Alicia Ault

Bill Seeks Consent for Off-Label Rx

A bill in the California assembly would require physicians to get informed consent from their patients before “prescribing, administering, or furnishing” a prescription for off-label use. A failure to adhere to the requirement would be considered a violation of the Medical Practice Act, which means physicians could be charged with a crime. The California Medical Association opposes the legislation and said the existing law is enough because physicians can be held liable for not disclosing risks. The bill would require physicians to specify that a medication is not approved by the Food and Drug Administration for the use that the doctor is recommending, and that the risks are unknown and there is not a consensus on the efficacy.

Obesity Linked to 2%–3% of Claims

Obesity accounts for 2%–3% of medical claims dollars, according to a retrospective study in the March issue of the Journal of Occupational and Environmental Medicine. Researchers at Gordian Health Solutions Inc. assessed claims from January 2000 to December 2004 from 61 employers. In 2004 inflation-adjusted dollars, total claims for the study period amounted to $4.55 billion. Obesity was responsible for 2.1% of total claims for male workers ($3.55/member per month) and 2.8% for female workers ($5.71/member per month). The true tally may be higher, said the researchers, noting that their analysis excluded prescription drug costs. Given that the data show a rise in obesity-related costs with increasing age, “childhood obesity may have significant lagged effects.”

IOM on Quality Improvement Groups

An Institute of Medicine committee has released a report on Medicare's Quality Improvement Organizations that describes these groups as spending too much time on reviewing beneficiary complaints and not enough on helping physicians and health care organizations to actually improve care. The panel said there are inherent conflicts when the QIO reviews complaints about organizations it needs to voluntarily participate in quality improvement efforts, and suggested that case reviews should be shifted to regional or national agencies. The 22-member IOM panel spent a year investigating the 41 organizations that are hired by Medicare to improve quality of care, address patient complaints, and review claims to ensure they meet quality benchmarks and reimbursement standards. Stephen M. Shortell, Ph.D., an IOM panel member, said the committee's main finding was that, while the quality of care has improved, “the pace of change is too slow, and gaps in quality persist.” QIOs should be providing more technical assistance to physicians and hospitals, said Dr. Shortell, who is a professor of health policy and management at the University of California, Berkeley. The IOM panel said that QIO boards—which it said are dominated by physicians—should include more consumers, representatives of other health fields, and health information technology experts, and have greater accountability to the public. The American Health Quality Association, a QIO trade group, said it supported most of the recommendations, but said that the organizations should continue to review complaints and appeals because it provided “invaluable opportunities to help providers improve care for all patients.” The AHQA also noted that 30 of 41 QIOs had signed a code of conduct that would make them more accountable.

Many Enrollees Happy With Part D

A new survey of Medicare beneficiaries who are receiving Part D drug benefits finds them to be largely satisfied. The survey—conducted 10 weeks into the new coverage—was paid for by America's Health Insurance Plans, and conducted by Ayres, McHenry & Associates Inc., a Republican polling firm. The poll surveyed 408 of the 5.2 million people over age 65 years who have self-enrolled in Part D, and 401 of the 6.5 million “dual eligibles,” who were automatically enrolled because they had Medicaid drug coverage. Of those who self-enrolled, 66% said it had been worth the time and effort to enroll, and four-fifths (84%) said they had no problem signing up. The majority—85%–90% of both groups—said they had no problem using the new benefit. “This is a dramatic departure from the conventional wisdom about this program,” said Whitfield Ayres, Ph.D., president of the polling firm. But Ron Pollack, executive director of the advocacy group Families USA, said it was not surprising that beneficiaries who went to the trouble to sign up were happy. Shockingly few have signed up, however, Mr. Pollack said. “America's seniors are clearly voting with their feet,” he said.

All Groups at Risk for Poor Care

Although disparities exist in health care among various ethnic and racial groups, those gaps are small compared with the health care everyone receives and what they should be receiving, according to a report from the Rand Corporation. “Differences exist. But they pale in comparison to the chasm between where we are today and where we should be,” said Dr. Steven M. Asch of the University of California, Los Angeles, the study's lead author. “These findings tell us that no one can afford to be complacent, and they underscore that the quality-of-care problem in this country is profound and systemic.” The study assessed preventive services and care for 30 acute and chronic conditions that constitute the leading causes of death and disability. Overall, participants received about 55% of recommended care, despite the fact that the recommendations for the conditions involved were widely known and accepted.

Bill Seeks Consent for Off-Label Rx

A bill in the California assembly would require physicians to get informed consent from their patients before “prescribing, administering, or furnishing” a prescription for off-label use. A failure to adhere to the requirement would be considered a violation of the Medical Practice Act, which means physicians could be charged with a crime. The California Medical Association opposes the legislation and said the existing law is enough because physicians can be held liable for not disclosing risks. The bill would require physicians to specify that a medication is not approved by the Food and Drug Administration for the use that the doctor is recommending, and that the risks are unknown and there is not a consensus on the efficacy.

Obesity Linked to 2%–3% of Claims

Obesity accounts for 2%–3% of medical claims dollars, according to a retrospective study in the March issue of the Journal of Occupational and Environmental Medicine. Researchers at Gordian Health Solutions Inc. assessed claims from January 2000 to December 2004 from 61 employers. In 2004 inflation-adjusted dollars, total claims for the study period amounted to $4.55 billion. Obesity was responsible for 2.1% of total claims for male workers ($3.55/member per month) and 2.8% for female workers ($5.71/member per month). The true tally may be higher, said the researchers, noting that their analysis excluded prescription drug costs. Given that the data show a rise in obesity-related costs with increasing age, “childhood obesity may have significant lagged effects.”

IOM on Quality Improvement Groups

An Institute of Medicine committee has released a report on Medicare's Quality Improvement Organizations that describes these groups as spending too much time on reviewing beneficiary complaints and not enough on helping physicians and health care organizations to actually improve care. The panel said there are inherent conflicts when the QIO reviews complaints about organizations it needs to voluntarily participate in quality improvement efforts, and suggested that case reviews should be shifted to regional or national agencies. The 22-member IOM panel spent a year investigating the 41 organizations that are hired by Medicare to improve quality of care, address patient complaints, and review claims to ensure they meet quality benchmarks and reimbursement standards. Stephen M. Shortell, Ph.D., an IOM panel member, said the committee's main finding was that, while the quality of care has improved, “the pace of change is too slow, and gaps in quality persist.” QIOs should be providing more technical assistance to physicians and hospitals, said Dr. Shortell, who is a professor of health policy and management at the University of California, Berkeley. The IOM panel said that QIO boards—which it said are dominated by physicians—should include more consumers, representatives of other health fields, and health information technology experts, and have greater accountability to the public. The American Health Quality Association, a QIO trade group, said it supported most of the recommendations, but said that the organizations should continue to review complaints and appeals because it provided “invaluable opportunities to help providers improve care for all patients.” The AHQA also noted that 30 of 41 QIOs had signed a code of conduct that would make them more accountable.

Many Enrollees Happy With Part D

A new survey of Medicare beneficiaries who are receiving Part D drug benefits finds them to be largely satisfied. The survey—conducted 10 weeks into the new coverage—was paid for by America's Health Insurance Plans, and conducted by Ayres, McHenry & Associates Inc., a Republican polling firm. The poll surveyed 408 of the 5.2 million people over age 65 years who have self-enrolled in Part D, and 401 of the 6.5 million “dual eligibles,” who were automatically enrolled because they had Medicaid drug coverage. Of those who self-enrolled, 66% said it had been worth the time and effort to enroll, and four-fifths (84%) said they had no problem signing up. The majority—85%–90% of both groups—said they had no problem using the new benefit. “This is a dramatic departure from the conventional wisdom about this program,” said Whitfield Ayres, Ph.D., president of the polling firm. But Ron Pollack, executive director of the advocacy group Families USA, said it was not surprising that beneficiaries who went to the trouble to sign up were happy. Shockingly few have signed up, however, Mr. Pollack said. “America's seniors are clearly voting with their feet,” he said.

All Groups at Risk for Poor Care

Although disparities exist in health care among various ethnic and racial groups, those gaps are small compared with the health care everyone receives and what they should be receiving, according to a report from the Rand Corporation. “Differences exist. But they pale in comparison to the chasm between where we are today and where we should be,” said Dr. Steven M. Asch of the University of California, Los Angeles, the study's lead author. “These findings tell us that no one can afford to be complacent, and they underscore that the quality-of-care problem in this country is profound and systemic.” The study assessed preventive services and care for 30 acute and chronic conditions that constitute the leading causes of death and disability. Overall, participants received about 55% of recommended care, despite the fact that the recommendations for the conditions involved were widely known and accepted.

Bill Seeks Consent for Off-Label Rx

A bill in the California assembly would require physicians to get informed consent from their patients before “prescribing, administering, or furnishing” a prescription for off-label use. A failure to adhere to the requirement would be considered a violation of the Medical Practice Act, which means physicians could be charged with a crime. The California Medical Association opposes the legislation and said the existing law is enough because physicians can be held liable for not disclosing risks. The bill would require physicians to specify that a medication is not approved by the Food and Drug Administration for the use that the doctor is recommending, and that the risks are unknown and there is not a consensus on the efficacy.

Obesity Linked to 2%–3% of Claims

Obesity accounts for 2%–3% of medical claims dollars, according to a retrospective study in the March issue of the Journal of Occupational and Environmental Medicine. Researchers at Gordian Health Solutions Inc. assessed claims from January 2000 to December 2004 from 61 employers. In 2004 inflation-adjusted dollars, total claims for the study period amounted to $4.55 billion. Obesity was responsible for 2.1% of total claims for male workers ($3.55/member per month) and 2.8% for female workers ($5.71/member per month). The true tally may be higher, said the researchers, noting that their analysis excluded prescription drug costs. Given that the data show a rise in obesity-related costs with increasing age, “childhood obesity may have significant lagged effects.”

IOM on Quality Improvement Groups

An Institute of Medicine committee has released a report on Medicare's Quality Improvement Organizations that describes these groups as spending too much time on reviewing beneficiary complaints and not enough on helping physicians and health care organizations to actually improve care. The panel said there are inherent conflicts when the QIO reviews complaints about organizations it needs to voluntarily participate in quality improvement efforts, and suggested that case reviews should be shifted to regional or national agencies. The 22-member IOM panel spent a year investigating the 41 organizations that are hired by Medicare to improve quality of care, address patient complaints, and review claims to ensure they meet quality benchmarks and reimbursement standards. Stephen M. Shortell, Ph.D., an IOM panel member, said the committee's main finding was that, while the quality of care has improved, “the pace of change is too slow, and gaps in quality persist.” QIOs should be providing more technical assistance to physicians and hospitals, said Dr. Shortell, who is a professor of health policy and management at the University of California, Berkeley. The IOM panel said that QIO boards—which it said are dominated by physicians—should include more consumers, representatives of other health fields, and health information technology experts, and have greater accountability to the public. The American Health Quality Association, a QIO trade group, said it supported most of the recommendations, but said that the organizations should continue to review complaints and appeals because it provided “invaluable opportunities to help providers improve care for all patients.” The AHQA also noted that 30 of 41 QIOs had signed a code of conduct that would make them more accountable.

Many Enrollees Happy With Part D

A new survey of Medicare beneficiaries who are receiving Part D drug benefits finds them to be largely satisfied. The survey—conducted 10 weeks into the new coverage—was paid for by America's Health Insurance Plans, and conducted by Ayres, McHenry & Associates Inc., a Republican polling firm. The poll surveyed 408 of the 5.2 million people over age 65 years who have self-enrolled in Part D, and 401 of the 6.5 million “dual eligibles,” who were automatically enrolled because they had Medicaid drug coverage. Of those who self-enrolled, 66% said it had been worth the time and effort to enroll, and four-fifths (84%) said they had no problem signing up. The majority—85%–90% of both groups—said they had no problem using the new benefit. “This is a dramatic departure from the conventional wisdom about this program,” said Whitfield Ayres, Ph.D., president of the polling firm. But Ron Pollack, executive director of the advocacy group Families USA, said it was not surprising that beneficiaries who went to the trouble to sign up were happy. Shockingly few have signed up, however, Mr. Pollack said. “America's seniors are clearly voting with their feet,” he said.

All Groups at Risk for Poor Care

Although disparities exist in health care among various ethnic and racial groups, those gaps are small compared with the health care everyone receives and what they should be receiving, according to a report from the Rand Corporation. “Differences exist. But they pale in comparison to the chasm between where we are today and where we should be,” said Dr. Steven M. Asch of the University of California, Los Angeles, the study's lead author. “These findings tell us that no one can afford to be complacent, and they underscore that the quality-of-care problem in this country is profound and systemic.” The study assessed preventive services and care for 30 acute and chronic conditions that constitute the leading causes of death and disability. Overall, participants received about 55% of recommended care, despite the fact that the recommendations for the conditions involved were widely known and accepted.

An old idea—using peers to facilitate recovery—is gaining new attention from public mental health specialists as they search for ways to help the mentally ill get care in an overstretched system and return to productivity.

Peer counseling is the foundation of Alcoholics Anonymous, Narcotics Anonymous, and similar groups that tap people during their recovery to help others get on the same path.

The counselors “can provide a powerful message of hope for people who are hopeless,” said Sue Bergeson, executive vice president of the Depression and Bipolar Support Alliance. They also “stand with that individual through their journey through recovery,” said Ms. Bergeson in an interview.

The DBSA believes that peer support improves recovery and is participating in a research project with Dr. Greg E. Simon, a psychiatrist at Group Health Cooperative of Puget Sound's Center for Health Studies, Seattle, to document the impact of peer support on patient outcomes compared with traditional care.

In the mental health field, people in recovery from depression, bipolar disorder, and other psychiatric conditions may offer one-on-one advice, lead mutual support groups, or staff desks at drop-in centers where they can counsel peers on finding employment and managing day-to-day living issues.

Some self-help groups have been around for decades: GROW Inc., Recovery Inc., and Schizophrenics Anonymous, for instance.

Peer support—defined partly as the sharing of experiential knowledge, skills, and social learning—was included as 1 of the 10 fundamental components of recovery in a recently released consensus statement by the Substance Abuse and Mental Health Services Administration.

Backers of peer support say it improves outcomes and reduces costs. In an overview of the field, Phyllis L. Solomon, Ph.D., a professor of social work at the University of Pennsylvania, Philadelphia, cited numerous studies showing that peer support programs improve symptoms, coping, social functioning, and medication adherence, as well as reduce hospitalizations and use of crisis services (Psychiatr. Rehabil. J. 2004;27:392–401).

Preliminary, yet-to-be-published data from a Georgia study show that peer support improved symptoms and patient functioning at half the cost of traditional care in Medicaid recipients with schizophrenia, depression, and bipolar disorder, said Larry Fricks, former director for consumer relations in the Georgia Department of Human Resources.

However, peer support is not meant to replace therapy—whether talk therapy or medication—provided by a licensed psychiatrist or psychologist.

In Georgia, for instance, where peer services are billable under Medicaid as a psychiatric rehabilitation benefit, a patient who enters the public mental health system is diagnosed by a clinician, who then can recommend peer support as one of the steps toward recovery, said Mr. Fricks, who is now director of the Appalachian Consulting Group in Cleveland, Ga.

The state will bill Medicaid $7 million this year for peer support, Mr. Fricks said in an interview. About 3,000 people are receiving peer support services in Georgia, he said. He is in recovery from bipolar disorder, and his consulting company is working with the federal government to adopt the Georgia model for use in other states.

Those seeking to become counselors in Georgia have to document that they are in recovery and must go through a certification process. About 300 people have completed that process, which includes two weeklong training modules and a written and oral exam.

Peer specialists are expected to help patients create a recovery action plan, find a job, handle employment-related issues, and learn how to use community and other support systems.

South Carolina and Hawaii have already begun peer certification programs, and seven other states are in the early stages, Mr. Fricks said.

Training is crucial, said Dr. Jana Spalding, the mental health specialist in the Broward County Sheriff's Office in Fort Lauderdale, Fla. Florida is one of the states seeking to start certification and receive Medicaid reimbursement.

“Just because you got better doesn't mean you can help other people,” said Dr. Spalding in an interview. Peer counselors have to demonstrate competency, be able to establish a rapport with someone who might be psychotic, and must be nonjudgmental and knowledgeable about medications, their side effects, and community resources, she said.

Dr. Spalding's professional path to pediatrics was interrupted several times and eventually derailed by her bipolar disease. She ended up taking a job at the peer support center where she had been receiving assistance.

Now, through the sheriff's office, she and a team of psychologists work with mentally ill inmates. Dr. Spalding considers it a successful day if she can get an inmate in solitary confinement to interact with other inmates or the psychologists by playing games or watching movies, for instance.

“This is another tool,” Dr. Spalding said. “It provides a lot of intangible benefits in restoring hope, expectation of recovery, and anticipation of improvement of life in general—not just symptoms going away,” she said.

An old idea—using peers to facilitate recovery—is gaining new attention from public mental health specialists as they search for ways to help the mentally ill get care in an overstretched system and return to productivity.

Peer counseling is the foundation of Alcoholics Anonymous, Narcotics Anonymous, and similar groups that tap people during their recovery to help others get on the same path.

The counselors “can provide a powerful message of hope for people who are hopeless,” said Sue Bergeson, executive vice president of the Depression and Bipolar Support Alliance. They also “stand with that individual through their journey through recovery,” said Ms. Bergeson in an interview.

The DBSA believes that peer support improves recovery and is participating in a research project with Dr. Greg E. Simon, a psychiatrist at Group Health Cooperative of Puget Sound's Center for Health Studies, Seattle, to document the impact of peer support on patient outcomes compared with traditional care.

In the mental health field, people in recovery from depression, bipolar disorder, and other psychiatric conditions may offer one-on-one advice, lead mutual support groups, or staff desks at drop-in centers where they can counsel peers on finding employment and managing day-to-day living issues.

Some self-help groups have been around for decades: GROW Inc., Recovery Inc., and Schizophrenics Anonymous, for instance.

Peer support—defined partly as the sharing of experiential knowledge, skills, and social learning—was included as 1 of the 10 fundamental components of recovery in a recently released consensus statement by the Substance Abuse and Mental Health Services Administration.

Backers of peer support say it improves outcomes and reduces costs. In an overview of the field, Phyllis L. Solomon, Ph.D., a professor of social work at the University of Pennsylvania, Philadelphia, cited numerous studies showing that peer support programs improve symptoms, coping, social functioning, and medication adherence, as well as reduce hospitalizations and use of crisis services (Psychiatr. Rehabil. J. 2004;27:392–401).

Preliminary, yet-to-be-published data from a Georgia study show that peer support improved symptoms and patient functioning at half the cost of traditional care in Medicaid recipients with schizophrenia, depression, and bipolar disorder, said Larry Fricks, former director for consumer relations in the Georgia Department of Human Resources.

However, peer support is not meant to replace therapy—whether talk therapy or medication—provided by a licensed psychiatrist or psychologist.

In Georgia, for instance, where peer services are billable under Medicaid as a psychiatric rehabilitation benefit, a patient who enters the public mental health system is diagnosed by a clinician, who then can recommend peer support as one of the steps toward recovery, said Mr. Fricks, who is now director of the Appalachian Consulting Group in Cleveland, Ga.

The state will bill Medicaid $7 million this year for peer support, Mr. Fricks said in an interview. About 3,000 people are receiving peer support services in Georgia, he said. He is in recovery from bipolar disorder, and his consulting company is working with the federal government to adopt the Georgia model for use in other states.

Those seeking to become counselors in Georgia have to document that they are in recovery and must go through a certification process. About 300 people have completed that process, which includes two weeklong training modules and a written and oral exam.

Peer specialists are expected to help patients create a recovery action plan, find a job, handle employment-related issues, and learn how to use community and other support systems.

South Carolina and Hawaii have already begun peer certification programs, and seven other states are in the early stages, Mr. Fricks said.

Training is crucial, said Dr. Jana Spalding, the mental health specialist in the Broward County Sheriff's Office in Fort Lauderdale, Fla. Florida is one of the states seeking to start certification and receive Medicaid reimbursement.

“Just because you got better doesn't mean you can help other people,” said Dr. Spalding in an interview. Peer counselors have to demonstrate competency, be able to establish a rapport with someone who might be psychotic, and must be nonjudgmental and knowledgeable about medications, their side effects, and community resources, she said.

Dr. Spalding's professional path to pediatrics was interrupted several times and eventually derailed by her bipolar disease. She ended up taking a job at the peer support center where she had been receiving assistance.

Now, through the sheriff's office, she and a team of psychologists work with mentally ill inmates. Dr. Spalding considers it a successful day if she can get an inmate in solitary confinement to interact with other inmates or the psychologists by playing games or watching movies, for instance.

“This is another tool,” Dr. Spalding said. “It provides a lot of intangible benefits in restoring hope, expectation of recovery, and anticipation of improvement of life in general—not just symptoms going away,” she said.

An old idea—using peers to facilitate recovery—is gaining new attention from public mental health specialists as they search for ways to help the mentally ill get care in an overstretched system and return to productivity.

Peer counseling is the foundation of Alcoholics Anonymous, Narcotics Anonymous, and similar groups that tap people during their recovery to help others get on the same path.

The counselors “can provide a powerful message of hope for people who are hopeless,” said Sue Bergeson, executive vice president of the Depression and Bipolar Support Alliance. They also “stand with that individual through their journey through recovery,” said Ms. Bergeson in an interview.

The DBSA believes that peer support improves recovery and is participating in a research project with Dr. Greg E. Simon, a psychiatrist at Group Health Cooperative of Puget Sound's Center for Health Studies, Seattle, to document the impact of peer support on patient outcomes compared with traditional care.

In the mental health field, people in recovery from depression, bipolar disorder, and other psychiatric conditions may offer one-on-one advice, lead mutual support groups, or staff desks at drop-in centers where they can counsel peers on finding employment and managing day-to-day living issues.

Some self-help groups have been around for decades: GROW Inc., Recovery Inc., and Schizophrenics Anonymous, for instance.

Peer support—defined partly as the sharing of experiential knowledge, skills, and social learning—was included as 1 of the 10 fundamental components of recovery in a recently released consensus statement by the Substance Abuse and Mental Health Services Administration.

Backers of peer support say it improves outcomes and reduces costs. In an overview of the field, Phyllis L. Solomon, Ph.D., a professor of social work at the University of Pennsylvania, Philadelphia, cited numerous studies showing that peer support programs improve symptoms, coping, social functioning, and medication adherence, as well as reduce hospitalizations and use of crisis services (Psychiatr. Rehabil. J. 2004;27:392–401).

Preliminary, yet-to-be-published data from a Georgia study show that peer support improved symptoms and patient functioning at half the cost of traditional care in Medicaid recipients with schizophrenia, depression, and bipolar disorder, said Larry Fricks, former director for consumer relations in the Georgia Department of Human Resources.

However, peer support is not meant to replace therapy—whether talk therapy or medication—provided by a licensed psychiatrist or psychologist.

In Georgia, for instance, where peer services are billable under Medicaid as a psychiatric rehabilitation benefit, a patient who enters the public mental health system is diagnosed by a clinician, who then can recommend peer support as one of the steps toward recovery, said Mr. Fricks, who is now director of the Appalachian Consulting Group in Cleveland, Ga.

The state will bill Medicaid $7 million this year for peer support, Mr. Fricks said in an interview. About 3,000 people are receiving peer support services in Georgia, he said. He is in recovery from bipolar disorder, and his consulting company is working with the federal government to adopt the Georgia model for use in other states.

Those seeking to become counselors in Georgia have to document that they are in recovery and must go through a certification process. About 300 people have completed that process, which includes two weeklong training modules and a written and oral exam.

Peer specialists are expected to help patients create a recovery action plan, find a job, handle employment-related issues, and learn how to use community and other support systems.

South Carolina and Hawaii have already begun peer certification programs, and seven other states are in the early stages, Mr. Fricks said.

Training is crucial, said Dr. Jana Spalding, the mental health specialist in the Broward County Sheriff's Office in Fort Lauderdale, Fla. Florida is one of the states seeking to start certification and receive Medicaid reimbursement.

“Just because you got better doesn't mean you can help other people,” said Dr. Spalding in an interview. Peer counselors have to demonstrate competency, be able to establish a rapport with someone who might be psychotic, and must be nonjudgmental and knowledgeable about medications, their side effects, and community resources, she said.

Dr. Spalding's professional path to pediatrics was interrupted several times and eventually derailed by her bipolar disease. She ended up taking a job at the peer support center where she had been receiving assistance.

Now, through the sheriff's office, she and a team of psychologists work with mentally ill inmates. Dr. Spalding considers it a successful day if she can get an inmate in solitary confinement to interact with other inmates or the psychologists by playing games or watching movies, for instance.

“This is another tool,” Dr. Spalding said. “It provides a lot of intangible benefits in restoring hope, expectation of recovery, and anticipation of improvement of life in general—not just symptoms going away,” she said.

GAITHERSBURG, MD. — A Food and Drug Administration advisory committee said modafinil is not safe for treating ADHD in children and adolescents by a 12–1 vote, although committee members unanimously agreed the drug was effective for that indication.

At a meeting of the FDA's Psychopharmacologic Drugs Advisory Committee, the panel members were mainly concerned about modafinil's potential to cause Stevens-Johnson syndrome (SJS). The severe rash, which is often due to a hypersensitivity reaction to a drug, can be fatal in up to 5% of cases, according to Dr. Michael E. Bigby of the dermatology department at Harvard Medical School, Boston, and consultant to the panel.

Among 933 children and adolescents exposed to the drug during trials, there were 12 cases that could have been definite erythema multiforme (EM) or SJS, early prodromal EM or SJS, or suggestive of prodromal EM or SJS—a rate of 1.29%, said Dr. Glenn B. Mannheim, a medical reviewer in the FDA's division of psychiatry products.

The panel's discussion focused on one case that seemed most likely to be SJS—indicating a 1 in 1,000 risk. But they were not certain that was the true risk.

Dr. Bigby and Dr. Mannheim said more cases could occur once modafinil (Provigil) is more widely used—even though there have been no reports of SJS in the 36,000 children who were prescribed the drug off-label in 2002–2005.

Given the trial data and the assumption that modafinil could capture 10% of the market for children under age 19 (based on other stimulants' sales), there could be 500–3,250 cases of EM or SJS, and 25–488 deaths, said Dr. Mannheim.

The dichotomy between the postmarketing experience and the trial data prompted the FDA to seek its advisers' input, said Dr. Robert J. Temple, director of the FDA's office of medical policy.

The FDA usually follows the advice of its panels.

The FDA has received six reports of serious skin reactions in adults, said Dr. Mannheim.

“I'd like to see an opportunity for the company to come back with additional data. That will give us additional assurance that this case was a fluke,” said panel chair Dr. Wayne K. Goodman, chair of the department of psychiatry at the University of Florida, Gainesville.

The committee said modafinil's manufacturer, Cephalon Inc., should conduct a 3,000-patient, open-label study to further clarify the risk of SJS.

After the meeting, Dr. Thomas Laughren, director of the FDA's division of psychiatry products, told reporters that if a case turns up in such a study, “then they have a problem.”

It was not clear why children had higher rates of skin-related adverse events than adults, but Dr. Mannheim noted that lab tests indicated that they had a 7–16 times higher area under the curve ratio of modafinil sulfone, a metabolite. The levels could not be explained by higher milligram-per-kilogram dosing, he said.

In two of the three phase III studies, children were given a flexible dose with weekly titration (170 mg, 255 mg, 340 mg, or 425 mg). In the third study they were given a fixed dose, with those under 30 kg receiving 340 mg daily, and those over 30 kg receiving 425 mg daily.

The primary outcome was the total score on the school ADHD rating scale. In all three trials, children taking modafinil had a more significant drop in scores than those taking placebo. The total score for modafinil recipients—just over 20—was close to the normative score for a 10-year-old male, according to a Cephalon statement.

Panelists did not dispute the drug's efficacy, although many said it would not be a first-line choice.

Lesley Russell, Cephalon's senior vice president of worldwide clinical research, said modafinil offers clinicians an alternative, especially when children don't respond to other marketed drugs.

But Dr. Temple said that even though it's plausible that modafinil might work in nonresponsive children, the company had not proved that.

“The mere fact that people given a second drug respond after failing to respond to the first tells you nothing at all,” he said.

According to a company statement, modafinil may be less addictive and less apt to be diverted because it does not offer a “high” to recreational users. Jeffrey L. Vaught, executive vice president of research and development at Cephalon, said the drug is not water soluble and is not stable at high heat, which makes it difficult to crush for injection or smoking. Studies have shown that modafinil does not activate reward centers in the brain, and that it does not cause release of dopamine in vitro or in vivo.

The Drug Enforcement Administration has deemed modafinil a schedule IV drug; other stimulants used to treat ADHD, such as Ritalin, are schedule II.

Despite potential advantages, the panel did not want modafinil to be marketed for children yet.

“I think we did err on the side of consumer protection,” said Dr. Goodman.

GAITHERSBURG, MD. — A Food and Drug Administration advisory committee said modafinil is not safe for treating ADHD in children and adolescents by a 12–1 vote, although committee members unanimously agreed the drug was effective for that indication.

At a meeting of the FDA's Psychopharmacologic Drugs Advisory Committee, the panel members were mainly concerned about modafinil's potential to cause Stevens-Johnson syndrome (SJS). The severe rash, which is often due to a hypersensitivity reaction to a drug, can be fatal in up to 5% of cases, according to Dr. Michael E. Bigby of the dermatology department at Harvard Medical School, Boston, and consultant to the panel.

Among 933 children and adolescents exposed to the drug during trials, there were 12 cases that could have been definite erythema multiforme (EM) or SJS, early prodromal EM or SJS, or suggestive of prodromal EM or SJS—a rate of 1.29%, said Dr. Glenn B. Mannheim, a medical reviewer in the FDA's division of psychiatry products.

The panel's discussion focused on one case that seemed most likely to be SJS—indicating a 1 in 1,000 risk. But they were not certain that was the true risk.

Dr. Bigby and Dr. Mannheim said more cases could occur once modafinil (Provigil) is more widely used—even though there have been no reports of SJS in the 36,000 children who were prescribed the drug off-label in 2002–2005.

Given the trial data and the assumption that modafinil could capture 10% of the market for children under age 19 (based on other stimulants' sales), there could be 500–3,250 cases of EM or SJS, and 25–488 deaths, said Dr. Mannheim.

The dichotomy between the postmarketing experience and the trial data prompted the FDA to seek its advisers' input, said Dr. Robert J. Temple, director of the FDA's office of medical policy.

The FDA usually follows the advice of its panels.

The FDA has received six reports of serious skin reactions in adults, said Dr. Mannheim.

“I'd like to see an opportunity for the company to come back with additional data. That will give us additional assurance that this case was a fluke,” said panel chair Dr. Wayne K. Goodman, chair of the department of psychiatry at the University of Florida, Gainesville.

The committee said modafinil's manufacturer, Cephalon Inc., should conduct a 3,000-patient, open-label study to further clarify the risk of SJS.

After the meeting, Dr. Thomas Laughren, director of the FDA's division of psychiatry products, told reporters that if a case turns up in such a study, “then they have a problem.”

It was not clear why children had higher rates of skin-related adverse events than adults, but Dr. Mannheim noted that lab tests indicated that they had a 7–16 times higher area under the curve ratio of modafinil sulfone, a metabolite. The levels could not be explained by higher milligram-per-kilogram dosing, he said.

In two of the three phase III studies, children were given a flexible dose with weekly titration (170 mg, 255 mg, 340 mg, or 425 mg). In the third study they were given a fixed dose, with those under 30 kg receiving 340 mg daily, and those over 30 kg receiving 425 mg daily.

The primary outcome was the total score on the school ADHD rating scale. In all three trials, children taking modafinil had a more significant drop in scores than those taking placebo. The total score for modafinil recipients—just over 20—was close to the normative score for a 10-year-old male, according to a Cephalon statement.

Panelists did not dispute the drug's efficacy, although many said it would not be a first-line choice.

Lesley Russell, Cephalon's senior vice president of worldwide clinical research, said modafinil offers clinicians an alternative, especially when children don't respond to other marketed drugs.

But Dr. Temple said that even though it's plausible that modafinil might work in nonresponsive children, the company had not proved that.

“The mere fact that people given a second drug respond after failing to respond to the first tells you nothing at all,” he said.

According to a company statement, modafinil may be less addictive and less apt to be diverted because it does not offer a “high” to recreational users. Jeffrey L. Vaught, executive vice president of research and development at Cephalon, said the drug is not water soluble and is not stable at high heat, which makes it difficult to crush for injection or smoking. Studies have shown that modafinil does not activate reward centers in the brain, and that it does not cause release of dopamine in vitro or in vivo.

The Drug Enforcement Administration has deemed modafinil a schedule IV drug; other stimulants used to treat ADHD, such as Ritalin, are schedule II.

Despite potential advantages, the panel did not want modafinil to be marketed for children yet.

“I think we did err on the side of consumer protection,” said Dr. Goodman.

GAITHERSBURG, MD. — A Food and Drug Administration advisory committee said modafinil is not safe for treating ADHD in children and adolescents by a 12–1 vote, although committee members unanimously agreed the drug was effective for that indication.

At a meeting of the FDA's Psychopharmacologic Drugs Advisory Committee, the panel members were mainly concerned about modafinil's potential to cause Stevens-Johnson syndrome (SJS). The severe rash, which is often due to a hypersensitivity reaction to a drug, can be fatal in up to 5% of cases, according to Dr. Michael E. Bigby of the dermatology department at Harvard Medical School, Boston, and consultant to the panel.

Among 933 children and adolescents exposed to the drug during trials, there were 12 cases that could have been definite erythema multiforme (EM) or SJS, early prodromal EM or SJS, or suggestive of prodromal EM or SJS—a rate of 1.29%, said Dr. Glenn B. Mannheim, a medical reviewer in the FDA's division of psychiatry products.

The panel's discussion focused on one case that seemed most likely to be SJS—indicating a 1 in 1,000 risk. But they were not certain that was the true risk.

Dr. Bigby and Dr. Mannheim said more cases could occur once modafinil (Provigil) is more widely used—even though there have been no reports of SJS in the 36,000 children who were prescribed the drug off-label in 2002–2005.

Given the trial data and the assumption that modafinil could capture 10% of the market for children under age 19 (based on other stimulants' sales), there could be 500–3,250 cases of EM or SJS, and 25–488 deaths, said Dr. Mannheim.

The dichotomy between the postmarketing experience and the trial data prompted the FDA to seek its advisers' input, said Dr. Robert J. Temple, director of the FDA's office of medical policy.

The FDA usually follows the advice of its panels.

The FDA has received six reports of serious skin reactions in adults, said Dr. Mannheim.

“I'd like to see an opportunity for the company to come back with additional data. That will give us additional assurance that this case was a fluke,” said panel chair Dr. Wayne K. Goodman, chair of the department of psychiatry at the University of Florida, Gainesville.

The committee said modafinil's manufacturer, Cephalon Inc., should conduct a 3,000-patient, open-label study to further clarify the risk of SJS.

After the meeting, Dr. Thomas Laughren, director of the FDA's division of psychiatry products, told reporters that if a case turns up in such a study, “then they have a problem.”

It was not clear why children had higher rates of skin-related adverse events than adults, but Dr. Mannheim noted that lab tests indicated that they had a 7–16 times higher area under the curve ratio of modafinil sulfone, a metabolite. The levels could not be explained by higher milligram-per-kilogram dosing, he said.

In two of the three phase III studies, children were given a flexible dose with weekly titration (170 mg, 255 mg, 340 mg, or 425 mg). In the third study they were given a fixed dose, with those under 30 kg receiving 340 mg daily, and those over 30 kg receiving 425 mg daily.

The primary outcome was the total score on the school ADHD rating scale. In all three trials, children taking modafinil had a more significant drop in scores than those taking placebo. The total score for modafinil recipients—just over 20—was close to the normative score for a 10-year-old male, according to a Cephalon statement.

Panelists did not dispute the drug's efficacy, although many said it would not be a first-line choice.

Lesley Russell, Cephalon's senior vice president of worldwide clinical research, said modafinil offers clinicians an alternative, especially when children don't respond to other marketed drugs.

But Dr. Temple said that even though it's plausible that modafinil might work in nonresponsive children, the company had not proved that.

“The mere fact that people given a second drug respond after failing to respond to the first tells you nothing at all,” he said.

According to a company statement, modafinil may be less addictive and less apt to be diverted because it does not offer a “high” to recreational users. Jeffrey L. Vaught, executive vice president of research and development at Cephalon, said the drug is not water soluble and is not stable at high heat, which makes it difficult to crush for injection or smoking. Studies have shown that modafinil does not activate reward centers in the brain, and that it does not cause release of dopamine in vitro or in vivo.

The Drug Enforcement Administration has deemed modafinil a schedule IV drug; other stimulants used to treat ADHD, such as Ritalin, are schedule II.

Despite potential advantages, the panel did not want modafinil to be marketed for children yet.

“I think we did err on the side of consumer protection,” said Dr. Goodman.

ROCKVILLE, MD. — The Food and Drug Administration's Anti-Infective Advisory Committee unanimously supported the approval of daptomycin (Cubicin) for Staphylococcus aureus bacteremia but was not as certain that the drug is safe and effective for infective endocarditis.

And despite the 9–0 vote on bacteremia, the panel had reservations. “I was shocked at how low the overall cure rate was,” said Dr. Jan Patterson, a committee member and professor of medicine at the University of Texas, San Antonio. “Nonetheless, it was as good as current therapy.”

The panel voted 5–4 to approve daptomycin for infective endocarditis (IE). Those in favor said that since the drug was already being used off label—Cubist Pharmaceuticals estimated that 25% of off-label use is for S. aureus bacteremia—physicians should get better guidance. Panelists who voted against approval for IE said there were too few patients in that arm to draw a conclusion.

Daptomycin was approved in 2003 for complicated skin and skin structure infections. Most physicians have been prescribing it at 4 mg/kg, but daptomycin was tested at 6 mg/kg for bacteremia and IE.

The FDA usually follows the advice of its advisory panels. In fact, within a few weeks of the meeting, the agency told Cubist that daptomycin was approvable, pending negotiations over the drug's label.

Cubist presented data from a 44-site, 236-patient trial, conducted during 2002–2005. Patients were randomized to daptomycin 6 mg/kg IV every 24 hours or vancomycin 1 g IV every 12 hours plus gentamicin 1 mg/kg every 8 hours for 4 days, or antistaphylococcus penicillin 2 g every 4 hours, plus the gentamicin regimen. The intent-to-treat population was 120 patients in the daptomycin arm and 115 in the comparator arms. Patients had to have a positive blood culture within 2 days of enrollment.

The investigators judged success or failure after therapy. Success was defined as being clinically cured or improved; having a negative blood culture; and not receiving a potentially effective nonstudy antibiotic. Cure was assessed by a blinded independent panel 6 weeks post therapy.

The panel determined that the overall success rate, which included bacteremia and endocarditis, was 44% (53 of 120) for daptomycin and 42% (48 of 115) for the comparator group. The daptomycin and comparator success rates were higher for uncomplicated (56% and 55%) than for complicated bacteremia (43% for both).

The cure rate was not as high for IE, which was confirmed in a subset of the patients. For right-sided IE, 8 of 19 daptomycin patients were cured, vs. 7 of 16 in the comparator arm. For left-sided IE, 1 of 19 daptomycin patients were cured, vs. with 2 of 9 in the comparator arm.

FDA reviewers and panel members were concerned about what they viewed as rising minimum inhibitory concentrations (MICs) of daptomycin. Peter Coderre, a microbiologist in the FDA's division of anti-infective and ophthalmology products, said breakpoints have not yet been established for intermediate and resistant isolates. According to the company, seven patients had high minimum inhibitory concentrations; only one was cured. He also noted that there have been eight reports of resistance to daptomycin since it was introduced last spring.

“The fact that you'll get resistance is no surprise,” Dr. John Bradley, a panelist, and director of the infectious diseases division at Children's Hospital and Health Center in San Diego. “But in these seriously ill patients, the consequences are huge.” Even so, he said he did not think a hint of resistance should prevent approval. Dr. Patterson said minimum inhibitory concentrations should be monitored closely, perhaps weekly, in treated patients.

Panel members were not as concerned about safety. Skeletal muscle is most often affected. Current labeling advises physicians to monitor creatine phosphokinase levels weekly and to consider discontinuing statins. In the trial, patients were monitored three times a week. Creatine phosphokinase elevations appear to be reversible, said Dr. Gloria Vigliani, Cubist's vice president of medical strategy.

ROCKVILLE, MD. — The Food and Drug Administration's Anti-Infective Advisory Committee unanimously supported the approval of daptomycin (Cubicin) for Staphylococcus aureus bacteremia but was not as certain that the drug is safe and effective for infective endocarditis.

And despite the 9–0 vote on bacteremia, the panel had reservations. “I was shocked at how low the overall cure rate was,” said Dr. Jan Patterson, a committee member and professor of medicine at the University of Texas, San Antonio. “Nonetheless, it was as good as current therapy.”

The panel voted 5–4 to approve daptomycin for infective endocarditis (IE). Those in favor said that since the drug was already being used off label—Cubist Pharmaceuticals estimated that 25% of off-label use is for S. aureus bacteremia—physicians should get better guidance. Panelists who voted against approval for IE said there were too few patients in that arm to draw a conclusion.

Daptomycin was approved in 2003 for complicated skin and skin structure infections. Most physicians have been prescribing it at 4 mg/kg, but daptomycin was tested at 6 mg/kg for bacteremia and IE.

The FDA usually follows the advice of its advisory panels. In fact, within a few weeks of the meeting, the agency told Cubist that daptomycin was approvable, pending negotiations over the drug's label.

Cubist presented data from a 44-site, 236-patient trial, conducted during 2002–2005. Patients were randomized to daptomycin 6 mg/kg IV every 24 hours or vancomycin 1 g IV every 12 hours plus gentamicin 1 mg/kg every 8 hours for 4 days, or antistaphylococcus penicillin 2 g every 4 hours, plus the gentamicin regimen. The intent-to-treat population was 120 patients in the daptomycin arm and 115 in the comparator arms. Patients had to have a positive blood culture within 2 days of enrollment.

The investigators judged success or failure after therapy. Success was defined as being clinically cured or improved; having a negative blood culture; and not receiving a potentially effective nonstudy antibiotic. Cure was assessed by a blinded independent panel 6 weeks post therapy.

The panel determined that the overall success rate, which included bacteremia and endocarditis, was 44% (53 of 120) for daptomycin and 42% (48 of 115) for the comparator group. The daptomycin and comparator success rates were higher for uncomplicated (56% and 55%) than for complicated bacteremia (43% for both).

The cure rate was not as high for IE, which was confirmed in a subset of the patients. For right-sided IE, 8 of 19 daptomycin patients were cured, vs. 7 of 16 in the comparator arm. For left-sided IE, 1 of 19 daptomycin patients were cured, vs. with 2 of 9 in the comparator arm.

FDA reviewers and panel members were concerned about what they viewed as rising minimum inhibitory concentrations (MICs) of daptomycin. Peter Coderre, a microbiologist in the FDA's division of anti-infective and ophthalmology products, said breakpoints have not yet been established for intermediate and resistant isolates. According to the company, seven patients had high minimum inhibitory concentrations; only one was cured. He also noted that there have been eight reports of resistance to daptomycin since it was introduced last spring.

“The fact that you'll get resistance is no surprise,” Dr. John Bradley, a panelist, and director of the infectious diseases division at Children's Hospital and Health Center in San Diego. “But in these seriously ill patients, the consequences are huge.” Even so, he said he did not think a hint of resistance should prevent approval. Dr. Patterson said minimum inhibitory concentrations should be monitored closely, perhaps weekly, in treated patients.

Panel members were not as concerned about safety. Skeletal muscle is most often affected. Current labeling advises physicians to monitor creatine phosphokinase levels weekly and to consider discontinuing statins. In the trial, patients were monitored three times a week. Creatine phosphokinase elevations appear to be reversible, said Dr. Gloria Vigliani, Cubist's vice president of medical strategy.

ROCKVILLE, MD. — The Food and Drug Administration's Anti-Infective Advisory Committee unanimously supported the approval of daptomycin (Cubicin) for Staphylococcus aureus bacteremia but was not as certain that the drug is safe and effective for infective endocarditis.

And despite the 9–0 vote on bacteremia, the panel had reservations. “I was shocked at how low the overall cure rate was,” said Dr. Jan Patterson, a committee member and professor of medicine at the University of Texas, San Antonio. “Nonetheless, it was as good as current therapy.”

The panel voted 5–4 to approve daptomycin for infective endocarditis (IE). Those in favor said that since the drug was already being used off label—Cubist Pharmaceuticals estimated that 25% of off-label use is for S. aureus bacteremia—physicians should get better guidance. Panelists who voted against approval for IE said there were too few patients in that arm to draw a conclusion.

Daptomycin was approved in 2003 for complicated skin and skin structure infections. Most physicians have been prescribing it at 4 mg/kg, but daptomycin was tested at 6 mg/kg for bacteremia and IE.

The FDA usually follows the advice of its advisory panels. In fact, within a few weeks of the meeting, the agency told Cubist that daptomycin was approvable, pending negotiations over the drug's label.

Cubist presented data from a 44-site, 236-patient trial, conducted during 2002–2005. Patients were randomized to daptomycin 6 mg/kg IV every 24 hours or vancomycin 1 g IV every 12 hours plus gentamicin 1 mg/kg every 8 hours for 4 days, or antistaphylococcus penicillin 2 g every 4 hours, plus the gentamicin regimen. The intent-to-treat population was 120 patients in the daptomycin arm and 115 in the comparator arms. Patients had to have a positive blood culture within 2 days of enrollment.

The investigators judged success or failure after therapy. Success was defined as being clinically cured or improved; having a negative blood culture; and not receiving a potentially effective nonstudy antibiotic. Cure was assessed by a blinded independent panel 6 weeks post therapy.

The panel determined that the overall success rate, which included bacteremia and endocarditis, was 44% (53 of 120) for daptomycin and 42% (48 of 115) for the comparator group. The daptomycin and comparator success rates were higher for uncomplicated (56% and 55%) than for complicated bacteremia (43% for both).

The cure rate was not as high for IE, which was confirmed in a subset of the patients. For right-sided IE, 8 of 19 daptomycin patients were cured, vs. 7 of 16 in the comparator arm. For left-sided IE, 1 of 19 daptomycin patients were cured, vs. with 2 of 9 in the comparator arm.

FDA reviewers and panel members were concerned about what they viewed as rising minimum inhibitory concentrations (MICs) of daptomycin. Peter Coderre, a microbiologist in the FDA's division of anti-infective and ophthalmology products, said breakpoints have not yet been established for intermediate and resistant isolates. According to the company, seven patients had high minimum inhibitory concentrations; only one was cured. He also noted that there have been eight reports of resistance to daptomycin since it was introduced last spring.

“The fact that you'll get resistance is no surprise,” Dr. John Bradley, a panelist, and director of the infectious diseases division at Children's Hospital and Health Center in San Diego. “But in these seriously ill patients, the consequences are huge.” Even so, he said he did not think a hint of resistance should prevent approval. Dr. Patterson said minimum inhibitory concentrations should be monitored closely, perhaps weekly, in treated patients.

Panel members were not as concerned about safety. Skeletal muscle is most often affected. Current labeling advises physicians to monitor creatine phosphokinase levels weekly and to consider discontinuing statins. In the trial, patients were monitored three times a week. Creatine phosphokinase elevations appear to be reversible, said Dr. Gloria Vigliani, Cubist's vice president of medical strategy.

Bill Seeks Consent for Off-Label Rx

A new bill in the California assembly would require physicians and surgeons to get informed consent from their patients before "prescribing, administering, or furnishing" a prescription for off-label use. A failure to adhere to the requirement would be considered a violation of the Medical Practice Act, which means physicians could be charged with a crime. For dermatologists, the requirements "would bring many a practice to a snail's pace," said John R. Valencia, a lobbyist for the California Society of Dermatology and Dermatologic Surgery. Karmi A. Ferguson, executive director of the organization, said the legislation "is on our hot list." If passed, the bill would not reach the governor's desk until September, but "we're hoping to kill it in committee," said Ms. Ferguson. AB 2856 was introduced by Assemblywoman Loni Hancock (D-Berkeley). It would require physicians to specify that the medication is not approved by the Food and Drug Administration for the use that the doctor is recommending, that the risks are unknown, and that there is not a consensus on the efficacy. A patient could withdraw consent at any time.

Botox Popularity

In 2005, the most popular nonsurgical cosmetic treatment was Botox injection, with almost 3.3 million procedures, according to the American Society for Aesthetic Plastic Surgery. Laser hair removal was second, with 1.5 million treatments in 2005. Rounding out the top five: hyaluronic acid injection (almost 1.2 million); microdermabrasion (1 million); and chemical peel (more than 550,000). The total number of nonsurgical procedures dropped 4% to 9.3 million. Last year, Americans spent $12.4 billion on cosmetic procedures—$8.2 billion for surgical and $4.2 billion for nonsurgical. To get the data, ASAPS sent 14,000 questionnaires to plastic surgeons certified by the American Board of Plastic Surgery and to other specialists.

MDs Preferred for Cosmetic Tx

A still-small but growing number of Americans are electing to have invasive (7% of those polled) and noninvasive (8%) cosmetic treatments even though these procedures are rarely covered by insurance, according to a Wall Street Journal Online/Harris Interactive Health-Care Poll. Noninvasive treatments included teeth whitening and cosmetic dental work, chemical and other facial skin resurfacing, filler injections, laser hair removal, or vein therapy. Most invasive procedures were not medically necessary, with the exception of bariatric surgery. Fifty-four percent of those who had bariatric surgery said the operation was medically necessary, but those who elected the surgery doubled from 23% in 2004 (when the last poll was conducted) to 46% in early 2006. Liposuction, on the other hand, was done more often as a medically necessary procedure—from 4% in 2004 to 19% in the latest poll. About 81% of those who had liposuction said it was elective, down from 96% in 2004. Most procedures were performed by physicians, except for laser treatments, which were performed by a technician in 61% of the cases, a 25% increase from 2004. Those contemplating a cosmetic procedure said they were somewhat concerned (24%) or very concerned (32%) about receiving care from a technician instead of a physician. Not surprisingly, the number of complications has increased with the growing volume. Ten percent of patients said they'd had complications, compared with 7% in 2004.

Lester Crawford, Lobbyist

Former Food and Drug Administration Commissioner Lester Crawford, D.V.M., has taken a position at Policy Directions, Inc., a Washington, DC-based lobbying firm with drug, biotechnology and food company clients. Mr. Crawford will be senior counsel. By law, he will be barred from directly lobbying Congress for at least a year. Policy Directions declined to make him available for an interview. Mr. Crawford resigned abruptly from his FDA post in September, 2 months after he was confirmed by the Senate. In the 5 years of the Bush Administration, the FDA has had a permanent commissioner for only 18 months. (Mr. Crawford served in an acting capacity for 16 months without Senate confirmation.) In early February, Sen. Chuck Grassley (R-Iowa) wrote to White House Chief of Staff Andrew Card asking that a permanent commissioner be nominated, adding that the agency was adrift without such leadership.

Medicare Drug Prices Up?

Several new reports charge that prescription drug prices rose in the first month that Medicare beneficiaries were eligible for coverage under the Part D drug benefit. For example, Consumers Union said it found an average increase of 5%. The group compared prices in five zip codes for Lipitor, and for a bundled package of the top-selling therapy in each of five classes (including Lipitor), from December to January. In a letter to the organization, Dr. Mark B. McClellan, administrator at the Centers for Medicare and Medicaid Services, said the sample was not representative because Lipitor and Celebrex had wholesale increases that contributed to most of the rise. Instead, he said, the increases were partly because of the expected rise in average wholesale prices that occurs each January. In another example, a report by the Democratic staff of the House Committee on Government Reform found that between December and mid-February, the prices of the 10 most popular drugs used by Medicare recipients at the 10 biggest drug plans increased by more than 4% on average—from $1,144 to $1,194. The Pharmaceutical Care Management Association said the House report did not acknowledge that drug plans can't set prices.

Bill Seeks Consent for Off-Label Rx

A new bill in the California assembly would require physicians and surgeons to get informed consent from their patients before "prescribing, administering, or furnishing" a prescription for off-label use. A failure to adhere to the requirement would be considered a violation of the Medical Practice Act, which means physicians could be charged with a crime. For dermatologists, the requirements "would bring many a practice to a snail's pace," said John R. Valencia, a lobbyist for the California Society of Dermatology and Dermatologic Surgery. Karmi A. Ferguson, executive director of the organization, said the legislation "is on our hot list." If passed, the bill would not reach the governor's desk until September, but "we're hoping to kill it in committee," said Ms. Ferguson. AB 2856 was introduced by Assemblywoman Loni Hancock (D-Berkeley). It would require physicians to specify that the medication is not approved by the Food and Drug Administration for the use that the doctor is recommending, that the risks are unknown, and that there is not a consensus on the efficacy. A patient could withdraw consent at any time.

Botox Popularity

In 2005, the most popular nonsurgical cosmetic treatment was Botox injection, with almost 3.3 million procedures, according to the American Society for Aesthetic Plastic Surgery. Laser hair removal was second, with 1.5 million treatments in 2005. Rounding out the top five: hyaluronic acid injection (almost 1.2 million); microdermabrasion (1 million); and chemical peel (more than 550,000). The total number of nonsurgical procedures dropped 4% to 9.3 million. Last year, Americans spent $12.4 billion on cosmetic procedures—$8.2 billion for surgical and $4.2 billion for nonsurgical. To get the data, ASAPS sent 14,000 questionnaires to plastic surgeons certified by the American Board of Plastic Surgery and to other specialists.

MDs Preferred for Cosmetic Tx

A still-small but growing number of Americans are electing to have invasive (7% of those polled) and noninvasive (8%) cosmetic treatments even though these procedures are rarely covered by insurance, according to a Wall Street Journal Online/Harris Interactive Health-Care Poll. Noninvasive treatments included teeth whitening and cosmetic dental work, chemical and other facial skin resurfacing, filler injections, laser hair removal, or vein therapy. Most invasive procedures were not medically necessary, with the exception of bariatric surgery. Fifty-four percent of those who had bariatric surgery said the operation was medically necessary, but those who elected the surgery doubled from 23% in 2004 (when the last poll was conducted) to 46% in early 2006. Liposuction, on the other hand, was done more often as a medically necessary procedure—from 4% in 2004 to 19% in the latest poll. About 81% of those who had liposuction said it was elective, down from 96% in 2004. Most procedures were performed by physicians, except for laser treatments, which were performed by a technician in 61% of the cases, a 25% increase from 2004. Those contemplating a cosmetic procedure said they were somewhat concerned (24%) or very concerned (32%) about receiving care from a technician instead of a physician. Not surprisingly, the number of complications has increased with the growing volume. Ten percent of patients said they'd had complications, compared with 7% in 2004.

Lester Crawford, Lobbyist

Former Food and Drug Administration Commissioner Lester Crawford, D.V.M., has taken a position at Policy Directions, Inc., a Washington, DC-based lobbying firm with drug, biotechnology and food company clients. Mr. Crawford will be senior counsel. By law, he will be barred from directly lobbying Congress for at least a year. Policy Directions declined to make him available for an interview. Mr. Crawford resigned abruptly from his FDA post in September, 2 months after he was confirmed by the Senate. In the 5 years of the Bush Administration, the FDA has had a permanent commissioner for only 18 months. (Mr. Crawford served in an acting capacity for 16 months without Senate confirmation.) In early February, Sen. Chuck Grassley (R-Iowa) wrote to White House Chief of Staff Andrew Card asking that a permanent commissioner be nominated, adding that the agency was adrift without such leadership.

Medicare Drug Prices Up?

Several new reports charge that prescription drug prices rose in the first month that Medicare beneficiaries were eligible for coverage under the Part D drug benefit. For example, Consumers Union said it found an average increase of 5%. The group compared prices in five zip codes for Lipitor, and for a bundled package of the top-selling therapy in each of five classes (including Lipitor), from December to January. In a letter to the organization, Dr. Mark B. McClellan, administrator at the Centers for Medicare and Medicaid Services, said the sample was not representative because Lipitor and Celebrex had wholesale increases that contributed to most of the rise. Instead, he said, the increases were partly because of the expected rise in average wholesale prices that occurs each January. In another example, a report by the Democratic staff of the House Committee on Government Reform found that between December and mid-February, the prices of the 10 most popular drugs used by Medicare recipients at the 10 biggest drug plans increased by more than 4% on average—from $1,144 to $1,194. The Pharmaceutical Care Management Association said the House report did not acknowledge that drug plans can't set prices.

Bill Seeks Consent for Off-Label Rx

A new bill in the California assembly would require physicians and surgeons to get informed consent from their patients before "prescribing, administering, or furnishing" a prescription for off-label use. A failure to adhere to the requirement would be considered a violation of the Medical Practice Act, which means physicians could be charged with a crime. For dermatologists, the requirements "would bring many a practice to a snail's pace," said John R. Valencia, a lobbyist for the California Society of Dermatology and Dermatologic Surgery. Karmi A. Ferguson, executive director of the organization, said the legislation "is on our hot list." If passed, the bill would not reach the governor's desk until September, but "we're hoping to kill it in committee," said Ms. Ferguson. AB 2856 was introduced by Assemblywoman Loni Hancock (D-Berkeley). It would require physicians to specify that the medication is not approved by the Food and Drug Administration for the use that the doctor is recommending, that the risks are unknown, and that there is not a consensus on the efficacy. A patient could withdraw consent at any time.

Botox Popularity

In 2005, the most popular nonsurgical cosmetic treatment was Botox injection, with almost 3.3 million procedures, according to the American Society for Aesthetic Plastic Surgery. Laser hair removal was second, with 1.5 million treatments in 2005. Rounding out the top five: hyaluronic acid injection (almost 1.2 million); microdermabrasion (1 million); and chemical peel (more than 550,000). The total number of nonsurgical procedures dropped 4% to 9.3 million. Last year, Americans spent $12.4 billion on cosmetic procedures—$8.2 billion for surgical and $4.2 billion for nonsurgical. To get the data, ASAPS sent 14,000 questionnaires to plastic surgeons certified by the American Board of Plastic Surgery and to other specialists.

MDs Preferred for Cosmetic Tx

A still-small but growing number of Americans are electing to have invasive (7% of those polled) and noninvasive (8%) cosmetic treatments even though these procedures are rarely covered by insurance, according to a Wall Street Journal Online/Harris Interactive Health-Care Poll. Noninvasive treatments included teeth whitening and cosmetic dental work, chemical and other facial skin resurfacing, filler injections, laser hair removal, or vein therapy. Most invasive procedures were not medically necessary, with the exception of bariatric surgery. Fifty-four percent of those who had bariatric surgery said the operation was medically necessary, but those who elected the surgery doubled from 23% in 2004 (when the last poll was conducted) to 46% in early 2006. Liposuction, on the other hand, was done more often as a medically necessary procedure—from 4% in 2004 to 19% in the latest poll. About 81% of those who had liposuction said it was elective, down from 96% in 2004. Most procedures were performed by physicians, except for laser treatments, which were performed by a technician in 61% of the cases, a 25% increase from 2004. Those contemplating a cosmetic procedure said they were somewhat concerned (24%) or very concerned (32%) about receiving care from a technician instead of a physician. Not surprisingly, the number of complications has increased with the growing volume. Ten percent of patients said they'd had complications, compared with 7% in 2004.

Lester Crawford, Lobbyist

Former Food and Drug Administration Commissioner Lester Crawford, D.V.M., has taken a position at Policy Directions, Inc., a Washington, DC-based lobbying firm with drug, biotechnology and food company clients. Mr. Crawford will be senior counsel. By law, he will be barred from directly lobbying Congress for at least a year. Policy Directions declined to make him available for an interview. Mr. Crawford resigned abruptly from his FDA post in September, 2 months after he was confirmed by the Senate. In the 5 years of the Bush Administration, the FDA has had a permanent commissioner for only 18 months. (Mr. Crawford served in an acting capacity for 16 months without Senate confirmation.) In early February, Sen. Chuck Grassley (R-Iowa) wrote to White House Chief of Staff Andrew Card asking that a permanent commissioner be nominated, adding that the agency was adrift without such leadership.

Medicare Drug Prices Up?

Several new reports charge that prescription drug prices rose in the first month that Medicare beneficiaries were eligible for coverage under the Part D drug benefit. For example, Consumers Union said it found an average increase of 5%. The group compared prices in five zip codes for Lipitor, and for a bundled package of the top-selling therapy in each of five classes (including Lipitor), from December to January. In a letter to the organization, Dr. Mark B. McClellan, administrator at the Centers for Medicare and Medicaid Services, said the sample was not representative because Lipitor and Celebrex had wholesale increases that contributed to most of the rise. Instead, he said, the increases were partly because of the expected rise in average wholesale prices that occurs each January. In another example, a report by the Democratic staff of the House Committee on Government Reform found that between December and mid-February, the prices of the 10 most popular drugs used by Medicare recipients at the 10 biggest drug plans increased by more than 4% on average—from $1,144 to $1,194. The Pharmaceutical Care Management Association said the House report did not acknowledge that drug plans can't set prices.

A Senate committee report showing that a vagus nerve stimulation device was approved for treatment-resistant depression over the objections of “more than 20 [Food and Drug Administration] scientists, medical officers, and management staff” could add to the reported difficulties of securing insurance coverage for the device.

The report, the culmination of a yearlong investigation by the Senate Finance Committee, said that given the findings, “it is questionable whether or not the VNS Therapy System for TRD met the agency's standard for safety and effectiveness.”

The committee said it began investigating the treatment-resistant depression approval after allegations about potential improprieties were brought to its attention.

The VNS device was approved in July 2005 for treatment-resistant depression. It has been available for treatment-resistant epilepsy since 1997, and is covered by Medicare and Medicaid for that indication.

Medicare has paid for VNS for treatment-resistant depression in some individual cases but has not yet made a coverage decision, according to Skip Cummins, chief executive officer of Cyberonics Inc., the company that makes the VNS device.

Mr. Cummins said he thought that the approval was proper and added that a senior FDA official with a lot of device experience had overruled reviewers who had less familiarity with treatment-resistant depression and implantable devices. “The report itself is full of half-truths and distortions, and reflects the perspectives of fewer than eight FDA staffers who disagreed with the ultimate decision,” he said.

The committee investigation found that Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiologic Health, decided to approve the device despite objections from other FDA staffers.

The Neurological Devices Panel of the Medical Devices Advisory Committee voted 5–2 in June 2004 to approve VNS for treatment-resistant depression, with the conditions that the company conduct a postmarketing dosing study and compile an outcomes registry.

In August 2004, the FDA issued a nonapprovable letter, going against the panel's recommendation. Cyberonics submitted additional data and responded to a warning letter, citing manufacturing deficiencies. Eventually, with Dr. Schultz's guidance, the company won approval, according to the Senate Committee report, which questioned the propriety of his assistance.

“Instead of relying on the comprehensive scientific evaluation of its scientists and medical officers, it appears that the FDA lowered its threshold for evidence of effectiveness,” the report said.

Mr. Cummins disagreed. “We believe that all the data from all the studies [are] considerably more important than the details of the FDA's internal debate about the data,” he said.

In two studies, after 2 years of VNS adjunctive therapy, 56% of the patients had a meaningful clinical benefit, more than one-third had at least a 50% improvement in symptoms, and 20% were free from symptoms, he said (J. Clin. Psychiatry 2005;66:1097–104 and Biol. Psychiatry 2005;58:364–73).

“The safety of this device is extraordinarily well known,” said Dr. A. John Rush, a VNS investigator and a paid adviser to Cyberonics. Dr. Rush is the Betty Jo Hay Distinguished Chair in Mental Health at the University of Texas Southwestern Medical Center in Dallas and is the vice chairman for research in the department of psychiatry.

Reimbursement for treatment-resistant depression, however, has been spotty. Mr. Cummins said 115 different insurers have approved 1–35 individual implants each. In August 2005, the Blue Cross Blue Shield Association's Technology Evaluation Center said that given the available evidence, it could not make a coverage recommendation. Cyberonics helps patients and physicians get prior authorization. So far, it has received 7,000 such requests, but only 550 patients have been granted approval, Mr. Cummins said.

He alleged that at least three patients have committed suicide when their appeals for treatment were denied.

Overall, the company estimates that 15%–20% of the 4 million Americans with depression have a treatment-resistant form of the illness. Cyberonics also said that 250,000 Medicare beneficiaries are disabled with the illness.

A Senate committee report showing that a vagus nerve stimulation device was approved for treatment-resistant depression over the objections of “more than 20 [Food and Drug Administration] scientists, medical officers, and management staff” could add to the reported difficulties of securing insurance coverage for the device.

The report, the culmination of a yearlong investigation by the Senate Finance Committee, said that given the findings, “it is questionable whether or not the VNS Therapy System for TRD met the agency's standard for safety and effectiveness.”

The committee said it began investigating the treatment-resistant depression approval after allegations about potential improprieties were brought to its attention.

The VNS device was approved in July 2005 for treatment-resistant depression. It has been available for treatment-resistant epilepsy since 1997, and is covered by Medicare and Medicaid for that indication.

Medicare has paid for VNS for treatment-resistant depression in some individual cases but has not yet made a coverage decision, according to Skip Cummins, chief executive officer of Cyberonics Inc., the company that makes the VNS device.

Mr. Cummins said he thought that the approval was proper and added that a senior FDA official with a lot of device experience had overruled reviewers who had less familiarity with treatment-resistant depression and implantable devices. “The report itself is full of half-truths and distortions, and reflects the perspectives of fewer than eight FDA staffers who disagreed with the ultimate decision,” he said.

The committee investigation found that Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiologic Health, decided to approve the device despite objections from other FDA staffers.

The Neurological Devices Panel of the Medical Devices Advisory Committee voted 5–2 in June 2004 to approve VNS for treatment-resistant depression, with the conditions that the company conduct a postmarketing dosing study and compile an outcomes registry.

In August 2004, the FDA issued a nonapprovable letter, going against the panel's recommendation. Cyberonics submitted additional data and responded to a warning letter, citing manufacturing deficiencies. Eventually, with Dr. Schultz's guidance, the company won approval, according to the Senate Committee report, which questioned the propriety of his assistance.

“Instead of relying on the comprehensive scientific evaluation of its scientists and medical officers, it appears that the FDA lowered its threshold for evidence of effectiveness,” the report said.

Mr. Cummins disagreed. “We believe that all the data from all the studies [are] considerably more important than the details of the FDA's internal debate about the data,” he said.

In two studies, after 2 years of VNS adjunctive therapy, 56% of the patients had a meaningful clinical benefit, more than one-third had at least a 50% improvement in symptoms, and 20% were free from symptoms, he said (J. Clin. Psychiatry 2005;66:1097–104 and Biol. Psychiatry 2005;58:364–73).

“The safety of this device is extraordinarily well known,” said Dr. A. John Rush, a VNS investigator and a paid adviser to Cyberonics. Dr. Rush is the Betty Jo Hay Distinguished Chair in Mental Health at the University of Texas Southwestern Medical Center in Dallas and is the vice chairman for research in the department of psychiatry.

Reimbursement for treatment-resistant depression, however, has been spotty. Mr. Cummins said 115 different insurers have approved 1–35 individual implants each. In August 2005, the Blue Cross Blue Shield Association's Technology Evaluation Center said that given the available evidence, it could not make a coverage recommendation. Cyberonics helps patients and physicians get prior authorization. So far, it has received 7,000 such requests, but only 550 patients have been granted approval, Mr. Cummins said.

He alleged that at least three patients have committed suicide when their appeals for treatment were denied.

Overall, the company estimates that 15%–20% of the 4 million Americans with depression have a treatment-resistant form of the illness. Cyberonics also said that 250,000 Medicare beneficiaries are disabled with the illness.

A Senate committee report showing that a vagus nerve stimulation device was approved for treatment-resistant depression over the objections of “more than 20 [Food and Drug Administration] scientists, medical officers, and management staff” could add to the reported difficulties of securing insurance coverage for the device.

The report, the culmination of a yearlong investigation by the Senate Finance Committee, said that given the findings, “it is questionable whether or not the VNS Therapy System for TRD met the agency's standard for safety and effectiveness.”

The committee said it began investigating the treatment-resistant depression approval after allegations about potential improprieties were brought to its attention.

The VNS device was approved in July 2005 for treatment-resistant depression. It has been available for treatment-resistant epilepsy since 1997, and is covered by Medicare and Medicaid for that indication.

Medicare has paid for VNS for treatment-resistant depression in some individual cases but has not yet made a coverage decision, according to Skip Cummins, chief executive officer of Cyberonics Inc., the company that makes the VNS device.

Mr. Cummins said he thought that the approval was proper and added that a senior FDA official with a lot of device experience had overruled reviewers who had less familiarity with treatment-resistant depression and implantable devices. “The report itself is full of half-truths and distortions, and reflects the perspectives of fewer than eight FDA staffers who disagreed with the ultimate decision,” he said.

The committee investigation found that Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiologic Health, decided to approve the device despite objections from other FDA staffers.

The Neurological Devices Panel of the Medical Devices Advisory Committee voted 5–2 in June 2004 to approve VNS for treatment-resistant depression, with the conditions that the company conduct a postmarketing dosing study and compile an outcomes registry.

In August 2004, the FDA issued a nonapprovable letter, going against the panel's recommendation. Cyberonics submitted additional data and responded to a warning letter, citing manufacturing deficiencies. Eventually, with Dr. Schultz's guidance, the company won approval, according to the Senate Committee report, which questioned the propriety of his assistance.

“Instead of relying on the comprehensive scientific evaluation of its scientists and medical officers, it appears that the FDA lowered its threshold for evidence of effectiveness,” the report said.

Mr. Cummins disagreed. “We believe that all the data from all the studies [are] considerably more important than the details of the FDA's internal debate about the data,” he said.

In two studies, after 2 years of VNS adjunctive therapy, 56% of the patients had a meaningful clinical benefit, more than one-third had at least a 50% improvement in symptoms, and 20% were free from symptoms, he said (J. Clin. Psychiatry 2005;66:1097–104 and Biol. Psychiatry 2005;58:364–73).

“The safety of this device is extraordinarily well known,” said Dr. A. John Rush, a VNS investigator and a paid adviser to Cyberonics. Dr. Rush is the Betty Jo Hay Distinguished Chair in Mental Health at the University of Texas Southwestern Medical Center in Dallas and is the vice chairman for research in the department of psychiatry.

Reimbursement for treatment-resistant depression, however, has been spotty. Mr. Cummins said 115 different insurers have approved 1–35 individual implants each. In August 2005, the Blue Cross Blue Shield Association's Technology Evaluation Center said that given the available evidence, it could not make a coverage recommendation. Cyberonics helps patients and physicians get prior authorization. So far, it has received 7,000 such requests, but only 550 patients have been granted approval, Mr. Cummins said.

He alleged that at least three patients have committed suicide when their appeals for treatment were denied.

Overall, the company estimates that 15%–20% of the 4 million Americans with depression have a treatment-resistant form of the illness. Cyberonics also said that 250,000 Medicare beneficiaries are disabled with the illness.

Although it was successful in one late-stage trial, StaphVax, a vaccine in development to combat Staphylococcus aureus, failed to meet the primary end point in a second pivotal trial.

The vaccine's development is now on hold, perhaps indefinitely, according to Thomas H. McLain, president and CEO of Rockville, Md.-based Nabi Biopharmaceuticals.

StaphVax targets S. aureus types 5 and 8, eliciting antibodies to the bacteria's polysaccharide capsule, Mr. McLain said in an interview. The initial market would be people having elective invasive procedures.

In a randomized, double-blind, placebo-controlled study of 3,600 hemodialysis patients, there was no reduction in the incidence of infection with S. aureus types 5 and 8 compared with placebo.

The company issued only a press release in November; full data will likely be released after several months of analysis, Mr. McLain said. Meanwhile, the company withdrew its application for European Union approval and halted all development.

In the first phase III study, StaphVax induced partial immunity for 40 weeks in an end-stage renal disease population (N. Engl. J. Med. 2002;346:491–6).

Results also seemed to be promising in a recently completed substudy, according to its principal investigator, Dr. Todd K. Rosengart head of cardiothoracic surgery at Stony Brook University Hospital, N.Y. In that study, conducted when Dr. Rosengart was at Evanston Northwestern Healthcare, Ill., 120 patients undergoing elective, open cardiac surgery were given either the vaccine or a sham injection 7–40 days before the procedure. “We found dramatic increases in antibodies to types 5 and 8 S. aureus in 90% of our patients,” Dr. Rosengart said in an interview.

A vaccine is definitely needed, he noted, adding that although infections occur in only 1% of cases, the mortality rate with an infection is 5–10 times greater than for open heart surgery alone. “Infection is probably one of the greatest concerns for our patients,” he said.

Antibiotics, as well as screening and prevention programs, are starting to make a dent against S. aureus, but the bacteria—particularly the methicillin-resistant S. aureus (MRSA) strains that are on the rise—are still anathema to hospitals, surgeons, and patients. MRSA is one of the top 10 causes of death in the United States. About 126,000 people a year are infected with the resistant strain.

The bar for vaccine acceptance will be high, given the success of other S. aureus elimination techniques, said Dr. Lance Peterson, a colleague of Dr. Rosengart's at Evanston Northwestern. Patients at Evanston are tested for MRSA on admission and treated with a nasal antibiotic ointment for 5 days before a procedure in an effort to reduce postsurgical infections. The effort seems to be paying off so far, although there are data only from a pilot study in knee surgery.

The vaccine would need to be at least 75% effective, said Dr. Peterson, director of microbiology and infectious disease research at the Chicago-area health system. To be safe, the vaccine should not permanently destroy nasal carriage of S. aureus, he added.

Even if Nabi does not proceed with StaphVax's development, it is going forward with what Mr. McLain calls its next-generation approach—a vaccine that attacks the bacteria's cell walls. That investigation is in a phase I study.

Although it was successful in one late-stage trial, StaphVax, a vaccine in development to combat Staphylococcus aureus, failed to meet the primary end point in a second pivotal trial.

The vaccine's development is now on hold, perhaps indefinitely, according to Thomas H. McLain, president and CEO of Rockville, Md.-based Nabi Biopharmaceuticals.

StaphVax targets S. aureus types 5 and 8, eliciting antibodies to the bacteria's polysaccharide capsule, Mr. McLain said in an interview. The initial market would be people having elective invasive procedures.

In a randomized, double-blind, placebo-controlled study of 3,600 hemodialysis patients, there was no reduction in the incidence of infection with S. aureus types 5 and 8 compared with placebo.

The company issued only a press release in November; full data will likely be released after several months of analysis, Mr. McLain said. Meanwhile, the company withdrew its application for European Union approval and halted all development.

In the first phase III study, StaphVax induced partial immunity for 40 weeks in an end-stage renal disease population (N. Engl. J. Med. 2002;346:491–6).

Results also seemed to be promising in a recently completed substudy, according to its principal investigator, Dr. Todd K. Rosengart head of cardiothoracic surgery at Stony Brook University Hospital, N.Y. In that study, conducted when Dr. Rosengart was at Evanston Northwestern Healthcare, Ill., 120 patients undergoing elective, open cardiac surgery were given either the vaccine or a sham injection 7–40 days before the procedure. “We found dramatic increases in antibodies to types 5 and 8 S. aureus in 90% of our patients,” Dr. Rosengart said in an interview.

A vaccine is definitely needed, he noted, adding that although infections occur in only 1% of cases, the mortality rate with an infection is 5–10 times greater than for open heart surgery alone. “Infection is probably one of the greatest concerns for our patients,” he said.

Antibiotics, as well as screening and prevention programs, are starting to make a dent against S. aureus, but the bacteria—particularly the methicillin-resistant S. aureus (MRSA) strains that are on the rise—are still anathema to hospitals, surgeons, and patients. MRSA is one of the top 10 causes of death in the United States. About 126,000 people a year are infected with the resistant strain.

The bar for vaccine acceptance will be high, given the success of other S. aureus elimination techniques, said Dr. Lance Peterson, a colleague of Dr. Rosengart's at Evanston Northwestern. Patients at Evanston are tested for MRSA on admission and treated with a nasal antibiotic ointment for 5 days before a procedure in an effort to reduce postsurgical infections. The effort seems to be paying off so far, although there are data only from a pilot study in knee surgery.

The vaccine would need to be at least 75% effective, said Dr. Peterson, director of microbiology and infectious disease research at the Chicago-area health system. To be safe, the vaccine should not permanently destroy nasal carriage of S. aureus, he added.

Even if Nabi does not proceed with StaphVax's development, it is going forward with what Mr. McLain calls its next-generation approach—a vaccine that attacks the bacteria's cell walls. That investigation is in a phase I study.

Although it was successful in one late-stage trial, StaphVax, a vaccine in development to combat Staphylococcus aureus, failed to meet the primary end point in a second pivotal trial.

The vaccine's development is now on hold, perhaps indefinitely, according to Thomas H. McLain, president and CEO of Rockville, Md.-based Nabi Biopharmaceuticals.

StaphVax targets S. aureus types 5 and 8, eliciting antibodies to the bacteria's polysaccharide capsule, Mr. McLain said in an interview. The initial market would be people having elective invasive procedures.

In a randomized, double-blind, placebo-controlled study of 3,600 hemodialysis patients, there was no reduction in the incidence of infection with S. aureus types 5 and 8 compared with placebo.

The company issued only a press release in November; full data will likely be released after several months of analysis, Mr. McLain said. Meanwhile, the company withdrew its application for European Union approval and halted all development.

In the first phase III study, StaphVax induced partial immunity for 40 weeks in an end-stage renal disease population (N. Engl. J. Med. 2002;346:491–6).

Results also seemed to be promising in a recently completed substudy, according to its principal investigator, Dr. Todd K. Rosengart head of cardiothoracic surgery at Stony Brook University Hospital, N.Y. In that study, conducted when Dr. Rosengart was at Evanston Northwestern Healthcare, Ill., 120 patients undergoing elective, open cardiac surgery were given either the vaccine or a sham injection 7–40 days before the procedure. “We found dramatic increases in antibodies to types 5 and 8 S. aureus in 90% of our patients,” Dr. Rosengart said in an interview.

A vaccine is definitely needed, he noted, adding that although infections occur in only 1% of cases, the mortality rate with an infection is 5–10 times greater than for open heart surgery alone. “Infection is probably one of the greatest concerns for our patients,” he said.

Antibiotics, as well as screening and prevention programs, are starting to make a dent against S. aureus, but the bacteria—particularly the methicillin-resistant S. aureus (MRSA) strains that are on the rise—are still anathema to hospitals, surgeons, and patients. MRSA is one of the top 10 causes of death in the United States. About 126,000 people a year are infected with the resistant strain.

The bar for vaccine acceptance will be high, given the success of other S. aureus elimination techniques, said Dr. Lance Peterson, a colleague of Dr. Rosengart's at Evanston Northwestern. Patients at Evanston are tested for MRSA on admission and treated with a nasal antibiotic ointment for 5 days before a procedure in an effort to reduce postsurgical infections. The effort seems to be paying off so far, although there are data only from a pilot study in knee surgery.

The vaccine would need to be at least 75% effective, said Dr. Peterson, director of microbiology and infectious disease research at the Chicago-area health system. To be safe, the vaccine should not permanently destroy nasal carriage of S. aureus, he added.

Even if Nabi does not proceed with StaphVax's development, it is going forward with what Mr. McLain calls its next-generation approach—a vaccine that attacks the bacteria's cell walls. That investigation is in a phase I study.

Among other changes engendered by the 80-hour workweek restrictions, more hospitals appear to be allowing physician assistants, nurse-midwives, and other midlevel staff to take over some duties from residents in the operating room.

"I absolutely think it's a trend," said Dr. Richard L. Prager, head of the division of adult cardiac surgery at the University of Michigan in Ann Arbor. But he sees it as a slow-simmering trend that has been given a boost by the declining number of residents in rotation in the surgical suite.

In July 2003, the Accreditation Council for Graduate Medical Education said residents' work hours should be limited to 80 per week and continuous duty limited to 24 hours, with a 6-hour extension if needed for continuity of care or for educational reasons. In addition, residents should be on call in-house only once every 3 nights, according to the ACGME guidelines.

Physician assistants (PAs) and nurse-practitioners are also expanding their roles in the critical care unit, said Dr. Prager. He views this as a positive development for residents. They should be on the floor or in the operating room "for educational aspects, and not simply to do chore work," he said.

"It is reasonable to guess that when the 80-hour workweek restrictions went in, a lot of programs looked into ways of supplementing the service component of what residents do," said Dr. Roger P. Smith, chair of the Council on Resident Education in Obstetrics and Gynecology Committee for the American College of Obstetricians and Gynecologists.

Dr. Smith said some of the surgical services provided by residents may be of questionable educational value. As a result, some hospitals have decided to shift the workload to people with the skills to perform the job who aren't under a restriction on hours, he added.

There is, however, no hard evidence that a big shift has occurred, said Dr. Smith, who is also director of the residency program in the department of obstetrics and gynecology at the University of Missouri-Kansas City.

A systematic review of approaches taken by hospitals to reduce residents' work hours found a mixed bag on how the increased use of PAs and nurses affected residents across specialties, including their presence in the operating room (JAMA 2005;294:1088–100).

According to the investigators, three programs increased residents' OR experience. Another program that added night float and weekend cross-coverage significantly boosted the number of cases for the chief residents. A program that added health technicians to the surgical service increased residents' average operating room time from 3.3 hours per week to 9.8 hours per week. Several studies found no change in residents' OR hours, and three found that the number of their operative cases decreased.

Meanwhile, the number of residency slots available in the United States has remained stable, according to the Association of American Medical Colleges. In 2005, of the available 24,012 residency positions in the United States, 22,221 of them were filled, the AAMC said. First-year residencies in general, orthopedic, and plastic surgery have generated a great deal of interest. From 2001 through 2005, the number of general surgery slots offered remained pretty steady at about 1,050, and orthopedic positions offered hovered around 600. The number of plastic surgery positions grew from 58 in 2001 to 81 in 2005.

The path taken by PAs generally follows that of medical students and physicians, said Nancy Hughes, vice president of communications and information services for the American Academy of Physician Assistants. According to AAPA's survey data, over the past 7 years there has been little change in the percentage of respondents who say they work in surgery or a surgical subspecialty, perform invasive procedures, or assist with surgery. But the growing number of practicing PAs has meant an overall increase in their presence during this same period.

In 1999, 3% of the 15,000 or so respondents said they practiced in general surgery and 17% in surgical subspecialties. A total of 44% said they performed invasive procedures, and 25% said they assisted with surgery. In the 2004 survey, 3% of the 20,500 respondents said they practiced in general surgery and 21% in surgical subspecialties; 42% performed invasive procedures, and 26.5% assisted with surgery.

Judith Zaczek, a certified physician assistant (PA-C) in the ob.gyn. department at Oakwood Hospital and Medical Center in Dearborn, Mich., believes there has been a trend toward more PAs replacing residents in the OR.

At her facility there are 16 residents total per year, with 4 on the ob.gyn. service. But there are three PAs and two midwives to help with the 6,000 deliveries per year. The attending physicians are happy to have the help, Ms. Zaczek said. "I think they've seen what continuity of care is, and they appreciate that."

Dr. Prager agrees that advanced practice PAs and nurse-practitioners are invaluable to a surgical team because they know the routines and are committed and efficient. At the University of Michigan Hospital, four PAs provide first and second assistance for cardiothoracic surgery. They are more skilled in harvesting arteries endoscopically than the junior-level residents, he said.

An advanced practice team of 10 PAs and nurse-practitioners manages the floor, generally covering 30–32 patients and freeing residents from rounds. Dr. Prager sees this as a boon to both the hospital, which gets more efficient patient care, and the residents, who spend more time on education.

A similar evolution has taken place at St. Joseph Mercy Hospital in Ann Arbor. Before workweek restrictions were in place, the cardiothoracic service had seven PAs. With the reduction in residents' hours, the hospital had to double that number to cover critical care 24 hours a day, 7 days a week, and to assist both during and after operations, said LaWaun Hance, a PA-C and education coordinator for the cardiothoracic PA residency program at St. Joseph.

The PAs provide first and second assists, including endoscopic vein harvest, and if necessary they open or close the chest, said Ms. Hance.

The increaseduse of midlevel providers isa positive developmentfor residents. DR. PRAGER

Among other changes engendered by the 80-hour workweek restrictions, more hospitals appear to be allowing physician assistants, nurse-midwives, and other midlevel staff to take over some duties from residents in the operating room.

"I absolutely think it's a trend," said Dr. Richard L. Prager, head of the division of adult cardiac surgery at the University of Michigan in Ann Arbor. But he sees it as a slow-simmering trend that has been given a boost by the declining number of residents in rotation in the surgical suite.

In July 2003, the Accreditation Council for Graduate Medical Education said residents' work hours should be limited to 80 per week and continuous duty limited to 24 hours, with a 6-hour extension if needed for continuity of care or for educational reasons. In addition, residents should be on call in-house only once every 3 nights, according to the ACGME guidelines.

Physician assistants (PAs) and nurse-practitioners are also expanding their roles in the critical care unit, said Dr. Prager. He views this as a positive development for residents. They should be on the floor or in the operating room "for educational aspects, and not simply to do chore work," he said.

"It is reasonable to guess that when the 80-hour workweek restrictions went in, a lot of programs looked into ways of supplementing the service component of what residents do," said Dr. Roger P. Smith, chair of the Council on Resident Education in Obstetrics and Gynecology Committee for the American College of Obstetricians and Gynecologists.

Dr. Smith said some of the surgical services provided by residents may be of questionable educational value. As a result, some hospitals have decided to shift the workload to people with the skills to perform the job who aren't under a restriction on hours, he added.

There is, however, no hard evidence that a big shift has occurred, said Dr. Smith, who is also director of the residency program in the department of obstetrics and gynecology at the University of Missouri-Kansas City.

A systematic review of approaches taken by hospitals to reduce residents' work hours found a mixed bag on how the increased use of PAs and nurses affected residents across specialties, including their presence in the operating room (JAMA 2005;294:1088–100).

According to the investigators, three programs increased residents' OR experience. Another program that added night float and weekend cross-coverage significantly boosted the number of cases for the chief residents. A program that added health technicians to the surgical service increased residents' average operating room time from 3.3 hours per week to 9.8 hours per week. Several studies found no change in residents' OR hours, and three found that the number of their operative cases decreased.

Meanwhile, the number of residency slots available in the United States has remained stable, according to the Association of American Medical Colleges. In 2005, of the available 24,012 residency positions in the United States, 22,221 of them were filled, the AAMC said. First-year residencies in general, orthopedic, and plastic surgery have generated a great deal of interest. From 2001 through 2005, the number of general surgery slots offered remained pretty steady at about 1,050, and orthopedic positions offered hovered around 600. The number of plastic surgery positions grew from 58 in 2001 to 81 in 2005.

The path taken by PAs generally follows that of medical students and physicians, said Nancy Hughes, vice president of communications and information services for the American Academy of Physician Assistants. According to AAPA's survey data, over the past 7 years there has been little change in the percentage of respondents who say they work in surgery or a surgical subspecialty, perform invasive procedures, or assist with surgery. But the growing number of practicing PAs has meant an overall increase in their presence during this same period.

In 1999, 3% of the 15,000 or so respondents said they practiced in general surgery and 17% in surgical subspecialties. A total of 44% said they performed invasive procedures, and 25% said they assisted with surgery. In the 2004 survey, 3% of the 20,500 respondents said they practiced in general surgery and 21% in surgical subspecialties; 42% performed invasive procedures, and 26.5% assisted with surgery.

Judith Zaczek, a certified physician assistant (PA-C) in the ob.gyn. department at Oakwood Hospital and Medical Center in Dearborn, Mich., believes there has been a trend toward more PAs replacing residents in the OR.

At her facility there are 16 residents total per year, with 4 on the ob.gyn. service. But there are three PAs and two midwives to help with the 6,000 deliveries per year. The attending physicians are happy to have the help, Ms. Zaczek said. "I think they've seen what continuity of care is, and they appreciate that."

Dr. Prager agrees that advanced practice PAs and nurse-practitioners are invaluable to a surgical team because they know the routines and are committed and efficient. At the University of Michigan Hospital, four PAs provide first and second assistance for cardiothoracic surgery. They are more skilled in harvesting arteries endoscopically than the junior-level residents, he said.

An advanced practice team of 10 PAs and nurse-practitioners manages the floor, generally covering 30–32 patients and freeing residents from rounds. Dr. Prager sees this as a boon to both the hospital, which gets more efficient patient care, and the residents, who spend more time on education.

A similar evolution has taken place at St. Joseph Mercy Hospital in Ann Arbor. Before workweek restrictions were in place, the cardiothoracic service had seven PAs. With the reduction in residents' hours, the hospital had to double that number to cover critical care 24 hours a day, 7 days a week, and to assist both during and after operations, said LaWaun Hance, a PA-C and education coordinator for the cardiothoracic PA residency program at St. Joseph.

The PAs provide first and second assists, including endoscopic vein harvest, and if necessary they open or close the chest, said Ms. Hance.

The increaseduse of midlevel providers isa positive developmentfor residents. DR. PRAGER

Among other changes engendered by the 80-hour workweek restrictions, more hospitals appear to be allowing physician assistants, nurse-midwives, and other midlevel staff to take over some duties from residents in the operating room.

"I absolutely think it's a trend," said Dr. Richard L. Prager, head of the division of adult cardiac surgery at the University of Michigan in Ann Arbor. But he sees it as a slow-simmering trend that has been given a boost by the declining number of residents in rotation in the surgical suite.

In July 2003, the Accreditation Council for Graduate Medical Education said residents' work hours should be limited to 80 per week and continuous duty limited to 24 hours, with a 6-hour extension if needed for continuity of care or for educational reasons. In addition, residents should be on call in-house only once every 3 nights, according to the ACGME guidelines.

Physician assistants (PAs) and nurse-practitioners are also expanding their roles in the critical care unit, said Dr. Prager. He views this as a positive development for residents. They should be on the floor or in the operating room "for educational aspects, and not simply to do chore work," he said.

"It is reasonable to guess that when the 80-hour workweek restrictions went in, a lot of programs looked into ways of supplementing the service component of what residents do," said Dr. Roger P. Smith, chair of the Council on Resident Education in Obstetrics and Gynecology Committee for the American College of Obstetricians and Gynecologists.

Dr. Smith said some of the surgical services provided by residents may be of questionable educational value. As a result, some hospitals have decided to shift the workload to people with the skills to perform the job who aren't under a restriction on hours, he added.

There is, however, no hard evidence that a big shift has occurred, said Dr. Smith, who is also director of the residency program in the department of obstetrics and gynecology at the University of Missouri-Kansas City.

A systematic review of approaches taken by hospitals to reduce residents' work hours found a mixed bag on how the increased use of PAs and nurses affected residents across specialties, including their presence in the operating room (JAMA 2005;294:1088–100).

According to the investigators, three programs increased residents' OR experience. Another program that added night float and weekend cross-coverage significantly boosted the number of cases for the chief residents. A program that added health technicians to the surgical service increased residents' average operating room time from 3.3 hours per week to 9.8 hours per week. Several studies found no change in residents' OR hours, and three found that the number of their operative cases decreased.

Meanwhile, the number of residency slots available in the United States has remained stable, according to the Association of American Medical Colleges. In 2005, of the available 24,012 residency positions in the United States, 22,221 of them were filled, the AAMC said. First-year residencies in general, orthopedic, and plastic surgery have generated a great deal of interest. From 2001 through 2005, the number of general surgery slots offered remained pretty steady at about 1,050, and orthopedic positions offered hovered around 600. The number of plastic surgery positions grew from 58 in 2001 to 81 in 2005.

The path taken by PAs generally follows that of medical students and physicians, said Nancy Hughes, vice president of communications and information services for the American Academy of Physician Assistants. According to AAPA's survey data, over the past 7 years there has been little change in the percentage of respondents who say they work in surgery or a surgical subspecialty, perform invasive procedures, or assist with surgery. But the growing number of practicing PAs has meant an overall increase in their presence during this same period.

In 1999, 3% of the 15,000 or so respondents said they practiced in general surgery and 17% in surgical subspecialties. A total of 44% said they performed invasive procedures, and 25% said they assisted with surgery. In the 2004 survey, 3% of the 20,500 respondents said they practiced in general surgery and 21% in surgical subspecialties; 42% performed invasive procedures, and 26.5% assisted with surgery.

Judith Zaczek, a certified physician assistant (PA-C) in the ob.gyn. department at Oakwood Hospital and Medical Center in Dearborn, Mich., believes there has been a trend toward more PAs replacing residents in the OR.

At her facility there are 16 residents total per year, with 4 on the ob.gyn. service. But there are three PAs and two midwives to help with the 6,000 deliveries per year. The attending physicians are happy to have the help, Ms. Zaczek said. "I think they've seen what continuity of care is, and they appreciate that."

Dr. Prager agrees that advanced practice PAs and nurse-practitioners are invaluable to a surgical team because they know the routines and are committed and efficient. At the University of Michigan Hospital, four PAs provide first and second assistance for cardiothoracic surgery. They are more skilled in harvesting arteries endoscopically than the junior-level residents, he said.

An advanced practice team of 10 PAs and nurse-practitioners manages the floor, generally covering 30–32 patients and freeing residents from rounds. Dr. Prager sees this as a boon to both the hospital, which gets more efficient patient care, and the residents, who spend more time on education.

A similar evolution has taken place at St. Joseph Mercy Hospital in Ann Arbor. Before workweek restrictions were in place, the cardiothoracic service had seven PAs. With the reduction in residents' hours, the hospital had to double that number to cover critical care 24 hours a day, 7 days a week, and to assist both during and after operations, said LaWaun Hance, a PA-C and education coordinator for the cardiothoracic PA residency program at St. Joseph.

The PAs provide first and second assists, including endoscopic vein harvest, and if necessary they open or close the chest, said Ms. Hance.

The increaseduse of midlevel providers isa positive developmentfor residents. DR. PRAGER

Psychiatrists say a new study should help convince the public that newer antidepressants do not appear to be associated with a risk of suicide.

In the study of about 60,000 enrollees at Group Health Cooperative (GHC), a nonprofit health care system based in Seattle, the risk of suicide fell by 60% in the first month after treatment began and continued to drop in the next 5 months (Am. J. Psychiatry 2006;163:41–7). The risk of suicide was highest in the month before treatment.

Looking at patients both before and after treatment gives a clearer look at the whole picture, said Dr. Greg Simon, the study's lead investigator, who noted that no other study has examined suicide risk before a patient began treatment. “If you didn't look at the months before treatment, the risk after treatment would look very high,” Dr. Simon said in an interview.

He said the study seems to debunk the idea that starting a medication somehow leads a depressed person to act out suicidal behaviors more aggressively than before treatment.

Dr. Darrel Regier, director of the American Psychiatric Association's research division, said one of the study's strengths was its examination of patients before medication started. And because it was observational, it included people with more severe mental disorders, who are normally excluded from randomized trials, he said.

The study “confirms that people who are partially treated are going to have a higher risk of suicide, and the longer they are in treatment, the risk of suicide decreases, which is the opposite of what you would see if the risk of the medication was greater than the illness,” Dr. Regier said in an interview. The GHC result “shows the opposite: The risk of the illness was far greater than the risk of treatment,” he said.

Dr. Simon emphasized, however, that the observational study could not definitively answer whether the decline in suicide was directly attributable to a medication. “It's quite probable that the risk might go down when people get placebo, because they are starting treatment,” he said.

But to truly gauge a medication's particular effects would require a clinical trial with 300,000 patients, “and that will never occur,” he said. The study did, however, address the risk of dying by suicide—something the Food and Drug Administration could not do with the data it used as the basis for its black box warning on use of antidepressants in adolescents because so few were studied in those trials, he said.

Dr. Simon and his coinvestigators at Harvard Medical School and Brigham and Women's Hospital, Boston, acknowledged other limitations of the study, including the possible underestimation of suicide risk before treatment and overestimation in the first month after starting because of misclassifications in prescription and hospitalization records.

Both Dr. Regier and Dr. David Fassler agreed, however, that the study was important because it took all comers and examined patients of all ages treated in real world settings.

“From my perspective, the findings are consistent with previous reports” that newer antidepressants are not associated with higher rates of suicide, said Dr. Fassler, a child and adolescent psychiatrist in Burlington, Vt.

“What we really need are more long-term studies with real world samples,” added Dr. Fassler, also of the University of Vermont, Burlington.

Dr. Simon and his colleagues examined pharmacy records and computerized records from GHC physicians, as well as hospital discharge data and mortality records. They found 65,103 members—70% female—who were treated for depression during the 10.5-year study period. The mean age at time of prescription was 44 years, but ranged from 5 to 105.

They examined several issues: risk of death by suicide and serious suicide attempt during acute-phase treatment with antidepressants, increased risk of death by suicide or serious suicide attempt during the month after starting, and the possibility that newer drugs were associated with a higher risk of death than were older antidepressants.

Overall, the researchers found that the rate of attempts in the first 6 months of treatment was 78 per 100,000 in adults and 314 per 100,000 in adolescents.

The higher rate in adolescents does not come as a surprise, explained Dr. Fassler, who noted that, according to the Centers for Disease Control and Prevention, 1 in 6 adolescents thinks about suicide each year, and by the end of high school, 1 in 10 has made an attempt.

Over the last decade, the rate of adolescent suicide has actually declined by one-third. However, he said, “I'm quite concerned that we could start to see a reversal in that very encouraging trend” if there is reduced access to “appropriate and effective treatment.”

That may be occurring with the increased concern about antidepressants over the last few years, and especially after the addition of black box warnings in early 2005, Dr. Fassler said.

The study was funded by the National Institute of Mental Health. Dr. Simon has received a research grant from Eli Lilly & Co., and consulting fees related to a Pfizer program. A coauthor, Dr. Philip Wang, has provided expert testimony on paroxetine (Paxil) and suicide risk.

Psychiatrists say a new study should help convince the public that newer antidepressants do not appear to be associated with a risk of suicide.

In the study of about 60,000 enrollees at Group Health Cooperative (GHC), a nonprofit health care system based in Seattle, the risk of suicide fell by 60% in the first month after treatment began and continued to drop in the next 5 months (Am. J. Psychiatry 2006;163:41–7). The risk of suicide was highest in the month before treatment.

Looking at patients both before and after treatment gives a clearer look at the whole picture, said Dr. Greg Simon, the study's lead investigator, who noted that no other study has examined suicide risk before a patient began treatment. “If you didn't look at the months before treatment, the risk after treatment would look very high,” Dr. Simon said in an interview.

He said the study seems to debunk the idea that starting a medication somehow leads a depressed person to act out suicidal behaviors more aggressively than before treatment.

Dr. Darrel Regier, director of the American Psychiatric Association's research division, said one of the study's strengths was its examination of patients before medication started. And because it was observational, it included people with more severe mental disorders, who are normally excluded from randomized trials, he said.

The study “confirms that people who are partially treated are going to have a higher risk of suicide, and the longer they are in treatment, the risk of suicide decreases, which is the opposite of what you would see if the risk of the medication was greater than the illness,” Dr. Regier said in an interview. The GHC result “shows the opposite: The risk of the illness was far greater than the risk of treatment,” he said.

Dr. Simon emphasized, however, that the observational study could not definitively answer whether the decline in suicide was directly attributable to a medication. “It's quite probable that the risk might go down when people get placebo, because they are starting treatment,” he said.

But to truly gauge a medication's particular effects would require a clinical trial with 300,000 patients, “and that will never occur,” he said. The study did, however, address the risk of dying by suicide—something the Food and Drug Administration could not do with the data it used as the basis for its black box warning on use of antidepressants in adolescents because so few were studied in those trials, he said.

Dr. Simon and his coinvestigators at Harvard Medical School and Brigham and Women's Hospital, Boston, acknowledged other limitations of the study, including the possible underestimation of suicide risk before treatment and overestimation in the first month after starting because of misclassifications in prescription and hospitalization records.

Both Dr. Regier and Dr. David Fassler agreed, however, that the study was important because it took all comers and examined patients of all ages treated in real world settings.

“From my perspective, the findings are consistent with previous reports” that newer antidepressants are not associated with higher rates of suicide, said Dr. Fassler, a child and adolescent psychiatrist in Burlington, Vt.

“What we really need are more long-term studies with real world samples,” added Dr. Fassler, also of the University of Vermont, Burlington.

Dr. Simon and his colleagues examined pharmacy records and computerized records from GHC physicians, as well as hospital discharge data and mortality records. They found 65,103 members—70% female—who were treated for depression during the 10.5-year study period. The mean age at time of prescription was 44 years, but ranged from 5 to 105.

They examined several issues: risk of death by suicide and serious suicide attempt during acute-phase treatment with antidepressants, increased risk of death by suicide or serious suicide attempt during the month after starting, and the possibility that newer drugs were associated with a higher risk of death than were older antidepressants.

Overall, the researchers found that the rate of attempts in the first 6 months of treatment was 78 per 100,000 in adults and 314 per 100,000 in adolescents.

The higher rate in adolescents does not come as a surprise, explained Dr. Fassler, who noted that, according to the Centers for Disease Control and Prevention, 1 in 6 adolescents thinks about suicide each year, and by the end of high school, 1 in 10 has made an attempt.

Over the last decade, the rate of adolescent suicide has actually declined by one-third. However, he said, “I'm quite concerned that we could start to see a reversal in that very encouraging trend” if there is reduced access to “appropriate and effective treatment.”

That may be occurring with the increased concern about antidepressants over the last few years, and especially after the addition of black box warnings in early 2005, Dr. Fassler said.

The study was funded by the National Institute of Mental Health. Dr. Simon has received a research grant from Eli Lilly & Co., and consulting fees related to a Pfizer program. A coauthor, Dr. Philip Wang, has provided expert testimony on paroxetine (Paxil) and suicide risk.

Psychiatrists say a new study should help convince the public that newer antidepressants do not appear to be associated with a risk of suicide.

In the study of about 60,000 enrollees at Group Health Cooperative (GHC), a nonprofit health care system based in Seattle, the risk of suicide fell by 60% in the first month after treatment began and continued to drop in the next 5 months (Am. J. Psychiatry 2006;163:41–7). The risk of suicide was highest in the month before treatment.

Looking at patients both before and after treatment gives a clearer look at the whole picture, said Dr. Greg Simon, the study's lead investigator, who noted that no other study has examined suicide risk before a patient began treatment. “If you didn't look at the months before treatment, the risk after treatment would look very high,” Dr. Simon said in an interview.

He said the study seems to debunk the idea that starting a medication somehow leads a depressed person to act out suicidal behaviors more aggressively than before treatment.

Dr. Darrel Regier, director of the American Psychiatric Association's research division, said one of the study's strengths was its examination of patients before medication started. And because it was observational, it included people with more severe mental disorders, who are normally excluded from randomized trials, he said.

The study “confirms that people who are partially treated are going to have a higher risk of suicide, and the longer they are in treatment, the risk of suicide decreases, which is the opposite of what you would see if the risk of the medication was greater than the illness,” Dr. Regier said in an interview. The GHC result “shows the opposite: The risk of the illness was far greater than the risk of treatment,” he said.

Dr. Simon emphasized, however, that the observational study could not definitively answer whether the decline in suicide was directly attributable to a medication. “It's quite probable that the risk might go down when people get placebo, because they are starting treatment,” he said.

But to truly gauge a medication's particular effects would require a clinical trial with 300,000 patients, “and that will never occur,” he said. The study did, however, address the risk of dying by suicide—something the Food and Drug Administration could not do with the data it used as the basis for its black box warning on use of antidepressants in adolescents because so few were studied in those trials, he said.

Dr. Simon and his coinvestigators at Harvard Medical School and Brigham and Women's Hospital, Boston, acknowledged other limitations of the study, including the possible underestimation of suicide risk before treatment and overestimation in the first month after starting because of misclassifications in prescription and hospitalization records.

Both Dr. Regier and Dr. David Fassler agreed, however, that the study was important because it took all comers and examined patients of all ages treated in real world settings.

“From my perspective, the findings are consistent with previous reports” that newer antidepressants are not associated with higher rates of suicide, said Dr. Fassler, a child and adolescent psychiatrist in Burlington, Vt.

“What we really need are more long-term studies with real world samples,” added Dr. Fassler, also of the University of Vermont, Burlington.

Dr. Simon and his colleagues examined pharmacy records and computerized records from GHC physicians, as well as hospital discharge data and mortality records. They found 65,103 members—70% female—who were treated for depression during the 10.5-year study period. The mean age at time of prescription was 44 years, but ranged from 5 to 105.

They examined several issues: risk of death by suicide and serious suicide attempt during acute-phase treatment with antidepressants, increased risk of death by suicide or serious suicide attempt during the month after starting, and the possibility that newer drugs were associated with a higher risk of death than were older antidepressants.

Overall, the researchers found that the rate of attempts in the first 6 months of treatment was 78 per 100,000 in adults and 314 per 100,000 in adolescents.

The higher rate in adolescents does not come as a surprise, explained Dr. Fassler, who noted that, according to the Centers for Disease Control and Prevention, 1 in 6 adolescents thinks about suicide each year, and by the end of high school, 1 in 10 has made an attempt.

Over the last decade, the rate of adolescent suicide has actually declined by one-third. However, he said, “I'm quite concerned that we could start to see a reversal in that very encouraging trend” if there is reduced access to “appropriate and effective treatment.”

That may be occurring with the increased concern about antidepressants over the last few years, and especially after the addition of black box warnings in early 2005, Dr. Fassler said.

The study was funded by the National Institute of Mental Health. Dr. Simon has received a research grant from Eli Lilly & Co., and consulting fees related to a Pfizer program. A coauthor, Dr. Philip Wang, has provided expert testimony on paroxetine (Paxil) and suicide risk.

WASHINGTON — A stent dedicated to difficult-to-treat bifurcated lesions appears to significantly reduce restenosis and in-stent late loss, according to results presented at a symposium sponsored by the Cardiovascular Research Foundation.

Dr. Eberhard Grube, chief of cardiology and angiology at the Siegburg (Germany) Heart Center, reported on the 6-month results of Axxess Plus, a registry designed to evaluate the safety and efficacy of the Axxess Plus stent in de novo coronary bifurcation lesions and to determine the best treatment strategy in branch vessels.

Axxess Plus is made from a self-expanding nickel-titanium (nitinol) alloy, which is coated with a bioabsorbable polylactic acid polymer that elutes biolimus A9, a sirolimus analogue. The device is manufactured by Devax Inc. (Irvine, Calif).

So far, the registry has enrolled 139 patients from 13 centers in the United States and abroad. Dr. Grube, principal investigator in the trial, reported on the first 125 patients. Data from Axxess Plus will be used to support applications for regulatory approval in Europe and the United States, according to Devax.

About 15%–20% of the 2.5 million percutaneous coronary interventions worldwide involve lesions at a bifurcation, but treating such lesions is extremely difficult, said Dr. Grube.

With Axxess Plus, the stent is implanted with the appropriate shape to treat the bifurcation, then more stents can be added as needed to cover the lesion, said Dr. Grube.

The registry accepts patients with any and all bifurcations. The primary end point is in-stent late loss at 6 months. With angiographic follow-up on 93% of the patients with Axxess Plus stents, the late loss was 0.11 mm, plus or minus 0.62 mm, compared with 0.46 mm, plus or minus 0.51 mm, for the control group of patients who had previously received an Axxess bare metal stent, a statistically significant difference.

Just over 5% of patients had binary restenosis in the parent vessel, as measured by qualitative coronary angiography, said Dr. Grube.

Patients with side branch involvement received no treatment, percutaneous transcatheter coronary angioplasty (PTCA), or a stent. The choice of procedure was left to the investigator's discretion, Dr. Grube said.

Across those three groups, the mean late loss was 0.24 mm for the 26 patients who received no treatment, 0.19 mm for the PTCA group (40 patients), and 0.21 mm for the stent group (70 patients).

The in-segment restenosis rate was 12% for the no treatment group, 25% for the PTCA group, and 7.9% for the Axxess Plus group. “The lesion success with PTCA was clearly lower than leaving it alone or using a stent,” noted Dr. Grube.

WASHINGTON — A stent dedicated to difficult-to-treat bifurcated lesions appears to significantly reduce restenosis and in-stent late loss, according to results presented at a symposium sponsored by the Cardiovascular Research Foundation.

Dr. Eberhard Grube, chief of cardiology and angiology at the Siegburg (Germany) Heart Center, reported on the 6-month results of Axxess Plus, a registry designed to evaluate the safety and efficacy of the Axxess Plus stent in de novo coronary bifurcation lesions and to determine the best treatment strategy in branch vessels.

Axxess Plus is made from a self-expanding nickel-titanium (nitinol) alloy, which is coated with a bioabsorbable polylactic acid polymer that elutes biolimus A9, a sirolimus analogue. The device is manufactured by Devax Inc. (Irvine, Calif).

So far, the registry has enrolled 139 patients from 13 centers in the United States and abroad. Dr. Grube, principal investigator in the trial, reported on the first 125 patients. Data from Axxess Plus will be used to support applications for regulatory approval in Europe and the United States, according to Devax.

About 15%–20% of the 2.5 million percutaneous coronary interventions worldwide involve lesions at a bifurcation, but treating such lesions is extremely difficult, said Dr. Grube.

With Axxess Plus, the stent is implanted with the appropriate shape to treat the bifurcation, then more stents can be added as needed to cover the lesion, said Dr. Grube.

The registry accepts patients with any and all bifurcations. The primary end point is in-stent late loss at 6 months. With angiographic follow-up on 93% of the patients with Axxess Plus stents, the late loss was 0.11 mm, plus or minus 0.62 mm, compared with 0.46 mm, plus or minus 0.51 mm, for the control group of patients who had previously received an Axxess bare metal stent, a statistically significant difference.

Just over 5% of patients had binary restenosis in the parent vessel, as measured by qualitative coronary angiography, said Dr. Grube.

Patients with side branch involvement received no treatment, percutaneous transcatheter coronary angioplasty (PTCA), or a stent. The choice of procedure was left to the investigator's discretion, Dr. Grube said.

Across those three groups, the mean late loss was 0.24 mm for the 26 patients who received no treatment, 0.19 mm for the PTCA group (40 patients), and 0.21 mm for the stent group (70 patients).

The in-segment restenosis rate was 12% for the no treatment group, 25% for the PTCA group, and 7.9% for the Axxess Plus group. “The lesion success with PTCA was clearly lower than leaving it alone or using a stent,” noted Dr. Grube.

WASHINGTON — A stent dedicated to difficult-to-treat bifurcated lesions appears to significantly reduce restenosis and in-stent late loss, according to results presented at a symposium sponsored by the Cardiovascular Research Foundation.

Dr. Eberhard Grube, chief of cardiology and angiology at the Siegburg (Germany) Heart Center, reported on the 6-month results of Axxess Plus, a registry designed to evaluate the safety and efficacy of the Axxess Plus stent in de novo coronary bifurcation lesions and to determine the best treatment strategy in branch vessels.

Axxess Plus is made from a self-expanding nickel-titanium (nitinol) alloy, which is coated with a bioabsorbable polylactic acid polymer that elutes biolimus A9, a sirolimus analogue. The device is manufactured by Devax Inc. (Irvine, Calif).

So far, the registry has enrolled 139 patients from 13 centers in the United States and abroad. Dr. Grube, principal investigator in the trial, reported on the first 125 patients. Data from Axxess Plus will be used to support applications for regulatory approval in Europe and the United States, according to Devax.

About 15%–20% of the 2.5 million percutaneous coronary interventions worldwide involve lesions at a bifurcation, but treating such lesions is extremely difficult, said Dr. Grube.

With Axxess Plus, the stent is implanted with the appropriate shape to treat the bifurcation, then more stents can be added as needed to cover the lesion, said Dr. Grube.

The registry accepts patients with any and all bifurcations. The primary end point is in-stent late loss at 6 months. With angiographic follow-up on 93% of the patients with Axxess Plus stents, the late loss was 0.11 mm, plus or minus 0.62 mm, compared with 0.46 mm, plus or minus 0.51 mm, for the control group of patients who had previously received an Axxess bare metal stent, a statistically significant difference.

Just over 5% of patients had binary restenosis in the parent vessel, as measured by qualitative coronary angiography, said Dr. Grube.

Patients with side branch involvement received no treatment, percutaneous transcatheter coronary angioplasty (PTCA), or a stent. The choice of procedure was left to the investigator's discretion, Dr. Grube said.

Across those three groups, the mean late loss was 0.24 mm for the 26 patients who received no treatment, 0.19 mm for the PTCA group (40 patients), and 0.21 mm for the stent group (70 patients).

The in-segment restenosis rate was 12% for the no treatment group, 25% for the PTCA group, and 7.9% for the Axxess Plus group. “The lesion success with PTCA was clearly lower than leaving it alone or using a stent,” noted Dr. Grube.