Noteworthy News Articles on Mental Health Topics, March 8-16, 2008 Gardiner Harris, New York Times- 3/8/2008 WASHINGTON — Study after study has failed to show any link between vaccines and autism, but many parents of autistic children remain unconvinced. For the skeptics, the case of 9-year-old Hannah Poling shows that they have been right along. The government has conceded that vaccines may have hurt Hannah, and it has agreed to pay her family for her care. Advocates say the settlement — reached last fall in a federal compensation court for people injured by vaccines, but disclosed only in recent days — is a long-overdue government recognition that vaccinations can cause autism. “This decision gives people significant reason to be cautious about vaccinating their children,” John Gilmore, executive director of the group Autism United, said Friday. Mr. Gilmore has filed his own claim that his son became autistic as a result of vaccinations. Government officials say they have made no such concession. “Let me be very clear that the government has made absolutely no statement indicating that vaccines are a cause of autism,” Dr. Julie L. Gerberding, director of the Centers for Disease Control and Prevention said Thursday. “That is a complete mischaracterization of the findings of the case and a complete mischaracterization of any of the science that we have at our disposal today.” Hannah, of Athens, Ga., was 19 months old and developing normally in 2000 when she received five shots against nine infectious diseases. Two days later, she developed a fever, cried inconsolably and refused to walk. Over the next seven months she spiraled downward, and in 2001 she was given a diagnosis of autism. Hannah’s father, Dr. Jon Poling, was a neurology resident at Johns Hopkins Hospital at the time, and she underwent an intensive series of tests that found a disorder in her mitochondria, the energy factories of the cells. Such disorders are uncommon, their effects can be significant but varied, and the problems associated with them can show up immediately or lie dormant for years. There are two theories about what happened to Hannah, said her mother, Terry Poling. The first is that she had an underlying mitochondrial disorder that vaccinations aggravated. The second is that vaccinations caused this disorder. “The government chose to believe the first theory,” Ms. Poling said, but added, “We don’t know that she had an underlying disorder.” In a news conference on Thursday, Dr. Edwin Trevathan, director of the National Center for Birth Defects and Development Disabilities at the disease control agency, said, “I don’t think we have any science that would lead us to believe that mitochondrial disorders are caused by vaccines.” Dr. Trevathan explained that children with mitochondrial disorders often develop normally until they come down with an infection. Then their mitochondria are unable to manufacture the energy needed to nourish the brain. As a result, they regress. The Poling case has become a flashpoint in the long-running controversy over thimerosal, a vaccine preservative containing mercury. Some people believe that thimerosal is behind the rising number of autism diagnoses. Among them is Lyn Redwood, director of the Coalition for SafeMinds. Many of the vaccines Hannah received contained thimerosal, and to Ms. Redwood, she is more proof of thimerosal’s dangers. The disease control centers, the Food and Drug Administration, the Institute of Medicine, the World Health Organization and the American Academy of Pediatrics have all largely dismissed the notion that thimerosal causes or contributes to autism. Five major studies have found no link, and since thimerosal’s removal from all routinely administered childhood vaccines in 2001, there has been no apparent effect on autism rates. Many of those who believe in an autism-vaccine link dismiss all this evidence, and Hannah’s case fuels their cause. “Her story is very important because it echoes so many others, and it’s clear that thimerosal played a role,” said Rita Shreffler, executive director of the National Autism Association. Dr. and Mrs. Poling said Hannah did not prove the case against thimerosal, but Dr. Poling noted that there was no debate that vaccines had risks. “They’re not safe for everybody,” he said, “and one person for whom they proved unsafe happened to be my daughter.” Lilly Waited Too Long to Warn About Schizophrenia Drug, Doctor Testifies Alex Berenson, New York Times- 3/8/2008 ANCHORAGE — Eli Lilly, the drug maker, could and should have warned physicians as early as 1998 about the link between Zyprexa, its best-selling schizophrenia medicine, and diabetes, an expert witness told jurors Friday in a lawsuit that claims that Zyprexa has caused many mentally ill people to develop diabetes. Instead, Lilly hid Zyprexa’s risks from doctors to protect the drug’s sales, according to the witness, Dr. John Gueriguian. Lilly waited until 2007 to add strong warnings to Zyprexa’s label to reflect the drug’s tendency to cause severe weight gain and blood sugar changes. Lilly put “profit over concern of the consumer,” Dr. Gueriguian said Friday near the end of four hours of testimony. Zyprexa, a drug for schizophrenia and bipolar disorder, is by far Lilly’s top-selling product, with worldwide sales of $4.8 billion last year. The company has said it did nothing wrong and fully disclosed what it knew about Zyprexa to the Food and Drug Administration. Dr. Gueriguian is testifying on behalf of the State of Alaska, which has sued Lilly to recover its costs for treating Medicaid patients who developed diabetes after taking Zyprexa. The trial is being heard in state court in downtown Anchorage before a jury of seven women and five men. Dr. Gueriguian is a specialist on diabetes and was a medical reviewer for the Food and Drug Administration for 20 years before retiring in 1998. At the F.D.A., he recommended against the approval of Rezulin, a diabetes drug that was later withdrawn for causing severe liver damage in patients. Under examination by Tommy Fibich, a lawyer from Houston who is representing Alaska, Dr. Gueriguian methodically reviewed about a dozen documents in which Lilly scientists and executives discussed the potential links between Zyprexa and diabetes. Zyprexa was introduced in September 1996 and hailed as a breakthrough medicine for the treatment of schizophrenia. But doctors quickly began to report to Lilly that patients suffered severe weight gain, high blood sugar and even diabetes after taking the drug. By the fall of 1998, the combination of adverse-event reports, clinical trial data that showed hyperglycemia and weight gain, and problems in animal studies should have been enough for Lilly to warn doctors about Zyprexa’s links to diabetes, Dr. Gueriguian said. Instead, the company did nothing. Documents from 1999 and 2000 also showed that Lilly was accumulating evidence of Zyprexa’s risks but not sharing it with doctors, he testified. And in 2002, only 10 months after Lilly began selling Zyprexa in Japan, medical regulators in that country required Lilly to warn doctors against using Zyprexa in diabetic patients. But Lilly did not issue a similar advisory to doctors in the United States. Instead, the company advised its sales representatives not to discuss diabetes with doctors unless the doctors brought it up first, according to another document presented at the trial. “We will NOT proactively address the diabetes concerns,” the document, an internal Lilly memorandum, said. Court recessed on Friday before lawyers for Lilly could cross-examine Dr. Gueriguian. They will have the opportunity to do so on Monday. A lawyer for Lilly said after Dr. Gueriguian’s testimony that the company had shared all it knew with the F.D.A. and that the question of the link between Zyprexa and diabetes was still a subject of scientific debate. Military Psychiatric Screening Still Lags Matthew Kauffman & Lisa Chedekel, Hartford Courant- 3/9/2008 The U.S. military continues to order mental health evaluations for only a tiny fraction of deploying combat troops, despite a congressional order to improve screening and evidence that mental illness is a growing problem in the Armed Forces, newly obtained data show. Fewer than 1 percent of troops sent to war in 2007 received referrals to a mental health specialist as part of the pre-deployment screening process, according to Pentagon data obtained by The Courant. Those numbers contrast with several military studies that have found mental-health problems in close to 10 percent of service members awaiting deployment. Most recently, Army researchers reported last month that among troops deployed to Afghanistan in late 2006 and early 2007, 9.6 percent had a diagnosis or a drug prescription indicating a mental health problem in the year before they were sent to war. Under pressure from Congress, the Pentagon in late 2006 pledged to improve the mental-health screening of troops preparing to go to war. Soon afterward referrals to mental health specialists jumped sharply. But even at the peak, in March 2007, only 2.4 percent of service members were sent to a mental-health professional by screeners. And the spike was short-lived. Two months later, referrals had fallen back below 1 percent, and have stayed there ever since. Although Congress in 1997 ordered the military to conduct an "assessment of mental health" for all deploying troops, that assessment consists of a single question on a health form, asking troops whether they have sought mental health care in the past year. Even for those who answer "yes" to that question, barely 1 in 10 were referred to a mental health professional last year, and 85 percent were ultimately deemed combat-ready. Paul Sullivan, executive director of Veterans for Common Sense, a nonprofit advocacy group, said he was discouraged, but not surprised, that so few service members are being seen by mental-health specialists. The need to maintain troop strength, he believes, is one reason. "They're just not doing it," he said of military leaders. "They don't have enough bodies to deploy to the war zone, and there's not enough clinicians" to do evaluations. "This was not supposed to happen again," Sullivan added, making reference to legislation passed after the Gulf War that aimed to ensure that troops' baseline health was recorded before they deployed. "We were not supposed to send unfit soldiers into the war zone." Military health officials, however, said the low referral rate was not an indication that the screening process was flawed. "Since this is a relatively recent process, and there is no similar procedure in civilian health care, we do not know what the optimal referral rates should be," said Col. Elspeth Cameron Ritchie, psychiatry consultant to the Army Surgeon General. "In any case, good clinical judgment is always utilized." In defending its screening process, the military noted in a report to Congress last year that among deployed troops who indicated past mental health care or received a mental health referral, only 1 percent were later evacuated for psychiatric reasons. Ritchie said last week that psychiatric evacuations from the war zone have remained steady, and low, throughout the war, ranging from about 20 to 40 a month — even as reported mental health problems among deployed troops have grown. Todd Bowers, director of government affairs for Iraq and Afghanistan Veterans of America, said evacuations are not a good measure of the quality of pre-deployment screening. "For every one that is evacuated, I guarantee there's approximately 10 who are dealing with these same type of issues," said Bowers, who served two tours in Iraq with the Marine Corps. "But because of the stigma … they're trying to push forward." A military report released last week found that repeat deployments are straining soldiers' mental well-being, with 27.2 percent of noncommissioned officers on third and fourth deployments screening positive for depression, anxiety or acute stress. Bowers said the impact of repeat deployments highlights the need for widespread mental health screening before troops are sent into war. "I think everyone should sit in front of a mental health professional and be properly screened to make sure they're all right, to make sure they're squared away, especially those who have deployed in the past," he said. The pre-deployment figures were obtained from a database of questionnaires filled out by the 342,911 troops preparing for deployment in 2007, including troops who were being deployed for the first time and those in the process of being sent back for subsequent tours. The data include the service members' answers to medical questions and notations on whether they were referred to specialists and whether they were ultimately cleared for deployment. The database was released to The Courant with names and other identifying information redacted. The data suggest that troops remain reluctant to disclose mental health concerns on the pre-deployment forms, despite efforts by the military to combat the stigma associated with psychiatric care. In 2006, just under 4 percent of troops disclosed that they had sought mental health care in the previous year. That figure rose in 2007 to about 4.7 percent, but is still less than the military's own estimates of the percentage of troops who have mental health issues. A recently published Army study, for example, found that about 7 percent of troops deployed to Afghanistan had one or more prescriptions for psychoactive drugs filled in the six months prior to deployment. The drugs included anticonvulsants, antidepressants, sedatives and antipsychotics. Military officials say that in addition to the questionnaire, they rely on observations from commanders and fellow service members to identify troops who may not be mentally fit for combat. But unless troops disclose past mental health care on the form, professional referrals for further evaluation are extremely rare. In 2007, fewer than one in 400 service members who answered "no" to the mental health question were referred for a professional evaluation. Though the referral rate remains small, it is an increase over the earliest years of the war, when as few as 0.3 percent of troops were referred for a mental health evaluation. And among troops who disclosed past mental health care, the percent referred to a specialist rose from 6.4 percent during the first three years of the Iraq war, to 9.6 percent over the past six months. Following a May 2006 Courant series detailing gaps in military mental health care, Congress approved legislation directing the military to establish mental health "minimum standards" for combat deployment. Congress also ordered the military to establish clinical guidelines for determining when service members should be referred for a mental health evaluation before being cleared for deployment. In response, the Pentagon issued new rules in late 2006 directing that service members with mental health disorders should be sent to war only if they demonstrate a "pattern of stability, without significant symptoms" for at least three months prior to deployment. In addition, troops who are prescribed psychiatric medications less than three months before deploying were not to be deployed to war unless there was evidence the drugs were working and had no significant side effects. Ritchie last week described the new policy as "much more stringent" than prior rules, though she acknowledged that the number of soldiers excluded from deployment had remained small. Troops who disclose possible mental health problems on the pre-deployment form are seen by low-level medical providers, who decide if a referral to a mental health professional is warranted. In a report to Congress last year, Dr. S. Ward Casscells, assistant secretary of defense for health affairs, said screeners are well-trained and follow clinical guidelines when making referral decisions. Ritchie said those screeners can generally resolve health-care issues. The military increased its focus on mental health following a spate of suicides in Iraq in 2003, and praised its suicide-prevention programs when the number of self-inflicted deaths dropped dramatically in 2004. But in 2005, and each year since, the suicide rate has reached the level that alarmed Pentagon officials early in the war. At least 145 service members have killed themselves in the Iraq war. In response, the military has established programs to improve troop "resiliency" and help service members recognize and address combat stress in their comrades. Military leaders have also attempted to increase the number of behavioral health professionals in the war zone, although the ratio of professionals to troops has dropped steadily as the military struggles to find psychologists and counselors willing to enlist. Last week, top military health officials said they would begin recruiting civilian mental health providers to augment those in uniform. For more stories related to the Courant's series on mental health in the military, go to www.courant.com/unfit. Compulsive Gambler Hits Casinos with Suit Associated Press, 3/9/2008 ATLANTIC CITY, N.J -- . -- She was an ambitious lawyer and TV commentator who started going to Atlantic City casinos to relax, and soon was getting high-roller treatment that included limousines whisking her to the resort. Arelia Margarita Taveras says she was even allowed to bring her dog, Sasha, to the blackjack tables in her purse. But her gambling spun out of control: She said she would go days at a time at the tables, not eating or sleeping, cleaning her teeth with disposable wipes so she didn't have to leave. She says her losses totaled nearly $1 million. Now she's chasing perhaps the longest of longshots: a $20-million racketeering lawsuit in federal court against six Atlantic City casinos and one in Las Vegas, claiming they had a duty to notice her compulsive gambling problem and cut her off. "They knew I was going for days without eating or sleeping," Taveras said. "I would pass out at the tables. They had a duty of care to me. Nobody in their right mind would gamble for four or five straight days without sleeping." Experts say her case will be difficult to prove, but it provides an unusually detailed window into the life of a problem gambler. "It's like crack, only gambling is worse than crack because it's mental," said Taveras, 37, a New Yorker who now lives in Minnesota. She lost her law practice, her apartment and her parents' home, and she owes the IRS $58,000. In interviews, Taveras admitted she dipped into her clients' escrow accounts to finance her gambling habit. She was disbarred in June and faces criminal charges stemming from those actions, but is trying to work out restitution agreements in order to avoid a prison term. Her lawsuit names Resorts Atlantic City, Trump Plaza Hotel & Casino, Trump Taj Mahal Casino Resort, the Tropicana Casino Resort, the Showboat Casino Hotel, Bally's Atlantic City and the MGM Grand Hotel & Casino in Las Vegas. The casinos deny any wrongdoing, maintaining in court papers that Taveras brought her problems on herself. Last month, a judge dismissed the Trump casinos, the Tropicana, Showboat and Bally's from the lawsuit on technical grounds, but Taveras is allowed to refile the suit against them by April. The suit remains in effect against Resorts and MGM because its allegations against them were more specific. Joe Corbo, president of the Casino Association of New Jersey, said casino workers undergo extensive training on spotting problem gamblers and referring them to help, including a self-exclusion list the state maintains. 1 in 4 Teen U.S. Girls Has Sexual Disease Associated Press, 3/11/2008 CHICAGO -- At least one in four teenage girls nationwide has a sexually transmitted disease, or more than 3 million teens, according to the first study of its kind in this age group. A virus that causes cervical cancer is by far the most common sexually transmitted infection in teen girls aged 14 to 19, while the highest overall prevalence is among black girls -- nearly half the blacks studied had at least one STD. That rate compared with 20 percent among both whites and Mexican-American teens, the study from the federal Centers for Disease Control and Prevention found. About half of the girls acknowledged ever having sex; among them, the rate was 40 percent. While some teens define sex as only intercourse, other types of intimate behavior including oral sex can spread some infections. For many, the numbers likely seem ''overwhelming because you're talking about nearly half of the sexually experienced teens at any one time having evidence of an STD,'' said Dr. Margaret Blythe, an adolescent medicine specialist at Indiana University School of Medicine and head of the American Academy of Pediatrics' committee on adolescence. But the study highlights what many doctors who treat teens see every day, Blythe said. Dr. John Douglas, director of the CDC's division of STD prevention, said the results are the first to examine the combined national prevalence of common sexually transmitted diseases among adolescent girls. He said the data, from 2003-04, likely reflect current rates of infection. ''High STD rates among young women, particularly African-American young women, are clear signs that we must continue developing ways to reach those most at risk,'' Douglas said. The CDC's Dr. Kevin Fenton said given that STDs can cause infertility and cervical cancer in women, ''screening, vaccination and other prevention strategies for sexually active women are among our highest public health priorities.'' The study by CDC researcher Dr. Sara Forhan is an analysis of nationally representative data on 838 girls who participated in a 2003-04 government health survey. Teens were tested for four infections: human papillomavirus, or HPV, which can cause cervical cancer and affected 18 percent of girls studied; chlamydia, which affected 4 percent; trichomoniasis, 2.5 percent; and herpes simplex virus, 2 percent. Blythe said the results are similar to previous studies examining rates of those diseases individually. The results were prepared for release Tuesday at a CDC conference in Chicago on preventing sexually transmitted diseases. HPV can cause genital warts but often has no symptoms. A vaccine targeting several HPV strains recently became available, but Douglas said it likely has not yet had much impact on HPV prevalence rates in teen girls. Chlamydia and trichomoniasis can be treated with antibiotics. The CDC recommends annual chlamydia screening for all sexually active women under age 25. It also recommends the three-dose HPV vaccine for girls aged 11-12 years, and catch-up shots for females aged 13 to 26. The American Academy of Pediatrics has similar recommendations. Douglas said screening tests are underused in part because many teens don't think they're at risk, but also, some doctors mistakenly think, '''Sexually transmitted diseases don't happen to the kinds of patients I see.''' Blythe said some doctors also are reluctant to discuss STDs with teen patients or offer screening because of confidentiality concerns, knowing parents would have to be told of the results. The American Academy of Pediatrics supports confidential teen screening, she said. On the Net: CDC: http://www.cdc.gov American Academy of Pediatrics: http://www.aap.org Many With Sleep Disorders Go Undiagnosed As many as 25 percent of men and 15 percent of women may experience sleep apnea, but many with this disorder go undiagnosed. As the population grows in size and girth, the number of patients suffering from sleep apnea continues to increase, leading many hospitals to open clinics to help those with a variety of sleep disorders. Nostrums: Aromatherapy Rarely Stands Up to Testing Eric Nagourney, New York Times- 3/11/2008 There is little that aromatherapy has not been claimed to help with at one time or another. It is said to reduce pain and anxiety, bring both energy and relaxation and even make the immune system stronger. But when researchers set out to see if they could prove any of the claims in the lab, they say, most did not pan out. The researchers, writing online in Psychoneuroendocrinology, did offer evidence that one odor, lemon, really seemed to improve mood. But they found no benefit with pain, stress levels, immune response or healing. Aromatherapy is a big business, and its roots run deep in folk medicine, say the researchers, led by Janice K. Kiecolt-Glaser of Ohio State University. But proving whether it works is hard, in part because study participants cannot help but know what they are smelling and so may be influenced by expectations. For this study, the researchers assessed volunteers’ moods and baseline physiological levels at the start of a series of visits. Then they had the volunteers smell lemon oil, lavender oil or water. Participants were asked to plunge a foot into ice-cold water for minute, as researchers measured their body’s stress reaction. They were also asked to report their pain level. Researchers also removed a layer of skin and watched to see if aromatherapy helped speed healing. Psychotherapy for All: An Experiment David Kohn, New York Times- 3/11/2008 SIOLIM, India — At the faded one-story medical clinic in this fishing and farming village, people with depression and anxiety typically got little or no attention. Busy doctors and nurses focused on physical ailments — children with diarrhea, laborers with injuries, old people with heart trouble. Patients, fearful of the stigma connected to mental illness, were reluctant to bring up emotional problems. Last year, two new workers arrived. Their sole task was to identify and treat patients suffering depression and anxiety. The workers found themselves busy. Almost every day, several new patients appeared. Depressed and anxious people now make up “a sizable crowd” at the clinic, said the doctor in charge, Anil Umraskar. The patients talk about all sorts of troubles. “Financial difficulties are there,” said one of the new counselors, Medha Upadhye, 29. “Interpersonal conflicts are there. Unemployment. Alcoholism is a major problem.” The clinic is at the forefront of a program that has the potential to transform mental health treatment in the developing world. Instead of doctors, the program trains laypeople to identify and treat depression and anxiety and sends them to six community health clinics in Goa, in western India. Depression and anxiety have long been seen as Western afflictions, diseases of the affluent. But new studies find that they are just as common in poor countries, with rates up to 20 percent in a given year. Researchers say that even in places with very poor people, the ailments require urgent attention. Severe depression can be as disabling as physical diseases like malaria, the researchers say, and can have serious economic effects. If a subsistence farmer is so depressed that he cannot get out of bed, neither he nor his children are likely to eat. In India, as in much of the developing world, depression and anxiety are rarely diagnosed or treated. With a population of more than one billion, India has fewer than 4,000 psychiatrists, one-tenth the United States total. Because most psychiatrists are clustered in a few urban areas, the problem is much worse elsewhere. As a result, most Indians with mental illness go untreated, especially in poor and rural areas. “There is a huge treatment gap for people with depression,” said Dr. Vikram Patel of the London School of Hygiene and Tropical Medicine, the psychiatrist who began the Siolim project. “In most places in the developing world, 80 percent to 90 percent of people with severe depression don’t receive adequate treatment.” For India, adding thousands of psychiatrists would take large sums of money and years of effort, resources unavailable to a developing country with many other health problems besides mental illness. By contrast, Dr. Patel’s strategy costs relatively little and does not require legions of doctors. “It’s a really interesting, exciting thing he’s doing,” said Dr. Greg E. Simon, a researcher at the Center for Health Studies in Seattle. Dr. Simon, a psychiatrist who studies mental health in the developing world, said the Goa strategy grew from a crucial idea. Unlike, say, heart disease and stroke, which can require expensive interventions, depression is relatively simple to diagnose and treat. Many studies have shown that talk therapy and antidepressants lead to significant improvement in most patients. “The fundamentals of helping people with depression are pretty low tech,” Dr. Simon said. “The core resource is humans,” people who can identify patients and offer treatments. The Goa program, financed by the Wellcome Trust, is not the first using nonmedical workers to treat mental illness, but it is the largest. Almost 2,000 patients have been treated. Dr. Patel is conducting a randomized clinical trial to see whether the strategy works, the first time such a careful study has been run in the developing world. If the research, which will finish in 2010, reports positive results, donors and governments are more likely to try it elsewhere in India and the world, Dr. Patel said, adding: “This is the most important question in psychiatry. How do we scale up treatments to a population in a low-resource setting?” “If you rolled this program out across India,” Dr. Simon said, “you’d be doing some good for a fifth of the world’s population.” Dr. Patel, 43, grew up in Bombay, now Mumbai, and wanted to be a caterer. His middle-class parents insisted on a more respectable career. He went to medical school. After completing training, he spent two years in Zimbabwe as a researcher. He hoped to prove that Western concepts of mental illness did not apply in the developing world. Instead, he came to the opposite conclusion, that the ailments were in fact just as common and just as treatable as in the West. He now splits his time between London and Goa, where he runs a social welfare organization, Sangath, which means partnership in Hindi. Known in the West for its beautiful beaches, Goa is relatively wealthy by Indian standards. But most of its three million residents earn a few dollars a day, not enough to afford much medical care. Public health officials say that poverty can lead to alcoholism, domestic abuse and stress, all contributors to depression and anxiety. At government clinics like the one here, overworked doctors lack time and inclination to ask patients about mental health. Even clinicians who look for depression may miss it. For reasons that no one fully understands, depressed patients in the developing world often complain of physical symptoms like fatigue, headache and insomnia rather than emotional problems like sadness or regret. As a result, Dr. Patel said, depressed patients in Goa may receive unnecessary and expensive treatments that fail to address the underlying problem. For all those reasons, he said, most depression and anxiety remains undiagnosed. But they are common. A survey by Dr. Patel found that one in three adults seeking care at public health clinics in Goa were depressed or anxious. Dr. Neerja Chowdhury, a psychiatrist at Sangath who is helping manage the project, said, “That might be an underrepresentation.” The program began in 2005, hiring 12 recent high school or college graduates who lacked medical backgrounds. Six “health assistants” received a week of training, and six “health counselors” had three months of training. The workers — paid the equivalent of $100 to $200 a month, significantly less than Indian psychiatrists — were sent to the six clinics. Five days a week, the assistants screen almost every patient who arrives at the door. Pregnant women, minors and emergency cases are excluded. The screening is created for the program. It includes questions about physical symptoms, as well as emotional problems. A patient meeting the criteria for mental illness is immediately sent to the health counselor, who provides a straightforward explanation of depression and anxiety and offers a range of treatments like talk therapy, yoga and, in conjunction with a doctor, antidepressant medication. Patients return every few weeks for follow-ups. The screening and first consultation typically take a half-hour. In the old system, the few patients with diagnoses of depression were referred to a psychiatrist at one of two state mental hospitals. Dr. Patel said many patients failed to show up for appointments because they could not afford to take time from work or pay for transportation. Most are also apparently wary of visiting a mental hospital. In India, the stigma of mental illness remains strong. To minimize the problem, health workers avoid using the words “mental illness,” “depression” or “anxiety” with patients, relying on more commonly used words like “strain” and “tension.” The patients “are happy to talk,” Dr. Sudipto Chatterjee, a psychiatrist at Sangath, said, “as long as you stay away from the idea of mental illness.” Dr. Chatterjee helped draw up the program and oversees the screeners and counselors. He said they not only diagnosed as well as doctors but were generally better listeners, partly because they have more time. Psychiatrists usually “have five minutes to see a patient,” Dr. Chatterjee said. In a society where many people have no place to share their worries, the effects of therapy can be striking. On a recent Saturday morning at the Siolim clinic, Ms. Upadhye, the health counselor, sat in her closet-size plywood-wall office, trying to stay cool under a negligible breeze from a tiny plastic fan, when a psychiatric patient arrived for a return visit. A housemaid in her 50s who wore large glasses, bright bangles on her wrists and a light blue sari, the patient had originally reported physical problems like headache, insomnia and pains but had been given a diagnosis of depression. As Ms. Upadhye listened, the woman let loose a flood of words. Speaking in Konkani, the predominant Goan language, she told the counselor that she was not getting along with her four children, especially her son, who had recently beaten her up in a drunken rage. She said she had no one to talk to. Holding tightly to her handkerchief, she began to cry. Within minutes, she began to relax. Her expression loosened. “I feel better when I tell my problems to somebody else,” she said. Ms. Upadhye ended by reminding the woman to keep taking her antidepressant medicine and to check in regularly. After the session, Ms. Upadhye reflected that just listening to her patients made a big difference. “I feel like I’m doing something, just giving them time to ventilate,” she said. “They can tell their problems, they can share their feelings.” Meth Use Has Fallen Across the Country WASHINGTON - Methamphetamine use continued to decline in nearly every part of the country last year as the government sharpened its crackdown on precursor chemicals used to make the illegal drug. Overall, the number of workplace employees who tested positive for meth dropped 22 percent last year, according to a study released today by New Jersey-based Quest Diagnostics Inc., the nation's largest drug-testing company. Meth use in the Northeast, however, remained steady. At the same time, the Drug Enforcement Administration issued a report showing the number of illegal meth lab seizures plunged 31 percent last year, from 7,347 to 5,080.
Anti-Meth Campaign Aimed at Gay Men Mary Engel, Los Angeles Times- 3/14/2008 California drug officials launched an $11-million barrage of billboards, bus wraps, cable TV ads and a website Thursday aimed at discouraging gay men from using methamphetamine, an illegal stimulant linked to risky sexual behavior and the spread of HIV. The drug, commonly known as "crystal" or "tina," has been a popular party drug in gay circles since the 1990s. A statewide survey, also released Thursday, found that crystal meth use was 11 times more common among gay men than in the California population overall. Fifty-five percent of 549 gay and bisexual men surveyed said they had used the drug, compared with 5% of the general population. Mike Rizzo, manager of the Los Angeles Gay & Lesbian Center's crystal meth recovery services, praised the state's campaign, especially the website videos of real people relaying the consequences of using crystal meth. Not only will they appeal to young people, he said, but they portrayed meth use in a way that "is real and relatable and not easily dismissed as being overly alarmist." The site, www.menotmeth.org, allows users to add their own videos. It also provides links to places to get help. The Gay & Lesbian Center, along with the San Francisco AIDS Foundation, helped push the Legislature to pass the California Methamphetamine Initiative in 2006. Data from the center's HIV testing program found that nearly one in every three gay or bisexual men who tested positive in the testing program in 2004 used crystal meth -- a threefold increase over 2001. In the state-sponsored survey, gay men were the only group to cite enhanced sexual arousal as part of drug's appeal. "Not only can it increase the likelihood of having unprotected sex, but people are also having more sex with more partners and having sex for a longer period of time, increasing the likelihood of infection," said Dr. Michelle Roland, chief of the AIDS office at the state Department of Public Health. Women and heterosexual men who use meth are also at risk for sexually transmitted diseases and hepatitis, she said. For many women, the drug is seen not as a sexual aid but as "Mom's little helper," according to Renee Zito, director of the California Department of Alcohol and Drug Programs. "It helps you lose weight," she said. "It gives you energy. If you are a working mother and juggling everything under the sun, it helps you cope -- initially." Yet methamphetamine is a factor in about 80% of child neglect and endangerment cases. For all users, the powerfully addictive drug "turns on you down the line," said Zito. "People get to the point that they need it so desperately that they're willing to do anything to get the drug," she said. Although the campaign is directed toward gay men, it applies to anyone who uses or is tempted to use meth, Zito said. The campaign "is about loss, really -- of family, friends, their looks, jobs, who they are. It essentially gets down to 'I lost myself.' " Bill Would Reward Mental Health Workers In Military Matthew Kauffman, Hartford Courant- 3/15/2008 Clinical psychologists could collect six-figure bonuses for enlisting — or staying — in the Armed Forces under legislation proposed to address high rates of suicide and a critical shortage of mental health workers in the military. The legislation, proposed Friday by U.S. Sens. Joseph I. Lieberman, an independent from Connecticut, and Barbara Boxer, D-Calif., would offer extra money to a variety of behavioral health professionals and extend "critical skills" bonuses to psychologists and social workers who join the military, and to psychiatrists, social workers and mental health nurses who agree to stay in uniform. The Armed Forces Mental Health Professionals Recruitment and Retention Enhancement Act of 2008 would also expand scholarships and other special-pay programs for mental health workers. Professionals with a doctorate in psychology who agree to serve as military officers for four years would be eligible for bonuses of as much as $100,000 each year under the proposed law. The legislation would also authorize bonuses as high as $25,000 a year for high-ranking mental health workers in the military who agree to extend their duty two to four years beyond their required commitment. The bill provides smaller bonuses of $5,000 to $15,000 a year for social workers and mental health nurses. The military has been stymied in efforts to increase the number of uniformed mental-health workers, both in the war zone and at home. In a report released last week, combat troops said access to mental health care became more difficult in 2007, and mental health workers reported higher rates of burnout. About 200 psychologists and other behavioral health providers are deployed in Iraq, a number that has remained constant despite last year's troop surge. To boost that number, military health officials said last week they will begin recruiting civilian counselors willing to work in the war zone. Lieberman, however, said troops have a strong preference for uniformed providers. Lieberman and Boxer also introduced legislation Friday that would establish an independent Defense Department board to investigate all suicides by service members, and would require the department to maintain a military-wide database of suicides and attempted suicides. Suicides are typically investigated by the individual military branches, each of which keeps its own data and makes reports. "Our highest priority must be an unwavering commitment to our service members," Lieberman said. "These bills will not only address current shortcomings, but will help build a stronger military mental health system for decades to come." Generics: Just as good? Melissa Healy, Los Angeles Times- 3/16/2008 In the contentious debate over insuring Americans' health, the value of generic prescription drugs is a rare point of consensus. Patients, physicians, employers, politicians -- all hail generics as powerful treatment for a swelling healthcare tab. On average, these copycat medicines cost less than a third of the brand-name drugs they mimic. In turn, the competition they provide drives down the cost of those first-to-market drugs. Officials of the Food and Drug Administration insist this feat of economics comes without any compromise to a medicine's effectiveness. To be marketed in the United States, these low-cost medicines must be approved by the FDA, which ensures they are "bioequivalent" to their brand-name counterparts -- the same dose of the same active ingredient, delivered in the same way, and manufactured according to the same standards of quality.The Generic Pharmaceutical Assn. touts them with a slightly catchier slogan: "Same Medicine. Same Results." But sometimes, patients and their doctors beg to differ. A switch from a long-used brand-name drug to its generic equivalent can, on occasion, bring a shifting profile of side effects. In a number of cases documented in medical journals and recounted in interviews with physicians, a generic version of what is often called a "pioneer" drug simply doesn't appear to work as well for many patients. "Everybody thinks generics are swell: To suggest otherwise is like saying you don't love your mother," said Dr. Peter R. Kowey, chief of cardiovascular diseases at the Philadelphia area's Main Line Health System, who reviewed the issue of generic substitution of certain heart drugs for the American Heart Assn. But between some pioneer drugs and their generic imitators, Kowey said, "we are concerned that the margin of difference is large enough" to risk patients' health. Last December, the American Epilepsy Society called on the FDA to approve a large clinical trial to determine "once and for all" whether the substitution of brand-name drugs with generics increases the risk of "breakthrough" seizures or toxicity among patients with epilepsy. This type of research would probably take years. But until such a study is completed, the society declared, it would oppose measures by state, federal or private insurance programs that would limit physicians' choices in prescribing anti-seizure medicines. Last fall, an independent laboratory, prompted by a flurry of consumer complaints, presented evidence that a generic version of the once-a-day antidepressant Wellbutrin XL may be less effective than the original at reducing some patients' depressive symptoms. An agency spokeswoman said the FDA is investigating the matter and will make its findings public when the inquiry is complete. In a report released today, the New York-based ConsumerLab.com, which conducted the Wellbutrin XL analysis, also urges the FDA to review the performance of a new generic for Toprol XL, a once-a-day version of a high blood pressure drug that is the fifth most-prescribed medicine in the United States. That challenge comes after dozens of patients complained to the People's Pharmacy -- a multimedia source of information about drugs and supplements -- of erratic spikes in blood pressure and side effects after they had switched from Toprol XL to a new generic version of the drug. Cardiologists, meanwhile, have been growing more vocal in their concern about "generic substitution" for newer, brand-name drugs. They have had long-standing worries about the effect of switching patients whose blood has been thinned with Coumadin to generic versions of the anticoagulant, including warfarin. Many have warned that patients with heart arrhythmias should be switched to generic drugs only when necessary. And many cardiologists view the swelling field of generic blood-pressure and cholesterol drugs with some distrust. The American Assn. of Clinical Endocrinologists, the Endocrine Society and the American Thyroid Assn. joined voices in 2004 to warn that patients with hypothyroidism could be harmed by switching among the many generics used to treat the condition. And physicians who care for organ transplant recipients have opposed generic substitution of immunosupressant drugs for their patients without a transplant specialist's prior approval. Societies that represent these doctors have been active in seeking state laws that would limit such switches. Kathleen Jaeger, president and chief executive of the Generic Pharmaceutical Assn., dismisses all of these debates as "misinformation campaigns" masterminded by brand-name pharmaceutical companies. As these companies' most profitable medicines face competition from generic upstarts, Jaeger said, they seek to "extend their monopoly" by sowing doubt in the minds of physicians, pharmacists and patients about the quality of the cheaper substitutes. Those who would question generic drugs' equivalence to the brand-name drugs they mimic are calling into question a stringent FDA review process, said Jaeger. "They do a disservice to our healthcare system," she added. "Consumers deserve better." But many physicians and pharmacologists interviewed said that with some drugs, the FDA -- an agency that has come in for harsh criticism on matters of drug safety in recent years -- may be overlooking differences that could be important to patients' health. FDA officials "have adopted a position that is in some respects quite brave," said Peter Meredith, a University of Glasgow pharmacologist who has written extensively about generic drugs and their regulation. "The FDA quite rigidly states that when they say a drug is substitutable, they mean that with no caveats, no qualifications. My concern would be that if you don't look for one, you don't see it." With about 9,000 generic drugs on the U.S. market, concerns raised about a handful do not suggest a broad failure in the nation's formulary of low-cost medications. But many physicians and pharmacologists caution that with new generics entering the market at a rate of almost 500 per year, and millions of consumers switching to them, their safety and effectiveness will be increasingly critical. "The reasonable people I know aren't pounding their fists saying all generics are bad," Kowey said. "They're saying to the FDA, 'C'mon guys, there may be some situations in which these differences may turn out to be important.' " Doctors, users speak out Dr. Gerald Naccarelli, chief of the Pennsylvania State medical center's division of cardiology, believes a switch to a generic drug to control heart arrhythmia contributed to the death of one patient in Houston early in his career. Recently, he said, another of his patients suffered a life-threatening ventricular arrhythmia after the man was switched from a long-standing regimen of a brand-name medication to a new generic. The patient was hospitalized but lived. When the FDA approved a generic version of an anti-arrhythmia drug that Naccarelli did not believe had been studied properly at higher doses, he wrote a letter to the FDA. "I'm confused why there's one set of standards for patented trade-name drugs for FDA approval and a separate standard for generic substitutions," he said. "Some generic drugs . . . should be held to higher standards than the FDA now enforces." Jillian Bealer of Buffalo, N.Y., is a fan of generics and the savings they bring. But she says her faith in their equivalence to brand-name drugs was shaken by a nasty recurrence of depression she suffered recently when she switched to a new generic for Wellbutrin XL. For three years, Bealer, who has been diagnosed with attention deficit disorder and an anxiety disorder, took 300 milligrams of the antidepressant Wellbutrin XL to stabilize her mood and maintain her focus and attention. It helped her feel like herself, she said, "very outgoing and very upbeat." But in early November, a new pharmacy refilled her prescription with a large yellow caplet -- a newly approved generic version of Wellbutrin XL identified by its chemical name, Bupropion Hydrochloride XL, and marketed by the generic manufacturing giant Teva under the commercial name Budeprion. The new generic had a smaller co-pay than the branded product under Bealer's employer-provided insurance policy, and the pharmacist assured her that the new pill would work just as well. Bealer began taking the pill. But as the holiday season approached, she found that her favorite time of year was feeling like "just a burden." For weeks, she didn't answer the phone, didn't go to parties and used up vacation days because she didn't want to get out of bed. She had headaches that made holiday shopping miserable and in spite of a flagging appetite, felt she was gaining weight. Bealer suspected that the new generic version of Wellbutrin XL wasn't working the way the original had. On a sleepless night in early January, she started combing the Internet to see if other patients might have detected a difference. Bealer discovered she had lots of company -- and some lab evidence to suggest her suspicions were on-base. "I was just so angry," the 30-year-old pharmaceutical saleswoman said. "I was so miserable . . . I am not the only one who's had these side effects. Something needs to be done, because someone could get really hurt or kill themselves." Denise Bradley, a spokeswoman for Teva Pharmaceutical Industries, said Teva's 300-milligram extended release antidepressant has met the FDA's specifications and performed well in its first year on the U.S. market. As of mid-October, 4.5 million prescriptions had been filled last year, and Teva had received 101 consumer complaints. That rate of concerns expressed, 0.002%, is "consistent with the rate of such reports for all prescription pharmaceuticals," said Bradley. Expanding market Currently, 64% of all prescriptions filled in the United States are for generics. That percentage is expected to rise steeply over the next few years. In 2007, the FDA approved manufacturers' plans to market 682 new generics in the United States. The agency still is working its way through a backlog of about 1,300 more applications from generic pharmaceutical manufacturers -- a tally that grows weekly. Among the widely prescribed medications expected to appear in generic form in the next few years: the migraine drug Imitrex; the cholesterol drug Lipitor; the blood pressure drug Norvasc; the gastrointestinal reflux drug Prevacid; and the psychiatric medications Risperdal, Effexor and Zyprexa. At the same time, consumers are finding themselves constrained by their health plans, or lack of one. In 2000, 22% of American workers with employer-sponsored health insurance had plans that made no distinctions in their coverage of medications: A patient's co-payment was the same whether she chose the expensive brand-name or the generic formulation of a drug. Today, only 6% of workers have prescription plans with such free choice, reports the Kaiser Family Foundation, which conducts an annual survey of employer health benefits. Kaiser's survey shows that more insurers are making more distinctions among medicines for which they will help pay and, in most cases, asking workers to shoulder a higher proportion of costs for drugs that cost more. Most patients welcome generics enthusiastically. Retail giants such as Wal-Mart and Target have begun filling most generic prescriptions for prices as low as $4 apiece. Generic drugs cost between 30% and 80% of the brand names they mimic, and price tags on those pioneer medicines are headed upward. Wholesale prices for the top-selling 50 brand-name medications rose by about 8% in 2007, according to a report by Delta Marketing Dynamics, which tracks drug trends. That's after hikes of about 7% in 2006 and about 6% in 2005. At the same time, Medicare, Medicaid, private insurance companies and hospital pharmacies are trying to hold down rising costs by aggressively encouraging patients to use generics. Increasingly, many are going further: They are asking patients to switch to a different class of drugs to treat a condition -- say, from an ACE inhibitor to a beta blocker to control high blood pressure -- because more generics may be available in one drug class than another. Such "formulary switches" can be more problematic than a brand-to-generic switch, because the old and new drugs work differently. As generics move into Americans' medicine chests in growing numbers, two things are likely, say experts: There will be copycat medications that work differently -- and sometimes less effectively -- than originals; and there will be patients who do not respond as well to them. Patients and doctors should be alert to variations in a new prescription's effectiveness, they advise, and report their concerns to the FDA's adverse-events monitoring system, called MedWatch, www.fda.gov/medwatch. "The generics industry is highly successful, and it wouldn't be if it was always failing patients," said R. William Soller, a professor of pharmacology at UC San Francisco. But, he added, "it's pretty hard to think you have an absolutely perfect system." 'Pandora's box' In recent years, the system by which generic prescription drugs are approved as "bioequivalent" to their brand-name counterparts has come in for criticism from many quarters. FDA's regulation of generics is most vulnerable to criticism in cases where a medicine must be administered in very precise doses and on a precise schedule to be safe and effective. These drugs have what pharmacologists call a "narrow therapeutic index": There's a fine line between a dose that's ineffective and one that could be dangerous. Typically, a patient's response to such medicine must be carefully monitored, and the consequences of failure could be dire: a seizure, dangerously erratic heartbeat, soaring blood pressure, blood clots or uncontrolled bleeding. But FDA regulators have been "very categorical" in their insistence that no differences exist between generics and the pioneer drugs they follow, said Kowey. As a result, the agency has resisted studies that might call that into question with any single class of drugs, fearing that consumers will come to question the equal effectiveness of all generics. "They don't want to open the Pandora's box," said Kowey. Dr. Gary Buehler, director of the FDA's office of generic drugs, declined an interview request. But FDA spokeswoman Sandy Walsh told The Times the "FDA cannot offer any examples where generics have been shown to not perform as expected." The "FDA has many years of experience in the review of generic drugs and has great confidence in the quality and equivalence of generic drug products," added Walsh. By the time Jillian Bealer turned to the Internet for information early this year, she found a chorus of complaints from Wellbutrin XL users who had switched to a new generic made by Teva. Their disappointment in the generic's performance began showing up on drug- and depression-related Internet chat sites in March 2007, about two months after Teva's generic hit the market. More than 300 of those patients had sent anguished letters and e-mails to Joe and Teresa Graedon, the founders of a respected multimedia clearinghouse that dispenses independent advice on drugs and dietary supplements. (The Graedons' syndicated column, People's Pharmacy, runs in this and other newspapers.) These consumers reported increased anxiety and irritability, headaches, nausea and insomnia since switching to the generic. Many reported a return of their previously controlled depressive symptoms. By summer 2007, the Graedons had collected enough letters from readers to alert the FDA and to ask an independent testing and certification lab, ConsumerLab.com, to compare the new Wellbutrin generics against their original counterparts and assess claims of equal performance. The results, confirmed by a second test lab and released last fall by ConsumerLab.com, raised questions about at least one version of the generic copies -- a 300-milligram dose of bupropion marketed by Teva -- as well as the FDA process by which a proposed generic's equivalence to a pioneer drug is established. "We were shocked when we got the results" comparing the 300-milligram tablet of Wellbutrin XL -- the most frequently prescribed dose of the product -- and Teva's generic, said Tod Cooperman, president of ConsumerLab.com. The rate at which the two pills dissolved when in a medium mimicking the human digestive system "was very different," he said. Both products released the same amount of bupropion hydrochloride into the solution over 16 hours, but the generic pumped out its active ingredient much faster than did the branded product: In the first two hours, the generic released a third of its active ingredient -- four times as much as its brand counterpart. At four hours, the generic had released almost half of its medicine, the brand-name about a quarter. The difference might well explain why consumers accustomed to taking Wellbutrin XL would feel different when taking Teva's generic, marketed as Budeprion XL, said Cooperman. With a more rapid release rate, the concentration of generic bupropion in the blood will rise quickly, but may also fall lower late in the 24-hour cycle than would be the case with the branded Wellbutrin XL. With a greater-than-accustomed dose of medicine in her system soon after taking her pill, a patient like Jillian Bealer might experience more of bupropion's recognized side effects, including irritability, headaches and insomnia. In the second half of her 24-hour pill cycle, she may feel the effects of a lower-than-accustomed dose, including depressed mood. Cooperman adds that the different dissolution rates of the two products could have safety implications, since patients who take too high a dose of bupropion are at increased risk of having a seizure. In December, Dr. Robert Temple of the FDA's Center for Drug Evaluation and Research confirmed that in the lab and in volunteers, the two products differed significantly in their dissolution rate. But that difference was within allowable limits set by regulators. By the time both pills had dissolved, he said, they had released equal levels of Wellbutrin's active ingredient into the bloodstreams of subjects. The agency thought the allowed variations in the rate at which the medicine was absorbed by patients "wouldn't make any difference," Temple told Southern California public radio station KPCC-FM (89.3). Back to brand names Jillian Bealer thinks it made the difference between functioning effectively and dragging herself through a holiday season she usually loves. When she shelled out $150 to refill her prescription with Wellbutrin XL, Bealer said, she regained her good humor within a week and a half. She now pays a $45 co-payment instead of $15 for a generic refill. But she said she'll never go back. The FDA, she said, will probably dismiss stories like hers as flukes. With so much company, Bealer thinks that would be a mistake. "This many people," she said, "could not be wrong." Eli Lilly E-Mail Discussed Unapproved Use of Xyprexa Alex Berenson, New York Times- 3/15/2008 ANCHORAGE — John C. Lechleiter, an Eli Lilly official who is about to become the company’s top executive, wrote an e-mail message in 2003 that appears to have encouraged Lilly to promote its schizophrenia medicine Zyprexa for a use not approved by federal drug regulators. Mr. Lechleiter’s comments came in a March 2003 e-mail message he wrote to other Lilly executives, after he traveled to Cincinnati to watch Lilly sales representatives talk to doctors. The e-mail message was discussed this week in an Anchorage courtroom in a lawsuit against Lilly by the State of Alaska. The suit seeks reimbursement for the medical costs of Medicaid patients who developed diabetes while taking Zyprexa. Zyprexa is federally approved only for use by adults diagnosed with schizophrenia or bipolar disorder. While doctors are free to prescribe it “off label” for any patients for any use, it would be a violation of federal law for Lilly to actively encourage off-label use of the drug. The drug causes severe weight gain and cholesterol problems in many patients and has been linked to diabetes. The federal government has investigated drug companies before for off-label promotion of their medicines, but Mr. Lechleiter’s note provides rare documentation of a senior drug executive’s openly discussing the practice. A spokeswoman for Eli Lilly said Mr. Lechleiter was not advocating off-label promotion in his note but simply wanted the company to respond to physicians’ requests for information. In his e-mail message, Mr. Lechleiter discusses the use of Zyprexa by children and teenagers. Mr. Lechleiter, who was then the company’s executive vice president for pharmaceutical products, noted to other Lilly officials that company representatives were already promoting Strattera, a second Lilly psychiatric drug, to pediatricians and child psychiatrists. The representatives could also discuss Zyprexa with such doctors, he said. “The fact we are now talking to child psychs and peds and others about Strattera means that we must seize the opportunity to expand our work with Zyprexa in this same child-adolescent population,” Mr. Lechleiter wrote in the message. He also encouraged Lilly to get data on the use of Zyprexa in treating “disruptive kids” in order to increase the drug’s sales. The company declined to make Mr. Lechleiter available for comment. Because of Zyprexa’s physical side effects, many psychiatrists now say it is appropriate only for severely mentally ill patients. Clinical trials have shown that its tendency to cause dangerous weight gain appears to be especially pronounced in younger patients. The Food and Drug Administration has for more than a year declined to act upon an application by Lilly to broaden the drug’s label to allow its use in people under 18. Mr. Lechleiter’s e-mail message has not previously been discussed publicly. In the Alaska trial, after plaintiff lawyers presented it without the jury present, Judge Mark Rindner said it could not be admitted into evidence in the trial because off-label use was not at issue in the case. Its disclosure nonetheless comes at a sensitive moment for Lilly, which is also under federal criminal investigation for the way it promoted Zyprexa and played down the drug’s risks to doctors. From 2000 to 2002, internal Lilly documents show that the company tried aggressively to expand Zyprexa’s sales into markets for which the drug was never approved, including elderly patients with dementia. To settle that investigation, and related investigations by several states, Lilly is negotiating with federal prosecutors in Pennsylvania on a deal that could result in the company’s paying $1 billion to $2 billion in fines and restitution, according to people involved in the investigation. The prosecutors declined to comment on Friday. Because Mr. Lechleiter, an organic chemist who is Lilly’s president and chief operating officer, is a senior official about to become the chief executive, the public disclosure of an e-mail message in which he appears to have encouraged off-label promotion of Zyprexa could complicate the talks. He is scheduled to become chief executive on April 1, succeeding Sidney Taurel, and is to succeed Mr. Taurel as Lilly’s chairman at the end of the year. Since 2003, as information about the drug’s risks has spread, prescriptions for Zyprexa have fallen sharply in the United States. But Lilly has repeatedly increased the drug’s price to counteract the slumping prescriptions, and Zyprexa remains by far Lilly’s best-selling product, with worldwide sales of $4.8 billion last year, about half in the United States. Zyprexa now costs about $8,000 a year at commonly prescribed doses. Marni Lemons, a spokeswoman for Eli Lilly, said Mr. Lechleiter’s e-mail message was meant to encourage Lilly representatives to answer questions from doctors who were already prescribing Zyprexa off label to children and teenagers. “Rather than driving physician demand, what he was doing was responding to demand from physicians, which we are allowed to do,” Ms. Lemons said. Federal law does let companies send “medical letters” with additional information about off-label uses to physicians who request the information, although sales representatives are not supposed to discuss it. In the e-mail message, Mr. Lechleiter made several other references to off-label use of Zyprexa. He wrote, “We are losing scripts to Risperdal for treatment of disruptive kids, because Johnson & Johnson has the data and we don’t.” Risperdal, made by Johnson & Johnson, is another drug for schizophrenia and bipolar disorder. Unlike Zyprexa, it has been approved for pediatric use. Mr. Lechleiter also wrote that “Zyprexa is getting traction with some neurologists for treatment of pain,” another off-label use of Zyprexa, which has never been approved for pain relief. The Alaska trial over Zyprexa began March 5 in Anchorage and is expected to last until late this month. In its initial complaint, the state tried to recover costs associated with Lilly’s off-label promotion of Zyprexa. But just before the jury was chosen, Judge Rindner dismissed that claim. As a result, jurors have not been permitted to hear any evidence relating to off-label promotion in the case. But lawyers for the state tried on Tuesday to introduce the e-mail message into evidence anyway. Although the judge ruled against them, the message became part of the court record. In Alabama, a Crackdown on Pregnant Drug Users Adam Nossiter, New York Times- 3/15/2008 ANDALUSIA, Ala. — A day after she gave birth in 2006, Tiffany Hitson, 20, sat on her front porch crying, barefoot and handcuffed. A police officer hovered in the distance. Ms. Hitson’s newborn daughter had traces of cocaine and marijuana in its system, and the young woman, baby-faced herself, had fallen afoul of a tough new state law intended to protect children from drugs, and a local prosecutor bent on pursuing it. She made arrangements for the baby’s care, and headed off to a year behind bars. “I couldn’t believe it,” recalled Ms. Hitson, who was released in November after spending much of the first year of her daughter’s life at the Julia Tutwiler Prison for Women in Alabama. Two worlds are colliding in this piney woods backcountry in southern Alabama: casual drug use and a local district attorney unsettled that children or fetuses might be affected by it. The result is an unusual burst of prosecutions in which young women using drugs are shocked to find themselves in the cross hairs for harming their children, even before giving birth. Over an 18-month period, at least eight women have been prosecuted for using drugs while pregnant in this rural jurisdiction of barely 37,000, a tally without any recent parallel that women’s advocates have been able to find. The district attorney, Greg L. Gambril, acknowledges the number puts him at the “forefront,” at least among Alabama prosecutors. Similar cases have come up elsewhere, usually with limited success. But Alabama, and in particular this hilly, remote terrain just above the Florida Panhandle, is pursuing these cases with special vigor. In Maryland, the state’s highest court in 2006 threw out the convictions of two women whose babies were born with cocaine in their bloodstreams, ruling that punishment was not the right deterrent. Last year, the New Mexico Supreme Court rejected a woman’s child-abuse conviction in a similar case, declaring a fetus was not a child. Some doctors and advocacy groups maintain that the effects of drugs on pregnant women and their fetuses are not fully known; in Alabama, though, these arguments have yet to be officially made. A cultural clash, unfolding within the confined world of Covington County, is at the origin of this prosecutorial crusade. Here, unlike in other jurisdictions, women are not appealing their convictions, and lawyers and doctors talk about these cases reluctantly, if at all. Too many people know one another in these quiet little towns that fade abruptly into the countryside. There has not been a murder here in over three years, the prosecutor said. But a year ago a newborn died at the local hospital, and the mother had traces of methamphetamines in her system. Doctors told the police that the infant’s premature birth could be attributed to maternal drug use, and she was charged with “chemical endangerment of child,” which carries a sentence of 10 years to life in prison. “In my jurisdiction, a baby being born dead because of drug abuse is a huge deal,” Mr. Gambril said. Mr. Gambril makes little distinction between fetus and child. He said his duty was to protect both — though the Alabama law he uses makes no reference to unborn children, and was primarily intended to protect youngsters from exposure to methamphetamine laboratories. “When drugs are introduced in the womb, the child-to-be is endangered,” Mr. Gambril said. “It is what I call a continuing crime.” He added that the purpose of the statute was to guarantee that the child has “a safe environment, a drug-free environment.” “No one is to say whether that environment is inside or outside the womb,” he said, and no judge or other authority in Alabama has so far disagreed. Covington County is an isolated rural terrain where drugs are a recreational outlet in the absence of others, where the police found nearly 200 methamphetamine laboratories in the first years of the decade, and where they made more arrests for abusing the drug than anywhere else in the state. “This is a meth town,” said Ms. Hitson’s grandmother, Shirley Hinson, who helped take care of the baby while Tiffany was in prison. Speaking of youth here, Ms. Hinson said, “There’s nothing for them to do.” The county is the kind of place where young women — white, working-class, on probation for other offenses — sometimes take a chance while pregnant. “I made the biggest mistake of my life & did some drugs with her father right before I went into labor, unaware I was about to have her,” Ms. Hitson wrote to the court from the Covington County Jail, in neat schoolgirl script, pleading to be released after her arrest in October 2006. “Please, please let me spend this most important time with my baby,” she wrote. But the judge had set bond at $200,000 — Ms. Hitson had earlier been charged in connection with a break-in, and with credit-card fraud — and in jail she stayed. The environment can be unforgiving. Rachel Barfoot, 31, who had been charged before with beating her niece, told her probation officer that she was pregnant. When she tested positive for cocaine, she was arrested. “I was in shock,” said Ms. Barfoot. “I told the truth, but the truth got me nowhere,” she said in an interview. Three months pregnant, already a mother of four, she spent five weeks in the Covington County Jail. “It was hell,” said Ms. Barfoot, now jobless and struggling. Police affidavits make it clear that local doctors are cooperating in these investigations. The women are sent off to county jails, state prisons, or drug rehabilitation clinics, and often emerge bitter at the collaboration of police, prosecutors, judges, doctors and social workers they say is less keen on help — Mr. Gambril insists otherwise — than punishment. “In Covington County, I don’t think they’re interested in helping mothers,” Ms. Hitson said. “They’re just sending people straight to prison. It doesn’t help their drug problems.” A few of the local defense lawyers express similar sentiments: “None of those cases should have been brought,” said Rod Sylvester, who represents another woman charged with chemical endangerment. “It’s an overreaching.” But others bring up the powerful, unspoken community sanction against the combination of drugs and pregnant women. And so far, none of the women have risked trial. “Our ultimate goal is to protect mothers and children,” Mr. Gambril said. Meanwhile, Shirley Hinson, Ms. Hitson’s grandmother, is still furious over Tiffany’s year of imprisonment. “They took something away from my granddaughter and my grandbaby they can’t give back,” she said. “They made an example out of Tiffany. That’s all they did.” |