Carl Sherman

Betty Ford–the former first lady whose husband, 38th president Gerald R. Ford, died in December–announced in April 1978 that she was undergoing rehabilitation for addiction to prescription drugs and alcohol. Her experience led her 4 years later to help establish a treatment facility, the Betty Ford Center, in Rancho Mirage, Calif.

As the nation recently mourned the passing of former President Ford, it marveled at the impact his wife has had on the way in which addiction is viewed and treated by physicians.

However, it is difficult to isolate the center's influence on addiction psychiatry within the overall evolution of the field during that period, said Dr. Marc Galanter, professor of psychiatry at New York University, New York, and former president of the American Academy for Addiction Psychiatry (AAAP).

The AAAP was formed in 1985, and the subspecialty recognized by the American Board of Psychiatry and Neurology in 1992. “Overlapping with other trends … [the center] played a significant role in legitimizing the field,” he said. “It put addiction on the map.”

Mrs. Ford, whose self-disclosure came in interviews and a memoir, also was instrumental in promoting public acceptance of alcoholism as a valid medical disorder, Dr. Galanter said. “She opened up the discussion of something not really acknowledged previously.”

Dr. Robert L. DuPont said Mrs. Ford's story changed the image of an addicted person. “She made it a disease that a good person could have and get well from,” said Dr. DuPont, who served as White House drug chief under President Ford and was the first director of the National Institute on Drug Abuse. In particular, her openness led to wider recognition of substance problems in women, he said.

The Betty Ford Center, which this year celebrates its 25th anniversary, extended that influence. The respectability of a former first lady, a popular image of elegance, and the glamour of A-list clientele that have included prominent entertainers (Elizabeth Taylor, Robert Mitchum, Liza Minnelli, and Johnny Cash) and sports figures, such as Mickey Mantle, have helped neutralize the stigma of addiction treatment.

In reality, those associated with the center emphasize, celebrities have made up only a fraction of the 26,000 clients and family members treated since 1982, and the cost is in “the low-average range”–about $23,000 for the standard 30-day program, according to Nancy Waite-O'Brien, Ph.D., vice president of clinical services. Also, the setting, while pleasant, is not luxurious. Residents, for example, share rooms and housekeeping duties.

In the area of addiction treatment, the center has innovated less than it has lent visibility and cachet to techniques and programs developed elsewhere. The basic program follows the rehabilitation protocol that Mrs. Ford underwent at the San Diego Naval Medical Center, a 12-step “recovery” approach based largely on the Minnesota Model.

Dr. Galanter noted that family involvement in treatment, a focus from the outset, has since been adopted more widely. “That an intervention was done on Mrs. Ford did much to legitimate that concept in addiction psychiatry,” he said. In his New York University substance abuse program, for example, “network therapy,” a more sustained, less confrontational approach, enlists family and peers to bring in–and keep–patients in treatment.

The center's program to maintain supportive contact with clients after discharge was new, said Dr. DuPont, who has been involved with the center since its beginning. And while programs for addicted physicians and other professionals were pioneered elsewhere, “the center has made [such programs] a major commitment,” he said.

Work with women has been “the most innovative” aspect of treatment at the center, Dr. Waite-O'Brien said. Equal numbers of male and female clients are admitted, and patients follow gender-specific treatment tracks.

“Women experience addiction differently from men,” she said. “We address the fact that women addicts have been sexually abused much more frequently than men,” and that men deal more with absent-father issues and with anger.

Beyond treatment, almost since its inception, the center has sponsored clerkships for medical students, who spend a week working with clients and clinicians. “It fills a void medical schools have created,” said Dr. Mark S. Gold, distinguished professor of psychiatry and chief of the McKnight Brain Institute at University of Florida, in Gainesville. “We've sent students there for years, and they come back and say they couldn't appreciate the practice of addiction psychiatry without this kind exposure.”

Dr. Gold noted that much of the work at the center has been corroborated by research: It represents a melding of “science and the Big Book [the central text of Alcoholics Anonymous].” The long-standing inclusion of dietary counseling and exercise regimens in the center's programs, for example, predates the research finding that food and drugs of abuse compete in the brain area associated with rewards and craving, he said.

“Abstinence is followed by rebound hyperphagia and weight gain, and an important way to avoid relapse is not to get too hungry.”

Today, the center represents “an influential minority” in addiction psychiatry, Dr. DuPont said. He noted “a kind of split” in the field about treatment goals, with harm reduction favored in academic and publicly funded settings, and institutions such as the Betty Ford Center taking a contrary view.

“We are very skeptical that harm reduction is helpful in cases of true addiction,” Dr. Waite-O'Brien said.

In addition, while drugs like buprenorphine and benzodiazepines are used to support detoxification at the center, “we're leery about medications to help people stay sober,” Dr. Waite-O'Brien said. “Treatment is an emotional and spiritual process, and we haven't found a medicine that works for that.”

Arguably, the center could help bridge differences within the field. In September, for example, it initiated the Betty Ford Institute “to conduct and support collaborative programs of research, prevention, education, and policy development.” Their first undertaking, a consensus conference on the concept of recovery, introduced “an academic psychiatry perspective into an important area in which it has been less involved,” said Dr. Galanter, who chaired the conference. “To operationally define [recovery] will be useful for outcome research.”

In general, “rehabilitation programs have not been integrated much into academically grounded addiction psychiatry,” Dr. Galanter observed. He is chairing an AAAP committee aimed at fostering more communication between camps, “and Betty Ford is illustrative of the concept.”

Betty Ford–the former first lady whose husband, 38th president Gerald R. Ford, died in December–announced in April 1978 that she was undergoing rehabilitation for addiction to prescription drugs and alcohol. Her experience led her 4 years later to help establish a treatment facility, the Betty Ford Center, in Rancho Mirage, Calif.

As the nation recently mourned the passing of former President Ford, it marveled at the impact his wife has had on the way in which addiction is viewed and treated by physicians.

However, it is difficult to isolate the center's influence on addiction psychiatry within the overall evolution of the field during that period, said Dr. Marc Galanter, professor of psychiatry at New York University, New York, and former president of the American Academy for Addiction Psychiatry (AAAP).

The AAAP was formed in 1985, and the subspecialty recognized by the American Board of Psychiatry and Neurology in 1992. “Overlapping with other trends … [the center] played a significant role in legitimizing the field,” he said. “It put addiction on the map.”

Mrs. Ford, whose self-disclosure came in interviews and a memoir, also was instrumental in promoting public acceptance of alcoholism as a valid medical disorder, Dr. Galanter said. “She opened up the discussion of something not really acknowledged previously.”

Dr. Robert L. DuPont said Mrs. Ford's story changed the image of an addicted person. “She made it a disease that a good person could have and get well from,” said Dr. DuPont, who served as White House drug chief under President Ford and was the first director of the National Institute on Drug Abuse. In particular, her openness led to wider recognition of substance problems in women, he said.

The Betty Ford Center, which this year celebrates its 25th anniversary, extended that influence. The respectability of a former first lady, a popular image of elegance, and the glamour of A-list clientele that have included prominent entertainers (Elizabeth Taylor, Robert Mitchum, Liza Minnelli, and Johnny Cash) and sports figures, such as Mickey Mantle, have helped neutralize the stigma of addiction treatment.

In reality, those associated with the center emphasize, celebrities have made up only a fraction of the 26,000 clients and family members treated since 1982, and the cost is in “the low-average range”–about $23,000 for the standard 30-day program, according to Nancy Waite-O'Brien, Ph.D., vice president of clinical services. Also, the setting, while pleasant, is not luxurious. Residents, for example, share rooms and housekeeping duties.

In the area of addiction treatment, the center has innovated less than it has lent visibility and cachet to techniques and programs developed elsewhere. The basic program follows the rehabilitation protocol that Mrs. Ford underwent at the San Diego Naval Medical Center, a 12-step “recovery” approach based largely on the Minnesota Model.

Dr. Galanter noted that family involvement in treatment, a focus from the outset, has since been adopted more widely. “That an intervention was done on Mrs. Ford did much to legitimate that concept in addiction psychiatry,” he said. In his New York University substance abuse program, for example, “network therapy,” a more sustained, less confrontational approach, enlists family and peers to bring in–and keep–patients in treatment.

The center's program to maintain supportive contact with clients after discharge was new, said Dr. DuPont, who has been involved with the center since its beginning. And while programs for addicted physicians and other professionals were pioneered elsewhere, “the center has made [such programs] a major commitment,” he said.

Work with women has been “the most innovative” aspect of treatment at the center, Dr. Waite-O'Brien said. Equal numbers of male and female clients are admitted, and patients follow gender-specific treatment tracks.

“Women experience addiction differently from men,” she said. “We address the fact that women addicts have been sexually abused much more frequently than men,” and that men deal more with absent-father issues and with anger.

Beyond treatment, almost since its inception, the center has sponsored clerkships for medical students, who spend a week working with clients and clinicians. “It fills a void medical schools have created,” said Dr. Mark S. Gold, distinguished professor of psychiatry and chief of the McKnight Brain Institute at University of Florida, in Gainesville. “We've sent students there for years, and they come back and say they couldn't appreciate the practice of addiction psychiatry without this kind exposure.”

Dr. Gold noted that much of the work at the center has been corroborated by research: It represents a melding of “science and the Big Book [the central text of Alcoholics Anonymous].” The long-standing inclusion of dietary counseling and exercise regimens in the center's programs, for example, predates the research finding that food and drugs of abuse compete in the brain area associated with rewards and craving, he said.

“Abstinence is followed by rebound hyperphagia and weight gain, and an important way to avoid relapse is not to get too hungry.”

Today, the center represents “an influential minority” in addiction psychiatry, Dr. DuPont said. He noted “a kind of split” in the field about treatment goals, with harm reduction favored in academic and publicly funded settings, and institutions such as the Betty Ford Center taking a contrary view.

“We are very skeptical that harm reduction is helpful in cases of true addiction,” Dr. Waite-O'Brien said.

In addition, while drugs like buprenorphine and benzodiazepines are used to support detoxification at the center, “we're leery about medications to help people stay sober,” Dr. Waite-O'Brien said. “Treatment is an emotional and spiritual process, and we haven't found a medicine that works for that.”

Arguably, the center could help bridge differences within the field. In September, for example, it initiated the Betty Ford Institute “to conduct and support collaborative programs of research, prevention, education, and policy development.” Their first undertaking, a consensus conference on the concept of recovery, introduced “an academic psychiatry perspective into an important area in which it has been less involved,” said Dr. Galanter, who chaired the conference. “To operationally define [recovery] will be useful for outcome research.”

In general, “rehabilitation programs have not been integrated much into academically grounded addiction psychiatry,” Dr. Galanter observed. He is chairing an AAAP committee aimed at fostering more communication between camps, “and Betty Ford is illustrative of the concept.”

Betty Ford–the former first lady whose husband, 38th president Gerald R. Ford, died in December–announced in April 1978 that she was undergoing rehabilitation for addiction to prescription drugs and alcohol. Her experience led her 4 years later to help establish a treatment facility, the Betty Ford Center, in Rancho Mirage, Calif.

As the nation recently mourned the passing of former President Ford, it marveled at the impact his wife has had on the way in which addiction is viewed and treated by physicians.

However, it is difficult to isolate the center's influence on addiction psychiatry within the overall evolution of the field during that period, said Dr. Marc Galanter, professor of psychiatry at New York University, New York, and former president of the American Academy for Addiction Psychiatry (AAAP).

The AAAP was formed in 1985, and the subspecialty recognized by the American Board of Psychiatry and Neurology in 1992. “Overlapping with other trends … [the center] played a significant role in legitimizing the field,” he said. “It put addiction on the map.”

Mrs. Ford, whose self-disclosure came in interviews and a memoir, also was instrumental in promoting public acceptance of alcoholism as a valid medical disorder, Dr. Galanter said. “She opened up the discussion of something not really acknowledged previously.”

Dr. Robert L. DuPont said Mrs. Ford's story changed the image of an addicted person. “She made it a disease that a good person could have and get well from,” said Dr. DuPont, who served as White House drug chief under President Ford and was the first director of the National Institute on Drug Abuse. In particular, her openness led to wider recognition of substance problems in women, he said.

The Betty Ford Center, which this year celebrates its 25th anniversary, extended that influence. The respectability of a former first lady, a popular image of elegance, and the glamour of A-list clientele that have included prominent entertainers (Elizabeth Taylor, Robert Mitchum, Liza Minnelli, and Johnny Cash) and sports figures, such as Mickey Mantle, have helped neutralize the stigma of addiction treatment.

In reality, those associated with the center emphasize, celebrities have made up only a fraction of the 26,000 clients and family members treated since 1982, and the cost is in “the low-average range”–about $23,000 for the standard 30-day program, according to Nancy Waite-O'Brien, Ph.D., vice president of clinical services. Also, the setting, while pleasant, is not luxurious. Residents, for example, share rooms and housekeeping duties.

In the area of addiction treatment, the center has innovated less than it has lent visibility and cachet to techniques and programs developed elsewhere. The basic program follows the rehabilitation protocol that Mrs. Ford underwent at the San Diego Naval Medical Center, a 12-step “recovery” approach based largely on the Minnesota Model.

Dr. Galanter noted that family involvement in treatment, a focus from the outset, has since been adopted more widely. “That an intervention was done on Mrs. Ford did much to legitimate that concept in addiction psychiatry,” he said. In his New York University substance abuse program, for example, “network therapy,” a more sustained, less confrontational approach, enlists family and peers to bring in–and keep–patients in treatment.

The center's program to maintain supportive contact with clients after discharge was new, said Dr. DuPont, who has been involved with the center since its beginning. And while programs for addicted physicians and other professionals were pioneered elsewhere, “the center has made [such programs] a major commitment,” he said.

Work with women has been “the most innovative” aspect of treatment at the center, Dr. Waite-O'Brien said. Equal numbers of male and female clients are admitted, and patients follow gender-specific treatment tracks.

“Women experience addiction differently from men,” she said. “We address the fact that women addicts have been sexually abused much more frequently than men,” and that men deal more with absent-father issues and with anger.

Beyond treatment, almost since its inception, the center has sponsored clerkships for medical students, who spend a week working with clients and clinicians. “It fills a void medical schools have created,” said Dr. Mark S. Gold, distinguished professor of psychiatry and chief of the McKnight Brain Institute at University of Florida, in Gainesville. “We've sent students there for years, and they come back and say they couldn't appreciate the practice of addiction psychiatry without this kind exposure.”

Dr. Gold noted that much of the work at the center has been corroborated by research: It represents a melding of “science and the Big Book [the central text of Alcoholics Anonymous].” The long-standing inclusion of dietary counseling and exercise regimens in the center's programs, for example, predates the research finding that food and drugs of abuse compete in the brain area associated with rewards and craving, he said.

“Abstinence is followed by rebound hyperphagia and weight gain, and an important way to avoid relapse is not to get too hungry.”

Today, the center represents “an influential minority” in addiction psychiatry, Dr. DuPont said. He noted “a kind of split” in the field about treatment goals, with harm reduction favored in academic and publicly funded settings, and institutions such as the Betty Ford Center taking a contrary view.

“We are very skeptical that harm reduction is helpful in cases of true addiction,” Dr. Waite-O'Brien said.

In addition, while drugs like buprenorphine and benzodiazepines are used to support detoxification at the center, “we're leery about medications to help people stay sober,” Dr. Waite-O'Brien said. “Treatment is an emotional and spiritual process, and we haven't found a medicine that works for that.”

Arguably, the center could help bridge differences within the field. In September, for example, it initiated the Betty Ford Institute “to conduct and support collaborative programs of research, prevention, education, and policy development.” Their first undertaking, a consensus conference on the concept of recovery, introduced “an academic psychiatry perspective into an important area in which it has been less involved,” said Dr. Galanter, who chaired the conference. “To operationally define [recovery] will be useful for outcome research.”

In general, “rehabilitation programs have not been integrated much into academically grounded addiction psychiatry,” Dr. Galanter observed. He is chairing an AAAP committee aimed at fostering more communication between camps, “and Betty Ford is illustrative of the concept.”

NEW YORK — Severe stress can have lasting effects, most dramatically in posttraumatic stress disorder. But many people undergo equally traumatic experiences—combat, natural disasters, imprisonment, torture—and emerge relatively intact.

What protects them?

Dr. Steven Southwick, a psychiatrist at Yale University, New Haven, Conn., has studied groups of combat veterans, former prisoners of war, and others who have done well after highly stressful experiences, using in-depth interviews and brain imaging to identify factors that may explain such resilience.

“Metaphorically, they resemble a twig with a green, growing core. When twisted out of shape, [the twig] springs back and continues to grow,” he said, citing Dr. George Vaillant, a professor of psychiatry at Harvard Medical School, Boston.

One biologic factor that distinguished this group involved neuropeptide Y, which is released along with norepinephrine under stressful conditions and has the effect of dampening arousal. “Neuropeptide Y turns the nervous system down,” Dr. Southwick said at a meeting on psychopharmacology sponsored by New York University. He noted that people with PTSD tend to have low levels of the chemical.

A group of U.S. Army Special Forces veterans who had done well under highly stressful combat conditions was found to have unusually high serum concentrations of neuropeptide Y. “This could enable them to remain cool under pressure,” he said.

A wider spectrum of personal and relationship traits emerged as being characteristic of resilient people. For example, a supportive social network—“having others around you”—may bolster the ability to contain one's own neurobiologic responses, Dr. Southwick said.

Mentors and powerful role models seemed to make a particular difference: “Everyone talked about them,” he said. The influence of a mentor appears to be a complex issue that can be understood from social, psychological, and biologic perspectives, and may involve the capacity for self-soothing under duress.

“Moral compass and integrity,” a factor mentioned by many interviewees, may offer protection against the guilt that appears to play a “huge” role in PTSD. One interviewee described his sense of right and wrong as “something to keep me afloat when drowning.”

The ability to find meaning and purpose even in very harsh circumstances—to “stand for an idea”—was a similar source of strength.

Interviewees “without exception” cited optimism and fighting spirit. “This wasn't 'rose-colored glasses,” but optimism born of adversity,” that neither ignored the negative nor dwelled on it, he said.

Optimism's complement was acceptance. Dr. Southwick noted that “every resilient person seemed to understand the necessity of knowing when to accept a situation as something that couldn't be changed.” Cognitive reappraisal was a related factor. “Really resilient people were very good at … focusing on what's left, not what's lost, and finding opportunity in adversity,” he said.

With regard to behavior, resilient people had an active—not passive—coping style that involved an approach to, rather than a withdrawal from, challenging situations. This style accords with neurobiologic studies showing that activity reduces amygdala arousal associated with fear.

Using signature strengths and skills seemed to be especially important. Engaging in activities that one does well was commonly described as invigorating: “One man, a firefighter, compared 'fighting a good fire' to pitching a no-hitter. In a desk job, he was no longer resilient; he wasn't using his skills and strengths,” Dr. Southwick said.

“There was no substitute for training,” he added.

The ability to face one's fears was crucial. “Most of us avoid fear—it's too painful—and find a way to reduce it. Avoidance helps in the short run but not the long run,” he said.

The Special Forces veterans interviewed said they had learned the skills necessary to move through fear, to confront it, and to develop plans to deal with its source. Dr. Southwick said his research with resilient people had changed his clinical approach as a psychiatrist: “I spend a lot more time working with people's strengths and finding out what they believe in.”

NEW YORK — Severe stress can have lasting effects, most dramatically in posttraumatic stress disorder. But many people undergo equally traumatic experiences—combat, natural disasters, imprisonment, torture—and emerge relatively intact.

What protects them?

Dr. Steven Southwick, a psychiatrist at Yale University, New Haven, Conn., has studied groups of combat veterans, former prisoners of war, and others who have done well after highly stressful experiences, using in-depth interviews and brain imaging to identify factors that may explain such resilience.

“Metaphorically, they resemble a twig with a green, growing core. When twisted out of shape, [the twig] springs back and continues to grow,” he said, citing Dr. George Vaillant, a professor of psychiatry at Harvard Medical School, Boston.

One biologic factor that distinguished this group involved neuropeptide Y, which is released along with norepinephrine under stressful conditions and has the effect of dampening arousal. “Neuropeptide Y turns the nervous system down,” Dr. Southwick said at a meeting on psychopharmacology sponsored by New York University. He noted that people with PTSD tend to have low levels of the chemical.

A group of U.S. Army Special Forces veterans who had done well under highly stressful combat conditions was found to have unusually high serum concentrations of neuropeptide Y. “This could enable them to remain cool under pressure,” he said.

A wider spectrum of personal and relationship traits emerged as being characteristic of resilient people. For example, a supportive social network—“having others around you”—may bolster the ability to contain one's own neurobiologic responses, Dr. Southwick said.

Mentors and powerful role models seemed to make a particular difference: “Everyone talked about them,” he said. The influence of a mentor appears to be a complex issue that can be understood from social, psychological, and biologic perspectives, and may involve the capacity for self-soothing under duress.

“Moral compass and integrity,” a factor mentioned by many interviewees, may offer protection against the guilt that appears to play a “huge” role in PTSD. One interviewee described his sense of right and wrong as “something to keep me afloat when drowning.”

The ability to find meaning and purpose even in very harsh circumstances—to “stand for an idea”—was a similar source of strength.

Interviewees “without exception” cited optimism and fighting spirit. “This wasn't 'rose-colored glasses,” but optimism born of adversity,” that neither ignored the negative nor dwelled on it, he said.

Optimism's complement was acceptance. Dr. Southwick noted that “every resilient person seemed to understand the necessity of knowing when to accept a situation as something that couldn't be changed.” Cognitive reappraisal was a related factor. “Really resilient people were very good at … focusing on what's left, not what's lost, and finding opportunity in adversity,” he said.

With regard to behavior, resilient people had an active—not passive—coping style that involved an approach to, rather than a withdrawal from, challenging situations. This style accords with neurobiologic studies showing that activity reduces amygdala arousal associated with fear.

Using signature strengths and skills seemed to be especially important. Engaging in activities that one does well was commonly described as invigorating: “One man, a firefighter, compared 'fighting a good fire' to pitching a no-hitter. In a desk job, he was no longer resilient; he wasn't using his skills and strengths,” Dr. Southwick said.

“There was no substitute for training,” he added.

The ability to face one's fears was crucial. “Most of us avoid fear—it's too painful—and find a way to reduce it. Avoidance helps in the short run but not the long run,” he said.

The Special Forces veterans interviewed said they had learned the skills necessary to move through fear, to confront it, and to develop plans to deal with its source. Dr. Southwick said his research with resilient people had changed his clinical approach as a psychiatrist: “I spend a lot more time working with people's strengths and finding out what they believe in.”

NEW YORK — Severe stress can have lasting effects, most dramatically in posttraumatic stress disorder. But many people undergo equally traumatic experiences—combat, natural disasters, imprisonment, torture—and emerge relatively intact.

What protects them?

Dr. Steven Southwick, a psychiatrist at Yale University, New Haven, Conn., has studied groups of combat veterans, former prisoners of war, and others who have done well after highly stressful experiences, using in-depth interviews and brain imaging to identify factors that may explain such resilience.

“Metaphorically, they resemble a twig with a green, growing core. When twisted out of shape, [the twig] springs back and continues to grow,” he said, citing Dr. George Vaillant, a professor of psychiatry at Harvard Medical School, Boston.

One biologic factor that distinguished this group involved neuropeptide Y, which is released along with norepinephrine under stressful conditions and has the effect of dampening arousal. “Neuropeptide Y turns the nervous system down,” Dr. Southwick said at a meeting on psychopharmacology sponsored by New York University. He noted that people with PTSD tend to have low levels of the chemical.

A group of U.S. Army Special Forces veterans who had done well under highly stressful combat conditions was found to have unusually high serum concentrations of neuropeptide Y. “This could enable them to remain cool under pressure,” he said.

A wider spectrum of personal and relationship traits emerged as being characteristic of resilient people. For example, a supportive social network—“having others around you”—may bolster the ability to contain one's own neurobiologic responses, Dr. Southwick said.

Mentors and powerful role models seemed to make a particular difference: “Everyone talked about them,” he said. The influence of a mentor appears to be a complex issue that can be understood from social, psychological, and biologic perspectives, and may involve the capacity for self-soothing under duress.

“Moral compass and integrity,” a factor mentioned by many interviewees, may offer protection against the guilt that appears to play a “huge” role in PTSD. One interviewee described his sense of right and wrong as “something to keep me afloat when drowning.”

The ability to find meaning and purpose even in very harsh circumstances—to “stand for an idea”—was a similar source of strength.

Interviewees “without exception” cited optimism and fighting spirit. “This wasn't 'rose-colored glasses,” but optimism born of adversity,” that neither ignored the negative nor dwelled on it, he said.

Optimism's complement was acceptance. Dr. Southwick noted that “every resilient person seemed to understand the necessity of knowing when to accept a situation as something that couldn't be changed.” Cognitive reappraisal was a related factor. “Really resilient people were very good at … focusing on what's left, not what's lost, and finding opportunity in adversity,” he said.

With regard to behavior, resilient people had an active—not passive—coping style that involved an approach to, rather than a withdrawal from, challenging situations. This style accords with neurobiologic studies showing that activity reduces amygdala arousal associated with fear.

Using signature strengths and skills seemed to be especially important. Engaging in activities that one does well was commonly described as invigorating: “One man, a firefighter, compared 'fighting a good fire' to pitching a no-hitter. In a desk job, he was no longer resilient; he wasn't using his skills and strengths,” Dr. Southwick said.

“There was no substitute for training,” he added.

The ability to face one's fears was crucial. “Most of us avoid fear—it's too painful—and find a way to reduce it. Avoidance helps in the short run but not the long run,” he said.

The Special Forces veterans interviewed said they had learned the skills necessary to move through fear, to confront it, and to develop plans to deal with its source. Dr. Southwick said his research with resilient people had changed his clinical approach as a psychiatrist: “I spend a lot more time working with people's strengths and finding out what they believe in.”

NEW YORK – Psychiatric residents may have learned a good deal about diagnosis and dosage, treatment options, and side effects in their training. But they are not eager to share this knowledge with patients, judging by the results of a study designed to assess compliance with informed consent criteria.

However, the same group of residents would quite readily provide appropriate information in response to patients' queries, Dr. Bret R. Rutherford said in a poster presentation at a meeting sponsored by the American Psychoanalytic Association. “They knew what they were supposed to say, but they weren't proactive.”

A relatively modest educational intervention aimed at informing residents of their responsibility to initiate informed consent discussions might have a substantial–and lasting–effect, he suggested.

The study used a questionnaire with vignettes describing initiation of treatment with three hypothetical patients with diverse diagnoses: an episode of major depressive disorder treated with medication, borderline personality disorder treated with psychotherapy, and psychotherapy for neurotic character traits.

Respondents were asked to say what they would tell patients spontaneously about various aspects of their disorder and its treatment, what they would tell patients if asked, and what they would refuse to discuss altogether.

The questionnaire was distributed to 220 residents at the seven largest psychiatric residency programs in the New York City area and returned by 108 (49%), of whom 27% were postgraduate year (PGY)-2, 42% were PGY-3, and 29% were PGY-4.

“We set a bare bones set of criteria of what would constitute informed consent,” said Dr. Rutherford of the Columbia University Center for Psychoanalytic Training and Research, New York. This included information about diagnosis and prognosis, treatment options, details of recommended treatment, side effects and logistics of treatment, and their own educational and personal background.

Eight of 324 responses to vignettes (2.5%) met these criteria; six residents accounted for all of them, and only one resident's responses met criteria for all vignettes. In general, residents were more forthcoming with depressed patients than with others, at least with regard to diagnosis and prognosis, recommended treatment, and side effects. They were best overall in giving information on treatment alternatives and costs, and worst in disclosing appropriate information about themselves.

Residents performed considerably better in answering hypothetical patients' questions: 173 (53.4%) of responses met a priori criteria. Again, a higher proportion of residents (71.2%) met criteria in dealing with the depressed patient than the borderline (42.6%) or neurotic patient (46.3%). The responses of one-third (36) of 108 residents met criteria for all three hypothetical patients.

In general, Dr. Rutherford observed, responses to patient queries suggested that participants knew what information should be provided for informed consent and what not to reveal, he said.

But they provided less information on diagnosis and prognosis, the ways treatment would help, and side effects to patients in psychotherapy than to those receiving medication. In fact, “most residents didn't seem aware that psychotherapy could have side effects; they wouldn't even answer questions if asked about them,” he said.

Residents aren't alone in their deficiencies in this area, according to other surveys, which have found that less than 50% of psychiatrists in community practice believe informed consent is important.

“We suspect that if they don't learn this in residency, the odds on learning it later are low,” Dr. Rutherford said. The topic seems to receive little attention in residency training, he said. “There needs to be more emphasis on the responsibility to tell patients things even if they don't ask.”

NEW YORK – Psychiatric residents may have learned a good deal about diagnosis and dosage, treatment options, and side effects in their training. But they are not eager to share this knowledge with patients, judging by the results of a study designed to assess compliance with informed consent criteria.

However, the same group of residents would quite readily provide appropriate information in response to patients' queries, Dr. Bret R. Rutherford said in a poster presentation at a meeting sponsored by the American Psychoanalytic Association. “They knew what they were supposed to say, but they weren't proactive.”

A relatively modest educational intervention aimed at informing residents of their responsibility to initiate informed consent discussions might have a substantial–and lasting–effect, he suggested.

The study used a questionnaire with vignettes describing initiation of treatment with three hypothetical patients with diverse diagnoses: an episode of major depressive disorder treated with medication, borderline personality disorder treated with psychotherapy, and psychotherapy for neurotic character traits.

Respondents were asked to say what they would tell patients spontaneously about various aspects of their disorder and its treatment, what they would tell patients if asked, and what they would refuse to discuss altogether.

The questionnaire was distributed to 220 residents at the seven largest psychiatric residency programs in the New York City area and returned by 108 (49%), of whom 27% were postgraduate year (PGY)-2, 42% were PGY-3, and 29% were PGY-4.

“We set a bare bones set of criteria of what would constitute informed consent,” said Dr. Rutherford of the Columbia University Center for Psychoanalytic Training and Research, New York. This included information about diagnosis and prognosis, treatment options, details of recommended treatment, side effects and logistics of treatment, and their own educational and personal background.

Eight of 324 responses to vignettes (2.5%) met these criteria; six residents accounted for all of them, and only one resident's responses met criteria for all vignettes. In general, residents were more forthcoming with depressed patients than with others, at least with regard to diagnosis and prognosis, recommended treatment, and side effects. They were best overall in giving information on treatment alternatives and costs, and worst in disclosing appropriate information about themselves.

Residents performed considerably better in answering hypothetical patients' questions: 173 (53.4%) of responses met a priori criteria. Again, a higher proportion of residents (71.2%) met criteria in dealing with the depressed patient than the borderline (42.6%) or neurotic patient (46.3%). The responses of one-third (36) of 108 residents met criteria for all three hypothetical patients.

In general, Dr. Rutherford observed, responses to patient queries suggested that participants knew what information should be provided for informed consent and what not to reveal, he said.

But they provided less information on diagnosis and prognosis, the ways treatment would help, and side effects to patients in psychotherapy than to those receiving medication. In fact, “most residents didn't seem aware that psychotherapy could have side effects; they wouldn't even answer questions if asked about them,” he said.

Residents aren't alone in their deficiencies in this area, according to other surveys, which have found that less than 50% of psychiatrists in community practice believe informed consent is important.

“We suspect that if they don't learn this in residency, the odds on learning it later are low,” Dr. Rutherford said. The topic seems to receive little attention in residency training, he said. “There needs to be more emphasis on the responsibility to tell patients things even if they don't ask.”

NEW YORK – Psychiatric residents may have learned a good deal about diagnosis and dosage, treatment options, and side effects in their training. But they are not eager to share this knowledge with patients, judging by the results of a study designed to assess compliance with informed consent criteria.

However, the same group of residents would quite readily provide appropriate information in response to patients' queries, Dr. Bret R. Rutherford said in a poster presentation at a meeting sponsored by the American Psychoanalytic Association. “They knew what they were supposed to say, but they weren't proactive.”

A relatively modest educational intervention aimed at informing residents of their responsibility to initiate informed consent discussions might have a substantial–and lasting–effect, he suggested.

The study used a questionnaire with vignettes describing initiation of treatment with three hypothetical patients with diverse diagnoses: an episode of major depressive disorder treated with medication, borderline personality disorder treated with psychotherapy, and psychotherapy for neurotic character traits.

Respondents were asked to say what they would tell patients spontaneously about various aspects of their disorder and its treatment, what they would tell patients if asked, and what they would refuse to discuss altogether.

The questionnaire was distributed to 220 residents at the seven largest psychiatric residency programs in the New York City area and returned by 108 (49%), of whom 27% were postgraduate year (PGY)-2, 42% were PGY-3, and 29% were PGY-4.

“We set a bare bones set of criteria of what would constitute informed consent,” said Dr. Rutherford of the Columbia University Center for Psychoanalytic Training and Research, New York. This included information about diagnosis and prognosis, treatment options, details of recommended treatment, side effects and logistics of treatment, and their own educational and personal background.

Eight of 324 responses to vignettes (2.5%) met these criteria; six residents accounted for all of them, and only one resident's responses met criteria for all vignettes. In general, residents were more forthcoming with depressed patients than with others, at least with regard to diagnosis and prognosis, recommended treatment, and side effects. They were best overall in giving information on treatment alternatives and costs, and worst in disclosing appropriate information about themselves.

Residents performed considerably better in answering hypothetical patients' questions: 173 (53.4%) of responses met a priori criteria. Again, a higher proportion of residents (71.2%) met criteria in dealing with the depressed patient than the borderline (42.6%) or neurotic patient (46.3%). The responses of one-third (36) of 108 residents met criteria for all three hypothetical patients.

In general, Dr. Rutherford observed, responses to patient queries suggested that participants knew what information should be provided for informed consent and what not to reveal, he said.

But they provided less information on diagnosis and prognosis, the ways treatment would help, and side effects to patients in psychotherapy than to those receiving medication. In fact, “most residents didn't seem aware that psychotherapy could have side effects; they wouldn't even answer questions if asked about them,” he said.

Residents aren't alone in their deficiencies in this area, according to other surveys, which have found that less than 50% of psychiatrists in community practice believe informed consent is important.

“We suspect that if they don't learn this in residency, the odds on learning it later are low,” Dr. Rutherford said. The topic seems to receive little attention in residency training, he said. “There needs to be more emphasis on the responsibility to tell patients things even if they don't ask.”

NEW YORK — Time is a crucial factor in depression treatment, as repeated failed trials and delay in achieving an adequate response take a cumulative toll on patient morale, ability to function, and finances, Jeffrey E. Kelsey, M.D., Ph.D., said at a meeting on psychopharmacology sponsored by New York University.

Good practice often requires the application of both evidence and clinical experience. “Proven therapies are a good place to start, but we can't get by solely on what evidence tells us,” said Dr. Kelsey, medical director of the Georgia Institute of Mood and Anxiety Disorders, Atlanta.

The choice of an initial antidepressant is “little more than an educated guess” for the most part, he said. If an adequate trial fails to achieve a response, the choice is between switching to a different agent and augmentation with polypharmacy.

“If the first drug isn't working at all, I would stop it before adding something else,” Dr. Kelsey said. An agent with a different mechanism of action would seem a better choice than one of the same class.

The switch, however, should not be too abrupt: A schedule that phases in the second drug while slowly tapering the first will minimize the possibility of the discontinuation syndrome that can occur when serotonergic drugs are withdrawn. The patient should be counseled about the possibility of such symptoms as malaise, gastrointestinal upset, anxiety, irritability, insomnia, and paresthesias so these symptoms are not ascribed to the new drug, he said.

Augmentation, when the first drug is well tolerated and has achieved some degree of response, is likely to achieve quicker results than switching, Dr. Kelsey said.

Lithium and thyroid hormone augmentation are “classic” strategies that have been shown to be more effective than placebo, he said.

Lithium, in particular, is underutilized. Dr. Kelsey advised a modest target blood level of 0.4–0.5 mEq/L, which is generally adequate and less likely to cause tolerability problems than higher blood levels.

Thyroid augmentation should be based on thyroid hormone assay. If only T₃ is low, just T₃ should be added; if both T₃ and T₄ are low, just T₄. “Sometimes the improvement is amazing,” he said.

When an atypical antipsychotic is used for augmentation, the possible effect of drug-drug interactions must be kept in mind. Risperidone (Risperdal), for example, should be started at 0.5 mg/day and increased to 1 mg/day, but when it is used to augment an SSRI that may inhibit cytochrome P450 2D6, those dosages should be halved.

Dopaminergic agents are particularly apt for augmentation when apathy and low energy are prominent. With use of a dopamine agonist like pramipexole (Mirapex), a gradual escalation from a low dose will minimize nausea and improve tolerability.

Reducing, rather than increasing, the SSRI should be considered in this situation since anergic, amotivational symptoms may be related to dopaminergic downregulation in the frontal lobe, Dr. Kelsey explained.

With any long-standing or treatment-resistant depression, the chances for a good response are substantially increased if psychotherapy is added to whatever medication regimen is used.

As patients become more refractory, a longer trial is necessary before concluding that a treatment approach isn't working. “You won't get an immediate response, as in early illness,” Dr. Kelsey said. “Remember, the clock is ticking.”

NEW YORK — Time is a crucial factor in depression treatment, as repeated failed trials and delay in achieving an adequate response take a cumulative toll on patient morale, ability to function, and finances, Jeffrey E. Kelsey, M.D., Ph.D., said at a meeting on psychopharmacology sponsored by New York University.

Good practice often requires the application of both evidence and clinical experience. “Proven therapies are a good place to start, but we can't get by solely on what evidence tells us,” said Dr. Kelsey, medical director of the Georgia Institute of Mood and Anxiety Disorders, Atlanta.

The choice of an initial antidepressant is “little more than an educated guess” for the most part, he said. If an adequate trial fails to achieve a response, the choice is between switching to a different agent and augmentation with polypharmacy.

“If the first drug isn't working at all, I would stop it before adding something else,” Dr. Kelsey said. An agent with a different mechanism of action would seem a better choice than one of the same class.

The switch, however, should not be too abrupt: A schedule that phases in the second drug while slowly tapering the first will minimize the possibility of the discontinuation syndrome that can occur when serotonergic drugs are withdrawn. The patient should be counseled about the possibility of such symptoms as malaise, gastrointestinal upset, anxiety, irritability, insomnia, and paresthesias so these symptoms are not ascribed to the new drug, he said.

Augmentation, when the first drug is well tolerated and has achieved some degree of response, is likely to achieve quicker results than switching, Dr. Kelsey said.

Lithium and thyroid hormone augmentation are “classic” strategies that have been shown to be more effective than placebo, he said.

Lithium, in particular, is underutilized. Dr. Kelsey advised a modest target blood level of 0.4–0.5 mEq/L, which is generally adequate and less likely to cause tolerability problems than higher blood levels.

Thyroid augmentation should be based on thyroid hormone assay. If only T₃ is low, just T₃ should be added; if both T₃ and T₄ are low, just T₄. “Sometimes the improvement is amazing,” he said.

When an atypical antipsychotic is used for augmentation, the possible effect of drug-drug interactions must be kept in mind. Risperidone (Risperdal), for example, should be started at 0.5 mg/day and increased to 1 mg/day, but when it is used to augment an SSRI that may inhibit cytochrome P450 2D6, those dosages should be halved.

Dopaminergic agents are particularly apt for augmentation when apathy and low energy are prominent. With use of a dopamine agonist like pramipexole (Mirapex), a gradual escalation from a low dose will minimize nausea and improve tolerability.

Reducing, rather than increasing, the SSRI should be considered in this situation since anergic, amotivational symptoms may be related to dopaminergic downregulation in the frontal lobe, Dr. Kelsey explained.

With any long-standing or treatment-resistant depression, the chances for a good response are substantially increased if psychotherapy is added to whatever medication regimen is used.

As patients become more refractory, a longer trial is necessary before concluding that a treatment approach isn't working. “You won't get an immediate response, as in early illness,” Dr. Kelsey said. “Remember, the clock is ticking.”

NEW YORK — Time is a crucial factor in depression treatment, as repeated failed trials and delay in achieving an adequate response take a cumulative toll on patient morale, ability to function, and finances, Jeffrey E. Kelsey, M.D., Ph.D., said at a meeting on psychopharmacology sponsored by New York University.

Good practice often requires the application of both evidence and clinical experience. “Proven therapies are a good place to start, but we can't get by solely on what evidence tells us,” said Dr. Kelsey, medical director of the Georgia Institute of Mood and Anxiety Disorders, Atlanta.

The choice of an initial antidepressant is “little more than an educated guess” for the most part, he said. If an adequate trial fails to achieve a response, the choice is between switching to a different agent and augmentation with polypharmacy.

“If the first drug isn't working at all, I would stop it before adding something else,” Dr. Kelsey said. An agent with a different mechanism of action would seem a better choice than one of the same class.

The switch, however, should not be too abrupt: A schedule that phases in the second drug while slowly tapering the first will minimize the possibility of the discontinuation syndrome that can occur when serotonergic drugs are withdrawn. The patient should be counseled about the possibility of such symptoms as malaise, gastrointestinal upset, anxiety, irritability, insomnia, and paresthesias so these symptoms are not ascribed to the new drug, he said.

Augmentation, when the first drug is well tolerated and has achieved some degree of response, is likely to achieve quicker results than switching, Dr. Kelsey said.

Lithium and thyroid hormone augmentation are “classic” strategies that have been shown to be more effective than placebo, he said.

Lithium, in particular, is underutilized. Dr. Kelsey advised a modest target blood level of 0.4–0.5 mEq/L, which is generally adequate and less likely to cause tolerability problems than higher blood levels.

Thyroid augmentation should be based on thyroid hormone assay. If only T₃ is low, just T₃ should be added; if both T₃ and T₄ are low, just T₄. “Sometimes the improvement is amazing,” he said.

When an atypical antipsychotic is used for augmentation, the possible effect of drug-drug interactions must be kept in mind. Risperidone (Risperdal), for example, should be started at 0.5 mg/day and increased to 1 mg/day, but when it is used to augment an SSRI that may inhibit cytochrome P450 2D6, those dosages should be halved.

Dopaminergic agents are particularly apt for augmentation when apathy and low energy are prominent. With use of a dopamine agonist like pramipexole (Mirapex), a gradual escalation from a low dose will minimize nausea and improve tolerability.

Reducing, rather than increasing, the SSRI should be considered in this situation since anergic, amotivational symptoms may be related to dopaminergic downregulation in the frontal lobe, Dr. Kelsey explained.

With any long-standing or treatment-resistant depression, the chances for a good response are substantially increased if psychotherapy is added to whatever medication regimen is used.

As patients become more refractory, a longer trial is necessary before concluding that a treatment approach isn't working. “You won't get an immediate response, as in early illness,” Dr. Kelsey said. “Remember, the clock is ticking.”

NEW YORK — Two new transdermal and intranasal drug delivery systems, for which approval is foreseeable, may have utility in treating depression and erectile dysfunction, Donald S. Robinson, M.D., said at a meeting on psychopharmacology sponsored by New York University.

Oral administration delays onset of action since the drug passes through the digestive tract and is absorbed in the small bowel. Moreover, when the drug enters the body via this route, it undergoes first-pass metabolism in the liver.

Often, a large dose must be taken to get a relatively small amount to the site of action, noted Dr. Robinson, a psychiatrist and pharmaceutical consultant in Melbourne, Fla.

Parenteral administration boosts bioavailability. Far more of the drug goes directly into central systemic circulation, which favors the brain, so a proportionally greater amount will be delivered to the central nervous system than to other organs. Avoiding first-pass metabolism in the liver prevents production of metabolites that can alter a drug's safety and side effect profile, said Dr. Robinson, a member of the board of directors of Pherin Pharmaceuticals and a vice president at Bristol-Myers Squibb.

Transdermal and intranasal formulations have promise for routine use. Transdermal selegiline may make it possible to achieve the antidepressant efficacy of a monoamine oxidase inhibitor without the dietary restrictions and acute hypertensive risks that have been largely responsible for the fall from favor of this drug class, Dr. Robinson said.

Conventional MAO inhibitors interfere with the action of an isoenzyme, MAO-A, that normally prevents the absorption of tyramine, a food component that can raise blood pressure dramatically, he said.

Although the MAO inhibitor selegiline is selective at low doses for MAO-B receptors, given in oral doses that achieve an antidepressant effect it loses its selectivity, inhibiting both MAO-A and MAO-B and arousing the same safety issues as with other MAO inhibitors.

The transdermal delivery route obviates this problem: The drug enters systemic circulation directly, so a therapeutic level is achieved in the brain at a dose that spares MAO-A receptors in the intestine, Dr. Robinson said.

Three placebo-controlled trials showed the efficacy of transdermal selegiline in major depression, and a 2-year trial found it to reduce relapse by half, he said.

“In all the clinical trials [in which more than 2,000 individuals were exposed to the drug] there was not a single episode of acute hypertensive crisis, although there were no dietary restrictions after the first trial,” he said. The formulation is expected to be marketed later this year by Bristol-Myers Squibb and Somerset Pharmaceuticals, Dr. Robinson said.

Intrasnasal delivery may allow the use of a novel drug for erectile dysfunction. PT-141, a synthetic peptide under development by Palatin Technologies, operates through a different mechanism than existing erectile dysfunction drugs such as sildenafil (Viagra): It acts centrally, not peripherally, he said.

Because the peptide is a large molecule, it cannot pass unaltered through the digestive system, but it is well absorbed nasally.

The rapid action of the drug when administered in a nasal spray—high blood levels are achieved within 10–15 minutes—allows superior flexibility in timing, Dr. Robinson said.

In a phase IIb clinical trial, 271 sildenafil-responsive men with erectile dysfunction (some with organic causes including diabetes and hypertension) were randomized to receive PT-141 or placebo. Changes in scores on the International Index of Erectile Dysfunction, a self-rating scale, were significantly greater with the drug than with placebo at three of the four doses tested.

“It looks like this drug will be available within 2–3 years,” Dr. Robinson said. Phase III trials are planned for late 2006, according to the Palatin Technologies Web site.

NEW YORK — Two new transdermal and intranasal drug delivery systems, for which approval is foreseeable, may have utility in treating depression and erectile dysfunction, Donald S. Robinson, M.D., said at a meeting on psychopharmacology sponsored by New York University.

Oral administration delays onset of action since the drug passes through the digestive tract and is absorbed in the small bowel. Moreover, when the drug enters the body via this route, it undergoes first-pass metabolism in the liver.

Often, a large dose must be taken to get a relatively small amount to the site of action, noted Dr. Robinson, a psychiatrist and pharmaceutical consultant in Melbourne, Fla.

Parenteral administration boosts bioavailability. Far more of the drug goes directly into central systemic circulation, which favors the brain, so a proportionally greater amount will be delivered to the central nervous system than to other organs. Avoiding first-pass metabolism in the liver prevents production of metabolites that can alter a drug's safety and side effect profile, said Dr. Robinson, a member of the board of directors of Pherin Pharmaceuticals and a vice president at Bristol-Myers Squibb.

Transdermal and intranasal formulations have promise for routine use. Transdermal selegiline may make it possible to achieve the antidepressant efficacy of a monoamine oxidase inhibitor without the dietary restrictions and acute hypertensive risks that have been largely responsible for the fall from favor of this drug class, Dr. Robinson said.

Conventional MAO inhibitors interfere with the action of an isoenzyme, MAO-A, that normally prevents the absorption of tyramine, a food component that can raise blood pressure dramatically, he said.

Although the MAO inhibitor selegiline is selective at low doses for MAO-B receptors, given in oral doses that achieve an antidepressant effect it loses its selectivity, inhibiting both MAO-A and MAO-B and arousing the same safety issues as with other MAO inhibitors.

The transdermal delivery route obviates this problem: The drug enters systemic circulation directly, so a therapeutic level is achieved in the brain at a dose that spares MAO-A receptors in the intestine, Dr. Robinson said.

Three placebo-controlled trials showed the efficacy of transdermal selegiline in major depression, and a 2-year trial found it to reduce relapse by half, he said.

“In all the clinical trials [in which more than 2,000 individuals were exposed to the drug] there was not a single episode of acute hypertensive crisis, although there were no dietary restrictions after the first trial,” he said. The formulation is expected to be marketed later this year by Bristol-Myers Squibb and Somerset Pharmaceuticals, Dr. Robinson said.

Intrasnasal delivery may allow the use of a novel drug for erectile dysfunction. PT-141, a synthetic peptide under development by Palatin Technologies, operates through a different mechanism than existing erectile dysfunction drugs such as sildenafil (Viagra): It acts centrally, not peripherally, he said.

Because the peptide is a large molecule, it cannot pass unaltered through the digestive system, but it is well absorbed nasally.

The rapid action of the drug when administered in a nasal spray—high blood levels are achieved within 10–15 minutes—allows superior flexibility in timing, Dr. Robinson said.

In a phase IIb clinical trial, 271 sildenafil-responsive men with erectile dysfunction (some with organic causes including diabetes and hypertension) were randomized to receive PT-141 or placebo. Changes in scores on the International Index of Erectile Dysfunction, a self-rating scale, were significantly greater with the drug than with placebo at three of the four doses tested.

“It looks like this drug will be available within 2–3 years,” Dr. Robinson said. Phase III trials are planned for late 2006, according to the Palatin Technologies Web site.

NEW YORK — Two new transdermal and intranasal drug delivery systems, for which approval is foreseeable, may have utility in treating depression and erectile dysfunction, Donald S. Robinson, M.D., said at a meeting on psychopharmacology sponsored by New York University.

Oral administration delays onset of action since the drug passes through the digestive tract and is absorbed in the small bowel. Moreover, when the drug enters the body via this route, it undergoes first-pass metabolism in the liver.

Often, a large dose must be taken to get a relatively small amount to the site of action, noted Dr. Robinson, a psychiatrist and pharmaceutical consultant in Melbourne, Fla.

Parenteral administration boosts bioavailability. Far more of the drug goes directly into central systemic circulation, which favors the brain, so a proportionally greater amount will be delivered to the central nervous system than to other organs. Avoiding first-pass metabolism in the liver prevents production of metabolites that can alter a drug's safety and side effect profile, said Dr. Robinson, a member of the board of directors of Pherin Pharmaceuticals and a vice president at Bristol-Myers Squibb.

Transdermal and intranasal formulations have promise for routine use. Transdermal selegiline may make it possible to achieve the antidepressant efficacy of a monoamine oxidase inhibitor without the dietary restrictions and acute hypertensive risks that have been largely responsible for the fall from favor of this drug class, Dr. Robinson said.

Conventional MAO inhibitors interfere with the action of an isoenzyme, MAO-A, that normally prevents the absorption of tyramine, a food component that can raise blood pressure dramatically, he said.

Although the MAO inhibitor selegiline is selective at low doses for MAO-B receptors, given in oral doses that achieve an antidepressant effect it loses its selectivity, inhibiting both MAO-A and MAO-B and arousing the same safety issues as with other MAO inhibitors.

The transdermal delivery route obviates this problem: The drug enters systemic circulation directly, so a therapeutic level is achieved in the brain at a dose that spares MAO-A receptors in the intestine, Dr. Robinson said.

Three placebo-controlled trials showed the efficacy of transdermal selegiline in major depression, and a 2-year trial found it to reduce relapse by half, he said.

“In all the clinical trials [in which more than 2,000 individuals were exposed to the drug] there was not a single episode of acute hypertensive crisis, although there were no dietary restrictions after the first trial,” he said. The formulation is expected to be marketed later this year by Bristol-Myers Squibb and Somerset Pharmaceuticals, Dr. Robinson said.

Intrasnasal delivery may allow the use of a novel drug for erectile dysfunction. PT-141, a synthetic peptide under development by Palatin Technologies, operates through a different mechanism than existing erectile dysfunction drugs such as sildenafil (Viagra): It acts centrally, not peripherally, he said.

Because the peptide is a large molecule, it cannot pass unaltered through the digestive system, but it is well absorbed nasally.

The rapid action of the drug when administered in a nasal spray—high blood levels are achieved within 10–15 minutes—allows superior flexibility in timing, Dr. Robinson said.

In a phase IIb clinical trial, 271 sildenafil-responsive men with erectile dysfunction (some with organic causes including diabetes and hypertension) were randomized to receive PT-141 or placebo. Changes in scores on the International Index of Erectile Dysfunction, a self-rating scale, were significantly greater with the drug than with placebo at three of the four doses tested.

“It looks like this drug will be available within 2–3 years,” Dr. Robinson said. Phase III trials are planned for late 2006, according to the Palatin Technologies Web site.

NEW YORK – Schizophrenia and bipolar disorder pose a triple health threat: The conditions themselves are associated with a higher prevalence of serious medical illness, some drugs used to treat them increase disease risk, and affected individuals are likely to have inadequate medical care, Ilise D. Lombardo, M.D., said at a conference on schizophrenia sponsored by Columbia University.

The unhealthful influence is bidirectional: The psychiatric course tends to be worse in individuals with chronic medical conditions or medical risk factors like obesity. (For example, a survey of 1,379 bipolar patients found that 44% had comorbid medical conditions and linked the presence and severity of medical problems to the severity of the psychiatric disorder.)

“Psychiatrists should monitor risk factors, coordinate care with internists, and involve families in medical issues,” said Dr. Lombardo of the university.

Serious mental illness is life-threatening: The rate of mortality from natural causes among patients with bipolar disorder and schizophrenia is double that of the population as a whole; for unipolar depression, the mortality rate is 1.5 times that of the general population. Cardiovascular disease and, to a lesser extent, endocrine disorders are mainly responsible for the higher rates.

This increased mortality is not surprising in light of the high prevalence of cardiovascular risk factors in the psychiatric population, Dr. Lombardo said.

Among patients with schizophrenia, 18% have elevated total cholesterol levels, 20% have hypertension, 75% smoke cigarettes, about 50% are overweight or obese, and 72% are sedentary.

An estimated 30%–60% of schizophrenia patients have metabolic syndrome–a constellation of abdominal obesity, lipid abnormalities, and abnormal glucose metabolism that triples the risk of dying of a myocardial infarction, Dr. Lombardo said at the meeting, which was cosponsored by the New York State Psychiatric Institute.

But although the medical needs of people with severe and persistent mental illness would appear to be greater, they “have less access and less quality medical care,” said Dr. Lombardo, who is also medical director for Pfizer Inc.

A review of 175,653 patients in Veterans Affairs medical centers in Southern California and Nevada found a highly significant association between a diagnosis of schizophrenia and fewer physician visits. Two-thirds of schizophrenia patients did not have such prevalent conditions as diabetes, hypertension, or chronic obstructive pulmonary disease listed among their medical diagnoses.

“If a patient with schizophrenia is hospitalized with chest pain, he is less likely to have aggressive cardiac care and more likely to die of a myocardial infarction,” Dr. Lombardo said.

Obesity, a risk factor for both diabetes and cardiovascular disease, is highly prevalent among patients with both schizophrenia and diabetes. In one study of 114 new-onset patients with schizophrenia, the mean body mass index at the time of diagnosis was 24.5 kg/m2–the upper limit of normal. After 1 year, mean body mass index in these patients had climbed to 27.5, within the obesity range. “Most weight gain occurred in the first 6 months,” she said.

“Is it due to the illness itself, lifestyle changes related to the psychological burden of the illness, or treatment? There is good evidence that all three are involved,” Dr. Lombardo said.

The problem is at least as pronounced in bipolar disorder: A study of 644 patients found that 60% were overweight, 20% were obese, and 5% were “extremely obese.”

Not only is being overweight associated with an increased risk of hypertension, arthritis, and diabetes, it apparently has negative psychiatric consequences as well. In one group of bipolar patients, time to relapse was significantly shorter among the 46 who were obese than among the 79 who were not. In 20 weeks, 30% of the obese patients had relapsed, compared with a negligible number of the nonobese.

In a study of individuals with schizophrenia, 26% of normal-weight patients were noncompliant with treatment, compared with 39% of overweight and 47% of obese patients, Dr. Lombardo said.

NEW YORK – Schizophrenia and bipolar disorder pose a triple health threat: The conditions themselves are associated with a higher prevalence of serious medical illness, some drugs used to treat them increase disease risk, and affected individuals are likely to have inadequate medical care, Ilise D. Lombardo, M.D., said at a conference on schizophrenia sponsored by Columbia University.

The unhealthful influence is bidirectional: The psychiatric course tends to be worse in individuals with chronic medical conditions or medical risk factors like obesity. (For example, a survey of 1,379 bipolar patients found that 44% had comorbid medical conditions and linked the presence and severity of medical problems to the severity of the psychiatric disorder.)

“Psychiatrists should monitor risk factors, coordinate care with internists, and involve families in medical issues,” said Dr. Lombardo of the university.

Serious mental illness is life-threatening: The rate of mortality from natural causes among patients with bipolar disorder and schizophrenia is double that of the population as a whole; for unipolar depression, the mortality rate is 1.5 times that of the general population. Cardiovascular disease and, to a lesser extent, endocrine disorders are mainly responsible for the higher rates.

This increased mortality is not surprising in light of the high prevalence of cardiovascular risk factors in the psychiatric population, Dr. Lombardo said.

Among patients with schizophrenia, 18% have elevated total cholesterol levels, 20% have hypertension, 75% smoke cigarettes, about 50% are overweight or obese, and 72% are sedentary.

An estimated 30%–60% of schizophrenia patients have metabolic syndrome–a constellation of abdominal obesity, lipid abnormalities, and abnormal glucose metabolism that triples the risk of dying of a myocardial infarction, Dr. Lombardo said at the meeting, which was cosponsored by the New York State Psychiatric Institute.

But although the medical needs of people with severe and persistent mental illness would appear to be greater, they “have less access and less quality medical care,” said Dr. Lombardo, who is also medical director for Pfizer Inc.

A review of 175,653 patients in Veterans Affairs medical centers in Southern California and Nevada found a highly significant association between a diagnosis of schizophrenia and fewer physician visits. Two-thirds of schizophrenia patients did not have such prevalent conditions as diabetes, hypertension, or chronic obstructive pulmonary disease listed among their medical diagnoses.

“If a patient with schizophrenia is hospitalized with chest pain, he is less likely to have aggressive cardiac care and more likely to die of a myocardial infarction,” Dr. Lombardo said.

Obesity, a risk factor for both diabetes and cardiovascular disease, is highly prevalent among patients with both schizophrenia and diabetes. In one study of 114 new-onset patients with schizophrenia, the mean body mass index at the time of diagnosis was 24.5 kg/m2–the upper limit of normal. After 1 year, mean body mass index in these patients had climbed to 27.5, within the obesity range. “Most weight gain occurred in the first 6 months,” she said.

“Is it due to the illness itself, lifestyle changes related to the psychological burden of the illness, or treatment? There is good evidence that all three are involved,” Dr. Lombardo said.

The problem is at least as pronounced in bipolar disorder: A study of 644 patients found that 60% were overweight, 20% were obese, and 5% were “extremely obese.”

Not only is being overweight associated with an increased risk of hypertension, arthritis, and diabetes, it apparently has negative psychiatric consequences as well. In one group of bipolar patients, time to relapse was significantly shorter among the 46 who were obese than among the 79 who were not. In 20 weeks, 30% of the obese patients had relapsed, compared with a negligible number of the nonobese.

In a study of individuals with schizophrenia, 26% of normal-weight patients were noncompliant with treatment, compared with 39% of overweight and 47% of obese patients, Dr. Lombardo said.

NEW YORK – Schizophrenia and bipolar disorder pose a triple health threat: The conditions themselves are associated with a higher prevalence of serious medical illness, some drugs used to treat them increase disease risk, and affected individuals are likely to have inadequate medical care, Ilise D. Lombardo, M.D., said at a conference on schizophrenia sponsored by Columbia University.

The unhealthful influence is bidirectional: The psychiatric course tends to be worse in individuals with chronic medical conditions or medical risk factors like obesity. (For example, a survey of 1,379 bipolar patients found that 44% had comorbid medical conditions and linked the presence and severity of medical problems to the severity of the psychiatric disorder.)

“Psychiatrists should monitor risk factors, coordinate care with internists, and involve families in medical issues,” said Dr. Lombardo of the university.

Serious mental illness is life-threatening: The rate of mortality from natural causes among patients with bipolar disorder and schizophrenia is double that of the population as a whole; for unipolar depression, the mortality rate is 1.5 times that of the general population. Cardiovascular disease and, to a lesser extent, endocrine disorders are mainly responsible for the higher rates.

This increased mortality is not surprising in light of the high prevalence of cardiovascular risk factors in the psychiatric population, Dr. Lombardo said.

Among patients with schizophrenia, 18% have elevated total cholesterol levels, 20% have hypertension, 75% smoke cigarettes, about 50% are overweight or obese, and 72% are sedentary.

An estimated 30%–60% of schizophrenia patients have metabolic syndrome–a constellation of abdominal obesity, lipid abnormalities, and abnormal glucose metabolism that triples the risk of dying of a myocardial infarction, Dr. Lombardo said at the meeting, which was cosponsored by the New York State Psychiatric Institute.

But although the medical needs of people with severe and persistent mental illness would appear to be greater, they “have less access and less quality medical care,” said Dr. Lombardo, who is also medical director for Pfizer Inc.

A review of 175,653 patients in Veterans Affairs medical centers in Southern California and Nevada found a highly significant association between a diagnosis of schizophrenia and fewer physician visits. Two-thirds of schizophrenia patients did not have such prevalent conditions as diabetes, hypertension, or chronic obstructive pulmonary disease listed among their medical diagnoses.

“If a patient with schizophrenia is hospitalized with chest pain, he is less likely to have aggressive cardiac care and more likely to die of a myocardial infarction,” Dr. Lombardo said.

Obesity, a risk factor for both diabetes and cardiovascular disease, is highly prevalent among patients with both schizophrenia and diabetes. In one study of 114 new-onset patients with schizophrenia, the mean body mass index at the time of diagnosis was 24.5 kg/m2–the upper limit of normal. After 1 year, mean body mass index in these patients had climbed to 27.5, within the obesity range. “Most weight gain occurred in the first 6 months,” she said.

“Is it due to the illness itself, lifestyle changes related to the psychological burden of the illness, or treatment? There is good evidence that all three are involved,” Dr. Lombardo said.

The problem is at least as pronounced in bipolar disorder: A study of 644 patients found that 60% were overweight, 20% were obese, and 5% were “extremely obese.”

Not only is being overweight associated with an increased risk of hypertension, arthritis, and diabetes, it apparently has negative psychiatric consequences as well. In one group of bipolar patients, time to relapse was significantly shorter among the 46 who were obese than among the 79 who were not. In 20 weeks, 30% of the obese patients had relapsed, compared with a negligible number of the nonobese.

In a study of individuals with schizophrenia, 26% of normal-weight patients were noncompliant with treatment, compared with 39% of overweight and 47% of obese patients, Dr. Lombardo said.

NEW YORK — Eclampsia has become increasingly rare in Western countries, but it still occurs in 1 in 2,000–3,500 pregnancies—and obstetric clinics must be prepared to treat it, Baha M. Sibai, M.D., said at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

Although most episodes occur late in pregnancy, an increasing number occur more than 2 days after delivery, and patients should be counseled accordingly, said Dr. Sibai, professor and chairman of the obstetrics and gynecology department at the University of Cincinnati.

Eclampsia does not always come with a warning. It has been reported that in 15%–20% of cases neither hypertension nor proteinuria has occurred.

“Most women with eclampsia have had good prenatal care,” Dr. Sibai said. In a 1992 U.K. study of 383 women, 85% had been seen by a medical care provider within a week before the episode.

Eclampsia is largely a late event: In a sample of 399 U.S. women, the episode occurred after the 32nd week of gestation in 72%, and before week 28 in roughly 10%.

In a substantial number of cases—28%, in the U.S. study—the condition developed after delivery; in two-thirds of these cases, it happened more than 48 hours later.

“More and more, the onset of convulsions is in the postpartum period. We've done an excellent job educating women to report signs and symptoms during pregnancy, but a poor one in educating them that they can have eclampsia after leaving the hospital,” Dr. Sibai said.

The lapse can have medicolegal implications, he said.

Emergency management of eclampsia should focus on protecting the mother from injury (e.g., cushioning extremities and preventing a fall off the bed), ensuring adequate oxygenation, and preventing aspiration. Once these are addressed, steps should be taken to avoid recurrent convulsions.

“Never give anything to stop the convulsion: No one dies from a seizure, and you could do damage if you give the wrong dose,” Dr. Sibai said.

Most seizures are self-limiting, and medications to contain them may depress respiration.

Hypertension should be the next concern, and then delivery. “[It] should be the last thing on your mind,” he said.

If hypoxemia develops, 8–10 L/min of supplementary oxygen should be supplied by face mask, and pulse oximetry monitored. Sodium bicarbonate may be required for acidemia.

To prevent further convulsions, begin IV magnesium sulfate with a loading dose of 6 g over a 20-minute period, followed by maintenance at 2 g/hour. The anticonvulsants diazepam and phenytoin, which can depress respiration and compromise alveolar reflexes, carry a higher mortality rate and should be avoided.

“Don't listen to what the neurologist or internist tells you to do,” Dr. Sibai said.

The risk of magnesium toxicity should be kept in mind: Look for such signs of rising serum levels as double vision, a feeling of warmth or flushing, and lethargy; monitor patellar reflexes hourly. “Always talk to the patient. Slurred speech shows paralysis of the muscles of the jaw,” he said.

Magnesium sulfate should be discontinued immediately while a blood level is taken, and restarted with appropriate adjustments. If serum magnesium is above 15 mg/dL—a level that threatens respiratory and cardiac arrest—1 g of calcium gluconate should be given intravenously and intubation and assisted ventilation provided if necessary.

For control of severe hypertension, labetalol and nifedipine are drugs of choice; hydralazine should be avoided, he said.

When possible, delivery should be done within 24 hours. Cesarean delivery is not always necessary, and vaginal delivery can be done with epidural or spinal anesthesia.

Fluid management is important at this time: 100–125 mL/hr of balanced salt solution should help the patient avoid both pulmonary edema and dehydration.

“Don't look at the fetal heart tracing during or immediately after the seizure: allow 10–15 minutes for the fetus to recover,” Dr. Sibai said.

Persistent changes like bradycardia and variable or late decelerations suggest poor fetal reserve or abruptio placentae, and indicate the need for cesarean delivery.

NEW YORK — Eclampsia has become increasingly rare in Western countries, but it still occurs in 1 in 2,000–3,500 pregnancies—and obstetric clinics must be prepared to treat it, Baha M. Sibai, M.D., said at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

Although most episodes occur late in pregnancy, an increasing number occur more than 2 days after delivery, and patients should be counseled accordingly, said Dr. Sibai, professor and chairman of the obstetrics and gynecology department at the University of Cincinnati.

Eclampsia does not always come with a warning. It has been reported that in 15%–20% of cases neither hypertension nor proteinuria has occurred.

“Most women with eclampsia have had good prenatal care,” Dr. Sibai said. In a 1992 U.K. study of 383 women, 85% had been seen by a medical care provider within a week before the episode.

Eclampsia is largely a late event: In a sample of 399 U.S. women, the episode occurred after the 32nd week of gestation in 72%, and before week 28 in roughly 10%.

In a substantial number of cases—28%, in the U.S. study—the condition developed after delivery; in two-thirds of these cases, it happened more than 48 hours later.

“More and more, the onset of convulsions is in the postpartum period. We've done an excellent job educating women to report signs and symptoms during pregnancy, but a poor one in educating them that they can have eclampsia after leaving the hospital,” Dr. Sibai said.

The lapse can have medicolegal implications, he said.

Emergency management of eclampsia should focus on protecting the mother from injury (e.g., cushioning extremities and preventing a fall off the bed), ensuring adequate oxygenation, and preventing aspiration. Once these are addressed, steps should be taken to avoid recurrent convulsions.

“Never give anything to stop the convulsion: No one dies from a seizure, and you could do damage if you give the wrong dose,” Dr. Sibai said.

Most seizures are self-limiting, and medications to contain them may depress respiration.

Hypertension should be the next concern, and then delivery. “[It] should be the last thing on your mind,” he said.

If hypoxemia develops, 8–10 L/min of supplementary oxygen should be supplied by face mask, and pulse oximetry monitored. Sodium bicarbonate may be required for acidemia.

To prevent further convulsions, begin IV magnesium sulfate with a loading dose of 6 g over a 20-minute period, followed by maintenance at 2 g/hour. The anticonvulsants diazepam and phenytoin, which can depress respiration and compromise alveolar reflexes, carry a higher mortality rate and should be avoided.

“Don't listen to what the neurologist or internist tells you to do,” Dr. Sibai said.

The risk of magnesium toxicity should be kept in mind: Look for such signs of rising serum levels as double vision, a feeling of warmth or flushing, and lethargy; monitor patellar reflexes hourly. “Always talk to the patient. Slurred speech shows paralysis of the muscles of the jaw,” he said.

Magnesium sulfate should be discontinued immediately while a blood level is taken, and restarted with appropriate adjustments. If serum magnesium is above 15 mg/dL—a level that threatens respiratory and cardiac arrest—1 g of calcium gluconate should be given intravenously and intubation and assisted ventilation provided if necessary.

For control of severe hypertension, labetalol and nifedipine are drugs of choice; hydralazine should be avoided, he said.

When possible, delivery should be done within 24 hours. Cesarean delivery is not always necessary, and vaginal delivery can be done with epidural or spinal anesthesia.

Fluid management is important at this time: 100–125 mL/hr of balanced salt solution should help the patient avoid both pulmonary edema and dehydration.

“Don't look at the fetal heart tracing during or immediately after the seizure: allow 10–15 minutes for the fetus to recover,” Dr. Sibai said.

Persistent changes like bradycardia and variable or late decelerations suggest poor fetal reserve or abruptio placentae, and indicate the need for cesarean delivery.

NEW YORK — Eclampsia has become increasingly rare in Western countries, but it still occurs in 1 in 2,000–3,500 pregnancies—and obstetric clinics must be prepared to treat it, Baha M. Sibai, M.D., said at an obstetrics symposium sponsored by Columbia University and New York Presbyterian Hospital.

Although most episodes occur late in pregnancy, an increasing number occur more than 2 days after delivery, and patients should be counseled accordingly, said Dr. Sibai, professor and chairman of the obstetrics and gynecology department at the University of Cincinnati.

Eclampsia does not always come with a warning. It has been reported that in 15%–20% of cases neither hypertension nor proteinuria has occurred.

“Most women with eclampsia have had good prenatal care,” Dr. Sibai said. In a 1992 U.K. study of 383 women, 85% had been seen by a medical care provider within a week before the episode.

Eclampsia is largely a late event: In a sample of 399 U.S. women, the episode occurred after the 32nd week of gestation in 72%, and before week 28 in roughly 10%.

In a substantial number of cases—28%, in the U.S. study—the condition developed after delivery; in two-thirds of these cases, it happened more than 48 hours later.

“More and more, the onset of convulsions is in the postpartum period. We've done an excellent job educating women to report signs and symptoms during pregnancy, but a poor one in educating them that they can have eclampsia after leaving the hospital,” Dr. Sibai said.

The lapse can have medicolegal implications, he said.

Emergency management of eclampsia should focus on protecting the mother from injury (e.g., cushioning extremities and preventing a fall off the bed), ensuring adequate oxygenation, and preventing aspiration. Once these are addressed, steps should be taken to avoid recurrent convulsions.

“Never give anything to stop the convulsion: No one dies from a seizure, and you could do damage if you give the wrong dose,” Dr. Sibai said.

Most seizures are self-limiting, and medications to contain them may depress respiration.

Hypertension should be the next concern, and then delivery. “[It] should be the last thing on your mind,” he said.

If hypoxemia develops, 8–10 L/min of supplementary oxygen should be supplied by face mask, and pulse oximetry monitored. Sodium bicarbonate may be required for acidemia.

To prevent further convulsions, begin IV magnesium sulfate with a loading dose of 6 g over a 20-minute period, followed by maintenance at 2 g/hour. The anticonvulsants diazepam and phenytoin, which can depress respiration and compromise alveolar reflexes, carry a higher mortality rate and should be avoided.

“Don't listen to what the neurologist or internist tells you to do,” Dr. Sibai said.

The risk of magnesium toxicity should be kept in mind: Look for such signs of rising serum levels as double vision, a feeling of warmth or flushing, and lethargy; monitor patellar reflexes hourly. “Always talk to the patient. Slurred speech shows paralysis of the muscles of the jaw,” he said.

Magnesium sulfate should be discontinued immediately while a blood level is taken, and restarted with appropriate adjustments. If serum magnesium is above 15 mg/dL—a level that threatens respiratory and cardiac arrest—1 g of calcium gluconate should be given intravenously and intubation and assisted ventilation provided if necessary.

For control of severe hypertension, labetalol and nifedipine are drugs of choice; hydralazine should be avoided, he said.

When possible, delivery should be done within 24 hours. Cesarean delivery is not always necessary, and vaginal delivery can be done with epidural or spinal anesthesia.

Fluid management is important at this time: 100–125 mL/hr of balanced salt solution should help the patient avoid both pulmonary edema and dehydration.

“Don't look at the fetal heart tracing during or immediately after the seizure: allow 10–15 minutes for the fetus to recover,” Dr. Sibai said.

Persistent changes like bradycardia and variable or late decelerations suggest poor fetal reserve or abruptio placentae, and indicate the need for cesarean delivery.

NEW YORK — When questions were raised about possible concealment of clinical trial data, two pharmaceutical companies agreed last year to set up Web sites where such data would be posted.

It appeared at that time that others in the industry would follow suit, "but as it turns out, very little has happened," Norman Sussman, M.D., said at a meeting on psychopharmacology sponsored by New York University.

According to Dr. Sussman, an Internet search performed in early March, followed by inquiries to the companies themselves, found that information was for the most part incomplete, difficult to use, or entirely absent.

"This says something about the goodwill of the companies," commented Dr. Sussman, professor of psychiatry at the university.

In June 2004, New York State Attorney General Eliot Spitzer filed suit against GlaxoSmithKline Inc., charging that the company's selective release of clinical trial data on the use of paroxetine (Paxil) in children constituted consumer fraud. As part of a settlement of the lawsuit at the end of August, the company agreed to post the clinical trial results for all GSK drugs on its corporate Web site.

An inquiry that had been conducted by the New York State Attorney General's Office into data relating to the off-label use of drugs manufactured by Forest Laboratories Inc. led to a similar agreement with that company.

Dr. Sussman's Internet investigation found that one pharmaceutical company has done what was promised; however, it was neither of those originally involved. The company was Eli Lilly. Its Web site (www.lillytrials.com

For completed trials, the site supplies PDF files of basic information—"not everything you want to know, but a sense of how the study was designed, the method, and outcomes," he said.

For the most part, the information given consists of raw data: "If you were expecting something simple, it's not here. You have to have an understanding of research methodology to evaluate these," Dr. Sussman said.

The "initiated trials" section lists phase 2, 3, and 4 studies that were begun since July 2004, most of which are still recruiting patients. "The idea is that once you do this, you can no longer hide the results of the study," Dr. Sussman said.

The speed with which Lilly put such complete clinical trial data on its Web site "tells you that any company that wanted to could do it tomorrow. They all have internal documents that summarize studies," he said.

The GlaxoSmithKline registry (http://ctr.gsk.co.uk/welcome.asp

The GSK presentation includes less narrative discussion of study findings than the Lilly site. "It's mostly numbers. … You have to look into the statistics and form your own conclusion. It's not intended for the average practitioner," he said.

The other company that agreed to post clinical trial data, Forest Laboratories, has set up a registry (www.forestclinicaltrials.com

"If you call Forest, they send you from one department to another," Dr. Sussman said.

An industry association, the Pharmaceutical Research and Manufacturers of America maintains a Web site of its own (www.clinicalstudyresults.org

A government site (www.clinicaltrials.gov

NEW YORK — When questions were raised about possible concealment of clinical trial data, two pharmaceutical companies agreed last year to set up Web sites where such data would be posted.

It appeared at that time that others in the industry would follow suit, "but as it turns out, very little has happened," Norman Sussman, M.D., said at a meeting on psychopharmacology sponsored by New York University.

According to Dr. Sussman, an Internet search performed in early March, followed by inquiries to the companies themselves, found that information was for the most part incomplete, difficult to use, or entirely absent.

"This says something about the goodwill of the companies," commented Dr. Sussman, professor of psychiatry at the university.

In June 2004, New York State Attorney General Eliot Spitzer filed suit against GlaxoSmithKline Inc., charging that the company's selective release of clinical trial data on the use of paroxetine (Paxil) in children constituted consumer fraud. As part of a settlement of the lawsuit at the end of August, the company agreed to post the clinical trial results for all GSK drugs on its corporate Web site.

An inquiry that had been conducted by the New York State Attorney General's Office into data relating to the off-label use of drugs manufactured by Forest Laboratories Inc. led to a similar agreement with that company.

Dr. Sussman's Internet investigation found that one pharmaceutical company has done what was promised; however, it was neither of those originally involved. The company was Eli Lilly. Its Web site (www.lillytrials.com

For completed trials, the site supplies PDF files of basic information—"not everything you want to know, but a sense of how the study was designed, the method, and outcomes," he said.

For the most part, the information given consists of raw data: "If you were expecting something simple, it's not here. You have to have an understanding of research methodology to evaluate these," Dr. Sussman said.

The "initiated trials" section lists phase 2, 3, and 4 studies that were begun since July 2004, most of which are still recruiting patients. "The idea is that once you do this, you can no longer hide the results of the study," Dr. Sussman said.

The speed with which Lilly put such complete clinical trial data on its Web site "tells you that any company that wanted to could do it tomorrow. They all have internal documents that summarize studies," he said.

The GlaxoSmithKline registry (http://ctr.gsk.co.uk/welcome.asp

The GSK presentation includes less narrative discussion of study findings than the Lilly site. "It's mostly numbers. … You have to look into the statistics and form your own conclusion. It's not intended for the average practitioner," he said.

The other company that agreed to post clinical trial data, Forest Laboratories, has set up a registry (www.forestclinicaltrials.com

"If you call Forest, they send you from one department to another," Dr. Sussman said.

An industry association, the Pharmaceutical Research and Manufacturers of America maintains a Web site of its own (www.clinicalstudyresults.org

A government site (www.clinicaltrials.gov

NEW YORK — When questions were raised about possible concealment of clinical trial data, two pharmaceutical companies agreed last year to set up Web sites where such data would be posted.

It appeared at that time that others in the industry would follow suit, "but as it turns out, very little has happened," Norman Sussman, M.D., said at a meeting on psychopharmacology sponsored by New York University.

According to Dr. Sussman, an Internet search performed in early March, followed by inquiries to the companies themselves, found that information was for the most part incomplete, difficult to use, or entirely absent.

"This says something about the goodwill of the companies," commented Dr. Sussman, professor of psychiatry at the university.

In June 2004, New York State Attorney General Eliot Spitzer filed suit against GlaxoSmithKline Inc., charging that the company's selective release of clinical trial data on the use of paroxetine (Paxil) in children constituted consumer fraud. As part of a settlement of the lawsuit at the end of August, the company agreed to post the clinical trial results for all GSK drugs on its corporate Web site.

An inquiry that had been conducted by the New York State Attorney General's Office into data relating to the off-label use of drugs manufactured by Forest Laboratories Inc. led to a similar agreement with that company.

Dr. Sussman's Internet investigation found that one pharmaceutical company has done what was promised; however, it was neither of those originally involved. The company was Eli Lilly. Its Web site (www.lillytrials.com

For completed trials, the site supplies PDF files of basic information—"not everything you want to know, but a sense of how the study was designed, the method, and outcomes," he said.

For the most part, the information given consists of raw data: "If you were expecting something simple, it's not here. You have to have an understanding of research methodology to evaluate these," Dr. Sussman said.

The "initiated trials" section lists phase 2, 3, and 4 studies that were begun since July 2004, most of which are still recruiting patients. "The idea is that once you do this, you can no longer hide the results of the study," Dr. Sussman said.

The speed with which Lilly put such complete clinical trial data on its Web site "tells you that any company that wanted to could do it tomorrow. They all have internal documents that summarize studies," he said.

The GlaxoSmithKline registry (http://ctr.gsk.co.uk/welcome.asp

The GSK presentation includes less narrative discussion of study findings than the Lilly site. "It's mostly numbers. … You have to look into the statistics and form your own conclusion. It's not intended for the average practitioner," he said.

The other company that agreed to post clinical trial data, Forest Laboratories, has set up a registry (www.forestclinicaltrials.com

"If you call Forest, they send you from one department to another," Dr. Sussman said.

An industry association, the Pharmaceutical Research and Manufacturers of America maintains a Web site of its own (www.clinicalstudyresults.org

A government site (www.clinicaltrials.gov

NEW YORK — When questions were raised about possible concealment of clinical trial data, two pharmaceutical companies agreed last year to set up Web sites where such data would be posted.

It appeared at that time that others in the industry would follow suit, “but as it turns out, very little has happened,” Norman Sussman, M.D., said at a meeting on psychopharmacology sponsored by New York University.

An Internet search performed at the beginning of March, followed by inquiries to the companies themselves, found that information was for the most part incomplete, difficult to use, or entirely absent.

“This says something about the goodwill of the companies,” said Dr. Sussman, professor of psychiatry at the university.

In June 2004, New York State Attorney General Eliot Spitzer filed suit against GlaxoSmithKline Inc., charging that the company's selective release of trial data on the use of paroxetine (Paxil) in children constituted consumer fraud. As part of a settlement of the lawsuit at the end of August, the company agreed to post clinical trial results for all GSK drugs on its Web site.

An inquiry by the attorney general's office into data relating to off-label use of drugs manufactured by Forest Laboratories Inc. led to a similar agreement with that company.

Dr. Sussman's Internet investigation found that one pharmaceutical company has done what was promised, and it was neither of those originally involved: Eli Lilly.

Its Web site (www.lillytrials.com

For completed trials, the site supplies PDF files of basic information—“not everything you want to know, but a sense of how the study was designed, the method, and outcomes,” he said.

For the most part, the information that is posted by the company on the site is raw data: “If you were expecting something simple, it's not here. You have to have an understanding of research methodology to eval-uate these,” he said.

The “initiated trials” section lists phase 2, 3, and 4 studies that were begun since July 2004, most of which are still recruiting patients. “The idea is that once you do this, you can no longer hide the results of the study,” Dr. Sussman said.

The speed with which Lilly put such complete data on its Web site “tells you that any company that wanted to could do it tomorrow. They all have internal documents that summarize studies,” he said.

The GlaxoSmithKline registry (http://ctr.gsk.co.uk/welcome.asp

The GSK presentation includes less narrative discussion of study findings than the Lilly site. “It's mostly numbers. … You have to look into the statistics and form your own conclusion. It's not intended for the average practitioner,” he said.

The other company that agreed to post data, Forest Laboratories, has set up a registry (www.forestclinicaltrials.com

An industry association, the Pharmaceutical Research and Manufacturers of America, maintains a Web site of its own (www.clinicalstudyresults.org

A government site (www.clinicaltrials.gov

NEW YORK — When questions were raised about possible concealment of clinical trial data, two pharmaceutical companies agreed last year to set up Web sites where such data would be posted.

It appeared at that time that others in the industry would follow suit, “but as it turns out, very little has happened,” Norman Sussman, M.D., said at a meeting on psychopharmacology sponsored by New York University.

An Internet search performed at the beginning of March, followed by inquiries to the companies themselves, found that information was for the most part incomplete, difficult to use, or entirely absent.

“This says something about the goodwill of the companies,” said Dr. Sussman, professor of psychiatry at the university.

In June 2004, New York State Attorney General Eliot Spitzer filed suit against GlaxoSmithKline Inc., charging that the company's selective release of trial data on the use of paroxetine (Paxil) in children constituted consumer fraud. As part of a settlement of the lawsuit at the end of August, the company agreed to post clinical trial results for all GSK drugs on its Web site.

An inquiry by the attorney general's office into data relating to off-label use of drugs manufactured by Forest Laboratories Inc. led to a similar agreement with that company.

Dr. Sussman's Internet investigation found that one pharmaceutical company has done what was promised, and it was neither of those originally involved: Eli Lilly.

Its Web site (www.lillytrials.com

For completed trials, the site supplies PDF files of basic information—“not everything you want to know, but a sense of how the study was designed, the method, and outcomes,” he said.

For the most part, the information that is posted by the company on the site is raw data: “If you were expecting something simple, it's not here. You have to have an understanding of research methodology to eval-uate these,” he said.

The “initiated trials” section lists phase 2, 3, and 4 studies that were begun since July 2004, most of which are still recruiting patients. “The idea is that once you do this, you can no longer hide the results of the study,” Dr. Sussman said.

The speed with which Lilly put such complete data on its Web site “tells you that any company that wanted to could do it tomorrow. They all have internal documents that summarize studies,” he said.

The GlaxoSmithKline registry (http://ctr.gsk.co.uk/welcome.asp

The GSK presentation includes less narrative discussion of study findings than the Lilly site. “It's mostly numbers. … You have to look into the statistics and form your own conclusion. It's not intended for the average practitioner,” he said.

The other company that agreed to post data, Forest Laboratories, has set up a registry (www.forestclinicaltrials.com

An industry association, the Pharmaceutical Research and Manufacturers of America, maintains a Web site of its own (www.clinicalstudyresults.org

A government site (www.clinicaltrials.gov

NEW YORK — When questions were raised about possible concealment of clinical trial data, two pharmaceutical companies agreed last year to set up Web sites where such data would be posted.

It appeared at that time that others in the industry would follow suit, “but as it turns out, very little has happened,” Norman Sussman, M.D., said at a meeting on psychopharmacology sponsored by New York University.

An Internet search performed at the beginning of March, followed by inquiries to the companies themselves, found that information was for the most part incomplete, difficult to use, or entirely absent.

“This says something about the goodwill of the companies,” said Dr. Sussman, professor of psychiatry at the university.

In June 2004, New York State Attorney General Eliot Spitzer filed suit against GlaxoSmithKline Inc., charging that the company's selective release of trial data on the use of paroxetine (Paxil) in children constituted consumer fraud. As part of a settlement of the lawsuit at the end of August, the company agreed to post clinical trial results for all GSK drugs on its Web site.

An inquiry by the attorney general's office into data relating to off-label use of drugs manufactured by Forest Laboratories Inc. led to a similar agreement with that company.

Dr. Sussman's Internet investigation found that one pharmaceutical company has done what was promised, and it was neither of those originally involved: Eli Lilly.

Its Web site (www.lillytrials.com

For completed trials, the site supplies PDF files of basic information—“not everything you want to know, but a sense of how the study was designed, the method, and outcomes,” he said.

For the most part, the information that is posted by the company on the site is raw data: “If you were expecting something simple, it's not here. You have to have an understanding of research methodology to eval-uate these,” he said.

The “initiated trials” section lists phase 2, 3, and 4 studies that were begun since July 2004, most of which are still recruiting patients. “The idea is that once you do this, you can no longer hide the results of the study,” Dr. Sussman said.

The speed with which Lilly put such complete data on its Web site “tells you that any company that wanted to could do it tomorrow. They all have internal documents that summarize studies,” he said.

The GlaxoSmithKline registry (http://ctr.gsk.co.uk/welcome.asp

The GSK presentation includes less narrative discussion of study findings than the Lilly site. “It's mostly numbers. … You have to look into the statistics and form your own conclusion. It's not intended for the average practitioner,” he said.

The other company that agreed to post data, Forest Laboratories, has set up a registry (www.forestclinicaltrials.com

An industry association, the Pharmaceutical Research and Manufacturers of America, maintains a Web site of its own (www.clinicalstudyresults.org

A government site (www.clinicaltrials.gov

NEW YORK — The branding of pharmaceuticals—the creation and manipulation of product identity through such media as direct-to-consumer advertising— exerts a potent influence on the way patients think and feel about their medication and their illness, Nathan Greenslit said at a meeting sponsored by the American Psychoanalytic Association.

“The marketers I've interviewed routinely think that compliance needs to be reframed as a problem of brand loyalty,” said Mr. Greenslit, a cultural anthropologist and doctoral candidate in the program in science, technology, and society at Massachusetts Institute of Technology, Cambridge.

To illustrate the impact of branding, Mr. Greenslit considered the case of Sarafem, a formulation of fluoxetine first marketed by Eli Lilly to women for premenstrual dysphoric disorder (PMDD). The rights to Sarafem have since been sold to another pharmaceutical company, Warner Chilcott Inc.

When Lilly was still marketing the drug, the “physician information” section of its Web site for Sarafem said that “fluoxetine was initially developed and marketed as an antidepressant (Prozac, fluoxetine hydrochloride),” while patients were told, in their section of the Web site, that “Sarafem contains fluoxetine hydrochloride, the same active ingredient found in Prozac.”

While both statements are technically true, “socially they produce very different meanings,” Mr. Greenslit said. Physicians were informed that Sarafem and Prozac were the same drug with different packages, while the message to patients was that “they are different drugs with the same ingredient.”

A contrast in appearance—Prozac is a green and white capsule, while Sarafem is pink and lavender—emphasized the distinction, he said.

The separate branding was justified by Lilly as a response to consumer demand, Mr. Greenslit said, citing a Lilly marketing associate who noted that women don't look at their PMDD symptoms as depression, that Prozac is closely associated with depression, and that “women told us they wanted a treatment with its own identity.”

The branding phenomenon underlines the idea that a person's relationship to a drug is more complex than his or her body's relationship to a chemical compound “whose only clinical relevance is its pharmaceutical activity,” he said.

A close look at direct-to-consumer advertising suggests the extent of pharmaceutical companies' concern with “the social—that is, precisely not the chemical— effects of these drugs,” he said. The companies manipulate the symbolic meanings of their products by “mobilizing images and texts,” and take great care to avoid mistakes that would increase stigma surrounding the drug and condition for which it is prescribed (e.g., a pink Viagra).

Mitchell D. Wilson, M.D., who discussed Mr. Greenslit's presentation, suggested that “drugs as brands take on the character of objects of fantasy, with a quality of aliveness … they are personified.”

NEW YORK — The branding of pharmaceuticals—the creation and manipulation of product identity through such media as direct-to-consumer advertising— exerts a potent influence on the way patients think and feel about their medication and their illness, Nathan Greenslit said at a meeting sponsored by the American Psychoanalytic Association.

“The marketers I've interviewed routinely think that compliance needs to be reframed as a problem of brand loyalty,” said Mr. Greenslit, a cultural anthropologist and doctoral candidate in the program in science, technology, and society at Massachusetts Institute of Technology, Cambridge.

To illustrate the impact of branding, Mr. Greenslit considered the case of Sarafem, a formulation of fluoxetine first marketed by Eli Lilly to women for premenstrual dysphoric disorder (PMDD). The rights to Sarafem have since been sold to another pharmaceutical company, Warner Chilcott Inc.

When Lilly was still marketing the drug, the “physician information” section of its Web site for Sarafem said that “fluoxetine was initially developed and marketed as an antidepressant (Prozac, fluoxetine hydrochloride),” while patients were told, in their section of the Web site, that “Sarafem contains fluoxetine hydrochloride, the same active ingredient found in Prozac.”

While both statements are technically true, “socially they produce very different meanings,” Mr. Greenslit said. Physicians were informed that Sarafem and Prozac were the same drug with different packages, while the message to patients was that “they are different drugs with the same ingredient.”

A contrast in appearance—Prozac is a green and white capsule, while Sarafem is pink and lavender—emphasized the distinction, he said.

The separate branding was justified by Lilly as a response to consumer demand, Mr. Greenslit said, citing a Lilly marketing associate who noted that women don't look at their PMDD symptoms as depression, that Prozac is closely associated with depression, and that “women told us they wanted a treatment with its own identity.”

The branding phenomenon underlines the idea that a person's relationship to a drug is more complex than his or her body's relationship to a chemical compound “whose only clinical relevance is its pharmaceutical activity,” he said.

A close look at direct-to-consumer advertising suggests the extent of pharmaceutical companies' concern with “the social—that is, precisely not the chemical— effects of these drugs,” he said. The companies manipulate the symbolic meanings of their products by “mobilizing images and texts,” and take great care to avoid mistakes that would increase stigma surrounding the drug and condition for which it is prescribed (e.g., a pink Viagra).

Mitchell D. Wilson, M.D., who discussed Mr. Greenslit's presentation, suggested that “drugs as brands take on the character of objects of fantasy, with a quality of aliveness … they are personified.”

NEW YORK — The branding of pharmaceuticals—the creation and manipulation of product identity through such media as direct-to-consumer advertising— exerts a potent influence on the way patients think and feel about their medication and their illness, Nathan Greenslit said at a meeting sponsored by the American Psychoanalytic Association.

“The marketers I've interviewed routinely think that compliance needs to be reframed as a problem of brand loyalty,” said Mr. Greenslit, a cultural anthropologist and doctoral candidate in the program in science, technology, and society at Massachusetts Institute of Technology, Cambridge.

To illustrate the impact of branding, Mr. Greenslit considered the case of Sarafem, a formulation of fluoxetine first marketed by Eli Lilly to women for premenstrual dysphoric disorder (PMDD). The rights to Sarafem have since been sold to another pharmaceutical company, Warner Chilcott Inc.

When Lilly was still marketing the drug, the “physician information” section of its Web site for Sarafem said that “fluoxetine was initially developed and marketed as an antidepressant (Prozac, fluoxetine hydrochloride),” while patients were told, in their section of the Web site, that “Sarafem contains fluoxetine hydrochloride, the same active ingredient found in Prozac.”

While both statements are technically true, “socially they produce very different meanings,” Mr. Greenslit said. Physicians were informed that Sarafem and Prozac were the same drug with different packages, while the message to patients was that “they are different drugs with the same ingredient.”

A contrast in appearance—Prozac is a green and white capsule, while Sarafem is pink and lavender—emphasized the distinction, he said.

The separate branding was justified by Lilly as a response to consumer demand, Mr. Greenslit said, citing a Lilly marketing associate who noted that women don't look at their PMDD symptoms as depression, that Prozac is closely associated with depression, and that “women told us they wanted a treatment with its own identity.”

The branding phenomenon underlines the idea that a person's relationship to a drug is more complex than his or her body's relationship to a chemical compound “whose only clinical relevance is its pharmaceutical activity,” he said.

A close look at direct-to-consumer advertising suggests the extent of pharmaceutical companies' concern with “the social—that is, precisely not the chemical— effects of these drugs,” he said. The companies manipulate the symbolic meanings of their products by “mobilizing images and texts,” and take great care to avoid mistakes that would increase stigma surrounding the drug and condition for which it is prescribed (e.g., a pink Viagra).

Mitchell D. Wilson, M.D., who discussed Mr. Greenslit's presentation, suggested that “drugs as brands take on the character of objects of fantasy, with a quality of aliveness … they are personified.”