Mary Ellen Schneider

PHILADELPHIA — There are just as many systems failures at the root of malpractice cases as individual errors or negligence, Dr. Luke Sato said at the annual meeting of the American College of Physicians.

For example, the Risk Management Foundation of the Harvard Medical Institutes Inc., the insurance carrier for 18 hospitals and about 10,000 physicians in the Massachusetts area, has spent nearly the same amount of money over the years on malpractice cases involving clinical support processes as on cases resulting from a problem with the patient-clinician interaction.

“What we see is that this is a process reengineering problem,” said Dr. Sato, assistant professor of medicine at Harvard University and chief medical officer and vice president of the Risk Management Foundation.

An analysis of 2,270 malpractice cases within the insurance carrier from September 1995 to August 2005 shows that there are four high-risk categories in their system—obstetrics, surgery, medication-related problems, and diagnosis-related problems.

The diagnosis-related cases are the most prevalent and expensive, Dr. Sato said. He advised physicians to take a look at their office processes and set up ways within the practice to gather and document information that is critical to both the continuity of care and to avoiding malpractice claims.

Physicians also leave themselves open to malpractice claims if they don't have proper systems for follow-up of abnormal test and lab results and other issues. Officials at Harvard's Risk Management Foundation have developed a best practice manual that includes examples from across the system.

One best practice was developed for following up on abnormal test results: The physician schedules a telephone appointment with a patient 1 week after a potentially concerning test. This forces the provider to find and review the results prior to the call, ensures that there will be some type of patient-physician discussion, and makes it easier to add the documentation directly into the medical record, Dr. Sato said.

Examples of best practices from the system are available online in the “office practices” portion of the Risk Management Foundation's Web site (www.rmf.harvard.edu

PHILADELPHIA — There are just as many systems failures at the root of malpractice cases as individual errors or negligence, Dr. Luke Sato said at the annual meeting of the American College of Physicians.

For example, the Risk Management Foundation of the Harvard Medical Institutes Inc., the insurance carrier for 18 hospitals and about 10,000 physicians in the Massachusetts area, has spent nearly the same amount of money over the years on malpractice cases involving clinical support processes as on cases resulting from a problem with the patient-clinician interaction.

“What we see is that this is a process reengineering problem,” said Dr. Sato, assistant professor of medicine at Harvard University and chief medical officer and vice president of the Risk Management Foundation.

An analysis of 2,270 malpractice cases within the insurance carrier from September 1995 to August 2005 shows that there are four high-risk categories in their system—obstetrics, surgery, medication-related problems, and diagnosis-related problems.

The diagnosis-related cases are the most prevalent and expensive, Dr. Sato said. He advised physicians to take a look at their office processes and set up ways within the practice to gather and document information that is critical to both the continuity of care and to avoiding malpractice claims.

Physicians also leave themselves open to malpractice claims if they don't have proper systems for follow-up of abnormal test and lab results and other issues. Officials at Harvard's Risk Management Foundation have developed a best practice manual that includes examples from across the system.

One best practice was developed for following up on abnormal test results: The physician schedules a telephone appointment with a patient 1 week after a potentially concerning test. This forces the provider to find and review the results prior to the call, ensures that there will be some type of patient-physician discussion, and makes it easier to add the documentation directly into the medical record, Dr. Sato said.

Examples of best practices from the system are available online in the “office practices” portion of the Risk Management Foundation's Web site (www.rmf.harvard.edu

PHILADELPHIA — There are just as many systems failures at the root of malpractice cases as individual errors or negligence, Dr. Luke Sato said at the annual meeting of the American College of Physicians.

For example, the Risk Management Foundation of the Harvard Medical Institutes Inc., the insurance carrier for 18 hospitals and about 10,000 physicians in the Massachusetts area, has spent nearly the same amount of money over the years on malpractice cases involving clinical support processes as on cases resulting from a problem with the patient-clinician interaction.

“What we see is that this is a process reengineering problem,” said Dr. Sato, assistant professor of medicine at Harvard University and chief medical officer and vice president of the Risk Management Foundation.

An analysis of 2,270 malpractice cases within the insurance carrier from September 1995 to August 2005 shows that there are four high-risk categories in their system—obstetrics, surgery, medication-related problems, and diagnosis-related problems.

The diagnosis-related cases are the most prevalent and expensive, Dr. Sato said. He advised physicians to take a look at their office processes and set up ways within the practice to gather and document information that is critical to both the continuity of care and to avoiding malpractice claims.

Physicians also leave themselves open to malpractice claims if they don't have proper systems for follow-up of abnormal test and lab results and other issues. Officials at Harvard's Risk Management Foundation have developed a best practice manual that includes examples from across the system.

One best practice was developed for following up on abnormal test results: The physician schedules a telephone appointment with a patient 1 week after a potentially concerning test. This forces the provider to find and review the results prior to the call, ensures that there will be some type of patient-physician discussion, and makes it easier to add the documentation directly into the medical record, Dr. Sato said.

Examples of best practices from the system are available online in the “office practices” portion of the Risk Management Foundation's Web site (www.rmf.harvard.edu

LOS ANGELES — Former smokers and people with a family history of inflammatory bowel disease are at increased risk for developing ulcerative colitis, data from a case-control study of more than 1,400 patients have confirmed.

Family history of inflammatory bowel disease (IBD) was associated with the highest risk for developing ulcerative colitis.

Those patients with one relative with IBD had an adjusted odds ratio (OR) of 2.48 of having ulcerative colitis; those with two such relatives were at even higher risk (OR 6.8), Dr. Richard Gearry of the department of gastroenterology at Christchurch Hospital in New Zealand said at the annual Digestive Disease Week.

Other risk factors that were significantly associated with development of ulcerative colitis included being a former smoker at diagnosis (OR 1.82) and having used more than four courses of antibiotics a year as an adolescent (OR 1.71).

Factors that appeared to lower the risk included having had an appendectomy (OR 0.45) and being breast-fed for more than 3 months (OR 0.71).

The study included more than 1,400 IBD patients, representing nearly all the IBD patients in the Canterbury, New Zealand, region.

Dr. Gearry and his colleagues recruited 668 patients with ulcerative colitis, 715 patients with Crohn's disease, and 599 sex and age frequency-matched controls.

All participants were asked to complete a self-administered survey containing questions that focused on more than 70 possible environmental risk factors.

About 95% of ulcerative colitis patients, 94% of Crohn's disease patients, and 84% of control subjects completed the survey.

Many of the risk factors identified in the study occurred during childhood, making it critical that researchers and clinicians be watchful of what is happening during that critical time before the development of IBD, Dr. Gearry said.

LOS ANGELES — Former smokers and people with a family history of inflammatory bowel disease are at increased risk for developing ulcerative colitis, data from a case-control study of more than 1,400 patients have confirmed.

Family history of inflammatory bowel disease (IBD) was associated with the highest risk for developing ulcerative colitis.

Those patients with one relative with IBD had an adjusted odds ratio (OR) of 2.48 of having ulcerative colitis; those with two such relatives were at even higher risk (OR 6.8), Dr. Richard Gearry of the department of gastroenterology at Christchurch Hospital in New Zealand said at the annual Digestive Disease Week.

Other risk factors that were significantly associated with development of ulcerative colitis included being a former smoker at diagnosis (OR 1.82) and having used more than four courses of antibiotics a year as an adolescent (OR 1.71).

Factors that appeared to lower the risk included having had an appendectomy (OR 0.45) and being breast-fed for more than 3 months (OR 0.71).

The study included more than 1,400 IBD patients, representing nearly all the IBD patients in the Canterbury, New Zealand, region.

Dr. Gearry and his colleagues recruited 668 patients with ulcerative colitis, 715 patients with Crohn's disease, and 599 sex and age frequency-matched controls.

All participants were asked to complete a self-administered survey containing questions that focused on more than 70 possible environmental risk factors.

About 95% of ulcerative colitis patients, 94% of Crohn's disease patients, and 84% of control subjects completed the survey.

Many of the risk factors identified in the study occurred during childhood, making it critical that researchers and clinicians be watchful of what is happening during that critical time before the development of IBD, Dr. Gearry said.

LOS ANGELES — Former smokers and people with a family history of inflammatory bowel disease are at increased risk for developing ulcerative colitis, data from a case-control study of more than 1,400 patients have confirmed.

Family history of inflammatory bowel disease (IBD) was associated with the highest risk for developing ulcerative colitis.

Those patients with one relative with IBD had an adjusted odds ratio (OR) of 2.48 of having ulcerative colitis; those with two such relatives were at even higher risk (OR 6.8), Dr. Richard Gearry of the department of gastroenterology at Christchurch Hospital in New Zealand said at the annual Digestive Disease Week.

Other risk factors that were significantly associated with development of ulcerative colitis included being a former smoker at diagnosis (OR 1.82) and having used more than four courses of antibiotics a year as an adolescent (OR 1.71).

Factors that appeared to lower the risk included having had an appendectomy (OR 0.45) and being breast-fed for more than 3 months (OR 0.71).

The study included more than 1,400 IBD patients, representing nearly all the IBD patients in the Canterbury, New Zealand, region.

Dr. Gearry and his colleagues recruited 668 patients with ulcerative colitis, 715 patients with Crohn's disease, and 599 sex and age frequency-matched controls.

All participants were asked to complete a self-administered survey containing questions that focused on more than 70 possible environmental risk factors.

About 95% of ulcerative colitis patients, 94% of Crohn's disease patients, and 84% of control subjects completed the survey.

Many of the risk factors identified in the study occurred during childhood, making it critical that researchers and clinicians be watchful of what is happening during that critical time before the development of IBD, Dr. Gearry said.

LOS ANGELES — Laparoscopic Nissen fundoplication is superior to medication for overall symptom control in patients with gastroesophageal reflux disease, according to preliminary research presented at the annual Digestive Disease Week.

Even patients who do well on medication may be candidates for surgery, said Dr. Mehran Anvari, director of the center for minimal access surgery at McMaster University in Hamilton, Ont., the study's lead author. Dr. Anvari presented the 1-year results of the study, in which patients whose symptoms were controlled by long-term use of proton pump inhibitors (PPIs) were randomized to receive either continued PPI therapy or laparoscopic Nissen fundoplication.

Of the more than 200 patients with gastroesophageal reflux disease (GERD) who were eligible for the study, 104 gave informed consent. Four surgeons performed the surgery, using a previously published technique. Investigators evaluated symptoms every 3 months using a validated instrument and conducted 24-hour pH testing after 1 year.

Of the 104 randomized patients, 98 were available for follow-up after 1 year. Patients in both arms of the study showed improvement in 24-hour pH and in GERD symptoms. However, overall patient satisfaction with symptom control in the surgical group increased from 73.3 to 90.2 on a 100-point global rating scale, whereas results from the medication group stayed the same, compared with baseline.

Laparoscopic Nissen fundoplication may be an alternative for patients who don't want to be on long-term therapy with medication, Dr. Anvari said. Although this trial showed surgery to be an effective option, particularly in terms of overall symptom control, surgery is operator dependent, he said.

For this study, the investigators selected surgeons who had performed 50 or more laparoscopic Nissen fundoplication procedures. Dr. Anvari said that patients should select surgeons who have done at least 30 of these procedures. The 3-year follow-up data are collected and will be released in about a year, he said.

LOS ANGELES — Laparoscopic Nissen fundoplication is superior to medication for overall symptom control in patients with gastroesophageal reflux disease, according to preliminary research presented at the annual Digestive Disease Week.

Even patients who do well on medication may be candidates for surgery, said Dr. Mehran Anvari, director of the center for minimal access surgery at McMaster University in Hamilton, Ont., the study's lead author. Dr. Anvari presented the 1-year results of the study, in which patients whose symptoms were controlled by long-term use of proton pump inhibitors (PPIs) were randomized to receive either continued PPI therapy or laparoscopic Nissen fundoplication.

Of the more than 200 patients with gastroesophageal reflux disease (GERD) who were eligible for the study, 104 gave informed consent. Four surgeons performed the surgery, using a previously published technique. Investigators evaluated symptoms every 3 months using a validated instrument and conducted 24-hour pH testing after 1 year.

Of the 104 randomized patients, 98 were available for follow-up after 1 year. Patients in both arms of the study showed improvement in 24-hour pH and in GERD symptoms. However, overall patient satisfaction with symptom control in the surgical group increased from 73.3 to 90.2 on a 100-point global rating scale, whereas results from the medication group stayed the same, compared with baseline.

Laparoscopic Nissen fundoplication may be an alternative for patients who don't want to be on long-term therapy with medication, Dr. Anvari said. Although this trial showed surgery to be an effective option, particularly in terms of overall symptom control, surgery is operator dependent, he said.

For this study, the investigators selected surgeons who had performed 50 or more laparoscopic Nissen fundoplication procedures. Dr. Anvari said that patients should select surgeons who have done at least 30 of these procedures. The 3-year follow-up data are collected and will be released in about a year, he said.

LOS ANGELES — Laparoscopic Nissen fundoplication is superior to medication for overall symptom control in patients with gastroesophageal reflux disease, according to preliminary research presented at the annual Digestive Disease Week.

Even patients who do well on medication may be candidates for surgery, said Dr. Mehran Anvari, director of the center for minimal access surgery at McMaster University in Hamilton, Ont., the study's lead author. Dr. Anvari presented the 1-year results of the study, in which patients whose symptoms were controlled by long-term use of proton pump inhibitors (PPIs) were randomized to receive either continued PPI therapy or laparoscopic Nissen fundoplication.

Of the more than 200 patients with gastroesophageal reflux disease (GERD) who were eligible for the study, 104 gave informed consent. Four surgeons performed the surgery, using a previously published technique. Investigators evaluated symptoms every 3 months using a validated instrument and conducted 24-hour pH testing after 1 year.

Of the 104 randomized patients, 98 were available for follow-up after 1 year. Patients in both arms of the study showed improvement in 24-hour pH and in GERD symptoms. However, overall patient satisfaction with symptom control in the surgical group increased from 73.3 to 90.2 on a 100-point global rating scale, whereas results from the medication group stayed the same, compared with baseline.

Laparoscopic Nissen fundoplication may be an alternative for patients who don't want to be on long-term therapy with medication, Dr. Anvari said. Although this trial showed surgery to be an effective option, particularly in terms of overall symptom control, surgery is operator dependent, he said.

For this study, the investigators selected surgeons who had performed 50 or more laparoscopic Nissen fundoplication procedures. Dr. Anvari said that patients should select surgeons who have done at least 30 of these procedures. The 3-year follow-up data are collected and will be released in about a year, he said.

CHICAGO — Individual health insurance mandates, direct-to-consumer advertising, and store-based health clinics topped the list of issues addressed at the annual meeting of the American Medical Association's House of Delegates.

On the heels of Massachusetts' new mandate that all individuals must obtain health insurance, AMA delegates voted to support a requirement that individuals and families earning more than 500% of the federal poverty level ($49,000 for individuals and $100,000 for a family of four) obtain a minimum level of catastrophic and “evidence-based” preventive health coverage. The new policy calls for using the tax structure to achieve compliance, although language about exact tax consequences is vague.

The policy also calls for individuals and families earning less than 500% of the federal poverty level to obtain coverage once refundable tax credits and other subsidies are available.

“We've taken a bold shift here, and we want to help lead this discussion because we want to have comprehensive reform,” said Dr. Edward L. Langston, a member of the AMA Board of Trustees, during a press conference at the meeting.

The recommendation would cover only a fraction of the more than 40 million uninsured Americans. About 11% of the uninsured had incomes that were more than 500% of the federal poverty level in 2004, according to an analysis by the Department of Health and Human Services. But the delegates' action gives AMA officials another tool with which to lobby for expanding the number of people with health coverage, said AMA Board of Trustees member Dr. Ardis D. Hoven.

The new policy has the support of the American Association of Clinical Endocrinologists, according to Dr. Carlos R. Hamilton Jr., a past president of AACE and one of the group's alternate delegates to the AMA House of Delegates. It's reasonable to expect individuals who can afford coverage to obtain it and it's inevitable that individuals will assume more and more responsibility for their health coverage, he said in an interview.

“We're all going to have to be more responsible for our own health care,” Dr. Hamilton, executive vice president for external affairs at the University of Texas, Houston, said.

Creating a market for insurance has the potential to bring down the cost of coverage, said Dr. Mary T. Herald, also an ACP delegate. “The insurance companies will love it and, hopefully, they will lower their premiums,” she said.

Dr. Daniel Heinemann, an AAFP alternate, praised the AMA policy of individual insurance responsibility as an initial step in creating health care access for all.

But Dr. David McKalip, an alternate delegate from Florida, said the AMA should stick with its current policy of using tax credits to broaden access to health insurance without imposing a requirement. Similar requirements for auto insurance, which are in place in 47 states, have failed to achieve universal insurance coverage, with noncompliance rates of 15%–30% despite penalties, he said. In addition, the Internal Revenue Service won't be able to enforce this type of policy, he said.

An individual insurance mandate would not solve the problems of free riders within the system and would result in a large bureaucracy to track compliance with the requirement, Dr. McKalip said.

Instead, Dr. McKalip proposed monitoring the effects of the individual health insurance mandate in Massachusetts. An individual mandate is a step toward socialized medicine and a “slippery slope,” he said.

In other issues, many physicians at the House of Delegates meeting expressed both dissatisfaction with the store-based health clinics that have sprung up in retail stores and pharmacies around the country and resignation that these clinics are here to stay.

In an effort to deal with that new reality, AMA delegates established principles for operating store-based health clinics, which include limiting their scope of practice, using standardized medical protocols from evidence-based guidelines, and informing patients in advance of the qualifications of those providing their care. In addition, the delegates called on the management of store-based health clinics to establish arrangements for their care providers to have direct access to and supervision by allopathic and osteopathic physicians, as consistent with state laws.

Clinic providers also should encourage patients to establish care with a primary care physician, the new AMA policy said.

Dr. Larry Fields, AAFP president, said the AMA guidelines are consistent with the principles for store-based health clinics developed by his organization and are necessary to ensure patient safety and to control the scope of these clinics.

In the area of direct-to-consumer advertising, AMA delegates voted in favor of placing a moratorium on DTC advertising for newly approved prescription drugs and medical devices until physicians have become educated about the new products. Under the AMA policy, the length of the moratorium would be determined on a product-by-product basis by the FDA in consultation with the drug or device sponsor. The guidelines are a response to the frustration that many physicians feel when patients ask for specific drugs or devices that they have seen advertised, which may not be appropriate for them, said Dr. Ronald M. Davis, an AMA Board of Trustees member, during a press conference.

The policy also recommends that product-specific DTC ads should not use actors to portray health care providers who are promoting drug or device products, because this portrayal may be misleading and deceptive. If an actor is used to portray a health care provider, a disclaimer should be prominently displayed. The AMA also voted to discourage active and retired physicians from participating in advertising that endorses a particular drug or device product. If physicians do choose to participate in an ad, there should be a clear disclaimer that they are being paid for their endorsement, according to the new AMA policy.

Last year, the Pharmaceutical Research and Manufacturers of America (PhRMA) issued voluntary “Guiding Principles” on DTC advertising that call on drug companies to spend time educating health care professionals before beginning a new DTC campaign. Under the PhRMA policy, the length of time that should be spent in this educational effort should vary from product to product.

“While there are subtle differences between our guiding principles and the AMA's report, both emphasize the critical need to educate physicians and other health care providers about a new medicine before it is advertised to the public,” Dr. Paul Antony, PhRMA's Chief Medical Officer, said in a statement.

In other news from the AMA House of Delegates:

▸ Scaling back on salt. In a series of actions, the AMA delegates voted to urge the FDA to revoke the “generally recognized as safe” status of salt, allowing the agency to develop limits on sodium in processed food and restaurant items.

The AMA called for at least a 50% reduction in the amount of sodium in processed foods, fast food products, and restaurant meals over the next decade. The delegates also instructed the AMA leadership to work with the FDA to improve labeling of foods and meals so consumers can better understand the amount of sodium they consume. Patients are often unaware of how much sodium is in their diet, cardiologist J. James Rohack, an AMA Board of Trustees member, said during a press conference. Patients with hypertension will often say they don't add salt to food, but they don't realize the high sodium content of processed meats, Dr. Rohack said.

▸ Obtaining organs. The delegates approved a policy that allows for public solicitation of organs from living donors as long as it adds to the overall number of available organs and does not disadvantage others who are waiting for a transplant. This type of directed donation is acceptable as long as donors do not receive payment beyond reimbursement for travel, lodging, lost wages, and medical care associated with the donation, according to the new policy.

▸ Emphasizing electronic records. Delegates voted for the AMA to support initiatives that minimize the financial burden to physician practices of adopting and maintaining electronic medical records and instructed AMA officials to get involved in efforts to define and promote standards for the interoperability of health information technology systems. But the delegates also established as AMA policy that physicians should not be required to adopt electronic medical records by either public or private payers.

▸ Meddling in medicine. AMA delegates voiced their opposition to the “interference of government in the practice of medicine” through the use of government-mandated recitations to patients. The issue was brought up in response to pending federal legislation, the Unborn Child Pain Awareness Act of 2005 (S. 51), which proposes that physicians read a mandatory script to all women who seek abortions at more than 20-week gestation.

▸ Interrogations and immigration. The delegates also touched on the role of physicians in military interrogations and in providing care for illegal immigrants.

The House of Delegates adopted a set of ethical guidelines to limit physician participation in interrogation of prisoners and detainees. Under the new guidelines, physicians must not conduct or directly participate in interrogations because it undermines the role of the physician as a healer. The prohibition on direct participation includes monitoring with the intention of intervening, under the AMA guidance.

However, the guidelines spell out a role for physicians to help develop interrogation strategies that are not coercive. Dr. Priscilla Ray, chair of the AMA Council on Ethical and Judicial Affairs, which developed the proposal, said during a press conference that physicians can work with the military on strategies such as rapport building.

On caring for illegal immigrants, delegates voted to have AMA leadership ask that when federal agencies such as the U.S. Department of Homeland Security or U.S. Customs and Border Protection have custody of an undocumented foreign national, that they assume the cost of that person's health care instead of passing it on to the physician or hospital. The delegates asked AMA leaders to encourage public policy solutions on illegal immigration that take into consideration the financial impact of uncompensated care provided by hospitals, as well as by physicians, Medicare, and Medicaid.

CHICAGO — Individual health insurance mandates, direct-to-consumer advertising, and store-based health clinics topped the list of issues addressed at the annual meeting of the American Medical Association's House of Delegates.

On the heels of Massachusetts' new mandate that all individuals must obtain health insurance, AMA delegates voted to support a requirement that individuals and families earning more than 500% of the federal poverty level ($49,000 for individuals and $100,000 for a family of four) obtain a minimum level of catastrophic and “evidence-based” preventive health coverage. The new policy calls for using the tax structure to achieve compliance, although language about exact tax consequences is vague.

The policy also calls for individuals and families earning less than 500% of the federal poverty level to obtain coverage once refundable tax credits and other subsidies are available.

“We've taken a bold shift here, and we want to help lead this discussion because we want to have comprehensive reform,” said Dr. Edward L. Langston, a member of the AMA Board of Trustees, during a press conference at the meeting.

The recommendation would cover only a fraction of the more than 40 million uninsured Americans. About 11% of the uninsured had incomes that were more than 500% of the federal poverty level in 2004, according to an analysis by the Department of Health and Human Services. But the delegates' action gives AMA officials another tool with which to lobby for expanding the number of people with health coverage, said AMA Board of Trustees member Dr. Ardis D. Hoven.

The new policy has the support of the American Association of Clinical Endocrinologists, according to Dr. Carlos R. Hamilton Jr., a past president of AACE and one of the group's alternate delegates to the AMA House of Delegates. It's reasonable to expect individuals who can afford coverage to obtain it and it's inevitable that individuals will assume more and more responsibility for their health coverage, he said in an interview.

“We're all going to have to be more responsible for our own health care,” Dr. Hamilton, executive vice president for external affairs at the University of Texas, Houston, said.

Creating a market for insurance has the potential to bring down the cost of coverage, said Dr. Mary T. Herald, also an ACP delegate. “The insurance companies will love it and, hopefully, they will lower their premiums,” she said.

Dr. Daniel Heinemann, an AAFP alternate, praised the AMA policy of individual insurance responsibility as an initial step in creating health care access for all.

But Dr. David McKalip, an alternate delegate from Florida, said the AMA should stick with its current policy of using tax credits to broaden access to health insurance without imposing a requirement. Similar requirements for auto insurance, which are in place in 47 states, have failed to achieve universal insurance coverage, with noncompliance rates of 15%–30% despite penalties, he said. In addition, the Internal Revenue Service won't be able to enforce this type of policy, he said.

An individual insurance mandate would not solve the problems of free riders within the system and would result in a large bureaucracy to track compliance with the requirement, Dr. McKalip said.

Instead, Dr. McKalip proposed monitoring the effects of the individual health insurance mandate in Massachusetts. An individual mandate is a step toward socialized medicine and a “slippery slope,” he said.

In other issues, many physicians at the House of Delegates meeting expressed both dissatisfaction with the store-based health clinics that have sprung up in retail stores and pharmacies around the country and resignation that these clinics are here to stay.

In an effort to deal with that new reality, AMA delegates established principles for operating store-based health clinics, which include limiting their scope of practice, using standardized medical protocols from evidence-based guidelines, and informing patients in advance of the qualifications of those providing their care. In addition, the delegates called on the management of store-based health clinics to establish arrangements for their care providers to have direct access to and supervision by allopathic and osteopathic physicians, as consistent with state laws.

Clinic providers also should encourage patients to establish care with a primary care physician, the new AMA policy said.

Dr. Larry Fields, AAFP president, said the AMA guidelines are consistent with the principles for store-based health clinics developed by his organization and are necessary to ensure patient safety and to control the scope of these clinics.

In the area of direct-to-consumer advertising, AMA delegates voted in favor of placing a moratorium on DTC advertising for newly approved prescription drugs and medical devices until physicians have become educated about the new products. Under the AMA policy, the length of the moratorium would be determined on a product-by-product basis by the FDA in consultation with the drug or device sponsor. The guidelines are a response to the frustration that many physicians feel when patients ask for specific drugs or devices that they have seen advertised, which may not be appropriate for them, said Dr. Ronald M. Davis, an AMA Board of Trustees member, during a press conference.

The policy also recommends that product-specific DTC ads should not use actors to portray health care providers who are promoting drug or device products, because this portrayal may be misleading and deceptive. If an actor is used to portray a health care provider, a disclaimer should be prominently displayed. The AMA also voted to discourage active and retired physicians from participating in advertising that endorses a particular drug or device product. If physicians do choose to participate in an ad, there should be a clear disclaimer that they are being paid for their endorsement, according to the new AMA policy.

Last year, the Pharmaceutical Research and Manufacturers of America (PhRMA) issued voluntary “Guiding Principles” on DTC advertising that call on drug companies to spend time educating health care professionals before beginning a new DTC campaign. Under the PhRMA policy, the length of time that should be spent in this educational effort should vary from product to product.

“While there are subtle differences between our guiding principles and the AMA's report, both emphasize the critical need to educate physicians and other health care providers about a new medicine before it is advertised to the public,” Dr. Paul Antony, PhRMA's Chief Medical Officer, said in a statement.

In other news from the AMA House of Delegates:

▸ Scaling back on salt. In a series of actions, the AMA delegates voted to urge the FDA to revoke the “generally recognized as safe” status of salt, allowing the agency to develop limits on sodium in processed food and restaurant items.

The AMA called for at least a 50% reduction in the amount of sodium in processed foods, fast food products, and restaurant meals over the next decade. The delegates also instructed the AMA leadership to work with the FDA to improve labeling of foods and meals so consumers can better understand the amount of sodium they consume. Patients are often unaware of how much sodium is in their diet, cardiologist J. James Rohack, an AMA Board of Trustees member, said during a press conference. Patients with hypertension will often say they don't add salt to food, but they don't realize the high sodium content of processed meats, Dr. Rohack said.

▸ Obtaining organs. The delegates approved a policy that allows for public solicitation of organs from living donors as long as it adds to the overall number of available organs and does not disadvantage others who are waiting for a transplant. This type of directed donation is acceptable as long as donors do not receive payment beyond reimbursement for travel, lodging, lost wages, and medical care associated with the donation, according to the new policy.

▸ Emphasizing electronic records. Delegates voted for the AMA to support initiatives that minimize the financial burden to physician practices of adopting and maintaining electronic medical records and instructed AMA officials to get involved in efforts to define and promote standards for the interoperability of health information technology systems. But the delegates also established as AMA policy that physicians should not be required to adopt electronic medical records by either public or private payers.

▸ Meddling in medicine. AMA delegates voiced their opposition to the “interference of government in the practice of medicine” through the use of government-mandated recitations to patients. The issue was brought up in response to pending federal legislation, the Unborn Child Pain Awareness Act of 2005 (S. 51), which proposes that physicians read a mandatory script to all women who seek abortions at more than 20-week gestation.

▸ Interrogations and immigration. The delegates also touched on the role of physicians in military interrogations and in providing care for illegal immigrants.

The House of Delegates adopted a set of ethical guidelines to limit physician participation in interrogation of prisoners and detainees. Under the new guidelines, physicians must not conduct or directly participate in interrogations because it undermines the role of the physician as a healer. The prohibition on direct participation includes monitoring with the intention of intervening, under the AMA guidance.

However, the guidelines spell out a role for physicians to help develop interrogation strategies that are not coercive. Dr. Priscilla Ray, chair of the AMA Council on Ethical and Judicial Affairs, which developed the proposal, said during a press conference that physicians can work with the military on strategies such as rapport building.

On caring for illegal immigrants, delegates voted to have AMA leadership ask that when federal agencies such as the U.S. Department of Homeland Security or U.S. Customs and Border Protection have custody of an undocumented foreign national, that they assume the cost of that person's health care instead of passing it on to the physician or hospital. The delegates asked AMA leaders to encourage public policy solutions on illegal immigration that take into consideration the financial impact of uncompensated care provided by hospitals, as well as by physicians, Medicare, and Medicaid.

CHICAGO — Individual health insurance mandates, direct-to-consumer advertising, and store-based health clinics topped the list of issues addressed at the annual meeting of the American Medical Association's House of Delegates.

On the heels of Massachusetts' new mandate that all individuals must obtain health insurance, AMA delegates voted to support a requirement that individuals and families earning more than 500% of the federal poverty level ($49,000 for individuals and $100,000 for a family of four) obtain a minimum level of catastrophic and “evidence-based” preventive health coverage. The new policy calls for using the tax structure to achieve compliance, although language about exact tax consequences is vague.

The policy also calls for individuals and families earning less than 500% of the federal poverty level to obtain coverage once refundable tax credits and other subsidies are available.

“We've taken a bold shift here, and we want to help lead this discussion because we want to have comprehensive reform,” said Dr. Edward L. Langston, a member of the AMA Board of Trustees, during a press conference at the meeting.

The recommendation would cover only a fraction of the more than 40 million uninsured Americans. About 11% of the uninsured had incomes that were more than 500% of the federal poverty level in 2004, according to an analysis by the Department of Health and Human Services. But the delegates' action gives AMA officials another tool with which to lobby for expanding the number of people with health coverage, said AMA Board of Trustees member Dr. Ardis D. Hoven.

The new policy has the support of the American Association of Clinical Endocrinologists, according to Dr. Carlos R. Hamilton Jr., a past president of AACE and one of the group's alternate delegates to the AMA House of Delegates. It's reasonable to expect individuals who can afford coverage to obtain it and it's inevitable that individuals will assume more and more responsibility for their health coverage, he said in an interview.

“We're all going to have to be more responsible for our own health care,” Dr. Hamilton, executive vice president for external affairs at the University of Texas, Houston, said.

Creating a market for insurance has the potential to bring down the cost of coverage, said Dr. Mary T. Herald, also an ACP delegate. “The insurance companies will love it and, hopefully, they will lower their premiums,” she said.

Dr. Daniel Heinemann, an AAFP alternate, praised the AMA policy of individual insurance responsibility as an initial step in creating health care access for all.

But Dr. David McKalip, an alternate delegate from Florida, said the AMA should stick with its current policy of using tax credits to broaden access to health insurance without imposing a requirement. Similar requirements for auto insurance, which are in place in 47 states, have failed to achieve universal insurance coverage, with noncompliance rates of 15%–30% despite penalties, he said. In addition, the Internal Revenue Service won't be able to enforce this type of policy, he said.

An individual insurance mandate would not solve the problems of free riders within the system and would result in a large bureaucracy to track compliance with the requirement, Dr. McKalip said.

Instead, Dr. McKalip proposed monitoring the effects of the individual health insurance mandate in Massachusetts. An individual mandate is a step toward socialized medicine and a “slippery slope,” he said.

In other issues, many physicians at the House of Delegates meeting expressed both dissatisfaction with the store-based health clinics that have sprung up in retail stores and pharmacies around the country and resignation that these clinics are here to stay.

In an effort to deal with that new reality, AMA delegates established principles for operating store-based health clinics, which include limiting their scope of practice, using standardized medical protocols from evidence-based guidelines, and informing patients in advance of the qualifications of those providing their care. In addition, the delegates called on the management of store-based health clinics to establish arrangements for their care providers to have direct access to and supervision by allopathic and osteopathic physicians, as consistent with state laws.

Clinic providers also should encourage patients to establish care with a primary care physician, the new AMA policy said.

Dr. Larry Fields, AAFP president, said the AMA guidelines are consistent with the principles for store-based health clinics developed by his organization and are necessary to ensure patient safety and to control the scope of these clinics.

In the area of direct-to-consumer advertising, AMA delegates voted in favor of placing a moratorium on DTC advertising for newly approved prescription drugs and medical devices until physicians have become educated about the new products. Under the AMA policy, the length of the moratorium would be determined on a product-by-product basis by the FDA in consultation with the drug or device sponsor. The guidelines are a response to the frustration that many physicians feel when patients ask for specific drugs or devices that they have seen advertised, which may not be appropriate for them, said Dr. Ronald M. Davis, an AMA Board of Trustees member, during a press conference.

The policy also recommends that product-specific DTC ads should not use actors to portray health care providers who are promoting drug or device products, because this portrayal may be misleading and deceptive. If an actor is used to portray a health care provider, a disclaimer should be prominently displayed. The AMA also voted to discourage active and retired physicians from participating in advertising that endorses a particular drug or device product. If physicians do choose to participate in an ad, there should be a clear disclaimer that they are being paid for their endorsement, according to the new AMA policy.

Last year, the Pharmaceutical Research and Manufacturers of America (PhRMA) issued voluntary “Guiding Principles” on DTC advertising that call on drug companies to spend time educating health care professionals before beginning a new DTC campaign. Under the PhRMA policy, the length of time that should be spent in this educational effort should vary from product to product.

“While there are subtle differences between our guiding principles and the AMA's report, both emphasize the critical need to educate physicians and other health care providers about a new medicine before it is advertised to the public,” Dr. Paul Antony, PhRMA's Chief Medical Officer, said in a statement.

In other news from the AMA House of Delegates:

▸ Scaling back on salt. In a series of actions, the AMA delegates voted to urge the FDA to revoke the “generally recognized as safe” status of salt, allowing the agency to develop limits on sodium in processed food and restaurant items.

The AMA called for at least a 50% reduction in the amount of sodium in processed foods, fast food products, and restaurant meals over the next decade. The delegates also instructed the AMA leadership to work with the FDA to improve labeling of foods and meals so consumers can better understand the amount of sodium they consume. Patients are often unaware of how much sodium is in their diet, cardiologist J. James Rohack, an AMA Board of Trustees member, said during a press conference. Patients with hypertension will often say they don't add salt to food, but they don't realize the high sodium content of processed meats, Dr. Rohack said.

▸ Obtaining organs. The delegates approved a policy that allows for public solicitation of organs from living donors as long as it adds to the overall number of available organs and does not disadvantage others who are waiting for a transplant. This type of directed donation is acceptable as long as donors do not receive payment beyond reimbursement for travel, lodging, lost wages, and medical care associated with the donation, according to the new policy.

▸ Emphasizing electronic records. Delegates voted for the AMA to support initiatives that minimize the financial burden to physician practices of adopting and maintaining electronic medical records and instructed AMA officials to get involved in efforts to define and promote standards for the interoperability of health information technology systems. But the delegates also established as AMA policy that physicians should not be required to adopt electronic medical records by either public or private payers.

▸ Meddling in medicine. AMA delegates voiced their opposition to the “interference of government in the practice of medicine” through the use of government-mandated recitations to patients. The issue was brought up in response to pending federal legislation, the Unborn Child Pain Awareness Act of 2005 (S. 51), which proposes that physicians read a mandatory script to all women who seek abortions at more than 20-week gestation.

▸ Interrogations and immigration. The delegates also touched on the role of physicians in military interrogations and in providing care for illegal immigrants.

The House of Delegates adopted a set of ethical guidelines to limit physician participation in interrogation of prisoners and detainees. Under the new guidelines, physicians must not conduct or directly participate in interrogations because it undermines the role of the physician as a healer. The prohibition on direct participation includes monitoring with the intention of intervening, under the AMA guidance.

However, the guidelines spell out a role for physicians to help develop interrogation strategies that are not coercive. Dr. Priscilla Ray, chair of the AMA Council on Ethical and Judicial Affairs, which developed the proposal, said during a press conference that physicians can work with the military on strategies such as rapport building.

On caring for illegal immigrants, delegates voted to have AMA leadership ask that when federal agencies such as the U.S. Department of Homeland Security or U.S. Customs and Border Protection have custody of an undocumented foreign national, that they assume the cost of that person's health care instead of passing it on to the physician or hospital. The delegates asked AMA leaders to encourage public policy solutions on illegal immigration that take into consideration the financial impact of uncompensated care provided by hospitals, as well as by physicians, Medicare, and Medicaid.

Public and private payers may soon be testing reimbursement strategies for secure electronic messaging between clinicians and patients, if the American Health Information Community has anything to say about it.

The group, which advises Health and Human Services Secretary Mike Leavitt on health information technology (IT) interoperability issues, voted in May to urge payers to pilot-test secure messaging to evaluate possible forms of reimbursement, physician work-flow issues, and the impact on patient involvement in their care.

The widespread use of secure systems that allow patients and physicians to communicate by e-mail has the potential to improve quality and lower costs, especially among patients with chronic diseases, Dr. Douglas E. Henley, executive vice president for the American Academy of Family Physicians, said at a teleconference of the American Health Information Community (AHIC). Reimbursement will be essential to stimulating the widespread use of email and other communication tools, said Dr. Henley, who is a member of AHIC.

AHIC also voted to recommend that the Healthcare Information Technology Standards Panel, an independent group that facilitates harmonization of standards, work on defining standards for secure messaging that will be interoperable with electronic health records. Dr. David J. Brailer, the former national coordinator for health IT and the vice chair of AHIC, said the development of standards in this area should move along quickly.

And in an effort to ensure that access to secure messaging is available to all patients and clinicians, AHIC is asking officials at the Health and Human Services Department to look at how to address the gaps in access to computers and the Internet for poor and underserved populations and the safety net providers that provide their care.

AHIC also recommended that the federal government work with state agencies and professional societies to develop new licensing alternatives that address the ability to provide electronic care delivery across state lines through secure messaging systems. This will be especially important in times of national emergency, said Dr. Mark McClellan, administrator of the Centers for Medicare and Medicaid Services and cochair of AHIC's chronic care workgroup.

In another recommendation, the group called on the Agency for Healthcare Research and Quality to look at existing studies on health IT use by the elderly, ill, and underserved populations.

Public and private payers may soon be testing reimbursement strategies for secure electronic messaging between clinicians and patients, if the American Health Information Community has anything to say about it.

The group, which advises Health and Human Services Secretary Mike Leavitt on health information technology (IT) interoperability issues, voted in May to urge payers to pilot-test secure messaging to evaluate possible forms of reimbursement, physician work-flow issues, and the impact on patient involvement in their care.

The widespread use of secure systems that allow patients and physicians to communicate by e-mail has the potential to improve quality and lower costs, especially among patients with chronic diseases, Dr. Douglas E. Henley, executive vice president for the American Academy of Family Physicians, said at a teleconference of the American Health Information Community (AHIC). Reimbursement will be essential to stimulating the widespread use of email and other communication tools, said Dr. Henley, who is a member of AHIC.

AHIC also voted to recommend that the Healthcare Information Technology Standards Panel, an independent group that facilitates harmonization of standards, work on defining standards for secure messaging that will be interoperable with electronic health records. Dr. David J. Brailer, the former national coordinator for health IT and the vice chair of AHIC, said the development of standards in this area should move along quickly.

And in an effort to ensure that access to secure messaging is available to all patients and clinicians, AHIC is asking officials at the Health and Human Services Department to look at how to address the gaps in access to computers and the Internet for poor and underserved populations and the safety net providers that provide their care.

AHIC also recommended that the federal government work with state agencies and professional societies to develop new licensing alternatives that address the ability to provide electronic care delivery across state lines through secure messaging systems. This will be especially important in times of national emergency, said Dr. Mark McClellan, administrator of the Centers for Medicare and Medicaid Services and cochair of AHIC's chronic care workgroup.

In another recommendation, the group called on the Agency for Healthcare Research and Quality to look at existing studies on health IT use by the elderly, ill, and underserved populations.

Public and private payers may soon be testing reimbursement strategies for secure electronic messaging between clinicians and patients, if the American Health Information Community has anything to say about it.

The group, which advises Health and Human Services Secretary Mike Leavitt on health information technology (IT) interoperability issues, voted in May to urge payers to pilot-test secure messaging to evaluate possible forms of reimbursement, physician work-flow issues, and the impact on patient involvement in their care.

The widespread use of secure systems that allow patients and physicians to communicate by e-mail has the potential to improve quality and lower costs, especially among patients with chronic diseases, Dr. Douglas E. Henley, executive vice president for the American Academy of Family Physicians, said at a teleconference of the American Health Information Community (AHIC). Reimbursement will be essential to stimulating the widespread use of email and other communication tools, said Dr. Henley, who is a member of AHIC.

AHIC also voted to recommend that the Healthcare Information Technology Standards Panel, an independent group that facilitates harmonization of standards, work on defining standards for secure messaging that will be interoperable with electronic health records. Dr. David J. Brailer, the former national coordinator for health IT and the vice chair of AHIC, said the development of standards in this area should move along quickly.

And in an effort to ensure that access to secure messaging is available to all patients and clinicians, AHIC is asking officials at the Health and Human Services Department to look at how to address the gaps in access to computers and the Internet for poor and underserved populations and the safety net providers that provide their care.

AHIC also recommended that the federal government work with state agencies and professional societies to develop new licensing alternatives that address the ability to provide electronic care delivery across state lines through secure messaging systems. This will be especially important in times of national emergency, said Dr. Mark McClellan, administrator of the Centers for Medicare and Medicaid Services and cochair of AHIC's chronic care workgroup.

In another recommendation, the group called on the Agency for Healthcare Research and Quality to look at existing studies on health IT use by the elderly, ill, and underserved populations.

Examples of best practices from the system are available online in the “office practices” portion of the Risk Management Foundation's Web site: www.rmf.harvard.edu

PHILADELPHIA — There are just as many systems failures at the root of malpractice cases as individual errors or negligence, Dr. Luke Sato said at the annual meeting of the American College of Physicians.

For example, the Risk Management Foundation of the Harvard Medical Institutes Inc., the insurance carrier for 18 hospitals and about 10,000 physicians in the Massachusetts area, has spent nearly the same amount of money over the years on malpractice cases involving clinical support processes as on cases resulting from a problem with the patient-clinician interaction.

“What we see is that this is a process reengineering problem,” said Dr. Sato, assistant professor of medicine at Harvard University and chief medical officer and vice president of the Risk Management Foundation.

An analysis of 2,270 malpractice cases within the insurance carrier from September 1995 to August 2005 shows that there are four high-risk categories in their system—obstetrics, surgery, medication-related problems, and diagnosis-related problems.

The diagnosis-related cases are the most prevalent and the most expensive, Dr. Sato said. Those claims usually involve some type of delayed diagnosis, failure in diagnosis, or missed diagnosis, he said.

Dr. Sato advised physicians to take a look at their office processes and set up ways within the practice to gather and document information that is critical to both the continuity of care and to avoiding malpractice claims. For example, a large portion of diagnosis-related claims in the Harvard system were traced to inadequate documentation of areas such as family history, allergy status, and medication lists.

Physicians are also leaving themselves open to malpractice claims if they don't have proper systems for follow-up of abnormal test and lab results and other issues. Referral management is another key area to focus on, Dr. Sato said.

Officials at Harvard's Risk Management Foundation have developed a best practice manual that includes examples from across the system. One best practice was developed for following up on abnormal test results: The physician schedules a telephone appointment with a patient 1 week after a potentially concerning test. This forces the provider to find and review the results prior to the call, ensures that there will be some type of patient-physician discussion, and makes it easier to add the documentation directly into the medical record, Dr. Sato said.

Examples of best practices from the system are available online in the “office practices” portion of the Risk Management Foundation's Web site: www.rmf.harvard.edu

PHILADELPHIA — There are just as many systems failures at the root of malpractice cases as individual errors or negligence, Dr. Luke Sato said at the annual meeting of the American College of Physicians.

For example, the Risk Management Foundation of the Harvard Medical Institutes Inc., the insurance carrier for 18 hospitals and about 10,000 physicians in the Massachusetts area, has spent nearly the same amount of money over the years on malpractice cases involving clinical support processes as on cases resulting from a problem with the patient-clinician interaction.

“What we see is that this is a process reengineering problem,” said Dr. Sato, assistant professor of medicine at Harvard University and chief medical officer and vice president of the Risk Management Foundation.

An analysis of 2,270 malpractice cases within the insurance carrier from September 1995 to August 2005 shows that there are four high-risk categories in their system—obstetrics, surgery, medication-related problems, and diagnosis-related problems.

The diagnosis-related cases are the most prevalent and the most expensive, Dr. Sato said. Those claims usually involve some type of delayed diagnosis, failure in diagnosis, or missed diagnosis, he said.

Dr. Sato advised physicians to take a look at their office processes and set up ways within the practice to gather and document information that is critical to both the continuity of care and to avoiding malpractice claims. For example, a large portion of diagnosis-related claims in the Harvard system were traced to inadequate documentation of areas such as family history, allergy status, and medication lists.

Physicians are also leaving themselves open to malpractice claims if they don't have proper systems for follow-up of abnormal test and lab results and other issues. Referral management is another key area to focus on, Dr. Sato said.

Officials at Harvard's Risk Management Foundation have developed a best practice manual that includes examples from across the system. One best practice was developed for following up on abnormal test results: The physician schedules a telephone appointment with a patient 1 week after a potentially concerning test. This forces the provider to find and review the results prior to the call, ensures that there will be some type of patient-physician discussion, and makes it easier to add the documentation directly into the medical record, Dr. Sato said.

Examples of best practices from the system are available online in the “office practices” portion of the Risk Management Foundation's Web site: www.rmf.harvard.edu

PHILADELPHIA — There are just as many systems failures at the root of malpractice cases as individual errors or negligence, Dr. Luke Sato said at the annual meeting of the American College of Physicians.

For example, the Risk Management Foundation of the Harvard Medical Institutes Inc., the insurance carrier for 18 hospitals and about 10,000 physicians in the Massachusetts area, has spent nearly the same amount of money over the years on malpractice cases involving clinical support processes as on cases resulting from a problem with the patient-clinician interaction.

“What we see is that this is a process reengineering problem,” said Dr. Sato, assistant professor of medicine at Harvard University and chief medical officer and vice president of the Risk Management Foundation.

An analysis of 2,270 malpractice cases within the insurance carrier from September 1995 to August 2005 shows that there are four high-risk categories in their system—obstetrics, surgery, medication-related problems, and diagnosis-related problems.

The diagnosis-related cases are the most prevalent and the most expensive, Dr. Sato said. Those claims usually involve some type of delayed diagnosis, failure in diagnosis, or missed diagnosis, he said.

Dr. Sato advised physicians to take a look at their office processes and set up ways within the practice to gather and document information that is critical to both the continuity of care and to avoiding malpractice claims. For example, a large portion of diagnosis-related claims in the Harvard system were traced to inadequate documentation of areas such as family history, allergy status, and medication lists.

Physicians are also leaving themselves open to malpractice claims if they don't have proper systems for follow-up of abnormal test and lab results and other issues. Referral management is another key area to focus on, Dr. Sato said.

Officials at Harvard's Risk Management Foundation have developed a best practice manual that includes examples from across the system. One best practice was developed for following up on abnormal test results: The physician schedules a telephone appointment with a patient 1 week after a potentially concerning test. This forces the provider to find and review the results prior to the call, ensures that there will be some type of patient-physician discussion, and makes it easier to add the documentation directly into the medical record, Dr. Sato said.

CHICAGO — Individual health insurance mandates, direct-to-consumer advertising, and store-based health clinics topped the list of issues addressed at the annual meeting of the American Medical Association's House of Delegates.

On the heels of Massachusetts' new mandate that all individuals must obtain health insurance, AMA delegates voted to support a requirement that individuals and families earning more than 500% of the federal poverty level ($49,000 for individuals and $100,000 for a family of four) obtain a minimum level of catastrophic and “evidence-based” preventive health coverage. The new policy calls for using the tax structure to achieve compliance, although language about exact tax consequences is vague.

The policy also calls for individuals and families earning less than 500% of the federal poverty level to obtain coverage once refundable tax credits and other subsidies are available.

“We've taken a bold shift here, and we want to help lead this discussion because we want to have comprehensive reform,” said Dr. Edward L. Langston, a member of the AMA Board of Trustees, during a press conference at the meeting.

The recommendation would cover only a fraction of the more than 40 million uninsured Americans. About 11% of the uninsured had incomes that were more than 500% of the federal poverty level in 2004, according to an analysis by the Department of Health and Human Services. But the delegates' action gives AMA officials another tool with which to lobby for expanding the number of people with health coverage, said AMA Board of Trustees member Dr. Ardis D. Hoven.

The new policy has the support of the American College of Physicians and the American Academy of Family Physicians; the American College of Obstetricians and Gynecologists has made no comment on the policy at this time. The endorsement of an individual mandate for coverage will bring the country one step closer to universal coverage, said Dr. Donna Sweet, an ACP delegate. Creating a market for insurance has the potential to bring down the cost of coverage, said Dr. Mary T. Herald, also an ACP delegate. “The insurance companies will love it and, hopefully, they will lower their premiums,” she said.

Dr. Daniel Heinemann, an AAFP alternate, praised the AMA policy of individual insurance responsibility as an initial step in creating health care access for all.

But Dr. David McKalip, an alternate delegate from Florida, said the AMA should stick with its current policy of using tax credits to broaden access to health insurance without imposing a requirement. Similar requirements for auto insurance, which are in place in 47 states, have failed to achieve universal insurance coverage, with noncompliance rates of 15%–30% despite penalties, he said. In addition, the Internal Revenue Service won't be able to enforce this type of policy, he said.

An individual insurance mandate would not solve the problems of free riders within the system and would result in a large bureaucracy to track compliance with the requirement, Dr. McKalip said.

Instead, Dr. McKalip proposed monitoring the effects of the individual health insurance mandate in Massachusetts. An individual mandate is a step toward socialized medicine and a “slippery slope,” he said.

In other issues, many physicians at the House of Delegates meeting expressed both dissatisfaction with the store-based health clinics that have sprung up in retail stores and pharmacies around the country and resignation that these clinics are here to stay.

In an effort to deal with that new reality, AMA delegates established principles for operating store-based health clinics, which include limiting their scope of practice, using standardized medical protocols from evidence-based guidelines, and informing patients in advance of the qualifications of those providing their care. In addition, the delegates called on the management of store-based health clinics to establish arrangements for their care providers to have direct access to and supervision by allopathic and osteopathic physicians, as consistent with state laws.

Clinic providers also should encourage patients to establish care with a primary care physician, the new AMA policy said.

Dr. Larry Fields, AAFP president, said the AMA guidelines are consistent with the principles for store-based health clinics developed by his organization and are necessary to ensure patient safety and to control the scope of these clinics.

In the area of direct-to-consumer advertising, AMA delegates voted in favor of placing a moratorium on DTC advertising for newly approved prescription drugs and medical devices until physicians have become educated about the new products. Under the AMA policy, the length of the moratorium would be determined on a product-by-product basis by the FDA in consultation with the drug or device sponsor.

The guidelines are a response to the frustration that many physicians feel when patients ask for specific drugs or devices that they have seen advertised, which may not be appropriate for them, said Dr. Ronald M. Davis, an AMA Board of Trustees member, during a press conference.

The policy also recommends that product-specific DTC ads should not use actors to portray health care providers who are promoting drug or device products, because this portrayal may be misleading and deceptive. If an actor is used to portray a health care provider, a disclaimer should be prominently displayed. The AMA also voted to discourage active and retired physicians from participating in advertising that endorses a particular drug or device product. If physicians do choose to participate in an ad, there should be a clear disclaimer that they are being paid for their endorsement, according to the new AMA policy.

Last year, the Pharmaceutical Research and Manufacturers of America (PhRMA) issued voluntary “Guiding Principles” on DTC advertising that call on drug companies to spend time educating health care professionals before beginning a new DTC campaign. Under the PhRMA policy, the length of time that should be spent in this educational effort should vary from product to product.

“While there are subtle differences between our guiding principles and the AMA's report, both emphasize the critical need to educate physicians and other health care providers about a new medicine before it is advertised to the public,” Dr. Paul Antony, PhRMA's Chief Medical Officer, said in a statement.

In other news from the AMA House of Delegates:

▸ Scaling back on salt. In a series of actions, the AMA delegates voted to urge the FDA to revoke the “generally recognized as safe” status of salt, allowing the agency to develop limits on sodium in processed food and restaurant items.

The AMA called for at least a 50% reduction in the amount of sodium in processed foods, fast food products, and restaurant meals over the next decade. The delegates also instructed the AMA leadership to work with the FDA to improve labeling of foods and meals so consumers can better understand the amount of sodium they consume. Patients are often unaware of how much sodium is in their diet, cardiologist J. James Rohack, an AMA Board of Trustees member, said during a press conference. Patients with hypertension will often say they don't add salt to food, but they don't realize the high sodium content of processed meats, Dr. Rohack said.

▸ Obtaining organs. The delegates approved a policy that allows for public solicitation of organs from living donors as long as it adds to the overall number of available organs and does not disadvantage others who are waiting for a transplant. This type of directed donation is acceptable as long as donors do not receive payment beyond reimbursement for travel, lodging, lost wages, and medical care associated with the donation, according to the new policy.

▸ Emphasizing electronic records. Delegates voted for the AMA to support initiatives that minimize the financial burden to physician practices of adopting and maintaining electronic medical records and instructed AMA officials to get involved in efforts to define and promote standards for the interoperability of health information technology systems. But the delegates also established as AMA policy that physicians should not be required to adopt electronic medical records by either public or private payers.

▸ Meddling in medicine. AMA delegates voiced their opposition to the “interference of government in the practice of medicine” through the use of government-mandated recitations to patients. The issue was brought up in response to pending federal legislation, the Unborn Child Pain Awareness Act of 2005 (S. 51), which proposes that physicians read a mandatory script to all women who seek abortions at more than 20 weeks' gestation.

▸ Interrogations and immigration. The delegates also touched on the role of physicians in military interrogations and in providing care for illegal immigrants.

The House of Delegates adopted a set of ethical guidelines to limit physician participation in interrogation of prisoners and detainees. Under the new guidelines, physicians must not conduct or directly participate in interrogations because it undermines the role of the physician as a healer. The prohibition on direct participation includes monitoring with the intention of intervening, under the AMA guidance.

However, the guidelines spell out a role for physicians to help develop interrogation strategies that are not coercive. Dr. Priscilla Ray, chair of the AMA Council on Ethical and Judicial Affairs, which developed the proposal, said during a press conference that physicians can work with the military on strategies such as rapport building.

On caring for illegal immigrants, delegates voted to have AMA leadership ask that when federal agencies such as the U.S. Department of Homeland Security or U.S. Customs and Border Protection have custody of an undocumented foreign national, that they assume the cost of that person's health care instead of passing it on to the physician or hospital. The delegates asked AMA leaders to encourage public policy solutions on illegal immigration that take into consideration the financial impact of uncompensated care provided by hospitals, as well as by physicians, Medicare, and Medicaid.

CHICAGO — Individual health insurance mandates, direct-to-consumer advertising, and store-based health clinics topped the list of issues addressed at the annual meeting of the American Medical Association's House of Delegates.

On the heels of Massachusetts' new mandate that all individuals must obtain health insurance, AMA delegates voted to support a requirement that individuals and families earning more than 500% of the federal poverty level ($49,000 for individuals and $100,000 for a family of four) obtain a minimum level of catastrophic and “evidence-based” preventive health coverage. The new policy calls for using the tax structure to achieve compliance, although language about exact tax consequences is vague.

The policy also calls for individuals and families earning less than 500% of the federal poverty level to obtain coverage once refundable tax credits and other subsidies are available.

“We've taken a bold shift here, and we want to help lead this discussion because we want to have comprehensive reform,” said Dr. Edward L. Langston, a member of the AMA Board of Trustees, during a press conference at the meeting.

The recommendation would cover only a fraction of the more than 40 million uninsured Americans. About 11% of the uninsured had incomes that were more than 500% of the federal poverty level in 2004, according to an analysis by the Department of Health and Human Services. But the delegates' action gives AMA officials another tool with which to lobby for expanding the number of people with health coverage, said AMA Board of Trustees member Dr. Ardis D. Hoven.

The new policy has the support of the American College of Physicians and the American Academy of Family Physicians; the American College of Obstetricians and Gynecologists has made no comment on the policy at this time. The endorsement of an individual mandate for coverage will bring the country one step closer to universal coverage, said Dr. Donna Sweet, an ACP delegate. Creating a market for insurance has the potential to bring down the cost of coverage, said Dr. Mary T. Herald, also an ACP delegate. “The insurance companies will love it and, hopefully, they will lower their premiums,” she said.

Dr. Daniel Heinemann, an AAFP alternate, praised the AMA policy of individual insurance responsibility as an initial step in creating health care access for all.

But Dr. David McKalip, an alternate delegate from Florida, said the AMA should stick with its current policy of using tax credits to broaden access to health insurance without imposing a requirement. Similar requirements for auto insurance, which are in place in 47 states, have failed to achieve universal insurance coverage, with noncompliance rates of 15%–30% despite penalties, he said. In addition, the Internal Revenue Service won't be able to enforce this type of policy, he said.

An individual insurance mandate would not solve the problems of free riders within the system and would result in a large bureaucracy to track compliance with the requirement, Dr. McKalip said.

Instead, Dr. McKalip proposed monitoring the effects of the individual health insurance mandate in Massachusetts. An individual mandate is a step toward socialized medicine and a “slippery slope,” he said.

In other issues, many physicians at the House of Delegates meeting expressed both dissatisfaction with the store-based health clinics that have sprung up in retail stores and pharmacies around the country and resignation that these clinics are here to stay.

In an effort to deal with that new reality, AMA delegates established principles for operating store-based health clinics, which include limiting their scope of practice, using standardized medical protocols from evidence-based guidelines, and informing patients in advance of the qualifications of those providing their care. In addition, the delegates called on the management of store-based health clinics to establish arrangements for their care providers to have direct access to and supervision by allopathic and osteopathic physicians, as consistent with state laws.

Clinic providers also should encourage patients to establish care with a primary care physician, the new AMA policy said.

Dr. Larry Fields, AAFP president, said the AMA guidelines are consistent with the principles for store-based health clinics developed by his organization and are necessary to ensure patient safety and to control the scope of these clinics.

In the area of direct-to-consumer advertising, AMA delegates voted in favor of placing a moratorium on DTC advertising for newly approved prescription drugs and medical devices until physicians have become educated about the new products. Under the AMA policy, the length of the moratorium would be determined on a product-by-product basis by the FDA in consultation with the drug or device sponsor.

The guidelines are a response to the frustration that many physicians feel when patients ask for specific drugs or devices that they have seen advertised, which may not be appropriate for them, said Dr. Ronald M. Davis, an AMA Board of Trustees member, during a press conference.

The policy also recommends that product-specific DTC ads should not use actors to portray health care providers who are promoting drug or device products, because this portrayal may be misleading and deceptive. If an actor is used to portray a health care provider, a disclaimer should be prominently displayed. The AMA also voted to discourage active and retired physicians from participating in advertising that endorses a particular drug or device product. If physicians do choose to participate in an ad, there should be a clear disclaimer that they are being paid for their endorsement, according to the new AMA policy.

Last year, the Pharmaceutical Research and Manufacturers of America (PhRMA) issued voluntary “Guiding Principles” on DTC advertising that call on drug companies to spend time educating health care professionals before beginning a new DTC campaign. Under the PhRMA policy, the length of time that should be spent in this educational effort should vary from product to product.

“While there are subtle differences between our guiding principles and the AMA's report, both emphasize the critical need to educate physicians and other health care providers about a new medicine before it is advertised to the public,” Dr. Paul Antony, PhRMA's Chief Medical Officer, said in a statement.

In other news from the AMA House of Delegates:

▸ Scaling back on salt. In a series of actions, the AMA delegates voted to urge the FDA to revoke the “generally recognized as safe” status of salt, allowing the agency to develop limits on sodium in processed food and restaurant items.

The AMA called for at least a 50% reduction in the amount of sodium in processed foods, fast food products, and restaurant meals over the next decade. The delegates also instructed the AMA leadership to work with the FDA to improve labeling of foods and meals so consumers can better understand the amount of sodium they consume. Patients are often unaware of how much sodium is in their diet, cardiologist J. James Rohack, an AMA Board of Trustees member, said during a press conference. Patients with hypertension will often say they don't add salt to food, but they don't realize the high sodium content of processed meats, Dr. Rohack said.

▸ Obtaining organs. The delegates approved a policy that allows for public solicitation of organs from living donors as long as it adds to the overall number of available organs and does not disadvantage others who are waiting for a transplant. This type of directed donation is acceptable as long as donors do not receive payment beyond reimbursement for travel, lodging, lost wages, and medical care associated with the donation, according to the new policy.

▸ Emphasizing electronic records. Delegates voted for the AMA to support initiatives that minimize the financial burden to physician practices of adopting and maintaining electronic medical records and instructed AMA officials to get involved in efforts to define and promote standards for the interoperability of health information technology systems. But the delegates also established as AMA policy that physicians should not be required to adopt electronic medical records by either public or private payers.

▸ Meddling in medicine. AMA delegates voiced their opposition to the “interference of government in the practice of medicine” through the use of government-mandated recitations to patients. The issue was brought up in response to pending federal legislation, the Unborn Child Pain Awareness Act of 2005 (S. 51), which proposes that physicians read a mandatory script to all women who seek abortions at more than 20 weeks' gestation.

▸ Interrogations and immigration. The delegates also touched on the role of physicians in military interrogations and in providing care for illegal immigrants.

The House of Delegates adopted a set of ethical guidelines to limit physician participation in interrogation of prisoners and detainees. Under the new guidelines, physicians must not conduct or directly participate in interrogations because it undermines the role of the physician as a healer. The prohibition on direct participation includes monitoring with the intention of intervening, under the AMA guidance.

However, the guidelines spell out a role for physicians to help develop interrogation strategies that are not coercive. Dr. Priscilla Ray, chair of the AMA Council on Ethical and Judicial Affairs, which developed the proposal, said during a press conference that physicians can work with the military on strategies such as rapport building.

On caring for illegal immigrants, delegates voted to have AMA leadership ask that when federal agencies such as the U.S. Department of Homeland Security or U.S. Customs and Border Protection have custody of an undocumented foreign national, that they assume the cost of that person's health care instead of passing it on to the physician or hospital. The delegates asked AMA leaders to encourage public policy solutions on illegal immigration that take into consideration the financial impact of uncompensated care provided by hospitals, as well as by physicians, Medicare, and Medicaid.

CHICAGO — Individual health insurance mandates, direct-to-consumer advertising, and store-based health clinics topped the list of issues addressed at the annual meeting of the American Medical Association's House of Delegates.

On the heels of Massachusetts' new mandate that all individuals must obtain health insurance, AMA delegates voted to support a requirement that individuals and families earning more than 500% of the federal poverty level ($49,000 for individuals and $100,000 for a family of four) obtain a minimum level of catastrophic and “evidence-based” preventive health coverage. The new policy calls for using the tax structure to achieve compliance, although language about exact tax consequences is vague.

The policy also calls for individuals and families earning less than 500% of the federal poverty level to obtain coverage once refundable tax credits and other subsidies are available.

“We've taken a bold shift here, and we want to help lead this discussion because we want to have comprehensive reform,” said Dr. Edward L. Langston, a member of the AMA Board of Trustees, during a press conference at the meeting.

The recommendation would cover only a fraction of the more than 40 million uninsured Americans. About 11% of the uninsured had incomes that were more than 500% of the federal poverty level in 2004, according to an analysis by the Department of Health and Human Services. But the delegates' action gives AMA officials another tool with which to lobby for expanding the number of people with health coverage, said AMA Board of Trustees member Dr. Ardis D. Hoven.

The new policy has the support of the American College of Physicians and the American Academy of Family Physicians; the American College of Obstetricians and Gynecologists has made no comment on the policy at this time. The endorsement of an individual mandate for coverage will bring the country one step closer to universal coverage, said Dr. Donna Sweet, an ACP delegate. Creating a market for insurance has the potential to bring down the cost of coverage, said Dr. Mary T. Herald, also an ACP delegate. “The insurance companies will love it and, hopefully, they will lower their premiums,” she said.

Dr. Daniel Heinemann, an AAFP alternate, praised the AMA policy of individual insurance responsibility as an initial step in creating health care access for all.

But Dr. David McKalip, an alternate delegate from Florida, said the AMA should stick with its current policy of using tax credits to broaden access to health insurance without imposing a requirement. Similar requirements for auto insurance, which are in place in 47 states, have failed to achieve universal insurance coverage, with noncompliance rates of 15%–30% despite penalties, he said. In addition, the Internal Revenue Service won't be able to enforce this type of policy, he said.

An individual insurance mandate would not solve the problems of free riders within the system and would result in a large bureaucracy to track compliance with the requirement, Dr. McKalip said.

Instead, Dr. McKalip proposed monitoring the effects of the individual health insurance mandate in Massachusetts. An individual mandate is a step toward socialized medicine and a “slippery slope,” he said.

In other issues, many physicians at the House of Delegates meeting expressed both dissatisfaction with the store-based health clinics that have sprung up in retail stores and pharmacies around the country and resignation that these clinics are here to stay.

In an effort to deal with that new reality, AMA delegates established principles for operating store-based health clinics, which include limiting their scope of practice, using standardized medical protocols from evidence-based guidelines, and informing patients in advance of the qualifications of those providing their care. In addition, the delegates called on the management of store-based health clinics to establish arrangements for their care providers to have direct access to and supervision by allopathic and osteopathic physicians, as consistent with state laws.

Clinic providers also should encourage patients to establish care with a primary care physician, the new AMA policy said.

Dr. Larry Fields, AAFP president, said the AMA guidelines are consistent with the principles for store-based health clinics developed by his organization and are necessary to ensure patient safety and to control the scope of these clinics.

In the area of direct-to-consumer advertising, AMA delegates voted in favor of placing a moratorium on DTC advertising for newly approved prescription drugs and medical devices until physicians have become educated about the new products. Under the AMA policy, the length of the moratorium would be determined on a product-by-product basis by the FDA in consultation with the drug or device sponsor.

The guidelines are a response to the frustration that many physicians feel when patients ask for specific drugs or devices that they have seen advertised, which may not be appropriate for them, said Dr. Ronald M. Davis, an AMA Board of Trustees member, during a press conference.

The policy also recommends that product-specific DTC ads should not use actors to portray health care providers who are promoting drug or device products, because this portrayal may be misleading and deceptive. If an actor is used to portray a health care provider, a disclaimer should be prominently displayed. The AMA also voted to discourage active and retired physicians from participating in advertising that endorses a particular drug or device product. If physicians do choose to participate in an ad, there should be a clear disclaimer that they are being paid for their endorsement, according to the new AMA policy.

Last year, the Pharmaceutical Research and Manufacturers of America (PhRMA) issued voluntary “Guiding Principles” on DTC advertising that call on drug companies to spend time educating health care professionals before beginning a new DTC campaign. Under the PhRMA policy, the length of time that should be spent in this educational effort should vary from product to product.

“While there are subtle differences between our guiding principles and the AMA's report, both emphasize the critical need to educate physicians and other health care providers about a new medicine before it is advertised to the public,” Dr. Paul Antony, PhRMA's Chief Medical Officer, said in a statement.

In other news from the AMA House of Delegates:

▸ Scaling back on salt. In a series of actions, the AMA delegates voted to urge the FDA to revoke the “generally recognized as safe” status of salt, allowing the agency to develop limits on sodium in processed food and restaurant items.

The AMA called for at least a 50% reduction in the amount of sodium in processed foods, fast food products, and restaurant meals over the next decade. The delegates also instructed the AMA leadership to work with the FDA to improve labeling of foods and meals so consumers can better understand the amount of sodium they consume. Patients are often unaware of how much sodium is in their diet, cardiologist J. James Rohack, an AMA Board of Trustees member, said during a press conference. Patients with hypertension will often say they don't add salt to food, but they don't realize the high sodium content of processed meats, Dr. Rohack said.

▸ Obtaining organs. The delegates approved a policy that allows for public solicitation of organs from living donors as long as it adds to the overall number of available organs and does not disadvantage others who are waiting for a transplant. This type of directed donation is acceptable as long as donors do not receive payment beyond reimbursement for travel, lodging, lost wages, and medical care associated with the donation, according to the new policy.

▸ Emphasizing electronic records. Delegates voted for the AMA to support initiatives that minimize the financial burden to physician practices of adopting and maintaining electronic medical records and instructed AMA officials to get involved in efforts to define and promote standards for the interoperability of health information technology systems. But the delegates also established as AMA policy that physicians should not be required to adopt electronic medical records by either public or private payers.

▸ Meddling in medicine. AMA delegates voiced their opposition to the “interference of government in the practice of medicine” through the use of government-mandated recitations to patients. The issue was brought up in response to pending federal legislation, the Unborn Child Pain Awareness Act of 2005 (S. 51), which proposes that physicians read a mandatory script to all women who seek abortions at more than 20 weeks' gestation.

▸ Interrogations and immigration. The delegates also touched on the role of physicians in military interrogations and in providing care for illegal immigrants.

The House of Delegates adopted a set of ethical guidelines to limit physician participation in interrogation of prisoners and detainees. Under the new guidelines, physicians must not conduct or directly participate in interrogations because it undermines the role of the physician as a healer. The prohibition on direct participation includes monitoring with the intention of intervening, under the AMA guidance.

However, the guidelines spell out a role for physicians to help develop interrogation strategies that are not coercive. Dr. Priscilla Ray, chair of the AMA Council on Ethical and Judicial Affairs, which developed the proposal, said during a press conference that physicians can work with the military on strategies such as rapport building.

On caring for illegal immigrants, delegates voted to have AMA leadership ask that when federal agencies such as the U.S. Department of Homeland Security or U.S. Customs and Border Protection have custody of an undocumented foreign national, that they assume the cost of that person's health care instead of passing it on to the physician or hospital. The delegates asked AMA leaders to encourage public policy solutions on illegal immigration that take into consideration the financial impact of uncompensated care provided by hospitals, as well as by physicians, Medicare, and Medicaid.

S. Dakota Faces Abortion Referendum

The question of whether South Dakota's recently passed abortion ban will stand is likely to be decided by the voters. A coalition called the South Dakota Campaign for Healthy Families submitted more than 38,000 signatures to refer the state abortion ban to the ballot in November, exceeding the 16,728 signatures required under state law. South Dakota Gov. Mike Rounds (R) signed the ban into law in March. The law was set to take effect on July 1, but if enough signatures were certified as valid, the law was to be suspended pending the results of the November ballot referendum. If the ban takes effect it would make it a felony to perform an abortion except in cases where the mother's life is in danger. At press time, the South Dakota secretary of state's office was in the process of reviewing the signatures.

Harvard Launches Stem Cell Project

Scientists at Harvard University and Children's Hospital Boston have been given the green light to begin research using somatic cell nuclear transfer in an effort to develop treatments for diabetes, blood disorders, and neurodegenerative diseases. The research, which will involve human embryonic stem cells, will be privately funded since the federal government will not provide money for research using human embryonic stem cells derived after August 9, 2001. The efforts were praised by the Coalition for the Advancement of Medical Research, which advocates for federal funding of stem cell research. “In the absence of federal support for and oversight of this type of research, CAMR is pleased that institutions like Harvard have taken the necessary steps to ensure that therapeutic cloning research happens in a manner fully consistent with the ethics and scientific standards in place for all research involving human subjects and tissues,” CAMR President Sean Tipton said in a statement.

Women and Medical Research

More than 60% of women age 50 years and older who have participated in a medical research study would “definitely” or “probably” do it again, according to a survey released by the Society for Women's Health Research. The group commissioned the national telephone survey of more than 1,000 women age 50 years and older. A similar survey was conducted in 2003. Overall, 10% of women age 50 years and older have participated in some type of medical research, the 2006 survey found, down slightly from 12% in 2003. However, a growing number of women said they aren't interested in or don't believe in medical research in the 2006 survey. Nearly 16% of women surveyed cited lack of interest as a reason for not wanting to participate, compared with about 9% in the 2003 survey.

Postpartum Depression Targeted

A new bill, introduced in the U.S. Senate last month, aims to help find the cause and the cure for postpartum depression. The legislation would award grants to states to educate and screen new mothers for postpartum depression and support programs that assist women with postpartum depression. The Mom's Opportunity to Access Help, Education, Research, and Support for Postpartum Depression Act or the MOTHERS Act (S. 3529) was introduced by Sen. Richard Durbin (D-Ill.) and Sen. Robert Menendez (D-N.J.). The so-called “baby blues” affect up to 80% of new mothers, with postpartum depression affecting 10%–20% of new mothers and postpartum psychosis occurring in 1:1,000 new mothers, according to the bill. The legislation calls on the secretary of Health and Human Services to organize a series of national meetings to develop a research plan for postpartum depression and psychosis. The plan should include basic research into the cause of postpartum conditions, epidemiologic studies looking at the natural history of the disorder, the development of improved diagnostic techniques, and clinical research into new treatments such as biologic agents, according to the legislation. The bill was referred to the Senate Committee on Health, Education, Labor, and Pensions.

FDA Infected by Politics, Most Think

A majority of Americans—82%—believe the Food and Drug Administration is greatly influenced by politics when making decisions about the safety and efficacy of new prescription drugs, according to a Wall Street Journal online Harris Interactive poll. The finding was similar across parties, with 87% of Democrats, 77% of Republicans, and 88% of Independents saying they thought that politics outweighed science greatly or to some extent in decision-making. The survey of more than 2,300 adults was conducted in mid-May. In addition, almost 60% said the agency is doing a fair or poor job in ensuring the safety and efficacy of new drugs. Only 36% said the FDA was doing an excellent or good job. That is a reversal from 2 years ago, when 56% had a positive view, and 37% a negative view, of the FDA.

S. Dakota Faces Abortion Referendum

The question of whether South Dakota's recently passed abortion ban will stand is likely to be decided by the voters. A coalition called the South Dakota Campaign for Healthy Families submitted more than 38,000 signatures to refer the state abortion ban to the ballot in November, exceeding the 16,728 signatures required under state law. South Dakota Gov. Mike Rounds (R) signed the ban into law in March. The law was set to take effect on July 1, but if enough signatures were certified as valid, the law was to be suspended pending the results of the November ballot referendum. If the ban takes effect it would make it a felony to perform an abortion except in cases where the mother's life is in danger. At press time, the South Dakota secretary of state's office was in the process of reviewing the signatures.

Harvard Launches Stem Cell Project

Scientists at Harvard University and Children's Hospital Boston have been given the green light to begin research using somatic cell nuclear transfer in an effort to develop treatments for diabetes, blood disorders, and neurodegenerative diseases. The research, which will involve human embryonic stem cells, will be privately funded since the federal government will not provide money for research using human embryonic stem cells derived after August 9, 2001. The efforts were praised by the Coalition for the Advancement of Medical Research, which advocates for federal funding of stem cell research. “In the absence of federal support for and oversight of this type of research, CAMR is pleased that institutions like Harvard have taken the necessary steps to ensure that therapeutic cloning research happens in a manner fully consistent with the ethics and scientific standards in place for all research involving human subjects and tissues,” CAMR President Sean Tipton said in a statement.

Women and Medical Research

More than 60% of women age 50 years and older who have participated in a medical research study would “definitely” or “probably” do it again, according to a survey released by the Society for Women's Health Research. The group commissioned the national telephone survey of more than 1,000 women age 50 years and older. A similar survey was conducted in 2003. Overall, 10% of women age 50 years and older have participated in some type of medical research, the 2006 survey found, down slightly from 12% in 2003. However, a growing number of women said they aren't interested in or don't believe in medical research in the 2006 survey. Nearly 16% of women surveyed cited lack of interest as a reason for not wanting to participate, compared with about 9% in the 2003 survey.

Postpartum Depression Targeted

A new bill, introduced in the U.S. Senate last month, aims to help find the cause and the cure for postpartum depression. The legislation would award grants to states to educate and screen new mothers for postpartum depression and support programs that assist women with postpartum depression. The Mom's Opportunity to Access Help, Education, Research, and Support for Postpartum Depression Act or the MOTHERS Act (S. 3529) was introduced by Sen. Richard Durbin (D-Ill.) and Sen. Robert Menendez (D-N.J.). The so-called “baby blues” affect up to 80% of new mothers, with postpartum depression affecting 10%–20% of new mothers and postpartum psychosis occurring in 1:1,000 new mothers, according to the bill. The legislation calls on the secretary of Health and Human Services to organize a series of national meetings to develop a research plan for postpartum depression and psychosis. The plan should include basic research into the cause of postpartum conditions, epidemiologic studies looking at the natural history of the disorder, the development of improved diagnostic techniques, and clinical research into new treatments such as biologic agents, according to the legislation. The bill was referred to the Senate Committee on Health, Education, Labor, and Pensions.

FDA Infected by Politics, Most Think

A majority of Americans—82%—believe the Food and Drug Administration is greatly influenced by politics when making decisions about the safety and efficacy of new prescription drugs, according to a Wall Street Journal online Harris Interactive poll. The finding was similar across parties, with 87% of Democrats, 77% of Republicans, and 88% of Independents saying they thought that politics outweighed science greatly or to some extent in decision-making. The survey of more than 2,300 adults was conducted in mid-May. In addition, almost 60% said the agency is doing a fair or poor job in ensuring the safety and efficacy of new drugs. Only 36% said the FDA was doing an excellent or good job. That is a reversal from 2 years ago, when 56% had a positive view, and 37% a negative view, of the FDA.

S. Dakota Faces Abortion Referendum

The question of whether South Dakota's recently passed abortion ban will stand is likely to be decided by the voters. A coalition called the South Dakota Campaign for Healthy Families submitted more than 38,000 signatures to refer the state abortion ban to the ballot in November, exceeding the 16,728 signatures required under state law. South Dakota Gov. Mike Rounds (R) signed the ban into law in March. The law was set to take effect on July 1, but if enough signatures were certified as valid, the law was to be suspended pending the results of the November ballot referendum. If the ban takes effect it would make it a felony to perform an abortion except in cases where the mother's life is in danger. At press time, the South Dakota secretary of state's office was in the process of reviewing the signatures.

Harvard Launches Stem Cell Project

Scientists at Harvard University and Children's Hospital Boston have been given the green light to begin research using somatic cell nuclear transfer in an effort to develop treatments for diabetes, blood disorders, and neurodegenerative diseases. The research, which will involve human embryonic stem cells, will be privately funded since the federal government will not provide money for research using human embryonic stem cells derived after August 9, 2001. The efforts were praised by the Coalition for the Advancement of Medical Research, which advocates for federal funding of stem cell research. “In the absence of federal support for and oversight of this type of research, CAMR is pleased that institutions like Harvard have taken the necessary steps to ensure that therapeutic cloning research happens in a manner fully consistent with the ethics and scientific standards in place for all research involving human subjects and tissues,” CAMR President Sean Tipton said in a statement.

Women and Medical Research

More than 60% of women age 50 years and older who have participated in a medical research study would “definitely” or “probably” do it again, according to a survey released by the Society for Women's Health Research. The group commissioned the national telephone survey of more than 1,000 women age 50 years and older. A similar survey was conducted in 2003. Overall, 10% of women age 50 years and older have participated in some type of medical research, the 2006 survey found, down slightly from 12% in 2003. However, a growing number of women said they aren't interested in or don't believe in medical research in the 2006 survey. Nearly 16% of women surveyed cited lack of interest as a reason for not wanting to participate, compared with about 9% in the 2003 survey.

Postpartum Depression Targeted

A new bill, introduced in the U.S. Senate last month, aims to help find the cause and the cure for postpartum depression. The legislation would award grants to states to educate and screen new mothers for postpartum depression and support programs that assist women with postpartum depression. The Mom's Opportunity to Access Help, Education, Research, and Support for Postpartum Depression Act or the MOTHERS Act (S. 3529) was introduced by Sen. Richard Durbin (D-Ill.) and Sen. Robert Menendez (D-N.J.). The so-called “baby blues” affect up to 80% of new mothers, with postpartum depression affecting 10%–20% of new mothers and postpartum psychosis occurring in 1:1,000 new mothers, according to the bill. The legislation calls on the secretary of Health and Human Services to organize a series of national meetings to develop a research plan for postpartum depression and psychosis. The plan should include basic research into the cause of postpartum conditions, epidemiologic studies looking at the natural history of the disorder, the development of improved diagnostic techniques, and clinical research into new treatments such as biologic agents, according to the legislation. The bill was referred to the Senate Committee on Health, Education, Labor, and Pensions.

FDA Infected by Politics, Most Think

A majority of Americans—82%—believe the Food and Drug Administration is greatly influenced by politics when making decisions about the safety and efficacy of new prescription drugs, according to a Wall Street Journal online Harris Interactive poll. The finding was similar across parties, with 87% of Democrats, 77% of Republicans, and 88% of Independents saying they thought that politics outweighed science greatly or to some extent in decision-making. The survey of more than 2,300 adults was conducted in mid-May. In addition, almost 60% said the agency is doing a fair or poor job in ensuring the safety and efficacy of new drugs. Only 36% said the FDA was doing an excellent or good job. That is a reversal from 2 years ago, when 56% had a positive view, and 37% a negative view, of the FDA.

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 while having 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 ACOG meeting.

At week 12 of therapy, nearly 38% of patients taking synthetic conjugated estrogens-A (SCE-A) reported no moderate to severe vasomotor symptoms vs. 7.8% 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 67.8 from a baseline of 95.9 at 12 weeks, compared with a mean drop of 42.9 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. Approximately 91% of the patients taking SCE-A and 67% of the patients taking placebo completed the full 12 weeks of the study.

The subjects were asked to keep a daily diary of the frequency and severity of their symptoms. Patients also had vital signs, body weight, and adverse events evaluated during six office visits. The investigators assessed the safety and tolerability of the treatment through standard laboratory evaluations at screening and at week 12 of the study.

The research was supported by Duramed Research Inc. of Bala Cynwyd, Pa., which markets SCE-A under the trade name Cenestin. Duramed is a wholly owned subsidiary of Barr Pharmaceuticals. Cenestin 0.45 mg was approved by the Food and Drug Administration in 2004 for the treatment of moderate to severe vasomotor symptoms. The patients recruited for the study were healthy women ages 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 while having 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 ACOG meeting.

At week 12 of therapy, nearly 38% of patients taking synthetic conjugated estrogens-A (SCE-A) reported no moderate to severe vasomotor symptoms vs. 7.8% 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 67.8 from a baseline of 95.9 at 12 weeks, compared with a mean drop of 42.9 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. Approximately 91% of the patients taking SCE-A and 67% of the patients taking placebo completed the full 12 weeks of the study.

The subjects were asked to keep a daily diary of the frequency and severity of their symptoms. Patients also had vital signs, body weight, and adverse events evaluated during six office visits. The investigators assessed the safety and tolerability of the treatment through standard laboratory evaluations at screening and at week 12 of the study.

The research was supported by Duramed Research Inc. of Bala Cynwyd, Pa., which markets SCE-A under the trade name Cenestin. Duramed is a wholly owned subsidiary of Barr Pharmaceuticals. Cenestin 0.45 mg was approved by the Food and Drug Administration in 2004 for the treatment of moderate to severe vasomotor symptoms. The patients recruited for the study were healthy women ages 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 while having 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 ACOG meeting.

At week 12 of therapy, nearly 38% of patients taking synthetic conjugated estrogens-A (SCE-A) reported no moderate to severe vasomotor symptoms vs. 7.8% 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 67.8 from a baseline of 95.9 at 12 weeks, compared with a mean drop of 42.9 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. Approximately 91% of the patients taking SCE-A and 67% of the patients taking placebo completed the full 12 weeks of the study.

The subjects were asked to keep a daily diary of the frequency and severity of their symptoms. Patients also had vital signs, body weight, and adverse events evaluated during six office visits. The investigators assessed the safety and tolerability of the treatment through standard laboratory evaluations at screening and at week 12 of the study.

The research was supported by Duramed Research Inc. of Bala Cynwyd, Pa., which markets SCE-A under the trade name Cenestin. Duramed is a wholly owned subsidiary of Barr Pharmaceuticals. Cenestin 0.45 mg was approved by the Food and Drug Administration in 2004 for the treatment of moderate to severe vasomotor symptoms. The patients recruited for the study were healthy women ages 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 — The use of forceps and vacuum did not increase the risk for cervical laceration among patients who had vaginal deliveries performed at a large community hospital, according to a poster presented at the annual meeting of the American College of Obstetricians and Gynecologists.

However, cervical cerclage and induction of labor appeared to be risk factors for cervical laceration in these deliveries, wrote Dr. Reshma Parikh and his colleagues at St. Luke's Hospital and Health Network in Bethlehem, Pa. The researchers performed a retrospective analysis of all vaginal deliveries at their large community hospital over a 5-year period.

They analyzed a number of suspected risk factors for cervical laceration including parity, body mass index, cervical cerclage, prior cervical procedures, induction of labor, duration of second stage, mode of delivery, and infant weight. Of the 16,931 vaginal deliveries performed at the hospital, 32 cervical lacerations were reported. Cervical cerclage was associated with an 11.5-fold increase in relative risk in cervical laceration, and induction of labor was associated with a threefold increase in relative risk, the researchers reported.

However, the researchers noted that they were surprised to find that operative delivery, using either forceps or vacuum, did not appear to be a risk factor for cervical laceration in the study population. In addition, none of the other factors examined were found to significantly increase risk for cervical laceration.

WASHINGTON — The use of forceps and vacuum did not increase the risk for cervical laceration among patients who had vaginal deliveries performed at a large community hospital, according to a poster presented at the annual meeting of the American College of Obstetricians and Gynecologists.

However, cervical cerclage and induction of labor appeared to be risk factors for cervical laceration in these deliveries, wrote Dr. Reshma Parikh and his colleagues at St. Luke's Hospital and Health Network in Bethlehem, Pa. The researchers performed a retrospective analysis of all vaginal deliveries at their large community hospital over a 5-year period.

They analyzed a number of suspected risk factors for cervical laceration including parity, body mass index, cervical cerclage, prior cervical procedures, induction of labor, duration of second stage, mode of delivery, and infant weight. Of the 16,931 vaginal deliveries performed at the hospital, 32 cervical lacerations were reported. Cervical cerclage was associated with an 11.5-fold increase in relative risk in cervical laceration, and induction of labor was associated with a threefold increase in relative risk, the researchers reported.

However, the researchers noted that they were surprised to find that operative delivery, using either forceps or vacuum, did not appear to be a risk factor for cervical laceration in the study population. In addition, none of the other factors examined were found to significantly increase risk for cervical laceration.

WASHINGTON — The use of forceps and vacuum did not increase the risk for cervical laceration among patients who had vaginal deliveries performed at a large community hospital, according to a poster presented at the annual meeting of the American College of Obstetricians and Gynecologists.

However, cervical cerclage and induction of labor appeared to be risk factors for cervical laceration in these deliveries, wrote Dr. Reshma Parikh and his colleagues at St. Luke's Hospital and Health Network in Bethlehem, Pa. The researchers performed a retrospective analysis of all vaginal deliveries at their large community hospital over a 5-year period.

They analyzed a number of suspected risk factors for cervical laceration including parity, body mass index, cervical cerclage, prior cervical procedures, induction of labor, duration of second stage, mode of delivery, and infant weight. Of the 16,931 vaginal deliveries performed at the hospital, 32 cervical lacerations were reported. Cervical cerclage was associated with an 11.5-fold increase in relative risk in cervical laceration, and induction of labor was associated with a threefold increase in relative risk, the researchers reported.

However, the researchers noted that they were surprised to find that operative delivery, using either forceps or vacuum, did not appear to be a risk factor for cervical laceration in the study population. In addition, none of the other factors examined were found to significantly increase risk for cervical laceration.