Through the tropics of mid-August, Michael Maccari, a men's clothing executive, was at it 10 to 12 hours a day, fretting over the details of an imminent holiday shipment to stores, the fittings for the spring 2005 lines and the designs for next fall -- three seasons, three sets of deadlines. But right now, at lunch hour on a Wednesday, the deadlines were dissolving beneath a gentle tide of deep breathing. Dressed in a T-shirt and shorts, Mr. Maccari joined 14 colleagues who were arrayed across the floor of a large conference room, holding the downward-facing-dog position, an upside-down V, with their rear ends in the air, arms and legs straight, as if they were playing a game of Twister. "Think of something you can let go of," said the yoga instructor, Margi Young. "Something, or some way, you could be doing less."
      The company, Armani Exchange, offers this yoga and meditation class free to help employees relax, reduce stress and recharge during the middle of the week. Similar classes are now familiar in workplaces across the country, from old-line firms like AT&T to New Economy outfits like Yahoo. About 20 percent of employers have some kind of dedicated stress-reduction program in place, surveys find, and corporate spending has helped fuel what is an $11.7-billion-a-year-and-growing stress management industry, according to estimates by Marketdata Enterprises, a market analyst in Tampa, Fla.
      But as the menu of techniques expands to include not only chair and table massages but practices like tai chi, feng shui ("wind and water") and energy dances, the trend has prompted some experts to ask how effective the popular programs are, and whose interests they serve. They wonder if the effects are lasting or just provide a brief break in an ever-longer day. And wouldn't some employees really prefer a raise to a massage? Researchers are finding, among other things, that the benefits of stress reduction programs are generally short-lasting, and may be as useful to a demanding employer as they are to stressed-out workers.
      All agree that, in part, the courses have sprung up in reaction to the enormous shifts in the nature of work itself, the kaleidoscopic flow of electronic information, the way work obligations have pushed like a climbing vine into almost every corner of private life. "The sheer diversity of hours people are working is just startling," said Dr. Harriet Presser, a University of Maryland sociologist whose book "Working in a 24/7 Economy" (Russell Sage Foundation, 2003) explores the social and physical effects of commercial activity that depends on people working at all hours of the day and night. "For some people, like dual wage earners with kids," she added, "the sleep deprivation adds to the stress and it's like they are never, ever away" from work.
      But researchers say companies' interest in stress gurus and breathing lessons has as much to do with pushing workers as it does with real, sustained stress reduction. The programs took off in the expanding economy of the late 1990's, experts say, when the labor market was tight, and workers' compensation suits claiming damage from stress were on the rise. "These stress programs were a part of the concierge services that companies were using at that time so that employees didn't notice how many hours they were working," said Dr. Peter Cappelli, a professor of management and director of the Center for Human Resources at Wharton School of Business in Philadelphia, "and they held over since then."
      It does not take an M.B.A. to understand why. After his hour of yoga and meditation, Mr. Maccari said: "It's not that different from going to therapy, the way I see it. It takes one hour of your time, and youre mind is clear, and you approach the rest of the day in a completely different way." Meditation usually makes people feel, well, meditative. The downward-facing dog certainly beats jumping like a circus dog for a demanding boss. For those who like it, acupuncture can be a godsend. And even lobsters relax when given a massage (their eye stalks go limp).
      Dr. Lawrence Murphy, a psychologist at the National Institute of Occupational Safety and Health who has done extensive reviews of the research, says studies of workplace stress reduction typically pick up the immediate effect of the technique in question. Massages relieves stress when stress is determined by measuring muscle tightness. Meditation appears psychologically soothing when people are answering questionnaires about how calm they feel after the classes. In a 2001 analysis of 48 studies of occupational stress reduction programs, Dutch researchers came to the same conclusion: Courses teaching meditation, acceptance and letting go provide mild relief, at least in terms of what participants report after having taken the classes. But the effects are short-lived, said Dr. Murphy, unless people make the yoga or meditation a part of a regular, or even daily, routine, and ideally combine it with some other activity, like jogging or massage.
      For anyone with a spare hour or two in the day, or who is living comfortably off interest income, this regimen might make sense. For those whose daily lives demand a mental jujitsu with competing appointments and deadlines, however, a tai chi class becomes just that: another appointment, another deadline. "I love the yoga class, but I just can't get to it anymore; I'm running all day," said Wendy Rothman, a public relations officer at Armani Exchange.
      Time is what most stressed people crave, of course, and this is where mind-body relaxation techniques can backfire. While a lunchtime course may add quiet space to a workday, it can also prime people to put in longer hours. John Sheehey, a business consultant based near San Francisco, had acupuncture for six months while working long hours in Los Angeles. "Finally, my acupuncturist said, 'Hey, all I'm doing is tuning you up so you can keep running longer.' I think if your tendency is to be a workaholic, it just enables you to do that. If stress is a warning system that you're about to burn out, all you're doing is overriding it so you can stay in the game."
      Some providers of stress reduction services acknowledge this effect, said Holden Zalma, the chief executive of Metatouch, a massage therapy practice in Culver City, Calif., whose clients have included Earthlink, eToys and other technology companies. "We got them all addicted to massage in the 90's; it was wonderful," he said. "But we were very clear that we were not going to fix the stress problem, we were only going to patch it."
      The one workplace stress-reduction technique that seems to outperform all others in preventing the buildup of stress -- rather than reducing symptoms temporarily -- is a form of counseling called cognitive therapy. In these classes, people learn to challenge the sort of assumptions about their work (that every assignment must be perfect, for instance, or that they must impress everyone) that unnecessarily amplify the pressure they are already getting from people around them. In 18 studies, including more than 850 people working in a wide variety of jobs, from hospital cleaners to telecom workers, this kind of counseling has significantly reduced work complaints, sometimes in as few as six sessions of training. But there is a catch. The counseling has been tested almost exclusively among the sorts of workers who have some control over their own schedules, like bankers, engineers and other professionals.
      When it comes to job stress, control over one's work may be the most important factor, said Dr. Peter L. Schnall of the Center for Occupational and Environmental Health at the University of California at Irvine. Dr. Schnall and others have shown that the workers most likely to develop high blood pressure are those who work under deadlines with little control over what the workday will bring, like bus drivers on heavily traveled routes or nurses in frantic hospital wards.
      In one study, of 195 New York men followed for three years, Dr. Schnall found that people in these "high strain" jobs had significantly increased blood pressure during work and at home compared with men in less stressful jobs. "When people have some say over how and when their job is done,'' he said, "when they are able to learn new things on the job, when they are able to improve their skills and see them improving, these are the things that are most important" in managing strain.
      These are also the very properties that most people associate with a satisfying job. By contrast, the 50-some studies of on-site stress reduction programs show little effect on job satisfaction, Dr. Murphy said. "Turnover, employee absenteeism, commitment to the organization, pride at work -- there's no good evidence that any of those things are affected" by mind-body techniques, he said. "It's not rocket science. If you're still overworked, still have a supervisor who doesn't support you and is making all kinds of demands, you're going to be unhappy."
      Perhaps the most stressful of all jobs is the one that might soon be gone. Companies hoping to ease employees through layoffs or restructuring with meditation, tai chi or other mind-body techniques are serving weak tea to people in need of Scotch, say organizational psychologists who study plant closings and downsizing. Rare is the employee who is going to spend the middle of the day chanting like a monk when fighting to keep his or her job.
      In these circumstances, researchers find that what best keeps stress levels in check is telling employees as clearly and quickly as possible who is being laid off and why, and offering meaningful benefits, like help in finding another job, generous severance payments and psychotherapy if needed. "Everything else is window dressing," said Dr. James Campbell Quick, a stress researcher at the University of Texas at Arlington who helped advise the military in closing Kelly Air Force base in San Antonio, which employed 13,000 people.
      The skeptic's view of stress management, said Dr. Samuel Culbert, a professor of human resources and organization at the University of California at Los Angeles, is that the programs are a cheap diversion from the real problems, which companies and managers themselves are creating. "Human resources departments hypothetically have a fabulous role to play in bridging the gap between employees who want to do well at work and managers who want them to do well," Dr. Culbert said. "But once you hear about stress programs for employees, you have to start wondering whose interest is being represented."
      Certainly, many of those who teach stress-management classes know this story from both sides. Often self-employed and formerly in stressful jobs themselves, they are entirely at the whim of their clients, and their services are among the first to be cut when management changes or times are tough. "Once the economy started dying down after 2000," said Mr. Zalma, "we were the first to go. We had to transform the business entirely, to treat injuries and pain." In this economy, stress managers need stress management too.



Drug Industry Website Will Show Drug Trials
Associated Press, 9/7/2004

WASHINGTON-- An association that represents the nation's leading drug manufacturers said Tuesday it has created a Web site where companies can list clinical trials they sponsored for drugs approved by the Food and Drug Administration. Unlike the FDA's clinicaltrials.gov, the Pharmaceutical Research and Manufacturers of America site will not list trials that are still enrolling patients. Nor will the PhRMA site post details of every clinical trial that companies sponsor, as drug makers GlaxoSmithKline PLC, Merck & Co. and Forest Labs have promised to do. Beginning Oct. 1, the site will summarize results from selected trials completed since Oct. 1, 2002, on FDA-approved drugs. No details will be listed from clinical trials for drugs that fail to gain FDA approval.
      The announcement precedes a congressional hearing that will examine when the industry minimizes trials with negative results. At least seven drug makers are scheduled to testify Thursday at a hearing prompted by the discovery that unpublished data linked antidepressants to suicidal behavior in children. Caroline Loew, PhRMA vice president for scientific and regulatory affairs, said the group's announcement was ``not a direct response to the congressional environment.'' Loew is among the witnesses scheduled to testify during the House Energy and Commerce subcommittee session.
      Dr. Jeffrey Drazen, editor in chief of The New England Journal of Medicine, dismissed PhRMA's proposal as ``too little too late.'' Because PhRMA's registry remains voluntary, drug companies won't feel compelled to include studies that reflect negatively on their products. Dr. Catherine DeAngelis, editor in chief of The Journal of the American Medical Association, said doctors and patients should have access to all results from medical studies because such data may affect treatment decisions. The American Medical Association has called for a government-run registry to ensure that consumers and physicians can read details of industry-sponsored trials that question a drug's safety.
      Later this week, editors of leading medical journals are expected to announce they will reject papers unless researchers include clinical trials in such a public registry as patients are first enrolled, The Wall Street Journal reported Tuesday. Alan Goldhammer, PhRMA associate vice president for regulatory affairs, said his group knew about the editors' plans. The group will take a ``hard look'' at the journals' formal announcement, he said, and remains open to suggested improvements. Still, Goldhammer said, PhRMA remains committed to its own Web site's mission. The PhRMA site aims to help physicians find drug information offered, bit by bit, through conference abstracts, posters and unpublished studies that didn't sufficiently pique the interest of journal editors, he said.
      The pharmaceutical industry is facing rising pressure from several sources to become more open in reporting clinical trial results. Forest Laboratories became on Tuesday the second company to announce it would begin its own Web-based clinical trials registry. New York Attorney General Eliot Spitzer inquired in June about off-label uses of the company's drugs, including Lexapro and Celexa. The New York-based company will post clinical studies involving children's use of those antidepressants on the Web. Forest Labs also will summarize results of all drug trials it sponsored after Jan. 1, 2000, the attorney general's office announced.
      And, elsewhere in Congress, Sens. Chris Dodd, D-Conn., and Edward M. Kennedy, D-Mass., said they will propose legislation within the coming days to make such clinical trial listings mandatory. ``Voluntary measures are fine -- to a point. But what is needed is federal legislation that will require all of the companies to do this,'' said Jim Manley, press secretary for Kennedy.
      Loew said the industry has a good record of compliance, and government mandates often take years to implement. ``We don't believe this needs to be mandated,'' Loew said. ``We believe that (companies) will be posting data. But it's out there. It's open for people to see. We would welcome the public and the media to look at it and to, you know, hold our feet to the fire.''
      On the Net: Pharmaceutical Research and Manufacturers of America: http://www.phrma.org/

Gene May Link Alcoholism and Depression
Cheryl Wittenauer, Associated Press- 9/8/2004

ST. LOUIS -- Scientists say they've identified a gene that appears to be linked to both alcoholism and depression, a finding that may one day help identify those at higher risk for the diseases and guide new treatments. Previous studies of twins and adopted siblings have suggested there likely are genes in common underlying alcoholism and depression, and that the two disorders seem to run in families. But the lead researcher of the new study says this is the first report of a specific gene that seems to increase risk for both disorders. "Clinicians have observed a connection between these two disorders for years, so we are excited to have found what could be a molecular underpinning for that association," said Alison Goate, the Washington University School of Medicine researcher who led the study.
      Follow-up research might help reveal the underlying biology that makes some people susceptible to alcoholism, others to depression, some to both diseases, and others to neither. Goate says a variation or alteration of the CHRM2 gene influences those four separate conditions. The study is published in the September issue of the journal Human Molecular Genetics.
      "What you want is to see someone obtain the same results in an independent study," said Goate, a psychiatric geneticist. Goate said the researchers will know in a few weeks whether they can replicate the finding from another group of people they're studying.
      Peter McGuffin, a psychiatric geneticist at the Institute of Psychiatry at King's College in London, said that if Goate's finding holds and is replicated by others, it will provide another potential target for developing new drugs to treat depression and alcoholism. McGuffin, who said he is working "feverishly" on the genetics of depression, said it is the first time this particular gene has been implicated. He said probably multiple genes are involved in these two disorders. Alcoholism affects 7.9 million American adults, and 18.8 million suffer from depression, according to the National Institutes of Health.
      Goate's team analyzed DNA from 2,310 people from 262 families in which at least three members were alcoholic. Some individuals in these families were also depressed alcoholics. Both groups had similar distinguishing characteristics in their DNA in a region on chromosome 7. Participants with both maladies were most likely to have the genetic similarity. Within that region of the chromosome, researchers isolated the CHRM2 gene, which is involved in attention, learning, memory and cognition. Goate's team found the gene was strongly associated with both alcoholism and depression. The association was strongest in those with both disorders, suggesting it's a susceptibility gene that puts people at risk for developing both diseases.



Zoloft Creator Hard-Pressed to Fathom What He's Wrought
Katrina T. Gathers, Associated Press- 9/9/2004

LEDYARD, Conn. -- Standing on a brightly lit stage, the picture from an overhead projector filling a screen behind him, Ken Koe looked uncomfortable. He smiled and blinked, shifted his weight and stole glances at a nearby exit as one speaker after another extolled his accomplishments as a scientist.
      A diminutive, bespectacled man, his hair sprinkled with gray, Koe would have preferred to be somewhere else. But there he was one day this spring, accepting an award from Pfizer Inc.'s Asian Pacific American Group , which recognized him for his role in developing Zoloft, the blockbuster drug used to treat depression, panic disorder, obsessive-compulsive disorder and post-traumatic stress disorder. "What am I going to do with this?" Koe asked, pointing to a glass statuette inscribed with his name. He shrugged, hoisted the gift for the audience to see and just as quickly set it down on the podium, hoping to quiet the applause that bounced off the walls in an auditorium at Pfizer's Groton facility.
      At home in Ledyard days later, Koe would warm to the tale, flailing his arms in the air, tracing equations on an imaginary chalkboard as he recalled in an interview his early years in Groton and the setbacks that preceded his work on Zoloft, which was introduced to the public 12 years ago. Pfizer has received hundreds of notes from aunts, grandfathers and wives praising the work of Koe and a colleague, Willard Welch. Koe has been stopped in grocery stores and at church, hugged by strangers eager to show their appreciation for a drug that's enabled them to go to work, volunteer in their communities and spend time with their families -- activities that otherwise would be all but impossible for them to enjoy. Nevertheless, the retired Koe, 79, said he still finds it hard to fathom the impact of the anti-depressant that's been prescribed for more than 115 million people in the United States. "I think of a white chemical in a bottle when I think of Zoloft," he said.
      Zoloft, the brand name for the chemical sertraline hydrochloride, is a selective serotonin reuptake inhibitor, or SSRI, a class of drugs that boosts the level of the neurotransmitter serotonin in the brain. Serotonin acts as a "messenger," sending signals to the brain that help patients function.
      In 1955, Koe began work in Pfizer's Brooklyn, N.Y., lab as a chemist, developing antibiotics. Four years later, he moved to the Groton facility, where he began studying serotonin in animals, research that would help lay the groundwork for the development of Zoloft. Later, in the 1970s, Koe searched for ways to treat pain without the use of opiates. During his 40 years at Pfizer, Koe authored more than 100 articles and papers. "He was always someone who put the quality of the science before all else," said Jim Heym, vice president of discovery at Pfizer's Groton-New London labs and a neuroscientist by training. "His results were beyond reproach and were highly reproducible. He set a high example for all (the people) who were around him."
      Koe learned to review previous studies and to build on findings that had failed to lead to successful products. In his early work with serotonin, for example, he studied the chemical tametraline, which proved ineffective as an anti-depressant. Tests showed the chemical functioned more as a stimulant, a use Pfizer was not interested in pursuing. Although his research had failed to yield the desired result, Koe was convinced that the development of a viable anti-depressant was within reach. "We knew we were looking for drugs for mental disorders, so those things are always in your mind," he said. "It's constant background noise." That was 1978.
      In a memo to Pfizer's director of chemistry, Chuck Harbert, Koe hypothesized that one or two chlorine atoms could be introduced into a tametraline molecule to produce new molecules potent enough to boost the level of serotonin in the brain. "Usually, directors just ignore your memos, but Chuck followed up on it and assigned a scientist to it," Koe said. Harbert assigned Welch, a chemist in Pfizer's central nervous system group, to make the new molecules. Welch completed the work and Koe performed tests in his lab to show that one of the new molecules, sertraline, acts as an SSRI.
      But the new compound, which was to be marketed as Zoloft, didn't fly onto pharmacy shelves. It was first approved for marketing in the United Kingdom in December 1990. One year later, the U.S. Food and Drug Administration approved the drug -- 13 years after the initial testing was begun, a span not uncommon in the pharmaceutical world. "Making pharmaceutical drugs takes so much preparation," Koe said. "That light bulb going on takes time to cultivate."
      Born in Astoria, Ore., and raised in Portland, Koe was the oldest of three children. His family lived in a moderate-size Asian community, where Koe worked part time in a Chinese restaurant and attended language school in the evenings and on Saturdays. "We were young and impressionable and our teachers were trying to instill a sense of Chinese, of your heritage," he said. "Some of it kind of rubbed off on me, but not until later." Koe earned his undergraduate degree at Reed College in Portland, which he attended on a scholarship, and got his master's at the University of Washington and his doctorate at the California Institute of Technology. He married his wife, Jo Ann, shortly before starting work at Pfizer. When the Koes moved to Ledyard in 1959, Jo Ann began a 25-year career as a teacher at the Juliet W. Long School.
      Koe retired in 1995. Thinking back, he said he would have stopped working earlier had he known his wife of 40 years would die that same year. He still lives in the same Woodridge Circle home that he and his wife designed and where they raised their two daughters. The dwelling reflects Koe's Chinese heritage. Koe continues to dabble in the scientific world. He attends a conference each year as a consultant for Pfizer, picking up new trends in the industry and reporting back to the drug company. "We still work on things that Ken was active in 10 years ago," said Heym, the Pfizer vice president. "Some of the techniques he used are standard biochemical techniques that we use today."

Journals Insist Drug Trials Be Registered
Shankar Vedantam,Washington Post- 9/9/2004

The Food and Drug Administration has repeatedly urged antidepressant manufacturers not to disclose to physicians and the public that some clinical trials of the medications in children found the drugs were no better than sugar pills, according to documents and testimony released at a congressional hearing yesterday. Regulators suppressed the negative information on the grounds that it might scare families and physicians away from the drugs, according to testimony by drug company executives. For at least three medications, they said, the FDA blocked the companies' plans to reveal the negative studies, and in one case the agency reversed a manufacturer's decision to disclose that its drug was associated in studies with increased hostility and suicidal thinking among children.
      "Why would FDA require a company to remove stronger labeling?" demanded an incredulous Rep. Greg Walden (R-Ore.) yesterday, at a hearing of the House Energy and Commerce subcommittee on oversight and investigations. "FDA should want to encourage a company to do that kind of thing." Janet Woodcock, FDA's deputy commissioner for operations, responded that regulators believe the jury is still out on the drugs. The negative trials, she said, did not mean the medications were ineffective.
      Several representatives noted that the study results were obtained at tremendous cost to the American public because Congress granted companies profitable patent extensions as an incentive to conduct the trials. Rep. Henry A. Waxman (D-Calif.), a member of the subcommittee, said it was absurd to give companies profitable patent extensions on their drugs to encourage the trials and then limit dissemination of the results. He said his staff had estimated that a patent extension given to Pfizer Inc. was worth $1 billion dollars. Wyeth Pharmaceuticals, he said, made $500 million.
      The hearing was prompted by widespread complaints that crucial information about the safety and effectiveness of antidepressant medications had not been communicated to physicians and the public. More than two-thirds of all studies of antidepressant use among depressed children have failed to show the drugs are effective.
      Prozac is the only medicine to be specifically approved to treat children's depression, but a number of other drugs are widely prescribed. Most physicians have not had access to the negative data and are prescribing the drugs to millions of American children largely because the drugs have proven effective among adults. Two internal FDA analyses recently concluded that the class of medications is associated with an increased risk of suicidal behavior among children.
      At the hearing, Pfizer Vice President Cathryn M. Clary testified that FDA had told the company that existing language in the label for Zoloft, which suggested "that efficacy has not been established" for depressed children, was sufficient. Pfizer had planned to add that two studies of Zoloft found the medication was no better than sugar pills.
      FDA's Woodcock said agency officials had told Wyeth to scale back a label change that warned that the drug Effexor had been linked to suicidal thoughts, hostility and self-harm. "It was not very understandable," Woodcock said in an interview when asked why the FDA had found the Wyeth label objectionable. Wyeth and other companies were instead asked to insert a general caution that physicians should carefully monitor the risk of suicide among all patients with depression. Agency officials said at the time that the caution was a reiteration of good clinical practice.
      Joseph S. Camardo, senior vice president at Wyeth Pharmaceuticals, said company scientists had disagreed with the FDA on how to interpret the data in its labeling. "We thought our proposal was reasonable, so it was a bit of a surprise," he said of the FDA ruling that substituted a less pointed warning.
      In the agency's most recent internal review of the antidepressant studies, FDA scientist Tarek Hammad concluded in August that children taking Effexor had 8.84 times the risk of suicidal behavior or thinking compared with children taking sugar pills. British authorities warned physicians last year not to prescribe a range of antidepressants to children. The FDA has called for a more cautious interpretation of the data, which an agency advisory committee is expected to discuss at a meeting next week.
      Yesterday's hearings, which included testimony from officials from seven pharmaceutical companies, grappled with ways to make negative study results about drugs more accessible to the public. Recent proposals by manufacturers, medical journal editors and members of Congress have called for various schemes for publicly registering all drug trials and, in some cases, disclosing the results.

Operator Fired From Two Homes for Mentally Ill
Clifford Levy, New York Times- 9/9/2004

The Pataki administration abruptly removed the new operator of a notorious adult home for the mentally ill in Queens yesterday, all but acknowledging that it had failed to examine his record when it put him in charge last month. The operator, Meyer Weber, was allowed to take over the 125-bed home, Ocean House, in Far Rockaway, even though another home for the mentally ill he runs in Albany had been cited for life-threatening violations in June, and two nursing homes he ran in Connecticut were seized by that state last year after nearly collapsing from financial malfeasance.
      The Pataki administration yesterday also barred Mr. Weber from running the Albany home, the 88-bed Pearl of Wisdom. In legal papers, officials offered new evidence of problems at Pearl of Wisdom that called into question why he was installed at Ocean House, and whether the administration had followed through on its pledge to reform the state's adult home system. Inspectors found that food was in such short supply at Pearl of Wisdom that some residents received no dinner. Twenty-six residents were deprived of psychotropic, cardiac and diabetic medication, some for as long as two weeks, with one missing angina pills for a month. Workers, including supervisors, resigned after not being paid.
      The State Health Department, which regulates adult homes, moved against Mr. Weber after The New York Times reported late last month on his appointment at Ocean House. Robert Kenny, a spokesman for the State Health Department, said Mr. Weber had been removed from the two homes "to protect the health and safety of residents." "We have placed temporary operators in the respective facilities to ensure that residents are receiving quality services and care," Mr. Kenny said. Asked whether the department had properly scrutinized Mr. Weber's record before installing him at Ocean House, Mr. Kenny would not comment. Mr. Weber also declined to comment.
      The removal of Mr. Weber means more turmoil for Ocean House, which has become a grim symbol of lax state regulation and poor, even corrupt, private management of the adult homes, which shelter 15,000 mentally ill people in New York. The State Department of Health installed Mr. Weber in August at Ocean House after the previous operator, Sherman Taub, pleaded guilty to a scheme to steal more than $2 million from the home. Mr. Taub, a disgraced lawyer, had been allowed to take over Ocean House by the Pataki administration in the mid-1990's after his brother-in-law, Beryl Zyskind, himself went to prison for diverting millions in revenue from the home for his personal use. Mr. Weber had been running Ocean House on a temporary basis while his application to become the permanent operator was pending. The new temporary operator is New York Hospital Medical Center of Queens.
      The Health Department named the Eddy Inc., an upstate health-care provider, to run Pearl of Wisdom temporarily. In fact, an examination of Mr. Weber's contacts with the Health Department shows that twice since last fall, it let him run adult homes despite his record. He was allowed by the Health Department to become permanent operator at Pearl of Wisdom last November a month after state officials in Connecticut went to court to seize his two nursing homes, Coleman Park in Bridgeport, which has 123 beds, and Rosewood in Waterbury, which has 84 beds. In June, a state inspection of Pearl of Wisdom revealed many problems. Still, the department approved Mr. Weber to run Ocean House in August.

Report: Prescription Drug Abuse on Rise
Associated Press, 9/9/2004

WASHINGTON -- Fewer American youths are using marijuana, LSD and Ecstasy, but more are abusing prescription drugs, the government reported Thursday. The 2003 National Survey on Drug Use and Health also found that youths and young adults are more aware of the risks of using pot. The study did find a 5 percent decline in the number of 12- to 17-year-olds who say they ever have used marijuana. Among 12- and 13-year olds, current marijuana smokers -- those who said they used it within a month of the survey -- declined nearly 30 percent. ``It is encouraging news that more American youths are getting the message that drugs are dangerous, including marijuana,'' Health and Human Services Secretary Tommy Thompson said.
      The survey was based on in-home interviews with 67,784 respondents age 12 and older. The margin of error for the survey is plus or minus 3 percentage points. For youths 12 to 17, use of Ecstasy and LSD in the year leading up to the survey dropped significantly -- 41 percent for Ecstasy and 54 percent for LSD. The study, which also included adults, found that overall nearly 20 million people 12 and older use illegal drugs. But there was a 20 percent decline between 2002 and 2003 in the number of youths described as ``heavy users'' of pot -- meaning they smoke daily or at least 20 days each month.
      Rates of tobacco use, however, remained fairly constant among all age groups. Almost 30 percent of people 12 and older reported that they had used it in the past month, compared with 30.4 percent in 2002. People 18 to 25 continued to have the highest rate of current use of cigarettes -- 40.2 percent, compared with 40.8 percent in 2002. Among boys age 12 to 17, 11.9 percent reported current cigarette use, down from 12.3 percent in 2002. There was a bigger dip among girls in that age group. Some 12.5 percent reported they had smoked cigarettes in the past month, compared with 13.6 in 2003.
      Survey results on alcohol use showed little change in the number of binge and heavy drinkers. About 54 million people 12 and older binged -- five or more alcoholic drinks -- at least once a month. Also, 16.1 million people were termed heavy drinkers, described as consuming five or more drinks on at least five separate occasions in a month. People 18 to 25 showed the highest prevalence of binge and heavy drinking. ``Obviously, we have a long way to go when it comes to smoking and even more so when for underage drinking,'' said Charles G. Curie, administrator of the Substance Abuse and Mental Health Services Administration. ``It remains a stubborn and destructive problem.''
      The study also found that more people had tried prescription pain relievers who did not need them for medical reasons. The most striking increase was a 15 percent rise in prescription drug abuse by people 18 to 25. In the broader population of 12 and over, 5 percent more people took those drugs recreationally.
      The study found that young people who were exposed to anti-drug messages outside school took notice, with rates of current pot use 25 percent lower than those who did not get those messages. And youths who believed their parents would strongly disapprove of marijuana used it 80 percent less than others.
     Among the other findings were these:
--Drunken driving declined from 2002, but drugged driving held steady.
--Smoking rates remained largely unchanged overall, with 71 million people who had used tobacco in the previous month. But fewer youths reported smoking in the previous year or ever.
--About 2.3 million people had used cocaine in the previous month, 1 million had used hallucinogens and 119,000 had used heroin.
--Of the nearly 17 million adult users of illegal drugs last year, nearly three-fourths had jobs.
--Marijuana continues to be the most commonly used illegal drug, with 14.6 million using it at least once a month, according to the survey. About two-thirds of new users surveyed were under 18.

Mom Fights to Bring Awareness of Disorder
Karen Mellen, Chicago Tribune- 9/10/004

Vivian Botka of Streator knows her 21-year-old adopted daughter, Kristy, who has a very low IQ and needs help feeding and dressing herself, is the extreme outcome from fetal alcohol syndrome. But about 1 percent--or about 40,000--of babies born each year suffer from fetal alcohol spectrum disorders, a wide range of problems from facial deformities to growth deficits to hyperactivity, caused by alcohol consumption during pregnancy, according to advocates.
     On Thursday, Illinois commemorated its first-ever Fetal Alcohol Syndrome Awareness Day, designated in a proclamation signed by Gov. Rod Blagojevich after Botka lobbied state officials. Although advocates concede that a proclamation is not as helpful as more money for prevention or treatment programs, they say that even small steps are necessary to educate the public and combat apathy.
      Emerging research suggests even a few drinks can harm a fetus in some pregnant women. But a survey of obstetricians by the American College of Obstetricians and Gynecologists in 1998 found about half of doctors questioned believed the occasional use of alcohol would not increase the risk of damage. That has led advocates to focus more energy on getting the word out to doctors and pregnant women who occasionally drink wine or beer. Studies show the most severe cases of fetal alcohol syndrome are caused by consuming significant amounts of alcohol.
      "Everyone recognizes that fetal alcohol syndrome is the leading cause of diagnosable mental retardation in the United States, and that's true," said Dr. Ira J. Chasnoff, a pediatrician at Chicago's Children's Research Triangle, which annually takes in 1,000 new patients. "However, the majority of children we see here have normal intelligence. ... The children look normal, and they have normal cognitive development. But they have severe problems in learning and behavior and development." These children often suffer from fetal alcohol spectrum disorders, which include a broad range of symptoms caused by alcohol exposure. Learning disabilities and behavioral problems are two examples.
      Chasnoff said medication sometimes is prescribed to treat symptoms and that therapy for the family and child is recommended. But all that can be prevented, he stresses, if women are encouraged to stop drinking entirely when they learn they are pregnant. The College of Obstetricians and Gynecologists, in literature available to patients, also tells women that the best course is to not drink any alcohol during pregnancy because it is unclear how much alcohol is too much.
      Chasnoff said not every woman who drinks alcohol during pregnancy will bear a child with fetal alcohol syndrome or fetal alcohol spectrum disorders. That's because genetics affect how a woman's body breaks down alcohol, and alcohol is more harmful at specific times during pregnancy, doctors say. Chasnoff said his center regularly has cases in which one fraternal twin has fetal alcohol syndrome and the other does not, showing genetic differences in babies also can contribute to the severity of problems from alcohol. "If you want what's best for our children, you simply won't drink during pregnancy," he said.
      In general, studies show the most severe cases of mental retardation and brain damage are caused by excessive alcohol consumption by pregnant women, including binge drinking. That was likely the case for Kristy Botka, her mother said. As a result, the National Organization on Fetal Alcohol Syndrome continues to push for more screening of pregnant women who are at risk of drinking heavily, to refer them to Alcoholics Anonymous meetings, for instance, or even in-patient treatment until the due date. That's not an easy job, as many women may not be forthright when discussing alcohol dependency, said Adam Litle, director of government affairs for the Washington-based organization. "There's a lot of shame and blame that goes with the mother," he said.
      But Botka, like other adoptive parents of children with fetal alcohol syndrome, hopes to change the stigma. She believes that no mother willingly would harm her child, but that pregnant women need to understand better the risks they face in drinking alcohol. "They weren't abused by their mothers; I believe all mothers love their children," Botka said. "We have to better educate doctors--educate doctors that mom's not to drink."
      When Botka and her late husband adopted Kristy at the age of 6 months, they knew she had problems but not the nature of them. "It didn't matter," Botka said. "What better baby to have, than one who needs more help?" Now, Botka said her daughter is learning independent living skills at Trinity Services in Mokena. She does not speak but can make the "g" sound, or lead her family to the object she wants. Botka said she would continue to lobby for more services for children who are disabled because of alcohol use, as well as push for more prevention of drinking for mothers. "We just want to make sure children are diagnosed right, so they get the right services," she said.



Drug Makers Explain Trials to Congress
Associated Press, 9/10/2004

WASHINGTON -- Drug manufacturers acknowledge they face a crisis of credibility that they hope to remedy by releasing information about their clinical trials in multiple locations. But at a contentious congressional hearing Thursday, representatives of the companies said they also are concerned that releasing all of the information will be so unwieldy that it could confuse doctors and patients.
      Dr. John R. Hayes, product team leader at Eli Lilly and Co., said a single report about a drug can number more than 400,000 pages. Flooding a Web site with 120,000 clinical trials may dilute the usefulness of the information, said Dr. David Wheadon, senior vice president of regulatory affairs for Philadelphia-based GlaxoSmithKline. ``We always want to make sure we're serving the good, the right purpose,'' he said. The pair testified at a House subcommittee hearing designed to give seven drug companies an opportunity to explain how they did -- or did not -- disclose studies that suggested links between antidepressant use and suicidal thoughts in children.
     Controversy first flared last summer with the disclosure that unpublished studies made that link. ``I think these hearings are evidence of the fact there is a great deal of mistrust,'' Hayes told reporters during a break.
      Federal health officials are preparing stronger warnings for some antidepressants used in children. But exactly what those warnings will say, and which drugs will be affected, hasn't been settled. An FDA advisory committee will consider the issue next week.
      ``While there remains a signal of risk ... for some drugs in some trials, it is important to note that the data are not black-and-white in providing a clear and definitive answer,'' Food and Drug Administration psychiatric drugs chief, Dr. Thomas Laughren, wrote the advisory panel last month.
      At the House subcommittee on oversight and investigations hearing Thursday, tempers flared, tears flowed and a major drug company Wyeth Pharmaceuticals found itself pitted against the FDA.
      As early as 2002, Wyeth attempted to add warning labels to its antidepressant Effexor, but ran into FDA opposition. The ultimate label changes mandated by the FDA dropped references to increased hostility seen with Effexor, Wyeth acknowledged under questioning from the panel's vice chairman, Rep. Greg Walden, R-Ore. Adopting FDA's wording was a ``reasonable compromise,'' Dr. Joseph Camardo, senior vice president of medical affairs for Wyeth, testified.
      Earlier in the hearing, Walden asked Dr. Janet Woodcock, FDA deputy commissioner for operations, whether the agency pressured drug companies to not issue such warnings. Woodcock began to say the agency cannot compel companies to reveal information about clinical trials for drugs pending review. Walden interrupted. ``But some of them have asked you for the ability to release that information, and you said no.'' ``I don't have information on that,'' Woodcock said.
      The panel's acting chair, Rep. Joe Barton, R-Texas, had already sharply criticized the FDA for what he described as the agency's reluctance to release records, which he said hampered the subcommittee's ability to investigate. Because of the volume of records, the FDA had offered to have records reviewed at the agency, an offer that still stands, Woodcock said.
      Subcommittee members said the FDA and drug companies have provided scant details of pediatric clinical trials for antidepressants. And, when the agency last month did publish five summaries, it did not include crucial details, such as links between antidepressants and heightened suicidal thoughts among children, said Rep. Bart Stupak, D-Mich. Stupak has been a harsh critic of the acne drug Accutane since his son committed suicide while using the drug, which has been linked to depression in some people.
      Reps. Edward Markey and Henry Waxman will propose legislation that would create a mandatory registry for drug trials. The drug industry this week also announced a new Web site where companies could voluntarily summarize clinical trial results for drugs approved by the FDA.
      Among the potential legislative solutions being considered by the panel: Resuscitating an amendment from Stupak requiring clinical trial publication and label changes before drug manufacturers receive six-month patent extensions for drugs they test in children. Such exclusive marketing to children yielded an extra $4 billion for drug makers of such leading antidepressants as Prozac, Zoloft, Paxil, Luvox, Celexa and Effexor, data released by the committee indicates.

Chicago Forum Tackles Autism Issues
Lisa Black, Chicago Tribune- 9/10/2004

Parents must demand better services and health insurance for their autistic children--a blunt message delivered at a North Shore seminar that attracted 200 people, more than double the number expected. The state should push for legislation to help people whose insurance policies typically reject treatments such as speech therapy for the neurological disability, experts said Wednesday during the meeting at Field School in Northbrook. "In our country we have a long tradition of discrimination with mental disorders," said Dr. Bennett Leventhal, a psychiatrist at the University of Chicago who helped discover the first gene for autism. "People are going to have to put their foot down and say there has to be parity in coverage."
      Parents from across the Chicago area described how they were shocked, then overwhelmed after learning their children had autism. Common symptoms include lack of eye contact, trouble with social interaction, repetitive behavior and speech and sensory problems. "It's a strange disorder because the kids seem normal on the surface sometimes, but they have serious, serious deficits," said Libertyville resident Christopher Kennedy, an attorney who 18 months ago learned his daughter, Shea, 3, is autistic. Kennedy is legislative chairman for the Autism Society of Illinois, which is pushing for a law that would make more children eligible for Medicaid.
      Legislators recently formed a task force to study autism but stopped short of approving new funding, officials said. Wednesday's forum was sponsored by the society, the Jewish Children's Bureau and state Sen. Susan Garrett (D-Lake Forest), who is on the Senate's Health and Human Services Committee. The need is obvious, said Garrett, who had to move the forum to a larger location because of the response.
      Mt. Prospect resident Barbara Mitalo attended the meeting. A year ago, she learned that her son, Jake, 3, has autism. Mitalo first began to worry when her son did not start talking at age 2. "You would call his name, and he wouldn't respond. We knew something was wrong," said Mitalo, whose son flaps his arms when excited and is learning to say words such as "drink."
      Linda Silber, an occupational therapist in Vernon Hills, said that in the last six years she has seen the number of autism diagnoses in children double. "One of the biggest issues is how . . . children are going to be worked with in the school system," she said. "It isn't that the school systems aren't trying. I think they're really taxed." Between 1997 and 2003, autism cases in Illinois schools doubled to 5,215 students, according to the Illinois State Board of Education. Leventhal believes the numbers only appear to be rising because the definition of autism has expanded and is classified differently than it used to be by schools.
      The cause of the disability baffles researchers, who believe it involves up to 20 genes that interact with one another and the environment in ways that aren't understood, said Dr. Michael Chez, a pediatric neurologist in Lake Bluff. Chez and Leventhal disputed the theory that children's vaccinations cause autism. Earlier this year, the Institute of Medicine reported that there is no evidence that the mercury-based vaccine preservative Thimerosal causes the disorder. "There are risks to any vaccination, but the risks of non-vaccinating may be worse," said Chez, sparking some dissension in the audience.
      No matter what its cause or how many cases exist, Kennedy argues that Illinois must support families by helping pay for treatments that fit children's individual needs. "Parents are in a giant rush to get their kids treated and educated during the period of time when their brains are most plastic and able to get around the neurological problems of autism," he said. "You know you can make an improvement, you don't know how much you can make, but you have a ticking clock."

L.A. Domestic Violence Hotline Stays Connected
Arlene Martínez, Los Angeles Times- 9/10/2004

Nicole Brown Simpson was found murdered 10 years ago. Her former husband, O.J. Simpson, who had been accused of spousal battery during their marriage, was charged with the crime. The trial riveted the nation, and that public interest created momentum for reforms in the criminal justice system, including creation of the Los Angeles County domestic violence hotline.
      The case highlighted the fact that domestic violence "could affect anyone across all cultures and economic groups," said Carol Baker, director of the Los Angeles County Bureau of Crime Prevention and Youth Services. "If someone with means can't get out, you can imagine how it is with people who don't have the resources," Baker said.
      The hotline recently added five languages — Tagalog, Khmer, Japanese, Thai and Armenian — to now total 11. English, Spanish, Korean, Vietnamese, Cantonese and Mandarin continue to be offered. "A lot of services have a separate hotline, but we wanted to have one hotline that anyone could call that could connect them to … help them find shelter and safety," said Mark Delgado, deputy director of the Bureau of Crime Prevention and Youth Services. "The last thing we want is for language to prevent anybody who needs assistance from coming forward."
      Twenty shelters are associated with the hotline. The hotline routes the caller to the appropriate agency. Organizations like Rainbow Services offer assistance to Spanish speakers, while the Glendale YWCA helps Armenian speakers. The Center for the Pan Pacific Asian Family offers counselors who speak seven Asian and Pacific Islander languages.
      The U.S. Justice Department estimates that 960,000 to 4-million incidents of domestic violence occur each year. In its first year, the hotline received an average 394 calls a month. Last year, the hotline recorded 1,359 calls a month, according to the district attorney's office. The cost of the service is $10,000 per year, paid for through a combination of government grants, corporate and organizational funds and private donations. Advocates have applauded the additional language service.
      Like the Latino community, the Asian population is not homogenous, said Debra Suh, executive director of the Center for the Pan Pacific Asian Family. Tending to the linguistic and cultural backgrounds of the area's diverse populations is a constant challenge. "The [Asian Pacific Islander population] has so many different languages," said Chun-Yen Chen, executive director of the Asian Pacific Women's Center in Los Angeles. "Even we still struggle for outreach and language." Her center does not serve the Hmong population because there are no volunteers who speak the language. Recently, a hearing-impaired Cantonese-speaking woman came into the shelter. The staff was forced to scramble to get someone who could communicate with her.
      Justice Department statistics show domestic violence is consistent across racial and ethnic boundaries. And while research suggests that immigrant women are as likely to be abused as U.S.-born women, they face additional hardships. Not understanding English, a lack of understanding of immigration law and, most importantly, fear over legal status are some of the additional issues for foreign-born women, said Leslye Orloff, director of Immigrant Women Program at Washington, D.C.-based Legal Momentum. "Immigrants are less likely to get help than U.S.-born women," Orloff said. "The biggest single barrier is not language access. The biggest barrier is fear of deportation."
      Even if an abused woman knows enough to file for her immigration status — which under law she can apply for on her own if her husband is a U.S. citizen — the process often takes a year or two. During that time, a woman is not eligible to work. And with few work skills and limited English abilities, even with legal status, the situation seems bleak. Orloff said battered immigrants sometimes must chose between danger at home and starvation and poverty if they leave.
      Laws in a woman's home country also can affect how or if an immigrant seeks help in the United States. In the Philippines, for example, divorce is illegal. Chilean law also banned divorce until recently. An old Mexican law, abandono de hogar, makes it illegal to abandon one's house or family. "Their culture tells them not to leave, to try to maintain their marriage … ," said Chen, of the Asian Pacific Women's Center in Los Angeles.