Noteworthy News Articles on Mental Health Topics, May 14- , 2005

Psychiatry Funding Questioned
Liz Kowalczyk, Boston Globe- 5/14/2005

For the first time, Massachusetts General Hospital's renowned psychiatry department has accepted money from the pharmaceutical industry to educate doctors around the country. After decades of offering continuing medical education classes in Boston, Harvard Medical School teaching hospital last year raised $6.5 million from Cephalon Inc., Janssen Medical Affairs, GlaxoSmithKline, and Wyeth for its 2005 program. The pool of money will allow the psychiatry department to dramatically expand its continuing medical education program with live lectures in 24 cities, teleconferences, and around-the-clock webcasts.
      Mass. General psychiatrists said without outside funding they would have to charge doctors prohibitively high tuition. They said they have developed ways to minimize the risk that drug company money could bias classroom instruction. ''The companies don't have any input into the curriculum, and there is no ongoing dialogue throughout the year," said Dr. Robert Birnbaum, medical director of the Division of Postgraduate Education for the psychiatry department. ''We're hoping this becomes a national model."
     In recent years, the pharmaceutical industry has become increasingly interested in funding continuing medical education. While companies say their motive is to help educate doctors, the practice is raising concerns in the medical profession. Recently enacted rules have explicitly forbidden companies from nudging course content toward positive discussion of their drugs. But even those measures have not satisfied some critics. ''I am skeptical that a company would give a lot of money just to be able to say 'We were nice to the Mass. General Hospital,' " said Dr. Arnold Relman, a Harvard Medical School professor, former editor of the New England Journal of Medicine, and long-time critic of drug company involvement in education. ''It's much more likely that despite the rules and regulations they hope they will influence the programs and improve their sales."
     Most states require physicians to take 30 to 50 hours of instruction a year to keep current on treatments and to stay licensed. Hospitals, medical schools, and media and education companies nationwide offer thousands of different courses, from hour-long lectures to weekend seminars in exotic locations. Increasingly, the courses are paid for by drug firms, allowing doctors to attend for free or to pay minimal fees. In 2003, drug companies for the first time accounted for more than half of the total funding of courses offered by organizations accredited by the Accreditation Council for Continuing Medical Education, which oversees continuing medical education for doctors. That year, the pharmaceutical industry gave those organizations $944 million for education. Total funding from all sources was $1.77 billion.
     The potential influence of drug companies on doctors' education was highlighted by a federal investigation of Parke-Davis, now owned by Pfizer Inc. According to internal company documents released as part of the probe, the company developed a strategy for marketing its epilepsy drug, Neurontin, for unapproved uses. In a report titled ''1998 Neurontin Tactics," a New York advertising firm suggested that the company sponsor classes on bipolar illness to increase awareness of Neurontin's effectiveness in treating the disorder. Last year, the company pled guilty to criminal conduct and agreed to pay a $430 million fine. 
     
Federal regulators and medical community leaders have called for stricter standards, and last year the accreditation council adopted explicit rules to protect against drug company bias in continuing education. For example, it prohibits companies from selecting faculty for courses or from advertising their products during educational activities. But critics say that even with the new rules, drug companies still set the overall agenda by funding only courses that emphasize treatment with expensive brand-name drugs, rather than courses that don't focus on profitable products, such as behavioral therapy for depression. Mass. General's psychiatry department, one of the nation's largest academic psychiatry departments, said it discourages that practice by asking firms to fund the entire curriculum for a year, rather than individual courses. Many of the psychiatrists who teach the courses are consultants for, or receive research funding from, pharmaceutical companies, which they disclose to their audiences as required by the accreditation council.
     Dr. Jerrold Rosenbaum, chief of psychiatry at Mass. General, said the department will not earn a profit from the expanded program. Ninety percent of the drug company money will be used to pay Primedia Healthcare, a Texas-based education and training company that produces brochures, arranges hotels and food during sessions and maintains the website. But psychiatrists who teach the classes will earn extra. In the past, the department gave course instructors credits they could put toward professional dues or books. Now, they will get paid $2,000 to $4,000 per course.
     Birnbaum said that when he raises money for the program, he tells drug companies only about the general therapeutic focus of the courses, the instructors, and the types and number of activities planned. He said some companies do not request more specific information because they are eager to demonstrate that funding decisions are not based on the potential for drug sales.
     Cephalon, a small pharmaceutical company based in Pennsylvania and the department's biggest funder, said it is developing products for anxiety and attention deficit hyperactivity disorder, so funding psychiatry courses fits into its overall strategy. ''We fully expect to be marketing drugs in the psychiatric market, so it helps having our name out there, and aligning ourselves with Mass. General is a positive," said Sheryl Williams, a Cephalon spokeswoman.



Problems Abound at Home for the Mentally Ill
Marc Santora, New York Times- 5/15/2005

For more than a decade, state investigators have been aware of a troubling and dangerous state of affairs at the Brooklyn Manor Adult Home, a place meant to offer refuge to mentally ill people not wanted by anyone else. In a series of reports, most recently a 200-page catalog of abuses, investigators found violations in every imaginable category -- from financial malfeasance to grossly inaccurate medical evaluations of the people, often very sick, who are living there. From Jan. 8 to June 22, 2004, inspectors from the New York State Department of Health, which is charged with overseeing the several dozen such homes in the city, visited Brooklyn Manor 39 times to respond to complaints and concerns. Still, Brooklyn Manor remains open. For the residents of the home, which has 216 beds, life there is as it ever was -- isolated, grim, and unimproved by action by the state.
      It was, then, business as usual last Sunday when a 51-year-old man burned to death in his bed after setting the mattress on fire with a cigarette, with some residents left walking the nearby streets dazed and complaining of how haphazard the resulting evacuation had been. The fire may have been accidental, but the death of the man, Charles Dunbar, gave rise to yet one more appreciation of how little has changed at the home, according to residents, lawyers who work with them and the state's own investigative reports.
     Despite attempts by the state to revoke its license, despite a temporary ban on referring new residents to the home, and despite the current battle by state officials to have the administrator fired, the home is still full of the ill and the defenseless. "It is hard for me to understand what has happened," said Tanya Kessler, a community organizer with the Coalition of Institutionalized Aged and Disabled. "Certainly the state last year responded to a lot of complaints from residents and was out at the home a lot," she said. "The question now is why has it failed to take the next step?"
     That failure, interviews and records show, is a result of a mixture of legal wrangling, bureaucratic infighting and historical indifference. The state, which is charged with monitoring adult homes like Brooklyn Manor, has been conflicted in its own response. On the one hand, investigators have been aggressive in finding out about problems and diligent in reporting them. On the other, lawyers and others who work with the residents say state officials have not always been aggressive in acting on the findings. William C. Van Slyke, a spokesman for the State Health Department, said that any inaction was the result of things beyond its control, including court decisions and the limited authority granted to the department by the State Legislature. "Our posture here is as aggressive as it can be given the loopholes that exist in the statutory authority," he said. He said the Health Department has much more power in its oversight of nursing homes and hospitals, for instance, than it does when it comes to adult homes. "We continue to have serious concerns about this facility," he said.
     The list of abuses compiled by state investigators is long. When patients were sick or injured, staff members failed to get them urgent medical care. When a doctor was made available, exams lasted only two or three minutes. Sometimes residents were taken into the home when they should have been sent elsewhere because of the severity of their illnesses, while at other times residents were discharged without due notice or explanation, including some who were barely capable of caring for themselves.
     As early as 1991, state investigators found problems at Brooklyn Manor, uncovering evidence that the operator of the home, Benito Fernandez, then the husband of State Senator Nellie Santiago, took more than $45,000 in retirement benefits from a resident who had entrusted the money to the home. Over the ensuing years, more reports by state investigators found that not only was money being misappropriated, but that the level of supervision and coordination of care was abysmal. As far back as 1996, there was a push to have the home's license revoked. However, senior officials in the State Department of Social Services, which oversaw the homes until 1998, reversed the effort without explanation. Throughout, the administrators of the home and their lawyers have defended their record, and characterized the investigations as flawed.
     Brooklyn Manor, anyway, has been able to fend off the state's efforts, which were energized after a series of articles in The New York Times in 2002 that documented the overall condition of the largest adult homes. At the time, the State Health Department made a full push to have the home's license revoked. But the effort was derailed in court. On Dec. 6, 2004, a judge ruled that the inspection reports compiled over more than a decade were invalid because they only documented problems and did not offer remedies. The ruling also provided the basis for a successful fight by Brooklyn Manor to be removed from the state's "Do Not Refer" list -- intended to warn nursing homes, hospitals and other care facilities against sending people to Brooklyn Manor. The state was frustrated by the ruling, which has made it harder to enforce actions against the most dangerous homes.
     The state should not have been surprised. A year earlier, a court had made a similar ruling after an effort to revoke the license of an adult home. Presumably, the state had had months to make its reports meet the court's standards. Mr. Van Slyke said the department had tried to adjust its inspection reports to account for the decision and said the judge's ruling was akin to a court invalidating a traffic ticket because the driver was not told that he could have stopped speeding by taking his foot off the accelerator. Mr. Van Slyke said the state opted not to try to take control of the home itself, and is still seeking to have the administrator who runs the home on a daily basis removed. But the most drastic action, closing the home, is not really an option: there is virtually nowhere else for the residents to go.
     After the state began closing its psychiatric wards in the 1960's, adult homes were used for some of those who were deemed too ill to live on their own but not sick enough for hospitalization. Although Gov. George E. Pataki's administration created a panel to study alternative housing options, adult homes remain the easiest solution for vast numbers of the vulnerable population they serve. There are some 15,000 mentally ill people living in more than 100 homes in the state. The panel studied the feasibility of creating smaller, more specialized homes for some residents of adult homes in 2003. State health officials said they had surveyed some 2,500 residents and helped many receive better care, but, to date, too few facilities have been built.


Nicotine Vaccine Shows Promise
Thomas Maugh II, Los Angeles Times- 5/15/2005

The world's 1.3 billion smokers could eventually have a powerful new way to kick the habit — a vaccine against nicotine. Nearly 60% of smokers who achieved high levels of antibodies against nicotine after receiving the vaccine stopped smoking for at least six months, according to a study presented Saturday at a meeting of the American Society of Clinical Oncology in Orlando, Fla.
About a third of those who developed lower levels of antibodies stopped smoking, about the same fraction as those who received a placebo vaccine, according to Dr. Jacques Cornuz of Centre Hospitalier Universitaire Vaudois in Lausanne, Switzerland, who led the study. "The data clearly suggest that antibodies against nicotine are effective in helping people quit smoking," Cornuz said in a telephone interview after he delivered the paper. "This confirms the concept of vaccination" against smoking.
      About a third of those who received the vaccine achieved the highest levels of antibodies. Before the company that makes the vaccine used in the study can begin larger clinical trials, Cornuz said, it will have to find ways "to intensify the immunization scheme" so that more people achieve the necessary antibody levels. That may mean more injections, he said, or higher levels of the immunizing agent in each dose. He estimated it would be as long as three years before new trials could begin.
     Dr. Roy Herbst of the M.D. Anderson Cancer Center in Houston said he found the results intriguing. "The best way to help patients is to prevent them from getting cancer in the first place," he said. "I find it very encouraging that there is something to treat the addiction." Smoking is thought to be the cause of 30% of all cancer deaths and 87% of deaths from lung cancer. But tobacco is very addictive — more so than cocaine and heroin, according to some researchers. There are a variety of prevention tools available to combat smoking, including nicotine patches, nicotine gums and drugs such as bupropion. "But there are groups of patients who fail all these therapies," Herbst said.
      At least four companies are testing nicotine vaccines: Cytos Biotechnology of Zurich, whose vaccine Cornuz studied; Xenova Group of Berkshire, England; Nabi Biopharmaceuticals of Boca Raton, Fla.; and Prommune of Omaha, Neb.
     The concept behind the vaccines is simple. Antibodies to nicotine bind to it in the blood and remove it, preventing the drug from reaching and stimulating the brain. "We're basically taking away the positive reinforcement, which is the main reason people can't stop smoking," said Dr. Henrik S. Rasmussen, a senior vice president of Nabi. Nicotine itself is too small to provoke an immune response in the body. The companies get around this by attaching nicotine molecules to much larger proteins or synthetic compounds that do stimulate a response.
      In the current trial, Cornuz and his colleagues enrolled 341 patients at three Swiss hospitals. Two-thirds of them were given the experimental vaccine in five doses over a four-month period. The rest were given a placebo. About a third of the subjects were not included in the final analysis because they also used a nicotine replacement, either gum or a patch, which would confuse the results, Cornuz said. Of the 53 patients who developed the highest levels of antibodies, 30 stopped smoking, and those who didn't smoked fewer cigarettes, he added. Researchers relied on subjects' reports of smoking and on measurements of carbon monoxide levels in the blood, a conventional measure of smoking activity.


Some Find ADHD Still There in Adulthood
Madlen Read, Associated Press- 5/15/2005

NEW YORK - Like dormitories and dining halls, Adderall was something Cory Clair figured he'd leave behind in college. But when he went off the medication and started a new job in January, his mind began wandering at work — just as it did in class before he was diagnosed with attention-deficit disorder and was prescribed the drug, a common treatment for a related problem, attention-deficit (hyperactivity) disorder. "I thought I'd have it for school, and then I'd be out and wouldn't need it anymore," said Clair, who works in public relations in New York. "I was wrong."
      After a few months of struggling to pay attention to co-workers and complete assignments on time, Clair finally made an appointment with a doctor and renewed his Adderall prescription, which his health insurance covers. "The difference is remarkable," Clair said. "When you're on it, you stay focused on what you're doing."
     The kids of the ADHD drug boom are growing up, and some are finding that what they thought would be a school-age ailment may in fact last a lifetime. As they enter the work force — and as older people are increasingly diagnosed — drugs for the disorder are becoming more common in the workplace.

Drug sales more than triple
ADHD is seen in 3 percent to 5 percent of children, according to the National Institute of Mental Health. About half continue to experience symptoms into adulthood, said Louis Kraus, chief of child and adolescent psychiatry at Rush Medical Center in Chicago. Symptoms include distraction, forgetfulness, fidgeting, impulsiveness and disorganization. Some patients, like Clair, are diagnosed with attention-deficit disorder only, not including hyperactivity.
      ADHD drug sales have skyrocketed in recent years — U.S. retail sales of the total ADHD drug market more than tripled between 2000 and 2004, according to health care information company Verispan — and pharmaceutical companies are increasingly marketing their drugs to adults. Experts disagree on whether the surge in sales is due to better recognition and publicity of the disorder, or doctors prescribing the drugs too leniently.
     Also, many question the safety of prescription stimulants — in February, Adderall XR, sold by Shire Pharmaceuticals, was pulled from the Canadian market amid reports connecting it to deaths. The U.S. Food and Drug Administration said it would continue evaluating the drug, but has not taken regulatory action. Sales of Adderall XR — the most popular type of Adderall in the United States, and the kind that Clair takes — rose 4 percent in the first quarter of 2005 from the first quarter of 2004, according to Shire.
     But when used correctly, the drugs can be career savers, said Gary, a 41-year-old from Memphis, Tenn., who asked that his last name be withheld. Before he was diagnosed with adult ADD in 2003, Gary lost two jobs due to missed deadlines. He also self-medicated with alcohol and marijuana to reduce his anxiety about falling behind.

A 'fog' since grade school
Gary's inability to focus, which he describes as a "fog," was something he suffered since grade school. "I was a frat boy who could make a gentleman's C's without doing any homework," Gary said. "I always felt like I could be doing better." Part of what held him back from seeing a psychiatrist was that he didn't want to identify himself as hyperactive. His revelation came a few years ago when he learned that an author he admired had been diagnosed with the disorder.
      ADHD drug abuse isn't as rampant in the workplace as it is on college campuses, where it's estimated that one in five students has abused prescription stimulants to study or get high. But it does exist, notably among bankers, stock brokers and others in high-pressure, long-hour positions, said Punyamurtula Kishore, president and director of the National Library of Addictions in Brookline, Mass.
     People who think they have adult ADHD are urged not to test out the drugs on their own, but see a doctor first. Because most of the drugs are stimulants, they raise blood pressure and speed up the heart. Unmonitored, they can cause heart problems and psychosis, said pharmacologist Peter Anderson, a clinical instructor in psychiatry at Harvard Medical School.

More than medication
To treat adult ADHD, most experts recommend relying on not only medication, but also therapy and lifestyle changes. These include maintaining a quiet work space, using personal digital assistants and task books to organize duties, requesting one-on-one training instead of group training, and using tape recorders during meetings. Such nonmedication techniques can, for some sufferers, be a substitute for drugs, Anderson said.
      But if bosses aren't accommodating, workers may need to tell them up front about their disorder. Gary, for instance, chose to tell his boss when he started taking Adderall to ensure that his workplace needs would be met. One can only be eligible for protection offered by the Americans with Disabilities Act and the Rehabilitation Act if one discloses the disability to the employer, according to the National Resource Center on ADHD. The act requires employers to make accommodations.
     Gary admits that Adderall isn't a cure, but being diagnosed was a step in the right direction for his career. "This is about chemistry," he said. "You should not feel bad about seeking psychological help."


Chicago Mental Hospital's Prognosis in Doubt
Karen Mellen, Chicago Tribune- 5/16/2005

A flurry of lobbying by mental health advocates and a push by legislators won a reprieve last spring for the Tinley Park Mental Health Center, which Gov. Rod Blagojevich wanted to shutter to help close a massive budget hole. This year, budget projections remain dire, state officials still want to close the hospital and some advocates believe the state will eventually sell the only facility for mentally ill patients from the South Side to Kankakee and Grundy Counties.
     As a result, many physicians and advocates are lobbying the Illinois Department of Human Services to ensure that enough money is allocated to programs in communities. Others say they will still fight to keep the center open, on behalf of employees and a group of people among the most vulnerable: those with severe mental illness who cannot pay for treatment. "If they're not stabilized and treated adequately, in a timely manner, in their communities, they often end up in the criminal justice system," said Anders Lindall, director of public affairs for the American Federation of State, County and Municipal Employees, Council 31, which represents state employees. "Those outcomes really cost more than if we were to make an appropriate investment in keeping Tinley open and operating at full capacity," Lindall said. People with the most severe mental diseases, such as bipolar disorder or schizophrenia, sometimes go into a psychotic state that leads to hospitalization.
     Beginning Monday, the state is reducing beds at the mental health center along 183rd Street by 25 percent and cutting 15 percent of staff. That will drop the Tinley Park budget to $20.22 million for the upcoming fiscal year. But the budget at the Madden Mental Health Center in Maywood would increase nearly 30 percent, to add patient beds and centralize some operations, such as intake of patients. The real boon to the state would be selling the 213-acre site in Tinley Park for an estimated $31 million. Some advocates and lawmakers, though, vow to fight to ensure proceeds from the sale would go toward building another hospital or programs to provide mental health care, and not to the general fund.
     Dr. Nada Stotland, incoming vice president of the American Psychiatric Association, said that when the Tinley Park center opened nearly 50 years ago, the country setting was touted as a therapeutic benefit though most patients do not walk the grounds now. The center belongs to the people who are mentally ill, she said, not the governor's office to wipe out red ink in the transportation budget, for instance. "This may be crying in the wind," Stotland said. "I want the proceeds from the sale of the land to be put in trust, so it can't be used for anything else but to be used for the care of people with mental illness."
     Others are concerned there is no plan for what to do with patients if the facility closes. State officials have suggested such scenarios as leasing beds in private hospitals or opening small offices for outpatient treatment and day programs. Dr. Christopher Fichtner, director of the Division of Mental Health in the Department of Human Services, could not provide specifics on what would happen if the Tinley Park center is closed. No date has been suggested for a possible closing and, under state law, a committee of the General Assembly must approve the action.
     But Fichtner said the trend in the medical community is to treat people with mental illness at outpatient centers. In such a scenario, more case managers would keep track of people in hopes of averting hospitalization by monitoring medication and stress levels. And when someone must be hospitalized, Madden would be available, he said.
      Fichtner said a better alternative would be for the state to pay for patients to be treated at private community-based hospitals. Doing so would allow the state to be reimbursed by the federal government, which does not happen when a patient receives treated in a state-run center, he said. "It is also possible to close an institution, put money into the community and maintain those services," Fichtner said.  Brenda Hampton, facility director for Tinley Park, acknowledged anxiety among patients and families, many of them worried about driving many miles to Madden. But she said the state wants to provide access to care within communities and is looking at ways to do so.
     On a recent morning, patients at Tinley Park played cards in a day room or watched TV. Staff described a schedule for patients that includes participation in group therapy daily as well as individual meetings with doctors.
     On Monday, advocates for the mentally ill and providers are scheduled to meet with officials from the Department of Human Services to discuss a task-force report. The task force concluded the state must "maintain a public hospital presence in the region," without defining exactly what that would be. State Sen. Maggie Crotty (D-Oak Forest) said there must be not just a presence but an actual hospital in the south region. She said that even when the budget is in the red, government must still care for the most defenseless. "There are times when a person is in crisis, when they would need to be somewhere with more intense help," Crotty said. "I think we should be there."


A Critic Takes On the Logic of Female Orgasm
Dinitia Smith, New York Times- 5/17/2005

Evolutionary scientists have never had difficulty explaining the male orgasm, closely tied as it is to reproduction. But the Darwinian logic behind the female orgasm has remained elusive. Women can have sexual intercourse and even become pregnant -- doing their part for the perpetuation of the species -- without experiencing orgasm. So what is its evolutionary purpose?
     Over the last four decades, scientists have come up with a variety of theories, arguing, for example, that orgasm encourages women to have sex and, therefore, reproduce or that it leads women to favor stronger and healthier men, maximizing their offspring's chances of survival. But in a new book, Dr. Elisabeth A. Lloyd, a philosopher of science and professor of biology at Indiana University, takes on 20 leading theories and finds them wanting. The female orgasm, she argues in the book, "The Case of the Female Orgasm: Bias in the Science of Evolution," has no evolutionary function at all.
      Rather, Dr. Lloyd says the most convincing theory is one put forward in 1979 by Dr. Donald Symons, an anthropologist. That theory holds that female orgasms are simply artifacts -- a byproduct of the parallel development of male and female embryos in the first eight or nine weeks of life. In that early period, the nerve and tissue pathways are laid down for various reflexes, including the orgasm, Dr. Lloyd said. As development progresses, male hormones saturate the embryo, and sexuality is defined. In boys, the penis develops, along with the potential to have orgasms and ejaculate, while "females get the nerve pathways for orgasm by initially having the same body plan." Nipples in men are similarly vestigial, Dr. Lloyd pointed out. While nipples in woman serve a purpose, male nipples appear to be simply left over from the initial stage of embryonic development. The female orgasm, she said, "is for fun."
     Dr. Lloyd said scientists had insisted on finding an evolutionary function for female orgasm in humans either because they were invested in believing that women's sexuality must exactly parallel that of men or because they were convinced that all traits had to be "adaptations," that is, serve an evolutionary function. Theories of female orgasm are significant, she added, because "men's expectations about women's normal sexuality, about how women should perform, are built around these notions." "And men are the ones who reflect back immediately to the woman whether or not she is adequate sexually," Dr. Lloyd continued.
     Central to her thesis is the fact that women do not routinely have orgasms during sexual intercourse. She analyzed 32 studies, conducted over 74 years, of the frequency of female orgasm during intercourse. When intercourse was "unassisted," that is not accompanied by stimulation of the clitoris, just a quarter of the women studied experienced orgasms often or very often during intercourse, she found. Five to 10 percent never had orgasms. Yet many of the women became pregnant.
     Dr. Lloyd's figures are lower than those of Dr. Alfred A. Kinsey, who in his 1953 book "Sexual Behavior in the Human Female" found that 39 to 47 percent of women reported that they always, or almost always, had orgasm during intercourse. But Kinsey, Dr. Lloyd said, included orgasms assisted by clitoral stimulation.
     Dr. Lloyd said there was no doubt in her mind that the clitoris was an evolutionary adaptation, selected to create excitement, leading to sexual intercourse and then reproduction. But, "without a link to fertility or reproduction," Dr. Lloyd said, "orgasm cannot be an adaptation."
     Not everyone agrees. For example, Dr. John Alcock, a professor of biology at Arizona State University, criticized an earlier version of Dr. Lloyd's thesis, discussed in in a 1987 article by Stephen Jay Gould in the magazine Natural History. In a phone interview, Dr. Alcock said that he had not read her new book, but that he still maintained the hypothesis that the fact that "orgasm doesn't occur every time a woman has intercourse is not evidence that it's not adaptive." "I'm flabbergasted by the notion that orgasm has to happen every time to be adaptive," he added.
     Dr. Alcock theorized that a woman might use orgasm "as an unconscious way to evaluate the quality of the male," his genetic fitness and, thus, how suitable he would be as a father for her offspring. "Under those circumstances, you wouldn't expect her to have it every time," Dr. Alcock said.
     Among the theories that Dr. Lloyd addresses in her book is one proposed in 1993, by Dr. R. Robin Baker and Dr. Mark A. Bellis, at Manchester University in England. In two papers published in the journal Animal Behaviour, they argued that female orgasm was a way of manipulating the retention of sperm by creating suction in the uterus. When a woman has an orgasm from one minute before the man ejaculates to 45 minutes after, she retains more sperm, they said.
      Furthermore, they asserted, when a woman has intercourse with a man other than her regular sexual partner, she is more likely to have an orgasm in that prime time span and thus retain more sperm, presumably making conception more likely. They postulated that women seek other partners in an effort to obtain better genes for their offspring. Dr. Lloyd said the Baker-Bellis argument was "fatally flawed because their sample size is too small." "In one table," she said, "73 percent of the data is based on the experience of one person."
     In an e-mail message recently, Dr. Baker wrote that his and Dr. Bellis's manuscript had "received intense peer review appraisal" before publication. Statisticians were among the reviewers, he said, and they noted that some sample sizes were small, "but considered that none of these were fatal to our paper."
     Dr. Lloyd said that studies called into question the logic of such theories. Research by Dr. Ludwig Wildt and his colleagues at the University of Erlangen-Nuremberg in Germany in 1998, for example, found that in a healthy woman the uterus undergoes peristaltic contractions throughout the day in the absence of sexual intercourse or orgasm. This casts doubt, Dr. Lloyd argues, on the idea that the contractions of orgasm somehow affect sperm retention.
     Another hypothesis, proposed in 1995 by Dr. Randy Thornhill, a professor of biology at the University of New Mexico and two colleagues, held that women were more likely to have orgasms during intercourse with men with symmetrical physical features. On the basis of earlier studies of physical attraction, Dr. Thornhill argued that symmetry might be an indicator of genetic fitness. Dr. Lloyd, however, said those conclusions were not viable because "they only cover a minority of women, 45 percent, who say they sometimes do, and sometimes don't, have orgasm during intercourse." "It excludes women on either end of the spectrum," she said. "The 25 percent who say they almost always have orgasm in intercourse and the 30 percent who say they rarely or never do. And that last 30 percent includes the 10 percent who say they never have orgasm under any circumstances." In a phone interview, Dr. Thornhill said that he had not read Dr. Lloyd's book but the fact that not all women have orgasms during intercourse supports his theory. "There will be patterns in orgasm with preferred and not preferred men," he said.
     Dr. Lloyd also criticized work by Sarah Blaffer Hrdy, an emeritus professor of anthropology at the University of California, Davis, who studies primate behavior and female reproductive strategies. Scientists have documented that orgasm occurs in some female primates; for other mammals, whether orgasm occurs remains an open question.
     In the 1981 book "The Woman That Never Evolved" and in her other work, Dr. Hrdy argues that orgasm evolved in nonhuman primates as a way for the female to protect her offspring from the depredation of males. She points out that langur monkeys have a high infant mortality rate, with 30 percent of deaths a result of babies' being killed by males who are not the fathers. Male langurs, she says, will not kill the babies of females they have mated with. In macaques and chimpanzees, she said, females are conditioned by the pleasurable sensations of clitoral stimulation to keep copulating with multiple partners until they have an orgasm. Thus, males do not know which infants are theirs and which are not and do not attack them. Dr. Hrdy also argues against the idea that female orgasm is an artifact of the early parallel development of male and female embryos. "I'm convinced," she said, "that the selection of the clitoris is quite separate from that of the penis in males."
     In critiquing Dr. Hrdy's view, Dr. Lloyd disputes the idea that longer periods of sexual intercourse lead to a higher incidence of orgasm, something that if it is true, may provide an evolutionary rationale for female orgasm. But Dr. Hrdy said her work did not speak one way or another to the issue of female orgasm in humans. "My hypothesis is silent," she said. One possibility, Dr. Hrdy said, is that orgasm in women may have been an adaptive trait in our prehuman ancestors. "But we separated from our common primate ancestors about seven million years ago," she said. "Perhaps the reason orgasm is so erratic is that it's phasing out," Dr. Hrdy said. "Our descendants on the starships may well wonder what all the fuss was about."
     Western culture is suffused with images of women's sexuality, of women in the throes of orgasm during intercourse and seeming to reach heights of pleasure that are rare, if not impossible, for most women in everyday life. "Accounts of our evolutionary past tell us how the various parts of our body should function," Dr. Lloyd said. If women, she said, are told that it is "natural" to have orgasms every time they have intercourse and that orgasms will help make them pregnant, then they feel inadequate or inferior or abnormal when they do not achieve it. "Getting the evolutionary story straight has potentially very large social and personal consequences for all women," Dr. Lloyd said. "And indirectly for men, as well."



Antidepressants Can Affect Newborns
Associated Press, 5/17/2005

CHICAGO -- Women who take Prozac or certain other antidepressants late in pregnancy raise the risk that their babies will suffer jitteriness, irritability and serious respiratory problems during their first couple of weeks, researchers say. Babies born to women taking antidepressants in the last three months of pregnancy were three times more likely to develop drug-related symptoms than those born to women who did not use the drugs or took them only in early pregnancy, according to a University of Pittsburgh study that pooled previous research. The study was published in Wednesday's Journal of the American Medical Association. Most of the symptoms are mild and usually disappear after about two weeks, but some require intensive care hospitalization, the researchers said.
      The drugs involved include Prozac, Paxil and other antidepressants known as selective serotonin reuptake inhibitors or SSRIs, and also serotonin norepinephrine reuptake inhibitors, which include Effexor. At least 80,000 U.S. women yearly take the drugs during pregnancy, the researchers estimated. Serious respiratory problems develop in perhaps one out of 100 infants born to these women, said Dr. Eydie Moses-Kolko, a psychiatrist who led the study.
     The Food and Drug Administration and drug makers recently agreed to labeling changes on these drugs to include information about the symptoms, which some doctors call neonatal behavioral syndrome, or withdrawal syndrome.
     Moses-Kolko said there has been little research on whether the drugs have any lasting effects in children, although one study found that affected newborns were developmentally normal at 8 months. ''I don't think this is cause for alarm,'' but patients and doctors should be aware of the risk, she said. Women should talk to their doctors about reducing use of the drugs late in pregnancy but should also be aware that the risks of major depression might outweigh the short-term problems the drugs might cause in newborns, she said.
     On the Net:
JAMA: http://www.jama-archives.org
FDA: http://www.fda.gov/medwatch/SAFETY/2004/may--PI/Effexor--PI.pdf


Study: Herb Helps Curb Binge Drinking
Associated Press, 5/17/2005

BOSTON -- A group of 20-something drinkers seemed to lose the urge to binge-drink when they took pills made from kudzu, that ubiquitous vine that blankets the South, researchers reported. The finding, described as groundbreaking by one expert, might one day lead to a way to attack the binge-drinking problem.
      Researcher Scott Lukas, with Harvard-affiliated McLean Hospital, had no trouble finding volunteers for the study, which required them to hang out in an ''apartment,'' complete with television, recliner and fridge stocked with beer. This apartment-style laboratory was set up in the hospital, and the volunteers were told to spend a 90-minute session drinking beer and watching TV. Those who took kudzu pills drank an average of 1.8 beers per session, compared with the 3.5 beers consumed by those who took a placebo.
     Lukas was not certain why, but speculated that kudzu increases blood-alcohol levels and speeds up its effects. In other words, the drinkers needed fewer beers to feel drunk. ''That rapid infusion of alcohol is satisfying them and taking away their desire for more drinks,'' Lukas said. ''That's only a theory. It's the best we've got so far.''
     In 2003, David Overstreet and other researchers at the University of North Carolina-Chapel Hill studied the plant found it had a similar effect on rats. ''There's a lot of anecdotal evidence from China that kudzu could be useful, but this is the first documented evidence that it could reduce drinking in humans,'' said Overstreet, who reviewed the study and called Lukas' work ''groundbreaking.''
     The 14 men and women chosen for the study were people who said they regularly had three to four drinks a day. After all of them spent a 90-minute session drinking and watching TV, they were divided in two groups for follow-up sessions. A chemist extracted several forms of plant estrogen from the roots, stems and leaves of kudzu and used it to make tablets. One group was given two tablets three times a day for a week, and the other group was given placebos. After another round of 90-minute beer-drinking, the placebo group was given the kudzu tablets and vice versa. ''Unbeknownst to them, I was weighing that mug of beer every time they took a sip,'' said Lukas, who hid a digital scale inside an end table where the subjects were told to rest their beers. ''We actually got a sip-by-sip analysis of their drinking behavior.''
     None of the test subjects had any side effects. ''It's perfectly safe, from what we can tell,'' Lukas said. ''Individuals reported feeling a little more tipsy or lightheaded, but not enough to make them walk into walls or stumble and fall.''
     Though kudzu won't turn drinkers into teetotalers, Lukas said, he hopes it can help heavy drinkers to cut back. ''That way, they're a lot closer to being able to cut down completely.'' Lukas' study, published in this month's issue of Alcoholism: Clinical and Experimental Research, was inspired by Dr. Wing Ming Keung, a pathology professor at Harvard Medical School who has studied the potential medical applications of kudzu. Keung said he has extracted a compound from kudzu root that he hopes to turn into a drug for reducing alcoholics' cravings. ''The most urgent need is helping people who cannot help themselves, who need a drug to help them stop drinking,'' Keung said.
     On the Net:
McLean Hospital: http://www.mclean.harvard.edu
Alcoholism: Clinical and Experimental Research: http://www.alcoholism-cer.com




Advocates Fear Loss of Mental Center Funds
Karen Mellen, Chicago Trubune- 5/17/2005

Keith Kemp wants to be optimistic. As legislative chairman of the National Alliance for the Mentally Ill of the South Suburbs, he believes in a proposal to eventually close the Tinley Park Mental Health Center and move more money into outpatient programs. But the draft budget for the next fiscal year calls for a decrease of $3.57 million to the Tinley Park center--and no corresponding increase in other programs for the mentally ill in the south suburbs. The budget for Madden Mental Health Center in Maywood would be increased for more beds and centralize intake. "We never get on the list for this governor, or any other governor," said Kemp, of Chicago Heights, at a meeting Monday with the head of the Illinois Department of Human Services. Later, Kemp said he would lobby legislators for more funds, even though Springfield is dealing with a budget shortfall. "We want that money back," he said.
     On Monday, Secretary Carol Adams of the Department of Human Services met at Tinley Park with members of a task force assembled to make recommendations on realigning mental health services. "We're looking for a plan with roots and legs," Adams said. She acknowledged that the decrease in spending for the Tinley hospital was not reinvested into community programs because of the budget shortfall. Eventually, Adams said, the state wants to close down the Tinley Park center. Estimates are the state could earn about $31 million by selling the 213-acre site at Harlem Avenue and 183rd Street. Adams left open the option of building another public hospital in the south region but said later that any such decisions would be guided by available funds.
     State officials are considering how to deliver services for poor people with mental disorders, with the trend toward keeping people out of hospitals by providing them with more outpatient care. As part of the planning process, the state is considering paying for treatment at private community hospitals, either by paying for beds as needed or by contracting for a wing to be set aside for state patients. Under those scenarios, the state would be eligible in most cases for reimbursement by the federal government. Under current rules, the federal government does not pay for care for adults at facilities where more than half of the beds are for psychiatric patients, which is the case at the freestanding state psychiatric hospitals.
      The National Alliance for the Mentally Ill of the South Suburbs agrees with the philosophy of treating people in their communities, said president John Rowley, but is concerned about how much money would be funneled toward the mentally ill if the Tinley Park center is closed. Indeed, one task-force recommendation is to ensure that a plan to move patients out of the public hospital is fully funded before the change occurs.
     John Cameron, director of community relations for American Federation of State, County and Municipal Employees, Council 31, which represents employees at Tinley Park, said he does not believe state officials will provide adequate funding for the mentally ill after the hospital is closed.
"Unfortunately, I believe it remains a cover story for the decision that has already been made," he said, referring to the discussions about how to change the system of care.




The Choice of Life
Gail Griffith, Washington Post- 5/18/2005

On Saturday evening, March 10, 2001, my 17-year-old son, Will, returned from an evening of bowling with friends. He sat at the kitchen table and told me he'd had a great night: He bowled over 100 twice in a row, he said, and then he, his girlfriend and cousin went to a pizza joint afterward. He appeared cheerful and light. "You seem to be feeling a lot better, Will," I told him. It wasn't a casual remark; Will had been diagnosed with major depression in the fall of 2000, and after an agonizing and worrisome few months, he appeared to be shaking it off. I thought the latest medications were finally beginning to take effect. Or maybe it was just the passage of time, but by all markers, he looked as though he was genuinely on the mend. "Yeah, Mom, I think I am better. No, really, I think I'm okay." I kissed him on the forehead and went to bed buoyed by our exchange. For the first time in months I felt confident that we, that he, had turned the corner.
      Will watched the basketball playoffs with his stepsister and her friends for an hour or so. He then went to his bedroom, wrote out four suicide notes and at 3 a.m. ingested 100 times the normal dose of the sedative antidepressant Remeron, washed down with a bottle of Snapple Iced Tea. I discovered Will late the next morning in his bed, semi-conscious, gagging and incoherent, his heart racing and skin covered in sweat. We rushed him to the emergency room at George Washington University Hospital. After a day-long battle by a medical team to stabilize his vital signs, we came face to face with the devastating realization that our son had attempted to take his own life. It was the worst moment of my life. Thankfully, Will survived.
     How do you explain the suicidal impulses of a child? We give our children life; we think we know everything about them. And why shouldn't we? We tell them what to think and do from the moment they are born. So it comes as a terrible shock to learn that your child is harboring such a deadly secret. Suicide is not a rational act; it is, rather, the worst possible outcome of a treatable illness, depression. A child in the throes of depression is suffering mental anguish not unlike the bodily pain of a wrenching physical illness. And the process of healing is no different: The sooner you obtain relief, the better the prognosis.
     In the immediate aftermath of Will's suicide attempt, our family and a set of clinicians came together to analyze what went wrong. We began an urgent and heart-rending process to determine the next course of action -- a treatment plan for Will that at a minimum might safeguard against another suicide attempt and at best might conquer his depression.
     As we grappled with the situation, we learned a lot about our son, and about the limited treatment options for teen depression. We immersed ourselves in the controversy over the use of antidepressants to treat teenage patients and weighed the advantages and drawbacks of outpatient vs. residential treatment. We were stymied by the staggering inadequacies of our managed-care system, and we discovered that our best hope for helping Will was to become at least as well informed as the therapists treating him. For any family in the thick of a crisis, it is a lot to handle.
     Teen suicide is now a public health crisis. In the years since Will's suicide attempt, I have watched it rip through families and lamented the paucity of ready solutions. Roughly 2,000 American teens between the ages of 13 and 18 attempt suicide every day. That's a stunning statistic for a society that, on the surface, has so much to offer children. In 1999 the U. S. Surgeon General issued a report stating that 3.5 million teenagers suffered from depression. Yet 80 to 90 percent of depressed adolescents go undiagnosed and untreated. And if left untreated, depression can lead to suicide.
     When depression strikes a teenager, it often shows up in a confusing set of symptoms that are difficult to distinguish from normal adolescent behavior -- moodiness, irritability, irregular sleep patterns, drug or alcohol use, difficulties at school. But there is another, less common but more troubling pattern of teen suicides, which occurs more often, but not exclusively, in adolescent boys. I call these the "stealth" candidates for suicide -- the kids who appear to be doing just fine, even very well. It's the type of kid my son Will appeared to be. How often have we seen media reports of the "star athlete" or "president of the student council" or the kid voted "most likely to succeed" -- the teenager with everything going for him -- who comes home on a Saturday night, loads a gun and shoots himself? If there is a suicide note, it is vague in the extreme: "Sorry for the inconvenience." Or "I just couldn't handle stuff anymore." This type of kid typically closets emotions while aiming at goals and self-imposed standards that are impossibly high or prompted by perceived expectations of their parents. They are loath to disappoint family and friends. In our pressure-cooker society, how do we convince our children that nothing is as important as their health and well-being?
     The first stop on the road to diagnosis is often the family pediatrician or managed care gatekeeper. Few are expert in diagnosing and treating adolescent depression. If you are lucky enough to locate a competent therapist or psychiatrist to treat a teen (no mean feat), you need to become educated about the therapeutic options for your child and weigh the risks vs. the benefits of antidepressant medication.
     As I talk with friends and families of depressed teenagers, I have concluded that parents are ill-equipped to steer their children through the rugged terrain of mental illness. Worse, we have so little confidence in our judgment that our anxiety over doing the "right thing" often results in doing nothing at all. Sometimes families of troubled teens refuse to accept the overwhelming evidence pointing to a teenager with depression when it is right in front of them. Abusing drugs and/or alcohol, risky sexual behavior, truancy, petty larceny, self-mutilation (including "cutting" and eating disorders) -- each one of these behaviors is in its own way a cry for help. Two or more together should make alarm bells go off.
     Parents confronted with the challenge of handling a troubled adolescent often see the problem as a reflection of our own parenting skills, or lack thereof. We worry that we will be judged harshly by the community if we own up to a "failing" kid. Some adults worry that a "mental illness" label will follow their children through school and prevent them from attaining their goals. If your child were battling cancer, you would not sit by and wait for the disease to run its course. And if your teen is depressed, he or she is up against a life-threatening illness and you need to seek help. Immediately.
     My experience with Will leads me to this: If you suspect your teen is depressed, doing nothing is a luxury you cannot afford. No one on the planet knows your child better than you do. Trust in that knowledge, trust your instincts and then fight like hell to get help for your child. If there is a hurt more wrenching than watching your child suffer, I do not know it.
     The six weeks following Will's suicide attempt were fraught with frustration bordering on panic. We were aware that, statistically, an adolescent who has made a failed attempt is 10 times more likely to try again if the depression is not treated successfully. I couldn't sleep through the night without getting up several times to make sure he was still breathing. We never let him out of our sight.
     Eventually, with the help of an educational consultant, we found a therapeutic boarding school in Montana with a stellar reputation. Despite Will's reluctance, we enrolled him. There he was monitored 24/7 and received the therapeutic treatment he needed and at the same time graduated from high school (with honors).
     After returning home from Montana, he began to contemplate his future. On a job application for a volunteer government program, Will was asked to write about a challenge he had faced in his life and how he managed to overcome it. He wrote: "A year and a half ago, I suffered from severe clinical depression. I tried several medications, spent time in a psychiatric hospital, but still continued to sink lower and lower. Finally, I came to a point where I was torn between my sense of obligation to my family and friends and my complete disinterest in continuing to live my life. My depression got the better of me and I tried to commit suicide in March of 2001. "Since then, I have made an almost full recovery -- I have found medications that work for me and I am feeling positive about where my life is going. It is a drastic change from how I felt before and it has taught me that absolutely no problem or negative situation is without a solution."
     We -- and Will -- were lucky. Our son survived a suicide attempt and a crippling bout of depression. And although the specter of Will's illness is never wholly erased, for now we are back on level ground. Moreover, I learned that depression does not need to kill its young victims. Families, communities and the medical establishment need to step up to the challenge and intervene swiftly to make available accurate diagnoses and effective treatment, so that our children, whose lives too often hang in the balance between risk and reason, are not left alone to choose death over life.

Those Who Outgrow Foster Care Still Struggle, Study Finds
Monica Davey, New York Times- 5/19/2005

CHICAGO - As the definition of adulthood has shifted in this country and young people are living with their parents even into their 20's, one group has been mostly left behind in this phenomenon: thousands of people who grow up in foster care. Nationally each year, some 20,000 youths who were once removed from their homes because of abuse or neglect leave their second home -- the child welfare system -- because they get too old for it. In some states, they are allowed to stay on until they turn 21, but in many more places, they "age out" when they turn 18. And that, the authors of a new study to be released on Thursday by the Chapin Hall Center for Children at the University of Chicago say, can have devastating consequences. The study, which is believed to be the broadest of its kind in 20 years, looked at a rarely examined group -- more than 600 young people, mostly 19 years old and in Illinois, Iowa and Wisconsin, who recently left foster care or will soon do so.
      As a group, the youths from foster care wrestled with tougher problems than a wide national sample of 19-year-old Americans, the study said. More than a third of those coming from foster care had no high school diploma or general equivalency diploma, compared with about 10 percent of people their age. Those from foster care were also far more likely to be pregnant, unemployed, unable to pay the rent, or getting counseling.
     Perhaps more striking about the group from foster care, though, those allowed to stay in the child welfare system -- living in foster homes or youth facilities beyond their 18th birthdays -- seemed to fare better than those who headed out at 18. Those who left at 18 were half as likely to be enrolled in school or a training program than those still in care, the study found. Those who had left care were 50 percent more likely to be unemployed and out of school than those who stayed in. About 14 percent of those who left, in fact, reported finding themselves homeless at some point. Of those who left care, 11.5 percent reported sometimes or often not having enough to eat, compared with less than 4 percent of those who stayed in care.
     "Most states do not allow them to stay in much beyond 18, and that's the legacy of what we thought, historically, was the point of becoming an adult," said Mark E. Courtney, the study's lead author and the director of Chapin Hall Center here. "But it doesn't make sense anymore. What parent kicks their child out at 18? Why are we treating these kids radically differently than parents are treating every other kid?" Dr. Courtney said he was unsure precisely how many states allow youths to stay in care until they are 21, but said that Illinois is one in that small group, while youths in Iowa and Wisconsin -- and most other states -- generally leave the foster care system when they turn 18 or 19.
     It is uncertain, though, how much it might cost states to extend such benefits to 21, and in tight budget times, money may be one reason states have been reluctant. "The reluctance could be a fiscal issue or it could be the whole issue, too, of older wards -- you're not cute and cuddly anymore," said Robert F. Harris, the public guardian who represents wards in Cook County, Ill. "But by and large, young people need the benefit of societal support past 18 -- and even past 21."
     Shalonda Williamson, one of those surveyed in Dr. Courtney's study, said in an interview that she has been in the system since she was 9. Now 20, she is studying computers at college in Chicago, but remains in the formal care of the child welfare system here. To her, that is a relief. She has somewhere to live. "If I had gotten out at 18, I think I'd be totally different than I am now," she said. "When you're 18, you're not really an adult anyway. I think it's around 20 when you start getting your life together." Even now, Ms. Williamson acknowledged, she does not have every adult question answered: She has no bank account or summer job.
     But Richard Wexler, executive director of the National Coalition for Child Protection Reform, based in Alexandria, Va., said the "dismal" findings described in Dr. Courtney's study and others emerging from the foster system across the country should not necessarily leave child welfare experts clamoring to hold youths in the system longer. "When we talk about people aging out, we get away from the central point," he said. "What these results should tell us is that we've got to stop throwing so many children into foster care in the first place. What you can see is, regardless of what the problems were going in, foster care surely didn't fix them."
     The Chapin Hall study cost $1.6 million and was financed by the three states and the William T. Grant Foundation.

 

F.D.A. Considers Implant Device for Depression
Benedict Carey, New York Times- 5/21/2005

The pacemaker-like device, called a vagus nerve stimulator, is surgically implanted in the upper chest, and its wires are threaded into the neck, where it stimulates a nerve leading to the brain. It has been approved since 1997 for the treatment of some epilepsy patients, and the drug agency has told the manufacturer that it is now "approvable" for severe depression that is resistant to other treatment. But in the only rigorously controlled trial so far in depressed patients, the stimulator was no more effective than surgery in which it was implanted but not turned on.
      While some patients show significantly improved moods after having the $15,000 device implanted, most do not, the study found. And once the device is implanted, it is hard to remove entirely; surgeons say the wire leads are usually left inside the neck.
     Proponents say that many severely depressed patients do not respond to antidepressants or electroshock therapy and that those patients are desperate for any treatment to relieve their suffering. "These people have no other options, so we need to consider anything that shows potential to help," said Dr. Harold A. Sackeim, chief of biological psychiatry at the New York State Psychiatric Institute, who consults for Cyberonics Inc., the Houston company that makes the stimulator.
     But Dr. Michael Thase, a psychiatrist at the University of Pittsburgh who consults for the company, said there was "simply not a good enough basis in evidence" for approval. While the device is promising, Dr. Thase said, "the shaky state of the evidence means we have to be very cautious with this and prepare for the possibility that the hoped-for benefit isn't there."
     The drug agency has given mixed signals about the stimulator. In August 2004, it told Cyberonics in a letter that the treatment was not approvable, saying more information was needed. But in February, after the company provided more data, the agency changed that position, informing the company that the stimulator could now be approved. The company's stock price has fluctuated as investors try to anticipate the agency's decision, which the company is hopeful will come by the end of the month. The Senate Finance Committee recently began looking into the F.D.A.'s potential reversal, but Cyberonics officials say they have been assured by the agency that this will have no bearing on its final decision.
     In a conference call with reporters and analysts on Thursday, Robert Cummins, the company's chief executive, said no other treatment had been deemed approvable by the drug agency for stubbornly depressed patients. Clearly, he said, "the status quo for millions of Americans, their families, psychiatrists and payers is neither safe nor effective."
     Still, some patient advocates and other experts are now questioning how the device has come so close to approval with such limited evidence for its effectiveness. "I've never seen anything quite like this," said Dr. Peter Lurie, deputy director of health research at Public Citizen, a nonprofit group that is a frequent critic of the F.D.A. and the drug and medical-device industries. "What we could be setting ourselves up for is an epidemic of implantation of a device with no proven effectiveness." Experts who were involved in the approval process say they were moved by the desperate prognosis for severe depression and by powerful testimonials.
     At a critical meeting of an F.D.A. panel last June, six patients with chronic severe depression said they felt much better that the stimulator had been implanted, as part of an investigational study. At that meeting, the panel voted 5 to 2 to recommend that the device be approved. One patient, Charles Donovan III of St. Louis, said the stimulator had saved his life. "I went from being a complete mental-health vegetable to someone who had the energy and confidence to do this book," Mr. Donovan said in an interview. But the panel did not hear from patients who did not benefit from the stimulator, according to the transcripts. One of them, Katherine Coram, 57, of Silver Spring, Md., signed up for the trial after seeing a newspaper advertisement about it. "Believe me, when you're depressed for long enough, you get to a stage where you're willing to try almost anything," Ms. Coram said in an interview.
     In the study, doctors implanted the device in 235 severely depressed people. The stimulator sends timed pulses of electricity to the vagus nerve, which has wide connections throughout the brain. Half of the patients then had their stimulators turned on. The investigators did not know which of their patients had their stimulators on. After three months, researchers "unblinded" the study and compared levels of depression in the two groups based on standard measures of disease severity, the F.D.A. documents show. They found that 17 of the 111 patients who had implants turned on and completed the trial showed significant improvement. But 11 of 110 who had no stimulation and completed the trial also felt significantly better. The difference between the two groups was small enough to be attributable to chance. Alan Totah, vice president of regulatory affairs for Cyberonics, said at the meeting, "The primary endpoint did not reach statistical significance." But Mr. Totah said "the results did show a positive trend in favor" of the stimulator.
     Hoarseness was a common complaint. Many patients who have had a stimulator on also said that it put a quiver, rumble or other odd inflection in their voices. "I certainly knew mine was on," Ms. Coram said. "I could feel it. You get this constricting pain in the back of the throat. I couldn't talk sometimes." Ms. Coram said that she was slightly more functional at work after the surgery but that it did not last. Later, she said, after she took a doctor's advice and had the stimulator's pulse turned up higher, "my life fell apart." "I was very anxious and agitated, much more so than before," she went on. "I felt suicidal for a while, worse than I had been in 8 to 10 years."
     But several members of the panel that voted for approval said that given the alternatives for people like Mr. Donovan and others who did well, the insignificant difference between the two groups was cast in a different light. "The feeling was that anything that gives these people hope is potentially worthwhile," the chairwoman, Dr. Kyra Becker, a neurologist at the University of Washington, said in an interview. "But the whole meeting was uncomfortable, and everyone wanted to see another trial done, no question about it."
     Dr. Becker said that if she had voted her conscience, solely on the basis of the evidence, she would have voted not to approve. A member who voted against approval, Dr. Richard Malone, a psychiatrist at Drexel University College of Medicine in Philadelphia, said he was bewildered by the recommendation. "I walked out of there thinking I was nuts," Dr. Malone said in an interview. "It was stunning, but then I find much of life is stunning." The F.D.A. usually follows the recommendations of advisory panels.
     Another reason some psychiatrists are intrigued by the device for depression is a finding in the evidence that some people with the implant might do better over time. In follow-up data, Cyberonics reported to the drug agency that about 30 percent of those in the study showed significant improvement on one measure of depression after six months or more. "The effect appears to be sustained, which is very significant in these patients, who almost always relapse," Dr. Sackeim said.
     But other experts say it is extremely difficult to interpret this long-term evidence. Many patients in the study were taking psychiatric medications, or had electroconvulsive therapy, both of which can improve mood. These and other factors are difficult to control for, despite the company's efforts to do so, they said.
     Cyberonics says that the long-term evidence it has provided to the federal agency satisfies requirements for approval, and that senior agency officials have told the company as much. The agency has a higher standard of proof for approving new drugs than it does for devices. Devices require a "reasonable assurance" that they are safe and effective and that potential benefit outweighs the risk.
     F.D.A. officials said they could not comment on any product that was pending approval. But Dr. Donna-Bea Tillman, director of the agency's office of device evaluation, said "it is not the kiss of death" if a product's effectiveness is not supported by a well-controlled clinical trial. "We consider safety and effectiveness in relation to the alternatives that patient population has, including whether they have any alternatives at all," Dr. Tillman said.
     If a device is approved, the agency specifies precisely which patients should have access to it, she said. Whether to recommend it is then left to doctors' judgment. And that is a prime concern among critics of the approval process, like Public Citizen and other groups concerned about patient protection. Once a product has been approved, the manufacturer can promote it aggressively, and some doctors may recommend it to any patient, whether severely or moderately depressed.
     Some people may not wait for approval. Sue Wanemaker, 51, who lives near Denver, said she had a vagus stimulator implanted last April for her depression. Ms. Wanemaker, who also has epilepsy, said she had noticed little benefit, and added that when turned up high the stimulation made her feel suicidal. She has since had the device turned down. "I'm going to hang in there," she said in a phone interview, "because why not, I've got it in now, and -- there it goes!" With that, her voice trilled for a few moments.



A Moviemaker Seen Through the Lens of His Son
Stephen Holden, New York Times- 5/21/2005

The legendary cinematographer Haskell Wexler, who preens, scolds, gives orders and sheds tears in the documentary biography "Tell Them Who You Are," belongs to an elite but ornery breed: the patrician radical. Claiming the moral high ground, such people are often arrogant, self-righteous know-it-alls, convinced (perhaps rightly) that they care more about humanity than the rest of us. Mr. Wexler grew up rich in Chicago, and as a young man, helped lead a strike at his own father's factory. But as "Tell Them Who You Are," filmed by Mr. Wexler's son Mark, illustrates, such virtuous certainty is easier to admire from a safe distance than to live with on a day-to-day basis. The only child of the second of Mr. Wexler's three marriages, Mark engages in a power struggle with his father for control of the movie being made. The father, now 83, makes no secret of his distaste for his son's more conservative politics. In one scene, Mark S. Wexler, who directed a documentary about Air Force One, twits his father by giving him a framed picture of himself with George H. W. Bush.
      Almost every frame of "Tell Them Who You Are" conveys an intimate, emotionally charged understanding that only a spouse or an immediate family member could bring to such a project. Near the beginning of the movie, the younger Wexler admits that the film is his attempt to get closer to his father. This sense of personal mission helps make "Tell Them Who You Are" the richest documentary of its kind since Terry Zwigoff's"Crumb."
     A pioneer of cinéma vérité, the elder Mr. Wexler won two Academy Awards as a cinematographer (for "Who's Afraid of Virginia Woolf?" and "Bound for Glory") and worked on such film classics as "In the Heat of the Night,""American Graffiti,""One Flew Over the Cuckoo's Nest,""America, America" and "Coming Home." He also directed, wrote and co-produced the 1969 film "Medium Cool," which used the riots at the 1968 Democratic Convention in Chicago as a backdrop. That film, a fascinating but forced juxtaposition of fact and fiction, stands as a groundbreaking but unwieldy attempt to achieve a spontaneous combustion between the two. His only other feature as a director was "Latino," a 1985 left-wing political drama set in Nicaragua and hardly ever seen. As a cinematographer, his recent credits include several John Sayles films.
     Movie stars (from Jane Fonda to Paul Newman) and directors (from Albert Maysles to George Lucas to Mr. Sayles) parade in front of the camera to describe their feelings about a man who boasts, "I don't think there's a movie I've been on that I didn't think I could direct better." He was so difficult during "One Flew Over the Cuckoo's Nest," its director, Milos Forman, recalls, that he had to be fired. Mr. Wexler's streak of paranoid grandiosity leads him to speculate even now that his dismissal was really the result of pressure from the F.B.I.
     But despite its film clips and professional recollections, "Tell Them Who You Are" is more a psychological study than a career assessment. Like an aged monarch who is not about to let go of life or to cede any control, Mr. Wexler, fully aware that his son's portrait may be taken as the final word on his character and achievements, treats the work-in-progress as an embattled collaboration. He sharply criticizes his son, suggests camera angles and lighting ideas, and refuses to sign a release form until the movie is completed and has met with his approval. His feistiness expresses more than just the impatience of an imperious prima donna. In a gym sequence in which he vigorously works out with a trainer and slugs at a punching bag, you sense him raging against old age itself.
     When, near the end of the film, father and son visit Mark's mother, Miriam, at a home for Alzheimer's patients, tears stream down the father's face as he gently talks to his once-beautiful former wife, a painter whose illness is so far advanced that she seems present only in body. The very next scene shows a picture of the couple in younger and happier days, aboard a boat on a lake in Guatemala. You will want to weep, too.
     Produced and directed by Mark S. Wexler; narration written by Mr. Wexler and Robert DeMaio; director of photography, Mr. Wexler; edited by Mr. DeMaio; music by Blake Leyh; released by ThinkFilm. Running time: 95 minutes. This film is rated R. WITH: Haskell Wexler, Miriam Wexler, Billy Crystal, Michael Douglas, Jane Fonda, Milos Forman, Dennis Hopper, Ron Howard, Norman Jewison, Elia Kazan, George Lucas, Albert Maysles, Paul Newman, Sidney Poitier, Julia Roberts, John Sayles, Martin Sheen, Studs Terkel and Jonathan Winters.