Noteworthy News Articles on Mental Health Topics, March 20-22, 2006



Domestic Abuse May Be Harder To Prove
David Savage, Los Angeles Times- 3/20/2006

WASHINGTON -- The Supreme Court appears poised to make it far harder to prosecute cases of domestic violence when victims are unwilling or unable to testify in court. Today the court will hear the appeals of two men who were convicted of assaulting women based, in one case, on a recorded 911 call, and in the other, on a police officer's testimony of what the victim told him.
      Over the past two decades, prosecutors in domestic violence and child abuse cases have relied heavily on testimony by police officers and counselors who interviewed the victims when those victims could not or would not appear in court. But those prosecutions have a formidable foe in Justice Antonin Scalia. He insists the Constitution guarantees all defendants a right to confront their accusers in court, and he sees no basis for an exception in cases of domestic violence or child abuse.
     Two years ago Scalia wrote an opinion for the court that all but barred the use of out-of-court statements at trials when the victim failed to testify. The only sure test of whether "testimonial statements" are reliable, Scalia concluded, "is the one the Constitution actually prescribes: confrontation." As he noted, the Sixth Amendment says, "In all criminal prosecutions, the accused shall enjoy the right ... to be confronted with the witnesses against him." His opinion in that case, Crawford v. Washington, affected prosecution units around the nation.
     "It had a huge impact," said Victoria Adams, the deputy who heads the Family Violence Division for the Los Angeles County district attorney's office. "In most of our cases, the victims are reluctant or afraid to testify." Since the Crawford decision, she said, prosecutors have relied more on recorded 911 calls and on "spontaneous" statements given to police officers who arrive at a crime scene. The theory is that these statements - which some refer to as a "cry for help" - are uniquely revealing and distinct from formal testimony and, therefore, should be allowed in court. But the Supreme Court appears ready to close that option in the pair of cases to be heard today. Scalia spoke for a 7-2 majority in the Crawford case, and the two dissenters - Chief Justice William Rehnquist and Justice Sandra Day O'Connor - are now gone.
     The National Network to End Domestic Violence and several women's rights groups filed a brief that warns the court about the dire impact of requiring in-court testimony in all cases. "This would make it very difficult, if not impossible, to prosecute the vast majority of domestic violence cases," said George Washington University law Professor Joan S. Meier, who helped write the group's brief. The victims are "traumatized and terrorized by the defendants themselves, and they can threaten them so they don't testify," she said. One study found that many victims are threatened with having their children kidnapped if they testify, she said.
     Prosecutors in 27 states, including California, have joined with the Bush administration in urging the court to permit the use of 911 tapes and crime scene statements in domestic violence cases. In most states, trial judges permit the use of spontaneous statements given to a police officer at a crime scene. Other states specifically allow the use of "excited utterances," such as a call to a 911 operator. In briefs filed with the court, civil libertarians and criminal defense lawyers urged the justices to uphold the confrontation right set out in the Constitution.
     In 1980, the high court opened the door to using "hearsay" statements in court when they were judged to be reliable. A tape recording of an accuser's words, for example, would be considered reliable. But shortly after joining the court in 1986, Scalia disagreed and began arguing that the 6th Amendment required a "face-to-face confrontation" in court when a witness accused a person of a crime. He dissented whenever the justices upheld special rules that allowed children who were said to have suffered sexual abuse to testify behind screens or on closed-circuit television. Liberal justices, including John Paul Stevens, and conservative Clarence Thomas, who joined the court in 1991, agreed with this view. By 2004, Scalia had built a large majority for his opinion in the Crawford case.
     "In this country, we haven't allowed people to be prosecuted based just on what someone said to a cop on the street," said University of Michigan law professor Richard D. Friedman, who is representing one of the two men whose cases are being heard. "There is not a domestic-violence exception to the Constitution." Friedman has proposed that the court adopt a simple rule: that a statement made to a police officer or government agent accusing someone of a crime is "testimonial" and cannot be used in court unless the accuser appears to be cross-examined.
     In Crawford vs. Washington, the court overturned the assault conviction of a man who was found guilty based on his wife's recorded statement at a police station. Scalia said such "testimonial statements" could not be used against a defendant if the witness refused to testify, but he did not say what defined a testimonial statement. The court agreed to hear the two cases to resolve that question. In the first case to be heard today, a recorded call to a 911 operator near Seattle provided the testimony that convicted Adrian Davis of violating a restraining order. "He's here jumpin' on me again," a woman later identified as Michelle McCottry told the operator in 2001. Her ex-boyfriend was there, she said, and "he's using his fists." She didn't appear at the trial, but a prosecutor played the tape for the jury. "She left her testimony on the day this happened," the prosecutor said. "It is right here in her voice." The defense lawyer objected, saying Davis had a right to cross-examine the witness in court. The Washington state Supreme Court upheld Davis' conviction and said that an emergency report or an "excited utterance" was different from the "testimonial statements" Scalia referred to in his Crawford opinion.
     The second case began when two police officers responded to a domestic disturbance call in Peru, Ind., in 2003. At first, Amy Hammon appeared too scared to talk. But when one officer took her to the front porch, she said her husband, in a rage, had thrown furniture and a lamp at her and had shoved her into the broken glass on the floor. She, too, did not testify, but based on the officer's account of her words, Hershel Hammon was convicted of domestic battery. The Indiana Supreme Court upheld the conviction and said the crime scene report was not a testimonial statement.
     Adams, the prosecutor in Los Angeles County, said it would be a significant setback if the high court barred the use of recorded 911 calls. "Since Crawford, we have been successful using those calls. Many such cases "come to the attention of law enforcement through a 911 call," she said. One remaining option — and one objected to by women's rights advocates — is to subpoena the victim, or even to arrest her, to force her to testify. "We can arrest the victim, but we also hate to re-victimize the victim. There is no easy answer to that," Adams said. "Regardless of what happens, we will do whatever we can. The job has been tougher after Crawford, but we will prosecute these cases."
     After hearing arguments in Davis vs. Washington and Hammon vs. Indiana, the justices will meet behind closed doors and decide on each case. Announcement of the rulings is expected by June.




Quest to Heal Leads Abuse Victim to Face Old Demons
Caryle Murphy, Washington Post- 3/20/2006

On a balmy, hint-of-spring day last week, Michael Donovan drove his rented car slowly past Holy Name School in Northeast Washington, where a billboard read, "He who angers you, controls you." The 63-year-old Vietnam veteran and retired businessman from California was on a mission into his past, a mission to banish his own anger and regain control. A mission of healing.
      After his 1995 conviction, Schaefer was sentenced to 16 years in prison by Prince George's County Circuit Court Judge William B. Spellbring Jr. But after Schaefer had served less than five months, the judge suspended the rest of the sentence and released him to a facility for priests with psychological problems. Now 80, Schaefer lives in Vianney Renewal Center in Dittmer, Mo., about 30 miles from St. Louis. Run by the Servants of the Paraclete, a religious order of men, the center is a community for priests who cannot engage in active ministry "for personal, health-related, psychological, social or canonical reasons," according to its Web site.
     The pale, redheaded priest at Holy Name favored him, Donovan said, often taking him out of class to spend time together because, as Schaefer told the nuns, he thought Donovan might have a vocation to be a priest. Schaefer also knew Donovan's love of wrestling, and during spring break in 1956, when no one else was in the school, he suggested that they wrestle. But the priest showed up saying that he had forgotten his wrestling gear and asked whether they could wrestle "Greco-Roman style," or nude, Donovan said. "I gave no thought to the impropriety of it," he said. As they wrestled for the next three-quarters of an hour, Schaefer got increasingly excited and aggressive, finally attempting to sodomize him, Donovan recalled. "At the very end, I was fighting someone who was trying to rape me," he said. He said he struck the priest with an open-handed slap across the face. "I expected a lightning bolt from God because I'd hit a priest, but he immediately stopped and whimpered," Donovan said.
     The building where he attended eighth grade is now a day care and parish activity center. On his visit, he quickly found the musty auditorium where he played a munchkin in the "Wizard of Oz" and the old basketball court "where I proved what a terrible basketball player I was." But the low-ceilinged room, with its dusty wrestling mats, that he had come to see was not there. A layer of concrete covers the brick wall where, as Donovan recalls, there used to be a door to the room where he was molested.  He said he was not disappointed. "I feel very good about being here. . . . It completes what I had to do. I've got what I needed out of it," he said. "There were many good days here. There was only one bad."
     Schaefer is not allowed to leave the community unsupervised, Washington Archdiocese spokeswoman Susan Gibbs said, adding that "the archdiocese pays to keep him in that facility. "He's asked several times to return to Washington. . . . He'd like to die here," Gibbs said. "And we have declined because we want to ensure that he never returns to this community where he harmed children." Schaefer is not receiving a church pension, she said. Schaefer did not respond to a message left with a Vianney official seeking comment.
     Donovan and his wife, Sharon, met Schaefer in St. Louis. A psychologist treating Schaefer was also present, Donovan said. Schaefer, who is tall, thin and balding, was aloof, the couple said in separate interviews. "We were expecting to find a feeble, old man in poor health," said Sharon Donovan. "He seemed to be a vigorous . . . quite a dapper man. Well-dressed, well-groomed, urbane, quite distant, quite cavalier about the whole thing." Schaefer did not admit doing anything wrong with Donovan, both said. But Sharon Donovan said he told her husband, "I'm sorry for anything I might have done to hurt you." Donovan recalled that Schaefer "said that he had found his peace with God and that God had forgiven him." Their meeting also included this: "He had no recollection of me," Donovan said. "Zero."
     Initially, Donovan said he felt "elation" that he had "conducted myself as a gentleman. . . . I came away feeling empowered. But a few weeks later, it hit me like a ton of bricks," and he sought professional help for an emotional breakdown. What Schaefer could not recall, Donovan could not forget. Almost 50 years ago, during Donovan's eighth-grade spring break, he was sexually abused at Holy Name by Thomas S. Schaefer, then a 30-year-old, newly minted Roman Catholic priest.
     Schaefer went on to molest at least 20 more boys in the Washington Archdiocese, according to church officials, before pleading guilty in 1995 in five of those cases. Only one other priest in the archdiocese, Robert J. Petrella, had more known victims, officials said. About 25 people have reported being molested by Petrella. The two priests were responsible for more than a third of the 123 reports of sexual abuse by clergy in the archdiocese's 59-year history.
     For decades, Donovan kept quiet about his traumatic experience, confiding only in his current wife. But in 2003, determined to be counted in a national survey of the church's abuse problem, he informed the archdiocese of Schaefer's 1956 misconduct. He learned then that he was Schaefer's earliest known victim. "It took me 47 years to raise my hand," Donovan said. "These are things that get buried in people's lives. But they don't forget it."
     Donovan, who served with the 101st Airborne in Vietnam, recalled that the priests who took his initial calls apologized immediately, which "was really heartfelt by me. Nobody had ever apologized to me for what happened." He decided that he needed to do two things to "face the dragon I need to face." One was to meet Schaefer. The other was to visit the room at his old school where the abuse occurred.
     Psychologists and victims' advocates say it is common for survivors of child sexual abuse to want to meet their abusers, partly because the once-powerless child becomes the empowered adult controlling the encounter. Gary Schoener, a Minneapolis psychologist whose clinic has treated more than 4,000 people abused by professionals, including teachers, doctors, psychiatrists and clergy, said that "at least half of child abuse victims want to physically see or visit with the offender. . . . They feel that any kind of clarity about why those things happened can help healing."
     Donovan asked the archdiocese to pay for him and his wife to travel to see Schaefer. In June 2004, the archdiocese sent him a check for $3,000. It has also paid for his psychological counseling, Donovan said. Donovan has retained a lawyer who is negotiating with the archdiocese for a financial settlement.




Killing in Texas Spotlights Attacks on Social Workers
Associated Press, 3/20/2006

AUSTIN, Tex.— In six years as a social worker with the state's Child Protective Services, Holly Jones has been cursed, chased by dogs and run out of houses by angry parents. Threats are a daily part of the job for caseworkers who investigate accusations of child abuse and neglect and often remove children from their homes. But the killing of a social worker in South Texas last week has prompted Ms. Jones and her colleagues to re-evaluate the steps they take to keep safe and has raised questions about what the state can do to better protect them. "We don't have weapons, we don't have training in self-defense, we didn't go through a police academy and we're dealing with the same people they are," Ms. Jones said.
     The social worker who was killed last week, Sally Blackwell, 53, was found in a field in Victoria on Wednesday. Her family said she had received threats in her position as program director, overseeing several offices of caseworkers. The authorities have ruled the case a homicide but have not said whether her death was related to her job. The killing comes a year after a woman fired a shotgun at two caseworkers who had come to her home near Alice, about 45 miles west of Corpus Christi, to investigate a child abuse complaint. The caseworkers fled. The woman was convicted in December of aggravated assault with a deadly weapon. Ms. Jones, 28, who recently became a supervisor for a Child Protective Services unit in suburban Austin, said caseworkers needed to know how to protect themselves.
     A study released last week by the National Association of Social Workers found that 55 percent of 5,000 licensed social workers surveyed said they faced safety issues on the job. Sixty-eight percent of them said their employers had not adequately addressed their concerns. A survey in 2002 of 800 workers found 19 percent had been victims of violence and 63 percent had been threatened.
     As the investigation into Ms. Blackwell's death continues, state protective services officials are thinking about ways to make the job safer, the Family and Protective Services commissioner, Carey Cockerell, said in an e-mail message to employees on Thursday. Currently, social workers in Texas receive a half day of safety training, and the issue frequently comes up in a 12-week course, said a spokesman, Chris Van Deusen. The child services department has no way of tracking how many threats its roughly 3,000 caseworkers receive, said Patrick Crimmins, spokesman for the Department of Family and Protective Services. But even people who have spent their entire careers with the agency can remember only a few instances in which threats escalated to violence, Mr. Crimmins said.
     In 2001, Michigan lawmakers toughened the penalties for people who threaten or attack social workers after a child welfare caseworker was beaten, bound, gagged and suffocated while checking on a family. The law also required safety training for workers who make home visits.
      The death of a Kansas mental health social worker prompted Representative Dennis Moore, Democrat of Kansas, to introduce a resolution last fall that would encourage state and local agencies to improve the safety of social workers. The resolution is pending.

Revisiting Schizophrenia: Are Drugs Always Needed?
Benedict Carey, New York Times- 3/21/2006

The only responsible way to manage schizophrenia, most psychiatrists have long insisted, is to treat its symptoms when they first surface with antipsychotic drugs, which help dissolve hallucinations and quiet imaginary voices. Delaying treatment, some researchers say, may damage the brain. But a report appearing next month in one of the field's premier journals suggests that when some people first develop psychosis they can function without medication — or with far less than is typically prescribed — as well as they can with the drugs. And the long-term advantage of treating first psychotic episodes with antipsychotics, the report found, was not clear. The analysis, based on a review of six studies carried out from 1959 to 2003, exposes deep divisions in the field that are rarely discussed in public.
      In the last two decades, psychiatrists have been treating people with antipsychotic drugs earlier and more aggressively than ever before, even testing the medications to prevent psychosis in high-risk adolescents. The studies demonstrate that the drugs are the most effective way to stabilize people suffering a psychosis. Millions of people rely on them, and the new report is not likely to alter the way psychiatrists practice anytime soon. But some doctors suspect that the wholesale push to early drug treatment has gone overboard and may be harming patients who could manage with significantly less medication, perhaps because they have mild forms of the disorder. About three million Americans suffer from schizophrenia, and a vast majority of them take antipsychotic drugs continually or periodically.
     "My personal view is that the pendulum has swung too far, and there's this knee-jerk reaction out there that says that any period off medication, even for research, is on the face of it unethical," said Dr. William Carpenter, director of the University of Maryland's Psychiatric Research Center and the editor of the journal Schizophrenia Bulletin, which will publish the article on April 1, along with several invited commentaries. Dr. Carpenter said that while antipsychotics are central to treatment in most cases the field's aggressive use of the drugs leaves "little maneuvering room" to try different options, like drug-free periods under close observation after a person's first episode of psychosis. "It's a very controversial issue, and I thought it was important to get it out there," he said.
     Other experts warned that the new report's conclusions were dangerous, and represented only one interpretation of the evidence. "I am usually a pretty moderate person," said Dr. Jeffrey Lieberman, chairman of psychiatry at Columbia University Medical Center and director of the New York State Psychiatric Institute. "But on this I am 110 percent emphatic: If the diagnosis is clear, not treating with medication is a huge mistake that risks the person's best chance at recovery. It's just flat-out nuts."
     In the report, John Bola, an assistant professor of social work at the University of Southern California, reviewed six long-term studies involving 623 people who had symptoms of psychosis. All of these men and women entered the studies soon after their psychosis was diagnosed, after a first or second break from reality. In the studies, roughly half of the patients were promptly treated with antipsychotic drugs while the other half went without the medication for periods ranging from three weeks to more than six months. Those who functioned well without medication remained drug free in several of the studies. Those who relapsed received drug treatment.
     Two studies found that after a year or more the patients on a full course of medication performed better on measures of social interaction, work success and the risk of rehospitalization than those who were initially drug-free. The other four studies found the opposite: that the less-medicated group did slightly better. Over all, the findings of the studies were a wash, showing no significant advantage for either group. The patients on full medication were taking older antipsychotics, like Haldol; similar studies have not been carried out with newer drugs, like Risperdal.
     "The most striking observation in this review," Dr. Bola wrote in the paper, "is the dearth of evidence that addresses the long-term effects of initial treatment." Previous reviews concluding that drugs provided significant benefits included many studies that did not have a comparison group of people who were not on medication, he found. "My hypothesis is that there is a subgroup of patients who are drug-free responders, probably because they have a mild form the disorder," Dr. Bola, who has argued against aggressive drug treatment in the past, said in an interview. "I think the implications of this are that we need to be additionally careful about medicating people after their first psychotic episode if there's reason to think they could" function without medication.
     Studies suggest that 10 percent to 40 percent of people with symptoms of psychosis can manage without medication. But there is no test to identify these people, and psychiatrists say that withholding drugs after a full-blown psychotic episode is highly risky. Psychotic episodes tend to become worse over time when untreated, they say, and the effect of the experience on the brain is still unknown. "The psychotic state is a crisis, an emergency; people do irrational things, dangerous things, and the initial treatment has to be with what works best — medication — along with an attempt to get them into a talking relationship," said Dr. Thomas McGlashan, a professor of psychiatry at Yale.
     The issue is most important to patients and their families. First episodes of psychosis, which often strike in high school or college, can derail young people at a crucial point in their lives and even lead to suicide. John Caswell, 50, a writer and an artist living in Lebanon, N.H., said he tried to kill himself twice after going off medication. "Once I was driving around and having hallucinations, listening to a gospel station, and I had this strong feeling that I should die and would wake up after that and start life anew," he said in an interview. He purposely drove his car off the road and into a guardrail, he said. Since then, Mr. Caswell has managed his symptoms with Risperdal, an antipsychotic he takes daily. He says he relies on the drug, "like a diabetic needs insulin."
     Yet a large, study in 2005 comparing the schizophrenia drugs found that over 18 months, about three-quarters of people stopped taking the medications they were on because they were dissatisfied. The drugs have significant side effects: older medications can induce Parkinson's disease-like tremors and the movement disorder known as tardive dyskinesia; some of the newer drugs also induce weight gain and increase the risk of diabetes; and in elderly people, both classes of drugs have been linked to higher rates of premature death.
     Antipsychotic medication also induces significant changes in brain function that are not well understood. The drugs numb brain cell receptors to the activity of dopamine, a neural messenger that appears to circulate at high levels when people are in the grip of psychosis. Ever adaptable, the body responds by manufacturing more dopamine receptors, which could make the brain more sensitive to future dopamine onslaughts that are untreated, experts say.
     "Medication can be lifesaving in a crisis, but it may render the patient more psychosis-prone should it be stopped and more deficit-ridden should it be maintained," Dr. McGlashan of Yale wrote in a commentary that accompanied Dr. Bola's report.
     For these reasons, many former psychiatric patients have challenged the wisdom of treating psychosis aggressively and early, especially for high-risk patients who have not yet shown full-blown psychotic symptoms. "If I had stayed on medication, I don't think there's any way my life would be as together as it is now," said Will Hall, 40, a mental health advocate in Northampton, Mass., who was hospitalized 14 years ago and put on antipsychotics for about four months after a suicide attempt. Mr. Hall said that he still heard voices, machine sounds and imaginary conversations but that the hallucinations had become less threatening over time. "I am very careful about the early warning signs, the noises, the sounds, and I make sure to talk to people and resist the urge to isolate myself," he said in a telephone interview. "People can learn tricks, ways of dealing with symptoms so they don't get overwhelmed."
     Several programs have helped people manage psychotic symptoms with minimal use of medication. In one, researchers in Finland found that intensive family therapy helped more than 40 percent of patients with early symptoms of psychosis recover significantly without antipsychotics — and they have remained off the drugs, for more than two years. Another program, in Sweden, also has found that many people do well when treated with low doses of antipsychotic medications, or none at all, after their first psychotic break. But both countries have health care systems in which psychotherapy and in-hospital care are readily accessible. In the United States, psychiatrists say, taking patients off medication would leave them vulnerable to life-altering relapses without sufficient support. Only in research settings, with carefully informed consent, are doctors likely to allow people suffering from a first psychosis to go drug free, they say.
     "My bottom line is that this is a very challenging illness, every patient is different, and we need more research to inform decisions about how to individualize care," said Dr. John Kane, chairman of the psychiatry department at Zucker Hillside Hospital in Glen Oaks, N.Y. With certain patients, he added, "We have to be very careful about making blanket statements about which treatment is best."

It's the first time doctors have documented what might seem like common sense, but the results have potentially big public health implications, the study authors and other experts say.

''It's a very dramatic and important finding,'' said co-author Dr. A. John Rush, a psychiatry professor at the University of Texas Southwestern Medical Center.

Depression runs in families and has a strong genetic component, but environmental factors can trigger it. The study results indicate that for children of depressed mothers, that trigger is sometimes their mothers' illness acting up, said lead author Myrna Weissman, a researcher at Columbia University and New York Psychiatric Institute.

Effective treatment for mothers could mean their children might avoid the need for prescription antidepressants, the researchers said.

''Depressed parents should be treated vigorously. It's a two-fer -- the impact is not only on them but it's also on their children,'' Weissman said.

In the study, those children whose mothers' depression disappeared during three months of treatment were much less likely to be diagnosed with depression, anxiety or behavior problems than those whose mothers did not improve.

The results are ''very plausible and very convincing and very useful,'' said Dr. Nada Stotland, vice president of the American Psychiatric Association and a psychiatry professor at Rush Medical College in Chicago.

''Our society gives a lot of lip service to how important mothers are but in fact we don't always appreciate just how profound their effects on their children are,'' said Stotland, who was not involved in the study.

While mothers often tend to put their own needs last, this research ''is a good argument for them to take care of themselves first,'' she said. ''It's a little like putting your own oxygen mask on first on the airplane. If you can't breathe, you can't help anybody.''

The study appears in Wednesday's Journal of the American Medical Association and involved 114 depressed women assessed after three months of treatment. Of the 114 children participants, aged 11 to 12 on average, 68 had no psychiatric disorder when their mothers began treatment.

Thirty-eight women went into complete remission from depression during treatment, which for most was Forest Laboratories' antidepressant Celexa.

Forest supplied the drug and several study authors have financial ties to other antidepressant makers, but the study was funded by grants from the National Institute of Mental Health.

Among children with psychiatric problems, the remission rate was 33 percent after three months for those whose mothers recovered versus 12 percent among those whose mothers did not.

Among children without psychiatric problems at the outset, all whose mothers recovered also remained healthy, whereas 17 percent of those whose mothers remained depressed were diagnosed with psychiatric problems by the study's end.

Weissman said similar results likely would occur with different drugs and/or psychotherapy. She also believes findings would be similar with depressed fathers, although none were studied.

Dr. Peter Robbins, a Fairfax, Va., psychiatrist, said he's seen similar results in his pediatric practice, and not just with depression.

For example, children with attention deficit/hyperactivity disorder often have similarly afflicted parents. Getting treatment for the parents yields improvement in the children's symptoms, he said.

The study underscores ''that taking care of the kid means taking care of the whole family,'' Robbins said.

On the Net:
JAMA: http://jama.ama-assn.org
NIMH: http://www.nimh.nih.gov
Weissman's ongoing depression-genetics study: http://depressiongenetics.med.upenn.edu

The scientific panel meets Wednesday.

The reviews show that the adverse events, particularly hallucinations, can occur in some patients at normal doses of any ADHD drug. The reviews included roughly 90 studies of the drugs as well as reports from doctors, parents and others.

The HDHD drugs include Ritalin, manufactured by Novartis Pharmaceuticals Corp. and in generic form by other companies; Adderall, made by Shire Pharmaceuticals Inc., and Strattera, produced by Eli Lilly and Company.

FDA officials say patients and doctors should be aware that the small number of events could represent side effects of the drugs, although they cannot point to a definitive link. However, they noted a ''complete absence'' of similar reports in children treated with dummy pills during dozens of clinical trials of the drugs. And in many children, the events ceased once they stopped taking the drugs -- and resumed if they restarted.

''The predominance in young children of hallucinations, both visual and tactile, involving insects, snakes and worms is striking, and deserves further evaluation,'' FDA officials said in a March 3 memorandum included in the briefing documents.

The FDA's pediatric advisory committee meets Wednesday to examine whether the labels of the drugs should be revised to further warn not only of potential psychiatric problems but cardiovascular issues -- like heart attack, stroke and hypertension -- as well.

McNeil Consumer & Specialty Pharmaceuticals said in the briefing documents that it is customary to weigh the ''therapeutic benefits and potential risks'' of treatment and warned of the negative effects of leaving ADHD untreated. The unit of Johnson & Johnson makes Concerta, a long-acting form of methylphenidate, the drug in Ritalin.

Wednesday's FDA committee will be the second in as many months to take up the issue of whether stronger warning labels are merited. The warnings had been under study by the agency since last year.

The FDA is not required to follow the recommendations of its advisory committees, but usually does.

In February, the FDA's Drug Safety and Risk Management advisory committee voted to recommend adding so-called ''black-box'' warnings to stimulants used to treat ADHD. A black-box is the most serious type of warning label a prescription drug can carry. In this case, it would alert doctors, patients and parents of the uncertainty regarding the risk that most of the drugs may pose to the cardiovascular system.

The recommendation excluded both Adderall, which has included such a warning since 2004, and Strattera, which does however bear a warning about suicidal thoughts. That drug is both ''safe and effective,'' Lilly said.

In the United States, nearly 3.3 million people age 19 and younger used an ADHD drug in 2005, according to Medco Health Solutions Inc., a prescription drug benefit program manager.

On the Net: http://www.fda.gov

Since its approval under unusual circumstances eight months ago by the Food and Drug Administration (FDA), more than 550 Americans have undergone surgery to have a vagus nerve stimulator (VNS) implanted in their chests to activate parts of their brains. Another 7,000 people -- aided by a network of nurses hired by Cyberonics, the Houston-based manufacturer of the device -- are seeking approval from their insurance companies for the $25,000 operation.

More than 3,700 psychiatrists, including doctors affiliated with Suburban, Georgetown, Sheppard Pratt and Howard University hospitals, have been trained in the use of VNS, the first device ever approved to treat depression. It consists of a battery-operated generator attached to an electrode implanted in the vagus nerve in the neck. The generator emits regular pulses of electricity that are supposed to stimulate serotonin and other brain chemicals believed to regulate mood, according to Cyberonics.

Yet despite the imprimatur of the FDA and an aggressive marketing campaign mounted by the company, the most basic question about the treatment remains unanswered: Does it work? Is VNS a lifesaving treatment for chronic depression, as some patients and doctors maintain, or an unproven and potentially harmful treatment based on flimsy science, as critics contend?

At the heart of the debate is this: The only rigorous clinical trial of the device -- which is approved to treat severe epilepsy -- failed to demonstrate effectiveness in alleviating depression. That study involved 235 patients, all of whom received the device, which was turned on in only half the group. At the end of three months, there was no statistically significant difference between the two groups.

A second study of 174 VNS recipients found that 30 percent showed significant improvement after one year. Because that study lacked a control group and because patients received other depression treatments after the device was implanted, there is no way to know whether the device was responsible. For years experts have known that depression -- unlike, say, type 1 diabetes -- can get better without treatment.

Last July, a top FDA official, citing the lack of alternatives for severely depressed patients, overruled unanimous opposition by 20 members of his staff and approved the device as a depression treatment for adults who had failed four other treatments.

FDA spokesman Stephen King said that VNS met federal standards for medical devices, which are less stringent than those governing drugs, and might help adults who had exhausted other options and were at a high risk of suicide. Cyberonics officials testified that 30,000 people commit suicide annually, most of whom were diagnosed with severe depression. The same rationale had led an FDA advisory panel in 2004 to approve the device by a 5-2 vote.

To Philadelphia psychiatrist Richard P. Malone, a member of the panel who voted against approval, such arguments are specious.

"Pancreatic cancer is a hopeless condition" with a much higher death rate than chronic depression, said Malone, a professor of psychiatry at Drexel University. "And we have as much evidence that this works for pancreatic cancer as it does for depression. Why not use it for that?"

VNS gave Kelly three "very good years," she said, and then her depression returned. "The past year has been abysmal," said Kelly, who urged the FDA advisory panel to approve the device. "I still keep hoping it's going to help me in some way."

But critics say they are not persuaded by Cyberonics's theory of how VNS works. The company's Web site says that "preliminary imaging studies suggest that VNS Therapy affects many areas of the brain implicated in mood regulation."

But Malone called the theory "all speculative."

"This almost has a feel of 18th-century psychiatry -- having a device and not being able to show how it works," he said.

Washington psychiatrist Wayne Blackmon agreed. "Psychiatry has been burned again and again by overextravagant claims" about devices and psychosurgery, said Blackmon, a lawyer and a past president of the D.C. Medical Society. "The history of psychiatry is plagued by psychiatrists jumping the gun because these poor people are suffering and the argument is we have to do something."

The device has also attracted attention on Capitol Hill, where the Senate Finance Committee has spent two years looking into decision-making at the FDA.

Last month committee chairman Charles E. Grassley (R-Iowa), whose panel issued a report highly critical of the agency's approval of VNS, said he was concerned that patients and their doctors were not being adequately informed about the risks of VNS, which include cardiovascular problems that can be life-threatening.

Grassley questioned whether Medicare and Medicaid should pay for the device, which costs $15,000 and must be replaced every five years or so when the battery runs low. So far neither the federal government nor private insurers have agreed to cover VNS for depression on a routine basis, although many have approved individual cases.

Last week, BlueCross BlueShield of Alabama announced it would pay for VNS treatment in chronically depressed patients who had failed four previous treatments.

Two recent technology assessments by major insurance companies have concluded there is insufficient evidence to find that VNS works for depression. A report by Harvard Pilgrim Health Care, an influential mental health insurer in Boston, called it "experimental, investigational and unproven."

Robert "Skip" Cummins, Cyberonics's CEO, dismissed such criticism and said his company, whose sole product is VNS, faced similar skepticism after the device was approved for epilepsy in 1997.

He noted that VNS is now accepted by insurers as a treatment for intractable seizures, which can be fatal if they are not controlled. About 35,000 epilepsy patients have received the implant.

Many FDA "regulators, politicians and third-party payers" know little about resistant depression, Cummins said. "Hundreds of psychiatric thought leaders and patients are rallying around the device" for "the worst of the worst" cases of depression, he said.

"There is nothing out there as safe and effective," Cummins said, adding that a company-financed study showed that the effectiveness of VNS improved over time. He added that he has a personal interest in intractable depression because his mother and grandfather committed suicide.

New York psychiatrist T. Byram Karasu, chairman of the task force that writes the section on depression for psychiatry's diagnostic and statistical manual, said that even though the effectiveness of VNS is uncertain, it appeals to patients and their psychiatrists.

In its marketing campaign, Cyberonics notes that VNS treatment does not cause the weight gain associated with antidepressants and the confusion and memory loss common after electroconvulsive therapy (ECT), psychiatry's term for shock treatments.

"VNS has a quality of cardiac surgery to it, a certain cachet," and it lacks the stigma of shock treatments, said Karasu, adding that six of his patients adamantly refused ECT and opted instead for VNS. "No one would know you didn't get a defibrillator."

"What would you do if you've not been getting better for years?" asked Negro. "It's a chance to get better. I'd take it."

That's what Charles E. Donovan III did. The St. Louis resident credits the implant he received five years ago with saving his life. At the time, the Georgetown University graduate said he was so depressed he told his doctor he hoped to die on the operating table.

But in the weeks after surgery, Donovan said, he started to feel better. Although he takes antidepressants, Donovan said, he is sure drugs are not responsible, because they hadn't helped him previously.

Donovan, who is featured on the Cyberonics Web site, said he has no financial relationship with the company. He recently self-published a book about his experiences, entitled "Out of the Black Hole," and runs a pro-VNS Web site for patients. "I am so humbled by this treatment and grateful," he said.

Others have had far less positive experiences. Among them is Katherine V. Coram, 58, of Silver Spring who got the implant in the same study as Donovan. Coram said she knew she was in the group with the activated device because she could feel it going off, she said. She frequently lost her voice while she was talking and felt a persistent constriction in the back of her throat. Both are common side effects of VNS treatment.

Coram said the device seemed to help a bit at first, but when the doctor turned up the settings, she felt suicidal for the first time in years. Worsening depression and suicide attempts were reported by one-third of patients in one study funded by Cyberonics, according to data presented to the FDA.

Last year Coram said she had the generator removed from her chest because it wasn't helping. The electrodes in her neck must remain forever; doctors tell VNS patients that removing them is too risky because tissue grows around them As a result, VNS recipients cannot undergo a full body MRI or therapeutic ultrasound.

"I'm still angry about the whole thing," said Coram, who said she regrets getting the implant and currently relies on the standby treatments: psychotherapy and antidepressants.

"You get desperate when you've been depressed for years," she said. "This sounds benign, like a pacemaker. My crusade is for people to know a lot more about it before they sign up."

With ADHD, Relationships Can Lose Focus
Matt McMillen, Washington Post- 3/21/2006

From the start of their marriage, Jeremy Gaylord had a habit of walking away from his wife, Nancy, while she was in mid-sentence. That annoyed her. But when he also did it to people at parties, she took action.

"I'd slam my foot down on his to keep him from drifting off," she recalled, laughing, in a recent phone interview from the couple's home in Bridgewater, Vt.

Nancy thought he was just plain rude. Five years ago, she learned there was another possible explanation: attention-deficit hyperactivity disorder, or ADHD. When Jeremy's attention wandered, he did, too.

Just about everyone occasionally zones out, procrastinates or speaks and acts without thinking. But for those with ADHD -- including many who don't know they have the disorder -- such experiences are more frequent, intense and disruptive, said Tom Brown, assistant clinical professor of psychiatry at Yale University and author of "Attention Deficit Disorder in Children and Adults" (Yale University Press, 2005).

All of which can be hard on a relationship -- especially a committed one.

It's not that people with ADHD don't inspire love or affection. "There are likable, lovable sides to ADHD, " said Brown. People with the disorder are often "spontaneous, funny as hell, and bring a fresh view on things to a relationship." It's just that their admirers generally have to balance these traits with a few exasperating ones.

For example, Brown said, "many [people with ADHD] have a reputation for being chronically late"-- a trait that others find more than a little irritating.

Take Michele Redalen, 31, of North Potomac. She met her husband, Aaron, also 31, when they were in college. They fell for each other hard and spent hours talking together. But he never seemed to be able to show up on time for dates. She accepted that -- sort of: "In college, people are always late, loud and obnoxious," she said.

New Orleans jazz singer Phillip Manuel, 52, and his wife, Janice, know something about the challenge of a long-term ADHD romance. A year after they met nearly two decades ago, they married. She was the organized and logical and cautious partner. He was impulsive and fearless.

"He was forgetful, easily distracted and constantly in motion," said Janice Manuel. "That energy was one of the first things that attracted me to him, but you start to wonder, where is it going?" Not into a steady job -- he relied instead on freelance singing gigs and voice-over work, the uncertainty of which became the source of many fights. But his energy took positive forms as well.

"He was always hands-on with the kids. He went on field trips, helped with homework and class projects. All the teachers knew him," said Manuel. "And he always made us breakfast. Not just cold cereal -- the works."

Remembering how he often felt he would never live up to his wife's expectations, Phillip Manuel insists, half-joking, that he tricked his level-headed and accomplished wife into marrying him. "I took her for a ride," he said. Since he started taking medication 5 1/2 years ago for his newly diagnosed ADHD, he said, "that ride is a lot smoother."

Janice Manuel agrees. "Sometimes, I think, you can become perhaps too serious, too focused. He's helped me to be a little lighter, a little freer, more of a risk-taker. He evens me out. There's this middle ground, and we've moved toward it."

The Gaylords' and the Manuels' experiences as couples are common for those with the disorder, said Patricia Quinn, a District-based pediatrician and author of several books on ADHD. "Most people with the disorder, they created the relationship before they knew they had ADHD," she said. "Later, they are struggling or suffering in relationships, and they don't know why."

Couples who are affected by the problem, she said, can't assume ADHD medication will solve all their problems. Education is also essential, Quinn said, so that "partners . . . don't take the behavior personally. The spouse starts to understand they're not doing this on purpose."

That kind of understanding has been crucial for Winnie and John Rodriguez. The Alexandria couple fought frequently over Winnie's piles of papers, magazines and other odds and ends that cluttered their house. (An inability to get organized is a hallmark of ADHD.) The mess often left neatnik John, 29, wondering, "When are we going to have an adult house?" But it was also frustrating for Winnie, 28.

"I don't know how John can walk through this house," she says she'd fret. "And when we'd go to other people's houses, I always asked myself, 'How do they keep it clean?' "

More troublesome to John was Winnie's tendency to tune out when he was talking to her, even when he was standing just a few feet away. "We were in the same room, but we weren't together," said John. He interpreted that as not caring.

Winnie now practices a few tips she learned from a therapist: "When I hear John talking, I stop what I'm doing and listen, and I've learned to make eye contact to focus on him."

And John? "I've learned I'm never going to have a clean house," he said. "I'm pretty proud of myself to have gotten over that."

Their first child, due in a few months, will bring new challenges: "We're still struggling to get organized," said Winnie. Added John, "She's already told me I've got full responsibility for the dogs."

A similar coming to terms has helped the Gaylords.

"Just having an explanation and knowing you have to make a point in a different way" has been tremendously important, said Nancy, who often holds Jeremy's face in her hands and looks right at him to be certain she is heard. They have also divided up the household chores in ways that take advantage of Jeremy's energy and creativity.

"I cook now and treat her like a queen to make up for everything," he said. "Sometimes, it's very seasonal, like last night's fillet of gray sole." After the interview, he was heading back to the kitchen to finish a chocolate cream pie.

By contrast, medication has been a marriage-saver for Aaron and Michele Redalen. Before diagnosis and treatment, they fought frequently, and always about the same things. Aaron promised to fix things around the house but never did. At parties, when he wasn't ignoring her, Aaron was interrupting her, finishing her stories, hurrying her along. Eventually, Michele would no longer go out socially with her husband.

Since he's been on medication, Aaron said, he's been better able to recognize when he's about to interrupt Michele and to rein himself in. "It's made it easier to accept what Michele was telling me. Before, I felt like a bad person," he said. "I still have all the same tendencies and urges, but now I see myself and can stop myself."

Both point to the survival of their marriage as proof, if they needed it, that they really loved each other. "I sort of feel it falls into the whatever-doesn't-kill-you-makes-you-stronger category," Michele explains. "It forced us to choose whether we really wanted to be together."

Rather, the Food and Drug Administration pediatric advisory committee recommended that the drug labels include warning language written so people can understand it. ''I wouldn't use the word 'tougher,' said panel chair Dr. Robert Nelson, of the Children's Hospital of Philadelphia. '''Clearer.'''

By rejecting the black-box warnings in a consensus decision, the advisory panel broke with another committee that voted just last month to include them on some ADHD drugs.

The FDA was poised Wednesday to follow the more recent recommendations.

''I think we are likely to follow them, yes,'' said Dr. Robert Temple, director of the FDA's office of medical policy, following the meeting.

Any updated language may not appear on labels until pharmaceutical companies begin using a recently adopted format, something that could take several years. And the FDA may yet require black-box warnings on stimulants to treat ADHD that would alert adults to increased risk of heart attacks, strokes and other similar problems, Temple said.

Nearly 3.3 million Americans age 19 and younger used an ADHD drug last year, according to Medco Health Solutions Inc., a prescription drug benefit program manager.

Psychiatrists and others had urged the committee to move cautiously before recommending strengthened warnings associated with the drugs.

In February, the FDA's Drug Safety and Risk Management advisory committee voted to recommend the agency add the strongest possible warning to some of the drugs regarding their potential cardiovascular risk.

The FDA then asked the pediatric panel to examine that same issue, as well as reports that psychosis or mania can occur in some juvenile patients at normal doses of any ADHD drug.

Adding black-box warnings to some or all the drugs, which also include Adderall and Strattera, could cause more harm than good, some experts told the panel.

''I suggest confusion, polarizing viewpoints, initial press hysteria. But then what?'' asked Julie Zito, a University of Maryland associate professor in pharmacy and psychiatry.

The FDA has struggled since last year with the question of how to communicate the potential risks associated with ADHD drugs. It now appears likely the warnings will come in the form of highlighted language on drug labels, as well as guides distributed -- admittedly infrequently, FDA officials said -- to patients.

Psychiatrists and mental health advocates said leaving the disease untreated could rival the risks the drugs may pose.

''It is important to not let the discussion of ADHD medications overshadow the public health crisis of untreated mental health disorders in children,'' said Cynthia Wainscott of the National Mental Health Association. Her 16-year-old granddaughter has ADHD.

Ritalin is manufactured by Novartis Pharmaceuticals Corp. and in generic form by other companies; Adderall is made by Shire Pharmaceuticals Inc.; and Strattera, which is produced by Eli Lilly and Co.

Earlier Wednesday, FDA officials say patients and doctors should be aware that the small number of reported psychiatric events, including hallucinations, could represent side effects of the drugs, although they cannot point to a definitive link.

The new labels should counsel parents to watch for such events and to both talk to their doctors and consider halting treatment, Nelson said.

McNeil Consumer & Specialty Pharmaceuticals said in briefing documents that it is customary to weigh the ''therapeutic benefits and potential risks'' of treatment. The unit of Johnson & Johnson makes Concerta, a long-acting form of methylphenidate, the drug in Ritalin.

Novartis believes current Ritalin labels are adequate, company medical safety director Dr. Todd Gruber said.

Jacqueline Bessner of Ishpeming, Mich., said her daughter, Leanne, 15, hanged herself last year two months after starting treatment with Concerta. Bessner said more black-box warnings would be useless without increased counseling and monitoring of patients.

''It's being handed out like it's candy,'' Bessner said of ADHD drugs. ''It's too easily accessible.''

A different FDA panel planned to consider on Thursday an application by Cephalon Inc. to sell its sleep-disorder drug Provigil, or modafinil, as an ADHD treatment for children.

The FDA wants members of its psychopharmalogic drugs advisory committee to examine that request, including whether serious skin rashes seen in children treated with modafinil should merit special warnings, follow-up studies and steps to limit the risk.

On the Net: Food and Drug Administration: http://www.fda.gov

Up to one-third of those who added or changed medicines recovered. When viewed with earlier results, the new findings mean that roughly half the people who suffer from serious, long-term depression can get over it -- not just improve their symptoms -- with adequate medication.

''The goal here was to find treatments that help people to get well, not just better,'' said Dr. Thomas Insel, director of the National Institute of Mental Health. ''We have safe and effective treatments.''

His agency paid for the $35 million study, which involved thousands of people across the United States and has been widely praised as a real-world test of popular drugs that have received only limited testing until now.

The study found little difference among the five drugs tested -- Celexa, Zoloft, Wellbutrin, Effexor and Buspar -- and wasn't designed to compare them. All proved similarly effective and relatively safe. The clear message, doctors said, was that antidepressants should be given a 6-to-12-week chance to work and that if one doesn't help, another should be tried.

''It's important not to give up if the first treatment doesn't work fully,'' or causes side effects, said one study leader, Dr. John Rush of the University of Texas Southwestern Medical Center in Dallas. Almost as many people were helped the second time around as the first, he said.

Two reports from the study were published Thursday in the New England Journal of Medicine.

About 15 million Americans each year suffer depression, and it is the leading cause of disability in people ages 15 to 44. It often recurs, and doctors sometimes talk of it as an emotional cancer that, rather than cured, is put ''in remission'' with successful treatment.

Nearly two dozen antidepressants are on the market -- 189 million prescriptions were filled last year alone -- but they are controversial. Evidence on their effectiveness is limited, and the government recently ordered stronger warnings that some can worsen suicidal tendencies in teenagers in rare cases. The risk in adults is still being studied.

The big federal study first tested Forest Laboratories' Celexa, a newer type of antidepressant called a selective serotonin reuptake inhibitor, or SSRI, mostly because it's an easy-to-take daily pill.

One-third of the roughly 3,000 taking it recovered, though they generally took higher doses and were monitored more closely than most patients, researchers reported several months ago.

The new research, step 2 of the study, was on people who didn't get well the first time around, an especially tough-to-treat group. They had depression for 16 years on average and two-thirds had other mental or physical problems.

Out of this group, 727 chose to switch from Celexa to a different medication and were randomly assigned to get either Zoloft, another SSRI made by Pfizer Inc.; Wellbutrin, a non-SSRI antidepressant made by GlaxoSmithKline; or Effexor, an antidepressant made by Wyeth that works on another brain chemical in addition to the one targeted by SSRIs.

Roughly one-fourth became symptom-free within 14 weeks. No big differences were seen in safety or side effects among the drugs.

Another 565 patients chose to add a second drug to Celexa and were given either Wellbutrin or Buspar, a Bristol-Myers Squibb anti-anxiety medication that can boost the effectiveness of SSRIs.

Within 14 weeks, about one-third were symptom-free. Those on Wellbutrin had slightly fewer symptoms and side effects than those on Buspar.

One study participant, Kasey Thompson, a 40-year-old medical school administrator from Fort Worth, had suffered depression for nearly 20 years despite having a good job and lots of family and friends.

''Everything should have been fine, but it wasn't. I was not happy and I could not figure out why. And it wasn't just not being happy, I was down. Deep down,'' she said.

Celexa helped, but she still had sleep problems and avoided friends until she added Wellbutrin.

''Piggybacking these two drugs together made a huge impact on my depression,'' Thompson said.

The study will continue to test third and even fourth treatment attempts, and to analyze genes to see if any patterns emerge with particular drugs.

''It's quite possible in the near future we may be able to predict who's going to respond to what,'' said another study leader, Dr. Madhukar Trivedi of UT Southwestern.

In an offshoot of the same study, researchers reported on Tuesday that treating depressed mothers can benefit their children.

In an editorial in the New England journal, Dr. David Rubinow of the University of North Carolina at Chapel Hill wrote that the study is encouraging, because half got well on drugs, but discouraging, because half did not.

Roughly 4 out of 10 people in the study were unemployed and nearly that many had no health insurance. Without access to treatment and less societal stigma toward depression, millions will continue to suffer, he wrote.

On the Net:

Study information: http://www.star-d.org and http://www.nimh.nih.gov/healthinformation/stard.cfm

New England Journal: www.nejm.org