Alicia Ault

Penn. Publishes Surgery Data

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

www.ph4c.org

Guidant Defib Suits Move Ahead

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

Avandia-Related Suits Start

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

New FDA Risk Panel

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

DTC Ads Still Fall Short

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

Penn. Publishes Surgery Data

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

www.ph4c.org

Guidant Defib Suits Move Ahead

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

Avandia-Related Suits Start

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

New FDA Risk Panel

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

DTC Ads Still Fall Short

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

Penn. Publishes Surgery Data

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

www.ph4c.org

Guidant Defib Suits Move Ahead

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

Avandia-Related Suits Start

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

New FDA Risk Panel

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

DTC Ads Still Fall Short

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Drug Side Effect Awareness Low

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

Teen Drug Chatter Pervasive

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

Failed Mental Health Mission

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

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

Limiting DXM Abuse

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

New FDA Risk Panel

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

DTC Ads Still Fall Short

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

Drug Side Effect Awareness Low

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

Teen Drug Chatter Pervasive

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

Failed Mental Health Mission

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

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

Limiting DXM Abuse

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

New FDA Risk Panel

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

DTC Ads Still Fall Short

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

Drug Side Effect Awareness Low

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

Teen Drug Chatter Pervasive

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

Failed Mental Health Mission

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

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

Limiting DXM Abuse

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

New FDA Risk Panel

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

DTC Ads Still Fall Short

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

CHICAGO – Depression prevalence may be as high as 30% in transformed migraine, according to a preliminary analysis of the American Migraine Prevalence and Prevention study presented on June 8 at the American Headache Society meeting.

By contrast, only 6%–7% of the U.S. general population has depression, said Dawn C. Buse, Ph.D., director of psychology at the Montefiore Headache Center at the Montefiore Medical Center in the Bronx.

Dr. Buse presented the analysis on behalf of colleagues at the Albert Einstein College of Medicine, New York; the Vedanta Research in Chapel Hill, N.C.; and the Diamond Headache Clinic in Chicago.

The American Migraine Prevalence and Prevention (AMPP) study is an ongoing multisite survey that began in 2004 when a random sample of 120,000 households was mailed self-administered headache questionnaires. Of the 162,576 individuals who responded, 30,721 self-reported severe headaches. A follow-up survey was sent in 2005 to a random subsample of 24,000 of the headache sufferers.

The data presented by Dr. Buse came from the follow-up survey. Respondents were asked for body mass index, and to respond to the Migraine Disability Assessment (MIDAS) questionnaire and the Patient Health Questionnaire-Nine Item Depressive Scale (PHQ-9).

The goal was to determine the relationship among depression, headache type, BMI, and disability.

Data were analyzed from 3,840 (16%) respondents whose scores placed them in the moderately-severe or severe major depression category.

Depression rates were highest in patients with transformed migraine, at 30% (1,152 patients), followed by chronic daily headache at about 20% (768 patients). Eighteen percent (691) of migraine patients had depression, followed by 15% (576) of other types of headache, 13% (500) of tension headache and 12% (461) of probable migraine.

Among patients with depression, 25% were morbidly obese, while 19% were underweight, Dr. Buse said.

Depression increased with rising disability. Only 11% of depressed patients had MIDAS Grade 1 disability, compared with 33% of those with MIDAS grade 4 disability, Dr. Buse said.

Because AMPP is a cross-sectional study, it cannot get at the mechanisms for these interrelationships, she said, adding that she and her colleagues currently are collecting data on medications used, and psychiatric and other comorbidities, and will be following this population for at least another survey, so there may be opportunities for cause-effect analyses in the future.

The AMPP study was supported by the National Headache Foundation through a grant from Ortho-McNeil. Dr. Buse reported that that she consults for Ortho-McNeil and Allergan Pharmaceuticals.

CHICAGO – Depression prevalence may be as high as 30% in transformed migraine, according to a preliminary analysis of the American Migraine Prevalence and Prevention study presented on June 8 at the American Headache Society meeting.

By contrast, only 6%–7% of the U.S. general population has depression, said Dawn C. Buse, Ph.D., director of psychology at the Montefiore Headache Center at the Montefiore Medical Center in the Bronx.

Dr. Buse presented the analysis on behalf of colleagues at the Albert Einstein College of Medicine, New York; the Vedanta Research in Chapel Hill, N.C.; and the Diamond Headache Clinic in Chicago.

The American Migraine Prevalence and Prevention (AMPP) study is an ongoing multisite survey that began in 2004 when a random sample of 120,000 households was mailed self-administered headache questionnaires. Of the 162,576 individuals who responded, 30,721 self-reported severe headaches. A follow-up survey was sent in 2005 to a random subsample of 24,000 of the headache sufferers.

The data presented by Dr. Buse came from the follow-up survey. Respondents were asked for body mass index, and to respond to the Migraine Disability Assessment (MIDAS) questionnaire and the Patient Health Questionnaire-Nine Item Depressive Scale (PHQ-9).

The goal was to determine the relationship among depression, headache type, BMI, and disability.

Data were analyzed from 3,840 (16%) respondents whose scores placed them in the moderately-severe or severe major depression category.

Depression rates were highest in patients with transformed migraine, at 30% (1,152 patients), followed by chronic daily headache at about 20% (768 patients). Eighteen percent (691) of migraine patients had depression, followed by 15% (576) of other types of headache, 13% (500) of tension headache and 12% (461) of probable migraine.

Among patients with depression, 25% were morbidly obese, while 19% were underweight, Dr. Buse said.

Depression increased with rising disability. Only 11% of depressed patients had MIDAS Grade 1 disability, compared with 33% of those with MIDAS grade 4 disability, Dr. Buse said.

Because AMPP is a cross-sectional study, it cannot get at the mechanisms for these interrelationships, she said, adding that she and her colleagues currently are collecting data on medications used, and psychiatric and other comorbidities, and will be following this population for at least another survey, so there may be opportunities for cause-effect analyses in the future.

The AMPP study was supported by the National Headache Foundation through a grant from Ortho-McNeil. Dr. Buse reported that that she consults for Ortho-McNeil and Allergan Pharmaceuticals.

CHICAGO – Depression prevalence may be as high as 30% in transformed migraine, according to a preliminary analysis of the American Migraine Prevalence and Prevention study presented on June 8 at the American Headache Society meeting.

By contrast, only 6%–7% of the U.S. general population has depression, said Dawn C. Buse, Ph.D., director of psychology at the Montefiore Headache Center at the Montefiore Medical Center in the Bronx.

Dr. Buse presented the analysis on behalf of colleagues at the Albert Einstein College of Medicine, New York; the Vedanta Research in Chapel Hill, N.C.; and the Diamond Headache Clinic in Chicago.

The American Migraine Prevalence and Prevention (AMPP) study is an ongoing multisite survey that began in 2004 when a random sample of 120,000 households was mailed self-administered headache questionnaires. Of the 162,576 individuals who responded, 30,721 self-reported severe headaches. A follow-up survey was sent in 2005 to a random subsample of 24,000 of the headache sufferers.

The data presented by Dr. Buse came from the follow-up survey. Respondents were asked for body mass index, and to respond to the Migraine Disability Assessment (MIDAS) questionnaire and the Patient Health Questionnaire-Nine Item Depressive Scale (PHQ-9).

The goal was to determine the relationship among depression, headache type, BMI, and disability.

Data were analyzed from 3,840 (16%) respondents whose scores placed them in the moderately-severe or severe major depression category.

Depression rates were highest in patients with transformed migraine, at 30% (1,152 patients), followed by chronic daily headache at about 20% (768 patients). Eighteen percent (691) of migraine patients had depression, followed by 15% (576) of other types of headache, 13% (500) of tension headache and 12% (461) of probable migraine.

Among patients with depression, 25% were morbidly obese, while 19% were underweight, Dr. Buse said.

Depression increased with rising disability. Only 11% of depressed patients had MIDAS Grade 1 disability, compared with 33% of those with MIDAS grade 4 disability, Dr. Buse said.

Because AMPP is a cross-sectional study, it cannot get at the mechanisms for these interrelationships, she said, adding that she and her colleagues currently are collecting data on medications used, and psychiatric and other comorbidities, and will be following this population for at least another survey, so there may be opportunities for cause-effect analyses in the future.

The AMPP study was supported by the National Headache Foundation through a grant from Ortho-McNeil. Dr. Buse reported that that she consults for Ortho-McNeil and Allergan Pharmaceuticals.

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

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

Many studies have shown an association between migraine and psychiatric conditions; the goal of this study was to determine potential impact on health outcomes and implications for health policies in Canada, Dr. Jette said. Patients with migraine and psychiatric comorbidities tend to use more health resources; identifying them can lead to more preventive treatment and better-targeted therapies, Dr. Jette said.

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

Dr. Jette said that he estimated lifetime prevalence of migraine in Canada is 7%–17%. In the survey, 15% of women and 6% of men self-reported that they had physician-diagnosed migraine. Mental health was assessed using the World Health Mental Composite International Diagnostic Interview.

As has been seen in other studies, migraine was most prevalent among lower-income respondents. Married respondents were less likely to have migraine than were those who were widowed, separated, or divorced, Dr. Jette said.

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

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

The authors also analyzed survey data on health-related outcomes, including 2-week disability, restrictions on activities, quality of life, and use of mental health care. They found that patients with a combination of migraine and major depressive disorder, bipolar disorder, panic disorder, or social phobia had a reduced likelihood of a good health outcome.

The study's strengths included its high participation rate and that it was a representative sample, said Dr. Jette, who reported no conflicts of interest. But, she noted, it did not use International Classification of Headache Disorder (ICHD) criteria, and it is cross-sectional, which she said limits inference on causal mechanisms for the relationship between migraine and psychiatric conditions.

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

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

Many studies have shown an association between migraine and psychiatric conditions; the goal of this study was to determine potential impact on health outcomes and implications for health policies in Canada, Dr. Jette said. Patients with migraine and psychiatric comorbidities tend to use more health resources; identifying them can lead to more preventive treatment and better-targeted therapies, Dr. Jette said.

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

Dr. Jette said that he estimated lifetime prevalence of migraine in Canada is 7%–17%. In the survey, 15% of women and 6% of men self-reported that they had physician-diagnosed migraine. Mental health was assessed using the World Health Mental Composite International Diagnostic Interview.

As has been seen in other studies, migraine was most prevalent among lower-income respondents. Married respondents were less likely to have migraine than were those who were widowed, separated, or divorced, Dr. Jette said.

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

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

The authors also analyzed survey data on health-related outcomes, including 2-week disability, restrictions on activities, quality of life, and use of mental health care. They found that patients with a combination of migraine and major depressive disorder, bipolar disorder, panic disorder, or social phobia had a reduced likelihood of a good health outcome.

The study's strengths included its high participation rate and that it was a representative sample, said Dr. Jette, who reported no conflicts of interest. But, she noted, it did not use International Classification of Headache Disorder (ICHD) criteria, and it is cross-sectional, which she said limits inference on causal mechanisms for the relationship between migraine and psychiatric conditions.

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

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

Many studies have shown an association between migraine and psychiatric conditions; the goal of this study was to determine potential impact on health outcomes and implications for health policies in Canada, Dr. Jette said. Patients with migraine and psychiatric comorbidities tend to use more health resources; identifying them can lead to more preventive treatment and better-targeted therapies, Dr. Jette said.

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

Dr. Jette said that he estimated lifetime prevalence of migraine in Canada is 7%–17%. In the survey, 15% of women and 6% of men self-reported that they had physician-diagnosed migraine. Mental health was assessed using the World Health Mental Composite International Diagnostic Interview.

As has been seen in other studies, migraine was most prevalent among lower-income respondents. Married respondents were less likely to have migraine than were those who were widowed, separated, or divorced, Dr. Jette said.

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

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

The authors also analyzed survey data on health-related outcomes, including 2-week disability, restrictions on activities, quality of life, and use of mental health care. They found that patients with a combination of migraine and major depressive disorder, bipolar disorder, panic disorder, or social phobia had a reduced likelihood of a good health outcome.

The study's strengths included its high participation rate and that it was a representative sample, said Dr. Jette, who reported no conflicts of interest. But, she noted, it did not use International Classification of Headache Disorder (ICHD) criteria, and it is cross-sectional, which she said limits inference on causal mechanisms for the relationship between migraine and psychiatric conditions.

NEW ORLEANS – New-onset depression after hip fracture is fairly common and may be explained in part by certain polymorphisms of the serotonin 1A and 2A receptors, Dr. Eric J. Lenze said in a poster presented at the annual meeting of the American Association for Geriatric Psychiatry.

He and his associates undertook the study to determine whether people with a given vulnerability gene might be more susceptible to late-life depression onset, and hip fracture was considered a good laboratory, Dr. Lenze, of the psychiatry department at the University of Pittsburgh, said in an interview.

Since serotonin is part of the stress response system, the investigators posited that a variation in those receptors might predict a depression response, he added.

They examined 145 older women (median age 81 years) hospitalized after a hip fracture and followed them for a year. Depression and functional status were measured by the Geriatric Depression Scale, the Physical Activities of Daily Living scale, and the Instrumental Activities of Daily Living (IADL) scale. Serum samples also were obtained. The women were genotyped for the risk allele for the two serotonin receptors: 5HTR1A and 5HTR2A.

Women with one to two copies of the risk allele for 5HTR1A had more depression and poorer IADL scores than women without the allele. Dr. Lenze noted the link between depression and bad outcomes.

Interestingly, women with one to two copies of the risk allele for the 2A receptor did not have a higher risk of depression, and they had higher IADL scores after hip fracture, he said.

Dr. Lenze said that the 2A finding might indicate some adaptability afforded by this allele in the 2A receptor, which might help explain why some elderly people are more resistant to the impact of injuries or disease.

The researchers aim to replicate the findings in a larger study and also use them as a springboard to possibly develop a model to help clinicians determine who is at risk for new-onset depression after hip fracture, said Dr. Lenze.

NEW ORLEANS – New-onset depression after hip fracture is fairly common and may be explained in part by certain polymorphisms of the serotonin 1A and 2A receptors, Dr. Eric J. Lenze said in a poster presented at the annual meeting of the American Association for Geriatric Psychiatry.

He and his associates undertook the study to determine whether people with a given vulnerability gene might be more susceptible to late-life depression onset, and hip fracture was considered a good laboratory, Dr. Lenze, of the psychiatry department at the University of Pittsburgh, said in an interview.

Since serotonin is part of the stress response system, the investigators posited that a variation in those receptors might predict a depression response, he added.

They examined 145 older women (median age 81 years) hospitalized after a hip fracture and followed them for a year. Depression and functional status were measured by the Geriatric Depression Scale, the Physical Activities of Daily Living scale, and the Instrumental Activities of Daily Living (IADL) scale. Serum samples also were obtained. The women were genotyped for the risk allele for the two serotonin receptors: 5HTR1A and 5HTR2A.

Women with one to two copies of the risk allele for 5HTR1A had more depression and poorer IADL scores than women without the allele. Dr. Lenze noted the link between depression and bad outcomes.

Interestingly, women with one to two copies of the risk allele for the 2A receptor did not have a higher risk of depression, and they had higher IADL scores after hip fracture, he said.

Dr. Lenze said that the 2A finding might indicate some adaptability afforded by this allele in the 2A receptor, which might help explain why some elderly people are more resistant to the impact of injuries or disease.

The researchers aim to replicate the findings in a larger study and also use them as a springboard to possibly develop a model to help clinicians determine who is at risk for new-onset depression after hip fracture, said Dr. Lenze.

NEW ORLEANS – New-onset depression after hip fracture is fairly common and may be explained in part by certain polymorphisms of the serotonin 1A and 2A receptors, Dr. Eric J. Lenze said in a poster presented at the annual meeting of the American Association for Geriatric Psychiatry.

He and his associates undertook the study to determine whether people with a given vulnerability gene might be more susceptible to late-life depression onset, and hip fracture was considered a good laboratory, Dr. Lenze, of the psychiatry department at the University of Pittsburgh, said in an interview.

Since serotonin is part of the stress response system, the investigators posited that a variation in those receptors might predict a depression response, he added.

They examined 145 older women (median age 81 years) hospitalized after a hip fracture and followed them for a year. Depression and functional status were measured by the Geriatric Depression Scale, the Physical Activities of Daily Living scale, and the Instrumental Activities of Daily Living (IADL) scale. Serum samples also were obtained. The women were genotyped for the risk allele for the two serotonin receptors: 5HTR1A and 5HTR2A.

Women with one to two copies of the risk allele for 5HTR1A had more depression and poorer IADL scores than women without the allele. Dr. Lenze noted the link between depression and bad outcomes.

Interestingly, women with one to two copies of the risk allele for the 2A receptor did not have a higher risk of depression, and they had higher IADL scores after hip fracture, he said.

Dr. Lenze said that the 2A finding might indicate some adaptability afforded by this allele in the 2A receptor, which might help explain why some elderly people are more resistant to the impact of injuries or disease.

The researchers aim to replicate the findings in a larger study and also use them as a springboard to possibly develop a model to help clinicians determine who is at risk for new-onset depression after hip fracture, said Dr. Lenze.

NEW ORLEANS – Adherence with medication regimens is poor among the mentally ill and tends to worsen as those patients age, but there are ways to help patients stick to their regimens, several speakers said at the annual meeting of the American Association for Geriatric Psychiatry.

There are not a lot of data on the elderly mentally ill and drug adherence, but a review of 39 studies published since 1980 that included patients of all ages estimated that the mean rate of nonadherence with antipsychotics was about 50% (J. Clin. Psychiatry 2002;63:892), said Dr. Dilip V. Jeste, distinguished professor of psychiatry and neurosciences at the University of California, San Diego.

While age was not a consistent risk factor for nonadherence, age might still contribute, he said.

Another study looked at adherence to antipsychotics and to medications for hypertension and hyperlipidemia in middle-aged elderly patients with schizophrenia. The authors found that the patients were as nonadherent with antipsychotics as with the medications for medical conditions, with fill rates ranging from 52% to 64% (Psychosom. Med. 2003;65:156). Nonadherence takes many different forms, Dr. Jeste said. A study of Medicaid beneficiaries with schizophrenia found that 41% were fully adherent, 16% were partially adherent, 24% were nonadherent, and 19% were excess fillers (Am. J. Psychiatry 2004;161:692), he said.

Adherence is affected by many factors, including side effects and the cost and complexity of the regimen, said Lawrence D. Cohen, Pharm.D., professor of pharmacotherapy at Washington State University, Spokane.

To get at the root of adherence issues, psychiatrists should assess mood, cognition, vision, mobility, and ability to pay for the prescription, said Dr. George T. Grossberg, director of the division of geriatric psychiatry at St. Louis University.

Adherence can be assessed through patient self-reports, but most overestimate their adherence, Dr. Jeste said. Caregivers may also be a source of information, but most don't observe the patient on a day-to-day basis, he said. Pill counts are not very accurate, because patients can throw the medication away.

He often uses the Brief Evaluation of Medication Influences and Beliefs, which was developed by a colleague (J. Clin. Psychopharmacol. 2004;24:404). The patient self-administers the eight-item test, which can be done in the waiting room in less than 5 minutes. The scores can be correlated with pharmacy refill records and Drug Attitude Inventory Scores, Dr. Jeste said.

To improve adherence, strike an alliance with your patients, Dr. Cohen said. That includes educating patients and families about the medications and emphasizing their value. “Patients have to believe that the medications or treatments we're suggesting are valuable, are worth their costs, even if they have adverse events,” he said.

Dr. Grossberg agreed that collaboration is important. He advocates what he calls “AIDES”–assessment, individualizing the regimen, choosing appropriate documentation, providing ongoing education tailored to the individual's age and needs, and continuing supervision after initiation.

Electronic caps, unit dosing, blister packs, and pillboxes with timers or calendars can also help, Dr. Grossberg said. He also encourages patients to keep a medication list in their purse or wallet. Telephone follow-up reminders from the physician office are very effective, he said.

Dr. Grossberg is a consultant for Bristol-Myers Squibb, Forest Pharmaceuticals, Janssen, Novartis, Organon, Sanofi-Aventis, Sepracor Inc., and Takeda Pharmaceuticals North America Inc. In addition, he receives grants or support from Abbott Laboratories, AstraZeneca, Eunoe Inc., Forest, GlaxoSmithKline, Myriad, Novartis, Ono Pharmaceutical Co., Pfizer Inc., and Wyeth.

Dr. Jeste is a consultant for Bristol-Myers, Janssen, Otsuka America Pharmaceutical, Solvay Pharmaceuticals, and Wyeth, and he receives other financial support from AstraZeneca, Bristol-Myers, Eli Lilly & Co., and Janssen.

Dr. Cohen is a consultant with Eli Lilly, Solvay, and Wyeth and is on the speakers' bureau for AstraZeneca, Eli Lilly, Forest, GlaxoSmithKline, Janssen, and Sepracor.

NEW ORLEANS – Adherence with medication regimens is poor among the mentally ill and tends to worsen as those patients age, but there are ways to help patients stick to their regimens, several speakers said at the annual meeting of the American Association for Geriatric Psychiatry.

There are not a lot of data on the elderly mentally ill and drug adherence, but a review of 39 studies published since 1980 that included patients of all ages estimated that the mean rate of nonadherence with antipsychotics was about 50% (J. Clin. Psychiatry 2002;63:892), said Dr. Dilip V. Jeste, distinguished professor of psychiatry and neurosciences at the University of California, San Diego.

While age was not a consistent risk factor for nonadherence, age might still contribute, he said.

Another study looked at adherence to antipsychotics and to medications for hypertension and hyperlipidemia in middle-aged elderly patients with schizophrenia. The authors found that the patients were as nonadherent with antipsychotics as with the medications for medical conditions, with fill rates ranging from 52% to 64% (Psychosom. Med. 2003;65:156). Nonadherence takes many different forms, Dr. Jeste said. A study of Medicaid beneficiaries with schizophrenia found that 41% were fully adherent, 16% were partially adherent, 24% were nonadherent, and 19% were excess fillers (Am. J. Psychiatry 2004;161:692), he said.

Adherence is affected by many factors, including side effects and the cost and complexity of the regimen, said Lawrence D. Cohen, Pharm.D., professor of pharmacotherapy at Washington State University, Spokane.

To get at the root of adherence issues, psychiatrists should assess mood, cognition, vision, mobility, and ability to pay for the prescription, said Dr. George T. Grossberg, director of the division of geriatric psychiatry at St. Louis University.

Adherence can be assessed through patient self-reports, but most overestimate their adherence, Dr. Jeste said. Caregivers may also be a source of information, but most don't observe the patient on a day-to-day basis, he said. Pill counts are not very accurate, because patients can throw the medication away.

He often uses the Brief Evaluation of Medication Influences and Beliefs, which was developed by a colleague (J. Clin. Psychopharmacol. 2004;24:404). The patient self-administers the eight-item test, which can be done in the waiting room in less than 5 minutes. The scores can be correlated with pharmacy refill records and Drug Attitude Inventory Scores, Dr. Jeste said.

To improve adherence, strike an alliance with your patients, Dr. Cohen said. That includes educating patients and families about the medications and emphasizing their value. “Patients have to believe that the medications or treatments we're suggesting are valuable, are worth their costs, even if they have adverse events,” he said.

Dr. Grossberg agreed that collaboration is important. He advocates what he calls “AIDES”–assessment, individualizing the regimen, choosing appropriate documentation, providing ongoing education tailored to the individual's age and needs, and continuing supervision after initiation.

Electronic caps, unit dosing, blister packs, and pillboxes with timers or calendars can also help, Dr. Grossberg said. He also encourages patients to keep a medication list in their purse or wallet. Telephone follow-up reminders from the physician office are very effective, he said.

Dr. Grossberg is a consultant for Bristol-Myers Squibb, Forest Pharmaceuticals, Janssen, Novartis, Organon, Sanofi-Aventis, Sepracor Inc., and Takeda Pharmaceuticals North America Inc. In addition, he receives grants or support from Abbott Laboratories, AstraZeneca, Eunoe Inc., Forest, GlaxoSmithKline, Myriad, Novartis, Ono Pharmaceutical Co., Pfizer Inc., and Wyeth.

Dr. Jeste is a consultant for Bristol-Myers, Janssen, Otsuka America Pharmaceutical, Solvay Pharmaceuticals, and Wyeth, and he receives other financial support from AstraZeneca, Bristol-Myers, Eli Lilly & Co., and Janssen.

Dr. Cohen is a consultant with Eli Lilly, Solvay, and Wyeth and is on the speakers' bureau for AstraZeneca, Eli Lilly, Forest, GlaxoSmithKline, Janssen, and Sepracor.

NEW ORLEANS – Adherence with medication regimens is poor among the mentally ill and tends to worsen as those patients age, but there are ways to help patients stick to their regimens, several speakers said at the annual meeting of the American Association for Geriatric Psychiatry.

There are not a lot of data on the elderly mentally ill and drug adherence, but a review of 39 studies published since 1980 that included patients of all ages estimated that the mean rate of nonadherence with antipsychotics was about 50% (J. Clin. Psychiatry 2002;63:892), said Dr. Dilip V. Jeste, distinguished professor of psychiatry and neurosciences at the University of California, San Diego.

While age was not a consistent risk factor for nonadherence, age might still contribute, he said.

Another study looked at adherence to antipsychotics and to medications for hypertension and hyperlipidemia in middle-aged elderly patients with schizophrenia. The authors found that the patients were as nonadherent with antipsychotics as with the medications for medical conditions, with fill rates ranging from 52% to 64% (Psychosom. Med. 2003;65:156). Nonadherence takes many different forms, Dr. Jeste said. A study of Medicaid beneficiaries with schizophrenia found that 41% were fully adherent, 16% were partially adherent, 24% were nonadherent, and 19% were excess fillers (Am. J. Psychiatry 2004;161:692), he said.

Adherence is affected by many factors, including side effects and the cost and complexity of the regimen, said Lawrence D. Cohen, Pharm.D., professor of pharmacotherapy at Washington State University, Spokane.

To get at the root of adherence issues, psychiatrists should assess mood, cognition, vision, mobility, and ability to pay for the prescription, said Dr. George T. Grossberg, director of the division of geriatric psychiatry at St. Louis University.

Adherence can be assessed through patient self-reports, but most overestimate their adherence, Dr. Jeste said. Caregivers may also be a source of information, but most don't observe the patient on a day-to-day basis, he said. Pill counts are not very accurate, because patients can throw the medication away.

He often uses the Brief Evaluation of Medication Influences and Beliefs, which was developed by a colleague (J. Clin. Psychopharmacol. 2004;24:404). The patient self-administers the eight-item test, which can be done in the waiting room in less than 5 minutes. The scores can be correlated with pharmacy refill records and Drug Attitude Inventory Scores, Dr. Jeste said.

To improve adherence, strike an alliance with your patients, Dr. Cohen said. That includes educating patients and families about the medications and emphasizing their value. “Patients have to believe that the medications or treatments we're suggesting are valuable, are worth their costs, even if they have adverse events,” he said.

Dr. Grossberg agreed that collaboration is important. He advocates what he calls “AIDES”–assessment, individualizing the regimen, choosing appropriate documentation, providing ongoing education tailored to the individual's age and needs, and continuing supervision after initiation.

Electronic caps, unit dosing, blister packs, and pillboxes with timers or calendars can also help, Dr. Grossberg said. He also encourages patients to keep a medication list in their purse or wallet. Telephone follow-up reminders from the physician office are very effective, he said.

Dr. Grossberg is a consultant for Bristol-Myers Squibb, Forest Pharmaceuticals, Janssen, Novartis, Organon, Sanofi-Aventis, Sepracor Inc., and Takeda Pharmaceuticals North America Inc. In addition, he receives grants or support from Abbott Laboratories, AstraZeneca, Eunoe Inc., Forest, GlaxoSmithKline, Myriad, Novartis, Ono Pharmaceutical Co., Pfizer Inc., and Wyeth.

Dr. Jeste is a consultant for Bristol-Myers, Janssen, Otsuka America Pharmaceutical, Solvay Pharmaceuticals, and Wyeth, and he receives other financial support from AstraZeneca, Bristol-Myers, Eli Lilly & Co., and Janssen.

Dr. Cohen is a consultant with Eli Lilly, Solvay, and Wyeth and is on the speakers' bureau for AstraZeneca, Eli Lilly, Forest, GlaxoSmithKline, Janssen, and Sepracor.

NEW ORLEANS – The dizzying array of scales available for measuring dementia and mental illness in the elderly can be whittled down to create an essential picture of an individual patient. Most importantly, these scales can be used to establish a baseline to monitor progression or worsening and to meet federal documentation requirements in nursing homes, speakers said at the annual meeting of the American Association for Geriatric Psychiatry.

“You should choose scales that are brief, easy to score and have proven validity and reliability,” said Dr. Allan Anderson, director of geriatric psychiatry at Shore Behavioral Health Services, Cambridge, Md.

Scales can enhance clinical practice and measure the effectiveness of psychiatric treatments, Dr. Anderson said.

Deborah Weber helps administer scales to patients at Shore Behavioral Health. Usually, she said, she spends an hour or more with patients and their caregivers. The tests are not used to make a diagnosis, she said.

The Mini-Mental Status Exam is one of the most frequently administered scales at Shore Behavioral Health, Ms. Weber said. Although this is a common exam measuring cognitive ability, it has some limitations. Patients have to be fluent in English, or they may not do well, she said, adding that they also have to be literate. If they can't spell “world” forward, then they won't be able to spell it backward, she notes. The MMSE usually only takes 10 minutes to administer, but, she said, “don't rush the patient–some patients take longer.”

Ms. Weber also uses several executive function tests, which occasionally require family or caregiver input. Examples include the Tinker Toy Test, Tower of Hanoi, and Proteus Mazes. Failure doesn't automatically mean dementia, she said, noting that medical illness or other mental disorders can interfere with executive function. Fluency tests–such as asking patients to categorize items–are also good ways to measure executive function, she said.

The clinician-administered CLOX test, developed by Dr. Donald Royall, has rapidly gained followers, Ms. Weber said. It is a good test, but “it's important that you understand the nuances of this scoring,” she said.

To measure depression, she uses the Geriatric Depression and the Cornell Scale for Depression in Dementia. Independence can be assessed with the Physical Self-Maintenance Scale or the Functional Activities Questionnaire, which takes only 5–10 minutes to complete, rating the patient's abilities in 10 areas.

Another test she likes is the Dementia Rating Scale II, which is clinician administered and computer scored, measuring competency in attention, initiation/preservation, construction, conceptualization, and memory. However, this test is not sensitive enough to detect mild forms of dementia in people who are intelligent or well educated, Ms. Weber said.

The choice of scales should be based on each patient's specific needs, she said. However, each battery should measure memory, executive function, and activities of daily living, she said.

For nursing home patients, there are several scales that will help establish a baseline of behavior and help meet federal documentation requirements under the Omnibus Reconciliation Act, said Dr. Alan Siegal of the department of psychiatry at Yale University, New Haven, Conn.

The Behave-AD can be done in as little as 10 minutes once the test-giver is familiar with the format, he said. This exam should be given by certified nurses' aides, as nurses are generally too overwhelmed, Dr. Siegal said.

The patient is asked questions covering behaviors over the last 2 weeks in seven domains: paranoid and delusional ideation, hallucinations, activity disturbances, aggressiveness, diurnal rhythm disturbances, affective disturbances, and anxieties and phobias. There are 25 questions with answers rated from 0 to 3. The staff is then asked to assign a global rating from 0 (not at all troubling to the caregiver or dangerous to the patient) to 3 (severely troubling or dangerous).

The scale establishes a baseline documenting the behaviors that led to a medication, or some other intervention, he said.

Another useful scale is the Cohen Mansfield Agitation Inventory. It provides “a wonderful thesaurus for 'agitation,'” Dr. Siegal said. It also allows the caregiver to give the physician a descriptive picture of what's happening with the patient. It only takes about 10–15 minutes to complete. The short form rates 14 areas of distressed behavior, including hitting, verbal aggression, grabbing, constant requests for attention, repetitive sentences, weird laughter, and hiding or hoarding things. The frequency of these behaviors is tabulated on a 5-point scale, from never to a few times an hour. Documenting the initial frequency allows the institution and the clinician to show what progress has occurred after a few weeks of intervention, he said.

Another scale that rates frequency and severity of behaviors is the Neuropsychiatric Inventory for Nursing Homes. The NPI is a little more difficult to complete but becomes easier with experience, Dr. Siegal said.

It has good concurrent reliability with both the Hamilton Depression Scale and the Behave-AD, he said, measuring behaviors in 12 domains. If the symptom has been present within the past month, the rater answers yes and then rates the frequency and severity on a 4-point scale and caregiver distress on a 0–5 scale. These scales are often used to establish baselines for medication-based intervention, but pharmaceuticals are not always necessary, Dr. Siegal said.

Sometimes, it's as simple as giving the patient a little attention, asking them how they are doing, and acquiescing to some requests, no matter how delusional they might seem. This approach can head off escalation and the need for a pharmacologic intervention, he said.

NEW ORLEANS – The dizzying array of scales available for measuring dementia and mental illness in the elderly can be whittled down to create an essential picture of an individual patient. Most importantly, these scales can be used to establish a baseline to monitor progression or worsening and to meet federal documentation requirements in nursing homes, speakers said at the annual meeting of the American Association for Geriatric Psychiatry.

“You should choose scales that are brief, easy to score and have proven validity and reliability,” said Dr. Allan Anderson, director of geriatric psychiatry at Shore Behavioral Health Services, Cambridge, Md.

Scales can enhance clinical practice and measure the effectiveness of psychiatric treatments, Dr. Anderson said.

Deborah Weber helps administer scales to patients at Shore Behavioral Health. Usually, she said, she spends an hour or more with patients and their caregivers. The tests are not used to make a diagnosis, she said.

The Mini-Mental Status Exam is one of the most frequently administered scales at Shore Behavioral Health, Ms. Weber said. Although this is a common exam measuring cognitive ability, it has some limitations. Patients have to be fluent in English, or they may not do well, she said, adding that they also have to be literate. If they can't spell “world” forward, then they won't be able to spell it backward, she notes. The MMSE usually only takes 10 minutes to administer, but, she said, “don't rush the patient–some patients take longer.”

Ms. Weber also uses several executive function tests, which occasionally require family or caregiver input. Examples include the Tinker Toy Test, Tower of Hanoi, and Proteus Mazes. Failure doesn't automatically mean dementia, she said, noting that medical illness or other mental disorders can interfere with executive function. Fluency tests–such as asking patients to categorize items–are also good ways to measure executive function, she said.

The clinician-administered CLOX test, developed by Dr. Donald Royall, has rapidly gained followers, Ms. Weber said. It is a good test, but “it's important that you understand the nuances of this scoring,” she said.

To measure depression, she uses the Geriatric Depression and the Cornell Scale for Depression in Dementia. Independence can be assessed with the Physical Self-Maintenance Scale or the Functional Activities Questionnaire, which takes only 5–10 minutes to complete, rating the patient's abilities in 10 areas.

Another test she likes is the Dementia Rating Scale II, which is clinician administered and computer scored, measuring competency in attention, initiation/preservation, construction, conceptualization, and memory. However, this test is not sensitive enough to detect mild forms of dementia in people who are intelligent or well educated, Ms. Weber said.

The choice of scales should be based on each patient's specific needs, she said. However, each battery should measure memory, executive function, and activities of daily living, she said.

For nursing home patients, there are several scales that will help establish a baseline of behavior and help meet federal documentation requirements under the Omnibus Reconciliation Act, said Dr. Alan Siegal of the department of psychiatry at Yale University, New Haven, Conn.

The Behave-AD can be done in as little as 10 minutes once the test-giver is familiar with the format, he said. This exam should be given by certified nurses' aides, as nurses are generally too overwhelmed, Dr. Siegal said.

The patient is asked questions covering behaviors over the last 2 weeks in seven domains: paranoid and delusional ideation, hallucinations, activity disturbances, aggressiveness, diurnal rhythm disturbances, affective disturbances, and anxieties and phobias. There are 25 questions with answers rated from 0 to 3. The staff is then asked to assign a global rating from 0 (not at all troubling to the caregiver or dangerous to the patient) to 3 (severely troubling or dangerous).

The scale establishes a baseline documenting the behaviors that led to a medication, or some other intervention, he said.

Another useful scale is the Cohen Mansfield Agitation Inventory. It provides “a wonderful thesaurus for 'agitation,'” Dr. Siegal said. It also allows the caregiver to give the physician a descriptive picture of what's happening with the patient. It only takes about 10–15 minutes to complete. The short form rates 14 areas of distressed behavior, including hitting, verbal aggression, grabbing, constant requests for attention, repetitive sentences, weird laughter, and hiding or hoarding things. The frequency of these behaviors is tabulated on a 5-point scale, from never to a few times an hour. Documenting the initial frequency allows the institution and the clinician to show what progress has occurred after a few weeks of intervention, he said.

Another scale that rates frequency and severity of behaviors is the Neuropsychiatric Inventory for Nursing Homes. The NPI is a little more difficult to complete but becomes easier with experience, Dr. Siegal said.

It has good concurrent reliability with both the Hamilton Depression Scale and the Behave-AD, he said, measuring behaviors in 12 domains. If the symptom has been present within the past month, the rater answers yes and then rates the frequency and severity on a 4-point scale and caregiver distress on a 0–5 scale. These scales are often used to establish baselines for medication-based intervention, but pharmaceuticals are not always necessary, Dr. Siegal said.

Sometimes, it's as simple as giving the patient a little attention, asking them how they are doing, and acquiescing to some requests, no matter how delusional they might seem. This approach can head off escalation and the need for a pharmacologic intervention, he said.

NEW ORLEANS – The dizzying array of scales available for measuring dementia and mental illness in the elderly can be whittled down to create an essential picture of an individual patient. Most importantly, these scales can be used to establish a baseline to monitor progression or worsening and to meet federal documentation requirements in nursing homes, speakers said at the annual meeting of the American Association for Geriatric Psychiatry.

“You should choose scales that are brief, easy to score and have proven validity and reliability,” said Dr. Allan Anderson, director of geriatric psychiatry at Shore Behavioral Health Services, Cambridge, Md.

Scales can enhance clinical practice and measure the effectiveness of psychiatric treatments, Dr. Anderson said.

Deborah Weber helps administer scales to patients at Shore Behavioral Health. Usually, she said, she spends an hour or more with patients and their caregivers. The tests are not used to make a diagnosis, she said.

The Mini-Mental Status Exam is one of the most frequently administered scales at Shore Behavioral Health, Ms. Weber said. Although this is a common exam measuring cognitive ability, it has some limitations. Patients have to be fluent in English, or they may not do well, she said, adding that they also have to be literate. If they can't spell “world” forward, then they won't be able to spell it backward, she notes. The MMSE usually only takes 10 minutes to administer, but, she said, “don't rush the patient–some patients take longer.”

Ms. Weber also uses several executive function tests, which occasionally require family or caregiver input. Examples include the Tinker Toy Test, Tower of Hanoi, and Proteus Mazes. Failure doesn't automatically mean dementia, she said, noting that medical illness or other mental disorders can interfere with executive function. Fluency tests–such as asking patients to categorize items–are also good ways to measure executive function, she said.

The clinician-administered CLOX test, developed by Dr. Donald Royall, has rapidly gained followers, Ms. Weber said. It is a good test, but “it's important that you understand the nuances of this scoring,” she said.

To measure depression, she uses the Geriatric Depression and the Cornell Scale for Depression in Dementia. Independence can be assessed with the Physical Self-Maintenance Scale or the Functional Activities Questionnaire, which takes only 5–10 minutes to complete, rating the patient's abilities in 10 areas.

Another test she likes is the Dementia Rating Scale II, which is clinician administered and computer scored, measuring competency in attention, initiation/preservation, construction, conceptualization, and memory. However, this test is not sensitive enough to detect mild forms of dementia in people who are intelligent or well educated, Ms. Weber said.

The choice of scales should be based on each patient's specific needs, she said. However, each battery should measure memory, executive function, and activities of daily living, she said.

For nursing home patients, there are several scales that will help establish a baseline of behavior and help meet federal documentation requirements under the Omnibus Reconciliation Act, said Dr. Alan Siegal of the department of psychiatry at Yale University, New Haven, Conn.

The Behave-AD can be done in as little as 10 minutes once the test-giver is familiar with the format, he said. This exam should be given by certified nurses' aides, as nurses are generally too overwhelmed, Dr. Siegal said.

The patient is asked questions covering behaviors over the last 2 weeks in seven domains: paranoid and delusional ideation, hallucinations, activity disturbances, aggressiveness, diurnal rhythm disturbances, affective disturbances, and anxieties and phobias. There are 25 questions with answers rated from 0 to 3. The staff is then asked to assign a global rating from 0 (not at all troubling to the caregiver or dangerous to the patient) to 3 (severely troubling or dangerous).

The scale establishes a baseline documenting the behaviors that led to a medication, or some other intervention, he said.

Another useful scale is the Cohen Mansfield Agitation Inventory. It provides “a wonderful thesaurus for 'agitation,'” Dr. Siegal said. It also allows the caregiver to give the physician a descriptive picture of what's happening with the patient. It only takes about 10–15 minutes to complete. The short form rates 14 areas of distressed behavior, including hitting, verbal aggression, grabbing, constant requests for attention, repetitive sentences, weird laughter, and hiding or hoarding things. The frequency of these behaviors is tabulated on a 5-point scale, from never to a few times an hour. Documenting the initial frequency allows the institution and the clinician to show what progress has occurred after a few weeks of intervention, he said.

Another scale that rates frequency and severity of behaviors is the Neuropsychiatric Inventory for Nursing Homes. The NPI is a little more difficult to complete but becomes easier with experience, Dr. Siegal said.

It has good concurrent reliability with both the Hamilton Depression Scale and the Behave-AD, he said, measuring behaviors in 12 domains. If the symptom has been present within the past month, the rater answers yes and then rates the frequency and severity on a 4-point scale and caregiver distress on a 0–5 scale. These scales are often used to establish baselines for medication-based intervention, but pharmaceuticals are not always necessary, Dr. Siegal said.

Sometimes, it's as simple as giving the patient a little attention, asking them how they are doing, and acquiescing to some requests, no matter how delusional they might seem. This approach can head off escalation and the need for a pharmacologic intervention, he said.