Only one month after the American Medical Association unveiled a major reorganization of its science and technology departments-one that included the dismantling of its department of mental health-the former director, psychiatrist Larry Goldman, M.D., was fired after he criticized the changes. This incident set the stage for an all-out effort at damage control by AMA officials, as they sought to allay fears that the organization was lessening its commitment to mental health issues.

Goldman's firing on Jan. 14-a day before the controversial dismissal of George Lundgren, M.D., editor in chief of 

The Journal of the American Medical Association

-drew no national media attention. Nevertheless, it caused consternation among officials at the American Psychiatric Association and other psychiatric professional associations who were not consulted prior to the AMA's action. Both the departmental reorganization and Goldman's termination are symbolic of an ongoing effort by the AMA to realign administrative functions in the wake of the furor that erupted over its failed agreement to endorse Sunbeam Corp. medical appliances in 1997.

In February 1998, the AMA announced a major effort to "strengthen and reposition its senior management" in order to "more aggressively advance the organization's objectives of professionalism in medical practice, service to its members and advocacy of the patient-physician relationship."

Three months later, the AMA hired its current executive vice president and chief executive officer, E. Ratcliffe Anderson Jr., M.D., the former surgeon general of the Air Force who most recently was CEO at a Kansas City health center, to lead the charge toward putting into place "the core management team necessary to intelligently and quickly transform the AMA's organizational culture so that it more closely reflects the vision and values of the AMA."

It didn't take long for new management to leave its imprint. On Dec. 17, 1998, the AMA's senior vice president of professional standards, Reed Tuckson, M.D., announced a reorganization that eliminated two divisions and nine departments, substituting in their stead a science and technology unit, an integrated public health unit and a clinical medicine unit. In addition to mental health, departments handling areas such as alcohol and other drugs, adolescent health, HIV, and geriatric health were also disbanded. Most of the former department heads were reassigned as program directors, which are nonmanagerial staff positions.

When former mental health director Goldman circulated an e-mail to colleagues within the AMA on Jan. 12 challenging the merits of the reorganization, officials were quick to respond. Two days later, Goldman was summarily dismissed. His supervisor called the e-mail "inciting and demoralizing" and charged Goldman with insubordinate conduct, inappropriate or unprofessional behavior, and inappropriate conduct to the "detriment of the AMA."

In his e-mail, a copy of which was obtained by 

, Goldman described the reorganization to a number of fellow employees and chronicled his efforts to discuss concerns over the manner, timing and propriety of the changes. "Many staff will doubtless remain with weakened enthusiasm for the AMA mission and trust of its staff leaders," Goldman wrote. "In any case, I fear that AMA Science will be damaged for some time to come."

Although AMA officials denied that the restructuring signaled a lessening commitment to mental health and called Goldman's firing a personnel issue, thus far few details have emerged regarding how the changes will affect psychiatrists and their patients. Despite a number of meetings and ongoing contact between AMA officials and leaders of several psychiatric professional associations, there has not been much specific information, according to participants. The AMA has, however, promised to fill the new position of mental health program director with a psychiatrist.

"We had struggled for a long time to get Dr. Goldman there, since that position was previously not in the hands of a psychiatrist," APA president Rodrigo A. Muoz, M.D., told 

. "We were distressed to be informed of the events after they had happened. We had been advocating for a very open and meaningful interaction with the AMA, and we suddenly felt as if psychiatry was no longer represented."

A meeting between high-level officials at the AMA and APA in March, however, was productive, according to Muoz, who added that "we are now discussing how the reorganization is not going to diminish the presence of psychiatry in the AMA." Muoz noted that psychiatrists have increased their presence in the AMA house of delegates over time, and that in his interactions with board of trustees president Nancy W. Dickey, M.D., he has come away believing they share similar goals, despite their occasional disagreements over tactics.

Meanwhile, Muoz said that during the meeting, attended by both Anderson and Tuckson, the APA leadership clarified its position regarding any future steps. "We have been building an interaction [with the AMA] in which we saw eye to eye on matters related to psychiatry," Muoz said, "so we would expect that if anything of importance would happen, we would participate in understanding the steps the AMA would take."

Muoz said that they would have to watch as events unfolded to see whether the restructuring had a negative effect. "On this I was very clear. We are going to be proactive. We are going to help [recruit] this new psychiatrist and we will [work with the AMA] so that we are satisfied psychiatry doesn't have a diminished role or the office is less important than it was before."

David Fassler, M.D., a child and adolescent psychiatrist in Burlington, Vt., and a member of the AMA's house of delegates representing the American Academy of Child and Adolescent Psychiatry, mirrored Muoz's cautious approach. "From the outside, and without having all the information, it looked like the reorganization happened in an abrupt manner without a full plan in place," said Fassler. In a vague reference to the Goldman termination, he added, "without knowing all the details, it would be my hope that people working at the AMA feel free to express their opinions and views about issues affecting the work that they do."

Nevertheless, Fassler pointed to an increasing level of cooperation between psychiatry and AMA staff. "We've made tremendous strides in educating fellow delegates about the concerns of psychiatry, and as a delegation we are very well accepted by our colleagues and our input is actively sought on a wide range of issues," he said. As for the changes unfolding at the AMA, Fassler added, "we are watching the situation closely and we are closely monitoring the reorganization. We have been reassured that mental health will continue to receive appropriate attention and AMA resources."

, Goldman said that his dismissal would have a chilling effect on existing and newly hired staff, comparing the treatment he received to physicians under managed care who are "deselected" without a hearing or due process. He has filed a complaint with the National Labor Relations Board, alleging that the AMA broke the law when it terminated him for communicating with fellow employees in the workplace over issues of common importance. He also said the dilution of the position from a department head to a program director may not bode well for psychiatry.

"One of the reasons I went to the AMA in the first place was because I thought it would be a place to work on integrating mental health into general medicine on a larger stage and to interact with more people on this," Goldman said. "There's not enough psychiatric presence in the AMA leadership, so there wasn't anyone pushing for something to happen from within. There needs to be someone with an interest powerful enough to carry it forward."

The AMA's Tuckson said that the reorganization would actually enhance integration of mental health into the goals and objectives of the association. He refuted charges that diminishing the position to a program director status from a department head would have any effect on the way the AMA viewed psychiatry or mental health. 

"We had an organization structure that consisted of a large number of extremely small departments that operated in isolation from the overall strategic direction of the association," Tuckson told 

"As such, programs like mental health were not integrated into the fabric of the normal conduct of the business of the association. They were more segregated and, because of that, we were not getting maximum value from the program. My desire and intent is to elevate not only mental health issues, but the psychological issues associated with human behavior that lead to a predisposition toward diseases. I'm also interested in the issues of the psychiatric and psychological components of behavior that exacerbate the natural history of diseases."

The restructuring effort, according to Tuckson, will actually address a longtime complaint that psychiatrists and mental health issues were pushed to the periphery of medicine. "We don't want to ghettoize the mental health issues any further, we want to integrate them more into the lifeblood of the association."  

Articles

Only one month after the American Medical Association unveiled a major reorganization of its science and technology departments-one that included the dismantling of its department of mental health-the former director, psychiatrist Larry Goldman, M.D., was fired after he criticized the changes.

AMA Eliminates Department of Mental Health Abrupt Firing of Director Raises Questions, Concerns

(This is the third in a series of articles summarizing presentations at the American College of Neuropsychopharmacology-Ed.)

Recent advances in the treatment of mental and addictive disorders, along with research findings in basic neuroscience, molecular genetics and molecular biology that contribute to the understanding of such disorders, were discussed at the American College of Neuropsychopharmacology's 37th annual meeting in Puerto Rico. The following are brief reports from selected presentations.

Valproate Therapy for Borderline Personality Disorder

To assess the efficacy of divalproex (Depakote) in borderline personality disorder (BPD), behavioral responses were examined in 16 outpatients meeting Structured Clinical Interview for Diagnosis (SCID) criteria for BPD. These patients, who were randomized to 10 weeks of double-blind, placebo-controlled treatment, comprised seven healthy males and nine nonpregnant females. Ten were white, three were black and three were Hispanic. 

They were randomized to divalproex or placebo starting at 250 mg/day and gradually increased to doses equivalent to 80 mcg/mL. Outcome measures included the Global Assessment Scale (GAS), the CGI Improvement Scale, the Aggression Questionnaire (AQ), the Overt Aggression Scale-Modified and the Beck Depression Inventory (BDI). The endpoint CGI improvement score was two (much improved) on divalproex versus five (minimally worse) on placebo. The GAS change score significantly improved from 49.1 (serious symptomatology of impairment in functioning) to 68 (some mild symptoms, generally functioning well) on divalproex versus 53 to 50 on placebo. Substantial decreases were found on the BDI (baseline=15.5, endpoint 2.6 on divalproex versus 14.6 to 21 on placebo) and on the AQ (baseline=79.6, endpoint=66.4 on divalproex versus 82 to 98 on placebo). These results suggest that divalproex may be an efficacious pharmacological treatment for BPD and indicate the need for larger controlled studies.

Fluoxetine Long-Term Treatment: Obsessive-Compulsive Disorder

 obsessive-compulsive disorder (OCD) criteria and had Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) scores =19 were treated with single-blind fluoxetine at 20 mg/day, 40 mg/day or 60 mg/day based on physician assessment of response and tolerability. Seventy-one patients (55%) met acute phase response criteria (60 mg/day, n=52 [73%]; 40 mg/day, n=18 [25%]; 20 mg/day, n=1 [1%]). 

For acute responders to 60 mg/day, continued fluoxetine treatment provided greater protection against relapse than placebo. Among acute responders to 20 mg/day to 40 mg/day, relapse rates were low for both fluoxetine- and placebo-randomized patients. Though the acute response rate was consistent with previous reports, the placebo relapse rate was lower than described elsewhere. Perhaps the long acute phase (20 weeks) optimized stability of response, reducing likelihood of symptom deterioration. Fluoxetine treatment was well-tolerated during 52 weeks, a factor that may contribute to successful long-term OCD management. This study was reported by Eli Lilly and Company researchers.

Olanzapine as First-Line Treatment for First-Episode Schizophrenia

As part of an ongoing study of first-episode patients with schizophrenia, a cohort were studied with olanzapine as their first-line drug of treatment by investigators at Hillside Hospital, Glen Oaks, N.Y. Twelve patients, six who participated in the study and six who were screened as clinically appropriate but chose not to consent to the study, were treated with open-label olanzapine. Olanzapine was started at 2.5 mg/day and titrated weekly based on clinical response. Preliminary clinical data suggest that these patients required olanzapine dosages from 10 mg/day to 25 mg/day. Only one patient responded to a dose of 10 mg/day. This dosage range is similar to or higher than the presently recommended dosage for patients with chronic schizophrenia. This finding is somewhat contrary to previous reports indicating that first-episode patients respond well to lower than average doses of antipsychotic drugs.

Antidepressant Onset: Fluoxetine, Venlafaxine and Placebo

A randomized, double-blind, placebocontrolled study was conducted by Wyeth-Ayerst Laboratories researchers to compare the onset of the antidepressant activity of venlafaxine (Effexor) titrated to 300 mg/day during week 1 with that of placebo and fluoxetine (Prozac) titrated to 60 mg/day during week 1 in outpatients with major depressive disorder. Patients (n=460) meeting 

 criteria for major depressive disorder and with a minimum baseline score of 26 on the Montgomery-Asberg Depression Rating Scale (MADRS), began treatment with placebo, venlafaxine 75 mg/day or fluoxetine 20 mg/day. 

The primary efficacy evaluations were time to sustained response (Clinical Global Impression [CGI] improvement score of one or two; 50% decrease on the MADRS total or Hamilton Depression Scale [HAM-D] total) and time to sustained improvement (20% decrease on MADRS or HAM-D total). To be classified as sustained, responses and improvements had to persist until the end of the study and be at least two weeks in duration. Cumulative proportions of sustained response or improvement over the course of the trial were compared with the log-rank test. 

By the end of week 1, significantly more venlafaxine- than placebo-treated patients had an onset of sustained response and sustained improvement. Based on the CGI improvement scores, the sustained response rates for venlafaxine and placebo groups at day 7 were 17% and 5%, respectively; at day 14 the corresponding rates were 30% for venlafaxine and 16% for placebo. Sustained response and improvement rates were greater with venlafaxine than with fluoxetine during weeks 1 and 2. No significant differences were found between fluoxetine and placebo during week 1, and few were found during week 2. These results indicate that rapid titration of venlafaxine to high doses may offer significant benefits to patients in whom a rapid response to therapy is important.

Mirtazapine Versus Citalopram in Major Depressive Disorder

The antidepressant and anxiolytic effects, tolerability, and effects on quality of life of mirtazapine (Remeron) and citalopram (Celexa) were compared in a randomized, double-blind, multicenter study. The results of the first eight weeks of treatment were presented by the Nordic Antidepressant Study Group. Efficacy was evaluated by the MADRS, HAM-Anxiety Scale, CGI and LESQ. The efficacy of analyses were performed on the Intent-To-Treat Group using the Last Observation Carried Forward method. 

Analysis of these data verified that both drugs were well-tolerated, with a low number of patients in either group prematurely terminating the study due to adverse events. Sweating and nausea were statistically significant more frequently in the citalopram group, and increased appetite and weight increase in the mirtazapine group. Mirtazapine and citalopram were equally effective in reducing symptoms of depression and anxiety. However, mirtazapine was significantly more effective than citalopram after two weeks of treatment on MADRS, HAM-A and CGI-Quality of Life Scales. This finding, consistently present at all major efficacy variables, suggests potentially faster onset of action for mirtazapine.

Long-Term (One Year) Risperidone Therapy in Elderly Dementia Patients

A multicenter double-blind study assessed the efficacy and safety of risperidone in 625 institutionalized patients with dementia (73% Alzheimer's disease, 15% vascular, 12% mixed). Patients were randomly assigned to receive placebo or 0.5 mg/day, 1 mg/day or 2 mg/day of risperidone for 12 weeks. According to scores on the Behavior Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD) and the Cohen-Mansfield Agitation Inventory, the severity and frequency of aggressive behaviors were reduced significantly more in patients receiving 1 mg/day or 2 mg/day of risperidone than placebo. A one-year open-label follow-up study consisting of 330 patients was completed. The mean modal risperidone dose was 0.96 mg/day. Efficacy scores (BEHAVE-AD) continued to improve throughout the one-year period. 

Only one case of tardive dyskinesia (TD) was clinically observed during the 12-month study (crude rate: 0.3%). Among patients without dyskinesia at baseline (n=255), there were only six cases of persistent emergent TD (2.4%), and the one-year survival rate of patients free of persistent TD was 97.4%. These data from a group of well-known American psychiatrists suggest a much lower incidence of TD with risperidone than that reported in elderly patients treated with conventional neuroleptics for one year. In addition, patients with symptoms of dyskinesia at baseline experienced significant reductions in the severity of dyskinesia as measured by Extrapyramidal Symptom Rating Scale scores (dyskinetic movements, hyperkinesia, buccolingo-masticatory factor, choreoathetoid movements and clinical global impression of dyskinesia).

Risperidone: Follow-Up on Once-Daily Dosage in a Day Treatment Program

The patients (n=27) in this study were on a once-daily (nightly) risperidone dosage over an extended period of time while attending a day treatment program. They were periodically assessed using rating scales such as the Brief Psychiatric Rating Scale, SANS, AIMS and the Simpson-Angus as part of the clinical follow-up. Their medical records were reviewed for information pertaining to medication side effects (akathisia, dystonic reactions and drug-induced parkinsonism). 

The diagnostic categories included schizophrenia (14), schizoaffective disorder (4), bipolar disorder (5), major depression with psychosis (3) and posttraumatic stress disorder (1). The risperidone once daily (dose range 1 mg to 16 mg) was well-tolerated by the patients as demonstrated by the low Simpson-Angus scores and the record review. The mean risperidone dosage was 6.1 mg (range 1 mg to 16 mg) and the mean duration of once-daily treatment was 18.5 months (range eight to 36 months). According to the patients' perceptions, the improvement was profound (2), moderate (16), mild (8) and none (2). The patients had been compliant with their treatment. These data demonstrate that 1) risperidone is effective, safe and well-tolerated even at high doses in a once-daily dosing schedule over an extended period of time and 2) once-daily dosing enhances compliance in the community setting.

Mirtazapine: Premenstrual Dysphoric Disorder

In an open two-phase trial, 95 women (ages 21 to 45 years) in good physical and mental health who met DSM-IV criteria for premenstrual dysphoric disorder (PMDD) were enrolled in mirtazapine treatment. Of the 95 patients assessed, 32 met criteria for the study and were included. Phase I was a two-cycle screening and Phase II was a three-cycle treatment. In Phase II, women were treated with mirtazapine 7.5 mg daily for the first cycle. A flexible dose of 7.5 mg daily or 15 mg daily was utilized for the last two cycles. Of the 32 patients included in Phase II, 27 patients completed the three-cycle treatment. Each patient scored her symptoms on a visual analogue scale. 

Analysis of this open trial reveals that the symptoms in the luteal phase were significantly lower on mirtazapine treatment. Moreover, mirtazapine seems to be well-tolerated by this patient population: only three patients stopped their treatment because of side effects. This study demonstrates that mirtazapine is an effective and well-tolerated treatment for PMDD patients. Double-blind, placebo-controlled studies should be initiated to verify the results of this open trial.

Results from clinical studies of acute trials of citalopram indicate that it does not produce significant weight gain or loss. In a parallel placebo-controlled trial of up to eight weeks' duration that included more than 1,000 citalopram-treated patients, citalopram patients lost an average of 0.5 kg (1.1 lb) as compared to a gain of 0.2 kg (0.4 lb) in the placebo group. Anorexia was reported by 4% and weight decrease was reported by less than 2% of citalopram-treated patients. Long-term weight change associated with citalopram treatment was evaluated in clinical trials of six and 12 months' duration. 

In one study, a slight weight gain was associated with a decrease in the reduced appetite item of the MADRS from 3.2 at baseline to 0.2 after 12 months, suggesting that it reflects an improvement in depressive symptomatology rather than appetite enhancement. These results suggest that citalopram has minimal effects on body weight during either acute or long-term therapy.

Cytochrome P450 Inhibition: A Comparison of Newer Antidepressants

The selective serotonin reuptake inhibitors (SSRIs) and other new antidepressants are all metabolized by CYP450. Each of these antidepressants also has an individual profile of inhibitory effects upon the CYP isozymes. This inhibitory profile is important in the selection of the optimal antidepressant to use in patients who are taking multiple medications, since the clearance of such medications can be substantially reduced by an inhibitor of their metabolic pathway. Pharmacologists from Tufts University compiled data based on clinical pharmacokinetic studies and in vitro studies using human liver microsomes. These data suggest that fluvoxamine (Luvox), fluoxetine, nefazodone (Serzone) and paroxetine (Paxil) have a relatively high risk of interaction with one or more enzymes of the CYP450 system; whereas citalopram, mirtazapine, sertraline (Zoloft) and venlafaxine have lower risks of such interactions.

Switching From Conventional Neuroleptics or Risperidone to Olanzapine

Eli Lilly researchers reported the results of a multisite study involving 209 outpatients with a diagnosis of schizophrenia or schizoaffective disorder and with documented clinical stability while treated with a conventional antipsychotic drug (APD) (n=139) or with risperidone (n=70) who were openly randomized to either abrupt discontinuation or graduated withdrawal of their prior APD. Patients were further randomized in a double-blind fashion to receive either: a) olanzapine 10 mg QD for three weeks or b) a sequence of one week each on placebo, olanzapine at 5 mg QD and olanzapine at 10 mg QD. 

The efficacy of these four medication-switching paradigms was assessed using the CGI Scale, Patient Global Impression Scale and Positive and Negative Syndrome Scale (PANSS). Safety assessments included ratings for extrapyramidal side effects and treatment emergent adverse events. 

Gradual APD discontinuation combined with an initial full dose of olanzapine at 10 mg showed the greatest efficacy and tolerability, evident as early as week 1. None of the four switching paradigms was associated with overall clinical worsening. These data suggest that stable outpatients can be switched to olanzapine treatment, if indicated, possibly without experiencing an increased vulnerability to relapse or to occurrence of clinically burdensome APD withdrawal symptoms.

ACNP Focuses on Recent Treatment Advances

It's the turn of the century. Workers, feeling oppressed by management and hoping to regain some control of working conditions, flock to the labor movement, hoping that solidarity will give them the leverage they need.

One hundred years ago? Yes-and no. While the conditions that led to the creation of International Ladies' Garment Workers' Union and other unions in the early 1900s have largely been ameliorated, a new group of workers is turning to organized labor for help in coping with a seemingly out-of-control marketplace. But today, the workers are physicians.

According to one estimate, 42,000 of the 757,000 practicing physicians in the United States-roughly 5.5%-were members of a union by the middle of last year. That number appears to have grown. 

The union movement is sweeping the medical profession around the country:

New Jersey-500 doctors have asked the National Labor Relations Board (NLRB) to allow them to join the United Food and Commercial Workers union to negotiate with AmeriHealth, a health maintenance organization that covers nearly 270,000 residents.

Washington, D.C.-The American Medical Association has added its conservative reputation and its muscle to a battle between the Federation of Physicians and Dentists and the Federal Trade Commission over antitrust laws that preclude private practice doctors from bargaining with insurers and managed care companies. The AMA has also helped staff doctors in Rockford, Ill., and at Tulane University in efforts to create bargaining units.

Tucson, Ariz.-Doctors won an NLRB election, allowing them to join the Federation of Dentists and Physicians to negotiate with Thomas-Davis Medical Centers. Management refused to bargain with the physicians and eventually declared bankruptcy. "Winning the battle caused [physicians] to lose the war," said one observer.

Seattle-Staff physicians at Medalia Health Care Clinics joined the United Salaried Physicians and Dentists Union, an affiliate of the Service Employees International Union, to create the largest private-sector physician bargaining unit in the country. Medalia subsequently filed for bankruptcy, but the union will continue to bargain with its successors.

Pennsylvania-A group calling itself the National Guild of Medical Providers has affiliated with the Office and Professional Employees International Union, an affiliate of the AFL-CIO.

Oakland, Calif.-The Union of American Physicians and Dentists reports having 10 contracts in force with managed care organizations covering 5,000 doctors. In addition, it has formed its own Independent Practice Association and negotiated contracts with 12 managed care organizations on behalf of 800 physicians.

New York-The Doctors Council, United Salaried Physicians and Dentists, and the Committee of Interns and Residents join to create the National Doctors Alliance with more than 15,000 members covered by collective bargaining agreements.

In Congress, Conservative Republican Rep. Tom Campbell of California has joined forces with Democrat John Conyers of

Michigan to introduce legislation that would allow medical professionals to form their own associations and bargain with insurers without fear of violating antitrust laws. A spokesperson for Campbell indicated that the House Judiciary Committee could be ready to draft a final version of the bill for action by the House by early summer.

Campbell sees his legislation as a means of "allowing market forces rather than the federal government to establish rules that specify the insurer-medical professional relationship." He is especially critical of the McCarran-Ferguson Act, a 1945 law that grants the insurance industry broad immunity from antitrust regulation.

"McCarran-Ferguson needs to be repealed," said Suhail Khan, an aide to Campbell. "In the absence of repeal, there needs to be a movement to provide antitrust relief to balance out the powers given to insurance industry. This bill would provide that relief for doctors, dentists and other health care professionals."

Salaried doctors-house staffs and physicians working in government hospitals and clinics-are eligible for membership in unions under certain circumstances. Private practice physicians, however, are treated as small businesspeople by the law. Engaging in organizing would be considered an antitrust violation for them.

The Federal Trade Commission, which has actively opposed previous legislation aimed at allowing doctors to organize, favors what is described as a

 that permits a doctor to hire a representative to negotiate with insurers. However, while physicians can communicate with the messenger, they are not supposed to communicate with one another. That would be price-fixing, which is illegal.

Under existing laws, "If independent doctors got together it would be considered price-fixing and a violation of antitrust law," said Mark Levy, executive director of the National Doctors Alliance. "But if two insurance company CEOs play golf, it's not considered antitrust, even if they merge.

"These rules were based on an antiquated economic system that doesn't exist anymore," he added.

The problem with the messenger model, Levy said, is that "the messenger is not allowed to bring together or relate to other people in the same category. You can have 500 doctors in a county, all of whom get insurance business from X company, and each one of them can hire a lawyer, but the lawyers can't talk to each other."

 Grace Budrys, Ph.D., noted exactly how much the health delivery system has changed. "Nearly 70% of all physicians are salaried," she wrote, "77% of the population is in managed care organizations, 93% of which are owned by for-profit firms.

"Doctors are now taking orders from all kinds of people who have no medical training," she continued. "They must get pretreatment approval from an insurance company's clerical employee, located in some other city. Health care decisions are made by third parties, and doctors no longer have personal responsibility for their patients."

The idea of doctors joining unions is not new. The Committee of Interns and Residents (CIR) dates back to 1957. The Union of American Physicians and Dentists (UAPD) began organizing doctors in 1972. Both organizations have enjoyed moderate success in the past, with CIR organizing house staffs and UAPD concentrating, until recently, on representing doctors employed by state or municipal health systems.

Budrys, a sociology professor at DePaul University, said the impetus for doctors to join a bargaining organization has come in waves.

"There was an early 1970s wave," she said in an interview with 

 "which was largely a response to what happened in [the] 1960s, with all the government legislation-and to some extent, the malpractice crisis. The second wave came in 1983-1984, and was largely concerned with the malpractice issue. Now we're in the third wave, and this one is in response to managed care. The previous two waves just let off some steam, and that's where it ended.

"In the 1970s, the doctors couldn't count on the AMA to represent them appropriately. They had no one to turn to," she said, so they have turned to unions.

Today, even the AMA favors a stronger voice for doctors in dealing with managed care. "We are in the midst of-having twice been directed to do so by the House of Delegates-forming a national bargaining unit for employed physicians," said William Mahood, M.D., a member of the AMA Board of Trustees.

"We now have a very strong policy favoring the ability of physicians to come together and collectively negotiate with third-party payers who have the dominant position in the marketplace," Mahood said. 

"But we need to add also that it is a policy that considers the withholding of care for any reasons as being totally unethical. We are against the threat of strikes or work stoppages or other euphemisms for interrupting delivery of needed care to patients," he added quickly.

It is the specter of possible strikes that managed care organizations and insurers have turned to when condemning doctors' moves toward collective bargaining. Responding to the Campbell bill, the Health Insurance Association of America issued a statement that said, "Patients want doctors in their offices and hospitals caring for the sick, not carrying picket signs on street corners. How will the threat of work stoppages and wildcat strikes improve quality of care to patients?"

"What I hear pretty consistently is that one of the major roadblocks is the unwillingness of most physicians to go on strike," added Susan Pisano, a spokesperson for the American Association of Health Plans. "I think as a practical matter this is not an activity that most physicians will or want to engage in."

Carol Schadelbauer, a spokesperson for the American Hospital Association, declined to discuss the issue of unionization with

 except to say that "Generally, we would say we have some sense of concern because of the situation. Our priority is the patients."

By and large, however, doctors and their representatives are not talking about striking; they say they are seeking a level playing field with managed care organizations and insurers.

In a recruitment pitch for prospective members, for example, the Office and Professional Employees International Union says, "All professionals really want is equal and just treatment for themselves and their patients. To some individual health care professionals, affiliating with a union is considered beneath their professional status. But the facts now dictate otherwise. The Union can be another tool in the physician's bag with which to effectively care for his/her patients in a reasonable and fair manner."

"Private practice doctors...are facing a loss of control over the practice of medicine as they feel it should be practiced, and they're seeing their incomes cut, and they're not happy," Gary Robinson, executive director the UAPD, told 

. "By organizing, they feel they can have some impact on quality-of-care issues. There's always a compromise: You have your goals, which are very high, and then there's the reality of what the companies are coming in with. We've been able to get some nice improvements, such as due process rights and giving the doctors a mechanism for filing complaints and how to get things accomplished."

Despite an almost knee-jerk initial opposition, some managed care providers are beginning to appreciate the opportunity to negotiate with physicians as a group. "[Managed care] companies are not interested in dealing with physicians on an individual basis," Budrys said.

Robinson says his experiences in negotiating with managed care organizations often have been positive. "We'll talk to them. Maybe they'll have a standardized contract. We'll review it and propose some changes. Oftentimes the changes are in the area of process: the right of doctors to protest decisions, the right of them to discharge or not discharge a doctor. On a couple of occasions, we've said this is the wrong contract, and they've asked us to draft a contract we felt was better."

But even as the growth of managed care has become the impetus for doctors to organize, it now appears that there are cracks in the managed care system. This system may not be the entity that doctors must ultimately relate to.

"This industry is in near-chaos," Robinson said. "Sometimes they hire people who are not particularly knowledgeable. The people who are good are constantly changing jobs. In one national company, the key representative we were dealing with turned over eight times in the first 18 months. We had to train eight new people and tell them what they're supposed to do.

"Many of the HMOs and IPAs are on the verge of bankruptcy," he added. "Every single one in our area is losing money at a rate that is not sustainable. In the short term, we're going to get a tremendous amount of members from that."

Levy agrees. "My own sense is that [HMOs and IPAs] really are sort of transitional forms. Ultimately, most doctors will become salaried, working for some form of health care provider, which could be a hospital or an insurance company."

In the meantime, Budrys says, the future of unionized physicians will rest with the government. "Legislation will have a lot to do with where that goes," she said. "All the unionized physicians who belong to the two major unions are now affiliated with the AFL-CIO. There are lots of benefits to doing that...People are discovering what kind of power they have."

 "I don't think we will ever go back to business as usual," the AMA's Mahood added. "I hate to use the term paradigm shift. We've gone through a transition, or we're in the process of transition, which is at the very least dramatic and which is taking us away from fee-for-service, cottage industry, authoritarian, male-dominated practices. We're never going there again."

According to one estimate, 42,000 of the 757,000 practicing physicians in the United States-roughly 5.5%-were members of a union by the middle of last year. That number appears to have grown. The union movement is sweeping the medical profession around the country.

Physicians' Unions: A Growing Power

More than 80 medications are in development to treat mental illnesses, including 18 for depression, 15 for schizophrenia and 16 for anxiety disorders, according to the Pharmaceutical Researchers and Manufacturers of America (1998). Which ones will most likely come to market in the United States?

Attempting to answer that question are Ira D. Glick, M.D., and Joseph K. Belanoff, M.D., of the department of psychiatry and behavioral sciences at Stanford University School of Medicine. They presented a poster session, "New Psychotropic Drugs for Axis I Disorders: Recently Arrived, In Development and Never Arrived," at the 37th annual meeting of the American College of Neuropsychophar-macology (ACNP) held in December 1998 in Puerto Rico.

To prepare for the presentation, Glick and Belanoff, along with Jacob S. Ballon, a colleague from the University of California, Los Angeles, reviewed the controlled trials reported in the literature. They also contacted expert psychopharmacologists-clinicians in the United States and Europe, and representatives of the pharmaceutical industry. 

Promising drugs in development for schizophrenia include ziprasidone (Zeldox, Pfizer, Inc.), aripiprazole (Otsuka America Pharmaceutical), M100907 (Hoechst Marion Roussel Inc.) and ORG 5222 (Organon Inc.), according to their research. A serotonin-dopamine antagonist, ziprasidone has been efficacious in blocking dopaminergic behaviors in animals. Trial data have shown the drug's effectiveness in treating both positive and negative symptoms of schizophrenia (Keck et al., 1998). 

"With ziprasidone, they are waiting for more studies on the issue of the QT interval, although it doesn't look like it's a clinically significant problem," Glick said in a recent interview with 

Early studies with aripiprazole, an antagonist at postsynaptic D

  receptors, and an agonist at presynaptic dopamine autoreceptors, show reduction in psychotic symptoms with a favorable extrapyramidal side effect (EPS) profile, according to the presenters. Animal models indicate the drug has less potential to cause side effects because of the relative lack of upregulation of D

 receptors in the striatum (Inoue et al., 1997).  

M100907 (formerly MDL 100907) is a selective 5-HT

 antagonist. It is notable for the absence of side effects associated with D2 or 

-adrenergic receptor blockage. Early studies show that it is well-tolerated, and that it lowers Brief Psychiatric Rating Scale scores without significant neurological side effects. 

Preliminary studies of ORG 5222, which binds to 5-HT

 receptors, demonstrate safety in low doses for healthy subjects (Andree et al., 1997). Further study regarding its therapeutic dosage and safety for a larger sample is required, according to Glick and Belanoff. 

Among the currently available antipsychotics, Glick and Belanoff noted that quetiapine (Seroquel), a serotonin-dopamine antagonist, was the newest of the antipsychotics to be added to the armamentarium. However, Glick said, there are two other drugs used in Europe for schizophrenia that are not available in the United States: sertindole (Serlect) and flupentixol. Sertindole is available in 18 countries in Europe, but was recently taken off the market in England. In the United States, Abbott Laboratories withdrew its New Drug Application for sertindole in 1998 and closed down two ongoing U.S. clinical trials after the U.S. Food and Drug Administration stated it would require further clinical experience before granting approval. This action followed concern over a mild prolongation in the QT cardiac rhythm interval in a few sertindole-treated patients (Brown and Weaver, 1998).

Flupentixol is a D1 and D2 blocker. It has been shown to be better than placebo and equal to standard antipsychotics and to have fewer EPS than haloperidol (Haldol) (Glick et al., 1998). It is used in maintenance therapy with chronic schizophrenic patients whose main manifestations do not include excitement, agitation or hyperactivity.

In discussing the atypical antipsychotics (clozapine [Clozaril], olanzapine [Zyprexa], risperidone [Risperdal], quetiapine, sertindole and ziprasidone), Glick said they are equal in efficacy to the traditional antipsychotics "and their side effect profile seems to be better in that they [have] fewer extrapyramidal side effects and so far seem to show a much reduced propensity for tardive dyskinesia. In addition, they help [with the acute secondary] negative symptoms of schizophrenia, and they may improve cognitive functioning more than the typical antipsychotics. They also may improve mood disturbances in schizoaffective disorder." 

Glick chaired an international group of experts sponsored by the International Pharmacology Algorithm Project (IPAP) to develop a new algorithm for treating schizophrenia (Pearsall et al., 1998). The IPAP effort was described as an attempt "to gather a consensus of clinical researchers from a variety of sites on the best current strategies for treating schizophrenia." (See related story on IPAP on page 63-Ed.)

"We are recommending atypicals as a first-line choice for almost everyone, unless there is a pressing reason not to use them, such as the patient is so agitated that you want to give an intramuscular preparation right away," Glick said. "None of the currently approved atypical antipsychotics has an IM formulation on the market, although ziprasidone IM is currently being tested. In addition, while many people believe that the atypical antipsychotics taken orally work just as fast as the conventional antipsychotics, others would argue that they don't. The definitive studies need to be done." 

In the United States, clozapine is often described as the "prototypical atypical," Glick said. But it is being used more and more in Europe and "the incidence of fatalities secondary to agranulocytosis has been quite low...In some countries like Switzerland, for example, it is a first-line drug for schizophrenia; they don't wait for treatment-resistance to develop. But other [clinicians] say it is a very difficult drug to manage and, therefore, you should only use it after you have tried everything else." Glick added, "There is an honest difference of opinion."

Asked if there is a difference in efficacy among the atypical antipsychotics, Glick continued, "There haven't been enough well-designed and adequately controlled head-to-head trials to know which of the atypicals is better than another for a specific symptom." He added that there are some studies suggesting that risperidone and olanzapine are about equal in efficacy, a couple of studies suggesting that risperidone might be better than olanzapine in terms of its efficacy/side effect profile (Brecher and the Risperidone/Olanzapine Study Group, 1998), and some studies suggesting the olanzapine might be better than risperidone (Tran et al., 1997).  

"I think the jury is out right now," he said. "More data [are] needed."

One of the surprises emerging from studies of atypical agents in various populations is that they seem to be efficacious for a variety of disorders. Sertindole, for example, is being used in different European countries for treatment of schizophrenia and schizoaffective disorders, major depressive episodes with psychosis, psychotic disorders due to medical conditions and psychosis in dementia, as well as for other indications in children, adolescents or in the elderly, Glick said. Clozapine also is being tried for other indications. Flupentixol is licensed for use in some countries in Europe as an antidepressant, and there are suggestions of its efficacy in the treatment of depression associated with impulse disorder (Glick et al., 1998).  

In their ACNP poster session, Glick and Belanoff also discussed drugs for mood and anxiety disorders. Among the new antidepressants on the market in the United States are nefazodone (Serzone), mirtazapine (Remeron) and citalopram (Celexa). Citalopram was approved by the FDA in July 1998. 

Promising psychopharmacological agents available in Europe for depression include tianeptine (Ardix), a presynaptic serotonin uptake enhancer licensed in France, and reboxetine (Edronax, Pharmacia & Upjohn, Inc.), a selective noradrenaline reuptake inhibitor recently marketed in the United Kingdom. Reboxetine is currently in phase III clinical evaluation in the United States. With regard to tianeptine, Glick said there have been "some positive placebo-controlled studies for major depression [Ginestet, 1997] and some evidence of efficacy for chronic alcoholism." 

Reboxetine has been shown to be equal in efficacy to tricyclic antidepressants and serotonin reuptake inhibitors with added benefits of few anticholinergic or sexual side effects. It has also been shown effective for various gradations of depression (including severe depression), and beneficial in increasing social functioning. At the ACNP meeting, the International Reboxetine Study Group reported on a study in which the drug was shown to be more effective than placebo in preventing relapse in patients with recurrent depression and to be well-tolerated in long-term treatment (Brown et al., 1998).  

In the antidepressant pipeline is MK 869 (Merck & Co. Inc.), a substance P blocker. In animal studies, MK 869 has been shown to have a pronounced calming effect in guinea pigs. Clinical trials on its antidepressant efficacy are underway (Kramer et al., 1998; Nutt, 1998). 

For bipolar disorder, new treatments include lamotrigine (Lamictal, Glaxo Wellcome Inc.); topiramate (Topamax, R.W. Johnson Pharmaceutical Research Institute), a sodium channel and GABAA modulator; and tiagabine (Gabitril, Abbott Laboratories), a GABA uptake inhibitor. Glick added that in the pipeline are vigabatrin (Sabril, Hoechst Marion Roussel Inc.), a GABA transamine inhibitor that is used to treat succinic semialdehyde dehydrogenase deficiency; oxcarbazepine (Novartis Pharmaceutical Corp.), a carbamazepine derivative that has fewer side effects; and zonisamide (Dainippon Pharmaceutical Co., Ltd.), an NA and T-type Ca blocker and weak carbonic anhydrase inhibitor that is used to treat epilepsy and has a mild side effect profile. 

For anxiety disorders, Glick said abecarnil (Novartis Pharmaceuticals Corp.), a benzodiazepine partial agonist, is in the pipeline. It has been found to be a potentially beneficial short-term (<4 weeks) anxiolytic, though additional investigation is needed to determine efficacy for generalized anxiety disorder (Aufdem-brinke, 1998; Pollack et al., 1997). Two other drugs that are unlikely to come to the United States are amisulpride (Solian, Sanofi-Synthlabo), a D2 and D3 antagonist licensed in France that is used both as an antidepressant and as an antipsychotic, and moclobemide (Novartis Pharmaceutical Corp.), a reversible monoamine oxidase inhibitor licensed in most parts of Europe and in Canada. 

"They are like orphan drugs," Glick said, "It's hard to say if they will be profitable."

Currently, Glick and his colleagues are involved in five different drug trials.

"We are looking at aripiprazole and ziprasidone. And we are part of the multinational clozapine study investigating whether clozapine can decrease the rate of suicide. Stephen Marder, M.D., [University of California, Los Angeles, School of Medicine and West Los Angeles Veterans Affairs Medical Center] and I are doing a study looking at [an] intramuscular depot preparation of conventional antipsychotics compared to the atypical antipsychotic Seroquel. These studies are a year or two away from publication." 

Glick, along with John M. Davis, M.D., of the department of psychiatry, University of Illinois, Chicago, is conducting a secondary analysis "trying to figure out whether there is any difference in the data between industry-sponsored and nonindustry-sponsored drug trials." New research is mostly industry sponsored, which represents a major shift from the pioneering work conducted on typical antipsychotics. The FDA, as part of the drug approval process, requires most of the design features found within industry-sponsored trials, Glick said. 

"The design is very rigidly mandated by the FDA, but there is only so much you can extrapolate. We need more studies coming from both industry and nonindustry sources."

Another problem in the development of pharmacological agents, according to Glick, is that it is "getting harder and harder to recruit patients for trials with antipsychotics." Glick said this is due in part to the development of the atypical antipsychotics and due in part to the persistence of attacks on psychiatric research in general, and on schizophrenia specifically because of the stigma associated with the disease. Additionally, he said, there are controversies surrounding the informed consent process.  

"Patients with ulcers don't have a cognitive difficulty, so they can understand what is going on [in a clinical trial]," Glick said. But because of the cognitive difficulties of patients with schizophrenia, "there are very important limitations in conducting clinical trials of antipsychotics medications as well as precautions that must be taken."

Given the schizophrenic population's crucial need for better medications, Glick advocated that researchers continue to work collaboratively with consumer advocacy organizations to make the trials more accessible to patients and their families. Just as critical as the development of new psychotropic medications is the need to combine such medications with psychotherapy. Glick added that "the best way to insure compliance is to work with patients and their families doing psychoeducation." 

Consumer education groups on schizophrenia, mood disorders and anxiety disorders meet regularly at Stanford Medical Center, according to Glick. As a routine part of his practice, Glick said he sees family members with patients on a regular basis.

"We give out a lot of literature [relevant to the patients' disorders] and use videos wherever possible," he said.

Glick also has been involved in controlled studies to determine whether psychoeducation makes a difference in medication compliance. John Clarkin, Ph.D., of Cornell University Medical College/New York Hospital-Cornell Medical Center, and Glick examined the effects of a psychoeducation intervention for married patients with bipolar disorders and their spouses (Clarkin et al., 1998). Patients were randomly assigned to receive either medication management or medication management plus a marital intervention with their spouses for an 11-month period. Patients' symptoms, functioning and adherence to their medication regimens were measured at study entry and at 11 months. The marital intervention was associated with improved medication adherence. The combined treatment did not affect the patients' symptom levels beyond the effects of the medication alone, but did result in significant incremental gains in overall patient functioning. 

"Before that, [Clarkin, Gretchen Haas, Ph.D. (University of Pittsburgh), and] I did a large study of inpatient family intervention," Glick said. In that study (Glick et al., 1993), 169 hospitalized patients with psychiatric disorders and their families were randomly assigned to a medication plus psychoeducational inpatient family intervention or to a medication alone group. Patient and family outcome measures were assessed at admission and discharge and at six and 18 months after admission. Analysis of statistically significant differences in outcome suggested that inpatient family intervention was associated with clinically significant improvement at discharge, especially for female patients and patients with chronic schizophrenia and bipolar disorder.

The bottom line, according to Glick, is that "no matter how good a medicine is, it is no good unless somebody takes it."

Andree B, Halldin C, Vrijmoed-de Vries M, Farde L (1997), Central 5-HT2A and D2 dopamine receptor occupancy after sublingual administration of ORG 5222 in healthy men. Psychopharmacology (Berl) 131(4):339-345.


Aufdembrinke B (1998), Abecarnil, a new beta-


carboline, in the treatment of anxiety disorders. Br J Psychiatry Suppl (34):55-63.


Brecher M, the Risperidone/Olanzapine Study Group (1998), Risperidone versus olanzapine in the treatment of patients with schizophrenia or schizoaffective disorder. Presented at the 37th annual meeting of the American College of Neuropsychopharmacology, Poster Session 128. Las Croabas, Puerto Rico. Dec.16.


Brown A, Weaver R (1998), Promising new medications in development. NARSAD Research Newsletter Summer.


Brown M, Montgomery SA, Versiani M (1998), Reboxetine is effective in preventing relapse and recurrence of major depressive disorder. Presented at the 37th annual meeting of the American College of Neuropsychopharmacology, Poster Session 84. Las Croabas, Puerto Rico. Dec. 16.


Clarkin JF, Carpenter D, Hull J et al. (1998), Effects of psychoeducational intervention for married patients with bipolar disorder and their spouses. Psychiatr Serv 49(4):531-533.


Ginestet D (1997), Efficacy of tianeptine in major depressive disorders with or without melancholia. Eur Neuropsychopharmacol Suppl 3:S341-S345.


Glick ID, Belanoff JK, Ballon JS (1998), New psychotropic drugs for Axis I disorders: recently arrived, in development and never arrived. Presented at the 37th annual meeting of the American College of Neuropsychopharmacology, Poster Session 156. Las Croabas, Puerto Rico. Dec. 15.


Glick ID, Clarkin JF, Haas GL, Spencer JH Jr. (1993), Clinical significance of inpatient family intervention: conclusions from a clinical trial. Hosp Community Psychiatry 44(9):869-873.


Promising Medications for Axis I Disorders

Psychogenic excoriation (also called neurotic excoriation, pathologic or compulsive skin picking, and dermatotillomania) is not yet recognized as a symptom of a distinct 

 The disorder is characterized by excessive scratching, gouging or squeezing normal skin or skin with minor surface irregularities. Excoriation may also occur in response to an itch or other skin sensation or to remove a lesion on the skin (e.g., acne excorie). 

 Most patients use fingernails to excoriate the skin, but the teeth and instruments (e.g., tweezers, nail files, pins or knives) also may be used (Arnold et al., 1998; Simeon et al., 1997). Excoriations are typically found in bodily areas that are easily reachable, and most patients excoriate multiple sites. The most common site of excoriation is the face (Arnold et al., 1998). 

 There is a 2% incidence of psychogenic excoriation among dermatology clinic patients, with higher prevalence among women (Gupta et al., 1986). Most studies report a mean age of onset between 30 and 40 years of age, and the reported mean duration of symptoms is 5.1 years, with the majority of patients having symptoms for 10 to 12 years (Gupta, et al., 1986; Simeon et al., 1997; Arnold et al., 1998). Psychogenic excoriation causes substantial distress in patients, with most experiencing impairment in social functioning and many reporting medical complications, some severe enough to warrant surgery (Arnold et al., 1998; Simeon et al., 1997).

 The behavior in psychogenic excoriation sometimes resembles obsessive-compulsive disorder (OCD) in that it is repetitive, ritualistic and tension-reducing. Likewise, patients attempt-often unsuccessfully-to resist excoriating, a behavior they find "ego-dystonic" (Stein and Hollander, 1992). Some patients describe obsessions about an irregularity on the skin or preoccupations with having smooth skin and excoriate in response to those thoughts. The preoccupation with appearance can be severe enough to meet criteria for body dysmorphic disorder (BDD), a disorder also thought to be related to OCD (Phillips and Taub, 1995). The excoriation can also have features characteristic of impulse control disorders (ICDs) in that patients often find themselves acting automatically. They sometimes experience an increase in tension prior to scratching with transient pleasure or relief immediately afterwards. 

 In a recent study of the phenomenology of a group of 34 adults with psychogenic excoriation (Arnold et al., 1998), the majority (79%; N=27) had features of an ICD. Many of these patients with ICD symptoms also had either BDD (32%; N=11) or OCD (12%; N=4). A minority of patients had OCD alone (6%; N=2). Thus, skin-related behaviors spanned a compulsivity-impulsivity continuum from purely obsessive-compulsive to purely impulsive with mixed symptoms in between (McElroy et al., 1994). 

 Studies examining the psychiatric comorbidity of patients with psychogenic excoriation have found depressive and anxiety disorders to be common (Arnold et al., 1998; Gupta et al., 1987; Simeon et al., 1997). In a study of 34 adults with psychogenic excoriation, lifetime mood disorders were diagnosed in 27 (79%) of subjects; lifetime major depression (38%; N=13) and bipolar disorder type II (26%; N=9) were the most common (Arnold et al., 1998). The elevated prevalence of bipolar disorders in this group is consistent with the observation that impulse control disorders may have a strong association with bipolar disorders (McElroy et al., 1996; McElroy et al., 1994). 

 Lifetime anxiety disorder was diagnosed in 19 (56%) subjects, with panic disorder (21%; N=7), generalized anxiety disorder (21%; N=7) and specific phobia (21%; N=7) as the most common anxiety disorders. 

 There are few studies of the pharmacological treatment of psychogenic excoriation, but case reports and open trials demonstrate the responsiveness of psychogenic excoriation to serotonin reuptake inhibitors (SRIs) (Gupta and Gupta, 1993; Kalivas et al., 1996; Phillips and Taub, 1995; Stein et al., 1993; Stout, 1990). One controlled trial found that fluoxetine (Prozac) may be beneficial (Simeon et al., 1997). 

 To examine further the efficacy of SRIs in the treatment of psychogenic excoriation, 14 subjects were enrolled in an open-label, 12-week trial of fluvoxamine maleate (Luvox) (Arnold et al., 1999). The subjects were outpatients from a group of 34 subjects enrolled in Arnold et als. earlier study. All subjects met 

 criteria for at least one comorbid psychiatric disorder, with mood disorder the most common (subjects with bipolar disorder type I were excluded from the trial).

 The mean final fluvoxamine dose was 112.5

82.7 mg/day with a range of 25 mg/day to 300 mg/day. Treatment-associated adverse events-most commonly anorexia, nausea, fatigue, insomnia and headache-limited dose escalation. Four subjects withdrew because of treatment-associated side effects, and three withdrew for reasons that were unrelated to the study. 

 Both completers (N=7) and the entire group had significant improvement on a modified Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (Goodman et al., 1989) that measured both preoccupation with skin and associated behaviors (time occupied, interference with functioning, distress, resistance and control). Approximately half of both the completers and the whole group had 30% or more improvement on the modified Y-BOCS score. Additional self-report data included eight visual analog scales that measured preoccupation with skin, skin appearance, skin sensations, severity of skin sensations, behaviors involving the skin, skin lesions, control over skin behaviors and a global assessment of symptoms. 

 The seven completers had significant reduction in behaviors involving the skin (e.g. scratching, picking, gouging or squeezing) and in global assessment of symptoms. Endpoint analysis of all 14 subjects' self-reported data demonstrated significant improvement in the presence of skin sensations, skin appearance and lesions, behaviors involving the skin, control over skin behavior and global assessment. The mean score for depression as assessed by the 17-item Hamilton Rating Scale for Depression did not improve significantly, with a mean decrease from 13.9

 The results of this preliminary open trial suggest that fluvoxamine may be effective in reducing psychogenic excoriation, and this resulting effect seems to be independent of mood. The response to fluvoxamine is consistent with other studies of SRIs in the treatment of psychogenic excoriation (Stout, 1990; Gupta and Gupta, 1993; Stein et al., 1993; Phillips and Taub, 1995; Kalivas et al., 1996; Simeon et al., 1997). The improvement with fluvoxamine may be consistent with the view of psychogenic excoriation as an obsessive-compulsive spectrum disorder (Stein and Hollander, 1992; McElroy et al., 1994). While most subjects met 

 criteria for ICD, many also had obsessive-compulsive symptoms, supporting the hypothesis that psychogenic excoriation lies on a compulsivity-impulsivity continuum (McElroy et al., 1993). A larger, controlled study is needed to confirm the responsiveness of psychogenic excoriation to fluvoxamine and to determine whether the presence of compulsive and/or impulsive features predicts treatment response to SRIs. 

Arnold LM, Mutasim DF, Dwight MM et al. (1999), An open clinical trial of fluvoxamine treatment of psychogenic excoriation. J Clin Psychopharmacol 19(1):15-18.
 

Arnold LM, McElroy SL, Mutasim DF et al. (1998), Characteristics of 34 adults with psychogenic excoriation. J Clin Psychiatry 59(10):509-514.
 

Goodman WK, Price LH, Rasmussen SA et al. (1989), The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry 46(11):1006-1011.
 

Gupta MA, Gupta AK (1993), Fluoxetine is an effective treatment for neurotic excoriations: case report. Cutis 51(5):386-387.
 

Gupta MA, Gupta AK, Haberman HF (1987), The self-inflicted dermatoses: a critical review. Gen Hosp Psychiatry 9(1):45-52.
 

Gupta MA, Gupta AK, Haberman HF (1986), Neurotic excoriations: a review and some new perspectives. Compr Psychiatry 27(4):381-386.
 

Kalivas J, Kalivas L, Gilman D, Hayden CT (1996), Sertraline in the treatment of neurotic excoriations and related disorders. Arch Dermatol 132:589-590.
 

McElroy SL, Pope HG Jr, Keck PE Jr. et al. (1996), Are impulse-control disorders related to bipolar disorder? Compr Psychiatry 37(4):229-240.
 

McElroy SL, Phillips KA, Keck PE Jr. (1994), Obsessive compulsive spectrum disorder. J Clin Psychiatry 55(suppl 10):33-53.
 

McElroy SL, Hudson JL, Phillips KA et al. (1993), Clinical and theoretical implications of a possible link between obsessive-compulsive and impulse control disorders. Depression 1:121-132. 
 

Phillips KA, Taub SL (1995), Skin picking as a symptom of body dysmorphic disorder. Psychopharmacol Bull 31(2):279-288.
 

Simeon D, Stein DJ, Gross S et al. (1997), A double-blind trial of fluoxetine in pathologic skin picking. J Clin Psychiatry 58(8):341-347.
 

Stein DJ, Hollander E (1992), Dermatology and conditions related to obsessive-compulsive disorder. J Am Acad Dermatol 26(2 Pt 1):237-242.
 

Stein DJ, Hutt CS, Spitz JL, Hollander E (1993), Compulsive picking and obsessive-compulsive disorder. Psychosomatics 34(2):177-181.
 

Stout RJ (1990), Fluoxetine for the treatment of compulsive facial picking. Am J Psychiatry 147(3):370. Letter.

Psychogenic excoriation (also called neurotic excoriation, pathologic or compulsive skin picking, and dermatotillomania) is not yet recognized as a symptom of a distinct DSM-IV disorder.

Open Clinical Trial of Fluvoxamine Treatment for Psychogenic Excoriation

Every year, more than half of newly approved drugs and biologics considered likely to be prescribed for children lack labeling information on safe and effective use, reported the U.S. Food and Drug Administration (1998). Seeking to rectify this situation, the FDA recently issued final regulations (21 CFR Parts 201, 312, 314 and 601) requiring new drugs and biologics that are therapeutically important for children or will be commonly used in children to have labeling information on safe pediatric use (HHS, 1998). 

This rule will also allow the FDA to require pediatric testing of already-marketed products in certain compelling circumstances, i.e., when a drug is commonly prescribed for use in children but the absence of adequate labeling could pose significant risks. The FDA (1999) has subsequently issued a written request for pediatric studies for buspirone (BuSpar), gabapentin (Neurontin) and lamotrigine chewable dispersible tablets (Lamictal), among other drugs. 

The FDA's actions reflect growing concern over the substantial and increasing use of psychotropic medications in children and adolescents, and the extensive need for pediatric psychopharmacology research. 

Every year, more than half of newly approved drugs and biologics considered likely to be prescribed for children lack labeling information on safe and effective use. Seeking to rectify this situation, the FDA recently issued final regulations requiring new drugs and biologics that are therapeutically important for children or will be commonly used in children to have labeling information on safe pediatric use.

Psychiatric Times Vol 16 No 5

AMA Eliminates Department of Mental Health Abrupt Firing of Director Raises Questions, Concerns

ACNP Focuses on Recent Treatment Advances

Physicians' Unions: A Growing Power

Promising Medications for Axis I Disorders

Open Clinical Trial of Fluvoxamine Treatment for Psychogenic Excoriation

Pediatric Psychopharmacology: Regulations and Research