Noteworthy News Articles on Mental Health Topics, May 17-28, 2000

 

NAMI Supports Mental Health Reform Bill to Reduce Suicides and Violence
P.R.Newswire, 5/17/2000

ARLINGTON, Va., The National Alliance for the Mentally Ill (NAMI) is supporting legislation to be introduced by Senators Pete Domenici (R-NM) and Ted Kennedy (D-MA) today, aimed at reducing suicides and episodes of violence involving people with mental illnesses. "Many kinds of violence confront people with mental illnesses," declares NAMI board member Jim McNulty in a statement prepared for a news conference on Capitol Hill.  "Those reported on the evening news or in newspaper headlines usually involve cases where a person with an illness harms a family member or another member of the community. Other cases involve fatal encounters with police."   "But there also is another kind of violence," he warns. "It is the violence that results from institutions that fail to serve the purposes for which they are intended. It is the violence of inattention or indifference on inadequate treatment. It is the violence of a system that allows a homeless person with a severe mental illness to suffer or die on a street or under a bridge."
    The Domenici-Kennedy bill provides for many reforms, including specialized training for state and local police, establishment of mental health courts, development or expansion of community-based treatment programs, and integrated treatment for co-occurring mental illnesses and addictive disorders. It also provides for research to determine factors that contribute to noncompliance with outpatient treatment plans and a national commission to study issues surrounding involuntary treatment alternatives. "This legislation will help stop violence by getting help to those who need it most, before tragedies occur," McNulty says. "It will move the nation forward in confronting many of the failures of the current mental health care system, as well as the limitations of the criminal justice system." With more than 210,000 members, NAMI is the nation's leading grassroots advocacy organization dedicated to improving the lives of people with severe mental illnesses, including schizophrenia, bipolar disorder (manic-depression), major depression, obsessive-compulsive disorder, and severe anxiety disorders.

Therapy Mix Eyed for Depression
Reuters, 5/18/2000

BOSTON - A three-month study of nearly 700 people with long-term depression found that psychotherapy and an antidepressant drug work best when used together, a study in today's New England Journal of Medicine found.  ''This is the first time that combination therapy has proven to be so much more effective than either medication or psychotherapy alone,'' said the study's chief author, Dr. Martin B. Keller of Brown University in Providence.  ''For some of the study's patients, who underwent the combination therapy, it was the first time in more than 20 years that they could sustain pleasure and function fully at work and with families and friends,'' Keller said.  In this case, the psychotherapy was cognitive behavioral analysis, which teaches patients to focus on the consequences of their behavior and solve problems linked to interpersonal relations. The antidepressant was nefazodone, sold under the brand name Serzone by Bristol-Myers Squibb, which paid for the research.
    The 12 principal authors of the study and the 17 secondary authors have so many ties to drug companies that make antidepressants that the editors of the Journal decided it would take too much space to publish the complete list of potential conflicts of interest. Instead, they posted the list on the Journal's Web site at www.nejm.org.   All but one of the 12 authors have direct ties to Bristol-Myers Squibb.  The Globe reported last year that more than half of Keller's $842,000 in compensation that year came from drug companies whose pharmaceuticals he had touted in medical journals and at conferences. In 1998, Brown was forced to return $300,170 that Keller's psychiatry department had collected from Massachusetts for research that state officials say the department never performed. Still, Keller's latest research, if confirmed by others, would be significant because it was a large, real-world test of a combined treatment for a problem that affects about 14 million Americans. Because 46 million people, age 15 to 54, become depressed at least once each year, the cost of their treatment is about $53 billion. However, the results are only based on the first 12 weeks after treatment was begun. Keller and his colleagues are continuing to follow the volunteers.
    ''We found that treatment with a combination of nefazodone and psychotherapy had significant advantages over treatment with nefazodone or psychotherapy alone,'' the researchers reported. One third of the 681 volunteers received drug treatment, another third received psychotherapy, and the remainder got the combination treatment.   ''Despite the fact that the patients had had active depression for many years and that many had other psychiatric disorders as well, among the patients who completed the study, 85 percent of the patients in the combined-treatment group had a response to treatment by week 12, as compared with 55 percent of patients in the nefazodone group and 52 percent of patients in the psychotherapy group,'' Keller's team concluded. Nearly one in four of the volunteers never finished the study. Among those getting nefazodone, more than half left because of side effects.

 

Analysts Drop Gay Therapy Discussion
Peter Gorner, Chicago Tribune- 05/18/2000

Twenty-seven years after the American Psychiatric Association took homosexuality off the books as a mental disorder, the group had planned to discuss at its Chicago convention Wednesday whether sexual preference can be changed through therapy. But the debate was canceled after two psychiatrists withdrew from the panel, saying in letters to the APA that the subject was too politically charged for a scientific meeting. The cancellation sparked a protest Wednesday by a group of self-described former homosexualswho say what psychiatrists call reorientation therapy can work. The treatment is not widely used; the most common approach today to treating people who are uncomfortable with being gay is not to change their orientation but to help them accept it.
    The cancellation of the discussion underscores how difficult it is to pin down whether homosexuality is biologically or socially based--or both. Even as society clarifies its stance on a number of legal and cultural issues surrounding homosexuality, scientific understanding of sexual orientation remains murky. Conventional wisdom about the origins of homosexuality has changed dramatically over the years, with each side in the classic nature versus nurture debate claiming the upper hand. Efforts to find definitively a "gay gene" have been unsuccessful. Endocrine differences in utero are intriguing but unproven. Studies of identical twins have been challenged. In psychological evaluations, gays are indistinguishable from straight people.
    In a recently published position statement on psychiatric treatment and sexual orientation, the APA cautioned mental health professionals that there is scant scientific evidence to support the efficacy of treatments designed to change sexual orientation. To do such therapy thus could be unethical and even dangerous. The statement was designed to take a clear stand "against discrimination, prejudice and unethical treatment ... including discrimination on the basis of sexual orientation." Last year, the American Psychological Association officially declared reparative therapy scientifically ineffective and possibly harmful. Its guidelines strongly discourage such therapy. Gays themselves apparently concur. A recent Newsweek poll found only 11 percent believed gay men and lesbians can change their sexual orientation through therapy, force of will or religious conviction.
    This week's debate was organized by the very man who in 1973 was the architect of the APA's decision to remove homosexuality from the list of mental disorders. Back then, Dr. Robert Spitzer had argued that homosexuality does not meet the criteria because it is not always associated with subjective distress and a generalized impairment in social effectiveness or functioning. Homosexuality was, he speculated, merely an "irregular" form of sexuality.  Gays took that idea and ran with it, using the decision as a building block of the Gay Pride movement. But now, the Columbia University psychiatry professor is trying to determine whether homosexuality can be reversed for some people. For that reason, he is viewed by some as hopelessly biased.
    To Spitzer, the decision to cancel Wednesday's debate was unfortunate. He believes that the way out of scientific murkiness is to do experiments and share knowledge. "I'm impartial, with no particular ax to grind," he said. "Therapies to reverse homosexuality have been ballyhooed for 30 years, but no one has done the basic scientific work. "There is no documentary evidence showing someone's sexual preference can be changed by therapy. There is only anecdotal evidence, mostly from the therapists themselves, claiming that what they do works. That's not very scientific. "On the other hand," he continued, "there's no scientific evidence to show that this is impossible. It hasn't been studied."
    Wednesday's protest was organized by Exodus International, a non-denominational Christian group dedicated to helping homosexuals change their orientation. Exodus believes boys with absent fathers or girls with absent mothers get stuck during development and lack proper role models, leading them to seek fulfillment by sex with members of their own gender. By becoming aware of their needs and through prayer, individuals can replace some gay desires with same-sex friendships. Heterosexual desire may or may not follow, the group says. "It took me about three years to overcome homosexuality," said Yvette Schneider, who says she is a former lesbian. "It was not an easy process, but any depression or anxiety I experienced could not be compared to what I experienced in the lesbian lifestyle. It's unfortunate the American Psychiatric Association has given up on homosexuals." Exodus claims 83 chapters in 35 states and says it has "touched" 200,000 people, though it keeps no figures on how many have gone through treatment. "I'm here as one representative for a virtually unseen but sizeable population," said Exodus' national board chairman, John Paulk of Colorado Springs. Paulk, a former drag queen, and his wife, Anne, a former lesbian, have two sons. "I once lived as a gay man, but now I'm heterosexual, something the American Psychiatric Association says does not exist," he said.
    Spitzer said the controversy pains him. "I have completed a pilot study in which I interviewed a group of individuals who believe that they have changed their sexual orientation, to varying degrees, from homosexual to heterosexual. As a result, I believe that change can occur in some individuals. "This is not for everybody. That seems obvious. But the refusal of my colleagues to even talk about it, I find distressing."



Employers Found to Violate Law on Mental Health Coverage
Chicago Tribune- 5/18/2000

WASHINGTON, D.C. -- Congressional investigators say thousands of employers are violating a federal law that requires similar levels of insurance coverage for mental and physical illnesses. The 1996 law has produced few of the benefits intended for people who need mental health care and does not appear to have increased access to such care, the investigators said. The General Accounting Office investigators will present their findings Thursday at a Senate hearing requested by lawmakers hoping to expand the law. The hearing is being held by the Committee on Health, Education, Labor and Pensions.
    Under the Mental Health Parity Act, group health plans may not set annual or lifetime dollar limits on a person's mental health care that are lower than limits for general medical and surgical services. The GAO surveyed employers in 26 states and found that 14 percent were not complying with the federal standards. Most of these companies, by their own account, had lifetime limits on mental health benefits of $100,000 or less, but set higher ceilings for medical and surgical benefits.

 

Domestic Abuse Incidents Fall 21%, Study Finds
Eric Lichtblau, Los Angeles Times- 05/18/2000

WASHINGTON--Years of stepped-up efforts by law enforcement, social services and women's advocates to reduce the toll of domestic violence appear to be paying off: Far fewer women are being beaten by their husbands and boyfriends, according to new data released Wednesday. "We're giving women escape routes that didn't exist 20 years ago," said Northeastern University criminologist James Alan Fox, who assisted in a new U.S. Justice Department study, the most extensive ever done on the incidence of domestic violence. "Rather than staying in a relationship to the point of becoming a murder victim, people in domestic abuse situations now have alternatives, from restraining orders and hotlines to shelters, support groups and mandatory arrest procedures," Fox said.
    The Justice Department's study found that instances of domestic violence have dropped 21% in recent years, falling from an estimated 1.1 million cases in 1993 to about 876,000 cases in 1998. The study's conclusions were based on interviews at nearly 300,000 households. And domestic abuse killings have dropped to their lowest numbers in a quarter century, with 1,830 homicides in 1998, the study found. Even more encouraging, domestic violence activists said, was the finding that women are reporting abuse to police far more frequently than in the past. Nearly 6 in 10 victims filed reports in 1998, compared with 48% of victims six years earlier, the Justice Department found.
With new laws and police training programs in many states, officers now are much more likely to make arrests in domestic situations that once were largely ignored as "private" matters, experts said. That has meant less of a stigma for victims and more of a deterrent for abusers who once had little fear of punishment.
    "We're bringing domestic abuse out of the closet," National Organization for Women President Patricia Ireland said in an interview. "It's a matter of showing women that this is not a problem of their own making and that it has very little to do with whether they had dinner on the table on time," Ireland said. Said Peggie Reyna, project director for the Los Angeles Commission on Assaults Against Women, a private nonprofit group: "It used to be that when someone slapped you around or gave you a black eye, you didn't think about reporting it, unless it was horrendous or you were hospitalized or something. That's changed."
    The nationwide statistics mirror trends in California. One measure of the problem, emergency calls to 911 about domestic violence, has fallen about 20% statewide over the last five years. Records from the California Department of Justice also show that a police crackdown on offenders sent arrests for domestic violence soaring 78% in the 1990s. In Los Angeles, where experts estimated just a few years ago that one woman was killed by domestic abuse every five days, the death rate now has decreased to once every seven days, Reyna said. "Whether we realize it or not, that's quite a difference. And it's happening clear across the United States," she said.
    While men's rights groups have drawn more attention in the last few years to male victims of domestic abuse, female victims still outnumber their male counterparts by a rate of more than 5 to 1, according to the new study, which expands on 1998 federal data. Domestic abuse against men in the 1993-98 study period was virtually unchanged, with about 1.5 men per 1,000 suffering violence at the hands of an "intimate partner," defined as current or former spouses, boyfriends and girlfriends. Women, on the other hand, saw their rate of abuse drop from 9.8 victims per 1,000 in 1993 to 7.7 per 1,000 in 1998.
    The new statistics offered a strong dose of good news for women's rights advocates who were jolted earlier in the week by a U.S. Supreme Court decision overturning a law that gave battered spouses and rape victims the right to sue their attackers in federal court. U.S. Atty. Gen. Janet Reno, joined by Sen. Joseph R. Biden Jr. (D-Del.) and other Democratic lawmakers at a Capitol Hill news conference Wednesday, said that the Supreme Court's "disappointing" decision underscores the urgent need for Congress to reauthorize funding for the Violence Against Women Act, which expires in October. Supporters said that the act's provisions--$1.5 billion in federal funds for education, hotlines, battered women's shelters and increased prosecutions--have had a direct effect on bringing down the rate of domestic abuse. "There was a time in New York City," said Rep. Anthony Weiner (D-N.Y.), "when it was easier to find a shelter for battered animals than for battered women."
    Yet prospects remain unclear for reauthorization of the law, portions of which were not affected by Monday's Supreme Court ruling. "It's either political finagling or just unwillingness, but the fact is that so far it has not moved," Ireland said. A spokeswoman for Sen. Orrin G. Hatch (R-Utah), chairman of the Senate Judiciary Committee, said that the measure has bipartisan support and that the senator hopes to see it passed by the full Senate in coming months. But Biden, author of the original 1994 bill, questioned his Republican colleagues' commitment.  "Nobody in the United States Senate will stand up and say they're against this bill . . . but many still are," Biden said. Public pronouncements "are hollow without the money." And some of the new study's findings are cause for concern. Domestic abuse has not declined as significantly as violent crime in general, which fell 27% from 1993 to 1998. The drop in domestic abuse "is great, but, compared to the overall decline, it shows we still have a long way to go," said Callie Marie Rennison, a statistician at the U.S. Bureau of Justice Statistics and co-author of the new report. And some women still are at unusually high risk. Black women are victims at a rate 2 1/2 times more than that for other women. Also particularly vulnerable are women who are divorced or separated, ages 20 to 24, or living in rental housing in an urban area, the study found.

 

The Pre-Freudian Freud: Physician, Analyze Thyself
A.O. Scott, New York Times- 5/18/2000

"Young Dr. Freud" begins in 1938, with old Dr. Freud boarding a train from Vienna to London. "Of all the wise men of his day," an unseen narrator intones, "he was perhaps the least loved, even by himself." Axel Corti's film, which was made for Austrian television in 1976 and opened yesterday in New York, arrives on these shores at a moment when Freud may be less loved than at any time since his arrival, in 1909, to give a series of lectures. ("They don't know it," he is supposed to have remarked to Jung, surveying the crowd waiting to greet him at the dock, "but I'm bringing them the plague.")
    As Corti's respectful chronicle of Freud's early obscurity languished in its own twilight, its subject has gone into what may be a permanent eclipse. The clinical methods he pioneered are rapidly being displaced by drug-based therapies, and the empirical validity and theoretical coherence of his ideas have come under attack from all sides. All of this makes watching "Young Dr. Freud" in the flickering dawn of the 21st century a somewhat uncanny experience. Shot in dreamy black and white and paced with the stagy sobriety of an educational film, the movie feels at once dated and curiously urgent, nearly impossible to place in historical perspective.
    Corti, who died in 1993, asks us to imagine a pre-Freudian Freud and to recall a world both innocent of psychoanalysis and desperately in need of it. Coming belatedly to light in an increasingly post-Freudian culture, his film serves as a salutary reminder both of Freud's centrality to the history of the 20th century and of his origins in the 19th. He seems like a character out of Ibsen: a restless, modern spirit full of contradictions, menaced by doubts and deformed by his own arrogance. This Freud is poor, lonely and ambitious. In the period covered by the film, he strives to establish himself professionally and matrimonially in the rigid, stuffy, anti-Semitic world of late-Hapsburg Vienna. His studies, his relationships with other doctors and scientists, and his long courtship of Martha Bernays are occasionally interrupted by a disembodied voice from the future who queries young Sigmund with the calm aggression of an analyst about his ambivalent Jewishness, his childhood and the implications of his work. In allowing Freud to step out of time, to look back on his early life in the midst of living it, the film emphasizes both his superhuman perspicacity and his almost inhuman detachment from his own life. Corti honors Freud's belief that the human predicament, his own included, could be understood and perhaps cured through objective, dispassionate analysis. But Corti's own analysis uncovers the coldness and insecurity beneath Freud's consuming intellectual passion.
    At times Corti's analysis feels interminable. The claustrophobic Viennese interiors and the long disquisitions on medical and scientific questions sometimes make you think you're listening to a lecture rather than watching a movie. All the same it is thrilling to witness the lurching, uncertain process of scientific discovery. Freud, obsessed with the need to make a contribution to knowledge, moves from studying the sex life of eels to helping the more established doctor Josef Breuer treat a young hysteric named Bertha Pappenheim, whom the two would later immortalize as Anna O. in their book "Studies in Hysteria." As the film chronicles Freud's apprenticeship with Breuer, his encounter with the French clinician Jean-Martin Charcot at the Salpetriere clinic in Paris, and the start of his long, strange friendship with Wilhelm Fliess, you can see the intuitive outlines of his later theories taking shape. "These ideas were in the air," he demurs when his interviewer asks if psychoanalysis would have existed without him, and that seems almost literally to be true, as though the unconscious, the sex drive and the Oedipus complex were ghosts haunting bourgeois Vienna, waiting to be brought to life, and exorcised.
    "Young Dr. Freud" is not a standard great man biography, though it sometimes looks like one. Doctrinaire Freudians may find it insufficiently reverential. Those who, like Freud's imperious laboratory supervisor, believe that the human mind is best understood with reference to chemical and physical processes, will be impatient with Corti's deference before Freud's now unfashionable dualism. Others may be troubled that the film glosses over some disturbing facts about Freud's early clinical experiments, especially those done in collaboration with Fleiss. And viewers without some grounding in the history of psychoanalysis may feel a bit lost. But somehow, in spite of its limitations, this film places Freud exactly where he belongs: in a shadowy, irrecoverable past and right here in our midst, the cause, cure and embodiment of so much that continues to plague us.


Antidepressant Can Help Women's Sex Drive, Study Says
Malcolm Ritter, Associated Press, 5/19/2000

CHICAGO - Some women with troublingly low sex drive received help from an antidepressant even though they were not depressed, a study found. By the end of eight weeks, 15 of 51 participants had responded to the drug, bupropion, with their condition rated as much improved. The preliminary study was led by Dr. R. Taylor Segraves of the Case Western University School of Medicine in Cleveland. Segraves was scheduled to present the results yesterday at a meeting of the American Psychiatric Association. The work was financed by Glaxo Wellcome Inc., which markets the drug as Wellbutrin SR.
    The women in the study had been diagnosed with ''hypoactive sexual desire disorder.'' It is marked by deficient or no sexual fantasies or desire for sex, causing the person distress. There are no exact figures on how common it is, but surveys find that at least 20 percent of women complain of a persistent lack of sexual desire. It has a variety of causes, including early sex abuse, a troubled marriage, and hormonal problems. Doctors use a variety of therapies, including psychotherapy and hormone injections. But they need more options, said Raymond Rosen, director of the sexual pharmacology research unit at the Robert Wood Johnson Medical School in Piscataway, N.J. He called the new study a significant advance.
    Bupropion boosts the brain's production of dopamine, a chemical messenger linked to sexual desire, Segraves said.  Study participants, whose average age was 41, started to get the drug after four weeks on a placebo. During that placebo phase, none improved. But the women began responding as early as two weeks after going on the antidepressant. Women's interest in sex increased from an average of about one episode per two weeks at the end of the placebo phase to 2.3 episodes per two weeks by the end of their eight weeks on bupropion. Five women stopped taking the drug because they developed a rash or hives.

 

Study: Women's Response to Stress May Lead to Healthier Lives
Robert Jablon, Associated Press, 5/19/2000

LOS ANGELES --Women react to stress differently than men, turning to their children and seeking out friends instead of using the ''fight-or-flight'' reflex, according to a study out today. The University of California, Los Angeles study suggests that the ''tend-and-befriend'' pattern keeps stressed women calmer. Researchers say the response also may help explain why women are less vulnerable to drug and alcohol abuse and stress-related disorders such as hypertension than men. Researchers cited several hundred previous studies on rodents, primates and humans to suggest a broad model of how women deal with stress, although they admitted the hypothesis needs more testing.  ''Men and women do have some reliably different responses to stress'' said lead researcher Shelley E. Taylor, a UCLA psychology professor. ''I think we've really been missing the boat on one of the most important responses.''
    Studies have shown that females facing a predator, disaster or a particularly bad day at the office tend to respond by caring for their offspring and seeking contact and support from others, especially other females, the UCLA researchers said. Such tendencies may explain why, for example, women are more likely to telephone friends in a crisis, or why ''women ask for directions and men don't,'' Taylor said. The ''tend-and-befriend'' pattern may be linked to the hormone oxytocin, which is released during stress and has been shown to make rats and humans calmer, less afraid and more social, researchers said. Men secrete oxytocin, but male hormones seem to reduce its effect, while the female hormone estrogen amplifies it, Taylor said. The concept is intriguing, said Dr. Jean Chen Shih, a professor of molecular pharmacology and toxicology at the University of Southern California. Chen said her own studies have found that male mice will fight an intruder placed in their cage but females will not. ''I'm just thinking when I'm stressed, what do I do?'' she added. ''I think that I talk to my friends. When I have a problem, I talk. In general, men don't.''
    Many human and animal studies have shown that females are more social and less physically aggressive than males. However, the ''tend-and-befriend'' pattern hasn't shown up sharply in scientific literature because until government grant policies changed in 1995, women were underrepresented in stress studies, Taylor said. The study is to be published late this year or early next year in the Psychological Review of the American Psychological Association.



Four Arrested After Girl Dies During 'Rebirthing' Therapy Session
Associated Press, 5/19/2000

GOLDEN, Colo. (AP) Four people were arrested after a 10-year-old girl suffocated while undergoing therapy intended to simulate birth, the sheriff's office said. Candace Newmaker was rolled up in a flannel sheet during the treatment at Connell Watkins and Associates in Evergreen and died of asphyxiation, the coroner said. Both ends of the sheet were twisted above the girl's head and large pillows were placed around her head. It was supposed to represent the womb. Connell Watkins, the center's owner, told authorities she and three others pressed on the pillows to simulate labor contractions and encouraged Candace to push her way out.
    Candace and her mother, Jeane Newmaker, came from Durham, N.C., to the counseling center for the April 18 session. The therapy is intended to enable troubled children to heal from past trauma by struggling out of the covering and being ''reborn.'' Newmaker said she adopted Candace in 1996 and had sought several different treatments for her, including help for depression and attention deficit disorder. She said she contracted with Watkins for a two-week intensive program for $7,000. Julie Ponder, 39, a therapist who was leading the session, and the others called paramedics after they unrolled the blanket and found that Candace wasn't breathing. She died at a hospital the next day.
    Ponder, along with Brita St. Clair, 41, the center's business manager; and Jack McDaniel 47, an intern, were charged Thursday with child abuse resulting in death. Watkins, 53, was arrested on the same charge Friday at Denver International Airport as she returned from out of state. Each was jailed on $250,000 bond. Ponder said she didn't know Candace was having problems during the session. McDaniel and St. Clair were helping her while the girl's mother talked to her daughter and Watkins videotaped the session. The Jefferson County Sheriff's Office said the videotape shows that Candace complained several times that she couldn't breathe and told them she had to vomit, authorities said.

 

Women May Have a Handle on Anger
Chicago Tribune- 5/21/2000

SAN FRANCISCO- Because men and women perceive anger differently, they experience and handle feelings of frustration and rage in different ways, according to a study by researchers at Southwest Missouri State University.  On the surface, men seem to embrace their anger and use it to their advantage whereas women view anger as being counter-productive. But in day-to-day interactions, women appear to take advantage of their anger just as frequently as men, the researchers reported. The study findings were presented as part of a symposium on women's anger at the 11th International Congress on Women's Health Issues held in San Francisco recently. The Congress is sponsored by the University of California, San Francisco's School of Nursing in affiliation with the International Council on Women's Health Issues and other co-sponsoring institutions. "Women may be uncomfortable with feeling angry, but when you get right down to it, they often act on their anger just as well as men do," said Deborah Cox, SMSU psychologist and assistant professor in the department of guidance and counseling and principal investigator of the study. "Women seem to be more comfortable holding anger in, but when the situation calls for it, they act on their feelings." Cox is co-author of the book "Women's Anger: Clinical and Developmental Perspectives."
    The study examined how men and women express their anger as well as their tendency to act on their own behalf. Some psychologists believe assertiveness and self-promoting behaviors, historically thought of as "masculine," are related to the ability to express anger outwardly and directly. The idea is that protecting one's rights and self-interests involves the ability to channel anger and create change, for example, by verbally expressing displeasure.  The researchers gave 80 men and 123 women a collection of five routine questionnaires used to assess anger expression and personality traits such as assertiveness, self-esteem, sense of effectiveness and expectations for success. The study subjects rated themselves on nearly 200 traits and scenarios directly or indirectly related to anger expression and self-promotional "masculine" traits.
    The researchers found that men felt less effective and less instrumental when forced to hold their anger in, whereas women didn't feel nearly as constricted when they didn't express their anger directly. Although women had fairly negative views about their anger in general, the in-depth conversations revealed that in numerous incidences, women did, in fact, draw upon their anger to affect change, from pushing for divorce to challenging incorrect bills. Women can and do use their anger, although they may call it something else, like frustration, said Cox.

 

Old, New Antidepressants About Same
Jonathan Poet, Associated Press- 5/21/2000

PHILADELPHIA (AP) — Family doctors should consider both old and new anti-depressant drugs as equally effective in treating depression, according to new guidelines issued by the American College of Physicians.  The guidelines, written because general practitioners are often responsible for treating depression, also state that St. John's wort, an herbal supplement, may be effective for short term relief from mild depression but telling patients to take it should be carefully weighed. ``Our view is that the major difference is in the side effect profiles,'' said Dr. Herbert Waxman, the college's senior vice president for education. ``If they're all equally efficacious and patient compliance is similar, then the best choice is based on side effects.''   Researchers found that older prescription antidepressants, such as Elavil and Vivactil, are just as effective in treating depression as newer drugs, such as Prozac and Paxil. Patients also follow the prescriptions' directions at similar rates, Waxman said. The study concluded that in 150 clinical trials involving more than 16,000 participants, no clinically or statistically significant differences were found between older and newer drugs. Whether they took older or newer drugs, about half the patients experienced at least a 50 percent improvement in depressive symptoms.
    In creating the guidelines, which were published in the May 2 issue of ACP's journal, the Annals of Internal Medicine, the ACP relied on work done by researchers at the University of Texas Health Science Center at San Antonio. The research examined all known studies of antidepressants and compared the studies' results.  The study notes that, compared to newer drugs, the rates of blurred vision, constipation, dizziness, dry mouth and tremors were significantly higher in patients using the older drugs. Newer classes of antidepressants showed higher rates of diarrhea, headache, insomnia and nausea.
    Researchers also found that the consensus of studies on St. John's wort is that the herbal remedy can be effective in treating mild depression. The guidelines note, however, that there are virtually no reliable studies comparing its effectiveness to that of prescription drugs. St. John's wort, the common name for hypericum perforatum, is widely used in Germany as a treatment for depression and anxiety. Over the past decade, its acceptance in the United States has grown significantly. The ACP also cautions that, as an herbal remedy, it is not regulated by the Food and Drug Administration. The guidelines also caution that St. John's wort supplements can have serious side effects, may interfere with other drugs and may contain additional herbal substances.
    In February, the FDA issued a public health advisory that St. John's wort could reduce the effectiveness of drugs used to treat heart disease, depression, seizures and certain cancers, as well as birth-control pills. ``There are a number of concerns about St. John's wort,'' Waxman said. ``It's important for us to summarize evidence for physicians because patients will come to physicians with some information in hand.'' The guidelines urge physicians to discuss herbal remedies and over-the-counter medications with their patients. ACP membership includes over 90,000 physicians in general internal medicine and related specialties. ``Physicians sometimes are reluctant to bring up things about what someone is taking that aren't prescription drugs,'' Waxman said. ``We hope this leads to better communication between the physician and the patient.

 

Julie Krone's Race Against Depression
Robert Lipsyte, New York Times- 5/21/2000

CHICAGO- Down the black hole of Julie Krone's depression four years ago slipped her career, marriage, friends, even the thoroughbred racers she once drove with flicks of her powerful little hands. "Horses felt my anxiety, they got weird, they reared up," she said last week in a torrent of memory. "I had been given a magical talent to positive image a loser right into the winner's circle. I had been possessed; I could pick a horse up with my will and put it right down in front. And then suddenly it was all gone, and I was exhausted." The magic eventually returned; three weeks ago, Krone became the first woman rider elected to racing's Hall of Fame. She "takes the pioneer responsibility with pride," which is a reason, she said, for also becoming the first major athlete in any sport to speak so publicly and openly about mental illness, psychotherapy and antidepressants.
    "A little boy once came up to me at the track and asked to hold my goggles," she said, "and then he looked up at me and said, 'I want to be like you when I grow up.' A boy said that. A boy! What a feeling of touching people. And then, after I first talked publicly about being suicidal and how the medicine made me feel like me again, I got calls and emails from people who said I'd given them hope to keep living." "So that's why I'm doing this." Her blue eyes suddenly widened, the sharp features scrunched and she unleashed the munchkin cackle. "And the drug company's paying me."
    Last week, at the American Psychiatric Association's annual meeting here, Krone was the star of a provocative symposium on psychiatric drugs and athletes sponsored by the International Society for Sport Psychiatry, which will be covered in a future column, along with your own responses to this subject posted to the thelipsite@aol.com. Krone, happy in the limelight again, vividly described the painful dilemma of elite athletes whose socialization makes them hesitant to seek help. Typically, she resisted therapy even after anxiety attacks, migraines, sleep and eating disorders had turned her into a recluse and a loser. She resisted medicine even longer. "I'm a jock," she said. "I can do anything on my own. I thought it was humiliating to get help. Meanwhile, the only real relief I felt was planning my suicide. I saved sleeping pills, but I was going to drink alcohol, slit my wrists and maybe hang myself, too. I wanted to do one thing right."
    Krone, 36, had done a lot of things right from the age of 15, when she first began a 19-year professional riding career that took her to the winner's circle 3,545 times until she retired last year. She won $81 million, 16th on the career earnings list. She was the only female jockey to win a Triple Crown race, the Belmont Stakes in 1993 aboard Colonial Affair. That summer, at Saratoga, she sustained the most horrendous and spectacular of a number of spills. A collision threw her under the hooves of the pack. Her heart was bruised when a horse kicked her chest and her right ankle needed to be rebuilt with 2 plates and 14 screws. "People think that's when the depression started, but, no, I like, 'Wow', look at those x-rays, when can I get back?" she said, posting in the restaurant banquette as if she were parading the paddock. "And it was a nightmarish hospital stay. The screw was sticking out of the ankle, right here," she pulled off her shoe as she raised her leg above her salad, "and that's how strong I was, back at Belmont in the fall, overcompensating for the tentativeness that usually comes after a bad spill."
    But the lurking darkness was moving in. As she would learn three years later when post traumatic stress disorder was diagnosed, the real trauma was not about blood and broken bones but about "childhood issues, traumatic in themselves, that I'm just not comfortable talking about right now because it would hurt other people." On Jan. 13, 1996, she was tied for leading rider at Gulfstream Park when her horse broke down in the middle of the race and pitched her off. Rolling on the turf, she covered her head with her hands, which were broken. "It fried me," she said, "I couldn't talk. The straw didn't break the camel's back, it gutted the sucker, left the camel for dead. I was numb, couldn't think, I was afraid of horses, hated riding" "My husband said: 'Get back in there, you're tough, that's what I love in you.' Which is about the worst thing the closest person can say to someone who is depressed. And typical."
    Six weeks later, she was back in there, but her mending hands were on fire and her brain was feverish with flashbacks and fears. Walking to the barns she imagined her execution. When she vomited before she rode, it was anxiety, not weight control (at 4 feet, 10 inches and 100 pounds, she has never had typical jockey's weight problems.) She heard voices telling her she was going to fall off, die, mess up, which she often did, her nerve and authority gone. She was afraid to ride the rail, to be in the middle of the pack, to take bold risks. Trainers pulled her off longtime mounts. To keep working, she rode 30-1 shots in bush-league tracks against jockeys she once could beat in her sleep, and lost because she held back. Other jockeys called her "chicken" and told her to quit.
    It was an almost casual encounter with an old friend that summer, a racing fan with a psychiatric practice in Saratoga Springs, N.Y., that began her healing process. She was shambling across the backstretch after another loss, her signature bopping bounce long gone, when Dr. Tom Qualtere invited her to come talk to him. Krone describes that night's two-hour session as "an emotional purge; I felt full and empty at the same time, joyful and like I was peeling off my skin." She began seeing Dr. Qualtere four times a week, eventually driving from Belmont to Saratoga. But she rejected his suggestion that she try a psychiatric drug. Talking to a shrink, she felt then, was enough of an admission of weakness. Krone's description of her early therapy is a high-spirited chattering that includes comic riffs on the joys and frustrations of erotic transference along with a remarkable bold willingness to use the term "mental illness," which is extremely rare among athletes. When she moved to central New Jersey two years ago and could no longer make the frequent trip to Saratoga, she picked a Red Bank, N. J. psychiatrist, Dr. Furey A. Lerro off the Internet because his first name was the same as a horse she liked. It was Dr. Lerro who put her on antidepressants.
    "I picked Zoloft," he said, "because some of the others take longer to clear from the body, not good if she had a reaction while racing, and the tendency to sedation, which is also not good for a jockey." Representatives of Pfizer, the makers of Zoloft, were on hand last week, and confirmed that Krone, while not a consultant, did receive money from the company to discuss her experiences. According to Krone, she felt manic the first three days on the drug, then suddenly felt "anchored, back to Julie Krone again, I'm not sorry I didn't start the medicine sooner--I needed to first get to a place in talk therapy." She said: "You don't fully realize how weird it was until you have yourself back. I'd been spending the minutes before a race using all my energy to defeat an anxiety attack, and now, well, listen to this. At the end of last year, in a 60-day period, my mother died, I got divorced and I moved to California. And I'm here, I'm O.K." These days, Krone, a racing analyst for TVG in Los Angeles, is taking psychology courses with a view of becoming a therapist. She expects to continue her paid campaign to demystify therapy and drugs for athlete and nonathlete. But on Aug. 7, when she is formally inducted into the Hall of Fame, she will not discuss depression. "Nobody really cares, " she said. "It's horse racing."


 

With TV Spots, Drug Firms Aim at Patients' Role
Susan Okie, Washington Post- 5/22/2000

In an animated television commercial for the anti-anxiety drug Buspar, a woman sweeps her list of woes--worry, sleeplessness, muscle aches, irritability--into the trash. In one for Prilosec, a long-acting heartburn remedy, smiling people play or recline on the faces of giant clocks. And in a commercial for the antihistamine Zyrtec, a man with "indoor and outdoor allergies" is sniffle-free as he flies a toy plane around his yard. A pill can fix whatever ails you: That's the message that makers of these and other heavily advertised prescription drugs seem to be sending American consumers. For years, pharmaceutical companies promoted such medicines exclusively to doctors, since they wrote the prescriptions and thus determined sales. But in the last decade, as managed care has limited the drugs that doctors can choose from health plans' formularies and as consumers have demanded more say in their treatment, some companies have dramatically shifted their marketing strategy.
    Now, for a growing number of drugs, the patient is the target. Direct-to-consumer advertising for prescription medicines increased nearly 20-fold during the 1990s. Last year, U.S. drug companies spent almost $1.9 billion urging consumers to try prescription remedies for conditions ranging from allergies and baldness to diabetes and high cholesterol. Of that total, $1.1 billion was spent on television commercials, the fastest-growing medium for advertising prescription medicines. The goal is to send patients to the doctor demanding a brand-name drug, even if they have to pay for it themselves. "There are a lot of forces now that are basically pushing the decision-making back to the consumer," said Jim Daly, general manager for respiratory and anti-infective marketing at Glaxo Wellcome, the top-spending company for consumer advertising of prescription drugs.
    Sabrina Smith of Arlington is the kind of consumer these companies are trying to reach. Smith, 32, suffers from hay fever and is allergic to her two cats. She has tried five different prescription medicines in the last two years in response to TV commercials, with little success. Drug ads "really grab my attention," she said. "Why is it that I trust them so much more than any other ad? . . . My allergies are so bad that I just get desperate." When a commercial mentioned a drug's side effects, she added, "I used to not even hear them, because I'd think, 'Oh my God, here's something else that might help me.' " Sales figures for heavily promoted drugs suggest that the strategy works. U.S. sales for the antihistamine Claritin, No. 1 in direct consumer advertising, were $2.3 billion last year; Prilosec, one of the top five, had $3.8 billion in sales. But whether such advertising is good for patients--and for the U.S. health care system--are hotly debated questions.
    Advocates say the ads alert people to new treatments and open up discussion of once-forbidden topics such as impotence or depression. Critics charge that the ads play down medicines' risks, contribute to steeply rising prescription drug costs and encourage Americans to believe that pills--rather than lifestyle changes or other nondrug interventions--are invariably the treatment of choice. "The aim is to sell a product," said Barbara Mintzes, a public health researcher at the University of British Columbia's Centre for Health Services and Policy Research. She noted that the United States and New Zealand are the only countries that allow direct-to-consumer advertising of prescription drugs, although Canada is considering such a policy. "It doesn't give [consumers] an overview of what's available and whether it's the most appropriate treatment or the best value for money," Mintzes said.
    Although most prescription drug advertising still focuses on doctors, the number of medicines being promoted to patients is growing. Many drugs marketed in this way are for problems that are more bothersome than dangerous: allergy symptoms, baldness, acne, migraine headaches. But medicines for serious, chronic illnesses such as diabetes and asthma are promoted, as well. "Even on TV, we're talking about over 40 drugs" advertised to consumers, said Nancy M. Ostrove, chief of the division of drug marketing, advertising and communications at the Food and Drug Administration's Center for Drug Evaluation and Research. "It's easily over 100 if you count print [advertising] too."
    The boom in television ads began in August 1997, after the FDA issued a "guidance" that made it easier for companies to craft commercials that complied with agency regulations. Previously, every broadcast advertisement linking a drug with a condition had to state the medicine's potential side effects and tell consumers how to get a copy of the product labeling. The new guidance allowed TV and radio ads to mention only major risks and to list four sources--"your doctor," a toll-free number, a Web site and a concurrent print ad--for people who wanted additional information. In the three years since the guidance, television ads for drugs have proliferated--and quite a few have run afoul of the FDA for lack of balance, incomplete information or misleading claims. Drug commercials need not be preapproved by the agency. Companies must send a copy to the FDA whenever a new TV ad (or any other prescription drug ad) debuts. Ostrove said her staff of 15 reviewers was responsible for screening about 30,000 pieces of promotional material last year, including more than 100 television commercials. Even though TV ads for drugs are a top priority, misleading ads have sometimes reached millions of viewers before FDA staffers saw them and picked up violations. According to an FDA official, 50 prescription drugs have been promoted on TV or radio since August 1997. In the same period, the agency has sent 23 regulatory letters to drug companies for advertisements that violated FDA rules. That total doesn't include violations found in so-called reminder ads, which the agency counts separately. (Reminder ads mention a drug's name but must not specify what it's for, and they are not required to list its side effects.)
    So far this year, two companies have received letters about TV commercials that violated FDA regulations. The offending ads were for the heartburn remedy Prevacid and the anti-allergy nasal spray Flonase. "Sometimes [companies] will argue with us, but generally they pull the ads," Ostrove said. "In some cases we have asked for remedial advertisements." Daly of Glaxo Wellcome, which makes Flonase, said the FDA's position on direct-to-consumer advertising is still evolving and often difficult for companies to predict. "It is far from black and white, in terms of what claims and what fair balance the agency feels comfortable with," he said. Every prescription drug ad contains some variation of the phrase "ask your doctor"--and physicians say that's just what patients are doing. As a result, direct-to-consumer advertising is shifting the agenda of many doctor-patient encounters and influencing treatment decisions. "One-fifth or one-sixth of the patients that I see either come in with an advertisement that they're holding or mention something that they've seen," said Michael S. Wilkes, a professor of medicine at the University of California at Los Angeles who has published studies on the impact of consumer advertising. About 75 percent to 80 percent of the time, a patient who asks for a specific drug receives it, according to several surveys. "The physician doesn't want to disappoint patients," Wilkes said. "It takes time to answer, to argue or to reeducate somebody. [Doctors] don't want to be perceived as cheap or cutting corners."
    A selection of Washington area doctors said drug advertisements sometimes prompt patients to seek treatment for serious problems that they might otherwise have ignored. "If they come in and say, 'I'm anxious or depressed and I'd like to consider medication,' it just makes talking about it so much easier," said Bryan J. Arling, who practices internal medicine in the District. But doctors also complained that responding to requests for specific drugs takes up time that might be better used discussing lifestyle changes or other issues. "[Patients] all say, 'Well, it [the drug] is paid for by my insurance plan,' " said Ronald E. Greger, a family physician in Gaithersburg. "It's going to take the doctor time to explain why an alternative might be better. . . . If I'm going to get paid $38 or $48 for the visit, I can just give you the [drug] that you really wanted in two minutes and you're going to leave happy."
    The explosion in consumer advertising is contributing to rising health care costs. Americans spent more than $100 billion on prescription medicines last year, about 10 cents in every health care dollar. The average cost of a prescription rose 11.6 percent last year--partly because of increasing research and development costs, but also because of hefty promotion budgets. Drugs advertised to consumers tend to be among the newest and most expensive on the market, and ads may woo patients away from cheaper generic drugs. There's indirect evidence that consumer advertising also increases visits to the doctor and medical testing. For example, in the year after an advertising campaign for Fosamax, an osteoporosis treatment, patient visits for osteoporosis evaluations almost doubled, according to the market research firm IMS Health Inc. In the first nine months of 1998, according to a survey by Scott-Levin, a drug-marketing research firm, total patient visits rose by only 2 percent compared with the same period in 1997, but visits for hair loss doubled and visits for smoking cessation more than tripled. Drugs for baldness and to help smokers quit were being heavily promoted at the time.
    Daly of Glaxo Wellcome said consumer advertising motivates people to seek help for problems--such as migraine, allergies or irritable bowel syndrome--that many doctors tend to minimize and treat in a limited way. "I think it's an empowering message . . . that the condition you have is real, it's not psychosomatic, it's not in your head, there's a biological basis and there are effective treatments available," he said. Smith, the Arlington woman, recalled one occasion when a drug ad provoked a valuable exchange with her doctor. She saw a commercial for Zyban, an antidepressant marketed for people who want to quit smoking. Smith, who was a longtime smoker, asked her doctor at Kaiser Permanente, an HMO, about the drug. "He said, 'Well, that's a lot of money, and it usually doesn't work,' " she recalled. Instead, the doctor suggested she try a nicotine patch and a smoking-cessation program at a local hospital. She did--and she hasn't smoked since. Cathy Alphin of Springfield, another Kaiser Permanente member, believes drug advertisements have made her a more knowledgeable patient. Alphin said seeing such ads prompted her to ask her doctor about alternative treatments for her chronic sinusitis. Drug ads directed her to pharmaceutical company Web sites, which she learned to check regularly for new treatments and rebate offers. From there, she began to surf other health sites to address her medical questions. "Now I go out and look on the Web," she said. "I'm responsible to be an informed consumer."

 

Falling Off Prozac
Robin Eisner, ABC News- 5/24/2000

The then-48-year-old mother of two from Norman, Okla., had forgotten to take her small dose of Paxil, an antidepressant prescription medication. But her suicidal feelings were not a return to symptoms of depression, her doctor said. Rather, they were withdrawal symptoms from seven months on a drug that had altered her brain chemistry. Calhoun’s reaction to ending her treatment with a serotonin booster — drugs that increase the neurotransmitter serotonin in the brain to treat depression, panic disorder and compulsive behavior — was extreme but not unique. Up to 85 percent of patients who take these kinds of drugs may have some type of symptom when they stop, studies say. Symptoms include balance problems, nausea, flu-like symptoms, tingling and electric shock sensations, vivid dreams, nervousness and melancholy.
    The problem, doctors now are saying, is that patients and even other doctors may not be aware that stopping these drugs, which are among the top 10 best-selling pills in the United States, may be causing the symptoms. Patients, they say, may unnecessarily continue taking the drugs after they try to stop because the symptoms of withdrawal may scare them into thinking they are still suffering from the bad feelings they had — such as depression — when they first started taking the drug. Many doctors and patients also may not know that to end treatment, levels of the drug should be tapered off while under a doctor’s care.
    According to recent research in the Journal of Clinical Psychiatry, as many as 70 percent of general practitioners and 30 percent of psychiatrists do not know about the side effects of ending serotonin-boosting drugs. Of those who do know, only 20 percent of psychiatrists and 17 percent of general practitioners caution their patients about the proper way to slowly lower the levels of these drugs to come off them. "Getting off these drugs properly is an issue that is underappreciated," says Dr. Alexander Bodkin, director of the clinical psychopharmacology research program at McLean Hospital, a teaching affiliate of Harvard Medical School located in Belmont, Mass. "These drugs are being prescribed without the full knowledge of how they should be monitored." Pharmaceutical companies place the responsibility of proper prescribing on the doctor. "The decision about how long a patient should be on treatment and how treatment should be stopped is a highly individual one between the physician and patient," says Brian Jones, a spokesman for SmithKline Beecham of Philadelphia, the manufacturer of Paxil.
    While these serotonin boosters can be life-savers for people who suffer from severe depression, panic disorder and obsessive-compulsive illnesses, and could offer help to thousands of others on a long-term basis, psychiatrists and doctors acknowledge that not everyone taking them should necessarily be on them and that stopping might be a problem. The numbers tell the story. Prozac, manufactured by Eli Lilly & Co., of Indianapolis, Ind., has been on the market since 1988 and is the third best-selling drug in the country, according to IMS Healthcare, a healthcare information company in Plymouth Meeting, Pa. Zoloft, made by Pfizer Inc., of New York City, was introduced in 1992 and is seventh. Paxil, available since 1993, is ninth. But the down side of these popular drugs has only recently been addressed."We are only beginning to see concerns about these drugs like what inevitably happened with other so-called miracle drugs over time," says Dr. Joseph Glenmullen, a clinical instructor of psychiatry at Harvard Medical School in Cambridge, Mass., and author of the recently published book Prozac Backlash. "People during last century have wanted to take drugs that will make them feel better, such as Valium, amphetamines and cocaine elixirs, but it takes time to see the side effects of these quick cures," he says. Glenmullen says today the serotonin boosters are being prescribed for more and more moderate conditions, but that they should be reserved for people who are truly debilitated by their mental illness.  And once on a drug, Glenmullen says, many people who don’t really need it for the long haul have trouble getting off. When the dosage is lowered, he says, it can be difficult to determine whether it’s the symptoms of the disorder returning or the side effects of withdrawal. "If a doctor is unaware of these withdrawal symptoms, they might put the patient back on the drug or another one and this can go on for years," Glenmullen says. Doctors also sometimes switch patients to other serotonin drugs when these discontinuation effects occur.
    Calhoun’s story about stopping Paxil is cautionary. At the time she forgot her medication, she had been trying to get off the drug for six months, after being hospitalized from what she calls the side effects of the drug — inability to sleep, constant suicidal thoughts and chemical sensitivity. Her general practitioner had prescribed Paxil when Calhoun had told him she was feeling anxious upon losing a job. She worried about supporting her two children. She says her doctor had not told her about potential adverse effects of the drug. Nor did he tell her the appropriate way to stop taking the medication. Eventually, another doctor, who agreed she was suffering from serious side and withdrawal effects, gradually lowered her dosage. Today, Calhoun has been off the drug for a year and a half, has two jobs and counsels people getting weaned from serotonin boosters. "When I felt the suicidal feelings that day I forgot the drug, I realized that it was not me that was crazy, but...the changing level of the drug inside my brain," Calhoun says.
    Each person will respond differently to stopping serotonin boosters, or selective serotonin reuptake inhibitors (SSRI), doctors say. While many people experience no problem stopping the drug, some people will have side effects from lowering the dosage, since the brain has become used to certain levels of serotonin. Medical research indicates that it is easier to get off Prozac than Paxil. That’s because Prozac lasts longer in the body. So when dosages are cut back, withdrawal effects are minimized. Doctors caution no one should stop taking their drug cold turkey and that use should be tapered off. "A doctor should communicate with a patient at least once a month when they are on these drugs," says Dr. Bruce Bagley, president of the American Academy of Family Physicians. "I tell patients that they may need to be on these drugs for at least six months to see an improvement, but you must talk to them to see if conditions in their life have changed to warrant considering ending the drug treatment."  SSRIs act by increasing the amount of the neurotransmitter serotonin available to the brain. Exactly how they work to treat all the disorders for which they are prescribed is unknown, but serotonin is a chemical that allows neurons in the brain to communicate with each other. Over time, the drug changes the way the neurons respond, according to Jerrold Rosenbaum, a psychiatrist at Harvard Medical School.


Interview with Dr. Joseph Glenmullen: Author of Prozac Backlash
ABC News, 5/24/2000

Prozac and other serotonin boosters are among the top 10 best-selling drugs in this country. They are medications to treat depression, obsessive-compulsive conditions and panic disorders. But some doctors and psychiatrists charge that many doctors are prescribing these drugs to patients with much less severe versions of these psychiatric illnesses — without warning them of the side effects that can occur when they stop the medications. When these individuals, who did not necessarily need to be on the drug on a long-term basis, try to stop taking the drugs because they are feeling better, up to 80 percent may start experiencing some withdrawal effects, such as sadness and dizziness. Fearing a return to the condition that put them on the drug to begin with, they continue taking the pill.
Dr. Joseph Glenmullen, clinical instructor in psychiatry at Harvard Medical School, and author of Prozac Backlash: Overcoming the Dangers of Prozac, Zoloft, Paxil, and Other Antidepressants with Safe, Effective Alternatives, joined us for a chat about this withdrawal phenomenon.
Moderator: Welcome Dr. Glenmullen.
Dr. Joseph Glenmullen: I'm clinical instructor in psychiatry at Harvard Medical School, I'm on the staff of Harvard University Health Services, and in private practice in Harvard Square. I'm the author of Prozac Backlash: Overcoming the Dangers of Prozac, Zoloft, Paxil, and Other Antidepressants with Safe, Effective Alternatives. One of the main topics in the book is withdrawal symptoms, which is the topic of tonight's (chat).
Greg Pope from oak.jps.net: Is it true that Omega 3 Fatty Acids are a good alternative to SSRIs for treating depression? What is a good source and dosage?
Dr. Joseph Glenmullen: I'm not familiar with the Omega 3 fatty acids. The herbal remedy that I talk about in the book is St.
John's Wort. It is the most widely-prescribed antidepressant in Germany and in other European countries. It has been tested in clinical studies modeled on the clinical studies of prescription antidepressants, and it's been found to be comparable to prescription antidepressants for mild to moderate depression. That's the circumstance under which I recommend it to people.
Patrick from tampabay.rr.com: My 9 year old son was just put on Buspar. How long can I expect him to be on the drug? What should I expect when he comes off? What if he comes off early?
Dr. Joseph Glenmullen: Buspar is not one of the Prozac-type antidepressants — it's an anti-anxiety agent. Antidepressants are used for depression, but they're also used for many other syndromes as well.
Anti-anxiety agents are more specifically to reduce anxiety. One of the concerns that I have about Buspar is that there are reports that it is having neurological side effects — ticks, muscle spasms, agitation, fatigue — so I have some concerns about it for those reasons. It doesn't necessarily have the same kinds of withdrawal effects that the kinds of antidepressants we're talking about have.
Moderator: Why aren't doctors more aware of the hazards of abrupt drop-offs in antidepressant use?
Dr. Joseph Glenmullen: The first antidepressant in this class was Prozac, and Prozac lingers in the body for weeks when you stop it — it takes a very long time to wash out. Because of that, it's less likely to cause withdrawal side effects, because it has this slow, built-in taper. So, for many years, doctors thought this group of antidepressants was not likely to cause withdrawal. Now what we've learned is that some of the later introductions into this class of antidepressants, like Paxil, Luvox, and another antidepressant that's sometimes classified in this group but sometimes not — it's related to them but not strictly in the group — Effexor. These antidepressants wash out very quickly, so if you stop them very abruptly, what happens is the brain has made adaptations to living with the antidepressant 24 hours a day, seven days a week, 52 weeks a year, and when you stop the antidepressant, the brain essentially has to dismantle the adaptations it has made and go back to living without the antidepressant. It's like throwing the brain into reverse, and you can have very dramatic withdrawal symptoms that make patients feel "held hostage" to the antidepressant, because it can take months to get off it.
Nancy from optima.org: Are there any long-term risks involved with using Zoloft? Have studies indicated potential liver damage?
Dr. Joseph Glenmullen: The risks with Zoloft are similar to the risks with other antidepressants in this class. Zoloft can cause fairly dramatic withdrawal side effects, significant weight gain, which is very disturbing to patients, suicidal urges in the first month or two after starting the drug or increasing the dose. Zoloft can wear off and patients can suddenly find themselves with a return of their original symptoms. Sixty percent of patients have sexual side effects, and we're seeing a whole range of symptom of loss of motor control: tics, twitches, muscle spasms, severe fatigue, tremors. Ten percent of patients on Zoloft have tremors. These are some of the more severe side effects that are showing us that the normal functioning of the brain is impaired by these antidepressants.
Moderator: What questions should patients ask their doctors when they stop taking antidepressants?
Dr. Joseph Glenmullen: The most common physical symptom is dizziness, and patients often describe feeling like they have water sloshing around inside of their head. They can have trouble with balance and walking straight. Some patients have to take to bed because they feel so terrible. There are dramatic perceptual abnormalities: patients can have electric shock-like sensations in the brain, visual hallucinations, or tingling sensations running down their arms into their hands. Some patients feel very impulsive — they'll do very impulsive, dangerous things. And many patients with these withdrawal symptoms will feel very emotional, very tearful and anxious. The greatest risk here is that the patient and the doctor don't know about withdrawal and confuse these symptoms, particularly the emotional symptoms, for a return of the original psychiatric symptoms that the patient went on the drugs for. So the patient gets put back on the drug, and of course they feel better, but they're chasing their tail — medicating withdrawal — and can needlessly end up on the drug for years more. We have a good survey showing that only 30% of primary care doctors know about withdrawal, and only 17% warn patients about withdrawal. So this is really a serious difficulty that patients can get into if they don't know and their doctor doesn't know about withdrawal.
Brenda K.:I have been taking 20 mg of Paxil once a day for depression for the last 3 1/2 years. I feel great and would like to stop. How do you go off the medication and minimize the withdrawal side effects?
Dr. Joseph Glenmullen: First of all, Brenda should do this under her doctor's supervision — one should never just stop an antidepressant one's self. If her doctor doesn't know anything about withdrawal, then she might want to get a second opinion. What I typically do with someone on 20 mg of Paxil would be to reduce it to 10 mg and see if they have any withdrawal symptoms. We have an estimate that about 50% of patients have withdrawal when stopping Paxil. If the withdrawal symptoms were tolerable, we might go to 0 mg, or to 5 mg and then to zero. There are patients who have such severe withdrawal that you have to go much more gradually — like from 20 to 17.5 mg to 15 mg and so forth and so on. You really have to individualize it to the patient.
Moderator: What are some alternatives to SSRIs?
Dr. Joseph Glenmullen at 6:22pm ET
There actually are many safe, effective alternatives. There's psychotherapy. If one is depressed because of a problem in one's relationship, there's couple's therapy. If one is on an antidepressant for a phobia or some other form of anxiety, we have good research showing behavioral treatment is the most effective in the long term. If the fundamental problem is substance abuse, 12-step programs are very effective. Aerobic exercise is a great natural antidepressant. If one is severely depressed, one probably doesn't have the energy to exercise. But once one is feeling better, perhaps on an antidepressant, aerobic exercise can be a great way to wean off the antidepressant.
Carla from ipset40.wt.net: What are your thoughts on children being prescribed these drugs for OCD, etc.?
Dr. Joseph Glenmullen: I'm very concerned about the huge number of children that are being prescribed these antidepressants. This has been described as a national health care crisis. I think children are the tip of the iceberg.
What we're seeing happening to children is happening across the board. These antidepressants are being vastly over prescribed, while their dangers are ignored. These antidepressants are actually not approved by the FDA for depressed children. And I think it's just a reflection of the irrational way they're being prescribed across the board that we're seeing them so commonly prescribed to children.
Amy from altinet.net: When withdrawing from Prozac, I experienced bouts of extreme anger. How long should I expect this to last?
Dr. Joseph Glenmullen: Irritability and anger are withdrawal effects that one sees with these antidepressants. Patients describe feeling like punching walls. Patients can look a lot like people trying to stop smoking cigarettes.
The best thing to do in these circumstances, again, is to taper the antidepressant slowly. So, if one is having withdrawal side effects with Prozac, then one would want to go down more slowly on the dosage — again, with a doctor's supervision.
Moderator: What should patients know when they start a prescription for antidepressants?
Dr. Joseph Glenmullen: Patients should be fully evaluated for whether or not their symptoms are serious enough to warrant an antidepressant. They should be fully informed about the risks and side effects, as well as the benefits. And everyone should have periodic reevaluations of whether or not they still need the antidepressant. That should be at least every six months to a year. As part of the reevaluation, they should be updated on side effects that are emerging, and they should have a good look at the alternative treatments to see if one of those or two of those would be better.
Mark Miller from bradv.com: A pharmacist and her doctor just told my mother-in-law that Paxil is a non-addictive drug. How can that be, if withdrawal is so difficult?
Dr. Joseph Glenmullen: The word addiction — one has to be a little bit careful about that word, because "addiction" is usually reserved for drugs that people use to get high. At prescription doses, people are not using these antidepressants to get high. The better word here is dependence. Many patients feel psychologically dependent on an antidepressant they've been on for a while. If they have withdrawal symptoms, then there may be a component of physical dependence. Unfortunately, many pharmacists and doctors don't fully understand the withdrawal symptoms and the issues of dependence.
Moderator: Are there any long-term dangers associated with taking Prozac?
Dr. Joseph Glenmullen: There are a number of dangerous side effects. One is becoming suicidal on the antidepressant. Another is the symptoms of the tic disorders, for example, disfiguring facial tics like sticking out the tongue uncontrollably. My patient Maura had disfiguring facial tics like this — the tics lasted for months after she went off the drug, and she still has some permanent twitching around her mouth. There is also a new study in the March, 2000 issue of Brain Research, which raises concerns that Prozac damages the serotonin cells that it targets in the brain. This is a preliminary study and we need more, but it's worrisome. We have a lot of research on other drugs that target serotonin, and appear to permanently damage the brain cells that they target.
Moderator: During your research for your book, were there facts that surprised you about SSRIs?
Dr. Joseph Glenmullen: There were two side effects in particular that kind of led to my doing the research and doing the book — that were, seeing patients become suicidal, and seeing patients have these disfiguring facial tics and muscle spasms. One of the recurrent themes was that some of these more serious side effects are believed by researchers to be caused by the drugs' indirect effects on another brain chemical called dopamine. So, we're learning that these antidepressants, in fact, are not so selective for serotonin, because there are connections in the circuitry in the brain between serotonin and dopamine. So, from the research we have, it appears that one of the backlashes in the brain, what I call Prozac backlash, is that if you boost serotonin, the brain reflexively lowers dopamine. And that's the mechanism by which many of these more serious side effects appear to be caused.
Moderator: Can side effects of SSRIs be mistaken for Parkinson's disease? Can they cause it?
Dr. Joseph Glenmullen: One of the neurological side effects of SSRIs is called drug-induced parkinsonism. Patients have severe fatigue and feel very slowed down. They move very slowly and have symptoms that look like Parkinson's disease. We have had people come on the Web site and say that they had this side effect, and that their doctor didn't recognize it, and they were diagnosed with chronic fatigue syndrome. And the dose of the drug was put up, and they got worse. Then they were diagnosed with fibromyalgia. Then they read the book and realized that the "cure" might be the illness. They stopped the "cure," and their "diseases" went away. Prozac-type antidepressants (SSRIs) can make Parkinson's disease in the elderly much worse. So, this is another of the serious side effects that doctors and patients really need to know about. As far as the drugs causing Parkinson's disease, we don't have good research, or evidence, to say that with any certainty. The type of studies that I just talked about in brain research — raising concern that these antidepressants damage the cells in the brain that they target — do raise concerns about them possibly accelerating the aging process and causing memory loss or motor problems. But this is an area that we need a lot more research in.
Moderator: Dr. Glenmullen, do you have any final thoughts to share?
Dr. Joseph Glenmullen: Prozac backlash refers to the backlash in the brain to these drugs upsetting the chemical balances in the brain. In addition, as I've gone around the country talking about the book, I've discovered that we have a kind of cultural Prozac backlash, because people are concerned about these drugs being over-prescribed while their dangers are ignored. Very serious side effects are emerging with these antidepressants. If you know anyone on an antidepressant, urge them to have a reevaluation of whether or not they really need the antidepressant, and a close look at the many safe, effective alternatives. We do have a Web site for people looking for more information: www.prozacbacklash.com

 

OPM Making 'Mental Health Parity' a Priority for Insurance Companies
Stephen Barr, Washington Post- 5/25/2000

The health care program for federal employees will soon serve as a testing ground for "mental health parity," an initiative aimed at helping patients obtain increased treatment in an affordable way. If the government program succeeds, it will likely serve as a model for what has emerged as a sensitive, difficult issue facing health care providers and insurance companies across the country. The Office of Personnel Management, which administers the federal health program, outlined the scope of the effort in a recent "call letter" to insurance companies. It asks the companies to submit their contract proposals by May 31 with an eye to completing negotiations by summer's end. "We expect your proposals for 2001 to eliminate differences in benefit levels and limitations between coverage for mental health and substance abuse services and medical, surgical and hospital services," OPM told the insurance carriers in the letter, dated April 11.
    To achieve parity, companies offering insurance in the Federal Employees Health Benefits Program must provide coverage for mental health and substance abuse that is identical to traditional medical care in its deductibles, co-payments and number of office visits allowed, OPM said. An employee or retiree going to a medical specialist for a physical illness will pay the same as a person going to the office of a mental health provider for therapy, the letter said. For example, OPM said, "the same cost sharing that applies to a test to diagnose a physical illness, such as diabetes, must be applied to a test to diagnose depression." If an insurance company limits coverage for certain medical services, then it also may limit coverage for similar mental health services, OPM said. " The allowable number of visits for speech, occupational or physical therapy may be no fewer for an autistic child who requires those services than for a person recovering from a stroke who needs the same services," the letter said.
    But federal employees who want to take advantage of mental health parity need to carefully check out the coverage that will be offered by the nearly 300 different FEHBP plans. There is, after all, no such thing as complete parity. Large carriers will likely offer enhanced mental health benefits through their "preferred provider" networks of doctors, hospitals and clinics. That means employees who go outside their health care network would pay more or encounter coverage restrictions when they filed claims for their mental health care. Between now and August, OPM and insurance companies will work out the details of providing comparable coverage for office visits that involve counseling and therapy. But insurance executives note that one of the most important tools for treating mental disabilities and substance abuse--prescription drugs--has always been available to federal employees and their doctors, just as drugs prescribed for physical ailments have been.
    To a large degree, OPM's letter reflects the Clinton administration's health care reform agenda, as well as the still evolving "managed care" revolution that has changed how patients select doctors and hospitals and how insurance companies provide coverage for medical services. Mental health parity, for instance, has been a long-standing goal of Tipper Gore, the vice president's wife and an advocate for improved mental health services in the nation. OPM and the insurance companies have been working on enhanced mental health coverage since June 1999, when President Clinton directed OPM to achieve parity by FEHBP's 2001 contract year.
    As with any enhanced benefit, the administration feels pressured to hold down premium costs. FEHBP premiums jumped an average of 9.3 percent this year, the third consecutive year of substantial rate increases. Industry experts expect the addition of mental health parity to increase FEHBP's overall costs by about 2 percent. The OPM letter also reflects another White House initiative--reducing medical errors and improving patient safety. Citing last year's Institute of Medicine study that indicated 44,000 to 98,000 people die in hospitals each year because of medical errors, OPM directed the insurance companies to report on their current initiatives to improve patient safety and to make recommendations on how to provide federal employees with "consumer information" on this issue.

 

Weak Laws Make Ecstasy Drug of Choice
Eric Ferkenhoff & Jeff Coen, Chicago Tribune- 5/28/2000

U.S. Customs officers were waiting for the three who arrived at O'Hare International Airport on United Flight 953 from Dusseldorf, Germany. Alerted by German authorities to watch for the two casually dressed women and a man, the agents tracked every step as the three walked nervously through the terminal, the man moving so clumsily a customs agent later commented that he looked "like the Michelin man." A quick pat-down revealed why. Wrapped tightly around their legs were heavy bandages and the women's hosiery were stuffed with thousands of tablets of the designer drug Ecstasy. The man alone had 14,500 pills tucked in his pants, said Larry Dennelly, resident agent in charge for the U.S. Customs office at the airport.
    The October seizure was a sizable bust. But law enforcement and drug experts have seen evidence mount in recent months that the three were only bit players in a vast and spreading international drug network that has dumped hundreds of thousands of European-produced Ecstasy pills into the Chicago market and scattered millions more across the country. Earlier this month, customs agents at O'Hare intercepted 31,000 tablets secreted in the dummy suitcase of a Slovakian man, adding to a seizure total now topping 150,000 pills in the last six months at O'Hare. Others have packed the drug in hollowed-out books, shoes and ceramics, customs agents say, and some couriers have begun swallowing packets to smuggle the substance. In all of 1997, U.S. Customs seized 400,000 Ecstasy tablets. The next year, the number was 750,000, rising to 3.5 million in 1999. Already this year, customs agents have intercepted 5.5 million of the tablets. "It's just phenomenal," said Customs Service spokesman Dean Boyd. "There is increased demand here, but it's also because people in criminal elements are realizing you can make a lot of money dealing in Ecstasy."
    Numbers from the Substance Abuse & Mental Health Services Administration's Drug Abuse Warning Network are even more sobering: Emergency room cases in which Ecstasy was identified rose to 1,142 in 1998, from 319 just two years earlier. The signs of a growing problem are clear on the streets as well. Two Chicago-area teens recently died of apparent overdoses on a dangerous hallucinogen disguised as Ecstasy. Police in many communities have issued repeated warnings about out-of-control drug use at rave parties, a popular Ecstasy outlet. And just last week, 11 people were arrested for allegedly selling more than 200 Ecstasy pills to undercover police at a Palatine teen club.
    But why the rush to a drug that seemed to disappear after becoming the rage on the college scene more than a decade ago? Experts offer many theories, but most say it's textbook economics. European, Israeli and Russian organized crime syndicates have taken over the trade and streamlined distribution networks, authorities say, enabling supply to finally catch up to the demand for a drug quickly reaching fad status among teens who disregard its dangers. In Chicago and the suburbs, the lure for dealers is simple: easy money and little fear of serving serious jail time. Penalties for dealing Ecstasy in Illinois are not as harsh as they are for other drugs. For example, selling 15 hits of LSD -- about $50 worth -- will earn a dealer an automatic sentence of 6 years in prison. It takes a $30,000 sale of 200 grams of methylenedioxymethamphetamine (MDMA), the active ingredient in Ecstasy, to warrant the same penalty. The discrepancy has Illinois and federal lawmakers calling for a rewrite of state and national drug laws.
    MDMA may have first been introduced in Germany as an appetite suppressant as early as 1912, experts said. Tests on human subjects have been limited, and authorities said the substance has no sanctioned medical uses. Sold under street names such as "XTC," "Clarity" and "Adam," the drug is a stimulant known for enhancing sensory perception and providing hallucinogenic effects. It also offers a soothing sense of well-being by boosting the levels of dopamine and serotonin in the brain, researchers said. But studies have shown that steady use can also damage neurotransmitters, affecting mood and memory. "No one wants to hear that it has a downside," said Dr. H. Westley Clark, director of the Federal Center for Substance Abuse Treatment in Washington. "People say, `This bath of serotonin that I got is so wonderful, I don't think there's anything wrong with it.'"
    Federal authorities have uncovered a handful of labs in the United States, but the industry remains firmly anchored in Europe, where the Netherlands and Belgium take the lead in production and where the precursors of the drug are more accessible. Terry Parham, chief spokesman for the Drug Enforcement Administration in Washington, said the region has developed significant expertise in manufacturing MDMA. Moreover, the finished product can be delivered cheaply to the United States, where the markup is so enormous that it is unnecessary to localize production. Recipes have become widely available on the Internet, but drug experts said the manufacture of MDMA remains a delicate and complicated procedure, which often begins with the distilling of sassafras or nutmeg oil to produce the chemical extract safrole. There are several ways to synthesize the drug from there, some of them producing unstable compounds. "For those with no knowledge of chemistry, the mixing of some of the reagents together and/or improper use can result (in) the displacement of your head from your shoulders," one Internet site on Ecstasy warns.
    The Drug Consultation Bureau in Amsterdam is an information clearinghouse that advises the Amsterdam City Council on drug matters. Herman Matser, a 12-year staffer at the center, said local production has become a study in specialization. Someone obtains the specialty chemicals, he said, someone else actually synthesizes the drugs, and a third person, a "tableter," puts the finished powder into pill form, stamping them with a trademark design. The production takes place in the countryside, he said, where it is easier to conceal, and the networks are loose. A person who winds up in MDMA production typically is an "amateur chemist" who starts by producing substances for friends, Matser said. Most are middle age, and a few have regular jobs they work part time. "Maybe you give sailing lessons for two months during the summer," he said. "The rest of the year, well, you have 10 months left to do other things. The type of people involved are those who say, `If I can get enough money, then I will take the risk.'"
    Major aviation hubs, such as Chicago, New York, Miami, Los Angeles and Atlanta, are obvious dropping-off points after passengers pass through the Dominican Republic, Suriname, and various European cities. But dealers are also using more remote ports, places like Mobile, Ala., where smugglers used Winnie the Pooh teddy bears to sneak the drug in. Once the drug lands in the Chicago area, law enforcement officials said, the trade of the substance mimics other drug-supply chains, insofar as the narcotics are handed off to middlemen to distribute to lower-level dealers. But unlike established drugs such as cocaine and heroin, whose sales are strictly governed by street gangs, the dealers who cart Ecstasy into clubs are not a tight-knit army. The drug eventually moves out into suburban neighborhoods by teens who frequent clubs and then bring MDMA home for their friends, said Mark Henry, leader of the DuPage County Metropolitan Enforcement Group. It's clear, he said, that Ecstasy and other club drugs have spread beyond the dance scene.
    According to law enforcement officials, when 18-year-old Sara Aeschlimann of Naperville overdosed on what she thought was Ecstasy earlier this month, she was at a friend's house on a Sunday morning. Steve Lorenz, a 17-year-old from McHenry, overdosed on a similar drug in an upstairs bedroom at his father's home with a small group of friends, according to family members and police. Ecstasy itself holds real dangers, too. Aside from the long-term mental effects, the drug can quickly push a user's body temperature and heart rate to dangerous levels. Still, the drug's attraction is potent. "The driving force behind most adolescent behavior is `I want to fit in and I want to belong,'" said Peter Palanca, executive director of Hazelden Chicago, a treatment facility. "Couple that with the availability of a drug like Ecstasy, which makes them feel good and decreases inhibitions dramatically, the answer is, `Why would I not take it?'"
    And it's quite easy to dismiss the warnings, said Keith McBurnett, a child psychologist at the University of Chicago.  "A lot of the kids feel most of the information from adults is either outdated or wrong," he said. "They've tried a number of things that they were supposed to drop dead from, or become immediately addicted to, and it didn't happen." As the problem spreads, the U.S. Customs Service and Interpol have launched special teams to track the drug, and Customs has even begun retraining its drug-sniffing dogs. Customs Service spokesman Dean Boyd said 13 dogs who had been trained to sniff out amphetamines were retrained and graduated in March. A black Labrador named Cameron is in service at O'Hare and 15 more are in training. "We are just seeing the tip of the iceberg in terms of acute adverse effects, like these deaths," Clark said. "The bottom line is Ecstasy is a very hazardous way to have a good time."

 

New HMO Fight: Medical Discipline
Richard A. Oppel, Jr., New York Times- 5/28/2000

A doctor refuses a treatment for a sick child. State medical officials later find the treatment should have been provided, and that the doctor blundered. Should the doctor escape punishment because he works as a medical director for an H.M.O. or other managed care company? That is the question before a federal court in Dallas in a lawsuit pitting one of the nation's largest health insurance providers, United Health Care, against Texas officials who have proposed disciplining one of the company's officials who decide whether to pay for the patient treatments. The outcome could have important consequences. If the state prevails in court and this kind of disciplinary action spreads, one of the basic premises of managed care--that insurers can contain costs by wielding an effective veto over frontline doctors' treatment decisions--could be hampered by state medical boards third-guessing the insurers' second-guessing. A decision in favor of United Health Care, on the other hand, could deflect growing efforts by many state boards to hold H.M.O.'s accountable for treatment decisions, physician groups say.
    The case stems from a United Health care medical director's decision two years ago not to approve coverage of at-home skilled nursing care for a 13-year-old boy, David Wiser, who had spent five weeks hospitalized after suffering respiratory failure. The boy's doctor called the treatment "medically necessary," but the medical director said it was "custodial care" and not covered by the insurance plan. In January, officials at the Texas State Board of Medical Examiners found that by denying coverage, the medical director failed to provide proper care. The facts of the case are not novel, but one question it raises is: Does a 26-year-old federal pension law, which managed care companies frequently use to beat down lawsuits by patients, also shield their medical decision-makers from state regulation? A dozen states have recently approved rules requiring H.M.O. medical directors to be physicians licensed in the state where their health plan resides, and thus subject to oversight by state medical boards; nine more require them to be licensed, but not necessarily in that state.
    The issue goes to the heart of the debate in Congress over whether injured patients should be able to take legal action against health maintenance organizations and other managed care companies that improperly deny care. The industry has long used provisions of the federal Employee Retirement Income Security Act, known as Erisa, to fight off patient lawsuits; the 1974 law limits state-court actions against benefit plans, including claims for wrongful death or injury. Federal courts lately have chipped away at Erisa's shield, but United Health Care contends in the Dallas case that the law nonetheless bars state officials from taking action against medical directors and other employees who approve or deny coverage of treatments. The case also highlights another important question in the patients' rights debate: What it is, exactly, that H.M.O.'s and other managed care companies are doing when they deny treatment--are they making a simple administrative decision about benefits, or are they, as physicians' groups contend, effectively practicing medicine, substituting their own judgment for that of the attending doctor?
    "The physicians who direct treatment need to be accountable to the public for their conduct," said Dr. James Winn, executive vice president of the Federation of State Medical Boards, in Euless, Texas. "Doctors shouldn't be able to claim a safe harbor simply because they work for an insurance company. I expect to see more and more litigation coming as a result of this issue." The industry and its crusade to rein in health care costs are already beset by lawsuits and legislative threats from all directions. On top of proposals in Congress and the states' efforts, a wave of class-action lawsuits has been filed against managed care plans, based on claims that the plans have systematically defrauded and short-changed patients by limiting care. The California Medical Association opened a new front last week when it filed a civil racketeering suit against three managed-care companies, accusing them of "using coercive, unfair and fraudulent means to dominate and control the physician-patient relationship for their own financial gain." An industry spokesman called the suit a groundless "shotgun attack on managed care."
    As pressures on the industry have grown, some companies have eased up. United Health Care, a unit of United Health Group based in Minneapolis, announced in November that it has given up most second-guessing of medical-necessity decisions made by patients' doctors, though they will still reject procedures that they determine are not covered by individual health plans. But in the Dallas case, Louis Saccoccio, general counsel of the American Association of Health Plans, said state officials are trying to second-guess a benefit-coverage call, something they have no authority to do. "The board of medical examiners is getting involved in what is basically a benefit or coverage determination," he said. "it's a concern for health plans and it would be a concern for medical directors, and it would be a concern for employers and consumers." Jay Silverstein, United Health Care's chief marketing officer, said, "The fundamental issue is that our medical director was making a benefit decision on behalf of an employer," he said. "It was never a question of medical necessity." Physicians' groups say the line between medical judgments and benefits determinations is not so easily drawn, and that insurers invoke it arbitrarily to suit themselves. Any time a managed care official "inappropriately makes a decision, then all of a sudden it's not a medical decision, it's a coverage decision," complained Connie Barron, associate director of legislative affairs for the Texas Medical Association, in Austin, Texas. "Whichever will get them out of accountability is what they will claim."
    The Wisers filed a complaint with the Texas state medical board. In January, after considering the complaint for more than a year, board officials found that when Dr. Ellis, the medical director of United Health Care, disallowed David Wiser's home treatment, he was engaging in the practice of medicine and had "failed to meet the standard of care, according to papers filed by United Health Care when it sued the board. To settle the matter, the board proposed that Dr. Ellis pay a $5,000 fine and accept a public reprimand and a two-year "probated suspension" of his medical license--he could continue to practice but would be required to complete 12 hours of home ventilator training and meet other conditions. Dr. Ellis, who did not return a telephone call seeking comment, could have accepted the proposed settlement or appealed to a state administrative law judge. Instead, United Health care sued the state board in March. The board's disciplinary action against Dr. Ellis is in abeyance awaiting the outcome of the suit; a hearing is scheduled in Dallas before U.S. District Court Judge Barbara M.G. Lynn next month.
    State actions against managed care medical directors are rare, but there have been some significant past cases, including a 1995 case in Rhode Island and the 1997 case in Arizona. There, the state Court of Appeals upheld the authority of the state Board of Medical Examiners to issue a "letter of concern"--a mild rebuke--to a medical director at Blue Cross Blue Shield of Arizona regarding his "inappropriate medical decision which could have caused harm to a patient." The patient went ahead with the gall bladder operation that the medical director had refused to approve, and tests afterward demonstrated that the procedure had in fact been necessary. Blue Cross then paid the bill, but the patient's surgeon complained to the state board.
    There is no Texas law requiring medical directors to be state-licensed physicians; instead, the state medical board, which is appointed by the governor, issued a position statement three years ago stating that anyone making a decision "so as to effect the diagnosis or treatment of a patient in Texas" must possess a state license or risk criminal prosecution. According to the Federation of State Medical Boards, 16 states now explicitly require H.M.O. medical directors to be licensed physicians in the state where the health plan resides; most of those rules were enacted in the past two years, including new laws in California, North Carolina and Virginia, according to the group. Nine more states require medical directors to have valid physician's licenses, but not necessarily from that state. But similar legislation has been turned back in other states recently. In Ohio, the state attorney general concluded last year that under current law, reviews of medical necessity by health insurance providers did not amount to the practice of medicine and were beyond the disciplinary reach of the state medical board.
    To Texas officials, it does not matter what you call it: Making decisions that affect medical care is the practice of medicine, plain and simple. Refusing to pay for skilled nursing at home for David Wiser included "a determination of whether the services of a health care professional are required," the Texas attorney general's office said in its motion to dismiss the United Health Care lawsuit against the medical board. "Nothing is more critical to the regulation of health care than the regulation of medical decision-making," the motion stated. "It is for the board, not an insurance company, to decide if medical judgment was exercised by a physician and if that judgment was exercised appropriately."