Noteworthy News Articles on Mental Health Topics, July 12-23, 2005
Study Links Parkinson's Drug to Gambling
Associated Press, 7/12/2005
CHICAGO -- Joe Neglia was a retired government intelligence worker with Parkinson's disease when he suddenly developed what he calls a gambling habit from hell. After losing thousands of dollars playing slot machines near his California home several times a day for nearly two years, Neglia stumbled across an Internet report linking a popular Parkinson's drug he used with compulsive gambling. ''I thought, 'Oh my God, this must be it,''' he said. Three days after stopping the drug, Mirapex, ''all desire to gamble just went away completely. I felt like I had my brain back.''
A Mayo Clinic study published Monday in July's Archives of Neurology describes 11 other Parkinson's patients who developed the unusual problem while taking Mirapex or similar drugs between 2002 and 2004. Doctors have since identified 14 additional Mayo patients with the problem, said lead author Dr. M. Leann Dodd, a Mayo psychiatrist. ''It's certainly enough for us to be cautious as we are using it,'' Dodd said. ''We wouldn't want them to have some kind of financial ruin or difficulties that could be prevented.'' Dr. Leo Verhagen, a Parkinson's specialist at Chicago's Rush University Medical Center who was not involved in the study, says he and some colleagues all have a few patients who developed compulsive gambling while taking Mirapex, a drug that relieves tremors and stiffness. The behavior usually disappears when the drug dose is lowered, Verhagen said. He praised the Mayo article for raising awareness for doctors and patients.
Neglia, 54, now living in Millersville, Md., was not treated at Mayo or involved in the study. He said the problem is underreported ''because of the embarrassment factor'' and is one of several patients suing manufacturer Boehringer-Ingelheim Pharmaceuticals Inc., accusing the company of failing to adequately warn patients about the potential side effects. California attorney Daniel Kodam, who filed the lawsuit last year, said he's spoken with more than 200 Mirapex patients who developed compulsive behaviors, including excessive gambling, sex and shopping. He is seeking to have the complaint certified as a nationwide class-action lawsuit. A similar suit has been filed in Canada, Kodam said. Neglia said he has contacted the Food and Drug Administration but that the agency has failed to act on numerous adverse reaction reports about Mirapex. An FDA spokeswoman said the agency is examining the reports to determine if there's any connection to the drug but declined to say how many it has received.
Katherine King O'Connor, a spokeswoman for the Ridgefield, Conn.-based Boehringer-Ingelheim Pharmaceuticals, said there's no scientific evidence that Mirapex causes the problem. Still, the company revised Mirapex's package insert earlier this year to include compulsive behavior among potential side effects after receiving ''rare'' reports -- all after the drug was approved for U.S. use in 1997, O'Connor said.
Mirapex was among top-selling Parkinson's drugs last year, with more than $200 million in U.S. sales, according to IMS Health, a pharmaceutical information and consulting firm. Mirapex, or pramipexole, reduces tremors and the slow, stiff movements that are a hallmark of Parkinson's disease. It belongs to a class of drugs that mimic the effects of dopamine, a brain chemical that controls movement and is deficient in Parkinson's disease. Mirapex targets dopamine receptors in a brain region associated with emotions that include pleasure and reward-seeking behavior, Dodd said. It can also cause extreme sudden sleepiness. It is sometimes used alone or with the mainstay Parkinson's drug, levodopa.
Though a few of the Mayo patients took related drugs, Dodd said most used Mirapex. They included a 68-year-old man who lost more than $200,000 at casinos over six months and a 41-year-old computer programmer who became ''consumed'' with Internet gambling, losing $5,000 within a few months. Dodd said Mayo doctors now ask patients using the drugs if they have suddenly taken up gambling. Affected patients are usually switched to different drugs or doses, and the result is often dramatic, ''like a light switch being turned off when they stopped the drug,'' she said.
On the Net: Archives of Neurology: http://www.archneurol.com
Lobotomy Back in Spotlight After 30 Years
Associated Press, 7/13/2005
The lobotomy, once a widely used method for treating mental illness, epilepsy and even chronic headaches, is generating fresh controversy 30 years after doctors stopped performing the procedure now viewed as barbaric. A new book and a medical historian contend the crude brain surgery actually helped roughly 10 percent of the estimated 50,000 Americans who underwent the procedure between the mid-1930s and the 1970s. But relatives of lobotomy patients want the Nobel Prize given to its inventor revoked. The lobotomy debate was discussed in an editorial in Thursday's New England Journal of Medicine.
Lobotomy was pioneered in 1936 by Portuguese neurologist Egas Moniz, who operated on people with severe psychiatric illnesses, particularly agitation and depression. Through holes drilled in the skull, Moniz cut through nerve fibers connecting the brain's frontal lobe, which controls thinking, with other brain regions -- believing that as new nerve connections formed the patient's abnormal behavior would end. Moniz, already widely respected for inventing an early brain-imaging method, gave sketchy reports that many patients benefited and was awarded the Nobel Prize for medicine in 1949. The procedure was so in vogue that Rosemary Kennedy, former President Kennedy's mildly retarded sister, had a lobotomy in the 1940s at age 23. She remained in an institution until she died in January. Other doctors used a more primitive version than Moniz, punching an ice pick into the brain above the eye socket and blindly manipulating it to sever nerve fibers.
By the late 1930s doctors were reporting many lobotomy patients were left childlike, apathetic and withdrawn -- not unlike the depiction in the novel and movie ''One Flew Over the Cuckoo's Nest.'' Use eventually waned with the advent of effective psychiatric drugs in the mid-1950s and the growing use of electroshock therapy.
Modern views of lobotomy have led to a call to pull Moniz's Nobel prize. ''How can anyone trust the Nobel Committee when they won't admit to such a terrible mistake?'' asks Christine Johnson, a Levittown, N.Y., medical librarian who started a campaign to have the prize revoked. Her grandmother, Beulah Jones, became delusional in 1949, was lobotomized in 1954 after unsuccessful psychiatric and electroshock treatments, and spent the rest of her life in institutions.
One member of Johnson's campaign, retired nurse Carol Noell Duncanson of Marietta, Ga., said her mother, Anna Ruth Channels, was lobotomized while pregnant to end chronic headaches in 1949. Channels, described as a brilliant and vivacious woman, was sent home incapacitated, Duncanson said. ''The woman could not feed herself, she could not toilet, she could not speak and she was combative,'' Duncanson said. Channels eventually re-learned those things but remained childlike and unable to care for her daughters, who spent years in foster care. Her husband abandoned her and she lived the rest of her life in a small West Virginia town with her mother, who was resentful and ashamed of her, and an abusive brother, Duncanson said. ''She never had a life after her lobotomy. She had nothing,'' the daughter said.
Johnson, whose grandmother died in 1989, several years ago started the Web site psychosurgery.org to build a support network among families of lobotomy patients. Then she and group members began urging removal of an article on the Nobel Web site praising Moniz and saying he deserved the prize because there were no alternative psychiatric treatments at the time. The Nobel Foundation refused to remove or change the article. Now Johnson is asking Nobel laureates to support her campaign to strip Moniz's Nobel. ''There's no possibility to revoke it,'' said foundation executive director Michael Sohlman, who could not recall a Medicine Prize ever being challenged. ''It's a nonstarter.'' The Nobel charter has no provision for appeal of a prize awarded, he said, and the foundation ignores such criticisms, as it did when Palestinian leader Yasser Arafat's Peace Prize was challenged.
Meanwhile, journalist Jack El-Hai recently published ''The Lobotomist,'' about the chief U.S. proponent, neurosurgeon Walter Freeman, who did roughly 3,400 operations. He developed the icepick technique.
In the New England Journal editorial, Dr. Barron H. Lerner, a medical historian and associate professor at Columbia University College of Physicians and Surgeons, wrote that the procedure was a desperate effort to help many of the 400,000 patients confined to U.S. mental hospitals at mid-century. He said a small number of patients became calmer and more manageable. ''I think the numbers that were harmed were quite substantial,'' Lerner said in an interview. ''It was way overused, and it was used in inappropriate circumstances -- retardation, anxiety, headaches.''
El-Hai began his research eight years ago after meeting a relative of a man committed to a mental hospital for epilepsy around 1930 and later lobotomized. As he got into his research about Freeman, El-Hai wondered, ''What led this undeniably gifted and compassionate doctor to champion a brain-mutilating procedure and why he stayed with it so long, past the point of reason?'' El-Hai said patients no longer felt strong emotions and their behavior changed immediately, which was Freeman's goal. But he concluded Freeman was driven to be a showman.
On the Net:
NEJM: http://www.nejm.org
Christine Johnson's site: http://www.psychosurgery.org
Nobel site on Moniz: http://nobelprize.org/medicine/articles/moniz
New Autism Cases Level Off in California
Thomas H. Maugh II, Los Angeles Times- 7/13/2005
The number of newly diagnosed cases of autism in California, which had been skyrocketing for more than a decade, has leveled off and may even be declining, according to new data compiled by the state Department of Developmental Services.
Although the total number of autistic children receiving special education services from the state continues to grow — bringing the current total to 28,046 — the rate of increase peaked in 2002 and has dropped slightly since then. The findings are important because California has the best reporting system for autism in the United States and is generally considered a bellwether for the rest of the country.
Experts do not have a good explanation for the slowdown in new cases. "Perhaps whatever caused the number of cases to go up — environmental insult, or whatever — is no longer present," said Dr. Robert Hendren, executive director of the UC Davis MIND Institute, which researches neurodevelopmental disorders. "It's all speculation. I wish we had good studies."
Parent activist Rick Rollens of Sacramento, who played a key role in the creation of the MIND Institute, said that the trend roughly corresponds to the removal of mercury preservatives from pediatric vaccines. Many activist groups say that the use of mercury in the vaccines caused the sudden increase in autism cases. Federal scientists, however, have continually said that the evidence does not support such a link.
The state data do not include children under the age of 3. According to the department, about 90% of all autistic children are entered into the system before the age of 6. That means, Rollens said, that children born since 1999, about the time that mercury was phased out of vaccines, are just now entering the system. The slowdown could thus reflect the change in vaccination practices. "We can argue till the cows come home about what caused the increase," Rollens said, but the bottom line is that the increase is slowing.
California guarantees access to special education for all children diagnosed with autism and other developmental problems. Thus, the state's data are considered particularly reliable. According to the state data, 2002 was a record year for new autism diagnoses, with 3,259 cases. In 2003, the number of new cases slipped to 3,125. In 2004, the number was 3,074. For the first half of 2005, there were 1,470 new cases, compared to 1,518 in the same period in 2004. "The interesting thing is that, before 2002, every quarterly report had shown an increase over the previous year," Rollens said. "Now, that is no longer the case."
Study Tries to Explain Anorexia Symptoms
Associated Press, 7/13/2005
PITTSBURGH -- Women who suffer from anorexia have increased chemical activity in a part of the brain that controls reward and reinforcement, something that may explain why they are driven to lose weight but don't get any pleasure from it, according to a new study. Researchers used brain-imaging technology on 10 women who had recovered from anorexia and 12 healthy women. In the anorexic women, they found overactivity by dopamine receptors in a part of the brain known as the basal ganglia. Dopamine is a brain chemical that is associated with regulating pleasure. ''The take-home message is dopamine in this area may be very important in how we respond to stimuli, how we view positive and negative reinforcement,'' said Dr. Walter Kaye, a psychiatry professor at the University of Pittsburgh Medical Center and one of the researchers involved in the study.
Dr. Guido Frank, a child psychiatry fellow at the University of California at San Diego and also a leader of the study, said the hope is that the research can lead to the development of drugs to treat anorexia. ''It's very, very hard to treat. They recognize it's wrong, but they still don't eat,'' Frank said. The research was reported this month online in the journal Biological Psychiatry.
About 1 percent of American women suffer from anorexia, a disease than can also affect men. It has the highest death rate of any psychiatric illness, Kaye said. Women suffering from anorexia have obsessional personalities, avoid harm and prefer routine, said Dr. Douglas Bunnell, past president of the National Eating Disorders Association and clinical director of the Renfrew Center of Connecticut. These women tend to resist therapy and have a distorted perception of themselves, he said.
Although only a small number of women get anorexia in its purest form, there are many more people who suffer from some form of an eating disorder, Bunnell said. Making the connection between anorexia and what's happening in the brain is important for understanding and treating eating disorders, he said. ''There's still considerable stigma attached to these disorders, particularly for families. People think it reflects something you did as a parent,'' Bunnell said.
Dr. Craig Johnson, director of the eating disorders program at Laureate Psychiatric Hospital in Tulsa, Okla., said anorexia was historically viewed as a disease brought on by its victims or just a diet gone bad. ''Up until this point we have been left with more sociocultural explanations for the illness and regretfully that has resulted in some levels of minimization, if not glamorization, of the illnesses,'' Johnson said.
Though the ultimate goal from the latest study would be to develop treatments for anorexia, the work may also provide data important in anorexia prevention and identifying people at risk of developing the disease, Johnson said. Frank said researchers still don't know what is causing the dopamine receptor to be overactive, but more research may provide an answer. Kaye and other researchers are involved in a large, multiyear study looking into a genetic link to the disease and an eventual cure. Funded with $10 million from the National Institute of Mental Health, the study is looking at hundreds of families that have two or more members with anorexia.
On the Net:
http://www.angenetics.org
http://www.nationaleatingdisorders.org
Study Links Protein to Severe Memory Loss
Associated Press, 7/14/2005
WASHINGTON -- Some recovery of memory may be possible in the early stages of Alzheimer's disease, suggests a provocative new study in mice that could help researchers open a two-pronged attack against the mind-robbing illness. The research shows a mutant protein named tau is poisoning brain cells, and that blocking its production may allow some of those sick neurons to recover. It worked in demented mice who, to the scientists' surprise, fairly rapidly regained memory.
The work is years away from being useful in people. There are no drugs yet to block tau, and most of the recent search for Alzheimer's treatments has focused instead on another protein, called beta-amyloid. But Thursday's study, published in the journal Science, is sure to refocus attention on finding ways to attack this second culprit, too. ''There basically are two prongs and we need to deal with both,'' said lead researcher Karen Ashe, a University of Minnesota neurologist. ''What we're showing is that there are neurons which are affected (by Alzheimer's) but not dead.''
It's important research because it bolsters the notion of targeting those sick neurons in hopes of one day reversing at least some of dementia's damage, said William Thies, scientific director of the Alzheimer's Association. Today's Alzheimer's drugs only treat symptoms. ''If you can actually rescue some of these sick cells, that really brings the possibility of return of some function, which would be of tremendous value,'' he said.
No one knows exactly what causes Alzheimer's, a creeping brain degeneration that afflicts about 4.5 million Americans and is on the rise as the population ages. The leading theory is that something spurs abnormal production of beta-amyloid, which forms sticky clumps that coat brain cells and kill them -- plaque that is the disease's hallmark. But tau clearly plays some role: A mutant form of this protein forms fibrous tangles in brain cells of Alzheimer's patients, and tau seems to be primarily responsible for another form of dementia.
To see if the tangles themselves are a cause or symptom of dementia, Ashe and colleagues specially engineered a mouse to mimic the kind of tau-and-tangle formation seen in Alzheimer's patients' brains. Sure enough, as the rodents aged, more tangles built up and more brain cells died -- and the mice showed dramatic memory loss.
How could they tell? Mice don't like water and thus quickly learned how to swim out of a water maze. But as they became demented, it took longer to get out of the water until eventually the mice just swam aimlessly. The mice were bred so that eating a certain antibiotic would switch off a gene responsible for producing the bad tau.
Here's the first surprise: As tau production plummeted, the rodents' memory loss didn't just stop, they regained some memory. It wasn't a full recovery — dead brain cells can't be brought back — but after repeated retesting to confirm the results, Ashe concluded that memory function improved to about half the pre-demented state. Also, neuron death stopped.
The second surprise: Those fibrous tangles continued to form even as the mice got better. That suggests the tangles aren't killing brain cells, but the mutant tau itself is. Perhaps the tangles form as the brain tries to fight off poisonous tau by sequestering it, Ashe said.
Studies using mice who overproduce that other Alzheimer's culprit, beta-amyloid, also have suggested that blocking that protein might reverse memory loss, with or without getting rid of the accompanying amyloid plaques, Thies noted. That's why numerous drug companies are hunting medicines to target amyloid production. Similar efforts to block tau have lagged because until now there hasn't been a good animal model of tau-caused dementia to test, he said. That now is likely to change, and Ashe foresees one day attacking both proteins simultaneously. She adds a caution: Don't think antibiotics are the key -- Ashe just happened to use one to switch off a gene specially bred into these mice.
When Art Imitates Pain, It Can Help Heal, a Therapy Group Finds
Abeer Allam, New York Times- 7/14/2005
The psychologist handed a painting by Frida Kahlo to a woman in a group therapy session for depression recently at a Brooklyn hospital. "I want you to tell me what you see here," the psychologist, María Sesín, said in Spanish. "What are you thinking about when you see this? How do you interpret it and relate it to your own lives?" The woman, Cricelva Villicres, 52, started to cry. "This is a united family," she said. "I cannot identify with them. There was so much violence and blood between my mother and father."
The painting, "My Parents, My Grandparents and I," shows Kahlo as a naked child holding a blood-red ribbon connecting her to portraits of her parents and grandparents. The 11 women gathered around a long table at Lutheran Medical Center in Sunset Park took turns looking at it. When it was her turn, Vilma, who is 59, said: "It makes me feel very lonely. I have two children, but I am always alone. I do not have a family like this one." Vilma, who lives in Prospect Park, spoke on the condition that her last name not be used, to protect her privacy. The painting is one of 12 works by Kahlo that Dr. Sesín uses to treat Hispanic women who are suffering from depression, have been abused and have physical illnesses. The sessions are in Spanish, and the paintings help the women feel more comfortable discussing their traumatic experiences.
Though the effectiveness of her novel practice has not been extensively evaluated, Dr. Sesín said Kahlo resonated with the women in her group not only because she was Mexican but also because she confronted some of the same emotional and physical problems. The paintings used in the therapy touch on themes like infidelity, violence, male dominance and infertility. "This was an attempt to develop treatment that was culturally sensitive," said Dr. Sesín, who works at the hospital's mental health center, adding that she has used Kahlo's artwork to treat about 60 women in the last eight years. "The beauty of this artwork therapy is that it brings out each individual's history, each individual's narrative."
In the paintings, Dr. Sesín said, Kahlo was brutally honest about her own troubles, like her turbulent marriage to the muralist Diego Rivera and the excruciating and chronic pain she endured after a bus accident. These kinds of paintings are especially helpful in opening the door, she said, for Hispanic women who are often too embarrassed to speak about intimate family matters.
Vilma said studying Kahlo's paintings helped her unlock and confront the painful memory of the three years of sexual abuse by her stepfather while she was growing up in El Salvador. "When I see Frida's problems, I do not feel ashamed of my problems anymore," said Vilma. "She, too, had physical and emotional problems like me."
Dr. Sesín's use of Kahlo's art in her practice emerged from a desire to serve the growing Hispanic community that has grown around Lutheran Medical Center. The one-on-one talk therapy that works with most patients does not always work as well with Hispanics, particularly those from places where seeking help for mental health problems is not as common as it is here, she said. Her method built upon the work of Dr. Giuseppe Costantino, a psychologist and the clinical director of the mental health center at Lutheran Medical Center. In the late 1980's he developed a form of therapy geared toward children and their parents that used Latino folk tales. But Dr. Sesín wanted something aimed specifically at adults and chose Kahlo's work because it is vivid and personal. "She belongs to us, to our culture," said Dr. Sesín, who was born in Cuba and has a doctorate in psychology from Yeshiva University.
While Dr. Costantino supports the approach, he said more study, including a comparison of Dr. Sesín's form of therapy with others, was needed to assess it. Dr. Sesín said that besides the 13-week Kahlo session, her patients also took medication for depression and continued with regular group therapy.
At the recent meeting, Dr. Sesín picked a painting called, "A Few Small Nips," in which a man stands next to a naked woman on a bed who is covered in blood and appears to be dead. One of Dr. Sesín's patients, Marta Gutierrez, started weeping. "I really identify with this painting because the father of my children stabbed me with a knife in my breast when I was seven months pregnant," said Ms. Gutierrez, 54. Ms. Gutierrez, who is from Puerto Rico and now lives in Sunset Park, said the father of her five children routinely beat her. He kidnapped their infant daughter but was eventually arrested, and she got her baby back, she said. Though she left him and now lives with another man, Ms. Gutierrez said, her mental wounds never healed. In 2000, her 26-year-old daughter died of a drug overdose, leaving behind six children. "I lost my faith in God, and I went crazy," Ms. Gutierrez said. Wrestling with severe depression, she sought help in 2001. Antidepressants helped, she said, but the group therapy and the Kahlo paintings led her to understand that she was not alone. "Sometimes it hurts when you see the paintings that make you remember your past," Ms. Gutierrez said. "But you feel relaxed after you take out what you have inside."
Ms. Villicres, who grew up in the Dominican Republic and lives in Sunset Park, said looking at Kahlo paintings of families together reminded her of the day she saw her father bang her mother's head into the wall and her mother slash his face. Though she vowed never to tolerate such treatment, Ms. Villicres married a man who became abusive. Her husband hit her, cut her off from her family and slept with other women in their bedroom, she said. He would bring her the phone to call the police whenever he hit her, knowing that she would not make the call because she was an illegal immigrant at the time. Eventually, she found the fortitude to leave him, though she still felt consumed by depression.
Ms. Villicres said the weeks spent in Dr. Sesín's group therapy had made her more assertive. She reacted with anger looking at one Kahlo painting in which Rivera towers over an image of Kahlo half his size. "How come she is not equal to him in the painting?" she asked. "How come she put up with so much suffering?" Though the image frustrated her, Ms. Villicres said that reflecting on the various paintings had helped her look at life differently. "When you see art and all things you can do for yourself, it is wonderful," Ms. Villicres said. "I wish we were happy. We cannot change what we have suffered already, but we can start changing things."
FDA OKs Brain Stimulator for Depression
Associated Press, 7/16/2005
WASHINGTON -- The government on Friday approved a new therapy for the severely depressed who have run out of treatment options: a pacemaker-like implant that sends tiny electric shocks to the brain. The Food and Drug Administration's clearance opens Cyberonics Inc.'s vagus nerve stimulator, or VNS, as a potential treatment for an estimated 4 million Americans with hard-to-treat depression-- despite controversy over whether it's really been proven to work. ''These are patients pretty much at the end of the line in terms of what treatment options are available to them,'' said FDA medical device chief Dr. Daniel Schultz, who said he personally was persuaded by Cyberonics' research despite initial skepticism within his agency.
The pacemaker-like implant has been sold since 1997 to control intractable epilepsy, a much smaller market. A generator the size of a pocket watch is implanted into the chest. Wires snake up the neck to the vagus nerve, delivering tiny electric shocks through that nerve and into a region of the brain thought to play a role in mood.
Cyberonics began a 200-patient study to see whether VNS could treat depression patients not adequately helped by other therapies. An FDA review last year found no difference after three months of implant treatment. Cyberonics argued that a year later, a significant number of the VNS recipients had had their depression ease. That yearlong follow-up hadn't been done according to standard scientific procedures -- it wasn't a randomized controlled study -- and thus critics questioned its validity. Cyberonics continued to track the VNS recipients, and two years later a third of patients in the original study had experienced some response and between 17 percent and 20 percent were in remission, Schultz said, evidence he ultimately found persuasive. Still, critics have complained that without a comparison group, it's unclear if the implant really helped or the depression eased for some other reason.
Schultz said there are some safety warnings. The chief risk: More than half of patients in the depression study experienced at least temporary voice alterations -- a hoarseness or raspiness, or voice ''breaks'' -- that seem to persist in a significant number, he said. Other complications include difficulty breathing or swallowing, he said. Deaths have been reported among some epilepsy patients who have a VNS implant, but Schultz said there was no sign of increased deaths in the depression study.
On the Net: Cyberonics: http://www.vnstherapy.com
Gay Teenager Stirs a Storm
Alex Williams, New York Times- 7/17/2005
It was the sort of confession that a decade ago might have been scribbled in a teenager's diary, then quietly tucked away in a drawer: "Somewhat recently," wrote a boy who identified himself only as Zach, 16, from Tennessee, on his personal webpage, "I told my parents I was gay." He noted, "This didn't go over very well," and "They tell me that there is something psychologically wrong with me, and they 'raised me wrong.' "
But what grabbed the attention of Zach's friends and subsequently of both gay activists and fundamentalist Christians around the world who came across the entry, made on May 29, was not the intimacy of the confession. Teenagers have been outing themselves online for years, and many of Zach's friends already knew he was gay. It was another sentence in the Web log: "Today, my mother, father and I had a very long 'talk' in my room, where they let me know I am to apply for a fundamentalist Christian program for gays." "It's like boot camp," Zach added in a dispatch the next day. "If I do come out straight, I'll be so mentally unstable and depressed it won't matter."
The camp in question, Refuge, is a youth program of Love in Action International, a group in Memphis that runs a religion-based program intended to change the sexual orientation of gay men and women. Often called reparative or conversion therapy, such programs took hold in fundamentalist Christian circles in the 1970's, when mainstream psychiatric organizations overturned previous designations of homosexuality as a mental disorder, and gained ground rapidly from the late 90's. Programs like Love in Action have always been controversial, but Zach's blog entries have brought wide attention to a less-known aspect of them, their application to teenagers.
Although Zach wrote only a handful of entries about the Refuge program, all posted before he arrived there in the Memphis suburbs on June 6, his words have been forwarded on the Internet over and over, inspiring online debates, news articles, sidewalk protests and an investigation into Love in Action by the Tennessee Department of Children's Services in response to a child abuse allegation. The investigation was dropped when the allegation proved unfounded, a spokeswoman for the agency said.
To some, Zach, whose family name is not disclosed on his blog and has not appeared in news accounts, is the embodiment of gay adolescent vulnerability, pulled away from friends who accepted him by adults who do not. To others he is a boy whose confused and formative sexual identity is being exploited by gay political activists. In his last blog entry before beginning the program, at 2:33 a.m. on June 4, Zach wrote, "I pray this blows over," adding that if his parents caught him online he'd be in trouble. He described arguments he had been having with his parents, his mother in particular. "I can't take this," his post reads. "No one can. I'm not a suicidal person. I think it's stupid, really. But I can't help it -- no I'm not going to commit suicide -- all I can think about is killing my mother and myself. It's so horrible."
The Rev. John J. Smid, the executive director of Love in Action, declined to discuss the details of Zach's experience, citing the program's confidentiality rules. In an interview early this month at his headquarters, a weathered 1960's A-frame building, which was until recently a vacant Episcopal Church, Mr. Smid explained that teenage participants in Refuge are forbidden to speak with anyone the program does not approve of. Requests made through Mr. Smid to interview Zach's parents were declined.
Founded in California in 1973, Love in Action moved to Memphis 11 years ago. It is one of 120 programs nationwide listed by Exodus International, which bills itself as the largest information and referral network for what is known among fundamentalist Christians as the "ex-gay" movement. In 2003 Love in Action introduced the first structured program specifically for teenagers, 24 of whom have participated, Mr. Smid said. The initial two weeks costs $2,000, and many participants stay six weeks more, as Zach has.
The goal of the program, said Mr. Smid, who said he was once gay but now renounces homosexual behavior, is not necessarily to turn gays into practicing heterosexuals, but to "put guardrails" on their sexual impulses. "In my life I've been out of homosexuality for over 20 years, and for me it's really a nonissue," Mr. Smid said. "I may see a man and say, he's handsome, he's attractive, and it might touch a part of me that is different from someone else," he said. "But it's really not an issue. Gosh, I've been married for 16 years and faithful in my marriage in every respect. I mean I don't think I could white-knuckle this ride for that long."
Mr. Smid first learned that one of his teenage participants was a cause célèbre when protesters appeared outside his headquarters for several days in early June, carrying signs saying, "This is child abuse" and "Jesus is no excuse for hate." He was bombarded by phone calls from reporters, he said, as well as by 100 e-mail messages a day from as far as Norway. Zach's writings, which appeared on his page on www.MySpace.com, were publicized by one of his online acquaintances, E. J. Friedman, a Memphis musician and writer, who read Zach's May 29 blog entry, "The World Coming to an Abrupt - Stop."
Mr. Friedman, 35, was disturbed by what he read and fired off an instant message. "I said: 'You should run away from home. There are people who will help you,' " Mr. Friedman recalled. "He said: 'I can't do that. I want to have my childhood. If this is what I have to go through to have it, then I will.' " Mr. Friedman posted an angry message about Zach's impending stay at Refuge on his own blog. Mr. Friedman's friends picked up on the story and started spreading it on blogs of their own. Soon a local filmmaker, Morgan Jon Fox, who had met Zach through mutual acquaintances, joined with others to start a group called Queer Action Coalition, which organized the protests at Love in Action. "We wanted to show support," said Mr. Fox, 26, who directed a fictional film about gay teenagers in 2003, shot at White Station High School in Memphis, where Zach is a student. "Then it kind of blew up."
Links to Zach's site bounced around the country. Mr. Friedman's Web page had so much traffic, "it blew my bandwidth," he said. Mr. Smid, too, was inundated with Internet traffic, much of it outraged at the attempts to change Zach's sexual orientation. "All of a sudden, 80,000 Internet hits later on our Web site, the world has decided that he should be freed," Mr. Smid said. "Maybe he didn't ask for this. Maybe he doesn't really have the personality that really is going to be able to deal with this. And they talk about our 'abuse' of him."
The program at Love in Action has parallels to 12-step recovery programs. Participants, referred to as clients, study the Bible, meet with counselors and keep a "moral inventory," a journal in which they detail their struggle with same-sex temptation over the years, which they read at emotionally raw group meetings, former clients say. Excessive jewelry or stylish clothing from labels like Calvin Klein and Tommy Hilfiger are forbidden, and so is watching television, listening to secular music (even Bach) and reading unapproved books or magazines. "It's like checking into prison," said Brandon Tidwell, 29, who completed the adult program in 2002 but eventually rejected its teachings, reconciling his Christian beliefs with being gay.
Physical contact among clients other than a handshake is forbidden, and so is "campy" talk or behavior, according to program rules that Zach posted on his blog before he began at Refuge. Occasionally, recalled Jeff Harwood, 41, a Love in Action graduate who still considers himself gay, some participants would mock the mandatory football games. "You could get away with maybe one limp-wristed pass before another client would catch you," he said, seated on a tattered sofa in a funky cafe called Java Cabana in the trendy midtown district of Memphis. Because teenagers, unlike adult clients, return home at night, parents are asked to help keep them away from television and, more important, a computer. Zach has not updated his blog since entering the program.
For Mr. Smid and his supporters, offering Love in Action to teenagers is vital to combat what they see as a growing tolerance of homosexuality among young people. "We just really believe that the resounding message for teenagers in our culture is, practice whatever you want, have sex however, whenever and with whoever you want," he said. "I very deeply believe that is harmful. I think exploring sexuality can lay a teenager up for numerous lifelong issues."
Critics of programs that seek to change sexual orientation say the programs themselves can open a person to lifelong problems, including guilt, shame and even suicidal impulses. The stakes are higher for adolescents, who are already wrestling with deep questions of identity and sexuality, mental-health experts say. "Their identities are still in flux," said Dr. Jack Drescher, the chairman of the committee on gay, lesbian and bisexual issues of the American Psychiatric Association, which in 2000 formally rejected regimens like reparative or conversion therapy as scientifically unproven. "One serious risk for the parent to consider is that most of the people who undergo these treatments don't change. That means that most people who go through these experiences often come out feeling worse than when they went in."
Two weeks ago the Tennessee Department of Health sent a letter to Love in Action, saying it was suspected of offering therapeutic services for which it was not licensed, a department spokeswoman said. Mr. Smid insisted in the interview that his program is a spiritual, not a counseling, center, and he is removing references to therapy from its Web site. He said he does not track his success rate. Mr. Harwood, who graduated from the adult program in 1999, said that of 11 fellow former clients he has kept track of, eight once again consider themselves gay.
Although critics say such programs threaten the adolescent psyche, at least one teenager who considers himself a successful graduate does not agree. "In my experience people who struggle with their sexuality are more mature in general," Ben Marshall, 18, said. He recounted being in turmoil, growing up gay in a conservative Christian household in Mobile, Ala. In 2004 his parents sent him to Refuge. "I went to Memphis kicking and screaming," he said. "I had grown to hate the church for the militant message it gave off toward homosexuality." While enrolled he spent days listening to stories of the pain that homosexuality had caused clients and their families. Slowly, he said, his attitude changed. He ended up choosing to continue in Love in Action's adult program for nine months. While the program has a "high rate of failure," he said "there are enough successes to know I'm not alone." But even success comes only through continuing struggle. Although he plans to date women in the future, Mr. Marshall said, he is avoiding any romantic relationships for the time being. "In all honesty, I'm just trying to figure out how to deal normally with men before I start to deal with women," he said.
Zach's parents did not reply to a request for comment for this article left on their answering machine. Last week his father, speaking to the Christian Broadcasting Network, said: "We felt good about Zach coming here. To let him see for himself the destructive lifestyle, what he has to face in the future." In Zach's case there is no indication he was particularly upset about his sexual identity. Although his high school is in a Bible belt city, the student body is fairly tolerant of homosexual classmates, some students said, particularly those who, like Zach, are not conspicuous about their orientation. "Stereotype me, if you dare," was the motto Zach chose for his blog, where he listed "Edward Scissorhands" and "Girl, Interrupted" as his favorite movies and Brandon Flowers, the lead singer of the alternative rock band the Killers, as the person he would most like to meet.
While Zach, as his blog recounted, only recently came out to his parents, many of his friends had known he was gay for more than a year, one classmate said. Zach openly identified himself as gay on his blog, which links to 213 friends' blogs listed in a Friend Space box on the site. Zach is due to leave the program next week. His June 4 message expressed thanks for the more than 1,700 messages on his page, many voicing support. "Don't worry," he wrote. "I'll get through this. They've promised me things will get better, whether this program does anything or not. Let's hope they're not lying."
Case Raises New Concern Over Withdrawal of Drugs
Nicholas Bakalar, New York Times- 7/19/2005
In recent years, many anticonvulsant drugs have been widely prescribed not only for seizure disorders, but for various kinds of chronic pain and for several different psychiatric illnesses, even though few have been approved by the Food and Drug Administration for those purposes. Now researchers are reporting a case of brain swelling, or cerebral edema, after abrupt withdrawal from pregabalin (Lyrica), a new antiepileptic drug that will be available this fall. The report appears online and in the August issue of Annals of Neurology.
The patient, an 80-year-old woman, was in a clinical trial testing the drug for the severe pain of shingles, or postherpetic neuralgia. About a day after abruptly discontinuing it, she suffered nausea, headache and loss of balance, which progressed to delirium and hallucinations a week later. An M.R.I. scan revealed swelling in the same part of the brain that is affected in some epileptic patients who suddenly stop their drugs.
Dr. Anne Louise Oaklander, the lead author on the paper, acknowledged that a single case did not constitute proof. "Maybe it's completely coincidental that she had M.R.I. abnormalities and a neurological illness, and that she'd recently stopped the drug," she said. "But the more likely explanation is that these things are linked."
Dr. Michael Berelowitz, a vice president of Pfizer, the manufacturer of pregabalin, said this case illustrated that "when you stop a medication, you should stop it under physician guidance and according to the instructions." "We've studied close to 9,000 patients in 53 studies," he continued, "and it's out of this that we develop the indications and the labeling we're seeking." Pregabalin has been approved for the adjunctive treatment of epilepsy, and for the nerve pain caused by diabetes and shingles.
Not all experts agree that withdrawal from these drugs is a significant problem that warrants a special warning. Dr. Eric Hollander, director of clinical psychopharmacology at Mount Sinai Hospital in New York, said that pregabalin, although not approved for the purpose, had had good results in treating anxiety. "I don't think you need to warn patients about withdrawal," he said, "but only suggest that in general for all medications, tapering is better than abruptly stopping."
Pregabalin is chemically close to the anticonvulsant Neurontin, also made by Pfizer and approved for both nerve pain and epilepsy. Neurontin is widely used for other kinds of chronic pain, as well as for bipolar illness, anxiety, insomnia, social phobia, panic disorder, cocaine craving and alcohol withdrawal, though not specifically approved for them. It is legal and ethical for doctors to prescribe drugs in any way they believe will help patients, but drug companies cannot promote products for those symptoms.
Among the anticonvulsants used in psychiatric illnesses, only Depakote and Lamictal are approved for psychiatric disorders. Some anticonvulsants, Tegretol for example, are approved for chronic pain, but others, like Dilantin, are prescribed for pain without F.D.A. approval. While it is well known that sudden withdrawal from the drugs can cause seizures in epilepsy patients, there is little information about withdrawal in people not suffering from seizures.
Dr. Oaklander, an assistant professor of anesthesiology and neurology at Harvard, said that at first everyone thought her patient had the flu, until the severe neurological symptoms set in and brain imaging confirmed a serious problem. "I haven't heard of any other similar cases of clinical illness caused by sudden discontinuance of these meds, but it's possible that other cases have gone unrecognized and now we'll start to hear about them," she said.
People with the edema of high altitude sickness have similar symptoms and M.R.I. abnormalities, and Dr. Oaklander believes this suggests a treatment. Steroids or acetazolamide, a drug that reduces water retention, are highly effective in altitude sickness. "It's wonderful when you can describe a new clinical syndrome, and immediately offer a potential treatment to try," she said.
Feds Again Dispute Vaccine - Autism Link
Associated Press, 7/19/2005
WASHINGTON -- The government assembled some leading scientists Tuesday to try again to lay to rest public suspicions that a mercury-based preservative once used in childhood vaccines causes autism. A day before parents who blame the chemical were to complain to Congress, federal health officials stressed that the only childhood vaccines that still contain the preservative are some, but not all, flu shots -- and that there's no credible evidence that it caused the brain disorder anyway. But they brought no new data to the unusual gathering that might close the case on thimerosal. ''We don't know, unfortunately, for most kids with autism what causes it,'' said Dr. Julie Gerberding, director of the Centers for Disease Control and Prevention. ''We are committed to getting answers. It's not going to happen overnight.''
A scientist who also has a 12-year-old autistic daughter joined the government in urging that the focus shift to hunting the real culprit and a good treatment. ''We need a war on autism, not a war on childhood vaccines,'' said Dr. Peter Hotez of George Washington University, who said he may rail against his daughter's grueling brain disorder but is sure that it ''had absolutely nothing to do with vaccines she received.'' Hotez is a microbiologist attempting to develop a vaccine against hookworm, which attacks children in developing countries.
Autism is a complex developmental disorder best known for impairing a child's ability to communicate and interact. Recent data suggest a 10-fold increase in autism rates over the last decade, although it's unclear how much of the surge reflects better diagnosis and how much is a true rise.
Thimerosal has been used as a pharmaceutical preservative since the 1930s. Although the amount of mercury it contains is very small, it was phased out of routine child vaccines as of 2001 because of concern about increasing doses as babies received ever-more shots. Studies tracking thousands of children have found no association between autism and thimerosal, but critics say those studies are flawed. Today, the last childhood shot to contain the preservative is flu vaccine. This fall, manufacturer Aventis Pasteur will provide 8 million thimerosal-free pediatric flu shots, double last year's amount, a spokesman said Tuesday.
Rep. Dave Weldon, R-Fla., has introduced legislation to speed thimerosal's phase-out from flu vaccine, and parents' groups plan a rally Wednesday to urge more study of thimerosal's past role. ''It's not surprising that some members of the public are left hanging because they're not doing what they should do to look at the issue,'' said Sallie Bernard, co-founder of SafeMinds. ''There's research they (the government) could do that specifically looks at autistic kids and mercury burden.'' The National Institutes of Health is funding a California researcher to do that, part of $102 million in autism research this year, said pediatric disease chief Dr. Duane Alexander.
On the Net: Health and Human Services on autism: http://www.hhs.gov/autism
Summer Camp Provides Therapy to ADHD Kids
Associated Press, 7/20/2005
BIRMINGHAM, Ala. -- Camp counselor Annie Artiga stood in a gymnasium on a rainy morning, jotting down marks on a clipboard as she watched her 10 charges play kickball. But she wasn't keeping score. Artiga was recording points based on each child's behavior, as part of a six-week program for children with behavioral disorders. One child got points for sportsmanship; another lost points because she couldn't remember the number of outs in the game.
The camp -- the University of Alabama at Birmingham's six-week Summer Treatment Program -- is one of a growing number nationwide that provide intense behavioral therapy for children in a summer day camp setting. ''It addresses a lot of important areas of daily life,'' said camp director Bart Hodgens, a clinical psychologist at the university. ''The children are developing social skills, problem-solving skills, academic skills, and we also spend a lot of time on recreation.''
Most of Artiga's charges have attention deficit hyperactivity, which often impairs children's ability to function in multiple settings -- including home, school, and in relationships with peers. Symptoms include impulsiveness, hyperactivity and inattention. The University of Alabama's highly detailed program addresses those impairments by guiding the 24 enrolled children through a strict schedule of sports, academics and art classes. Before and after each session, staff members lead the children in a discussion about rules for the games and classroom and camp life. Children receive points for correct answers and maintaining eye contact, among other behaviors. Those points earn the children rewards, such as permission to participate in weekly field trips.
Vicki Norris, whose 9-year-old son, William, is returning to the camp for a second year, said she found the points-and-rewards system so effective that she adopted it at home. ''I was actually able to adapt the points system for daily use, and it absolutely changed the way the whole school year went,'' Norris said.
The camp's therapy is based around the concept that medication is simply a quick fix for children with such disorders -- and does nothing, in the long run, without behavior modification. It follows a manual designed by William E. Pelham Jr., professor of psychology, pediatrics and psychiatry at the State University of New York at Buffalo. ''People are becoming increasingly aware that even though medication is what's tried with most ADHD kids, medication alone is not a sufficient long-term treatment,'' Pelham said. ''There's a lot of data showing that parents don't like to medicate their kids.''
According to ADHD experts, such behavioral therapy programs have proven effective in repeated studies. ''The behavioral interventions, when combined with medication, are really what we consider to be the standard of care,'' said Russell A. Barkley, a research professor of psychiatry at SUNY Upstate Medical University in Syracuse, N.Y. ''We often recommend that they be combined,'' said Barkley, who has written nearly 20 books on ADHD and treatment options. ''Many children obviously succeed with medication alone, but the medication doesn't address all of their difficulties.''
Pelham said the demand for his manual has increased significantly since he developed the program in the early 1980s. He estimated there are about 100 programs across the country -- including the University at Alabama's camp -- that use a version of his plan. That program -- with graduate and undergraduate staff members -- costs $2,800 for each child -- a sum usually paid by the families. Parents and staff said they hoped that, in the future, camps would lower their prices or insurance companies would become more willing to pay for the programs. ''I'd like to see more of these kind of camps ... and have them be more financially within reach,'' said Norris, the mother of camp attendee William. ''It gave him back a world of confidence -- helped him develop better techniques for meeting people and approaching people.''
On the Net:
University's site: http://www.circ.uab.edu/Sparks/ADHD/adhd.htm
Children and Adults with Attention-Deficit/Hyperactivity Disorder: http://www.chadd.org
Illinois Drug Court Sees Its 1st Case
Barbara Bell, Chicago Tribune- 7/20/2005
The Lake Zurich man told the judge Tuesday that he was grateful for a chance to leave behind a jail cell and county-issued clothing to get help with drug and alcohol problems. The 21-year-old was the first defendant in Lake County's drug court, officially known as Therapeutic Intensive Drug Monitoring Court. It was established to aid addicts who have repeatedly committed property crimes such as auto burglary, forgery and theft to support their habit. "If we can treat the addiction, we can stop the criminal activity," said Joy Gossman, Lake County chief deputy public defender.
The man was arrested a year ago and charged with riding a motorcycle with a blood-alcohol level of 0.13, Assistant State's Atty. Daniel Shanes said. The legal limit in Illinois is 0.08. His driver's license had been revoked for previous DUI convictions, and in October he stole a car, authorities said. The man pleaded guilty to enhanced DUI and theft Tuesday before Associate Judge John Phillips, who is overseeing drug court.
Phillips sentenced him to 4 years in prison but stayed the sentence if he meets the requirements of drug court. The man was ordered into a residential treatment program in Waukegan. He must perform 100 hours of community service, serve 12 months in County Jail on work release and report to drug court every Friday. He also was sentenced to 30 months of probation. "I don't like the sound of prison. I'd rather do anything than prison," the man said. Phillips asked him to face the drug team and say, "I need help."
The man said he was a "little nervous" about being the county's first drug court case. Officials hope the program will be therapeutic as well as punitive. "This is dealing with them as a human being," said Public Defender David Brodsky. "It's everything that's good about the court system and what the court system can be."
Officials considered targeting first-time offenders but decided on repeat offenders whose crimes were related to their addiction, said Victor Geib, assistant director of adult probation. "We want to focus our energy on those who really need our help," said Laura Lopez, a probation officer and drug unit coordinator who will meet regularly with defendants.
The County Board provided $100,000 to start drug court, and the county has applied for a grant from the Justice Department. About 50 people are expected to be referred to drug court in the first year. Court officials are holding a seminar next week for private attorneys to discuss the new court. Waukegan attorney John Curnyn said, "I think it's a doable process; it all depends on the clients."
The first drug court was started in the 1980s in Miami, and there are 38 in Illinois, Lopez said. DuPage County started its drug court in 2000, but it was shut down in 2001 because of problems with a defendant. It was restarted in 2002 and treats about 140 people a year. "We feel these are the numbers we can maintain," said Robin Partin, program coordinator. "These are higher-risk people that we're dealing with."
A drug court faces political pressures, said DuPage County State's Atty. Joe Birkett. Some prosecutors, he said, are so concerned with their success rate that they don't want to participate in a drug court where some people get another chance fail. But "it can be and is a successful alternative to prosecution," Birkett said. Lake County officials are aware of the challenge. "There will always be people that you're going to lose, but you can't stop trying," said Circuit Judge Margaret Mullen, who spearheaded the drug court idea.
The state's attorney's office, the addict's attorney and members of the Lake County Probation Department and the Pretrial Services Division will decide whether to accept a person into drug court. "It's something the person has to want to do," Shanes said.
In Tuesday's case, the man said he wanted to start a new life. "I'm sick of being in handcuffs, of being dressed like this," he said of his jailhouse uniform. Defendants will meet at least twice a week with Lopez, who is certified in drug and alcohol treatment. They will be subject to random drug tests, and most defendants will be required to have a job. If a defendant makes steady progress, a jail sentence may be stayed, Shanes said. "The person knows if they don't make it, they're going to prison," he added.
Because it depends heavily on a willingness to kick an addiction, some may choose prison rather than dealing with the rules and regulations of drug court, Lopez said. Helping an addict can be difficult because there are often complex reasons behind their dependency. "We have multiple problems," with addicts, she said, such as mental illness and a non-supportive family.
FDA Approves New Insomnia Treatment
Associated Press, 7/22/2005
WASHINGTON -- The government approved a new treatment for insomnia on Friday, the first prescription sleep aid not designated as a controlled substance. Called Rozerem, the drug works differently from its competitors.
Rozerem is chemically related to the natural hormone melatonin, which helps regulate the body's sleep-wake cycle, and is thought to work by stimulating melatonin receptors in the brain, explained Dr. Robert Meyer of the Food and Drug Administration. ''It's another option'' for people with the main form of insomnia, difficulty in falling asleep, Meyer said. ''By working through a different pathway, it's entirely possible that this might work for some people in ways that the other drugs do not.'' Nor do studies show any sign that Rozerem, known chemically as ramelteon, causes dependence, the reason it was not designated as a controlled substance. The main warning: Rozerem is metabolized by the liver, so people with liver problems shouldn't take it, Meyer said Manufacturer Takeda Pharmaceuticals said Rozerem will be available in late September but would not reveal a price.
Almost a third of adults have trouble sleeping, and about 10 percent have symptoms of daytime impairment that signal true insomnia. Rozerem joins a list of newer prescription sleep pills that work without many of the side-effect concerns of older agents. Takeda Pharmaceuticals, based in Lincolnshire, Ill., is a wholly owned subsidiary of Takeda Pharmaceutical Co. Ltd., Japan's largest pharmaceutical company.
On the Net: Takeda Pharmaceuticals North America, Inc.: www.tpna.com
Ad War Looming in Sleep Aids
Mark Jewell, Associated Press- 7/23/2005
BOSTON -- Terry Bagley spen nearly two decades searching for a way to get a good night's sleep. She toyed with keeping her bedroom pitch black and sniffing in the soothing smell of lavender. But neither those tricks nor over-the-counter and prescription medications made much of a difference.
Bagley, a 44-year-old operator of a small cleaning service. in Pelham, N.C., is typical of the millions of Americans believed to suffer from chronic insomnia who until recently had mostly short-term solutions available. She found help in a clinical trial for Lunesta, one of a new generation of prescription sleep medications, and continued taking the drug after it hit the market in April. "If you're tired for 20 years, you don't realize how much better you can feel until you start getting a full night's sleep again, she said.
An emerging class of sleep aids is spurring an advertising effort that industry watchers say could rival the saturation campaign for erectile dysfunction drugs. "I would expect this to become a very active category of drugs in consumer advertising," said Judy Franks, of Starcom Worldwide, a Chicago-based ad buying agency.
U.S. advertising for prescription and over-the-counter insomnia drugs totaled nearly $68 million last year, according to TNS Media Intelligence, a media research firm. But spending in the first four months of this year alone was already $48.7 million; at that rate, it could top $146 million this year.
The total is still far less than the $382 million spent last year to advertise erectile dysfunction drugs. But advertising industry officials expect advertising spots encouraging insomniacs to talk to their doctor will become more frequent in coming months as more sleep aids hit the market.
"When a new competitor comes into the marketplace, it ususally heightens spending on the part of all the competitors, because they need to defend their positions in the marketplace," said Michael Guarini, managing director of the New. York City-based Ogilvy Health care.
Lunesta is so far the only prescription sleep aid approved by the Food and Drug Administration for long-term use, in contrast with more established short-term medications such as Ambien and Sonata. While most of the eight FDA approved sleep aids tend to lose their effectiveness after a week or so of use, Lunesta has been shown in Sepracor-funded clinical studies to remain effective for up to six months.
Some of the emerging new insomnia medications are believed to enhance the action of so-called GABA receptors within the brain believed to promote sleep, while minimizing the side effects more common to older drugs. The short-term indication labeling on older drugs put doctors "into a very difficult double bind," said Dr. John Winkelman, medical director of the Sleep Health Center at Brigham and Women's Hospital in Boston. "Patients complaining of chronic nightly sleeplessness were being treated with medicines that were only for short term use now that double-bind has been lifted."
At least two other medications could win U.S. regulatory approval later this year or early next. year. Pfizer Inc. and San Diego-based Neurocrine Biosciences Inc. are teaming up to develop indiplon, a GABA receptor drug which hasn't yet been given a brand name. And Japan-based Takeda Pharmaceuticals is developing Rozerem, a drug that targets receptors of the natural hormone melatonin in an area of the brain that regulates the body's sleep-wake cycle.
Like the heavily marketed erectile dysfunction drugs, the new insomnia medications are aimed at people who have gone largely untreated and maybe unaware of new treatment options. An estimated 126 million adult Americans experience at least one insomnia symptom a few nights a week, according to the National Sleep Foundation; a group which receives some of its funding from drug companies. Only about a third of sufferers are actually diagnosed with insomnia, and a small fraction of those are treated with prescription medication.
Drugmakers are trying to overcome concerns about addiction that were related partly to older barbiturate sleep aids, as well as lingering drowsiness associated with over-the-counter antihistamines. "A lot of doctors have been historically somewhat reticent to prescribe these drugs, so a patient-driven marketing approach makes sense," said analyst David Steinberg of Deutsche Bank North America.
Sepracor Inc., the Marlborough, Mass.-based manufacturer of Lunesta, has nearly tripled the size of its sales staff to 1,250 and is spending $60 million this year on ads for the drug. Lunesta averaged' about 60,000 new prescriptions per week after its launch, and Sepracor reported on Tuesday that the drug posted $83.5 million in second-quarter sales. Because of the quick sales pickup, the company increased its forecast of Lunesta sales for the full year from $160 million to $220 million. Several analysts forecast Lunesta sales will eventually reach $1 billion a year.
The new drugs are gunning. to topple Sanofi-Aventis's Ambien, which accounts for about $1.9 billion of a $2.1 billion U.S. prescription sleep aid market. Sepracor Chief Financial Officer David Southwell said he expects the market to eventually grow to $5.5 billion because of
the new drugs and large number of insomniacs who go untreated.. Sanofi-Aventis's patent for the current version of Ambien is set to expire in October 2006, and the company is rolling out a new version called Ambien CR. That formulation is expected to win approval soon, leading to ads touting its ability to keep patients asleep longer than the original formulation.
The predicted marketing wars are raising alarms among critics who say ads touting medications for common problems -- from heartburn to shyness -- too often unnecessarily steer: patients to prescription drugs. "We've already started to see an enormous marketing push for these drugs, with insomnia now labeled the latest 'epidemic' threatening the health of America," said Dr. Jerry Avorn, a Harvard Medical. School professor and author of the book "Powerful Medicines." Avorn says many insomnia patients could find restful sleep by simply avoiding stimulants like caffeine and nicotine or getting enough exercise. "There's no money to be made advertising those simple lifestyle solutions, but there are billions to be made getting patients onto lifelong use of expensive medications," Avorn said.
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