Betsy Bates

LOS ANGELES – Parents want to be with their children in the operating room during the anxious moments that precede induction of anesthesia.

And children want their parents to be present. Even anesthesiologists, surgeons, and nurses think this is a good idea.

But in a series of randomized trials in Canada, Europe, and the United States, only an expensive, multiday “Cadillac” behavioral intervention program has proved its worth in reducing child anxiety in meaningful ways when parents are present in the operating room before surgical procedures, Dr. Zeev N. Kain said at the conference.

The Advance program – which involves a psychoeducational and behavior modeling video, graduated shaping exercises, distraction techniques, supportive telephone coaching, and adherence checks – reduced emergence from anesthetics, lowered analgesic use, and reduced time to discharge (Anesthesiology 2010; 112:751-5).

“It's a great intervention. The problem is, it's an expensive intervention,” he said.

Of course, anyone who has been involved in pediatric surgery can easily point to anecdotal situations in which parental presence in the operating room was highly comforting to the child, easing induction of anesthesia, said Dr. Kain, who is professor and chair of anesthesiology and perioperative care at the University of California, Irvine.

“A randomized controlled trial is not a real-life situation [in which] you look at the child, you look at the parent, you look at yourself on that day and [decide], 'Do I think this would be beneficial at this time?'” he said.

Any systematic revision in standard operating room procedures needs to be more widely applicable to a variety of children of different ages, temperaments, and coping styles and parents with styles to match.

A moment-to-moment factor analysis of what actually happens in the operating room may shed light on where anxiety-prevention efforts have gone wrong and what needs to happen to bring calm to this and other settings for major medical procedures.

“We're not asking the right question,” said Dr. Kain in summarizing results of his previous studies. “We shouldn't ask, should we or should we not be bringing parents into the operating room? We should ask, what did the parents do in the operating room?”

Dr. Kain and his associates recently reviewed videotapes of OR encounters, painstakingly recording hundreds of variables in behavior, verbal and physical interchanges, and physiological responses.

They found that parents and health professionals alike tend to stop utilizing the most effective interventions – distraction techniques and strengthening of coping mechanisms – and start relying on unhelpful strategies once a child's anxiety begins to build.

In a study of 273 children undergoing surgical procedures, the minute-to-minute analysis showed that most were coping well while walking to the OR.

Their coping behaviors increased as caregivers and professionals engaged in distraction techniques.

“Then it's just downhill from there,” said Dr. Kain, pointing to parallel behavior graphs.

Reassurance and empathy – strategies proven to be quite unhelpful in reducing children's anxiety – were increasingly used with children as they entered the OR, were notified of what was happening, and had the mask placed on their faces for anesthesia induction.

“When we put the mask on, almost 38% of the kids started crying,” he said. Videotapes showed that parents and professionals resorted to repeatedly making statements such as, “It's going to be OK,” when the going got tough.

As a result of the sequential analysis, Dr. Kain and his associates are developing a training program in data-driven behavioral preparation techniques to reduce children's perioperative distress.

The program, which is being piloted at the University of California, Los Angeles, will help nurses and anesthesiologists anticipate and recognize signs of children's emotional suffering and teach them effective tools to intervene.

If all goes well, the study will be expanded to five hospitals in a randomized clinical trial, said Dr. Kain, who reported no relevant financial conflicts of interest.

LOS ANGELES – Parents want to be with their children in the operating room during the anxious moments that precede induction of anesthesia.

And children want their parents to be present. Even anesthesiologists, surgeons, and nurses think this is a good idea.

But in a series of randomized trials in Canada, Europe, and the United States, only an expensive, multiday “Cadillac” behavioral intervention program has proved its worth in reducing child anxiety in meaningful ways when parents are present in the operating room before surgical procedures, Dr. Zeev N. Kain said at the conference.

The Advance program – which involves a psychoeducational and behavior modeling video, graduated shaping exercises, distraction techniques, supportive telephone coaching, and adherence checks – reduced emergence from anesthetics, lowered analgesic use, and reduced time to discharge (Anesthesiology 2010; 112:751-5).

“It's a great intervention. The problem is, it's an expensive intervention,” he said.

Of course, anyone who has been involved in pediatric surgery can easily point to anecdotal situations in which parental presence in the operating room was highly comforting to the child, easing induction of anesthesia, said Dr. Kain, who is professor and chair of anesthesiology and perioperative care at the University of California, Irvine.

“A randomized controlled trial is not a real-life situation [in which] you look at the child, you look at the parent, you look at yourself on that day and [decide], 'Do I think this would be beneficial at this time?'” he said.

Any systematic revision in standard operating room procedures needs to be more widely applicable to a variety of children of different ages, temperaments, and coping styles and parents with styles to match.

A moment-to-moment factor analysis of what actually happens in the operating room may shed light on where anxiety-prevention efforts have gone wrong and what needs to happen to bring calm to this and other settings for major medical procedures.

“We're not asking the right question,” said Dr. Kain in summarizing results of his previous studies. “We shouldn't ask, should we or should we not be bringing parents into the operating room? We should ask, what did the parents do in the operating room?”

Dr. Kain and his associates recently reviewed videotapes of OR encounters, painstakingly recording hundreds of variables in behavior, verbal and physical interchanges, and physiological responses.

They found that parents and health professionals alike tend to stop utilizing the most effective interventions – distraction techniques and strengthening of coping mechanisms – and start relying on unhelpful strategies once a child's anxiety begins to build.

In a study of 273 children undergoing surgical procedures, the minute-to-minute analysis showed that most were coping well while walking to the OR.

Their coping behaviors increased as caregivers and professionals engaged in distraction techniques.

“Then it's just downhill from there,” said Dr. Kain, pointing to parallel behavior graphs.

Reassurance and empathy – strategies proven to be quite unhelpful in reducing children's anxiety – were increasingly used with children as they entered the OR, were notified of what was happening, and had the mask placed on their faces for anesthesia induction.

“When we put the mask on, almost 38% of the kids started crying,” he said. Videotapes showed that parents and professionals resorted to repeatedly making statements such as, “It's going to be OK,” when the going got tough.

As a result of the sequential analysis, Dr. Kain and his associates are developing a training program in data-driven behavioral preparation techniques to reduce children's perioperative distress.

The program, which is being piloted at the University of California, Los Angeles, will help nurses and anesthesiologists anticipate and recognize signs of children's emotional suffering and teach them effective tools to intervene.

If all goes well, the study will be expanded to five hospitals in a randomized clinical trial, said Dr. Kain, who reported no relevant financial conflicts of interest.

LOS ANGELES – Parents want to be with their children in the operating room during the anxious moments that precede induction of anesthesia.

And children want their parents to be present. Even anesthesiologists, surgeons, and nurses think this is a good idea.

But in a series of randomized trials in Canada, Europe, and the United States, only an expensive, multiday “Cadillac” behavioral intervention program has proved its worth in reducing child anxiety in meaningful ways when parents are present in the operating room before surgical procedures, Dr. Zeev N. Kain said at the conference.

The Advance program – which involves a psychoeducational and behavior modeling video, graduated shaping exercises, distraction techniques, supportive telephone coaching, and adherence checks – reduced emergence from anesthetics, lowered analgesic use, and reduced time to discharge (Anesthesiology 2010; 112:751-5).

“It's a great intervention. The problem is, it's an expensive intervention,” he said.

Of course, anyone who has been involved in pediatric surgery can easily point to anecdotal situations in which parental presence in the operating room was highly comforting to the child, easing induction of anesthesia, said Dr. Kain, who is professor and chair of anesthesiology and perioperative care at the University of California, Irvine.

“A randomized controlled trial is not a real-life situation [in which] you look at the child, you look at the parent, you look at yourself on that day and [decide], 'Do I think this would be beneficial at this time?'” he said.

Any systematic revision in standard operating room procedures needs to be more widely applicable to a variety of children of different ages, temperaments, and coping styles and parents with styles to match.

A moment-to-moment factor analysis of what actually happens in the operating room may shed light on where anxiety-prevention efforts have gone wrong and what needs to happen to bring calm to this and other settings for major medical procedures.

“We're not asking the right question,” said Dr. Kain in summarizing results of his previous studies. “We shouldn't ask, should we or should we not be bringing parents into the operating room? We should ask, what did the parents do in the operating room?”

Dr. Kain and his associates recently reviewed videotapes of OR encounters, painstakingly recording hundreds of variables in behavior, verbal and physical interchanges, and physiological responses.

They found that parents and health professionals alike tend to stop utilizing the most effective interventions – distraction techniques and strengthening of coping mechanisms – and start relying on unhelpful strategies once a child's anxiety begins to build.

In a study of 273 children undergoing surgical procedures, the minute-to-minute analysis showed that most were coping well while walking to the OR.

Their coping behaviors increased as caregivers and professionals engaged in distraction techniques.

“Then it's just downhill from there,” said Dr. Kain, pointing to parallel behavior graphs.

Reassurance and empathy – strategies proven to be quite unhelpful in reducing children's anxiety – were increasingly used with children as they entered the OR, were notified of what was happening, and had the mask placed on their faces for anesthesia induction.

“When we put the mask on, almost 38% of the kids started crying,” he said. Videotapes showed that parents and professionals resorted to repeatedly making statements such as, “It's going to be OK,” when the going got tough.

As a result of the sequential analysis, Dr. Kain and his associates are developing a training program in data-driven behavioral preparation techniques to reduce children's perioperative distress.

The program, which is being piloted at the University of California, Los Angeles, will help nurses and anesthesiologists anticipate and recognize signs of children's emotional suffering and teach them effective tools to intervene.

If all goes well, the study will be expanded to five hospitals in a randomized clinical trial, said Dr. Kain, who reported no relevant financial conflicts of interest.

NEW ORLEANS – Some of the most important drugs of abuse, misuse, and diversion remain undetected by common immunoassay drug screens, according to Dr. Dwight Zach Smith.

Moreover, widely used drug screens produce false-positive results in as many as 1 in 10 cases.

“We trust in science. We believe [accuracy] is going to be higher than that, when it's not. We need to have these tests confirmed,” Dr. Smith, a psychiatrist with the Veterans Affairs Black Hills (S.D.) Health Care System, said at the meeting.

Dr. Smith and his associates reviewed nearly 30 years of peer-reviewed studies concerning the coverage, accuracy, and specific nuances of commercially available drug-screening immunoassays and found that, although they have improved, they are “not so good.”

Drug testing, he said, “is simply a fact of life in America in the 21st century,” with one drug-screening test performed for every two Americans in 2009.

“We have drug tests for our students, for our athletes, [and] as a condition for employment for many federal and private agencies,” he noted.

Considering how prevalent they are, however, “unfortunately there remains a significant gap in our knowledge and our scientific understanding of drug tests [pertaining to] clinical practice,” Dr. Smith said.

For example, a 2007 study included in the review found that 88% of physicians did not realize that oxycodone is not detected in most opiate assays.

They also might be surprised to learn that methadone, fentanyl, tramadol, hydromorphone, and buprenorphine also go largely undetected in opiate immunoassays, unless a physician specifically requests them, he said during a session on issues within addiction psychiatry.

Benzodiazepine drug screens report on use of diazepam, nordazepam, and oxazepam, but “surprisingly to me,” not some of the most commonly misused drugs within the class, including clonazepam, alprazolam, and lorazepam, Dr. Smith said.

Unlike other drug classes, benzodiazepine screens are regulated by no federal guidelines establishing minimal thresholds for defining a positive test result. “Each lab sets its own minimal thresholds, sets of guidelines, and procedures … with differing specificities and sensitivities,” Dr. Smith pointed out.

Dr. Smith advised physicians requesting drug screens to be very specific about what they want and to “become friends with the toxicologist in charge of the lab” to discuss laboratory standards and unexpected test results.

Ordering a confirmatory test using gas chromatography/mass spectrometry also is a useful step in the face of unexpected results, but cost is a barrier for some. A standard immunoassay might cost $12, compared with almost $120 for the much more accurate confirmatory test (99% sensitivity, 99% specificity), he said. Another problem with drug screening arises when a careful medical history is not taken before the ordering of a drug screen, he said.

False-positive results might arise if a patient is taking sympathomimetics such as Vicks nasal inhaler, tricyclic antidepressants, bupropion, selegiline, ranitidine (false-positive amphetamine results); sertraline or oxaprozin (false-positive benzodiazepine results); efavirenz or hemp-containing foods (cannabis); or poppy seeds, dextromethorphan, rifampin, or quinolones (false-positive opioid results).

With regard to poppy seeds, 1 teaspoon or more within 2-3 days of a test could alter results.

False-positive test results are a relatively common phenomenon with immunoassays used for the majority of drug-screening tests in the United States, with a mean specificity of 85%-90%, his research found.

“I look at those numbers, and I can't help but think 1 in 10 … are going to be inaccurate results,” he said.

Sensitivities are better, at about 90%-95%, but that range does not account for myriad ways drug users thwart the test results: by drinking a gallon of water, diluting urine with bleach or drain cleaner, or using someone else's urine to fill a commercially available product such as the “Real Whizzinator,” a device that contains a prosthetic penis with synthetic urine for men who seek to pass drug tests.

He estimated that about half of cheaters get away with their ruse, since many laboratories do not check samples for urine-specific gravity, creatinine, pH, or exogenous substances that might give them away.

Dr. Smith reported he had no relevant financial conflicts.

Widely used drug screens produce false-positive results in as many as 1 in 10 cases; the results need to be confirmed.

Source DR. SMITH

NEW ORLEANS – Some of the most important drugs of abuse, misuse, and diversion remain undetected by common immunoassay drug screens, according to Dr. Dwight Zach Smith.

Moreover, widely used drug screens produce false-positive results in as many as 1 in 10 cases.

“We trust in science. We believe [accuracy] is going to be higher than that, when it's not. We need to have these tests confirmed,” Dr. Smith, a psychiatrist with the Veterans Affairs Black Hills (S.D.) Health Care System, said at the meeting.

Dr. Smith and his associates reviewed nearly 30 years of peer-reviewed studies concerning the coverage, accuracy, and specific nuances of commercially available drug-screening immunoassays and found that, although they have improved, they are “not so good.”

Drug testing, he said, “is simply a fact of life in America in the 21st century,” with one drug-screening test performed for every two Americans in 2009.

“We have drug tests for our students, for our athletes, [and] as a condition for employment for many federal and private agencies,” he noted.

Considering how prevalent they are, however, “unfortunately there remains a significant gap in our knowledge and our scientific understanding of drug tests [pertaining to] clinical practice,” Dr. Smith said.

For example, a 2007 study included in the review found that 88% of physicians did not realize that oxycodone is not detected in most opiate assays.

They also might be surprised to learn that methadone, fentanyl, tramadol, hydromorphone, and buprenorphine also go largely undetected in opiate immunoassays, unless a physician specifically requests them, he said during a session on issues within addiction psychiatry.

Benzodiazepine drug screens report on use of diazepam, nordazepam, and oxazepam, but “surprisingly to me,” not some of the most commonly misused drugs within the class, including clonazepam, alprazolam, and lorazepam, Dr. Smith said.

Unlike other drug classes, benzodiazepine screens are regulated by no federal guidelines establishing minimal thresholds for defining a positive test result. “Each lab sets its own minimal thresholds, sets of guidelines, and procedures … with differing specificities and sensitivities,” Dr. Smith pointed out.

Dr. Smith advised physicians requesting drug screens to be very specific about what they want and to “become friends with the toxicologist in charge of the lab” to discuss laboratory standards and unexpected test results.

Ordering a confirmatory test using gas chromatography/mass spectrometry also is a useful step in the face of unexpected results, but cost is a barrier for some. A standard immunoassay might cost $12, compared with almost $120 for the much more accurate confirmatory test (99% sensitivity, 99% specificity), he said. Another problem with drug screening arises when a careful medical history is not taken before the ordering of a drug screen, he said.

False-positive results might arise if a patient is taking sympathomimetics such as Vicks nasal inhaler, tricyclic antidepressants, bupropion, selegiline, ranitidine (false-positive amphetamine results); sertraline or oxaprozin (false-positive benzodiazepine results); efavirenz or hemp-containing foods (cannabis); or poppy seeds, dextromethorphan, rifampin, or quinolones (false-positive opioid results).

With regard to poppy seeds, 1 teaspoon or more within 2-3 days of a test could alter results.

False-positive test results are a relatively common phenomenon with immunoassays used for the majority of drug-screening tests in the United States, with a mean specificity of 85%-90%, his research found.

“I look at those numbers, and I can't help but think 1 in 10 … are going to be inaccurate results,” he said.

Sensitivities are better, at about 90%-95%, but that range does not account for myriad ways drug users thwart the test results: by drinking a gallon of water, diluting urine with bleach or drain cleaner, or using someone else's urine to fill a commercially available product such as the “Real Whizzinator,” a device that contains a prosthetic penis with synthetic urine for men who seek to pass drug tests.

He estimated that about half of cheaters get away with their ruse, since many laboratories do not check samples for urine-specific gravity, creatinine, pH, or exogenous substances that might give them away.

Dr. Smith reported he had no relevant financial conflicts.

Widely used drug screens produce false-positive results in as many as 1 in 10 cases; the results need to be confirmed.

Source DR. SMITH

NEW ORLEANS – Some of the most important drugs of abuse, misuse, and diversion remain undetected by common immunoassay drug screens, according to Dr. Dwight Zach Smith.

Moreover, widely used drug screens produce false-positive results in as many as 1 in 10 cases.

“We trust in science. We believe [accuracy] is going to be higher than that, when it's not. We need to have these tests confirmed,” Dr. Smith, a psychiatrist with the Veterans Affairs Black Hills (S.D.) Health Care System, said at the meeting.

Dr. Smith and his associates reviewed nearly 30 years of peer-reviewed studies concerning the coverage, accuracy, and specific nuances of commercially available drug-screening immunoassays and found that, although they have improved, they are “not so good.”

Drug testing, he said, “is simply a fact of life in America in the 21st century,” with one drug-screening test performed for every two Americans in 2009.

“We have drug tests for our students, for our athletes, [and] as a condition for employment for many federal and private agencies,” he noted.

Considering how prevalent they are, however, “unfortunately there remains a significant gap in our knowledge and our scientific understanding of drug tests [pertaining to] clinical practice,” Dr. Smith said.

For example, a 2007 study included in the review found that 88% of physicians did not realize that oxycodone is not detected in most opiate assays.

They also might be surprised to learn that methadone, fentanyl, tramadol, hydromorphone, and buprenorphine also go largely undetected in opiate immunoassays, unless a physician specifically requests them, he said during a session on issues within addiction psychiatry.

Benzodiazepine drug screens report on use of diazepam, nordazepam, and oxazepam, but “surprisingly to me,” not some of the most commonly misused drugs within the class, including clonazepam, alprazolam, and lorazepam, Dr. Smith said.

Unlike other drug classes, benzodiazepine screens are regulated by no federal guidelines establishing minimal thresholds for defining a positive test result. “Each lab sets its own minimal thresholds, sets of guidelines, and procedures … with differing specificities and sensitivities,” Dr. Smith pointed out.

Dr. Smith advised physicians requesting drug screens to be very specific about what they want and to “become friends with the toxicologist in charge of the lab” to discuss laboratory standards and unexpected test results.

Ordering a confirmatory test using gas chromatography/mass spectrometry also is a useful step in the face of unexpected results, but cost is a barrier for some. A standard immunoassay might cost $12, compared with almost $120 for the much more accurate confirmatory test (99% sensitivity, 99% specificity), he said. Another problem with drug screening arises when a careful medical history is not taken before the ordering of a drug screen, he said.

False-positive results might arise if a patient is taking sympathomimetics such as Vicks nasal inhaler, tricyclic antidepressants, bupropion, selegiline, ranitidine (false-positive amphetamine results); sertraline or oxaprozin (false-positive benzodiazepine results); efavirenz or hemp-containing foods (cannabis); or poppy seeds, dextromethorphan, rifampin, or quinolones (false-positive opioid results).

With regard to poppy seeds, 1 teaspoon or more within 2-3 days of a test could alter results.

False-positive test results are a relatively common phenomenon with immunoassays used for the majority of drug-screening tests in the United States, with a mean specificity of 85%-90%, his research found.

“I look at those numbers, and I can't help but think 1 in 10 … are going to be inaccurate results,” he said.

Sensitivities are better, at about 90%-95%, but that range does not account for myriad ways drug users thwart the test results: by drinking a gallon of water, diluting urine with bleach or drain cleaner, or using someone else's urine to fill a commercially available product such as the “Real Whizzinator,” a device that contains a prosthetic penis with synthetic urine for men who seek to pass drug tests.

He estimated that about half of cheaters get away with their ruse, since many laboratories do not check samples for urine-specific gravity, creatinine, pH, or exogenous substances that might give them away.

Dr. Smith reported he had no relevant financial conflicts.

Widely used drug screens produce false-positive results in as many as 1 in 10 cases; the results need to be confirmed.

Source DR. SMITH

NEW ORLEANS — Proposed changes to the Diagnostic and Statistical Manual will likely put an end to separate diagnoses of substance “abuse” and “dependence,” distinctions that puzzled even addiction experts, members of the DSM-5 work group on substance-related disorders said at the meeting.

On the basis of discussions held during the meeting, it seems probable that both categories will be subsumed within the general diagnosis, “substance use disorder,” under an expanded DSM addiction section that will include for the first time a behavioral addiction, compulsive gambling.

“Change is good if change can be shown to do more good than bad and can be supported by data,” commented Dr. Marc A. Schuckit during a progress report presented by the APA DSM-5 substance-related disorders work group at the meeting.

If the prime objectives for inclusion in the DSM are making diagnoses that are clear, straightforward, flexible enough to be clinically useful, valid, “moderately” reliable, predictable, and inclusive of “the people who need help,” current substance use categories in the DSM-IV-R admittedly are “out of focus,” said Dr. Schuckit, professor of psychiatry at the University of California, San Diego.

However, the committee wants to be cautious, so that they do not “go from one very useful but not perfectly focused image to another very useful but not very well-focused image,” he said, noting that a rich database has been exceedingly useful in guiding directions for change.

For example, when data from studies representing more than 100,000 subjects were analyzed by the committee, DSM-IV diagnostic criteria for substance dependence were highly reliable and valid, but those for substance abuse were much lower and more variable, said Deborah S. Hasin, Ph.D., professor of clinical public health at Columbia University, New York, a work group committee member, and cochair of the meeting symposium.

The hierarchical relationship between abuse and dependence (with abuse only diagnosed in the absence of dependence) was “often misunderstood, even by people functioning at a very senior level [of the substance abuse research community],” she noted.

Confusion led to widely held, but false beliefs, such as the notion that abuse is a milder disorder than dependence, or that all individuals who are dependent also meet criteria for abuse, Dr. Hasin said.

The extensive data review conformed to what clinicians were seeing, that severity of dependence and of abuse, like other criteria, were intermixed, and that patients could have one of the disorders, or both.

A factor analysis of patient characteristics found “there really wasn't a good rationale to keep abuse and dependence separate,” Dr. Hasin said.

“The evidence seemed quite overwhelming.”

The new DSM, then, will most likely contain 11 potential diagnostic criteria for combined substance use disorder, with severity gauged on the number of criteria met. A patient who meets two criteria would merit a diagnosis of a disorder; a patient who met four or more would be considered to have a severe form of the disorder.

The specific diagnostic criteria for a substance use disorder also will likely change in the DSM-5, with craving being considered a potentially core feature of addiction for the first time.

Likely to be dropped from the list of criteria will be recurrent substance-related legal problems, Dr. Hasin said in an interview.

Nicotine use disorder is highly likely to be included under the substance use disorder umbrella, again on the basis of analysis of characteristics of patients enrolled in many studies that show convergence with other substance use disorders.

The new inclusion of a behavioral disorder—compulsive gambling—might appear as an addiction alongside substance use disorders for the first time, based on years of study, said committee member Dr. Eric Hollander, director of the Compulsive, Impulsive, and Autism Spectrum Disorders Program at Montefiore Medical Center and Albert Einstein College of Medicine, New York.

Currently classified as an impulse control disorder, a large body of evidence now supports compulsive gambling as an addiction, he said in an interview.

None of the working group members disclosed any relevant financial conflicts of interest with regard to the DSM-5.

An analysis found that 'there really wasn't a good rationale to keep abuse and dependence separate.'

Source DR. HASIN

For the first time, an expanded DSM addiction section will include a behavioral addiction, compulsive gambling.

Source ©Andrew Brown/Fotolia.com

NEW ORLEANS — Proposed changes to the Diagnostic and Statistical Manual will likely put an end to separate diagnoses of substance “abuse” and “dependence,” distinctions that puzzled even addiction experts, members of the DSM-5 work group on substance-related disorders said at the meeting.

On the basis of discussions held during the meeting, it seems probable that both categories will be subsumed within the general diagnosis, “substance use disorder,” under an expanded DSM addiction section that will include for the first time a behavioral addiction, compulsive gambling.

“Change is good if change can be shown to do more good than bad and can be supported by data,” commented Dr. Marc A. Schuckit during a progress report presented by the APA DSM-5 substance-related disorders work group at the meeting.

If the prime objectives for inclusion in the DSM are making diagnoses that are clear, straightforward, flexible enough to be clinically useful, valid, “moderately” reliable, predictable, and inclusive of “the people who need help,” current substance use categories in the DSM-IV-R admittedly are “out of focus,” said Dr. Schuckit, professor of psychiatry at the University of California, San Diego.

However, the committee wants to be cautious, so that they do not “go from one very useful but not perfectly focused image to another very useful but not very well-focused image,” he said, noting that a rich database has been exceedingly useful in guiding directions for change.

For example, when data from studies representing more than 100,000 subjects were analyzed by the committee, DSM-IV diagnostic criteria for substance dependence were highly reliable and valid, but those for substance abuse were much lower and more variable, said Deborah S. Hasin, Ph.D., professor of clinical public health at Columbia University, New York, a work group committee member, and cochair of the meeting symposium.

The hierarchical relationship between abuse and dependence (with abuse only diagnosed in the absence of dependence) was “often misunderstood, even by people functioning at a very senior level [of the substance abuse research community],” she noted.

Confusion led to widely held, but false beliefs, such as the notion that abuse is a milder disorder than dependence, or that all individuals who are dependent also meet criteria for abuse, Dr. Hasin said.

The extensive data review conformed to what clinicians were seeing, that severity of dependence and of abuse, like other criteria, were intermixed, and that patients could have one of the disorders, or both.

A factor analysis of patient characteristics found “there really wasn't a good rationale to keep abuse and dependence separate,” Dr. Hasin said.

“The evidence seemed quite overwhelming.”

The new DSM, then, will most likely contain 11 potential diagnostic criteria for combined substance use disorder, with severity gauged on the number of criteria met. A patient who meets two criteria would merit a diagnosis of a disorder; a patient who met four or more would be considered to have a severe form of the disorder.

The specific diagnostic criteria for a substance use disorder also will likely change in the DSM-5, with craving being considered a potentially core feature of addiction for the first time.

Likely to be dropped from the list of criteria will be recurrent substance-related legal problems, Dr. Hasin said in an interview.

Nicotine use disorder is highly likely to be included under the substance use disorder umbrella, again on the basis of analysis of characteristics of patients enrolled in many studies that show convergence with other substance use disorders.

The new inclusion of a behavioral disorder—compulsive gambling—might appear as an addiction alongside substance use disorders for the first time, based on years of study, said committee member Dr. Eric Hollander, director of the Compulsive, Impulsive, and Autism Spectrum Disorders Program at Montefiore Medical Center and Albert Einstein College of Medicine, New York.

Currently classified as an impulse control disorder, a large body of evidence now supports compulsive gambling as an addiction, he said in an interview.

None of the working group members disclosed any relevant financial conflicts of interest with regard to the DSM-5.

An analysis found that 'there really wasn't a good rationale to keep abuse and dependence separate.'

Source DR. HASIN

For the first time, an expanded DSM addiction section will include a behavioral addiction, compulsive gambling.

Source ©Andrew Brown/Fotolia.com

NEW ORLEANS — Proposed changes to the Diagnostic and Statistical Manual will likely put an end to separate diagnoses of substance “abuse” and “dependence,” distinctions that puzzled even addiction experts, members of the DSM-5 work group on substance-related disorders said at the meeting.

On the basis of discussions held during the meeting, it seems probable that both categories will be subsumed within the general diagnosis, “substance use disorder,” under an expanded DSM addiction section that will include for the first time a behavioral addiction, compulsive gambling.

“Change is good if change can be shown to do more good than bad and can be supported by data,” commented Dr. Marc A. Schuckit during a progress report presented by the APA DSM-5 substance-related disorders work group at the meeting.

If the prime objectives for inclusion in the DSM are making diagnoses that are clear, straightforward, flexible enough to be clinically useful, valid, “moderately” reliable, predictable, and inclusive of “the people who need help,” current substance use categories in the DSM-IV-R admittedly are “out of focus,” said Dr. Schuckit, professor of psychiatry at the University of California, San Diego.

However, the committee wants to be cautious, so that they do not “go from one very useful but not perfectly focused image to another very useful but not very well-focused image,” he said, noting that a rich database has been exceedingly useful in guiding directions for change.

For example, when data from studies representing more than 100,000 subjects were analyzed by the committee, DSM-IV diagnostic criteria for substance dependence were highly reliable and valid, but those for substance abuse were much lower and more variable, said Deborah S. Hasin, Ph.D., professor of clinical public health at Columbia University, New York, a work group committee member, and cochair of the meeting symposium.

The hierarchical relationship between abuse and dependence (with abuse only diagnosed in the absence of dependence) was “often misunderstood, even by people functioning at a very senior level [of the substance abuse research community],” she noted.

Confusion led to widely held, but false beliefs, such as the notion that abuse is a milder disorder than dependence, or that all individuals who are dependent also meet criteria for abuse, Dr. Hasin said.

The extensive data review conformed to what clinicians were seeing, that severity of dependence and of abuse, like other criteria, were intermixed, and that patients could have one of the disorders, or both.

A factor analysis of patient characteristics found “there really wasn't a good rationale to keep abuse and dependence separate,” Dr. Hasin said.

“The evidence seemed quite overwhelming.”

The new DSM, then, will most likely contain 11 potential diagnostic criteria for combined substance use disorder, with severity gauged on the number of criteria met. A patient who meets two criteria would merit a diagnosis of a disorder; a patient who met four or more would be considered to have a severe form of the disorder.

The specific diagnostic criteria for a substance use disorder also will likely change in the DSM-5, with craving being considered a potentially core feature of addiction for the first time.

Likely to be dropped from the list of criteria will be recurrent substance-related legal problems, Dr. Hasin said in an interview.

Nicotine use disorder is highly likely to be included under the substance use disorder umbrella, again on the basis of analysis of characteristics of patients enrolled in many studies that show convergence with other substance use disorders.

The new inclusion of a behavioral disorder—compulsive gambling—might appear as an addiction alongside substance use disorders for the first time, based on years of study, said committee member Dr. Eric Hollander, director of the Compulsive, Impulsive, and Autism Spectrum Disorders Program at Montefiore Medical Center and Albert Einstein College of Medicine, New York.

Currently classified as an impulse control disorder, a large body of evidence now supports compulsive gambling as an addiction, he said in an interview.

None of the working group members disclosed any relevant financial conflicts of interest with regard to the DSM-5.

An analysis found that 'there really wasn't a good rationale to keep abuse and dependence separate.'

Source DR. HASIN

For the first time, an expanded DSM addiction section will include a behavioral addiction, compulsive gambling.

Source ©Andrew Brown/Fotolia.com

NEW ORLEANS — Worrisome and clinically measurable metabolic changes can be seen in just 12 weeks among children and adolescents who received antipsychotic medications in a National Institutes of Health–sponsored study, prompting serious concern among clinicians who learned of the results at the meeting.

The results struck at the heart of a troubling dichotomy: an explosion of prescriptions of antipsychotic medications for children, but little evidence in real-world practice that young patients are being routinely screened for metabolic changes that have the potential to shorten life expectancy.

The ongoing Metabolic Effects of Antipsychotics in Children study has already enrolled more than 140 children aged 7-18 years who were already slated to be placed on antipsychotics in the community.

Investigators closely monitored changes over 3 months in body fat using dual-energy x-ray absorptiometry (DXA) and insulin sensitivity using gold-standard methods, as well as tracking clinically available measures such as body mass index (BMI) percentile, and plasma glucose and lipids.

Body fat percentages rose in “not all, but certainly the majority of these children and youth,” said Dr. John W. Newcomer, professor of psychiatry and medicine and Director of the Center for Clinical Studies at Washington University in St. Louis.

Mean increases were highly variable among children and adolescents taking antipsychotic medications, but have averaged almost 3 kilos, or 6.5 pounds, “of body fat, not just weight,” in just 12 weeks, he said.

Some variance was seen in mean percent body fat accrual depending on which antipsychotic medication the children and adolescents received in the randomized open-label study, with olanzapine linked to a roughly 5% increase; aripiprazole, about a 1% increase; and risperidone falling somewhere in the middle at about 3%.

However, box plots revealed “substantial overlap” in the results, showing that each individual child's metabolic response to a given drug is somewhat unpredictable.

“You can find kids who take any one of these medications and potentially get a substantial increase in body fat, and you can also find kids who take any one of these agents who actually have very little change in body fat, although some medications are associated with a higher risk of substantial increase,” Dr. Newcomer said.

Increases in BMI percentiles were “substantial” as well, and closely paralleled more sophisticated measures of body fat, such as DXA.

“The good news is, it's pretty easy to track the changes in adiposity,” said Dr. Newcomer in an interview following the meeting.

“We used very fancy and expensive measures of body fat, but what pediatricians have in the front of every kid's chart (the BMI percentage table) does a darned good job of not only lining up where the child is at the baseline screen, but also in tracking changes over time.”

In a similar vein, the study found that simple blood cholesterol profiles—especially triglycerides and HDL—did a “halfway decent job” of estimating insulin sensitivity at baseline and then tracking changes through the early months of therapy, Dr. Newcomer added.

“The point is … don't wait a year to check the labs,” he said. “Don't not look.”

What is troubling to many is the fact that many clinicians indeed are not looking.

A Medicaid claims data study published earlier this year found that glucose screening was performed in just 31.6% and lipid testing in just 13.4% of 5,370 children aged 6-17 years prescribed antipsychotic drugs from July 1, 2004, to June 30, 2006 (Arch. Pediatr. Adolesc. Med. 2010;164:344-51).

Dr. Newcomer, a coauthor on the Medicaid claims research, said a growing number of “very eye-opening studies” about the enduring impact of childhood metabolic dysregulation and obesity should make clinicians weigh risks and consequences carefully when choosing drugs to prescribe for childhood schizophrenia, and perhaps even more so for use in disruptive behavior disorders and other nonpsychotic diagnoses.

“I have certainly learned that there are children at the end of the road of clinical options who are either not going to be in school or unable to participate without some heroic treatment measures, such as low-dose antipsychotic treatment, to help them to re-engage in education,” he said.

At the same time, relatively brief pharmacologic interventions for children who do not have schizophrenia or bipolar disorder should leave “a metabolic footprint … as modest as possible,” he said.

The Washington University study extended body weight findings from the nonrandomized SATIETY study published last year (JAMA 2009;302:1765-73), in which 272 4- to 19-year-olds prescribed antipsychotic drugs gained from a mean 4.4 kg (aripiprazole) to 8.5 kg (olanzapine) in a median of just 10.8 weeks on medication.

At the APA scientific session where interim data were released from the MEAC study, one audience member rose to call the findings “catastrophic.”

“What you're showing us is very, very scary,” he told Dr. Newcomer, who replied that the metabolic impacts of other classes of drugs widely used in children, including benzodiazepines and high-dose antidepressants, are also potentially concerning.

“We're having this policy debate under a streetlamp as though second-generation antipsychotics are the only drugs that cause weight gain,” Dr. Newcomer said. “Let's not kid ourselves.”

One alternative raised at the session was intensive behavioral modification, such as a year-long, school-based program for disruptive children described by Dr. Jacob Venter, of Wellesley, Mass., and his colleagues at the same APA scientific session.

Dr. Newcomer pointed to the University of Arizona behavioral study as an example of how nonpharmacologic interventions can produce “some good results,” even among children with severe behavioral dysregulation.

“The problem is, I don't know about your town, but in St. Louis, there is a 6-month waiting list to see a child psychiatrist,” he told the audience.

By the time they can be seen, “These families are in great distress and sometimes aren't terribly interested in taking those referrals for behavioral treatments, either because they already tried some therapy or because they seek rapid change,” he said.

Families want the quick responses they associate with medication, and when a trial of behavioral modification is suggested as a starting place, “We can't give it away.”

As for trying to reduce prescribing of antipsychotic medications to children, particularly among those who do not have symptoms consistent with bipolar disorder or schizo-phrenia, Dr. Newcomer, who also chairs Missouri's Drug Utilization Review Board, was somewhat skeptical about the potential to substantially reduce that clinical practice.

“Like it or not, that horse is out of the barn. The clinical benefits can be obvious to parents, children, and their doctors, so there will continue to be interest in this therapeutic approach, even as we fully elaborate the risks. This is happening all over the country. The rates of prescriptions are going up. The off-label use is tremendous, suggesting a lot of unmet need,” he said.

Indeed, a series of studies conducted by a team led by Dr. Mark Olfson at Columbia University, New York, has found that prescribing of antipsychotic medications by psychiatrists and primary care physicians has skyrocketed in the United States since the mid-1990s, with treatment of disruptive behavior disorders, including attention-deficit/hyperactivity disorder, playing a significant role in the increase.

In one recent example, Dr. Olfson reported that antipsychotic use by 2- to 5-year-olds covered by private insurance rose from 0.78 per 1,000 to 1.59 per 1,000 from 1999 to 2007. Less than half of the children in the study had received a mental health assessment, a psychotherapy visit, or a consultation with a psychiatrist.

Antipsychotic medication was prescribed in more than 1.2 million outpatient office visits by children in 2002, up from 201,000 in 1993, Dr. Olfson reported (Arch. Gen. Psychiatry 2006;63:679-85). Diagnoses of disruptive behavior disorders (37.8%), mood disorders (31.8%), pervasive developmental disorders or mental retardation (17.3%), and psychotic disorders (14.2%) accounted for most of those visits.

Disclosures: Dr. Newcomer disclosed that he has served as a consultant to several pharmaceutical companies but reported no relevant financial conflicts of interest associated with his study.

Dr. John W. Newcomer says that mean increases “of body fat, not just weight” averaged 6 lbs in just 12 weeks.

Source Courtesy Amber Spies

NEW ORLEANS — Worrisome and clinically measurable metabolic changes can be seen in just 12 weeks among children and adolescents who received antipsychotic medications in a National Institutes of Health–sponsored study, prompting serious concern among clinicians who learned of the results at the meeting.

The results struck at the heart of a troubling dichotomy: an explosion of prescriptions of antipsychotic medications for children, but little evidence in real-world practice that young patients are being routinely screened for metabolic changes that have the potential to shorten life expectancy.

The ongoing Metabolic Effects of Antipsychotics in Children study has already enrolled more than 140 children aged 7-18 years who were already slated to be placed on antipsychotics in the community.

Investigators closely monitored changes over 3 months in body fat using dual-energy x-ray absorptiometry (DXA) and insulin sensitivity using gold-standard methods, as well as tracking clinically available measures such as body mass index (BMI) percentile, and plasma glucose and lipids.

Body fat percentages rose in “not all, but certainly the majority of these children and youth,” said Dr. John W. Newcomer, professor of psychiatry and medicine and Director of the Center for Clinical Studies at Washington University in St. Louis.

Mean increases were highly variable among children and adolescents taking antipsychotic medications, but have averaged almost 3 kilos, or 6.5 pounds, “of body fat, not just weight,” in just 12 weeks, he said.

Some variance was seen in mean percent body fat accrual depending on which antipsychotic medication the children and adolescents received in the randomized open-label study, with olanzapine linked to a roughly 5% increase; aripiprazole, about a 1% increase; and risperidone falling somewhere in the middle at about 3%.

However, box plots revealed “substantial overlap” in the results, showing that each individual child's metabolic response to a given drug is somewhat unpredictable.

“You can find kids who take any one of these medications and potentially get a substantial increase in body fat, and you can also find kids who take any one of these agents who actually have very little change in body fat, although some medications are associated with a higher risk of substantial increase,” Dr. Newcomer said.

Increases in BMI percentiles were “substantial” as well, and closely paralleled more sophisticated measures of body fat, such as DXA.

“The good news is, it's pretty easy to track the changes in adiposity,” said Dr. Newcomer in an interview following the meeting.

“We used very fancy and expensive measures of body fat, but what pediatricians have in the front of every kid's chart (the BMI percentage table) does a darned good job of not only lining up where the child is at the baseline screen, but also in tracking changes over time.”

In a similar vein, the study found that simple blood cholesterol profiles—especially triglycerides and HDL—did a “halfway decent job” of estimating insulin sensitivity at baseline and then tracking changes through the early months of therapy, Dr. Newcomer added.

“The point is … don't wait a year to check the labs,” he said. “Don't not look.”

What is troubling to many is the fact that many clinicians indeed are not looking.

A Medicaid claims data study published earlier this year found that glucose screening was performed in just 31.6% and lipid testing in just 13.4% of 5,370 children aged 6-17 years prescribed antipsychotic drugs from July 1, 2004, to June 30, 2006 (Arch. Pediatr. Adolesc. Med. 2010;164:344-51).

Dr. Newcomer, a coauthor on the Medicaid claims research, said a growing number of “very eye-opening studies” about the enduring impact of childhood metabolic dysregulation and obesity should make clinicians weigh risks and consequences carefully when choosing drugs to prescribe for childhood schizophrenia, and perhaps even more so for use in disruptive behavior disorders and other nonpsychotic diagnoses.

“I have certainly learned that there are children at the end of the road of clinical options who are either not going to be in school or unable to participate without some heroic treatment measures, such as low-dose antipsychotic treatment, to help them to re-engage in education,” he said.

At the same time, relatively brief pharmacologic interventions for children who do not have schizophrenia or bipolar disorder should leave “a metabolic footprint … as modest as possible,” he said.

The Washington University study extended body weight findings from the nonrandomized SATIETY study published last year (JAMA 2009;302:1765-73), in which 272 4- to 19-year-olds prescribed antipsychotic drugs gained from a mean 4.4 kg (aripiprazole) to 8.5 kg (olanzapine) in a median of just 10.8 weeks on medication.

At the APA scientific session where interim data were released from the MEAC study, one audience member rose to call the findings “catastrophic.”

“What you're showing us is very, very scary,” he told Dr. Newcomer, who replied that the metabolic impacts of other classes of drugs widely used in children, including benzodiazepines and high-dose antidepressants, are also potentially concerning.

“We're having this policy debate under a streetlamp as though second-generation antipsychotics are the only drugs that cause weight gain,” Dr. Newcomer said. “Let's not kid ourselves.”

One alternative raised at the session was intensive behavioral modification, such as a year-long, school-based program for disruptive children described by Dr. Jacob Venter, of Wellesley, Mass., and his colleagues at the same APA scientific session.

Dr. Newcomer pointed to the University of Arizona behavioral study as an example of how nonpharmacologic interventions can produce “some good results,” even among children with severe behavioral dysregulation.

“The problem is, I don't know about your town, but in St. Louis, there is a 6-month waiting list to see a child psychiatrist,” he told the audience.

By the time they can be seen, “These families are in great distress and sometimes aren't terribly interested in taking those referrals for behavioral treatments, either because they already tried some therapy or because they seek rapid change,” he said.

Families want the quick responses they associate with medication, and when a trial of behavioral modification is suggested as a starting place, “We can't give it away.”

As for trying to reduce prescribing of antipsychotic medications to children, particularly among those who do not have symptoms consistent with bipolar disorder or schizo-phrenia, Dr. Newcomer, who also chairs Missouri's Drug Utilization Review Board, was somewhat skeptical about the potential to substantially reduce that clinical practice.

“Like it or not, that horse is out of the barn. The clinical benefits can be obvious to parents, children, and their doctors, so there will continue to be interest in this therapeutic approach, even as we fully elaborate the risks. This is happening all over the country. The rates of prescriptions are going up. The off-label use is tremendous, suggesting a lot of unmet need,” he said.

Indeed, a series of studies conducted by a team led by Dr. Mark Olfson at Columbia University, New York, has found that prescribing of antipsychotic medications by psychiatrists and primary care physicians has skyrocketed in the United States since the mid-1990s, with treatment of disruptive behavior disorders, including attention-deficit/hyperactivity disorder, playing a significant role in the increase.

In one recent example, Dr. Olfson reported that antipsychotic use by 2- to 5-year-olds covered by private insurance rose from 0.78 per 1,000 to 1.59 per 1,000 from 1999 to 2007. Less than half of the children in the study had received a mental health assessment, a psychotherapy visit, or a consultation with a psychiatrist.

Antipsychotic medication was prescribed in more than 1.2 million outpatient office visits by children in 2002, up from 201,000 in 1993, Dr. Olfson reported (Arch. Gen. Psychiatry 2006;63:679-85). Diagnoses of disruptive behavior disorders (37.8%), mood disorders (31.8%), pervasive developmental disorders or mental retardation (17.3%), and psychotic disorders (14.2%) accounted for most of those visits.

Disclosures: Dr. Newcomer disclosed that he has served as a consultant to several pharmaceutical companies but reported no relevant financial conflicts of interest associated with his study.

Dr. John W. Newcomer says that mean increases “of body fat, not just weight” averaged 6 lbs in just 12 weeks.

Source Courtesy Amber Spies

NEW ORLEANS — Worrisome and clinically measurable metabolic changes can be seen in just 12 weeks among children and adolescents who received antipsychotic medications in a National Institutes of Health–sponsored study, prompting serious concern among clinicians who learned of the results at the meeting.

The results struck at the heart of a troubling dichotomy: an explosion of prescriptions of antipsychotic medications for children, but little evidence in real-world practice that young patients are being routinely screened for metabolic changes that have the potential to shorten life expectancy.

The ongoing Metabolic Effects of Antipsychotics in Children study has already enrolled more than 140 children aged 7-18 years who were already slated to be placed on antipsychotics in the community.

Investigators closely monitored changes over 3 months in body fat using dual-energy x-ray absorptiometry (DXA) and insulin sensitivity using gold-standard methods, as well as tracking clinically available measures such as body mass index (BMI) percentile, and plasma glucose and lipids.

Body fat percentages rose in “not all, but certainly the majority of these children and youth,” said Dr. John W. Newcomer, professor of psychiatry and medicine and Director of the Center for Clinical Studies at Washington University in St. Louis.

Mean increases were highly variable among children and adolescents taking antipsychotic medications, but have averaged almost 3 kilos, or 6.5 pounds, “of body fat, not just weight,” in just 12 weeks, he said.

Some variance was seen in mean percent body fat accrual depending on which antipsychotic medication the children and adolescents received in the randomized open-label study, with olanzapine linked to a roughly 5% increase; aripiprazole, about a 1% increase; and risperidone falling somewhere in the middle at about 3%.

However, box plots revealed “substantial overlap” in the results, showing that each individual child's metabolic response to a given drug is somewhat unpredictable.

“You can find kids who take any one of these medications and potentially get a substantial increase in body fat, and you can also find kids who take any one of these agents who actually have very little change in body fat, although some medications are associated with a higher risk of substantial increase,” Dr. Newcomer said.

Increases in BMI percentiles were “substantial” as well, and closely paralleled more sophisticated measures of body fat, such as DXA.

“The good news is, it's pretty easy to track the changes in adiposity,” said Dr. Newcomer in an interview following the meeting.

“We used very fancy and expensive measures of body fat, but what pediatricians have in the front of every kid's chart (the BMI percentage table) does a darned good job of not only lining up where the child is at the baseline screen, but also in tracking changes over time.”

In a similar vein, the study found that simple blood cholesterol profiles—especially triglycerides and HDL—did a “halfway decent job” of estimating insulin sensitivity at baseline and then tracking changes through the early months of therapy, Dr. Newcomer added.

“The point is … don't wait a year to check the labs,” he said. “Don't not look.”

What is troubling to many is the fact that many clinicians indeed are not looking.

A Medicaid claims data study published earlier this year found that glucose screening was performed in just 31.6% and lipid testing in just 13.4% of 5,370 children aged 6-17 years prescribed antipsychotic drugs from July 1, 2004, to June 30, 2006 (Arch. Pediatr. Adolesc. Med. 2010;164:344-51).

Dr. Newcomer, a coauthor on the Medicaid claims research, said a growing number of “very eye-opening studies” about the enduring impact of childhood metabolic dysregulation and obesity should make clinicians weigh risks and consequences carefully when choosing drugs to prescribe for childhood schizophrenia, and perhaps even more so for use in disruptive behavior disorders and other nonpsychotic diagnoses.

“I have certainly learned that there are children at the end of the road of clinical options who are either not going to be in school or unable to participate without some heroic treatment measures, such as low-dose antipsychotic treatment, to help them to re-engage in education,” he said.

At the same time, relatively brief pharmacologic interventions for children who do not have schizophrenia or bipolar disorder should leave “a metabolic footprint … as modest as possible,” he said.

The Washington University study extended body weight findings from the nonrandomized SATIETY study published last year (JAMA 2009;302:1765-73), in which 272 4- to 19-year-olds prescribed antipsychotic drugs gained from a mean 4.4 kg (aripiprazole) to 8.5 kg (olanzapine) in a median of just 10.8 weeks on medication.

At the APA scientific session where interim data were released from the MEAC study, one audience member rose to call the findings “catastrophic.”

“What you're showing us is very, very scary,” he told Dr. Newcomer, who replied that the metabolic impacts of other classes of drugs widely used in children, including benzodiazepines and high-dose antidepressants, are also potentially concerning.

“We're having this policy debate under a streetlamp as though second-generation antipsychotics are the only drugs that cause weight gain,” Dr. Newcomer said. “Let's not kid ourselves.”

One alternative raised at the session was intensive behavioral modification, such as a year-long, school-based program for disruptive children described by Dr. Jacob Venter, of Wellesley, Mass., and his colleagues at the same APA scientific session.

Dr. Newcomer pointed to the University of Arizona behavioral study as an example of how nonpharmacologic interventions can produce “some good results,” even among children with severe behavioral dysregulation.

“The problem is, I don't know about your town, but in St. Louis, there is a 6-month waiting list to see a child psychiatrist,” he told the audience.

By the time they can be seen, “These families are in great distress and sometimes aren't terribly interested in taking those referrals for behavioral treatments, either because they already tried some therapy or because they seek rapid change,” he said.

Families want the quick responses they associate with medication, and when a trial of behavioral modification is suggested as a starting place, “We can't give it away.”

As for trying to reduce prescribing of antipsychotic medications to children, particularly among those who do not have symptoms consistent with bipolar disorder or schizo-phrenia, Dr. Newcomer, who also chairs Missouri's Drug Utilization Review Board, was somewhat skeptical about the potential to substantially reduce that clinical practice.

“Like it or not, that horse is out of the barn. The clinical benefits can be obvious to parents, children, and their doctors, so there will continue to be interest in this therapeutic approach, even as we fully elaborate the risks. This is happening all over the country. The rates of prescriptions are going up. The off-label use is tremendous, suggesting a lot of unmet need,” he said.

Indeed, a series of studies conducted by a team led by Dr. Mark Olfson at Columbia University, New York, has found that prescribing of antipsychotic medications by psychiatrists and primary care physicians has skyrocketed in the United States since the mid-1990s, with treatment of disruptive behavior disorders, including attention-deficit/hyperactivity disorder, playing a significant role in the increase.

In one recent example, Dr. Olfson reported that antipsychotic use by 2- to 5-year-olds covered by private insurance rose from 0.78 per 1,000 to 1.59 per 1,000 from 1999 to 2007. Less than half of the children in the study had received a mental health assessment, a psychotherapy visit, or a consultation with a psychiatrist.

Antipsychotic medication was prescribed in more than 1.2 million outpatient office visits by children in 2002, up from 201,000 in 1993, Dr. Olfson reported (Arch. Gen. Psychiatry 2006;63:679-85). Diagnoses of disruptive behavior disorders (37.8%), mood disorders (31.8%), pervasive developmental disorders or mental retardation (17.3%), and psychotic disorders (14.2%) accounted for most of those visits.

Disclosures: Dr. Newcomer disclosed that he has served as a consultant to several pharmaceutical companies but reported no relevant financial conflicts of interest associated with his study.

Dr. John W. Newcomer says that mean increases “of body fat, not just weight” averaged 6 lbs in just 12 weeks.

Source Courtesy Amber Spies

NEW ORLEANS – If the DSM-5 will one day be a butterfly, the document today can best be thought of as a poky caterpillar, voraciously consuming its way toward a faraway date when it could take flight.

Ten years into the revision process, the unprecedented public posting on the Internet of proposed changes to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-R) in February unleashed a torrent of responses. The work groups have yet to sort through and synthesize thousands of comments from clinicians, professional organizations, and the public.

“This is not a final document. The DSM is a work in progress right now,” said Dr. David Kupfer at the annual meeting of the American Psychiatric Association, the site of vigorous debate about proposed changes at 12 formal symposia and additional workshops and feedback sessions.

“We want to try to be as transparent and inclusive as possible,” said Dr. Kupfer, chairman of the APA's DSM-5 Task Force and professor and chair of psychiatry at the University of Pittsburgh.

The resulting dialogue has been as spirited as it has been exhaustive, and in general has been applauded as a welcome attempt to merge scientific evidence with the day-to-day realities of clinical practice.

“It's extraordinary,” said Dr. Nora Volkow, who is the director of the National Institute on Drug Abuse and serves on the DSM-5 substance abuse task force.

“You're taking advantage of the experience of the clinical world out there, as opposed to saying, this is what my laboratory experiments tell me,” she said in an interview at the meeting. “Of course, it slows the process, but in a way that's OK. You want it to be as close to reality and predictive… of symptoms patient present with, as possible.”

The immediate response to the online posting of proposed DSM changes took nearly everyone by surprise. The document received 41 million hits and generated thousands of formal and informal comments.

“At the end of the day, we've probably received 10,000 comments about what people around the world would like to see and not see in the DSM,” Dr. Kupfer said.“It's actually, I would say, quite invigorating.”

Thirteen DSM-5 Task Force work groups are meeting regularly to review public comments and tweak their draft recommendations in preparation for phase I field trials to test the feasibility, clinical utility, and reliability of proposed diagnostic criteria. (To follow the process online, go to the APA's Web site at www.dsm5.org/ProposedRevisions/Pages/Default.aspx

Pilot trials are slated to begin this summer, with larger field trials planned to be underway by fall, said Dr. Kupfer during a press briefing held at the meeting.

The Task Force budget of less than $2.5 million will likely confine trial settings to just 8-10 clinical sites, to be drawn from among 47 institutions that have completed applications and 70 that have sent letters of intent to participate.

The first field trials will be conducted on “priority disorders,” largely the group of diagnoses that generated the most numerous and heated public comments, Dr. Kupfer explained.

“Not to our surprise, the largest number of comments were received by the working group looking at autism and the autism spectrum disorders,” he said.

At issue is whether to define autism spectrum disorders along a continuous spectrum, “which would allow us to adjudicate levels of severity, difficulties, disabilities, and impairment, instead of simply categorizing somebody as one [diagnosis] or another,” he said.

A similar philosophy underlies proposed changes to diagnoses of eating disorders, a draft category that also generated considerable input from individual clinicians, professional organizations, families, and patients.

Other diagnostic categories that received abundant public comment included anxiety disorders, especially proposed changes to posttraumatic stress disorder and generalized anxiety disorder; and substance use disorders, Dr. Kupfer said.

He said much commentary also focused on the controversial issue of bipolar disorder in children. C new diagnosis, temper dysregulation disorder of childhood, is being considered. “Half the people liked the disorder but didn't like the name; half the people liked the name but not the disorder.”

General comments were also received in response to proposals about assessments and outcome measures for all patients seeking mental health care.

“One of the things some of us feel very, very strongly about is that assessment needs to be enhanced, covering a number of areas that should always be addressed, regardless of the diagnosis,” he said.

Such categories, to be self-rated by a patient at each clinical visit, might include depression, anxiety, anger, and substance use, according to the DSM-5 draft document.

Dr. Alan Schatzberg, outgoing president of the APA, praised the ongoing efforts to revise the DSM as a “major, major effort that the APA undertakes.”

Although the process is painstaking, he said it is necessary to insure that the document is reliable and relevant to a wide range of professionals who depend on it to provide a common diagnostic language that evolves in tandem with burgeoning understanding of mental illnesses.

“It's a labor of love,” said Dr. Schatzberg, professor and chair of psychiatry at Stanford (Calif.) University.

Neither Dr. Kupfer nor Dr. Schatzberg reported any relevant financial conflicts of interest with regard to the DSM-5.

NEW ORLEANS – If the DSM-5 will one day be a butterfly, the document today can best be thought of as a poky caterpillar, voraciously consuming its way toward a faraway date when it could take flight.

Ten years into the revision process, the unprecedented public posting on the Internet of proposed changes to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-R) in February unleashed a torrent of responses. The work groups have yet to sort through and synthesize thousands of comments from clinicians, professional organizations, and the public.

“This is not a final document. The DSM is a work in progress right now,” said Dr. David Kupfer at the annual meeting of the American Psychiatric Association, the site of vigorous debate about proposed changes at 12 formal symposia and additional workshops and feedback sessions.

“We want to try to be as transparent and inclusive as possible,” said Dr. Kupfer, chairman of the APA's DSM-5 Task Force and professor and chair of psychiatry at the University of Pittsburgh.

The resulting dialogue has been as spirited as it has been exhaustive, and in general has been applauded as a welcome attempt to merge scientific evidence with the day-to-day realities of clinical practice.

“It's extraordinary,” said Dr. Nora Volkow, who is the director of the National Institute on Drug Abuse and serves on the DSM-5 substance abuse task force.

“You're taking advantage of the experience of the clinical world out there, as opposed to saying, this is what my laboratory experiments tell me,” she said in an interview at the meeting. “Of course, it slows the process, but in a way that's OK. You want it to be as close to reality and predictive… of symptoms patient present with, as possible.”

The immediate response to the online posting of proposed DSM changes took nearly everyone by surprise. The document received 41 million hits and generated thousands of formal and informal comments.

“At the end of the day, we've probably received 10,000 comments about what people around the world would like to see and not see in the DSM,” Dr. Kupfer said.“It's actually, I would say, quite invigorating.”

Thirteen DSM-5 Task Force work groups are meeting regularly to review public comments and tweak their draft recommendations in preparation for phase I field trials to test the feasibility, clinical utility, and reliability of proposed diagnostic criteria. (To follow the process online, go to the APA's Web site at www.dsm5.org/ProposedRevisions/Pages/Default.aspx

Pilot trials are slated to begin this summer, with larger field trials planned to be underway by fall, said Dr. Kupfer during a press briefing held at the meeting.

The Task Force budget of less than $2.5 million will likely confine trial settings to just 8-10 clinical sites, to be drawn from among 47 institutions that have completed applications and 70 that have sent letters of intent to participate.

The first field trials will be conducted on “priority disorders,” largely the group of diagnoses that generated the most numerous and heated public comments, Dr. Kupfer explained.

“Not to our surprise, the largest number of comments were received by the working group looking at autism and the autism spectrum disorders,” he said.

At issue is whether to define autism spectrum disorders along a continuous spectrum, “which would allow us to adjudicate levels of severity, difficulties, disabilities, and impairment, instead of simply categorizing somebody as one [diagnosis] or another,” he said.

A similar philosophy underlies proposed changes to diagnoses of eating disorders, a draft category that also generated considerable input from individual clinicians, professional organizations, families, and patients.

Other diagnostic categories that received abundant public comment included anxiety disorders, especially proposed changes to posttraumatic stress disorder and generalized anxiety disorder; and substance use disorders, Dr. Kupfer said.

He said much commentary also focused on the controversial issue of bipolar disorder in children. C new diagnosis, temper dysregulation disorder of childhood, is being considered. “Half the people liked the disorder but didn't like the name; half the people liked the name but not the disorder.”

General comments were also received in response to proposals about assessments and outcome measures for all patients seeking mental health care.

“One of the things some of us feel very, very strongly about is that assessment needs to be enhanced, covering a number of areas that should always be addressed, regardless of the diagnosis,” he said.

Such categories, to be self-rated by a patient at each clinical visit, might include depression, anxiety, anger, and substance use, according to the DSM-5 draft document.

Dr. Alan Schatzberg, outgoing president of the APA, praised the ongoing efforts to revise the DSM as a “major, major effort that the APA undertakes.”

Although the process is painstaking, he said it is necessary to insure that the document is reliable and relevant to a wide range of professionals who depend on it to provide a common diagnostic language that evolves in tandem with burgeoning understanding of mental illnesses.

“It's a labor of love,” said Dr. Schatzberg, professor and chair of psychiatry at Stanford (Calif.) University.

Neither Dr. Kupfer nor Dr. Schatzberg reported any relevant financial conflicts of interest with regard to the DSM-5.

NEW ORLEANS – If the DSM-5 will one day be a butterfly, the document today can best be thought of as a poky caterpillar, voraciously consuming its way toward a faraway date when it could take flight.

Ten years into the revision process, the unprecedented public posting on the Internet of proposed changes to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-R) in February unleashed a torrent of responses. The work groups have yet to sort through and synthesize thousands of comments from clinicians, professional organizations, and the public.

“This is not a final document. The DSM is a work in progress right now,” said Dr. David Kupfer at the annual meeting of the American Psychiatric Association, the site of vigorous debate about proposed changes at 12 formal symposia and additional workshops and feedback sessions.

“We want to try to be as transparent and inclusive as possible,” said Dr. Kupfer, chairman of the APA's DSM-5 Task Force and professor and chair of psychiatry at the University of Pittsburgh.

The resulting dialogue has been as spirited as it has been exhaustive, and in general has been applauded as a welcome attempt to merge scientific evidence with the day-to-day realities of clinical practice.

“It's extraordinary,” said Dr. Nora Volkow, who is the director of the National Institute on Drug Abuse and serves on the DSM-5 substance abuse task force.

“You're taking advantage of the experience of the clinical world out there, as opposed to saying, this is what my laboratory experiments tell me,” she said in an interview at the meeting. “Of course, it slows the process, but in a way that's OK. You want it to be as close to reality and predictive… of symptoms patient present with, as possible.”

The immediate response to the online posting of proposed DSM changes took nearly everyone by surprise. The document received 41 million hits and generated thousands of formal and informal comments.

“At the end of the day, we've probably received 10,000 comments about what people around the world would like to see and not see in the DSM,” Dr. Kupfer said.“It's actually, I would say, quite invigorating.”

Thirteen DSM-5 Task Force work groups are meeting regularly to review public comments and tweak their draft recommendations in preparation for phase I field trials to test the feasibility, clinical utility, and reliability of proposed diagnostic criteria. (To follow the process online, go to the APA's Web site at www.dsm5.org/ProposedRevisions/Pages/Default.aspx

Pilot trials are slated to begin this summer, with larger field trials planned to be underway by fall, said Dr. Kupfer during a press briefing held at the meeting.

The Task Force budget of less than $2.5 million will likely confine trial settings to just 8-10 clinical sites, to be drawn from among 47 institutions that have completed applications and 70 that have sent letters of intent to participate.

The first field trials will be conducted on “priority disorders,” largely the group of diagnoses that generated the most numerous and heated public comments, Dr. Kupfer explained.

“Not to our surprise, the largest number of comments were received by the working group looking at autism and the autism spectrum disorders,” he said.

At issue is whether to define autism spectrum disorders along a continuous spectrum, “which would allow us to adjudicate levels of severity, difficulties, disabilities, and impairment, instead of simply categorizing somebody as one [diagnosis] or another,” he said.

A similar philosophy underlies proposed changes to diagnoses of eating disorders, a draft category that also generated considerable input from individual clinicians, professional organizations, families, and patients.

Other diagnostic categories that received abundant public comment included anxiety disorders, especially proposed changes to posttraumatic stress disorder and generalized anxiety disorder; and substance use disorders, Dr. Kupfer said.

He said much commentary also focused on the controversial issue of bipolar disorder in children. C new diagnosis, temper dysregulation disorder of childhood, is being considered. “Half the people liked the disorder but didn't like the name; half the people liked the name but not the disorder.”

General comments were also received in response to proposals about assessments and outcome measures for all patients seeking mental health care.

“One of the things some of us feel very, very strongly about is that assessment needs to be enhanced, covering a number of areas that should always be addressed, regardless of the diagnosis,” he said.

Such categories, to be self-rated by a patient at each clinical visit, might include depression, anxiety, anger, and substance use, according to the DSM-5 draft document.

Dr. Alan Schatzberg, outgoing president of the APA, praised the ongoing efforts to revise the DSM as a “major, major effort that the APA undertakes.”

Although the process is painstaking, he said it is necessary to insure that the document is reliable and relevant to a wide range of professionals who depend on it to provide a common diagnostic language that evolves in tandem with burgeoning understanding of mental illnesses.

“It's a labor of love,” said Dr. Schatzberg, professor and chair of psychiatry at Stanford (Calif.) University.

Neither Dr. Kupfer nor Dr. Schatzberg reported any relevant financial conflicts of interest with regard to the DSM-5.

NEW ORLEANS – Proposed changes to the Diagnostic and Statistical Manual will likely put an end to separate diagnoses of substance “abuse” and “dependence,” distinctions that puzzled even addiction experts, members of the DSM-5 work group on substance-related disorders said at the annual meeting of the American Psychiatric Association.

On the basis of discussions held during the meeting, it seems probable that both categories will be subsumed within the general diagnosis, “substance use disorder,” under an expanded DSM addiction section that will include for the first time a behavioral addiction, compulsive gambling.

“Change is good if change can be shown to do more good than bad and can be supported by data,” said Dr. Marc A. Schuckit during a progress report presented by the APA DSM-5 substance-related disorders work group at the meeting.

If the prime objectives for inclusion in the DSM are making diagnoses that are clear, straightforward, flexible enough to be clinically useful, valid, “moderately” reliable, predictable, and inclusive of “the people who need help,” current substance use categories in the DSM-IV-R admittedly are “out of focus,” said Dr. Schuckit, professor of psychiatry at the University of California, San Diego.

However, the committee wants to be cautious, so that they do not “go from one very useful but not perfectly focused image to another very useful but not very well focused image,” he said, noting that a rich database has been exceedingly useful in guiding directions for change.

For example, when data from studies representing more than 100,000 subjects were analyzed by the committee, DSM-IV diagnostic criteria for substance dependence were highly reliable and valid, but those for substance abuse were much lower and more variable, said Deborah S. Hasin, Ph.D., professor of clinical public health at Columbia University, New York, a work group committee member, and cochair of the meeting symposium.

The hierarchical relationship between abuse and dependence (with abuse only diagnosed in the absence of dependence) was “often misunderstood, even by people functioning at a very senior level [of the substance abuse research community],” she noted.

Confusion led to widely held, but false beliefs, such as the notion that abuse is a milder disorder than dependence, or that all individuals who are dependent also meet criteria for abuse, Dr. Hasin said.

The extensive data review conformed to what clinicians were seeing, that severity of dependence and of abuse, like other criteria, were intermixed, and that patients could have one of the disorders, or both.

A factor analysis of patient characteristics found “there really wasn't good rationale to keep abuse and dependence separate,” Dr. Hasin said.

“The evidence seemed quite overwhelming.”

The new DSM, then, will most likely contain 11 potential diagnostic criteria for combined substance use disorder, with severity gauged on the number of criteria met. A patient who meets two criteria would merit a diagnosis of a disorder; a patient who met four or more would be considered to have a severe form of the disorder.

The specific diagnostic criteria for a substance use disorder also will likely change in the DSM-5, with craving being considered a potentially core feature of addiction for the first time.

Likely to be dropped from the list of criteria will be recurrent substance-related legal problems, which tend to only occur when patients fulfill so many other criteria for addiction that the category becomes virtually meaningless, Dr. Hasin said in an interview.

Nicotine use disorder is highly likely to be included under the substance use disorder umbrella, again on the basis of analysis of characteristics of patients enrolled in many studies that show convergence with other substance use disorders.

The new inclusion of a behavioral disorder–compulsive gambling–might appear as an addiction alongside substance use disorders for the first time, based on years of study, said committee member Dr. Eric Hollander, director of the Compulsive, Impulsive, and Autism Spectrum Disorders Program at Montefiore Medical Center and Albert Einstein College of Medicine, New York.

Currently classified as an impulse control disorder, a large body of evidence now supports compulsive gambling as an addiction, he said in an interview.

“Based on extensive studies, we now know a lot about the clinical features and the course of the illness … the brain circuitry, neurotransmitter features, and the genetic features,” Dr. Hollander said.

Other behavioral disorders eventually might make their way into the DSM based on the weight of a similar body of evidence, but data are lacking for them at this point, he said.

“Waiting in the wings” … perhaps for DSM-6, may be compulsive overeating, video gaming, shopping, and even overexercise.

The scientific bar for inclusion will be held high, stressed Nancy M. Petry, Ph.D., professor of psychiatry at the University of Connecticut, Farmington.

Even with an extensive database of studies, consistency is lacking in the characterization of Internet gaming as a potentially diagnosable addiction, with prevalence estimates, for example, ranging from 0.9% to 64%, she said.

“Until we can better define what this addiction is, it doesn't seem like it's ready yet,” Dr. Petry said.

“Are we going to end up with chocolate addiction in DSM-6?”

The working group members disclosed no relevant financial conflicts of interest with regard to the DSM-5.

NEW ORLEANS – Proposed changes to the Diagnostic and Statistical Manual will likely put an end to separate diagnoses of substance “abuse” and “dependence,” distinctions that puzzled even addiction experts, members of the DSM-5 work group on substance-related disorders said at the annual meeting of the American Psychiatric Association.

On the basis of discussions held during the meeting, it seems probable that both categories will be subsumed within the general diagnosis, “substance use disorder,” under an expanded DSM addiction section that will include for the first time a behavioral addiction, compulsive gambling.

“Change is good if change can be shown to do more good than bad and can be supported by data,” said Dr. Marc A. Schuckit during a progress report presented by the APA DSM-5 substance-related disorders work group at the meeting.

If the prime objectives for inclusion in the DSM are making diagnoses that are clear, straightforward, flexible enough to be clinically useful, valid, “moderately” reliable, predictable, and inclusive of “the people who need help,” current substance use categories in the DSM-IV-R admittedly are “out of focus,” said Dr. Schuckit, professor of psychiatry at the University of California, San Diego.

However, the committee wants to be cautious, so that they do not “go from one very useful but not perfectly focused image to another very useful but not very well focused image,” he said, noting that a rich database has been exceedingly useful in guiding directions for change.

For example, when data from studies representing more than 100,000 subjects were analyzed by the committee, DSM-IV diagnostic criteria for substance dependence were highly reliable and valid, but those for substance abuse were much lower and more variable, said Deborah S. Hasin, Ph.D., professor of clinical public health at Columbia University, New York, a work group committee member, and cochair of the meeting symposium.

The hierarchical relationship between abuse and dependence (with abuse only diagnosed in the absence of dependence) was “often misunderstood, even by people functioning at a very senior level [of the substance abuse research community],” she noted.

Confusion led to widely held, but false beliefs, such as the notion that abuse is a milder disorder than dependence, or that all individuals who are dependent also meet criteria for abuse, Dr. Hasin said.

The extensive data review conformed to what clinicians were seeing, that severity of dependence and of abuse, like other criteria, were intermixed, and that patients could have one of the disorders, or both.

A factor analysis of patient characteristics found “there really wasn't good rationale to keep abuse and dependence separate,” Dr. Hasin said.

“The evidence seemed quite overwhelming.”

The new DSM, then, will most likely contain 11 potential diagnostic criteria for combined substance use disorder, with severity gauged on the number of criteria met. A patient who meets two criteria would merit a diagnosis of a disorder; a patient who met four or more would be considered to have a severe form of the disorder.

The specific diagnostic criteria for a substance use disorder also will likely change in the DSM-5, with craving being considered a potentially core feature of addiction for the first time.

Likely to be dropped from the list of criteria will be recurrent substance-related legal problems, which tend to only occur when patients fulfill so many other criteria for addiction that the category becomes virtually meaningless, Dr. Hasin said in an interview.

Nicotine use disorder is highly likely to be included under the substance use disorder umbrella, again on the basis of analysis of characteristics of patients enrolled in many studies that show convergence with other substance use disorders.

The new inclusion of a behavioral disorder–compulsive gambling–might appear as an addiction alongside substance use disorders for the first time, based on years of study, said committee member Dr. Eric Hollander, director of the Compulsive, Impulsive, and Autism Spectrum Disorders Program at Montefiore Medical Center and Albert Einstein College of Medicine, New York.

Currently classified as an impulse control disorder, a large body of evidence now supports compulsive gambling as an addiction, he said in an interview.

“Based on extensive studies, we now know a lot about the clinical features and the course of the illness … the brain circuitry, neurotransmitter features, and the genetic features,” Dr. Hollander said.

Other behavioral disorders eventually might make their way into the DSM based on the weight of a similar body of evidence, but data are lacking for them at this point, he said.

“Waiting in the wings” … perhaps for DSM-6, may be compulsive overeating, video gaming, shopping, and even overexercise.

The scientific bar for inclusion will be held high, stressed Nancy M. Petry, Ph.D., professor of psychiatry at the University of Connecticut, Farmington.

Even with an extensive database of studies, consistency is lacking in the characterization of Internet gaming as a potentially diagnosable addiction, with prevalence estimates, for example, ranging from 0.9% to 64%, she said.

“Until we can better define what this addiction is, it doesn't seem like it's ready yet,” Dr. Petry said.

“Are we going to end up with chocolate addiction in DSM-6?”

The working group members disclosed no relevant financial conflicts of interest with regard to the DSM-5.

NEW ORLEANS – Proposed changes to the Diagnostic and Statistical Manual will likely put an end to separate diagnoses of substance “abuse” and “dependence,” distinctions that puzzled even addiction experts, members of the DSM-5 work group on substance-related disorders said at the annual meeting of the American Psychiatric Association.

On the basis of discussions held during the meeting, it seems probable that both categories will be subsumed within the general diagnosis, “substance use disorder,” under an expanded DSM addiction section that will include for the first time a behavioral addiction, compulsive gambling.

“Change is good if change can be shown to do more good than bad and can be supported by data,” said Dr. Marc A. Schuckit during a progress report presented by the APA DSM-5 substance-related disorders work group at the meeting.

If the prime objectives for inclusion in the DSM are making diagnoses that are clear, straightforward, flexible enough to be clinically useful, valid, “moderately” reliable, predictable, and inclusive of “the people who need help,” current substance use categories in the DSM-IV-R admittedly are “out of focus,” said Dr. Schuckit, professor of psychiatry at the University of California, San Diego.

However, the committee wants to be cautious, so that they do not “go from one very useful but not perfectly focused image to another very useful but not very well focused image,” he said, noting that a rich database has been exceedingly useful in guiding directions for change.

For example, when data from studies representing more than 100,000 subjects were analyzed by the committee, DSM-IV diagnostic criteria for substance dependence were highly reliable and valid, but those for substance abuse were much lower and more variable, said Deborah S. Hasin, Ph.D., professor of clinical public health at Columbia University, New York, a work group committee member, and cochair of the meeting symposium.

The hierarchical relationship between abuse and dependence (with abuse only diagnosed in the absence of dependence) was “often misunderstood, even by people functioning at a very senior level [of the substance abuse research community],” she noted.

Confusion led to widely held, but false beliefs, such as the notion that abuse is a milder disorder than dependence, or that all individuals who are dependent also meet criteria for abuse, Dr. Hasin said.

The extensive data review conformed to what clinicians were seeing, that severity of dependence and of abuse, like other criteria, were intermixed, and that patients could have one of the disorders, or both.

A factor analysis of patient characteristics found “there really wasn't good rationale to keep abuse and dependence separate,” Dr. Hasin said.

“The evidence seemed quite overwhelming.”

The new DSM, then, will most likely contain 11 potential diagnostic criteria for combined substance use disorder, with severity gauged on the number of criteria met. A patient who meets two criteria would merit a diagnosis of a disorder; a patient who met four or more would be considered to have a severe form of the disorder.

The specific diagnostic criteria for a substance use disorder also will likely change in the DSM-5, with craving being considered a potentially core feature of addiction for the first time.

Likely to be dropped from the list of criteria will be recurrent substance-related legal problems, which tend to only occur when patients fulfill so many other criteria for addiction that the category becomes virtually meaningless, Dr. Hasin said in an interview.

Nicotine use disorder is highly likely to be included under the substance use disorder umbrella, again on the basis of analysis of characteristics of patients enrolled in many studies that show convergence with other substance use disorders.

The new inclusion of a behavioral disorder–compulsive gambling–might appear as an addiction alongside substance use disorders for the first time, based on years of study, said committee member Dr. Eric Hollander, director of the Compulsive, Impulsive, and Autism Spectrum Disorders Program at Montefiore Medical Center and Albert Einstein College of Medicine, New York.

Currently classified as an impulse control disorder, a large body of evidence now supports compulsive gambling as an addiction, he said in an interview.

“Based on extensive studies, we now know a lot about the clinical features and the course of the illness … the brain circuitry, neurotransmitter features, and the genetic features,” Dr. Hollander said.

Other behavioral disorders eventually might make their way into the DSM based on the weight of a similar body of evidence, but data are lacking for them at this point, he said.

“Waiting in the wings” … perhaps for DSM-6, may be compulsive overeating, video gaming, shopping, and even overexercise.

The scientific bar for inclusion will be held high, stressed Nancy M. Petry, Ph.D., professor of psychiatry at the University of Connecticut, Farmington.

Even with an extensive database of studies, consistency is lacking in the characterization of Internet gaming as a potentially diagnosable addiction, with prevalence estimates, for example, ranging from 0.9% to 64%, she said.

“Until we can better define what this addiction is, it doesn't seem like it's ready yet,” Dr. Petry said.

“Are we going to end up with chocolate addiction in DSM-6?”

The working group members disclosed no relevant financial conflicts of interest with regard to the DSM-5.

NEW ORLEANS – Worrisome and clinically measurable metabolic changes can be seen in just 12 weeks among children and adolescents who received antipsychotic medications in a National Institutes of Health–sponsored study, prompting serious concern among clinicians who learned of the results at the annual meeting of the American Psychiatric Association.

The results struck at the heart of a troubling dichotomy: an explosion of prescriptions of antipsychotic medications for children, but little evidence in real-world practice that young patients are being routinely screened for metabolic changes that have the potential to shorten life expectancy.

The ongoing Metabolic Effects of Antipsychotics in Children study has already enrolled more than 140 children aged 7-18 years who were already slated to be placed on antipsychotics in the community. Investigators closely monitored changes over 3 months in body fat using dual–energy x-ray absorptiometry (DEXA) and insulin sensitivity using gold-standard methods, as well as tracking clinically available measures such as body mass index (BMI) percentile, and plasma glucose and lipids.

Body fat percentages rose in “not all, but certainly the majority of these children and youth,” said Dr. John W. Newcomer, professor of psychiatry and medicine and Director of the Center for Clinical Studies at Washington University in St. Louis.

Mean increases were highly variable among children and adolescents taking antipsychotic medications, but have averaged almost 3 kilos, or 6.5 pounds, “of body fat, not just weight,” in just 12 weeks, he said.

Some variance was seen in mean percent body fat accrual depending on which antipsychotic the children and adolescents received in the randomized open-label study. However, box plots revealed “substantial overlap” in the results, showing that each individual child's metabolic response to a given drug is somewhat unpredictable.

“You can find kids who take any one of these medications and potentially get a substantial increase in body fat, and you can also find kids who take any one of these agents who actually have very little change in body fat, although some medications are associated with a higher risk of substantial increase,” Dr. Newcomer said.

Increases in BMI percentiles were “substantial” as well, and closely paralleled more sophisticated measures of body fat, such as DEXA. “The good news is, it's pretty easy to track the changes in adiposity,” said Dr. Newcomer in an interview after the meeting.

“We used very fancy and expensive measures of body fat, but what pediatricians have in the front of every kid's chart (the BMI percentage table) does a darned good job of not only lining up where the child is at the baseline screen, but also in tracking changes over time.”

In a similar vein, the study found that simple blood cholesterol profiles–especially triglycerides and HDL–did a “halfway decent job” of estimating insulin sensitivity at baseline and then tracking changes through the early months of therapy, Dr. Newcomer added. “The point is… don't wait a year to check the labs,” he said. “Don't not look.”

What is troubling to many is the fact that many clinicians indeed are not looking.

A Medicaid claims data study published earlier this year found that glucose screening was performed in just 31.6% and lipid testing in just 13.4% of 5,370 children aged 6-17 years prescribed antipsychotic drugs from July 1, 2004 to June 30, 2006 (Arch. Pediatr. Adolesc. Med. 2010;164:344-51).

Dr. Newcomer, a coauthor on the Medicaid claims research, said a growing number of “very eye-opening studies” about the enduring impact of childhood metabolic dysregulation and obesity should make clinicians weigh risks and consequences carefully when choosing drugs to prescribe for childhood schizophrenia, and perhaps even more so for use in disruptive behavior disorders and other nonpsychotic diagnoses.

“I have certainly learned that there are children at the end of the road of clinical options who are either not going to be in school or unable to participate without some heroic treatment measures, such as low-dose antipsychotic treatment, to help them to re-engage in education,” he said.

At the same time, relatively brief pharmacologic interventions for children who do not have schizophrenia or bipolar disorder should leave “a metabolic footprint… as modest as possible,” he said.

The Washington University study extended body weight findings from the nonrandomized SATIETY study published last year (JAMA 2009;302:1765-73), in which 272 4- to 19-year-olds prescribed antipsychotic drugs gained from a mean 4.4 kg (aripiprazole) to 8.5 kg (olanzapine) in a median of just 10.8 weeks on medication.

At the APA scientific session where interim data were released from the MEAC study, one audience member rose to call the findings “catastrophic.”

“What you're showing us is very, very scary,” he told Dr. Newcomer, who replied that the metabolic effects of other classes of drugs widely used in children, including benzodiazepines and high-dose antidepressants, are also potentially concerning. “We're having this policy debate under a streetlamp as though second-generation antipsychotics are the only drugs that cause weight gain,” Dr. Newcomer said. “Let's not kid ourselves.”

One alternative raised at the session was intensive behavioral modification, such as a year-long, school-based program for disruptive children described by Dr. Jacob Venter, of Wellesley, Mass., and his colleagues at the same APA scientific session.

Dr. Newcomer pointed to the University of Arizona behavioral study as an example of how nonpharmacologic interventions can produce “some good results,” even among children with severe behavioral dysregulation.

“The problem is, I don't know about your town, but in St. Louis, there is a 6-month waiting list to see a child psychiatrist,” he told the audience.

By the time they can be seen, “These families are in great distress and sometimes aren't terribly interested in taking those referrals for behavioral treatments, either because they already tried some therapy or because they seek rapid change,” he said. Families want the quick responses they associate with medication, and when a trial of behavioral modification is suggested as a starting place, “We can't give it away.”

As for trying to reduce prescribing of antipsychotic medications to children, particularly among those who do not have symptoms consistent with bipolar disorder or schizophrenia, Dr. Newcomer, who also chairs Missouri's Drug Utilization Review Board, was somewhat skeptical about the potential to substantially reduce that clinical practice.

“Like it or not, that horse is out of the barn. The clinical benefits can be obvious to parents, children, and their doctors, so there will continue to be interest in this therapeutic approach, even as we fully elaborate the risks. This is happening all over the country. The rates of prescriptions are going up. The off-label use is tremendous, suggesting a lot of unmet need,” he said.

Indeed, a series of studies conducted by a team led by Dr. Mark Olfson at Columbia University, New York, has found that prescribing of antipsychotic medications by psychiatrists and primary care physicians has skyrocketed in the United States since the mid-1990s, with treatment of disruptive behavior disorders, including attention-deficit/hyperactivity disorder, playing a significant role in the increase.

In one recent example, Dr. Olfson reported that antipsychotic use by 2- to 5-year-olds covered by private insurance rose from 0.78 per 1,000 to 1.59 per 1,000 from 1999 to 2007. Less than half of the children in the study had received a mental health assessment, a psychotherapy visit, or a consultation with a psychiatrist.

Dr. Newcomer disclosed that he has served as a consultant to several pharmaceutical companies but reported no relevant financial conflicts of interest associated with his study.

Dr. John W. Newcomer says his early data suggest that clinically measurable changes can occur in 12 weeks in children and teens taking antipsychotics.

Source Courtesy Amber Spies

NEW ORLEANS – Worrisome and clinically measurable metabolic changes can be seen in just 12 weeks among children and adolescents who received antipsychotic medications in a National Institutes of Health–sponsored study, prompting serious concern among clinicians who learned of the results at the annual meeting of the American Psychiatric Association.

The results struck at the heart of a troubling dichotomy: an explosion of prescriptions of antipsychotic medications for children, but little evidence in real-world practice that young patients are being routinely screened for metabolic changes that have the potential to shorten life expectancy.

The ongoing Metabolic Effects of Antipsychotics in Children study has already enrolled more than 140 children aged 7-18 years who were already slated to be placed on antipsychotics in the community. Investigators closely monitored changes over 3 months in body fat using dual–energy x-ray absorptiometry (DEXA) and insulin sensitivity using gold-standard methods, as well as tracking clinically available measures such as body mass index (BMI) percentile, and plasma glucose and lipids.

Body fat percentages rose in “not all, but certainly the majority of these children and youth,” said Dr. John W. Newcomer, professor of psychiatry and medicine and Director of the Center for Clinical Studies at Washington University in St. Louis.

Mean increases were highly variable among children and adolescents taking antipsychotic medications, but have averaged almost 3 kilos, or 6.5 pounds, “of body fat, not just weight,” in just 12 weeks, he said.

Some variance was seen in mean percent body fat accrual depending on which antipsychotic the children and adolescents received in the randomized open-label study. However, box plots revealed “substantial overlap” in the results, showing that each individual child's metabolic response to a given drug is somewhat unpredictable.

“You can find kids who take any one of these medications and potentially get a substantial increase in body fat, and you can also find kids who take any one of these agents who actually have very little change in body fat, although some medications are associated with a higher risk of substantial increase,” Dr. Newcomer said.

Increases in BMI percentiles were “substantial” as well, and closely paralleled more sophisticated measures of body fat, such as DEXA. “The good news is, it's pretty easy to track the changes in adiposity,” said Dr. Newcomer in an interview after the meeting.

“We used very fancy and expensive measures of body fat, but what pediatricians have in the front of every kid's chart (the BMI percentage table) does a darned good job of not only lining up where the child is at the baseline screen, but also in tracking changes over time.”

In a similar vein, the study found that simple blood cholesterol profiles–especially triglycerides and HDL–did a “halfway decent job” of estimating insulin sensitivity at baseline and then tracking changes through the early months of therapy, Dr. Newcomer added. “The point is… don't wait a year to check the labs,” he said. “Don't not look.”

What is troubling to many is the fact that many clinicians indeed are not looking.

A Medicaid claims data study published earlier this year found that glucose screening was performed in just 31.6% and lipid testing in just 13.4% of 5,370 children aged 6-17 years prescribed antipsychotic drugs from July 1, 2004 to June 30, 2006 (Arch. Pediatr. Adolesc. Med. 2010;164:344-51).

Dr. Newcomer, a coauthor on the Medicaid claims research, said a growing number of “very eye-opening studies” about the enduring impact of childhood metabolic dysregulation and obesity should make clinicians weigh risks and consequences carefully when choosing drugs to prescribe for childhood schizophrenia, and perhaps even more so for use in disruptive behavior disorders and other nonpsychotic diagnoses.

“I have certainly learned that there are children at the end of the road of clinical options who are either not going to be in school or unable to participate without some heroic treatment measures, such as low-dose antipsychotic treatment, to help them to re-engage in education,” he said.

At the same time, relatively brief pharmacologic interventions for children who do not have schizophrenia or bipolar disorder should leave “a metabolic footprint… as modest as possible,” he said.

The Washington University study extended body weight findings from the nonrandomized SATIETY study published last year (JAMA 2009;302:1765-73), in which 272 4- to 19-year-olds prescribed antipsychotic drugs gained from a mean 4.4 kg (aripiprazole) to 8.5 kg (olanzapine) in a median of just 10.8 weeks on medication.

At the APA scientific session where interim data were released from the MEAC study, one audience member rose to call the findings “catastrophic.”

“What you're showing us is very, very scary,” he told Dr. Newcomer, who replied that the metabolic effects of other classes of drugs widely used in children, including benzodiazepines and high-dose antidepressants, are also potentially concerning. “We're having this policy debate under a streetlamp as though second-generation antipsychotics are the only drugs that cause weight gain,” Dr. Newcomer said. “Let's not kid ourselves.”

One alternative raised at the session was intensive behavioral modification, such as a year-long, school-based program for disruptive children described by Dr. Jacob Venter, of Wellesley, Mass., and his colleagues at the same APA scientific session.

Dr. Newcomer pointed to the University of Arizona behavioral study as an example of how nonpharmacologic interventions can produce “some good results,” even among children with severe behavioral dysregulation.

“The problem is, I don't know about your town, but in St. Louis, there is a 6-month waiting list to see a child psychiatrist,” he told the audience.

By the time they can be seen, “These families are in great distress and sometimes aren't terribly interested in taking those referrals for behavioral treatments, either because they already tried some therapy or because they seek rapid change,” he said. Families want the quick responses they associate with medication, and when a trial of behavioral modification is suggested as a starting place, “We can't give it away.”

As for trying to reduce prescribing of antipsychotic medications to children, particularly among those who do not have symptoms consistent with bipolar disorder or schizophrenia, Dr. Newcomer, who also chairs Missouri's Drug Utilization Review Board, was somewhat skeptical about the potential to substantially reduce that clinical practice.

“Like it or not, that horse is out of the barn. The clinical benefits can be obvious to parents, children, and their doctors, so there will continue to be interest in this therapeutic approach, even as we fully elaborate the risks. This is happening all over the country. The rates of prescriptions are going up. The off-label use is tremendous, suggesting a lot of unmet need,” he said.

Indeed, a series of studies conducted by a team led by Dr. Mark Olfson at Columbia University, New York, has found that prescribing of antipsychotic medications by psychiatrists and primary care physicians has skyrocketed in the United States since the mid-1990s, with treatment of disruptive behavior disorders, including attention-deficit/hyperactivity disorder, playing a significant role in the increase.

In one recent example, Dr. Olfson reported that antipsychotic use by 2- to 5-year-olds covered by private insurance rose from 0.78 per 1,000 to 1.59 per 1,000 from 1999 to 2007. Less than half of the children in the study had received a mental health assessment, a psychotherapy visit, or a consultation with a psychiatrist.

Dr. Newcomer disclosed that he has served as a consultant to several pharmaceutical companies but reported no relevant financial conflicts of interest associated with his study.

Dr. John W. Newcomer says his early data suggest that clinically measurable changes can occur in 12 weeks in children and teens taking antipsychotics.

Source Courtesy Amber Spies

NEW ORLEANS – Worrisome and clinically measurable metabolic changes can be seen in just 12 weeks among children and adolescents who received antipsychotic medications in a National Institutes of Health–sponsored study, prompting serious concern among clinicians who learned of the results at the annual meeting of the American Psychiatric Association.

The results struck at the heart of a troubling dichotomy: an explosion of prescriptions of antipsychotic medications for children, but little evidence in real-world practice that young patients are being routinely screened for metabolic changes that have the potential to shorten life expectancy.

The ongoing Metabolic Effects of Antipsychotics in Children study has already enrolled more than 140 children aged 7-18 years who were already slated to be placed on antipsychotics in the community. Investigators closely monitored changes over 3 months in body fat using dual–energy x-ray absorptiometry (DEXA) and insulin sensitivity using gold-standard methods, as well as tracking clinically available measures such as body mass index (BMI) percentile, and plasma glucose and lipids.

Body fat percentages rose in “not all, but certainly the majority of these children and youth,” said Dr. John W. Newcomer, professor of psychiatry and medicine and Director of the Center for Clinical Studies at Washington University in St. Louis.

Mean increases were highly variable among children and adolescents taking antipsychotic medications, but have averaged almost 3 kilos, or 6.5 pounds, “of body fat, not just weight,” in just 12 weeks, he said.

Some variance was seen in mean percent body fat accrual depending on which antipsychotic the children and adolescents received in the randomized open-label study. However, box plots revealed “substantial overlap” in the results, showing that each individual child's metabolic response to a given drug is somewhat unpredictable.

“You can find kids who take any one of these medications and potentially get a substantial increase in body fat, and you can also find kids who take any one of these agents who actually have very little change in body fat, although some medications are associated with a higher risk of substantial increase,” Dr. Newcomer said.

Increases in BMI percentiles were “substantial” as well, and closely paralleled more sophisticated measures of body fat, such as DEXA. “The good news is, it's pretty easy to track the changes in adiposity,” said Dr. Newcomer in an interview after the meeting.

“We used very fancy and expensive measures of body fat, but what pediatricians have in the front of every kid's chart (the BMI percentage table) does a darned good job of not only lining up where the child is at the baseline screen, but also in tracking changes over time.”

In a similar vein, the study found that simple blood cholesterol profiles–especially triglycerides and HDL–did a “halfway decent job” of estimating insulin sensitivity at baseline and then tracking changes through the early months of therapy, Dr. Newcomer added. “The point is… don't wait a year to check the labs,” he said. “Don't not look.”

What is troubling to many is the fact that many clinicians indeed are not looking.

A Medicaid claims data study published earlier this year found that glucose screening was performed in just 31.6% and lipid testing in just 13.4% of 5,370 children aged 6-17 years prescribed antipsychotic drugs from July 1, 2004 to June 30, 2006 (Arch. Pediatr. Adolesc. Med. 2010;164:344-51).

Dr. Newcomer, a coauthor on the Medicaid claims research, said a growing number of “very eye-opening studies” about the enduring impact of childhood metabolic dysregulation and obesity should make clinicians weigh risks and consequences carefully when choosing drugs to prescribe for childhood schizophrenia, and perhaps even more so for use in disruptive behavior disorders and other nonpsychotic diagnoses.

“I have certainly learned that there are children at the end of the road of clinical options who are either not going to be in school or unable to participate without some heroic treatment measures, such as low-dose antipsychotic treatment, to help them to re-engage in education,” he said.

At the same time, relatively brief pharmacologic interventions for children who do not have schizophrenia or bipolar disorder should leave “a metabolic footprint… as modest as possible,” he said.

The Washington University study extended body weight findings from the nonrandomized SATIETY study published last year (JAMA 2009;302:1765-73), in which 272 4- to 19-year-olds prescribed antipsychotic drugs gained from a mean 4.4 kg (aripiprazole) to 8.5 kg (olanzapine) in a median of just 10.8 weeks on medication.

At the APA scientific session where interim data were released from the MEAC study, one audience member rose to call the findings “catastrophic.”

“What you're showing us is very, very scary,” he told Dr. Newcomer, who replied that the metabolic effects of other classes of drugs widely used in children, including benzodiazepines and high-dose antidepressants, are also potentially concerning. “We're having this policy debate under a streetlamp as though second-generation antipsychotics are the only drugs that cause weight gain,” Dr. Newcomer said. “Let's not kid ourselves.”

One alternative raised at the session was intensive behavioral modification, such as a year-long, school-based program for disruptive children described by Dr. Jacob Venter, of Wellesley, Mass., and his colleagues at the same APA scientific session.

Dr. Newcomer pointed to the University of Arizona behavioral study as an example of how nonpharmacologic interventions can produce “some good results,” even among children with severe behavioral dysregulation.

“The problem is, I don't know about your town, but in St. Louis, there is a 6-month waiting list to see a child psychiatrist,” he told the audience.

By the time they can be seen, “These families are in great distress and sometimes aren't terribly interested in taking those referrals for behavioral treatments, either because they already tried some therapy or because they seek rapid change,” he said. Families want the quick responses they associate with medication, and when a trial of behavioral modification is suggested as a starting place, “We can't give it away.”

As for trying to reduce prescribing of antipsychotic medications to children, particularly among those who do not have symptoms consistent with bipolar disorder or schizophrenia, Dr. Newcomer, who also chairs Missouri's Drug Utilization Review Board, was somewhat skeptical about the potential to substantially reduce that clinical practice.

“Like it or not, that horse is out of the barn. The clinical benefits can be obvious to parents, children, and their doctors, so there will continue to be interest in this therapeutic approach, even as we fully elaborate the risks. This is happening all over the country. The rates of prescriptions are going up. The off-label use is tremendous, suggesting a lot of unmet need,” he said.

Indeed, a series of studies conducted by a team led by Dr. Mark Olfson at Columbia University, New York, has found that prescribing of antipsychotic medications by psychiatrists and primary care physicians has skyrocketed in the United States since the mid-1990s, with treatment of disruptive behavior disorders, including attention-deficit/hyperactivity disorder, playing a significant role in the increase.

In one recent example, Dr. Olfson reported that antipsychotic use by 2- to 5-year-olds covered by private insurance rose from 0.78 per 1,000 to 1.59 per 1,000 from 1999 to 2007. Less than half of the children in the study had received a mental health assessment, a psychotherapy visit, or a consultation with a psychiatrist.

Dr. Newcomer disclosed that he has served as a consultant to several pharmaceutical companies but reported no relevant financial conflicts of interest associated with his study.

Dr. John W. Newcomer says his early data suggest that clinically measurable changes can occur in 12 weeks in children and teens taking antipsychotics.

Source Courtesy Amber Spies

NEW ORLEANS — Proposed changes to the Diagnostic and Statistical Manual will likely put an end to separate diagnoses of substance “abuse” and “dependence,” distinctions that puzzled even addiction experts, members of the DSM-5 work group on substance-related disorders said at the meeting.

On the basis of discussions held during the meeting, it seems probable that both categories will be subsumed within the general diagnosis, “substance use disorder,” under an expanded DSM addiction section that will include for the first time a behavioral addiction, compulsive gambling.

“Change is good if change can be shown to do more good than bad and can be supported by data,” said Dr. Marc A. Schuckit during a progress report presented by the APA DSM-5 substance-related disorders work group at the meeting.

If the prime objectives for inclusion in the DSM are making diagnoses that are clear, straightforward, flexible enough to be clinically useful, valid, “moderately” reliable, predictable, and inclusive of “the people who need help,” current substance use categories in the DSM-IV-R admittedly are “out of focus,” said Dr. Schuckit, professor of psychiatry at the University of California, San Diego.

However, the committee wants to be cautious, so that they do not “go from one very useful but not perfectly focused image to another very useful but not very well-focused image,” he said, noting that a rich database has been exceedingly useful in guiding directions for change.

For example, when data from studies representing more than 100,000 subjects were analyzed by the committee, DSM-IV diagnostic criteria for substance dependence were highly reliable and valid, but those for substance abuse were much lower and more variable, said Deborah S. Hasin, Ph.D., professor of clinical public health at Columbia University, New York, a work group committee member, and cochair of the meeting symposium.

The hierarchical relationship between abuse and dependence (with abuse only diagnosed in the absence of dependence) was “often misunderstood, even by people functioning at a very senior level [of the substance abuse research community],” she noted.

Confusion led to widely held, but false beliefs, such as the notion that abuse is a milder disorder than dependence, or that all individuals who are dependent also meet criteria for abuse, Dr. Hasin said.

The extensive data review conformed to what clinicians were seeing, that severity of dependence and of abuse, like other criteria, were intermixed, and that patients could have one of the disorders, or both.

A factor analysis of patient characteristics found “there really wasn't good rationale to keep abuse and dependence separate,” Dr. Hasin said.

“The evidence seemed quite overwhelming.”

The new DSM, then, will most likely contain 11 potential diagnostic criteria for combined substance use disorder, with severity gauged on the number of criteria met. A patient who meets two criteria would merit a diagnosis of a disorder; a patient who met four or more would be considered to have a severe form of the disorder.

The specific diagnostic criteria for a substance use disorder also will likely change in the DSM-5, with craving being considered a potentially core feature of addiction for the first time.

Likely to be dropped from the list of criteria will be recurrent substance-related legal problems, which tend to only occur when patients fulfill so many other criteria for addiction that the category becomes virtually meaningless, Dr. Hasin said in an interview.

Nicotine use disorder is highly likely to be included under the substance use disorder umbrella, again on the basis of analysis of characteristics of patients enrolled in many studies that show convergence with other substance use disorders.

The new inclusion of a behavioral disorder—compulsive gambling—might appear as an addiction alongside substance use disorders for the first time, based on years of study, said committee member Dr. Eric Hollander, director of the Compulsive, Impulsive, and Autism Spectrum Disorders Program at Montefiore Medical Center and Albert Einstein College of Medicine, New York.

Currently classified as an impulse control disorder, a large body of evidence now supports compulsive gambling as an addiction, he said in an interview.

“Based on extensive studies, we now know a lot about the clinical features and the course of the illness … the brain circuitry, neurotransmitter features, and the genetic features,” Dr. Hollander said.

Other behavioral disorders eventually might make their way into the DSM based on the weight of a similar body of evidence, but data are lacking for them at this point, he said.

“Waiting in the wings,” perhaps for DSM-6, may be compulsive overeating, video gaming, shopping, and even overexercise.

None of the working group members disclosed any relevant financial conflicts of interest with regard to the DSM-5.

The new DSM will likely classify compulsive gambling as an addiction disorder. Compulsive gambling is currently classified as an impulse control disorder.

Source ©Andrew Brown/Fotolia.com

NEW ORLEANS — Proposed changes to the Diagnostic and Statistical Manual will likely put an end to separate diagnoses of substance “abuse” and “dependence,” distinctions that puzzled even addiction experts, members of the DSM-5 work group on substance-related disorders said at the meeting.

On the basis of discussions held during the meeting, it seems probable that both categories will be subsumed within the general diagnosis, “substance use disorder,” under an expanded DSM addiction section that will include for the first time a behavioral addiction, compulsive gambling.

“Change is good if change can be shown to do more good than bad and can be supported by data,” said Dr. Marc A. Schuckit during a progress report presented by the APA DSM-5 substance-related disorders work group at the meeting.

If the prime objectives for inclusion in the DSM are making diagnoses that are clear, straightforward, flexible enough to be clinically useful, valid, “moderately” reliable, predictable, and inclusive of “the people who need help,” current substance use categories in the DSM-IV-R admittedly are “out of focus,” said Dr. Schuckit, professor of psychiatry at the University of California, San Diego.

However, the committee wants to be cautious, so that they do not “go from one very useful but not perfectly focused image to another very useful but not very well-focused image,” he said, noting that a rich database has been exceedingly useful in guiding directions for change.

For example, when data from studies representing more than 100,000 subjects were analyzed by the committee, DSM-IV diagnostic criteria for substance dependence were highly reliable and valid, but those for substance abuse were much lower and more variable, said Deborah S. Hasin, Ph.D., professor of clinical public health at Columbia University, New York, a work group committee member, and cochair of the meeting symposium.

The hierarchical relationship between abuse and dependence (with abuse only diagnosed in the absence of dependence) was “often misunderstood, even by people functioning at a very senior level [of the substance abuse research community],” she noted.

Confusion led to widely held, but false beliefs, such as the notion that abuse is a milder disorder than dependence, or that all individuals who are dependent also meet criteria for abuse, Dr. Hasin said.

The extensive data review conformed to what clinicians were seeing, that severity of dependence and of abuse, like other criteria, were intermixed, and that patients could have one of the disorders, or both.

A factor analysis of patient characteristics found “there really wasn't good rationale to keep abuse and dependence separate,” Dr. Hasin said.

“The evidence seemed quite overwhelming.”

The new DSM, then, will most likely contain 11 potential diagnostic criteria for combined substance use disorder, with severity gauged on the number of criteria met. A patient who meets two criteria would merit a diagnosis of a disorder; a patient who met four or more would be considered to have a severe form of the disorder.

The specific diagnostic criteria for a substance use disorder also will likely change in the DSM-5, with craving being considered a potentially core feature of addiction for the first time.

Likely to be dropped from the list of criteria will be recurrent substance-related legal problems, which tend to only occur when patients fulfill so many other criteria for addiction that the category becomes virtually meaningless, Dr. Hasin said in an interview.

Nicotine use disorder is highly likely to be included under the substance use disorder umbrella, again on the basis of analysis of characteristics of patients enrolled in many studies that show convergence with other substance use disorders.

The new inclusion of a behavioral disorder—compulsive gambling—might appear as an addiction alongside substance use disorders for the first time, based on years of study, said committee member Dr. Eric Hollander, director of the Compulsive, Impulsive, and Autism Spectrum Disorders Program at Montefiore Medical Center and Albert Einstein College of Medicine, New York.

Currently classified as an impulse control disorder, a large body of evidence now supports compulsive gambling as an addiction, he said in an interview.

“Based on extensive studies, we now know a lot about the clinical features and the course of the illness … the brain circuitry, neurotransmitter features, and the genetic features,” Dr. Hollander said.

Other behavioral disorders eventually might make their way into the DSM based on the weight of a similar body of evidence, but data are lacking for them at this point, he said.

“Waiting in the wings,” perhaps for DSM-6, may be compulsive overeating, video gaming, shopping, and even overexercise.

None of the working group members disclosed any relevant financial conflicts of interest with regard to the DSM-5.

The new DSM will likely classify compulsive gambling as an addiction disorder. Compulsive gambling is currently classified as an impulse control disorder.

Source ©Andrew Brown/Fotolia.com

NEW ORLEANS — Proposed changes to the Diagnostic and Statistical Manual will likely put an end to separate diagnoses of substance “abuse” and “dependence,” distinctions that puzzled even addiction experts, members of the DSM-5 work group on substance-related disorders said at the meeting.

On the basis of discussions held during the meeting, it seems probable that both categories will be subsumed within the general diagnosis, “substance use disorder,” under an expanded DSM addiction section that will include for the first time a behavioral addiction, compulsive gambling.

“Change is good if change can be shown to do more good than bad and can be supported by data,” said Dr. Marc A. Schuckit during a progress report presented by the APA DSM-5 substance-related disorders work group at the meeting.

If the prime objectives for inclusion in the DSM are making diagnoses that are clear, straightforward, flexible enough to be clinically useful, valid, “moderately” reliable, predictable, and inclusive of “the people who need help,” current substance use categories in the DSM-IV-R admittedly are “out of focus,” said Dr. Schuckit, professor of psychiatry at the University of California, San Diego.

However, the committee wants to be cautious, so that they do not “go from one very useful but not perfectly focused image to another very useful but not very well-focused image,” he said, noting that a rich database has been exceedingly useful in guiding directions for change.

For example, when data from studies representing more than 100,000 subjects were analyzed by the committee, DSM-IV diagnostic criteria for substance dependence were highly reliable and valid, but those for substance abuse were much lower and more variable, said Deborah S. Hasin, Ph.D., professor of clinical public health at Columbia University, New York, a work group committee member, and cochair of the meeting symposium.

The hierarchical relationship between abuse and dependence (with abuse only diagnosed in the absence of dependence) was “often misunderstood, even by people functioning at a very senior level [of the substance abuse research community],” she noted.

Confusion led to widely held, but false beliefs, such as the notion that abuse is a milder disorder than dependence, or that all individuals who are dependent also meet criteria for abuse, Dr. Hasin said.

The extensive data review conformed to what clinicians were seeing, that severity of dependence and of abuse, like other criteria, were intermixed, and that patients could have one of the disorders, or both.

A factor analysis of patient characteristics found “there really wasn't good rationale to keep abuse and dependence separate,” Dr. Hasin said.

“The evidence seemed quite overwhelming.”

The new DSM, then, will most likely contain 11 potential diagnostic criteria for combined substance use disorder, with severity gauged on the number of criteria met. A patient who meets two criteria would merit a diagnosis of a disorder; a patient who met four or more would be considered to have a severe form of the disorder.

The specific diagnostic criteria for a substance use disorder also will likely change in the DSM-5, with craving being considered a potentially core feature of addiction for the first time.

Likely to be dropped from the list of criteria will be recurrent substance-related legal problems, which tend to only occur when patients fulfill so many other criteria for addiction that the category becomes virtually meaningless, Dr. Hasin said in an interview.

Nicotine use disorder is highly likely to be included under the substance use disorder umbrella, again on the basis of analysis of characteristics of patients enrolled in many studies that show convergence with other substance use disorders.

The new inclusion of a behavioral disorder—compulsive gambling—might appear as an addiction alongside substance use disorders for the first time, based on years of study, said committee member Dr. Eric Hollander, director of the Compulsive, Impulsive, and Autism Spectrum Disorders Program at Montefiore Medical Center and Albert Einstein College of Medicine, New York.

Currently classified as an impulse control disorder, a large body of evidence now supports compulsive gambling as an addiction, he said in an interview.

“Based on extensive studies, we now know a lot about the clinical features and the course of the illness … the brain circuitry, neurotransmitter features, and the genetic features,” Dr. Hollander said.

Other behavioral disorders eventually might make their way into the DSM based on the weight of a similar body of evidence, but data are lacking for them at this point, he said.

“Waiting in the wings,” perhaps for DSM-6, may be compulsive overeating, video gaming, shopping, and even overexercise.

None of the working group members disclosed any relevant financial conflicts of interest with regard to the DSM-5.

The new DSM will likely classify compulsive gambling as an addiction disorder. Compulsive gambling is currently classified as an impulse control disorder.

Source ©Andrew Brown/Fotolia.com

Obstetrics and gynecology, under siege by diminishing reimbursement and escalating malpractice premiums, has broadly expanded its scope over recent years to include the cosmetic treatment of wrinkles, age spots, and love handles.

The trend has met with mild consternation voiced at medical meetings and in the commentary sections of professional journals, but little fervent pushback—with one notable exception: commercialization of cosmetic genital surgery.

Cosmetic labial surgery and vulvar fat transfers have been at the center of escalating controversy in the literature, pitting critics against proponents in a battle of words over medical ethics, evidence-based medicine, and philosophical questions of free choice and societal pressure.

An opinion about "procedures that are not medically indicated" issued in 2007 by the American College of Obstetricians and Gynecologists' Committee on Gynecologic Practice was considered too tepid by some in its recommendation that women be educated about the lack of evidence supporting the efficacy and safety of cosmetic vulvovaginal surgery.

Doing such procedures and advertising them with photographs of purportedly "attractive" versus "unattractive" genitalia constitutes a violation of the ethical relationship physicians have with their patients, maintains Dr. Paul Indman, an ob.gyn. in solo private practice in Los Gatos, Calif.

"What we do is destroy women's self-esteem [with such photographs] and then charge them a lot of money to fix what we have destroyed. I think our job … is to help women understand what the range of normal is, [to counteract] society-caused, society-influenced perceived differences," he said in an interview.

Dr. Robert D. Moore represents another point of view.

He and longtime partner Dr. John R. Miklos began incorporating cosmetic gynecologic procedures in their practice at the Atlanta Center for Laparoscopic Urogynecology and Reconstructive Pelvic Surgery 10 years ago to fill an unmet need, he said in an interview. "We were starting to see some of these procedures being done, and to be honest, the results were not very good at all. Clearly the surgeons who were doing it did not have experience or expertise in doing reconstructive surgery in this region, and patients were being harmed."

Whether women need the surgery is not a question Dr. Moore considers relevant, although he and the other physicians interviewed for this article all said they refuse to operate on women being pressured by a partner or those who have signs of psychiatric diagnoses such as body dysmorphic disorder.

To question whether patients know enough about normal genital variations to make an informed decision "is an insult to women's intelligence and confidence," he said.

In some cases, clinicians offering the procedures also cite functional indications, such as diminished sexual satisfaction or entrapment of hypertrophic labia with intercourse.

A review of 131 cases published by Dr. Miklos and Dr. Moore found that 37% of women undergoing labiaplasty cited purely aesthetic concerns (including their appearance in tight clothing), 32% cited functional impairment (such as discomfort while bicycling), and 31% had both concerns (J. Sex. Med. 2008;5:1492-5).

In his Los Angeles practice, though, only the "rare" woman cites functional discomfort, said Dr. David Matlock, who directs the Laser Vaginal Rejuvenation Institute of Los Angeles and has trademarked terms such as Laser Vaginal Rejuvenation, Designer Laser Vaginoplasty, and the G-Shot, or G-Spot Amplification.

In most cases, "it's aesthetic surgery. It's personal preference," driven in part by social trends, including Brazilian waxing.

"You don't need your breasts done, tummy tucked, or nose done. None of it is indicated. The patient wants to alter something. I listen to what the patient wants," he said in an interview.

As opposed to surgical innovations that enter the literature through clinical trials, results of which are presented at scientific meetings, "designer vaginoplasty" and aesthetic procedures are taught at profitable seminars and sponsored by surgeons such as Dr. Marco A. Pelosi II, director of the Pelosi Medical Center in Bayonne, N.J., and cofounder with his son, Dr. Marco A. Pelosi III, of the newly established International Society of Cosmetogynecology.

The elder Dr. Pelosi staunchly defended the profit motive for offering cosmetic training, saying that the objective is "totally different" from relatively inexpensive training obtained through professional medical societies. He and a small group of experts spent years developing these procedures and quite reasonably should be compensated for sharing their specialized knowledge with surgeons who stand to profit from what they learn, he said.

"We're not using this to cure cancer," he said in an interview. "This is something that is a service to enhance patients' self-concepts."

The idea that the seminars offer "industry secrets," as well as the general lack of solid data about indications and outcomes, is what concerns Dr. Erin Tracy, an ob.gyn. at Massachusetts General Hospital and a faculty member at Harvard Medical School, both in Boston.

"If they truly have procedures that are safe and beneficial for women, I would think they would want to share this data with the scientific community," she said. "Women need to be educated that at this point, these procedures are not proven to be safe or effective, and carry risks of bleeding, infection, pain with intercourse, and scar tissue."

She and other critics also questioned potential sexual and long-term complications of aesthetic gynecologic surgery, because the labia minora contain clitoral tissue, and the labia undergo physical changes over a woman's lifetime.

"Papers are coming," promised Dr. Matlock, who said a large, multicenter outcomes study of cosmetic genital procedures has been completed and accepted for publication.

Up to now, a handful of papers in scientific journals have been dwarfed by coverage of the procedures in women's magazines and the lay press, driving requests for the procedure.

"It's obviously interesting to the media," said Dr. Matlock. "Sex sells."
Papers decrying the lack of objective outcomes "miss the point," he said. "Is the patient happy or unhappy? That's what it's all about."

"Despite the fact that ob.gyns. are involved their whole lives in dealing with women, [they] have no idea how to meet the needs of female patients," said the elder Dr. Pelosi. "If they are treating anything objective—pain, infections—they are extremely competent, but anything beyond that, they don't want to hear about."

Frequently the argument is made that women have not seen hundreds of vulvas and labias to compare to their own genital appearance, and should be educated during about the wide range of normal anatomy, including labia minora widths at midline ranging from 7-50 mm (BJOG 2005;112:643-6).

The Web site for Dr. Miklos and Dr. Moore explains that labiaplasty can result in a "sleeker, thinner ... more youthful" appearance of the labia, and "inner lips [that] do not protrude past the labia majora at all, giving them a much more appealing shape and eliminating many of the symptoms of enlarged labia."

To question women's decision to obtain a different aesthetic appearance of their genitals is arrogant and demeaning, said Dr. Matlock.

Meanwhile, in the Netherlands, Dr. Karen Marieke Paarlberg reviews a booklet of 38 pictures of normal vulvas with patients requesting labiaplasty and discusses with them alternative means of addressing discomfort, if that is an issue.

"I think that more than 50% of women can be reassured by a doctor who can listen very well and who tries to reassure the woman that she is perfectly normal," she said in an interview.

Obstetrics and gynecology, under siege by diminishing reimbursement and escalating malpractice premiums, has broadly expanded its scope over recent years to include the cosmetic treatment of wrinkles, age spots, and love handles.

The trend has met with mild consternation voiced at medical meetings and in the commentary sections of professional journals, but little fervent pushback—with one notable exception: commercialization of cosmetic genital surgery.

Cosmetic labial surgery and vulvar fat transfers have been at the center of escalating controversy in the literature, pitting critics against proponents in a battle of words over medical ethics, evidence-based medicine, and philosophical questions of free choice and societal pressure.

An opinion about "procedures that are not medically indicated" issued in 2007 by the American College of Obstetricians and Gynecologists' Committee on Gynecologic Practice was considered too tepid by some in its recommendation that women be educated about the lack of evidence supporting the efficacy and safety of cosmetic vulvovaginal surgery.

Doing such procedures and advertising them with photographs of purportedly "attractive" versus "unattractive" genitalia constitutes a violation of the ethical relationship physicians have with their patients, maintains Dr. Paul Indman, an ob.gyn. in solo private practice in Los Gatos, Calif.

"What we do is destroy women's self-esteem [with such photographs] and then charge them a lot of money to fix what we have destroyed. I think our job … is to help women understand what the range of normal is, [to counteract] society-caused, society-influenced perceived differences," he said in an interview.

Dr. Robert D. Moore represents another point of view.

He and longtime partner Dr. John R. Miklos began incorporating cosmetic gynecologic procedures in their practice at the Atlanta Center for Laparoscopic Urogynecology and Reconstructive Pelvic Surgery 10 years ago to fill an unmet need, he said in an interview. "We were starting to see some of these procedures being done, and to be honest, the results were not very good at all. Clearly the surgeons who were doing it did not have experience or expertise in doing reconstructive surgery in this region, and patients were being harmed."

Whether women need the surgery is not a question Dr. Moore considers relevant, although he and the other physicians interviewed for this article all said they refuse to operate on women being pressured by a partner or those who have signs of psychiatric diagnoses such as body dysmorphic disorder.

To question whether patients know enough about normal genital variations to make an informed decision "is an insult to women's intelligence and confidence," he said.

In some cases, clinicians offering the procedures also cite functional indications, such as diminished sexual satisfaction or entrapment of hypertrophic labia with intercourse.

A review of 131 cases published by Dr. Miklos and Dr. Moore found that 37% of women undergoing labiaplasty cited purely aesthetic concerns (including their appearance in tight clothing), 32% cited functional impairment (such as discomfort while bicycling), and 31% had both concerns (J. Sex. Med. 2008;5:1492-5).

In his Los Angeles practice, though, only the "rare" woman cites functional discomfort, said Dr. David Matlock, who directs the Laser Vaginal Rejuvenation Institute of Los Angeles and has trademarked terms such as Laser Vaginal Rejuvenation, Designer Laser Vaginoplasty, and the G-Shot, or G-Spot Amplification.

In most cases, "it's aesthetic surgery. It's personal preference," driven in part by social trends, including Brazilian waxing.

"You don't need your breasts done, tummy tucked, or nose done. None of it is indicated. The patient wants to alter something. I listen to what the patient wants," he said in an interview.

As opposed to surgical innovations that enter the literature through clinical trials, results of which are presented at scientific meetings, "designer vaginoplasty" and aesthetic procedures are taught at profitable seminars and sponsored by surgeons such as Dr. Marco A. Pelosi II, director of the Pelosi Medical Center in Bayonne, N.J., and cofounder with his son, Dr. Marco A. Pelosi III, of the newly established International Society of Cosmetogynecology.

The elder Dr. Pelosi staunchly defended the profit motive for offering cosmetic training, saying that the objective is "totally different" from relatively inexpensive training obtained through professional medical societies. He and a small group of experts spent years developing these procedures and quite reasonably should be compensated for sharing their specialized knowledge with surgeons who stand to profit from what they learn, he said.

"We're not using this to cure cancer," he said in an interview. "This is something that is a service to enhance patients' self-concepts."

The idea that the seminars offer "industry secrets," as well as the general lack of solid data about indications and outcomes, is what concerns Dr. Erin Tracy, an ob.gyn. at Massachusetts General Hospital and a faculty member at Harvard Medical School, both in Boston.

"If they truly have procedures that are safe and beneficial for women, I would think they would want to share this data with the scientific community," she said. "Women need to be educated that at this point, these procedures are not proven to be safe or effective, and carry risks of bleeding, infection, pain with intercourse, and scar tissue."

She and other critics also questioned potential sexual and long-term complications of aesthetic gynecologic surgery, because the labia minora contain clitoral tissue, and the labia undergo physical changes over a woman's lifetime.

"Papers are coming," promised Dr. Matlock, who said a large, multicenter outcomes study of cosmetic genital procedures has been completed and accepted for publication.

Up to now, a handful of papers in scientific journals have been dwarfed by coverage of the procedures in women's magazines and the lay press, driving requests for the procedure.

"It's obviously interesting to the media," said Dr. Matlock. "Sex sells."
Papers decrying the lack of objective outcomes "miss the point," he said. "Is the patient happy or unhappy? That's what it's all about."

"Despite the fact that ob.gyns. are involved their whole lives in dealing with women, [they] have no idea how to meet the needs of female patients," said the elder Dr. Pelosi. "If they are treating anything objective—pain, infections—they are extremely competent, but anything beyond that, they don't want to hear about."

Frequently the argument is made that women have not seen hundreds of vulvas and labias to compare to their own genital appearance, and should be educated during about the wide range of normal anatomy, including labia minora widths at midline ranging from 7-50 mm (BJOG 2005;112:643-6).

The Web site for Dr. Miklos and Dr. Moore explains that labiaplasty can result in a "sleeker, thinner ... more youthful" appearance of the labia, and "inner lips [that] do not protrude past the labia majora at all, giving them a much more appealing shape and eliminating many of the symptoms of enlarged labia."

To question women's decision to obtain a different aesthetic appearance of their genitals is arrogant and demeaning, said Dr. Matlock.

Meanwhile, in the Netherlands, Dr. Karen Marieke Paarlberg reviews a booklet of 38 pictures of normal vulvas with patients requesting labiaplasty and discusses with them alternative means of addressing discomfort, if that is an issue.

"I think that more than 50% of women can be reassured by a doctor who can listen very well and who tries to reassure the woman that she is perfectly normal," she said in an interview.

Obstetrics and gynecology, under siege by diminishing reimbursement and escalating malpractice premiums, has broadly expanded its scope over recent years to include the cosmetic treatment of wrinkles, age spots, and love handles.

The trend has met with mild consternation voiced at medical meetings and in the commentary sections of professional journals, but little fervent pushback—with one notable exception: commercialization of cosmetic genital surgery.

Cosmetic labial surgery and vulvar fat transfers have been at the center of escalating controversy in the literature, pitting critics against proponents in a battle of words over medical ethics, evidence-based medicine, and philosophical questions of free choice and societal pressure.

An opinion about "procedures that are not medically indicated" issued in 2007 by the American College of Obstetricians and Gynecologists' Committee on Gynecologic Practice was considered too tepid by some in its recommendation that women be educated about the lack of evidence supporting the efficacy and safety of cosmetic vulvovaginal surgery.

Doing such procedures and advertising them with photographs of purportedly "attractive" versus "unattractive" genitalia constitutes a violation of the ethical relationship physicians have with their patients, maintains Dr. Paul Indman, an ob.gyn. in solo private practice in Los Gatos, Calif.

"What we do is destroy women's self-esteem [with such photographs] and then charge them a lot of money to fix what we have destroyed. I think our job … is to help women understand what the range of normal is, [to counteract] society-caused, society-influenced perceived differences," he said in an interview.

Dr. Robert D. Moore represents another point of view.

He and longtime partner Dr. John R. Miklos began incorporating cosmetic gynecologic procedures in their practice at the Atlanta Center for Laparoscopic Urogynecology and Reconstructive Pelvic Surgery 10 years ago to fill an unmet need, he said in an interview. "We were starting to see some of these procedures being done, and to be honest, the results were not very good at all. Clearly the surgeons who were doing it did not have experience or expertise in doing reconstructive surgery in this region, and patients were being harmed."

Whether women need the surgery is not a question Dr. Moore considers relevant, although he and the other physicians interviewed for this article all said they refuse to operate on women being pressured by a partner or those who have signs of psychiatric diagnoses such as body dysmorphic disorder.

To question whether patients know enough about normal genital variations to make an informed decision "is an insult to women's intelligence and confidence," he said.

In some cases, clinicians offering the procedures also cite functional indications, such as diminished sexual satisfaction or entrapment of hypertrophic labia with intercourse.

A review of 131 cases published by Dr. Miklos and Dr. Moore found that 37% of women undergoing labiaplasty cited purely aesthetic concerns (including their appearance in tight clothing), 32% cited functional impairment (such as discomfort while bicycling), and 31% had both concerns (J. Sex. Med. 2008;5:1492-5).

In his Los Angeles practice, though, only the "rare" woman cites functional discomfort, said Dr. David Matlock, who directs the Laser Vaginal Rejuvenation Institute of Los Angeles and has trademarked terms such as Laser Vaginal Rejuvenation, Designer Laser Vaginoplasty, and the G-Shot, or G-Spot Amplification.

In most cases, "it's aesthetic surgery. It's personal preference," driven in part by social trends, including Brazilian waxing.

"You don't need your breasts done, tummy tucked, or nose done. None of it is indicated. The patient wants to alter something. I listen to what the patient wants," he said in an interview.

As opposed to surgical innovations that enter the literature through clinical trials, results of which are presented at scientific meetings, "designer vaginoplasty" and aesthetic procedures are taught at profitable seminars and sponsored by surgeons such as Dr. Marco A. Pelosi II, director of the Pelosi Medical Center in Bayonne, N.J., and cofounder with his son, Dr. Marco A. Pelosi III, of the newly established International Society of Cosmetogynecology.

The elder Dr. Pelosi staunchly defended the profit motive for offering cosmetic training, saying that the objective is "totally different" from relatively inexpensive training obtained through professional medical societies. He and a small group of experts spent years developing these procedures and quite reasonably should be compensated for sharing their specialized knowledge with surgeons who stand to profit from what they learn, he said.

"We're not using this to cure cancer," he said in an interview. "This is something that is a service to enhance patients' self-concepts."

The idea that the seminars offer "industry secrets," as well as the general lack of solid data about indications and outcomes, is what concerns Dr. Erin Tracy, an ob.gyn. at Massachusetts General Hospital and a faculty member at Harvard Medical School, both in Boston.

"If they truly have procedures that are safe and beneficial for women, I would think they would want to share this data with the scientific community," she said. "Women need to be educated that at this point, these procedures are not proven to be safe or effective, and carry risks of bleeding, infection, pain with intercourse, and scar tissue."

She and other critics also questioned potential sexual and long-term complications of aesthetic gynecologic surgery, because the labia minora contain clitoral tissue, and the labia undergo physical changes over a woman's lifetime.

"Papers are coming," promised Dr. Matlock, who said a large, multicenter outcomes study of cosmetic genital procedures has been completed and accepted for publication.

Up to now, a handful of papers in scientific journals have been dwarfed by coverage of the procedures in women's magazines and the lay press, driving requests for the procedure.

"It's obviously interesting to the media," said Dr. Matlock. "Sex sells."
Papers decrying the lack of objective outcomes "miss the point," he said. "Is the patient happy or unhappy? That's what it's all about."

"Despite the fact that ob.gyns. are involved their whole lives in dealing with women, [they] have no idea how to meet the needs of female patients," said the elder Dr. Pelosi. "If they are treating anything objective—pain, infections—they are extremely competent, but anything beyond that, they don't want to hear about."

Frequently the argument is made that women have not seen hundreds of vulvas and labias to compare to their own genital appearance, and should be educated during about the wide range of normal anatomy, including labia minora widths at midline ranging from 7-50 mm (BJOG 2005;112:643-6).

The Web site for Dr. Miklos and Dr. Moore explains that labiaplasty can result in a "sleeker, thinner ... more youthful" appearance of the labia, and "inner lips [that] do not protrude past the labia majora at all, giving them a much more appealing shape and eliminating many of the symptoms of enlarged labia."

To question women's decision to obtain a different aesthetic appearance of their genitals is arrogant and demeaning, said Dr. Matlock.

Meanwhile, in the Netherlands, Dr. Karen Marieke Paarlberg reviews a booklet of 38 pictures of normal vulvas with patients requesting labiaplasty and discusses with them alternative means of addressing discomfort, if that is an issue.

"I think that more than 50% of women can be reassured by a doctor who can listen very well and who tries to reassure the woman that she is perfectly normal," she said in an interview.