes, and even large-scale events like the Olympics or presidential inaugurations. The NDMS was set up to supplement state and local medical resources.

The disaster medical assistance teams (DMATs) make up one component of the NDMS. DMATs are 35-person teams that can be on the ground at a disaster anywhere around the country within 24 hours. A DMAT typically comprises physicians, nurses, paramedics, emergency medical technicians, pharmacists, respiratory therapists, psychologists, and social workers. All team members are cross-trained in medical, logistical, communications, and administrative aspects of the response, said Dr. Scott, who serves as medical officer for a DMAT based in south Florida.

These teams handle a variety of medical situations—from triage to primary medical care to trauma—once they are on the ground, he said. The DMAT usually rolls out the door with a cache of medications provided by the federal government. The medications include drugs for treatment as well as for dispensing purposes, because most pharmacies will be shut down in a disaster, Dr. Scott said. The NDMS also supplies the equipment, but Dr. Scott said his group also accepts donated equipment to supplement that stock.

Emergency medicine training is ideal for these types of teams, he said. Experience with urgent care, trauma, and pediatrics is especially important for disaster deployments.

The usual deployment period for members of a DMAT is about 1–2 weeks, which includes predisaster staging. Physicians in the past were required to commit to a 2-week deployment, but that has been changing to 1 week for physicians only, he said.

Volunteering to be part of an organized response team can forestall many of the problems that can occur at a disaster site when individual, well-meaning volunteers flood the scene. An overabundance of volunteers can divert resources, Dr. Scott said. And unsolicited volunteers often lack appropriate training, equipment, and supplies. They may also be outside the formal accountability system and may lack proper credentials, he said.

A big fear when volunteers—especially physicians—show up without formal coordination is that no one will be at home to take care of the regular emergencies, he said. Thus, physicians who can't volunteer for a DMAT can still help in a disaster while staying home, Dr. Scott said. Not everyone has the flexibility—either at home or at work—to volunteer for a 1- to 2-week deployment. But physicians can make a difference by volunteering to cover shifts for a colleague who is a member of a response team.

There are also increasing opportunities for physicians to volunteer for similar teams at the state level. Physicians can check with their state emergency management offices to find out if their state has a team, he said.

Other federal teams that need physician volunteers include:

▸ National medical response teams. These are 50-member teams that deploy less often than DMATs. They are generally tasked to respond to nuclear, biologic, and chemical incidents.

▸ Disaster mortuary operational response teams. These teams include pathologists, forensic pathologists, fingerprint experts, and dental assistants who help to identify victims' remains in a disaster. There are about 9 or 10 such teams in the country.

▸ International medical/surgical response teams. These teams generally take care of American civilians overseas, Dr. Scott said. They are similar to DMATs, but generally deploy with a trauma surgeon and anesthesiologist; they can perform surgery in the field.

▸ Urban search and rescue teams. These teams specialize in on-site medical treatment for victims trapped in confined spaces, such as those resulting from structural collapses. The physicians on these teams frequently care for both victims and responders, he said.

Physicians who are deployed as part of a federal team become federal employees during deployment and do collect a small paycheck, Dr. Scott said. Physicians get other protections during their deployment, including federal liability protection.

But there are some disadvantages, Dr. Scott said. The initial credentialing process can take 6 months or more.

Overall, the experience can be very rewarding, Dr. Scott said. It's an opportunity to provide good care to appreciative patients with minimal paperwork.

To learn more about volunteering for a disaster response team, visit www.ndms.fema.govjack.beall@dhs.gov

How to Prepare For Deployment

Dr. Joseph A. Scott, who serves on both a disaster medical assistance team and an international medical/surgical response team, offered tips for physicians preparing for deployment:

▸ Update your immunizations before heading into the field.

▸ Get packed. Physicians should carry cash, water, food, protective clothing, medications, flashlight, batteries, sleeping bag, gasoline, insect repellent, and their credentials, Dr. Scott said. Credit cards will be useless if the power is out. Physicians need to carry enough of their own supplies that they don't end up becoming victims themselves, he said.

▸ Take care of your own mental health. This means making sure that your home and work situations are under control during deployment, he said. Make sure in advance that colleagues can cover your shifts. This will go a long way toward making you more effective during deployment, he said.

DALLAS — Last year's Gulf Coast hurricanes and their devastating aftermath left many physicians wondering how they could help in future disasters, Dr. Joseph A. Scott, director of the division of prehospital and emergency health care at the University of Miami, said at the annual meeting of the National Medical Association.

There are a number of federal disaster response teams for which physicians can volunteer, Dr. Scott said.

The National Disaster Medical System (NDMS) is a public-private partnership, based primarily in the Department of Homeland Security, which coordinates teams of medical providers to respond to storms, floods, airplane crashes, and even large-scale events like the Olympics or presidential inaugurations. The NDMS was set up to supplement state and local medical resources.

The disaster medical assistance teams (DMATs) make up one component of the NDMS. DMATs are 35-person teams that can be on the ground at a disaster anywhere around the country within 24 hours. A DMAT typically comprises physicians, nurses, paramedics, emergency medical technicians, pharmacists, respiratory therapists, psychologists, and social workers. All team members are cross-trained in medical, logistical, communications, and administrative aspects of the response, said Dr. Scott, who serves as medical officer for a DMAT based in south Florida.

These teams handle a variety of medical situations—from triage to primary medical care to trauma—once they are on the ground, he said. The DMAT usually rolls out the door with a cache of medications provided by the federal government. The medications include drugs for treatment as well as for dispensing purposes, because most pharmacies will be shut down in a disaster, Dr. Scott said. The NDMS also supplies the equipment, but Dr. Scott said his group also accepts donated equipment to supplement that stock.

Emergency medicine training is ideal for these types of teams, he said. Experience with urgent care, trauma, and pediatrics is especially important for disaster deployments.

The usual deployment period for members of a DMAT is about 1–2 weeks, which includes predisaster staging. Physicians in the past were required to commit to a 2-week deployment, but that has been changing to 1 week for physicians only, he said.

Volunteering to be part of an organized response team can forestall many of the problems that can occur at a disaster site when individual, well-meaning volunteers flood the scene. An overabundance of volunteers can divert resources, Dr. Scott said. And unsolicited volunteers often lack appropriate training, equipment, and supplies. They may also be outside the formal accountability system and may lack proper credentials, he said.

A big fear when volunteers—especially physicians—show up without formal coordination is that no one will be at home to take care of the regular emergencies, he said. Thus, physicians who can't volunteer for a DMAT can still help in a disaster while staying home, Dr. Scott said. Not everyone has the flexibility—either at home or at work—to volunteer for a 1- to 2-week deployment. But physicians can make a difference by volunteering to cover shifts for a colleague who is a member of a response team.

There are also increasing opportunities for physicians to volunteer for similar teams at the state level. Physicians can check with their state emergency management offices to find out if their state has a team, he said.

Other federal teams that need physician volunteers include:

▸ National medical response teams. These are 50-member teams that deploy less often than DMATs. They are generally tasked to respond to nuclear, biologic, and chemical incidents.

▸ Disaster mortuary operational response teams. These teams include pathologists, forensic pathologists, fingerprint experts, and dental assistants who help to identify victims' remains in a disaster. There are about 9 or 10 such teams in the country.

▸ International medical/surgical response teams. These teams generally take care of American civilians overseas, Dr. Scott said. They are similar to DMATs, but generally deploy with a trauma surgeon and anesthesiologist; they can perform surgery in the field.

▸ Urban search and rescue teams. These teams specialize in on-site medical treatment for victims trapped in confined spaces, such as those resulting from structural collapses. The physicians on these teams frequently care for both victims and responders, he said.

Physicians who are deployed as part of a federal team become federal employees during deployment and do collect a small paycheck, Dr. Scott said. Physicians get other protections during their deployment, including federal liability protection.

But there are some disadvantages, Dr. Scott said. The initial credentialing process can take 6 months or more.

Overall, the experience can be very rewarding, Dr. Scott said. It's an opportunity to provide good care to appreciative patients with minimal paperwork.

To learn more about volunteering for a disaster response team, visit www.ndms.fema.govjack.beall@dhs.gov

How to Prepare For Deployment

Dr. Joseph A. Scott, who serves on both a disaster medical assistance team and an international medical/surgical response team, offered tips for physicians preparing for deployment:

▸ Update your immunizations before heading into the field.

▸ Get packed. Physicians should carry cash, water, food, protective clothing, medications, flashlight, batteries, sleeping bag, gasoline, insect repellent, and their credentials, Dr. Scott said. Credit cards will be useless if the power is out. Physicians need to carry enough of their own supplies that they don't end up becoming victims themselves, he said.

▸ Take care of your own mental health. This means making sure that your home and work situations are under control during deployment, he said. Make sure in advance that colleagues can cover your shifts. This will go a long way toward making you more effective during deployment, he said.

DALLAS — Last year's Gulf Coast hurricanes and their devastating aftermath left many physicians wondering how they could help in future disasters, Dr. Joseph A. Scott, director of the division of prehospital and emergency health care at the University of Miami, said at the annual meeting of the National Medical Association.

There are a number of federal disaster response teams for which physicians can volunteer, Dr. Scott said.

The National Disaster Medical System (NDMS) is a public-private partnership, based primarily in the Department of Homeland Security, which coordinates teams of medical providers to respond to storms, floods, airplane crashes, and even large-scale events like the Olympics or presidential inaugurations. The NDMS was set up to supplement state and local medical resources.

The disaster medical assistance teams (DMATs) make up one component of the NDMS. DMATs are 35-person teams that can be on the ground at a disaster anywhere around the country within 24 hours. A DMAT typically comprises physicians, nurses, paramedics, emergency medical technicians, pharmacists, respiratory therapists, psychologists, and social workers. All team members are cross-trained in medical, logistical, communications, and administrative aspects of the response, said Dr. Scott, who serves as medical officer for a DMAT based in south Florida.

These teams handle a variety of medical situations—from triage to primary medical care to trauma—once they are on the ground, he said. The DMAT usually rolls out the door with a cache of medications provided by the federal government. The medications include drugs for treatment as well as for dispensing purposes, because most pharmacies will be shut down in a disaster, Dr. Scott said. The NDMS also supplies the equipment, but Dr. Scott said his group also accepts donated equipment to supplement that stock.

Emergency medicine training is ideal for these types of teams, he said. Experience with urgent care, trauma, and pediatrics is especially important for disaster deployments.

The usual deployment period for members of a DMAT is about 1–2 weeks, which includes predisaster staging. Physicians in the past were required to commit to a 2-week deployment, but that has been changing to 1 week for physicians only, he said.

Volunteering to be part of an organized response team can forestall many of the problems that can occur at a disaster site when individual, well-meaning volunteers flood the scene. An overabundance of volunteers can divert resources, Dr. Scott said. And unsolicited volunteers often lack appropriate training, equipment, and supplies. They may also be outside the formal accountability system and may lack proper credentials, he said.

A big fear when volunteers—especially physicians—show up without formal coordination is that no one will be at home to take care of the regular emergencies, he said. Thus, physicians who can't volunteer for a DMAT can still help in a disaster while staying home, Dr. Scott said. Not everyone has the flexibility—either at home or at work—to volunteer for a 1- to 2-week deployment. But physicians can make a difference by volunteering to cover shifts for a colleague who is a member of a response team.

There are also increasing opportunities for physicians to volunteer for similar teams at the state level. Physicians can check with their state emergency management offices to find out if their state has a team, he said.

Other federal teams that need physician volunteers include:

▸ National medical response teams. These are 50-member teams that deploy less often than DMATs. They are generally tasked to respond to nuclear, biologic, and chemical incidents.

▸ Disaster mortuary operational response teams. These teams include pathologists, forensic pathologists, fingerprint experts, and dental assistants who help to identify victims' remains in a disaster. There are about 9 or 10 such teams in the country.

▸ International medical/surgical response teams. These teams generally take care of American civilians overseas, Dr. Scott said. They are similar to DMATs, but generally deploy with a trauma surgeon and anesthesiologist; they can perform surgery in the field.

▸ Urban search and rescue teams. These teams specialize in on-site medical treatment for victims trapped in confined spaces, such as those resulting from structural collapses. The physicians on these teams frequently care for both victims and responders, he said.

Physicians who are deployed as part of a federal team become federal employees during deployment and do collect a small paycheck, Dr. Scott said. Physicians get other protections during their deployment, including federal liability protection.

But there are some disadvantages, Dr. Scott said. The initial credentialing process can take 6 months or more.

Overall, the experience can be very rewarding, Dr. Scott said. It's an opportunity to provide good care to appreciative patients with minimal paperwork.

To learn more about volunteering for a disaster response team, visit www.ndms.fema.govjack.beall@dhs.gov

How to Prepare For Deployment

Dr. Joseph A. Scott, who serves on both a disaster medical assistance team and an international medical/surgical response team, offered tips for physicians preparing for deployment:

▸ Update your immunizations before heading into the field.

▸ Get packed. Physicians should carry cash, water, food, protective clothing, medications, flashlight, batteries, sleeping bag, gasoline, insect repellent, and their credentials, Dr. Scott said. Credit cards will be useless if the power is out. Physicians need to carry enough of their own supplies that they don't end up becoming victims themselves, he said.

▸ Take care of your own mental health. This means making sure that your home and work situations are under control during deployment, he said. Make sure in advance that colleagues can cover your shifts. This will go a long way toward making you more effective during deployment, he said.

LOS ANGELES — Even small amounts of acetaminophen can cause acute liver failure and death in some patients with acute viral hepatitis, according to research presented at the annual Digestive Diseases Week.

Acetaminophen adducts—the toxic byproducts of acetaminophen liver damage—were found in serum samples of 9 out of 72 patients (12.5%) with confirmed hepatitis A or B that had progressed to liver failure. The patients were part of a registry of acute liver failure cases, said senior study author Dr. William M. Lee, professor of medicine at the University of Texas Southwestern Medical School, Dallas.

The investigators compared the findings with serum results from 10 patients whose acute liver failure was known to have been induced by an overdose of acetaminophen. The acetaminophen adducts found in the 10 patients who had overdosed were significantly higher than the levels in the 72 patients, which was consistent with patient reports that they had used acetaminophen in the days before the study but not in doses greater than 4 g per day. The study also showed that about two-thirds of the acute viral hepatitis patients with acetaminophen adducts died within 3 weeks of admission to the study, compared with 27% of hepatitis patients without adducts.

Acetaminophen is a dose-related toxin and for patients with hepatitis A or B, there is a serious risk of liver failure with even therapeutic doses of the drug, Dr. Lee said. Patients may inadvertently take excessive doses of the over-the-counter pain reliever either by taking it in combination with an acetaminophen-containing narcotic or in combination with an over-the-counter flu medication that also contains acetaminophen. Since many patients with early viral hepatitis experience flu-like symptoms, it's key that they are educated about the risks of taking acetaminophen, according to Dr. Lee.

The study was supported by a grant from the National Institutes of Health.

LOS ANGELES — Even small amounts of acetaminophen can cause acute liver failure and death in some patients with acute viral hepatitis, according to research presented at the annual Digestive Diseases Week.

Acetaminophen adducts—the toxic byproducts of acetaminophen liver damage—were found in serum samples of 9 out of 72 patients (12.5%) with confirmed hepatitis A or B that had progressed to liver failure. The patients were part of a registry of acute liver failure cases, said senior study author Dr. William M. Lee, professor of medicine at the University of Texas Southwestern Medical School, Dallas.

The investigators compared the findings with serum results from 10 patients whose acute liver failure was known to have been induced by an overdose of acetaminophen. The acetaminophen adducts found in the 10 patients who had overdosed were significantly higher than the levels in the 72 patients, which was consistent with patient reports that they had used acetaminophen in the days before the study but not in doses greater than 4 g per day. The study also showed that about two-thirds of the acute viral hepatitis patients with acetaminophen adducts died within 3 weeks of admission to the study, compared with 27% of hepatitis patients without adducts.

Acetaminophen is a dose-related toxin and for patients with hepatitis A or B, there is a serious risk of liver failure with even therapeutic doses of the drug, Dr. Lee said. Patients may inadvertently take excessive doses of the over-the-counter pain reliever either by taking it in combination with an acetaminophen-containing narcotic or in combination with an over-the-counter flu medication that also contains acetaminophen. Since many patients with early viral hepatitis experience flu-like symptoms, it's key that they are educated about the risks of taking acetaminophen, according to Dr. Lee.

The study was supported by a grant from the National Institutes of Health.

LOS ANGELES — Even small amounts of acetaminophen can cause acute liver failure and death in some patients with acute viral hepatitis, according to research presented at the annual Digestive Diseases Week.

Acetaminophen adducts—the toxic byproducts of acetaminophen liver damage—were found in serum samples of 9 out of 72 patients (12.5%) with confirmed hepatitis A or B that had progressed to liver failure. The patients were part of a registry of acute liver failure cases, said senior study author Dr. William M. Lee, professor of medicine at the University of Texas Southwestern Medical School, Dallas.

The investigators compared the findings with serum results from 10 patients whose acute liver failure was known to have been induced by an overdose of acetaminophen. The acetaminophen adducts found in the 10 patients who had overdosed were significantly higher than the levels in the 72 patients, which was consistent with patient reports that they had used acetaminophen in the days before the study but not in doses greater than 4 g per day. The study also showed that about two-thirds of the acute viral hepatitis patients with acetaminophen adducts died within 3 weeks of admission to the study, compared with 27% of hepatitis patients without adducts.

Acetaminophen is a dose-related toxin and for patients with hepatitis A or B, there is a serious risk of liver failure with even therapeutic doses of the drug, Dr. Lee said. Patients may inadvertently take excessive doses of the over-the-counter pain reliever either by taking it in combination with an acetaminophen-containing narcotic or in combination with an over-the-counter flu medication that also contains acetaminophen. Since many patients with early viral hepatitis experience flu-like symptoms, it's key that they are educated about the risks of taking acetaminophen, according to Dr. Lee.

The study was supported by a grant from the National Institutes of Health.

DALLAS — Becoming an investigator for a phase IV postmarketing study can be a good starting place for dermatologists interested in clinical research, Dr. Fran E. Cook-Bolden told attendees at the annual meeting of the National Medical Association.

But there is a lot expected of physicians who conduct these studies, from allocating secure storage space to hiring research staff, said Dr. Cook-Bolden of the department of dermatology at Columbia University.

Dr. Cook-Bolden has a private dermatology practice in New York City and is active as well in conducting research for a number of different drug and device companies.

"You really need to enjoy clinical research," she said. "It's really more than just a notion."

Phase IV studies are postmarketing studies that allow researchers to delineate additional information about drugs or devices that have already been approved by the Food and Drug Administration, she said.

"It is an opportunity to talk [about] additional risks, benefits, or optimal use of the drug," Dr. Cook-Bolden said.

A phase IV study, for example, might examine different doses, schedules of administration, different patient populations, or use of the therapy for different stages of disease.

These studies can be initiated by the drug or device sponsor, but also by physicians, Dr. Cook-Bolden said.

If dermatologists are having success among their patients with an off-label use of a drug, that might be something worth investigating in a study, she said at the meeting.

When pitching an idea for a trial to industry, physicians need to provide the drug or device sponsor with a detailed protocol proposal that includes the background, the rationale for the study, the objective, the design and methodology, the statistical considerations, and the organization of the study. And the proposal should include references. "Industry needs to know that you've done your research," she said.

Companies will also want to know about the physician's previous experience as a principal investigator and their track record in recruiting and retaining patients for a study. There is currently a lot of competition to conduct clinical research, she said.

Availability of staff for the clinical study is another key consideration. This type of research can't be done by a physician alone, Dr. Cook-Bolden said. Phase IV studies generally require a physician subinvestigator and a research coordinator in addition to the principal investigator. A pharmacist, a specialist in regulatory documentation, and a nurse are also helpful.

Conducting a research study also requires setting aside some secure storage space. Physicians will need to have locked cabinets to safely store confidential study materials in their offices, and secure, climate-controlled storage for drugs, Dr. Cook-Bolden said. And while it's not essential to set aside clinical exam space for the research, physicians who do a number of studies may find it useful to do so, she said.

Dr. Cook-Bolden said she conducts clinical research because it puts her on the "cutting edge" and allows her to have more input on study design. It can also be opportunity to reach out to patients who can't get health care, she said.

But physicians shouldn't embark on clinical research as a way to get rich, Dr. Cook-Bolden said. Drug and device sponsors generally pay physicians for the time spent in study activities and cover some overhead, but physicians are still responsible for paying their own research staff and paying the rent for space used in the study.

It generally doesn't make financial sense to conduct just one study, but physicians who are active in clinical research can be successful, she said.

DALLAS — Becoming an investigator for a phase IV postmarketing study can be a good starting place for dermatologists interested in clinical research, Dr. Fran E. Cook-Bolden told attendees at the annual meeting of the National Medical Association.

But there is a lot expected of physicians who conduct these studies, from allocating secure storage space to hiring research staff, said Dr. Cook-Bolden of the department of dermatology at Columbia University.

Dr. Cook-Bolden has a private dermatology practice in New York City and is active as well in conducting research for a number of different drug and device companies.

"You really need to enjoy clinical research," she said. "It's really more than just a notion."

Phase IV studies are postmarketing studies that allow researchers to delineate additional information about drugs or devices that have already been approved by the Food and Drug Administration, she said.

"It is an opportunity to talk [about] additional risks, benefits, or optimal use of the drug," Dr. Cook-Bolden said.

A phase IV study, for example, might examine different doses, schedules of administration, different patient populations, or use of the therapy for different stages of disease.

These studies can be initiated by the drug or device sponsor, but also by physicians, Dr. Cook-Bolden said.

If dermatologists are having success among their patients with an off-label use of a drug, that might be something worth investigating in a study, she said at the meeting.

When pitching an idea for a trial to industry, physicians need to provide the drug or device sponsor with a detailed protocol proposal that includes the background, the rationale for the study, the objective, the design and methodology, the statistical considerations, and the organization of the study. And the proposal should include references. "Industry needs to know that you've done your research," she said.

Companies will also want to know about the physician's previous experience as a principal investigator and their track record in recruiting and retaining patients for a study. There is currently a lot of competition to conduct clinical research, she said.

Availability of staff for the clinical study is another key consideration. This type of research can't be done by a physician alone, Dr. Cook-Bolden said. Phase IV studies generally require a physician subinvestigator and a research coordinator in addition to the principal investigator. A pharmacist, a specialist in regulatory documentation, and a nurse are also helpful.

Conducting a research study also requires setting aside some secure storage space. Physicians will need to have locked cabinets to safely store confidential study materials in their offices, and secure, climate-controlled storage for drugs, Dr. Cook-Bolden said. And while it's not essential to set aside clinical exam space for the research, physicians who do a number of studies may find it useful to do so, she said.

Dr. Cook-Bolden said she conducts clinical research because it puts her on the "cutting edge" and allows her to have more input on study design. It can also be opportunity to reach out to patients who can't get health care, she said.

But physicians shouldn't embark on clinical research as a way to get rich, Dr. Cook-Bolden said. Drug and device sponsors generally pay physicians for the time spent in study activities and cover some overhead, but physicians are still responsible for paying their own research staff and paying the rent for space used in the study.

It generally doesn't make financial sense to conduct just one study, but physicians who are active in clinical research can be successful, she said.

DALLAS — Becoming an investigator for a phase IV postmarketing study can be a good starting place for dermatologists interested in clinical research, Dr. Fran E. Cook-Bolden told attendees at the annual meeting of the National Medical Association.

But there is a lot expected of physicians who conduct these studies, from allocating secure storage space to hiring research staff, said Dr. Cook-Bolden of the department of dermatology at Columbia University.

Dr. Cook-Bolden has a private dermatology practice in New York City and is active as well in conducting research for a number of different drug and device companies.

"You really need to enjoy clinical research," she said. "It's really more than just a notion."

Phase IV studies are postmarketing studies that allow researchers to delineate additional information about drugs or devices that have already been approved by the Food and Drug Administration, she said.

"It is an opportunity to talk [about] additional risks, benefits, or optimal use of the drug," Dr. Cook-Bolden said.

A phase IV study, for example, might examine different doses, schedules of administration, different patient populations, or use of the therapy for different stages of disease.

These studies can be initiated by the drug or device sponsor, but also by physicians, Dr. Cook-Bolden said.

If dermatologists are having success among their patients with an off-label use of a drug, that might be something worth investigating in a study, she said at the meeting.

When pitching an idea for a trial to industry, physicians need to provide the drug or device sponsor with a detailed protocol proposal that includes the background, the rationale for the study, the objective, the design and methodology, the statistical considerations, and the organization of the study. And the proposal should include references. "Industry needs to know that you've done your research," she said.

Companies will also want to know about the physician's previous experience as a principal investigator and their track record in recruiting and retaining patients for a study. There is currently a lot of competition to conduct clinical research, she said.

Availability of staff for the clinical study is another key consideration. This type of research can't be done by a physician alone, Dr. Cook-Bolden said. Phase IV studies generally require a physician subinvestigator and a research coordinator in addition to the principal investigator. A pharmacist, a specialist in regulatory documentation, and a nurse are also helpful.

Conducting a research study also requires setting aside some secure storage space. Physicians will need to have locked cabinets to safely store confidential study materials in their offices, and secure, climate-controlled storage for drugs, Dr. Cook-Bolden said. And while it's not essential to set aside clinical exam space for the research, physicians who do a number of studies may find it useful to do so, she said.

Dr. Cook-Bolden said she conducts clinical research because it puts her on the "cutting edge" and allows her to have more input on study design. It can also be opportunity to reach out to patients who can't get health care, she said.

But physicians shouldn't embark on clinical research as a way to get rich, Dr. Cook-Bolden said. Drug and device sponsors generally pay physicians for the time spent in study activities and cover some overhead, but physicians are still responsible for paying their own research staff and paying the rent for space used in the study.

It generally doesn't make financial sense to conduct just one study, but physicians who are active in clinical research can be successful, she said.

Uninsured Figures Climb

The number of people in the United States without health insurance edged higher in 2005, fueled in part by a drop in employer-sponsored health insurance, according to figures released in August from the U.S. Census Bureau. In 2005, 46.6 million people were uninsured, up from 45.3 million the year before. The percentage of people covered by employer-sponsored health insurance dropped from 59.8% to 59.5% between 2004 and 2005, while the percentage covered by government insurance stayed the same, according to the Census figures. The new figures, compiled as part of the Current Population Survey, showed that the number of uninsured children also increased. Between 2004 and 2005, the number of uninsured children rose from 7.9 million to 8.3 million. And children living in poverty were the most likely to be uninsured, with a rate of 19% vs. 11.2% of children overall in 2005. The American Medical Association issued a statement calling for action to address the uninsured problem. “The AMA plan for reducing the number of the uninsured advocates expanded coverage and choice through a system of refundable tax credits based on income, individually selected and owned health insurance, and market reforms that will enhance new, affordable insurance options,” Dr. Ardis Hoven, an AMA board member, said in a statement.

Mammography Capacity Dips

The national capacity to provide mammography services is adequate, despite a 6% drop in the number of mammography facilities from 2001 to 2004, according to a recent report from the Government Accountability Office. In addition to the decrease in the number of facilities, the GAO reported a 4% drop in the number of machines, a 3% drop in the number of radiologic technologists, and a 5% drop in the number of physicians who interpret mammograms. Experts interviewed by the GAO said that the capacity nationwide is likely adequate to meet the current demand for screening and diagnostic mammograms, but cautioned that there could be access problems in the future. The report was requested by Sen. Arlen Specter (R-Pa.) and Sen. Barbara Mikulski (D-Md.).

Cost of Infertility Treatments

The majority of employers who provide insurance coverage for infertility treatment have not experienced a significant increase in their health plan costs, according to the results of a survey commissioned by RESOLVE: The National Infertility Association and supported by Organon USA. More than 90% of employers who cover infertility treatment beyond an evaluation reported no measurable increase in their medical costs as a result of the additional coverage. The survey of 931 employers found that about 39% cover drug therapy for infertility treatment and 22% cover in vitro fertilization. More employers cover evaluation by an infertility specialist, with about 63% providing at least that level of coverage, according to RESOLVE. “This survey clearly debunks the myth that infertility coverage increases medical coverage costs significantly,” RESOLVE President Joseph C. Isaacs said in a statement.

Improving Latina Cancer Screening

The use of a bilingual staff and free screenings may help to improve breast and cervical cancer screening frequency among Latina patients, according to a report published in the August issue of the Journal of Health Care for the Poor and Underserved. The study presents the first 6 years of experience with a program that provides free breast and cervical cancer screening to Latina patients, along with education on the importance of regular screening. The program was tested at Georgetown University, Washington. Between September 1998 and August 2004, 928 cancer screening visits were conducted, with 489 women (53%) returning for at least one additional annual screening exam. More than 90% of the women reported that they were more comfortable speaking Spanish when discussing their medical care and scheduling appointments, according to the study.

Most Americans Aware of HPV

About 58% of Americans recently surveyed said they had heard of human papillomavirus or HPV, according to a Wall Street Journal Online/Harris Interactive poll. More women (70%) were familiar with HPV than were men (47%). And parents of a female child under 18 years old were more aware than the general public, with 65% of that group having heard of HPV. Awareness of the newly approved HPV vaccine was lower, with only 48% of all adults surveyed saying that they had heard or seen anything about it. Among those surveyed who had heard of the HPV vaccine, 78% agreed that encouraging young women to get the vaccine is a good way to prevent cervical cancer. The survey was conducted among more than 2,600 adults in July.

WIC Would Add Vegetables, Fruits

More vegetables, fruits, and whole grains would be available to beneficiaries of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) program, under a proposal issued last month by the U.S. Department of Agriculture. Based in large part on the findings of Institute of Medicine report published last year, the proposed rules would promote greater consistency with established dietary guidelines for infants and children under age 2 years, and would better support breast-feeding, according to USDA. Current WIC-covered foods help increase beneficiaries' intake of protein, iron, calcium, vitamin A, and vitamin C—nutrients that were found lacking in the WIC population when the program was started in 1974, USDA said. The department is taking comments until Nov. 6.

Uninsured Figures Climb

The number of people in the United States without health insurance edged higher in 2005, fueled in part by a drop in employer-sponsored health insurance, according to figures released in August from the U.S. Census Bureau. In 2005, 46.6 million people were uninsured, up from 45.3 million the year before. The percentage of people covered by employer-sponsored health insurance dropped from 59.8% to 59.5% between 2004 and 2005, while the percentage covered by government insurance stayed the same, according to the Census figures. The new figures, compiled as part of the Current Population Survey, showed that the number of uninsured children also increased. Between 2004 and 2005, the number of uninsured children rose from 7.9 million to 8.3 million. And children living in poverty were the most likely to be uninsured, with a rate of 19% vs. 11.2% of children overall in 2005. The American Medical Association issued a statement calling for action to address the uninsured problem. “The AMA plan for reducing the number of the uninsured advocates expanded coverage and choice through a system of refundable tax credits based on income, individually selected and owned health insurance, and market reforms that will enhance new, affordable insurance options,” Dr. Ardis Hoven, an AMA board member, said in a statement.

Mammography Capacity Dips

The national capacity to provide mammography services is adequate, despite a 6% drop in the number of mammography facilities from 2001 to 2004, according to a recent report from the Government Accountability Office. In addition to the decrease in the number of facilities, the GAO reported a 4% drop in the number of machines, a 3% drop in the number of radiologic technologists, and a 5% drop in the number of physicians who interpret mammograms. Experts interviewed by the GAO said that the capacity nationwide is likely adequate to meet the current demand for screening and diagnostic mammograms, but cautioned that there could be access problems in the future. The report was requested by Sen. Arlen Specter (R-Pa.) and Sen. Barbara Mikulski (D-Md.).

Cost of Infertility Treatments

The majority of employers who provide insurance coverage for infertility treatment have not experienced a significant increase in their health plan costs, according to the results of a survey commissioned by RESOLVE: The National Infertility Association and supported by Organon USA. More than 90% of employers who cover infertility treatment beyond an evaluation reported no measurable increase in their medical costs as a result of the additional coverage. The survey of 931 employers found that about 39% cover drug therapy for infertility treatment and 22% cover in vitro fertilization. More employers cover evaluation by an infertility specialist, with about 63% providing at least that level of coverage, according to RESOLVE. “This survey clearly debunks the myth that infertility coverage increases medical coverage costs significantly,” RESOLVE President Joseph C. Isaacs said in a statement.

Improving Latina Cancer Screening

The use of a bilingual staff and free screenings may help to improve breast and cervical cancer screening frequency among Latina patients, according to a report published in the August issue of the Journal of Health Care for the Poor and Underserved. The study presents the first 6 years of experience with a program that provides free breast and cervical cancer screening to Latina patients, along with education on the importance of regular screening. The program was tested at Georgetown University, Washington. Between September 1998 and August 2004, 928 cancer screening visits were conducted, with 489 women (53%) returning for at least one additional annual screening exam. More than 90% of the women reported that they were more comfortable speaking Spanish when discussing their medical care and scheduling appointments, according to the study.

Most Americans Aware of HPV

About 58% of Americans recently surveyed said they had heard of human papillomavirus or HPV, according to a Wall Street Journal Online/Harris Interactive poll. More women (70%) were familiar with HPV than were men (47%). And parents of a female child under 18 years old were more aware than the general public, with 65% of that group having heard of HPV. Awareness of the newly approved HPV vaccine was lower, with only 48% of all adults surveyed saying that they had heard or seen anything about it. Among those surveyed who had heard of the HPV vaccine, 78% agreed that encouraging young women to get the vaccine is a good way to prevent cervical cancer. The survey was conducted among more than 2,600 adults in July.

WIC Would Add Vegetables, Fruits

More vegetables, fruits, and whole grains would be available to beneficiaries of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) program, under a proposal issued last month by the U.S. Department of Agriculture. Based in large part on the findings of Institute of Medicine report published last year, the proposed rules would promote greater consistency with established dietary guidelines for infants and children under age 2 years, and would better support breast-feeding, according to USDA. Current WIC-covered foods help increase beneficiaries' intake of protein, iron, calcium, vitamin A, and vitamin C—nutrients that were found lacking in the WIC population when the program was started in 1974, USDA said. The department is taking comments until Nov. 6.

Uninsured Figures Climb

The number of people in the United States without health insurance edged higher in 2005, fueled in part by a drop in employer-sponsored health insurance, according to figures released in August from the U.S. Census Bureau. In 2005, 46.6 million people were uninsured, up from 45.3 million the year before. The percentage of people covered by employer-sponsored health insurance dropped from 59.8% to 59.5% between 2004 and 2005, while the percentage covered by government insurance stayed the same, according to the Census figures. The new figures, compiled as part of the Current Population Survey, showed that the number of uninsured children also increased. Between 2004 and 2005, the number of uninsured children rose from 7.9 million to 8.3 million. And children living in poverty were the most likely to be uninsured, with a rate of 19% vs. 11.2% of children overall in 2005. The American Medical Association issued a statement calling for action to address the uninsured problem. “The AMA plan for reducing the number of the uninsured advocates expanded coverage and choice through a system of refundable tax credits based on income, individually selected and owned health insurance, and market reforms that will enhance new, affordable insurance options,” Dr. Ardis Hoven, an AMA board member, said in a statement.

Mammography Capacity Dips

The national capacity to provide mammography services is adequate, despite a 6% drop in the number of mammography facilities from 2001 to 2004, according to a recent report from the Government Accountability Office. In addition to the decrease in the number of facilities, the GAO reported a 4% drop in the number of machines, a 3% drop in the number of radiologic technologists, and a 5% drop in the number of physicians who interpret mammograms. Experts interviewed by the GAO said that the capacity nationwide is likely adequate to meet the current demand for screening and diagnostic mammograms, but cautioned that there could be access problems in the future. The report was requested by Sen. Arlen Specter (R-Pa.) and Sen. Barbara Mikulski (D-Md.).

Cost of Infertility Treatments

The majority of employers who provide insurance coverage for infertility treatment have not experienced a significant increase in their health plan costs, according to the results of a survey commissioned by RESOLVE: The National Infertility Association and supported by Organon USA. More than 90% of employers who cover infertility treatment beyond an evaluation reported no measurable increase in their medical costs as a result of the additional coverage. The survey of 931 employers found that about 39% cover drug therapy for infertility treatment and 22% cover in vitro fertilization. More employers cover evaluation by an infertility specialist, with about 63% providing at least that level of coverage, according to RESOLVE. “This survey clearly debunks the myth that infertility coverage increases medical coverage costs significantly,” RESOLVE President Joseph C. Isaacs said in a statement.

Improving Latina Cancer Screening

The use of a bilingual staff and free screenings may help to improve breast and cervical cancer screening frequency among Latina patients, according to a report published in the August issue of the Journal of Health Care for the Poor and Underserved. The study presents the first 6 years of experience with a program that provides free breast and cervical cancer screening to Latina patients, along with education on the importance of regular screening. The program was tested at Georgetown University, Washington. Between September 1998 and August 2004, 928 cancer screening visits were conducted, with 489 women (53%) returning for at least one additional annual screening exam. More than 90% of the women reported that they were more comfortable speaking Spanish when discussing their medical care and scheduling appointments, according to the study.

Most Americans Aware of HPV

About 58% of Americans recently surveyed said they had heard of human papillomavirus or HPV, according to a Wall Street Journal Online/Harris Interactive poll. More women (70%) were familiar with HPV than were men (47%). And parents of a female child under 18 years old were more aware than the general public, with 65% of that group having heard of HPV. Awareness of the newly approved HPV vaccine was lower, with only 48% of all adults surveyed saying that they had heard or seen anything about it. Among those surveyed who had heard of the HPV vaccine, 78% agreed that encouraging young women to get the vaccine is a good way to prevent cervical cancer. The survey was conducted among more than 2,600 adults in July.

WIC Would Add Vegetables, Fruits

More vegetables, fruits, and whole grains would be available to beneficiaries of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) program, under a proposal issued last month by the U.S. Department of Agriculture. Based in large part on the findings of Institute of Medicine report published last year, the proposed rules would promote greater consistency with established dietary guidelines for infants and children under age 2 years, and would better support breast-feeding, according to USDA. Current WIC-covered foods help increase beneficiaries' intake of protein, iron, calcium, vitamin A, and vitamin C—nutrients that were found lacking in the WIC population when the program was started in 1974, USDA said. The department is taking comments until Nov. 6.

Earlier this year, officials at Duke University announced plans to phase out the school's family medicine residency program, drawing criticism from many in the academic family medicine community.

The officials announced the plan in May, citing a need to provide “more consistent care by senior clinicians” and to better coordinate “innovative programs” in the community with the on-campus faculty practice.

But Dr. Lloyd Michener, professor and chairman of the department of community and family medicine at Duke, left the door open to revisiting the decision at some point if the Accreditation Council on Graduate Medical Education would give the university more flexibility in how it structured the residency program.

Most of the care being provided by Duke clinicians is outpatient care and chronic disease management, Dr. Michener said, but they found that the residency training requirements had too much of an emphasis on other areas such as inpatient care and obstetrics. “What we were teaching no longer matched what we were practicing.”

Under the phase-out plan, Duke will continue to train current residents, including four new first-year residents who began training in July.

The officials also plan to ramp up training of nonphysician providers such as physician assistants and physical therapists. The idea is not to replace physicians, Dr. Michener stressed, but to train an adequate number of nonphysician providers who would work as part of a physician-led team approach to care.

In addition, they also plan to expand their community and family medicine fellowship program. Fellowship training may be a better environment than residency in which to teach physicians about community health.

Although the move was right for Duke, Dr. Michener said, officials at the institution wouldn't want to see other academic medical centers following their lead. Instead, they hope that their action will encourage officials at the Accreditation Council for Graduate Medical Education's Residency Review Committee to allow for greater flexibility in structuring residency programs to meet the individual needs of the community, he said.

If and when that greater amount of flexibility becomes available, Dr. Michener said, Duke officials would gladly revisit their decision to scrap their program.

“When they're ready, we're ready,” he commented.

The Duke move was greeted with disappointment by much of the academic community in family medicine. The American Academy of Family Physicians, the Association of Departments of Family Medicine, the Association of Family Medicine Residency Directors, and the Society of Teachers of Family Medicine issued a joint statement this summer that took issue with Duke's argument for closing the program.

“Most respected family medicine departments across the nation, including those at other top-tier private universities, have been able to balance the priorities of patient care, research, and training while maintaining the integrity of their residency training programs,” the groups said in a statement.

Each year, a few family medicine residency programs close for a variety of reasons, some of which are financial, said AAFP President Larry Fields. But the move by Duke is not a signal of any type of larger trend among residency programs, he said.

But although other programs have not followed suit, there is concern that other institutions will begin to question their residency programs, said Roger Sherwood, executive director of the Society of Teachers of Family Medicine. The announcement has already caused some ripples from outside family medicine, with some institutions taking a second look at their residency programs. “This shouldn't be happening,” he said.

But being able to create innovative residency programs within the requirements mandated by the Residency Review Committee is not a concern unique to the Duke program, said Dr. Warren Newton, president of the Association of Departments of Family Medicine and chair of the department of family medicine at the University of North Carolina, Chapel Hill.

Many residency directors feel that the Residency Review Committee has been too conservative, he said, but many programs have been successful in making changes even in that environment.

Earlier this year, officials at Duke University announced plans to phase out the school's family medicine residency program, drawing criticism from many in the academic family medicine community.

The officials announced the plan in May, citing a need to provide “more consistent care by senior clinicians” and to better coordinate “innovative programs” in the community with the on-campus faculty practice.

But Dr. Lloyd Michener, professor and chairman of the department of community and family medicine at Duke, left the door open to revisiting the decision at some point if the Accreditation Council on Graduate Medical Education would give the university more flexibility in how it structured the residency program.

Most of the care being provided by Duke clinicians is outpatient care and chronic disease management, Dr. Michener said, but they found that the residency training requirements had too much of an emphasis on other areas such as inpatient care and obstetrics. “What we were teaching no longer matched what we were practicing.”

Under the phase-out plan, Duke will continue to train current residents, including four new first-year residents who began training in July.

The officials also plan to ramp up training of nonphysician providers such as physician assistants and physical therapists. The idea is not to replace physicians, Dr. Michener stressed, but to train an adequate number of nonphysician providers who would work as part of a physician-led team approach to care.

In addition, they also plan to expand their community and family medicine fellowship program. Fellowship training may be a better environment than residency in which to teach physicians about community health.

Although the move was right for Duke, Dr. Michener said, officials at the institution wouldn't want to see other academic medical centers following their lead. Instead, they hope that their action will encourage officials at the Accreditation Council for Graduate Medical Education's Residency Review Committee to allow for greater flexibility in structuring residency programs to meet the individual needs of the community, he said.

If and when that greater amount of flexibility becomes available, Dr. Michener said, Duke officials would gladly revisit their decision to scrap their program.

“When they're ready, we're ready,” he commented.

The Duke move was greeted with disappointment by much of the academic community in family medicine. The American Academy of Family Physicians, the Association of Departments of Family Medicine, the Association of Family Medicine Residency Directors, and the Society of Teachers of Family Medicine issued a joint statement this summer that took issue with Duke's argument for closing the program.

“Most respected family medicine departments across the nation, including those at other top-tier private universities, have been able to balance the priorities of patient care, research, and training while maintaining the integrity of their residency training programs,” the groups said in a statement.

Each year, a few family medicine residency programs close for a variety of reasons, some of which are financial, said AAFP President Larry Fields. But the move by Duke is not a signal of any type of larger trend among residency programs, he said.

But although other programs have not followed suit, there is concern that other institutions will begin to question their residency programs, said Roger Sherwood, executive director of the Society of Teachers of Family Medicine. The announcement has already caused some ripples from outside family medicine, with some institutions taking a second look at their residency programs. “This shouldn't be happening,” he said.

But being able to create innovative residency programs within the requirements mandated by the Residency Review Committee is not a concern unique to the Duke program, said Dr. Warren Newton, president of the Association of Departments of Family Medicine and chair of the department of family medicine at the University of North Carolina, Chapel Hill.

Many residency directors feel that the Residency Review Committee has been too conservative, he said, but many programs have been successful in making changes even in that environment.

Earlier this year, officials at Duke University announced plans to phase out the school's family medicine residency program, drawing criticism from many in the academic family medicine community.

The officials announced the plan in May, citing a need to provide “more consistent care by senior clinicians” and to better coordinate “innovative programs” in the community with the on-campus faculty practice.

But Dr. Lloyd Michener, professor and chairman of the department of community and family medicine at Duke, left the door open to revisiting the decision at some point if the Accreditation Council on Graduate Medical Education would give the university more flexibility in how it structured the residency program.

Most of the care being provided by Duke clinicians is outpatient care and chronic disease management, Dr. Michener said, but they found that the residency training requirements had too much of an emphasis on other areas such as inpatient care and obstetrics. “What we were teaching no longer matched what we were practicing.”

Under the phase-out plan, Duke will continue to train current residents, including four new first-year residents who began training in July.

The officials also plan to ramp up training of nonphysician providers such as physician assistants and physical therapists. The idea is not to replace physicians, Dr. Michener stressed, but to train an adequate number of nonphysician providers who would work as part of a physician-led team approach to care.

In addition, they also plan to expand their community and family medicine fellowship program. Fellowship training may be a better environment than residency in which to teach physicians about community health.

Although the move was right for Duke, Dr. Michener said, officials at the institution wouldn't want to see other academic medical centers following their lead. Instead, they hope that their action will encourage officials at the Accreditation Council for Graduate Medical Education's Residency Review Committee to allow for greater flexibility in structuring residency programs to meet the individual needs of the community, he said.

If and when that greater amount of flexibility becomes available, Dr. Michener said, Duke officials would gladly revisit their decision to scrap their program.

“When they're ready, we're ready,” he commented.

The Duke move was greeted with disappointment by much of the academic community in family medicine. The American Academy of Family Physicians, the Association of Departments of Family Medicine, the Association of Family Medicine Residency Directors, and the Society of Teachers of Family Medicine issued a joint statement this summer that took issue with Duke's argument for closing the program.

“Most respected family medicine departments across the nation, including those at other top-tier private universities, have been able to balance the priorities of patient care, research, and training while maintaining the integrity of their residency training programs,” the groups said in a statement.

Each year, a few family medicine residency programs close for a variety of reasons, some of which are financial, said AAFP President Larry Fields. But the move by Duke is not a signal of any type of larger trend among residency programs, he said.

But although other programs have not followed suit, there is concern that other institutions will begin to question their residency programs, said Roger Sherwood, executive director of the Society of Teachers of Family Medicine. The announcement has already caused some ripples from outside family medicine, with some institutions taking a second look at their residency programs. “This shouldn't be happening,” he said.

But being able to create innovative residency programs within the requirements mandated by the Residency Review Committee is not a concern unique to the Duke program, said Dr. Warren Newton, president of the Association of Departments of Family Medicine and chair of the department of family medicine at the University of North Carolina, Chapel Hill.

Many residency directors feel that the Residency Review Committee has been too conservative, he said, but many programs have been successful in making changes even in that environment.

WASHINGTON — A 0.45-mg daily dose of synthetic conjugated estrogens, A improves moderate to severe menopausal vasomotor symptoms, compared with placebo, according to data presented at the annual meeting of the American College of Obstetricians and Gynecologists.

The results indicate that postmenopausal women who start estrogen therapy at a low dose may be able to gain the efficacy of higher-dose treatments with minimal side effects, Dr. James A. Simon of George Washington University in Washington and Dr. Sam S. Miller of the SAM Clinical Research Center in San Antonio wrote in a poster presented at the meeting.

At week 12 of therapy, nearly 38% of patients taking synthetic conjugated estrogens, A (SCE-A) reported no moderate to severe vasomotor symptoms, compared with 8% of patients taking placebo, according to the researchers. In addition, the 0.45-mg daily dose of SCE-A reduced the mean weekly frequency of moderate to severe vasomotor symptoms by 68 from a baseline of 96 at 12 weeks, compared with a 43 mean drop among placebo patients from the same baseline score.

The multicenter, double-blind trial included postmenopausal women, with or without a uterus, who had experienced at least 60 moderate to severe vasomotor symptoms per week. A total of 104 patients were randomized to receive either the 0.45-mg dose of SCE-A or placebo daily for 12 weeks. About 91% of patients taking SCE-A and 67% of patients taking placebo completed the full 12 weeks of the study.

The research was supported by Duramed Research Inc. of Bala Cynwyd, Pa., which markets SCE-A under the trade name Cenestin.

The patients recruited for the study were healthy women aged 30–80 years who had experienced spontaneous amenorrhea for 12 months before screening or had a bilateral oophorectomy, with or without hysterectomy, at least 6 weeks before screening. Patients taking SCE-A had a greater reduction in frequency of symptoms starting at week 2 and reaching statistical significance from week 3 on. The drug also resulted in greater reduction in severity of symptoms at week 2, reaching statistical significance from week 5 on.

WASHINGTON — A 0.45-mg daily dose of synthetic conjugated estrogens, A improves moderate to severe menopausal vasomotor symptoms, compared with placebo, according to data presented at the annual meeting of the American College of Obstetricians and Gynecologists.

The results indicate that postmenopausal women who start estrogen therapy at a low dose may be able to gain the efficacy of higher-dose treatments with minimal side effects, Dr. James A. Simon of George Washington University in Washington and Dr. Sam S. Miller of the SAM Clinical Research Center in San Antonio wrote in a poster presented at the meeting.

At week 12 of therapy, nearly 38% of patients taking synthetic conjugated estrogens, A (SCE-A) reported no moderate to severe vasomotor symptoms, compared with 8% of patients taking placebo, according to the researchers. In addition, the 0.45-mg daily dose of SCE-A reduced the mean weekly frequency of moderate to severe vasomotor symptoms by 68 from a baseline of 96 at 12 weeks, compared with a 43 mean drop among placebo patients from the same baseline score.

The multicenter, double-blind trial included postmenopausal women, with or without a uterus, who had experienced at least 60 moderate to severe vasomotor symptoms per week. A total of 104 patients were randomized to receive either the 0.45-mg dose of SCE-A or placebo daily for 12 weeks. About 91% of patients taking SCE-A and 67% of patients taking placebo completed the full 12 weeks of the study.

The research was supported by Duramed Research Inc. of Bala Cynwyd, Pa., which markets SCE-A under the trade name Cenestin.

The patients recruited for the study were healthy women aged 30–80 years who had experienced spontaneous amenorrhea for 12 months before screening or had a bilateral oophorectomy, with or without hysterectomy, at least 6 weeks before screening. Patients taking SCE-A had a greater reduction in frequency of symptoms starting at week 2 and reaching statistical significance from week 3 on. The drug also resulted in greater reduction in severity of symptoms at week 2, reaching statistical significance from week 5 on.

WASHINGTON — A 0.45-mg daily dose of synthetic conjugated estrogens, A improves moderate to severe menopausal vasomotor symptoms, compared with placebo, according to data presented at the annual meeting of the American College of Obstetricians and Gynecologists.

The results indicate that postmenopausal women who start estrogen therapy at a low dose may be able to gain the efficacy of higher-dose treatments with minimal side effects, Dr. James A. Simon of George Washington University in Washington and Dr. Sam S. Miller of the SAM Clinical Research Center in San Antonio wrote in a poster presented at the meeting.

At week 12 of therapy, nearly 38% of patients taking synthetic conjugated estrogens, A (SCE-A) reported no moderate to severe vasomotor symptoms, compared with 8% of patients taking placebo, according to the researchers. In addition, the 0.45-mg daily dose of SCE-A reduced the mean weekly frequency of moderate to severe vasomotor symptoms by 68 from a baseline of 96 at 12 weeks, compared with a 43 mean drop among placebo patients from the same baseline score.

The multicenter, double-blind trial included postmenopausal women, with or without a uterus, who had experienced at least 60 moderate to severe vasomotor symptoms per week. A total of 104 patients were randomized to receive either the 0.45-mg dose of SCE-A or placebo daily for 12 weeks. About 91% of patients taking SCE-A and 67% of patients taking placebo completed the full 12 weeks of the study.

The research was supported by Duramed Research Inc. of Bala Cynwyd, Pa., which markets SCE-A under the trade name Cenestin.

The patients recruited for the study were healthy women aged 30–80 years who had experienced spontaneous amenorrhea for 12 months before screening or had a bilateral oophorectomy, with or without hysterectomy, at least 6 weeks before screening. Patients taking SCE-A had a greater reduction in frequency of symptoms starting at week 2 and reaching statistical significance from week 3 on. The drug also resulted in greater reduction in severity of symptoms at week 2, reaching statistical significance from week 5 on.

BOSTON — Women with polycystic ovarian morphology and normal menstrual cycles do not appear to be at significant risk for polycystic ovary syndrome, according to a study presented at the annual meeting of the Endocrine Society.

Researchers at Harvard University and Massachusetts General Hospital in Boston followed 40 women with regular menstrual cycles and either normal or polycystic ovarian morphology to see which women would develop polycystic ovary syndrome (PCOS). The women were followed for 1.7–17.5 years after the initial ultrasound and given a follow-up ultrasound.

The researchers defined polycystic ovarian morphology (PCOM) as an ovary with 12 or more follicles of 2 to 10 mm in a single plane or an ovarian volume of more than 10 mL without a dominant follicle.

At baseline, 17 women had normal morphology and 23 were diagnosed with PCOM. The average age at baseline was 30, and the average age at follow-up was 38, according to Meagan K. Murphy, a medical student at Harvard University.

At follow-up, 1 of the 17 women with normal ovarian morphology at the beginning of the study had developed PCOM. Of the 23 women who had PCOM at baseline, about half had PCOM at follow-up and the rest had converted to normal ovarian morphology; their follicle and ovarian volume decreased significantly, she said.

One woman who was classified as having PCOM at baseline was diagnosed with PCOS. But her menses became regular with weight loss and the previous PCOS diagnosis was not confirmed in the study.

Development of PCOS is uncommon in women with PCOM and regular cycles, the researchers concluded. And a normal drop in follicle number with aging may result in women with PCOM developing normal cycles over time, Ms. Murphy said.

BOSTON — Women with polycystic ovarian morphology and normal menstrual cycles do not appear to be at significant risk for polycystic ovary syndrome, according to a study presented at the annual meeting of the Endocrine Society.

Researchers at Harvard University and Massachusetts General Hospital in Boston followed 40 women with regular menstrual cycles and either normal or polycystic ovarian morphology to see which women would develop polycystic ovary syndrome (PCOS). The women were followed for 1.7–17.5 years after the initial ultrasound and given a follow-up ultrasound.

The researchers defined polycystic ovarian morphology (PCOM) as an ovary with 12 or more follicles of 2 to 10 mm in a single plane or an ovarian volume of more than 10 mL without a dominant follicle.

At baseline, 17 women had normal morphology and 23 were diagnosed with PCOM. The average age at baseline was 30, and the average age at follow-up was 38, according to Meagan K. Murphy, a medical student at Harvard University.

At follow-up, 1 of the 17 women with normal ovarian morphology at the beginning of the study had developed PCOM. Of the 23 women who had PCOM at baseline, about half had PCOM at follow-up and the rest had converted to normal ovarian morphology; their follicle and ovarian volume decreased significantly, she said.

One woman who was classified as having PCOM at baseline was diagnosed with PCOS. But her menses became regular with weight loss and the previous PCOS diagnosis was not confirmed in the study.

Development of PCOS is uncommon in women with PCOM and regular cycles, the researchers concluded. And a normal drop in follicle number with aging may result in women with PCOM developing normal cycles over time, Ms. Murphy said.

BOSTON — Women with polycystic ovarian morphology and normal menstrual cycles do not appear to be at significant risk for polycystic ovary syndrome, according to a study presented at the annual meeting of the Endocrine Society.

Researchers at Harvard University and Massachusetts General Hospital in Boston followed 40 women with regular menstrual cycles and either normal or polycystic ovarian morphology to see which women would develop polycystic ovary syndrome (PCOS). The women were followed for 1.7–17.5 years after the initial ultrasound and given a follow-up ultrasound.

The researchers defined polycystic ovarian morphology (PCOM) as an ovary with 12 or more follicles of 2 to 10 mm in a single plane or an ovarian volume of more than 10 mL without a dominant follicle.

At baseline, 17 women had normal morphology and 23 were diagnosed with PCOM. The average age at baseline was 30, and the average age at follow-up was 38, according to Meagan K. Murphy, a medical student at Harvard University.

At follow-up, 1 of the 17 women with normal ovarian morphology at the beginning of the study had developed PCOM. Of the 23 women who had PCOM at baseline, about half had PCOM at follow-up and the rest had converted to normal ovarian morphology; their follicle and ovarian volume decreased significantly, she said.

One woman who was classified as having PCOM at baseline was diagnosed with PCOS. But her menses became regular with weight loss and the previous PCOS diagnosis was not confirmed in the study.

Development of PCOS is uncommon in women with PCOM and regular cycles, the researchers concluded. And a normal drop in follicle number with aging may result in women with PCOM developing normal cycles over time, Ms. Murphy said.

Hospitals, health plans, and other health care organizations will soon be able to assist physicians in obtaining health information technology without running afoul of federal fraud laws under regulations issued last month by the Department of Health and Human Services.

In two final regulations published in the Federal Register on August 8, the Centers for Medicare and Medicaid Services and the HHS Office of Inspector General carved out new exceptions to the Stark physician self-referral law and the federal antikickback statute. Under these new exceptions, certain health care entities will be able to donate interoperable electronic health record (EHR) software and training. And hospitals and other health care organizations will also be able to provide hardware, software, and training services that are “necessary and used solely” for electronic prescribing.

The regulations did not cap the donations to physicians for electronic prescribing technology, but the government is requiring physicians to share some of the costs of donated electronic health record technology. Under the rules, physicians will be required to pay 15% of the donor's cost of the EHR technology and services.

The regulations go into effect in early October (60 days after publication in the Federal Register). The provisions related to EHR arrangements are slated to sunset on Dec. 31, 2013.

The regulations were widely praised by physician organizations and health IT industry groups for breaking down barriers to physician adoption. But Patrick Hope, legislative counsel for the American College of Physicians, said the changes aren't likely to do a whole lot to speed physician adoption of the technologies since few hospitals will be able to afford to donate the expensive technology to physicians.

“They are operating at the margins just as physician offices are,” Mr. Hope said.

ACP officials are urging members of Congress to establish an add-on payment to the Medicare reimbursement for an office visit to help offset the ongoing costs of an electronic health record system, Mr. Hope said. While the regulations are helpful in removing some barriers, he said, an add-on payment would create a better business case for physician adoption of health IT.

The jury is still out as to what impact these regulations will have on physician adoption, said Chantal Worzala, senior associate director for policy at the American Hospital Association. Not all hospitals will have the financial resources to donate health IT services, she said, since only about a third of U.S. hospitals are profitable.

But the regulations will give hospital administrators more options. “Hospitals really should have flexibility in working with community physicians,” she said.

While some health plans may be interested in offering electronic prescribing products, Ms. Worzala said, hospitals are likely to want to help physicians acquire more comprehensive EHR systems.

The relaxation of the Stark physician self-referral law and the antikickback statute is a good thing, said Dr. Steven E. Waldren, assistant director of the American Academy of Family Physicians' Center for Health Information Technology, since the changes will allow more health IT resources to flow to physicians. However, he cautioned physicians not to count on getting this support.

This type of support won't be available to all physicians and in some cases may not be appropriate, he said. For example, Dr. Waldren said that some hospital electronic health record systems are not designed for the ambulatory environment and may end up costing physicians more money in the long run. The bottom line is that physicians need to continue to do their “due diligence” in researching systems, he said.

The Medicare Modernization Act of 2003 mandated that the HHS Secretary create exemptions to allow for certain health care organizations to help furnish physician practices with electronic prescribing technology. The changes were outlined in a proposed rule issued last October.

Under the provisions related to electronic prescribing technology, hospitals can donate hardware, software, and services to members of their medical staffs; group practices can donate to physician members; and Medicare prescription drug plan sponsors and Medicare Advantage plans can donate to pharmacies and prescribing physicians. The Stark law exemption and antikickback safe harbors have slightly different definitions of who can donate the comprehensive electronic health record system software and training.

The electronic prescribing safe harbors and exemptions allow organizations to donate hardware, software, Internet connectivity, and training and support services. The provisions for electronic health records are slightly different and do not include hardware. For EHRs, organizations can donate software, which must include an electronic prescribing component. Also, organizations can donate information technology and training services, which can include Internet connectivity.

Hospitals, health plans, and other health care organizations will soon be able to assist physicians in obtaining health information technology without running afoul of federal fraud laws under regulations issued last month by the Department of Health and Human Services.

In two final regulations published in the Federal Register on August 8, the Centers for Medicare and Medicaid Services and the HHS Office of Inspector General carved out new exceptions to the Stark physician self-referral law and the federal antikickback statute. Under these new exceptions, certain health care entities will be able to donate interoperable electronic health record (EHR) software and training. And hospitals and other health care organizations will also be able to provide hardware, software, and training services that are “necessary and used solely” for electronic prescribing.

The regulations did not cap the donations to physicians for electronic prescribing technology, but the government is requiring physicians to share some of the costs of donated electronic health record technology. Under the rules, physicians will be required to pay 15% of the donor's cost of the EHR technology and services.

The regulations go into effect in early October (60 days after publication in the Federal Register). The provisions related to EHR arrangements are slated to sunset on Dec. 31, 2013.

The regulations were widely praised by physician organizations and health IT industry groups for breaking down barriers to physician adoption. But Patrick Hope, legislative counsel for the American College of Physicians, said the changes aren't likely to do a whole lot to speed physician adoption of the technologies since few hospitals will be able to afford to donate the expensive technology to physicians.

“They are operating at the margins just as physician offices are,” Mr. Hope said.

ACP officials are urging members of Congress to establish an add-on payment to the Medicare reimbursement for an office visit to help offset the ongoing costs of an electronic health record system, Mr. Hope said. While the regulations are helpful in removing some barriers, he said, an add-on payment would create a better business case for physician adoption of health IT.

The jury is still out as to what impact these regulations will have on physician adoption, said Chantal Worzala, senior associate director for policy at the American Hospital Association. Not all hospitals will have the financial resources to donate health IT services, she said, since only about a third of U.S. hospitals are profitable.

But the regulations will give hospital administrators more options. “Hospitals really should have flexibility in working with community physicians,” she said.

While some health plans may be interested in offering electronic prescribing products, Ms. Worzala said, hospitals are likely to want to help physicians acquire more comprehensive EHR systems.

The relaxation of the Stark physician self-referral law and the antikickback statute is a good thing, said Dr. Steven E. Waldren, assistant director of the American Academy of Family Physicians' Center for Health Information Technology, since the changes will allow more health IT resources to flow to physicians. However, he cautioned physicians not to count on getting this support.

This type of support won't be available to all physicians and in some cases may not be appropriate, he said. For example, Dr. Waldren said that some hospital electronic health record systems are not designed for the ambulatory environment and may end up costing physicians more money in the long run. The bottom line is that physicians need to continue to do their “due diligence” in researching systems, he said.

The Medicare Modernization Act of 2003 mandated that the HHS Secretary create exemptions to allow for certain health care organizations to help furnish physician practices with electronic prescribing technology. The changes were outlined in a proposed rule issued last October.

Under the provisions related to electronic prescribing technology, hospitals can donate hardware, software, and services to members of their medical staffs; group practices can donate to physician members; and Medicare prescription drug plan sponsors and Medicare Advantage plans can donate to pharmacies and prescribing physicians. The Stark law exemption and antikickback safe harbors have slightly different definitions of who can donate the comprehensive electronic health record system software and training.

The electronic prescribing safe harbors and exemptions allow organizations to donate hardware, software, Internet connectivity, and training and support services. The provisions for electronic health records are slightly different and do not include hardware. For EHRs, organizations can donate software, which must include an electronic prescribing component. Also, organizations can donate information technology and training services, which can include Internet connectivity.

Hospitals, health plans, and other health care organizations will soon be able to assist physicians in obtaining health information technology without running afoul of federal fraud laws under regulations issued last month by the Department of Health and Human Services.

In two final regulations published in the Federal Register on August 8, the Centers for Medicare and Medicaid Services and the HHS Office of Inspector General carved out new exceptions to the Stark physician self-referral law and the federal antikickback statute. Under these new exceptions, certain health care entities will be able to donate interoperable electronic health record (EHR) software and training. And hospitals and other health care organizations will also be able to provide hardware, software, and training services that are “necessary and used solely” for electronic prescribing.

The regulations did not cap the donations to physicians for electronic prescribing technology, but the government is requiring physicians to share some of the costs of donated electronic health record technology. Under the rules, physicians will be required to pay 15% of the donor's cost of the EHR technology and services.

The regulations go into effect in early October (60 days after publication in the Federal Register). The provisions related to EHR arrangements are slated to sunset on Dec. 31, 2013.

The regulations were widely praised by physician organizations and health IT industry groups for breaking down barriers to physician adoption. But Patrick Hope, legislative counsel for the American College of Physicians, said the changes aren't likely to do a whole lot to speed physician adoption of the technologies since few hospitals will be able to afford to donate the expensive technology to physicians.

“They are operating at the margins just as physician offices are,” Mr. Hope said.

ACP officials are urging members of Congress to establish an add-on payment to the Medicare reimbursement for an office visit to help offset the ongoing costs of an electronic health record system, Mr. Hope said. While the regulations are helpful in removing some barriers, he said, an add-on payment would create a better business case for physician adoption of health IT.

The jury is still out as to what impact these regulations will have on physician adoption, said Chantal Worzala, senior associate director for policy at the American Hospital Association. Not all hospitals will have the financial resources to donate health IT services, she said, since only about a third of U.S. hospitals are profitable.

But the regulations will give hospital administrators more options. “Hospitals really should have flexibility in working with community physicians,” she said.

While some health plans may be interested in offering electronic prescribing products, Ms. Worzala said, hospitals are likely to want to help physicians acquire more comprehensive EHR systems.

The relaxation of the Stark physician self-referral law and the antikickback statute is a good thing, said Dr. Steven E. Waldren, assistant director of the American Academy of Family Physicians' Center for Health Information Technology, since the changes will allow more health IT resources to flow to physicians. However, he cautioned physicians not to count on getting this support.

This type of support won't be available to all physicians and in some cases may not be appropriate, he said. For example, Dr. Waldren said that some hospital electronic health record systems are not designed for the ambulatory environment and may end up costing physicians more money in the long run. The bottom line is that physicians need to continue to do their “due diligence” in researching systems, he said.

The Medicare Modernization Act of 2003 mandated that the HHS Secretary create exemptions to allow for certain health care organizations to help furnish physician practices with electronic prescribing technology. The changes were outlined in a proposed rule issued last October.

Under the provisions related to electronic prescribing technology, hospitals can donate hardware, software, and services to members of their medical staffs; group practices can donate to physician members; and Medicare prescription drug plan sponsors and Medicare Advantage plans can donate to pharmacies and prescribing physicians. The Stark law exemption and antikickback safe harbors have slightly different definitions of who can donate the comprehensive electronic health record system software and training.

The electronic prescribing safe harbors and exemptions allow organizations to donate hardware, software, Internet connectivity, and training and support services. The provisions for electronic health records are slightly different and do not include hardware. For EHRs, organizations can donate software, which must include an electronic prescribing component. Also, organizations can donate information technology and training services, which can include Internet connectivity.

BOSTON — Testosterone therapy should not be offered to all older men with low testosterone levels, according to experts commissioned by the Endocrine Society to examine the treatment of androgen deficiency in adult men.

Guidelines issued by the task force members advise that physicians instead offer testosterone therapy on an individual basis to older men with consistently low testosterone levels on more than one occasion and clinically significant symptoms of androgen deficiency. The guidelines were published in June (J. Clin. Endocrinol. Metab. 2006;91:1995–2010).

But task force members disagreed about the serum testosterone threshold that should trigger therapy in older men with symptoms of androgen deficiency, Dr. Shalender Bhasin, chair of the task force, said at the annual meeting of the Endocrine Society. Some would initiate treatment in symptomatic older men with testosterone levels less than 300 ng/dL; others favored a threshold of 200 ng/dL and said the severity of symptoms should guide treatment.

The Endocrine Society decided to address the treatment of androgen deficiency because it's an area with rapid advances in basic science and product development. In addition, testosterone prescriptions are up; but at the same time, there is considerable misinformation and controversy surrounding the use of testosterone therapy, said Dr. Bhasin, chief of endocrinology at Boston University.

“We tried to do the right thing,” he said. “We anguished a great deal because of the realization that … we know so little.”

The new guidelines are based on systematic reviews of available evidence and discussions among the task force members. The guidelines outline recommendations for diagnosis, screening, treatment, and monitoring for testosterone therapy in adult men with androgen deficiency syndromes.

Diagnosis

The members of the task force opposed screening for androgen deficiency in the general population because of a lack of consensus on the case definition and a lack of data on the public health impact of androgen deficiency.

The experts recommended making the diagnosis of androgen deficiency only in individuals with consistent symptoms and signs of low serum testosterone levels. A diagnosis should not be made during an acute or subacute illness, Dr. Bhasin said.

The diagnosis can be challenging because the signs and symptoms of androgen deficiency are nonspecific and appropriate threshold testosterone levels are unknown and may depend on age, Dr. Bhasin said. Further, testosterone measures may vary because of circadian rhythms as well as accuracy problems with commercial assays, he said.

The task force advised using a reliable assay to measure the morning total testosterone level to establish the diagnosis and confirming it either by repeating the measurement of morning total testosterone or by measuring the free or bioavailable testosterone level.

Treatment

Testosterone therapy is appropriate in symptomatic men who have classic androgen deficiency syndromes and low testosterone levels, according to the guidelines. The therapy should be used to induce and maintain secondary sex characteristics. It can also be used to improve sexual function, sense of well-being, muscle mass, strength, and bone mineral density.

Testosterone therapy is not appropriate in patients who have metastatic prostate cancer, breast cancer, or a palpable prostate nodule or induration. Patients with a prostate-specific antigen (PSA) greater than 3 ng/mL without further urologic evaluation are not candidates for testosterone therapy. Other contraindications noted in the guidelines include erythrocytosis, hyperviscosity, untreated obstructive sleep apnea, severe benign prostatic hyperplasia symptoms, or uncontrolled severe heart failure.

Because of a lack of randomized controlled trial data, the task force did not make a recommendation on treating men with prostate cancer who have been disease free for 2 years or more.

For HIV-infected men who have low testosterone levels and weight loss, the task force members suggested short-term testosterone therapy as an adjunctive approach to promote weight maintenance and improvements in lean body mass and muscle strength.

Monitoring

The task force recommended a standardized monitoring plan with evaluation and measures of testosterone levels at 3 months after initiating treatment and annual assessments.

Hematocrit should be measured at baseline, 3 months, and annually, the task force recommended. If hematocrit exceeds 54%, therapy should be stopped until hematocrit decreases to a safe level. Therapy can be restarted at a lower dose, but evaluations for hypoxia and sleep apnea should be conducted.

The task force recommended urologic consultation if there is a verified serum or plasma PSA concentration of more than 4.0 ng/mL or an increase in serum or PSA concentration of more than 1.4 ng/mL in any 12-month period.

BOSTON — Testosterone therapy should not be offered to all older men with low testosterone levels, according to experts commissioned by the Endocrine Society to examine the treatment of androgen deficiency in adult men.

Guidelines issued by the task force members advise that physicians instead offer testosterone therapy on an individual basis to older men with consistently low testosterone levels on more than one occasion and clinically significant symptoms of androgen deficiency. The guidelines were published in June (J. Clin. Endocrinol. Metab. 2006;91:1995–2010).

But task force members disagreed about the serum testosterone threshold that should trigger therapy in older men with symptoms of androgen deficiency, Dr. Shalender Bhasin, chair of the task force, said at the annual meeting of the Endocrine Society. Some would initiate treatment in symptomatic older men with testosterone levels less than 300 ng/dL; others favored a threshold of 200 ng/dL and said the severity of symptoms should guide treatment.

The Endocrine Society decided to address the treatment of androgen deficiency because it's an area with rapid advances in basic science and product development. In addition, testosterone prescriptions are up; but at the same time, there is considerable misinformation and controversy surrounding the use of testosterone therapy, said Dr. Bhasin, chief of endocrinology at Boston University.

“We tried to do the right thing,” he said. “We anguished a great deal because of the realization that … we know so little.”

The new guidelines are based on systematic reviews of available evidence and discussions among the task force members. The guidelines outline recommendations for diagnosis, screening, treatment, and monitoring for testosterone therapy in adult men with androgen deficiency syndromes.

Diagnosis

The members of the task force opposed screening for androgen deficiency in the general population because of a lack of consensus on the case definition and a lack of data on the public health impact of androgen deficiency.

The experts recommended making the diagnosis of androgen deficiency only in individuals with consistent symptoms and signs of low serum testosterone levels. A diagnosis should not be made during an acute or subacute illness, Dr. Bhasin said.

The diagnosis can be challenging because the signs and symptoms of androgen deficiency are nonspecific and appropriate threshold testosterone levels are unknown and may depend on age, Dr. Bhasin said. Further, testosterone measures may vary because of circadian rhythms as well as accuracy problems with commercial assays, he said.

The task force advised using a reliable assay to measure the morning total testosterone level to establish the diagnosis and confirming it either by repeating the measurement of morning total testosterone or by measuring the free or bioavailable testosterone level.

Treatment

Testosterone therapy is appropriate in symptomatic men who have classic androgen deficiency syndromes and low testosterone levels, according to the guidelines. The therapy should be used to induce and maintain secondary sex characteristics. It can also be used to improve sexual function, sense of well-being, muscle mass, strength, and bone mineral density.

Testosterone therapy is not appropriate in patients who have metastatic prostate cancer, breast cancer, or a palpable prostate nodule or induration. Patients with a prostate-specific antigen (PSA) greater than 3 ng/mL without further urologic evaluation are not candidates for testosterone therapy. Other contraindications noted in the guidelines include erythrocytosis, hyperviscosity, untreated obstructive sleep apnea, severe benign prostatic hyperplasia symptoms, or uncontrolled severe heart failure.

Because of a lack of randomized controlled trial data, the task force did not make a recommendation on treating men with prostate cancer who have been disease free for 2 years or more.

For HIV-infected men who have low testosterone levels and weight loss, the task force members suggested short-term testosterone therapy as an adjunctive approach to promote weight maintenance and improvements in lean body mass and muscle strength.

Monitoring

The task force recommended a standardized monitoring plan with evaluation and measures of testosterone levels at 3 months after initiating treatment and annual assessments.

Hematocrit should be measured at baseline, 3 months, and annually, the task force recommended. If hematocrit exceeds 54%, therapy should be stopped until hematocrit decreases to a safe level. Therapy can be restarted at a lower dose, but evaluations for hypoxia and sleep apnea should be conducted.

The task force recommended urologic consultation if there is a verified serum or plasma PSA concentration of more than 4.0 ng/mL or an increase in serum or PSA concentration of more than 1.4 ng/mL in any 12-month period.

BOSTON — Testosterone therapy should not be offered to all older men with low testosterone levels, according to experts commissioned by the Endocrine Society to examine the treatment of androgen deficiency in adult men.

Guidelines issued by the task force members advise that physicians instead offer testosterone therapy on an individual basis to older men with consistently low testosterone levels on more than one occasion and clinically significant symptoms of androgen deficiency. The guidelines were published in June (J. Clin. Endocrinol. Metab. 2006;91:1995–2010).

But task force members disagreed about the serum testosterone threshold that should trigger therapy in older men with symptoms of androgen deficiency, Dr. Shalender Bhasin, chair of the task force, said at the annual meeting of the Endocrine Society. Some would initiate treatment in symptomatic older men with testosterone levels less than 300 ng/dL; others favored a threshold of 200 ng/dL and said the severity of symptoms should guide treatment.

The Endocrine Society decided to address the treatment of androgen deficiency because it's an area with rapid advances in basic science and product development. In addition, testosterone prescriptions are up; but at the same time, there is considerable misinformation and controversy surrounding the use of testosterone therapy, said Dr. Bhasin, chief of endocrinology at Boston University.

“We tried to do the right thing,” he said. “We anguished a great deal because of the realization that … we know so little.”

The new guidelines are based on systematic reviews of available evidence and discussions among the task force members. The guidelines outline recommendations for diagnosis, screening, treatment, and monitoring for testosterone therapy in adult men with androgen deficiency syndromes.

Diagnosis

The members of the task force opposed screening for androgen deficiency in the general population because of a lack of consensus on the case definition and a lack of data on the public health impact of androgen deficiency.

The experts recommended making the diagnosis of androgen deficiency only in individuals with consistent symptoms and signs of low serum testosterone levels. A diagnosis should not be made during an acute or subacute illness, Dr. Bhasin said.

The diagnosis can be challenging because the signs and symptoms of androgen deficiency are nonspecific and appropriate threshold testosterone levels are unknown and may depend on age, Dr. Bhasin said. Further, testosterone measures may vary because of circadian rhythms as well as accuracy problems with commercial assays, he said.

The task force advised using a reliable assay to measure the morning total testosterone level to establish the diagnosis and confirming it either by repeating the measurement of morning total testosterone or by measuring the free or bioavailable testosterone level.

Treatment

Testosterone therapy is appropriate in symptomatic men who have classic androgen deficiency syndromes and low testosterone levels, according to the guidelines. The therapy should be used to induce and maintain secondary sex characteristics. It can also be used to improve sexual function, sense of well-being, muscle mass, strength, and bone mineral density.

Testosterone therapy is not appropriate in patients who have metastatic prostate cancer, breast cancer, or a palpable prostate nodule or induration. Patients with a prostate-specific antigen (PSA) greater than 3 ng/mL without further urologic evaluation are not candidates for testosterone therapy. Other contraindications noted in the guidelines include erythrocytosis, hyperviscosity, untreated obstructive sleep apnea, severe benign prostatic hyperplasia symptoms, or uncontrolled severe heart failure.

Because of a lack of randomized controlled trial data, the task force did not make a recommendation on treating men with prostate cancer who have been disease free for 2 years or more.

For HIV-infected men who have low testosterone levels and weight loss, the task force members suggested short-term testosterone therapy as an adjunctive approach to promote weight maintenance and improvements in lean body mass and muscle strength.

Monitoring

The task force recommended a standardized monitoring plan with evaluation and measures of testosterone levels at 3 months after initiating treatment and annual assessments.

Hematocrit should be measured at baseline, 3 months, and annually, the task force recommended. If hematocrit exceeds 54%, therapy should be stopped until hematocrit decreases to a safe level. Therapy can be restarted at a lower dose, but evaluations for hypoxia and sleep apnea should be conducted.

The task force recommended urologic consultation if there is a verified serum or plasma PSA concentration of more than 4.0 ng/mL or an increase in serum or PSA concentration of more than 1.4 ng/mL in any 12-month period.

Unless Congress intervenes by the end of the year, physicians are scheduled to face a 5.1% cut in Medicare payments starting Jan. 1, 2007.

Officials at the Centers for Medicare and Medicaid Services published the proposed physician fee schedule changes in the Aug. 22 issue of the Federal Register; the final regulation is expected in the fall.

The proposed cut, which comes on the heels of years of pay freezes and minor increases, is likely to force some physicians to stop accepting new Medicare patients, several physicians have told this newspaper.

About 45% of physicians surveyed by the American Medical Association in February and March of this year reported that they would either decrease or stop seeing new Medicare patients if Medicare payments were reduced by 5% in 2007. The AMA surveyed more than 8,000 physicians, including both members and nonmembers.

That trend has already begun in some communities. Dr. Michael McAdoo, a family physician in Milan, Tenn., who works in a four-physician practice, stopped taking new Medicare patients about 3 years ago. “We saw this coming,” he said.

Now, with potentially deeper cuts on the horizon, he is considering stopping his hospital coverage and has begun limiting the number of Medicare patients he sees each day.

In Milan, a town of about 10,000, there is only one physician in the community who is still accepting new Medicare patients. “I anticipate this will probably get worse,” Dr. McAdoo said.

Over time, there will likely be access to care problems in rheumatology as well, said Dr. Michael Schweitz, vice president of the Coalition of State Rheumatology Organizations and a rheumatologist in West Palm Beach, Fla. He has already started to hear about physicians who are not accepting new Medicare patients, though the practice is not widespread, he said.

And for physicians who care for a large number of Medicare patients and aren't willing to limit access, the cut will mean a significant drop in their take home pay, Dr. Schweitz said.

The cuts are especially tough on general internists and other primary care physicians who already face difficulty in recruiting young physicians to their practices, said Dr. Yul Ejnes, an internist in Cranston, R.I., and chair of the board of governors of the American College of Physicians.

Many physicians have been willing to continue to see Medicare patients despite the falling reimbursement rates, Dr. Ejnes said, but lawmakers can't count on that indefinitely.

In his practice, about 20%–30% of his patients are Medicare beneficiaries, so Dr. Ejnes said he expects to see an impact on his bottom line due to the projected cuts. The impact could be greater if private insurance companies that tie their payments rates to Medicare choose to lower their payments at the same time.

The cuts are also likely to result in access issues beyond Medicare beneficiaries, he said. For example, if a physician has to cut back on staff because of Medicare payment cuts, that will affect all patients.

And if a physician chooses to retire early, that affects thousands of patients who have to seek care elsewhere. “The impact is on the system as a whole,” Dr. Ejnes said.

The proposed cut comes just a few weeks after CMS officials announced plans to change the way Medicare pays for evaluation and management services, with physicians who provide more cognitive services getting a bigger piece of the Medicare pie.

But those increases to primary care physicians are likely to be nearly wiped out by the projected payment cuts based on the sustainable growth rate (SGR) formula.

And for specialties in which physicians are expected to experience cuts based on the proposed changes to the way Medicare pays for evaluation and management services, the latest SGR cut compounds the problem.

For example, Medicare payments to cardiologists could drop by about 7% next year, due to the 5.1% proposed fee schedule cut plus a proposed 1% decrease in work and practice expense relative value units for 2007, and a 1% decrease based on the implementation of imaging provisions in the Deficit Reduction Act of 2005 (DRA).

While the impact will vary among individual cardiologists based on the mix of services that are provided, practices with a high volume of imaging services are likely to see overall payment cuts of more than 7%, according to the American College of Cardiology.

The AMA called on Congress to stop proposed 2007 payment cut and begin to reimburse physicians based on the actual cost of providing care.

AMA officials estimate that without a change to the current payment formula, Medicare payments will be cut 37% over the next 9 years, while at the same time practice costs will rise 22%.

Medicare physician payment rates are set annually based on a statutory formula. That formula adjusts the Medicare Economic Index based on how actual medical expenditures compare to a target rate—the SGR.

The SGR is based in part on medical inflation, the projected growth in the domestic economy, and projected changes in the total number of Medicare beneficiaries.

While there has been legislation introduced in Congress this year aimed at changing the formula that calculates physician payments under Medicare, a permanent fix to the payment problem is unlikely this year, said Dr. Larry Fields, president of the American Academy of Family Physicians.

The AAFP is pushing for a positive update of between 2% and 5% for 2007 and real engagement to permanently fix the problem next year, he said. Officials at the AAFP have commissioned a health care consulting firm, the Lewin Group, to examine alternative payment mechanisms that would not involve the use of the SGR formula, he said. They hope to use that information to work with Congress on a permanent solution next year, Dr. Fields said.

In addition to the 5.1% payment cut, the CMS proposal also seeks to expand coverage for some preventive services.

For example, the proposed rule would implement the provisions of the DRA that call for making abdominal aortic aneurysm screening a Medicare-covered preventive service.

The benefit would include a one-time ultrasound screening for beneficiaries who seek the “Welcome to Medicare” physical, along with education, counseling, and referral services.

The CMS proposed rule would also implement other provisions of the DRA which call for exempting colorectal cancer screening from the Part B Medicare deductible.

Unless Congress intervenes by the end of the year, physicians are scheduled to face a 5.1% cut in Medicare payments starting Jan. 1, 2007.

Officials at the Centers for Medicare and Medicaid Services published the proposed physician fee schedule changes in the Aug. 22 issue of the Federal Register; the final regulation is expected in the fall.

The proposed cut, which comes on the heels of years of pay freezes and minor increases, is likely to force some physicians to stop accepting new Medicare patients, several physicians have told this newspaper.

About 45% of physicians surveyed by the American Medical Association in February and March of this year reported that they would either decrease or stop seeing new Medicare patients if Medicare payments were reduced by 5% in 2007. The AMA surveyed more than 8,000 physicians, including both members and nonmembers.

That trend has already begun in some communities. Dr. Michael McAdoo, a family physician in Milan, Tenn., who works in a four-physician practice, stopped taking new Medicare patients about 3 years ago. “We saw this coming,” he said.

Now, with potentially deeper cuts on the horizon, he is considering stopping his hospital coverage and has begun limiting the number of Medicare patients he sees each day.

In Milan, a town of about 10,000, there is only one physician in the community who is still accepting new Medicare patients. “I anticipate this will probably get worse,” Dr. McAdoo said.

Over time, there will likely be access to care problems in rheumatology as well, said Dr. Michael Schweitz, vice president of the Coalition of State Rheumatology Organizations and a rheumatologist in West Palm Beach, Fla. He has already started to hear about physicians who are not accepting new Medicare patients, though the practice is not widespread, he said.

And for physicians who care for a large number of Medicare patients and aren't willing to limit access, the cut will mean a significant drop in their take home pay, Dr. Schweitz said.

The cuts are especially tough on general internists and other primary care physicians who already face difficulty in recruiting young physicians to their practices, said Dr. Yul Ejnes, an internist in Cranston, R.I., and chair of the board of governors of the American College of Physicians.

Many physicians have been willing to continue to see Medicare patients despite the falling reimbursement rates, Dr. Ejnes said, but lawmakers can't count on that indefinitely.

In his practice, about 20%–30% of his patients are Medicare beneficiaries, so Dr. Ejnes said he expects to see an impact on his bottom line due to the projected cuts. The impact could be greater if private insurance companies that tie their payments rates to Medicare choose to lower their payments at the same time.

The cuts are also likely to result in access issues beyond Medicare beneficiaries, he said. For example, if a physician has to cut back on staff because of Medicare payment cuts, that will affect all patients.

And if a physician chooses to retire early, that affects thousands of patients who have to seek care elsewhere. “The impact is on the system as a whole,” Dr. Ejnes said.

The proposed cut comes just a few weeks after CMS officials announced plans to change the way Medicare pays for evaluation and management services, with physicians who provide more cognitive services getting a bigger piece of the Medicare pie.

But those increases to primary care physicians are likely to be nearly wiped out by the projected payment cuts based on the sustainable growth rate (SGR) formula.

And for specialties in which physicians are expected to experience cuts based on the proposed changes to the way Medicare pays for evaluation and management services, the latest SGR cut compounds the problem.

For example, Medicare payments to cardiologists could drop by about 7% next year, due to the 5.1% proposed fee schedule cut plus a proposed 1% decrease in work and practice expense relative value units for 2007, and a 1% decrease based on the implementation of imaging provisions in the Deficit Reduction Act of 2005 (DRA).

While the impact will vary among individual cardiologists based on the mix of services that are provided, practices with a high volume of imaging services are likely to see overall payment cuts of more than 7%, according to the American College of Cardiology.

The AMA called on Congress to stop proposed 2007 payment cut and begin to reimburse physicians based on the actual cost of providing care.

AMA officials estimate that without a change to the current payment formula, Medicare payments will be cut 37% over the next 9 years, while at the same time practice costs will rise 22%.

Medicare physician payment rates are set annually based on a statutory formula. That formula adjusts the Medicare Economic Index based on how actual medical expenditures compare to a target rate—the SGR.

The SGR is based in part on medical inflation, the projected growth in the domestic economy, and projected changes in the total number of Medicare beneficiaries.

While there has been legislation introduced in Congress this year aimed at changing the formula that calculates physician payments under Medicare, a permanent fix to the payment problem is unlikely this year, said Dr. Larry Fields, president of the American Academy of Family Physicians.

The AAFP is pushing for a positive update of between 2% and 5% for 2007 and real engagement to permanently fix the problem next year, he said. Officials at the AAFP have commissioned a health care consulting firm, the Lewin Group, to examine alternative payment mechanisms that would not involve the use of the SGR formula, he said. They hope to use that information to work with Congress on a permanent solution next year, Dr. Fields said.

In addition to the 5.1% payment cut, the CMS proposal also seeks to expand coverage for some preventive services.

For example, the proposed rule would implement the provisions of the DRA that call for making abdominal aortic aneurysm screening a Medicare-covered preventive service.

The benefit would include a one-time ultrasound screening for beneficiaries who seek the “Welcome to Medicare” physical, along with education, counseling, and referral services.

The CMS proposed rule would also implement other provisions of the DRA which call for exempting colorectal cancer screening from the Part B Medicare deductible.

Unless Congress intervenes by the end of the year, physicians are scheduled to face a 5.1% cut in Medicare payments starting Jan. 1, 2007.

Officials at the Centers for Medicare and Medicaid Services published the proposed physician fee schedule changes in the Aug. 22 issue of the Federal Register; the final regulation is expected in the fall.

The proposed cut, which comes on the heels of years of pay freezes and minor increases, is likely to force some physicians to stop accepting new Medicare patients, several physicians have told this newspaper.

About 45% of physicians surveyed by the American Medical Association in February and March of this year reported that they would either decrease or stop seeing new Medicare patients if Medicare payments were reduced by 5% in 2007. The AMA surveyed more than 8,000 physicians, including both members and nonmembers.

That trend has already begun in some communities. Dr. Michael McAdoo, a family physician in Milan, Tenn., who works in a four-physician practice, stopped taking new Medicare patients about 3 years ago. “We saw this coming,” he said.

Now, with potentially deeper cuts on the horizon, he is considering stopping his hospital coverage and has begun limiting the number of Medicare patients he sees each day.

In Milan, a town of about 10,000, there is only one physician in the community who is still accepting new Medicare patients. “I anticipate this will probably get worse,” Dr. McAdoo said.

Over time, there will likely be access to care problems in rheumatology as well, said Dr. Michael Schweitz, vice president of the Coalition of State Rheumatology Organizations and a rheumatologist in West Palm Beach, Fla. He has already started to hear about physicians who are not accepting new Medicare patients, though the practice is not widespread, he said.

And for physicians who care for a large number of Medicare patients and aren't willing to limit access, the cut will mean a significant drop in their take home pay, Dr. Schweitz said.

The cuts are especially tough on general internists and other primary care physicians who already face difficulty in recruiting young physicians to their practices, said Dr. Yul Ejnes, an internist in Cranston, R.I., and chair of the board of governors of the American College of Physicians.

Many physicians have been willing to continue to see Medicare patients despite the falling reimbursement rates, Dr. Ejnes said, but lawmakers can't count on that indefinitely.

In his practice, about 20%–30% of his patients are Medicare beneficiaries, so Dr. Ejnes said he expects to see an impact on his bottom line due to the projected cuts. The impact could be greater if private insurance companies that tie their payments rates to Medicare choose to lower their payments at the same time.

The cuts are also likely to result in access issues beyond Medicare beneficiaries, he said. For example, if a physician has to cut back on staff because of Medicare payment cuts, that will affect all patients.

And if a physician chooses to retire early, that affects thousands of patients who have to seek care elsewhere. “The impact is on the system as a whole,” Dr. Ejnes said.

The proposed cut comes just a few weeks after CMS officials announced plans to change the way Medicare pays for evaluation and management services, with physicians who provide more cognitive services getting a bigger piece of the Medicare pie.

But those increases to primary care physicians are likely to be nearly wiped out by the projected payment cuts based on the sustainable growth rate (SGR) formula.

And for specialties in which physicians are expected to experience cuts based on the proposed changes to the way Medicare pays for evaluation and management services, the latest SGR cut compounds the problem.

For example, Medicare payments to cardiologists could drop by about 7% next year, due to the 5.1% proposed fee schedule cut plus a proposed 1% decrease in work and practice expense relative value units for 2007, and a 1% decrease based on the implementation of imaging provisions in the Deficit Reduction Act of 2005 (DRA).

While the impact will vary among individual cardiologists based on the mix of services that are provided, practices with a high volume of imaging services are likely to see overall payment cuts of more than 7%, according to the American College of Cardiology.

The AMA called on Congress to stop proposed 2007 payment cut and begin to reimburse physicians based on the actual cost of providing care.

AMA officials estimate that without a change to the current payment formula, Medicare payments will be cut 37% over the next 9 years, while at the same time practice costs will rise 22%.

Medicare physician payment rates are set annually based on a statutory formula. That formula adjusts the Medicare Economic Index based on how actual medical expenditures compare to a target rate—the SGR.

The SGR is based in part on medical inflation, the projected growth in the domestic economy, and projected changes in the total number of Medicare beneficiaries.

While there has been legislation introduced in Congress this year aimed at changing the formula that calculates physician payments under Medicare, a permanent fix to the payment problem is unlikely this year, said Dr. Larry Fields, president of the American Academy of Family Physicians.

The AAFP is pushing for a positive update of between 2% and 5% for 2007 and real engagement to permanently fix the problem next year, he said. Officials at the AAFP have commissioned a health care consulting firm, the Lewin Group, to examine alternative payment mechanisms that would not involve the use of the SGR formula, he said. They hope to use that information to work with Congress on a permanent solution next year, Dr. Fields said.

In addition to the 5.1% payment cut, the CMS proposal also seeks to expand coverage for some preventive services.

For example, the proposed rule would implement the provisions of the DRA that call for making abdominal aortic aneurysm screening a Medicare-covered preventive service.

The benefit would include a one-time ultrasound screening for beneficiaries who seek the “Welcome to Medicare” physical, along with education, counseling, and referral services.

The CMS proposed rule would also implement other provisions of the DRA which call for exempting colorectal cancer screening from the Part B Medicare deductible.