Noteworthy News Articles on Mental Health Topics, December 13-20, 2006



FDA May Expand Antidepressant Warning
Associated Press, 12/13/2006

WASHINGTON -- Antidepressants increase the risk of suicidal behavior for people up to age 24, the government said Wednesday. It plans new warning labels, and says users of all ages should be closely monitored. The label change proposed Wednesday would expand a warning now on the antidepressants that applies only to children and adolescents.
      The Food and Drug Administration presented its plan to update the drug labels at a meeting of outside advisers on the issue. They endorsed the plan. The FDA also stressed that patients of all ages should continue to be carefully monitored for signs of suicidal tendencies when they are beginning treatment on the drugs.
     Public reaction was split, with some saying the changes were overdue and others arguing they could keep drugs from those who need them. In emotional testimony illustrated at times by slides of family photos, relatives of suicide victims pleaded for the new warnings. Suzanne Gonzalez, shouting and in tears, goaded the panel to action, telling the experts that her 40-year-old husband who had been taking Paxil shot himself. ''I wake up every morning thinking, 'Oh my God, he's dead. He is freaking dead.' Do you wake up and think, 'How many people are going to die today because I am doing nothing?''' Gonzalez asked.
     Still, mental health experts worry that additional warnings could curtail use of the drugs and ultimately do more harm than good. Dr. John Mann, a Columbia University psychiatrist, suggested simply replacing the proposed expanded warnings with the recommendation that doctors more closely monitor their patients. ''We can do more good by providing more treatment for depressed children and adults,'' Mann said.
     The FDA proposed the changes after completing a review that found use of the drugs may increase the risk of suicidal thoughts and behavior among young adults 18 to 24, as well as among younger patients. Psychiatrists testified Wednesday that the 2004 addition of a warning for children led to a falloff in antidepressant prescriptions being written for patients under 18 -- and an increase in suicides in that age group. Still, overall use of antidepressants continues to grow, with nearly 190 million prescriptions dispensed in the United States last year, according to IMS Health, a health care information company. That suggests doctors have placed more weight on the long-term benefits of the drugs than on any short-term risks, said Dr. Thomas Laughren, director of the FDA's division of psychiatry products.
     Expanding the ''black box'' or other warnings on the drugs could dissuade patients from seeking or starting treatment, mental health experts said. They warned that people with untreated depression -- about half of those who suffer from the disease -- face an estimated 15 percent greater likelihood of death by suicide. Dr. Joseph Glenmullen, a Harvard Medical School clinical instructor in psychiatry and author of ''Prozac Backlash,'' said expanding the warnings wouldn't scare off patients, but instead would allow them to make informed choices.
     The FDA recently completed a review of 372 studies involving about 100,000 patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil. When the results were analyzed by age, it became clear there was an elevated though small and short-term risk for suicidal thoughts and behavior among adults 18 to 24, the FDA said in documents released ahead of Wednesday's meeting of its psychopharmacologic drugs advisory committee. The FDA's analysis of the multiple studies suggests an age-related shift in the risk of suicidal thoughts and behavior associated with treatment with the drugs. For instance, antidepressants seem to protect against suicidal thoughts and behavior in adults 30 and older, with the effect most pronounced in patients over 65. The FDA said the increased risk could mean as many as 14 additional cases of suicidal thoughts or behavior in every 1,000 children treated with antidepressants. For adults 18 to 24, there could be four additional such cases per 1,000.
     In May, GlaxoSmithKline and the FDA warned Paxil may raise the risk of suicidal behavior in young adults and added that to the drug's label. ''Anytime suicide is involved it is a tragic outcome. It is one of the things that keeps us motivated to search for better treatments because depression can be a fatal illness,'' GlaxoSmithKline spokeswoman Mary Anne Rhyne said.
     On the Net:
FDA on the use of antidepressants in children, adolescents and adults: http://www.fda.gov/cder/drug/antidepressants/default.htm



Sleep a Problem in Alcohol Recovery
Ann Arbor News, 12/13/2006

New research by a team from the University of Michigan's Department of Psychiatry provides further evidence that insomnia and other sleep problems can impede recovery from an alcohol problem. In addition the researchers found that people's perception of how bad their sleep problems are may be as important as the actual sleep problems themselves.
     The results show how important it is for alcohol-recovery patients, and those who are helping
them through their recovery, to discuss sleep disturbances and. seek help. Often, sleep isn't discussed in alcohol-recovery programs, the researchers say.
     The team has launched a new study that aims to help those who have just entered treatment for alcohol problems. Instead of using sleep medications, which can carry their own risk of addiction, the treatment is based on a series of "talk, therapy" sessions with a trained sleep therapist who can help patients change behaviors and patterns of thinking that contribute to sleep problems.


Antidepressants a Suicide Risk for Young Adults
Shankar Vedantam, Washington Post- 12/14/2006

Widely used antidepressants double the risk of suicidal behavior in young adults, from around three cases per thousand to seven cases per thousand, according to a huge federal analysis of hundreds of clinical trials. It marks the first time regulators have acknowledged that the drugs can trigger suicidal behavior among patients older than 18. Officials at the Food and Drug Administration said yesterday that the higher risk was found in patients 18 to 25 and that the risk faded among older patients. The finding comes two years after the agency ordered a "black box" warning on the drug labels following the discovery of a heightened risk of suicidal behavior among children taking the pills.
      After reviewing the latest data, an expert federal panel yesterday recommended that agency officials tell doctors and the public of the risk but also find a way to note that the risk declines with age, and that leaving depression untreated is also risky. While the studies on the relationship between the drugs and suicide appear contradictory, the experts said one possibility is that the drugs may pose a risk early in treatment but have a protective effect in the long term.
     The agency is leaning toward expanding its black box warning, said Thomas Laughren, director of FDA's division of psychiatric drug products. Officials said they will try to craft language that would urge clinicians to use the drugs carefully, not abandon them.
     The new finding created a dilemma for the regulators. Even as it vindicated some of what critics of drugs such as Prozac, Paxil and Zoloft have said for years, the earlier official warnings about the drugs appear to have led to a drop in their use -- and there are troubling signs that this can lead to an increase in suicides. After concerns were raised in the Netherlands about the suicide risk, there was a 22 percent drop from 2003 to 2005 in antidepressant prescriptions for patients under 18 and a 50 percent increase in suicides, said Robert Gibbons, a professor of psychiatry at the University of Illinois in Chicago. The number of suicides went from 34 to 51. 'What we are seeing is the early signs of an epidemic of suicide in children who are no longer being treated for their depression," Gibbons said in an interview. U.S. suicide data for 2005 is not yet available, but Gibbons said the FDA's black box warning had caused a similar decline in prescriptions among children here. He predicted dozens of additional suicides as a result and warned that any expansion of the black box would have a similar impact on adults.
     Robert Temple, director of FDA's Office of Medical Policy, said regulators are in a bind. On the one hand, they need to tell physicians about the new results to warn them to monitor patients closely for suicidal behavior, but if that means doctors stop prescribing the drugs altogether, "I don't know what you are supposed to do."
     Emotions ran high at the meeting of expert advisers yesterday, with both advocates for the drugs and their critics warning the federal regulators that a wrong move would cost lives. Critics of the drugs said they were deeply distrustful of both the medical profession and FDA itself because of conflicts of interest with the pharmaceutical industry. Allen Jones, of the consumer advocacy group Alliance for Human Research Protection, said, "the love affair between the pharmaceutical industry and our government institutions has to end." Gwen Olsen, a former pharmaceutical industry representative, told the panel she had influenced doctors by offering them free food, gifts and gimmicks to get access and then presented them with skillfully manipulated data. Olsen said she had a change of heart after her 20 year-old niece committed suicide following a withdrawal reaction from the antidepressant Paxil. She said her niece first tried to hang herself from a ceiling fan. When the fan broke, Olsen said, she doused herself in oil and set herself alight.
     Two experts critical of the drugs, British psychiatrist David Healy, and Joseph Glenmullen, a psychiatrist who lectures at Harvard University, said the FDA analysis played down the magnitude of the suicide risk. Information uncovered in lawsuits, they said, suggested that several suicides in industry trials were never disclosed. "Industry controls the data, and industry with the aid of FDA have miscoded the data so all the articles in all the journals that purport to represent clinical trial data are misleading," Healy said in an interview. His own analysis, published in the British Medical Journal in 2005, found a two-fold increase in risk among all adults taking the drugs. "The idea you would have a risk in one age group but not another is just wrong," Healy said.
     Other medical experts and patient advocates, however, warned that black box warnings could scare patients away from necessary treatment. Christopher Kratochvil, a psychiatrist who spoke on behalf of the American Academy for Child and Adolescent Psychiatry; John Mann, a Columbia University psychiatrist who spoke on behalf of the American Foundation for Suicide Prevention; and Donna Barnes, president of the National Organization for People of Color Against Suicide, all said additional warnings might harm patients by making them fearful of treatment.
     Unlike the case with children, in whom antidepressants have generally failed to show they are superior to sugar pills in short-term trials, the drugs have a track record of working in adults. A recent federal study showed that while the drugs do leave much to be desired, treatment provided in the best care settings helped two-thirds of depressed patients recover. "I feel I am listening to a chapter from [the novel] 'Animal Farm' saying, 'industry bad, industry bad,' " said Carolyn Robinowitz, president-elect of the American Psychiatric Association, in an interview. "Pharmaceutical research has brought us a lot of good things."



Panel Wants Broader Antidepressant Labeling
Benedict Carey, New York Times- 12/14/2006

SILVER SPRING, Md., — Strong warning labels about the suicide risk associated with antidepressants, which now include children and adolescents, should be extended to adults under 25, a federal advisory panel concluded Wednesday. The panel, which voted 6 to 2 to recommend the warnings after a daylong hearing, also advised the Food and Drug Administration to require including information in the drugs’ labels highlighting the risks of untreated depression.
      Since 2004, antidepressants have carried black-box warnings — the strongest the F.D.A. can require — about the risk of suicidal thinking and behavior for children and adolescents. The warnings appear in bold type set off by black borders, usually at the top of the prescribing information provided by drug makers to doctors and patients. “I really feel we have an obligation to warn the public when we have new information, and we do,” said Jean Bronstein, a consumer representative and panel member from Sunnyvale, Calif., referring to a recent F.D.A. analysis that found a link between suicidal behavior and antidepressants in young adults, but not in older people.
     The recommendation followed hours of emotional public testimony on both sides of the issue, and comes amid a long-running debate about the safety of the drugs, which include medications like Prozac, from Eli Lilly, Paxil, from GlaxoSmithKline, and Effexor, from Wyeth. Some psychiatrists said expanded warnings could lead to more suicides. Dr. Carolyn B. Robinowitz, president-elect of the American Psychiatric Association, said the labels might cause a “black-box panic.” “We’re talking about a devastating, chronic and recurrent disorder, and a black-box warning may serve as another barrier to care that people need,” Dr. Robinowitz said. But other psychiatrists said the labeling might make doctors be more cautious about how they prescribe the drugs, reserving them for patients who are seriously depressed.
     The panel also heard from many patients and family members who told stories of devastating loss. One woman said her niece set herself on fire and died just after having stopped the drug Effexor. Another woman, shaking, her daughter at her side, described how her 44-year-old husband had shot himself while he was on Paxil, and said, “I hold you responsible for this and always will,” pointing at the panel members. Other patients, however, said they had done well on the drugs.
     The panel based its decision in part on a recently completed analysis by F.D.A scientists of data from studies involving about 100,000 patients. Men and women under 25 who took the drugs were twice as likely as those given placebo pills to attempt suicide or prepare for a suicide attempt, the analysis found. For every 1,000 patients given the drugs, about 4 will act on suicidal urges who would not have done so had they not been taking the medications, the analysis suggested. “It’s about as unequivocal a result as you can get,” said Dr. Marc Stone, a senior F.D.A. reviewer and an author of the report. The analysis found that the drugs did not increase the risk of suicide in adults from 25 to 65, and significantly lowered suicide risk in people over 65.
     The F.D.A. does not have to follow the recommendations of its advisory panels but usually does, and did so after a panel recommended similar warnings for minors in 2004. Since then, researchers have found that antidepressant prescription rates to children and adolescents have dropped in the United States and elsewhere. And the Centers for Disease Control and Prevention said last week that suicide rates in teenagers increased slightly in 2004, for the first time in more than a decade.
     Several psychiatric researchers at the hearing argued that these trends suggested, in effect, that the agency’s previous warning for children had led to the deaths of people who were scared away from treatment. “I recommend that the committee reverse its previous warning for children and adolescents and instead encourage careful monitoring” of side effects, said Dr. John Mann, a professor of psychiatry and radiology at Columbia University and director of psychiatric research at the New York State Psychiatric Institute.
     But others said extending the warnings to include young adults was essential so patients could make informed choices. “Had my son been told about this risk, had any of us been told, we wouldn’t be here,” said Jayne Richner, whose 22-year-old son, Sean, hanged himself in August just after he stopped taking the antidepressant Celexa. “It’s only been four months since he killed himself, and we’re still trying figure out how to get through every day because of this.” Some former patients said the drugs had saved their lives. The apparently stark contradictions in the testimony and in studies might suggest the drugs increase suicidal urges in some and reduce them in others. “It’s possible for a drug to opposite effects over time, even within same domain,” said Dr. Thomas Laughren, director of the division of psychiatry products at the F.D.A.



Giving Troubled Families a Say in Child Welfare
Lynette Clemetson, New York Times- 12/16/2006

McMINNVILLE, Tenn. — In an effort to correct dysfunctional foster care systems, a growing number of child welfare agencies around the country are reaching outside their ranks to involve troubled families and the people in their lives in wrenching decisions about where endangered children should live. Some agencies find that by enlisting help from grandparents, church members, school counselors and sports coaches, they can reach faster, safer and more lasting decisions that result in fewer children languishing in foster care. Under the practice, known as team decision making, a group is assembled within 24 to 48 hours after a state agency is called into a crisis situation.
      Programs exist in at least 21 states. Indiana, Michigan and Tennessee have adopted the team-approach statewide, while other programs are run at the county level. Officials in Denver County, Colo., credit the team approach for a 32 percent drop in out-of-home placements since 2002. In Cuyahoga County, Ohio, the program has reduced the number of children in foster care by more than half since 2001. Tennessee has reduced the number of children in state care by more than 1,000 since March 2004, when there were 10,600 in the system. Methods differ, but the philosophy is the same: that even families under scrutiny from state agencies can help make positive decisions for their children.
     Some advocates for children say the strategy gives negligent parents too much sway. But many child welfare officials believe the team process works. Historically, “agencies called all the shots and told families everything that was wrong with them,” said Viola P. Miller, commissioner of the Tennessee Department of Children’s Services, who instituted her state’s new model. “But kids don’t exist in isolation,” Ms. Miller said. “If we are really going to keep families safe, we need to do that in the context of communities and family.”
     In this rural outpost between Nashville and Knoxville, 12 people gathered recently to decide whether Misty N., a 26-year-old single mother of four, whose children were taken into state custody last February, deserved to get them back. “Let’s start by acknowledging Misty’s strengths,” said Carrie McCrary, a group facilitator with the state, welcoming “Misty’s team.” The group included Misty, her mother, the children’s court-appointed guardian, a local Head Start coordinator, her older children’s school psychologist and several social workers. One by one they offered affirmations.
     Misty (who asked that her family members’ last names be withheld to protect their privacy) had moved from a homeless shelter into a two-bedroom trailer with her mother. Though Misty has mild retardation, she was absorbing newly learned parenting skills, yelling at her children less and offering more positive reinforcement. She was also providing nutritious food during visits with her children. And it was clear, everyone agreed, that she loved her children: Ramon, 6; Domiann, 5; Roberto, 4, and Pedro, 2.
     “We need to talk about the sex offenders,” Rachel Kirby, the children’s court-appointed guardian, said, shattering the mood. Misty had been living with a sex offender when her children were taken away. She had a brief involvement with another. “We just need to be clear,” Ms. Kirby said to Misty. “When you’re standing in court, if there is a sexual offender in the home, that throws all the other good work out the window.”
     Around the country, where similar strategies are in place, a group can meet for as long as two years, helping social workers assess whether families can be reunited or whether children should be moved toward adoption or legal guardianship, with relatives or an outside family. Groups sometimes continue to meet after a placement to monitor children’s progress. Child welfare agencies maintain ultimate power of approval, but deference is given to the collective wisdom and recommendation of the team.
     No comprehensive long-term studies have been conducted to assess whether the team approach reduces incidents of child abuse. But in Cuyahoga County, Ohio, which instituted its program in 1994, Jim McCafferty, director of the county’s Department of Children and Family Services, credits team meetings with helping reduce the number of children in the system to 2,702 this month from 6,237 in 2001, when the county’s largest city, Cleveland, was rebounding from a crack epidemic. The number of children re-entering the system within 18 months dropped to 9 percent in 2004 from 16 percent in 1996. Roxane White, manager of the Denver Department of Human Services, said that in addition to reducing out-of-home placements, team meetings had reduced incidents of new abuse to just over 2.6 percent from 6 percent in 2002.
     But some advocates for children say the team system may be keeping children with parents when they would benefit more from foster care. “The pendulum may have swung too much in the opposite direction,” said Cyndy Bailes, executive director of CASA of the Tennessee Heartland, part of a national group of court-appointed special advocates for children. Ms. Bailes’s organization works in five counties in East Tennessee. She says her volunteers have complained that the team system there is poorly organized, that families do not cooperate and that participants have felt pressured by the Department of Children’s Services to support family reunification over foster care or termination of parental rights. Some social workers disagree. “I have really bought into it, because it is not so much about blaming, so there is less resentment all around,” said Ms. McCrary of Children’s Services.
     Cheryl McGuire, the caseworker who leads Misty’s team, said the system relieved pressure on overworked case managers. Misty and her mother, Geraldine, have seen the change in the system, they said, from the inside out. Geraldine took Misty in as a foster child when she was 5 weeks old. Geraldine, who tacked down beltloops in a garment factory, and her husband adopted Misty and her older brother, Chris, when they were 2 and 3 years old. After Geraldine’s husband died in 1983, she was unable to cope. Misty and Chris went back into state care. Now Misty’s four children are in the system. Of the three known fathers, only one has been tangentially involved. It was Geraldine who called Children’s Services in February, because Misty, she said, “was running wild.” At 64, Geraldine said, she was too old to care for the children on her own. “It scares me half to death to think that she might not get her kids back,” said Geraldine, who is now retired. “But at the time it was best for the children. I hoped it would straighten her out.”
     Geraldine said the team approach offered families more support than in years past when decisions were made by a single caseworker. “When I was a foster parent, they just dropped off the kids and came back once a month to make sure they were clothed and fed,” she said. Misty, too, said the experience differed from her past memories. “It ain’t the first time I’ve been in here,” she said, referring to the county office of the Department of Children’s Services. “But this way here, it’s helping me more. Helping me to get my kids back.”
     Teams around the country adhere to tight timelines for determining permanent placements, typically within a year or two. Placements with relatives are preferred, but sometimes so-called kinship placements are not with biological relatives, but with people whom the child considers family.
     In Rutherford County, southeast of Nashville, a 13-year-old girl was recently placed in foster care after her mother’s suicide. She responded poorly, acting out and wetting her bed. She asked to be with her mother’s boyfriend’s mother, whom she called Granny. The girl’s participation in the team resulted in her adoption, last month, by her grandmother figure.
     With no similar possibilities for Misty’s children, the stakes of her team’s decision are higher. By the one-year mark in February they must recommend reunification or make the children available for adoption. The children are in a rare situation in which the foster parents, a stable family in a nearby town, have agreed to keep all four long term. Misty and Geraldine are living on Geraldine’s $789-a-month Social Security check, plus food stamps. Where would the children sleep in the two-bedroom mobile home and could the women’s limited resources provide for them? asked Ms. McGuire, the team leader, in the hour-and-a-half meeting on Misty’s case. “It don’t leave a lot of room for extras, but it can sustain us,” Geraldine said, adding that they would get extra food stamps with the children.
     The discussion turned to the children. Roberto has continuing problems with aggression. Domiann, one person suggested, had taken on a “dominant mother role” among the sibling group. Pedro, someone mentioned, might suffer from an attachment disorder. Ramon, participants observed, has been gorging during visits with his mother, a nervous behavior he does not engage in at his foster home.
      Next, the group laid out goals for Misty to reach before February: She must have a psychological evaluation and continue training with social workers. She must stop associating with criminals. After she and Geraldine left the room, the team members discussed the weight of the decision yet to come. “The tough fact is that she may do everything we tell her to,” Ms. Kirby said. “She may work as hard as she can, and still not be able to get her children back.”


Eli Lilly Said to Play Down Risk of Top Pill
Alex Berenson, New York Times- 12/17/2006

The drug maker Eli Lilly has engaged in a decade-long effort to play down the health risks of Zyprexa, its best-selling medication for schizophrenia, according to hundreds of internal Lilly documents and e-mail messages among top company managers. The documents, given to The Times by a lawyer representing mentally ill patients, show that Lilly executives kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar — both known risk factors for diabetes.
      Lilly’s own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. But Lilly was concerned that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents, which cover the period 1995 to 2004. Zyprexa has become by far Lilly’s best-selling product, with sales of $4.2 billion last year, when about two million people worldwide took the drug.
     Critics, including the American Diabetes Association, have argued that Zyprexa, introduced in 1996, is more likely to cause diabetes than other widely used schizophrenia drugs. Lilly has consistently denied such a link, and did so again on Friday in a written response to questions about the documents. The company defended Zyprexa’s safety, and said the documents had been taken out of context.But as early as 1999, the documents show that Lilly worried that side effects from Zyprexa, whose chemical name is olanzapine, would hurt sales. “Olanzapine-associated weight gain and possible hyperglycemia is a major threat to the long-term success of this critically important molecule,” Dr. Alan Breier wrote in a November 1999 e-mail message to two-dozen Lilly employees that announced the formation of an “executive steering committee for olanzapine-associated weight changes and hyperglycemia.” Hyperglycemia is high blood sugar. At the time Dr. Breier, who is now Lilly’s chief medical officer, was the chief scientist on the Zyprexa program.
     In 2000, a group of diabetes doctors that Lilly had retained to consider potential links between Zyprexa and diabetes warned the company that “unless we come clean on this, it could get much more serious than we might anticipate,” according to an e-mail message from one Lilly manager to another. And in that year and 2001, the documents show, Lilly’s own marketing research found that psychiatrists were consistently saying that many more of their patients developed high blood sugar or diabetes while taking Zyprexa than other antipsychotic drugs. The documents were collected as part of lawsuits on behalf of mentally ill patients against the company. Last year, Lilly agreed to pay $750 million to settle suits by 8,000 people who claimed they developed diabetes or other medical problems after taking Zyprexa. Thousands more suits against the company are pending.
     On Friday, in its written response, Lilly said that it believed that Zyprexa remained an important treatment for patients with schizophrenia and bipolar disorder. The company said it had given the Food and Drug Administration all its data from clinical trials and reports of adverse events, as it is legally required to do. Lilly also said it shared data from literature reviews and large studies of Zyprexa’s real-world use. “In summary, there is no scientific evidence establishing that Zyprexa causes diabetes,” the company said. Lilly also said the documents should not have been made public because they might “cause unwarranted fear among patients that will cause them to stop taking their medication.”
     As did similar documents disclosed by the drug maker Merck last year in response to lawsuits over its painkiller Vioxx, the Lilly documents offer an inside look at how a company marketed a drug while seeking to play down its side effects. Lilly, based in Indianapolis, is the sixth-largest American drug maker, with $14 billion in revenue last year. The documents — which include e-mail, marketing material, sales projections and scientific reports — are replete with references to Zyprexa’s importance to Lilly’s future and the need to keep concerns about diabetes and obesity from hurting sales. But that effort became increasingly difficult as doctors saw Zyprexa’s side effects, the documents show.
     In 2002, for example, Lilly rejected plans to give psychiatrists guidance about how to treat diabetes, worrying that doing so would tarnish Zyprexa’s reputation. “Although M.D.’s like objective, educational materials, having our reps provide some with diabetes would further build its association to Zyprexa,” a Lilly manager wrote in a March 2002 e-mail message. But Lilly did expand its marketing to primary care physicians, who its internal studies showed were less aware of Zyprexa’s side effects. Lilly sales material encouraged representatives to promote Zyprexa as a “safe, gentle psychotropic” suitable for people with mild mental illness.
     Some top psychiatrists say that Zyprexa will continue to be widely used despite its side effects, because it works better than most other antipsychotic medicines in severely ill patients. But others say that Zyprexa appears no more effective overall than other medicines. And some doctors who specialize in diabetes care dispute Lilly’s assertion that Zyprexa does not cause more cases of diabetes than other psychiatric drugs. “When somebody gains weight, they need more insulin, they become more insulin resistant,” Dr. Joel Zonszein, the director of the clinical diabetes center at Montefiore Medical Center in the Bronx, said when asked about the drug.
     In 2003, after reviewing data provided by Lilly and other drug makers, the F.D.A. said that the current class of antipsychotic drugs may cause high blood sugar. It did not specifically single out Zyprexa, nor did it say that the drugs had been proven to cause diabetes. The drugs are known as atypical antipsychotics and include Johnson & Johnson’s Risperdal and AstraZeneca’s Seroquel. When they were introduced in the mid-1990s, psychiatrists hoped they would relieve mental illness without the tremors and facial twitches associated with older drugs. But the new drugs have not proven significantly better and have their own side effects, said Dr. Jeffrey Lieberman, the lead investigator on a federally sponsored clinical trial that compared Zyprexa and other new drugs with one older one.
     The Zyprexa documents were provided to the Times by James B. Gottstein, a lawyer who represents mentally ill patients and has sued the state of Alaska over its efforts to force patients to take psychiatric medicines against their will. Mr. Gottstein said the information in the documents raised public health issues. “Patients should be told the truth about drugs like Zyprexa,” Mr. Gottstein said.
     Lilly originally provided the documents, under seal, to plaintiffs lawyers who sued the company claiming their clients developed diabetes from taking Zyprexa. Mr. Gottstein, who is not subject to the confidentiality agreement that covers the product liability suits, subpoenaed the documents in early December from a person involved in the suits. In its statement, Lilly called the release of the documents “illegal.” The company said it could not comment on specific documents because of the continuing product liability suits.
     In some ways, the Zyprexa documents are reminiscent of those produced in litigation over Vioxx, which Merck stopped selling in 2004 after a clinical trial proved it caused heart problems. They treat very different conditions, but Zyprexa and Vioxx are not entirely dissimilar. Both were thought to be safer than older and cheaper drugs, becoming bestsellers as a result, but turned out to have serious side effects. After being pressed by doctors and regulators, Merck eventually did test Vioxx’s cardiovascular risks and withdrew the drug after finding that Vioxx increased heart attacks and strokes.
     Lilly has never conducted a clinical trial to determine exactly how much Zyprexa raises patients’ diabetes risks. But scientists say conducting such a study would be exceedingly difficult, because diabetes takes years to develop, and it can be hard to keep mentally ill patients enrolled in a clinical trial. When it was introduced, Zyprexa was the third and most heralded of the atypical antipsychotics. With psychiatrists eager for new treatments for schizophrenia, bipolar disorder, and dementia, Zyprexa’s sales soared. But as sales grew, reports rolled in to Lilly and drug regulators that the medicine caused massive weight gain in many patients and was associated with diabetes. For example, a California doctor reported that 8 of his 35 patients on Zyprexa had developed high blood sugar, including two who required hospitalization.
     The documents show that Lilly encouraged its sales representatives to play down those effects when talking to doctors. In one 1998 presentation, for example, Lilly said its salespeople should be told, “Don’t introduce the issue!!!” Meanwhile, the company researched combinations of Zyprexa with several other drugs, hoping to alleviate the weight gain. But the combinations failed. To reassure doctors, Lilly also publicly said that when it followed up with patients who had taken Zyprexa in a clinical trial for three years, it found that weight gain appeared to plateau after about nine months. But the company did not discuss a far less reassuring finding in early 1999, disclosed in the documents, that blood sugar levels in the patients increased steadily for three years.
     In 2000 and 2001, more warning signs emerged, the documents show. In four surveys conducted by Lilly’s marketing department, the company found that 70 percent of psychiatrists polled had seen at least one of their patients develop high blood sugar or diabetes while taking Zyprexa, compared with about 20 percent for Risperdal or Seroquel. Lilly never disclosed those findings. By mid-2003, Lilly began to change its stance somewhat, publicly acknowledging that Zyprexa can cause severe obesity. Marketing documents make clear that by then Lilly believed it had no choice. On June 23, 2003, an internal committee reported that Zyprexa sales were “below plan” and that doctors were “switching/avoiding Zyprexa.” Since then, Lilly has acknowledged Zyprexa’s effect on weight but has argued that it does not necessarily correlate to diabetes. But Zyprexa’s share of antipsychotic drug prescriptions is falling, and some psychiatrists say they no longer believe the information Lilly offers.
     “From my personal experience, at first my concerns about weight gain with this drug were very significantly downplayed by their field representatives,” said Dr. James Phelps, a psychiatrist in Corvallis, Or. ‘Their continued efforts to downplay that, I think in retrospect, was an embarrassment to the company.” Dr. Phelps says that he tries to avoid Zyprexa because of its side effects but sometimes still prescribes it, especially when patients are acutely psychotic and considering suicide, because it works faster than other medicines. “I wind up using it as an emergency medicine, where it’s superb,” he said. “But I’m trying to get my patients off of Zyprexa, not put them on.”



Drug Files Show Lilly Promoted Unapproved Use
Alex Berenson, New York Times- 12/18/2006

Eli Lilly encouraged primary care physicians to use Zyprexa, a powerful drug for schizophrenia and bipolar disorder, in patients who did not have either condition, according to internal Lilly marketing materials. The marketing documents, given to The New York Times by a lawyer representing mentally ill patients, detail a multiyear promotional campaign that Lilly began in Orlando, Fla., in late 2000. In the campaign, called Viva Zyprexa, Lilly told its sales representatives to suggest that doctors prescribe Zyprexa to older patients with symptoms of dementia.
      A Lilly executive said that she could not comment on specific documents but that the company had never promoted Zyprexa for off-label uses and that it always showed the marketing materials used by its sales representatives to the Food and Drug Administration, as required by law. “We have extensive training for sales reps to assure that they provide information to the doctors that’s within the scope of the prescribing information approved by the F.D.A.,” Anne Nobles, Lilly’s vice president for corporate affairs, said in an interview yesterday.
     Zyprexa is not approved to treat dementia or dementia-related psychosis, and in fact carries a prominent warning from the F.D.A. that it increases the risk of death in older patients with dementia-related psychosis. Federal laws bar drug makers from promoting prescription drugs for conditions for which they have not been approved — a practice known as off-label prescription — although doctors can prescribe drugs to any patient they wish.
     Yet in 1999 and 2000 Lilly considered ways to convince primary care doctors that they should use Zyprexa on their patients. In one document, an unnamed Lilly marketing executive wrote that these doctors “do treat dementia” but “do not treat bipolar; schizophrenia is handled by psychiatrists.” As a result, “dementia should be first message,” of a campaign to primary doctors, according to the document, which appears to be part of a larger marketing presentation but is not marked more specifically. Later, the same document says that some primary care doctors “might prescribe outside of label.” Ms. Nobles said that the company had never promoted its drug for any conditions except schizophrenia and bipolar disorder. Older patients who seem to have dementia may actually have schizophrenia that has gone untreated, Ms. Nobles said. Several psychiatrists outside the company said yesterday that they strongly disagreed with Lilly’s claim. Schizophrenia is a severe disease that is almost always diagnosed when patients are in their teens or 20s. Its symptoms could not be confused with mild dementia, these doctors said.
     Zyprexa is by far Lilly’s best-selling product, with $4.2 billion in sales in 2005, 30 percent of its overall revenues. About two million people worldwide received it last year. Based in Indianapolis, Lilly is the sixth-largest American drug company.
     The issue of off-label marketing is controversial in the drug industry. Nearly every company is under either civil or criminal investigation for alleged efforts to expand the use of its drugs beyond the specific illness or condition for which they are approved. Lilly faces federal and state investigations over its marketing of Zyprexa. In its annual report for 2005, Lilly said that it faced an investigation by federal prosecutors in Pennsylvania and that the Florida attorney general’s office had subpoenaed the company “seeking production of documents relating to sales of Zyprexa and our marketing and promotional practices with respect to Zyprexa.”
     Since Lilly introduced Zyprexa in 1996, about 20 million patients worldwide have received the drug, which helps control the hallucinations and delusions associated with schizophrenia and severe mania. But Zyprexa also causes weight gain in many patients, and the American Diabetes Association found in 2004 that Zyprexa was more likely to cause diabetes than other widely used drugs for schizophrenia. Lilly says that no link between Zyprexa and diabetes has been proven.
     As part of the “Viva Zyprexa” campaign, in packets for its sales representatives, Eli Lilly created the profiles of patients whom it said would be suitable candidates for Zyprexa. Representatives were told to discuss the patient profiles with doctors. One of the patients was a woman in her 20s who showed mild symptoms of schizophrenia, while another was a man in his 40s who appeared to have bipolar disorder. The third patient was “Martha,” a widow with adult children “who lives independently and has been your patient for some time.” Martha was described as being agitated and having disturbed sleep, but without the symptoms of paranoia or mania that typically marked a person with schizophrenia or bipolar disorder.
     Ms. Nobles said that Lilly had actually intended Martha’s profile to represent a patient with schizophrenia. But psychiatrists outside the company said this claim defied credibility, especially given Martha’s age. Instead, she appeared to have mild dementia, they said. “It’d be very unusual for this to be a schizophrenic patient,” said Dr. John March, chief of child and adolescent psychiatry at Duke University medical center. “Schizophrenia is a disease of teenagers and young adults.” Dr. March serves on Lilly’s scientific advisory board. Diagnostic criteria for schizophrenia include delusions, hallucinations, disorganized and incoherent speech, and grossly disorganized behavior. They also include so-called negative symptoms like social isolation and a flattening of the voice and facial expressions.
     The documents also show that Lilly encouraged primary care doctors to treat the symptoms and behaviors of schizophrenia and bipolar disorder even if the doctors had not actually diagnosed those diseases in their patients. Lilly’s market research had found that many primary care doctors did not consider themselves qualified to treat people with schizophrenia or severe bipolar disorder.
     The campaign was successful, the documents show. By March 2001, about three months after the start of Viva Zyprexa, the campaign had led to 49,000 new prescriptions, according to a presentation that Michael Bandick, the brand manager for Zyprexa, gave at a national meeting of Lilly sales representatives in Dallas. Mr. Bandick did not say how many of those new prescriptions were for older patients with dementia. Over all, sales of Zyprexa doubled between 1999 and 2002, rising from $1.5 billion to $3 billion in the United States. In 2002, the company changed the name of the primary care campaign to “Zyprexa Limitless” and began to focus on people with mild bipolar disorder who had previously been diagnosed as depressed — even though Zyprexa has been approved only for the treatment of mania in bipolar disorder, not depression. In a 2002 guide for representatives, Lilly presented the profile of “Donna,” a single mother in her mid-30s whose “chief complaint is, ‘I feel so anxious and irritable lately.’ ” Several doctors’ appointments earlier, she was “talkative, elated, and reported little need for sleep.”
     Lilly’s efforts to promote Zyprexa to primary care doctors disturbed some physicians, the documents show. In August 2001, a doctor in Virginia sent an e-mail message to Lilly and the F.D.A., complaining about a presentation from a Lilly sales representative who had discussed the hypothetical Martha with him. The representative “presented an elderly female patient who was presented to her physician by her family complaining of insomnia, agitation, slight confusion, and had no physical finding to explain her state,” the doctor wrote. The representative then suggested that the doctor prescribe Zyprexa. “I inquired what Zyprexa was indicated for; she then indicated that many physicians might prescribe an antipsychotic for this patient. I then asked for her package insert and read to her that her product was indicated for schizophrenia and bipolar mania — neither of which the presented patient had been diagnosed with,” the doctor wrote. He added that he had never contacted the F.D.A. before but was “genuinely concerned about the promotion of this powerful drug to my peer community of primary care physicians outside of its approved and intended purpose.” Tara Ryker, a spokeswoman for Lilly, said the company no longer uses “Martha” or “Donna” in its marketing. “We are constantly developing new promotional materials and new profiles,” she said.
     The Zyprexa documents were provided to The Times by James B. Gottstein, a lawyer who represents mentally ill patients and has sued the state of Alaska over its efforts to force patients to take psychiatric medicines against their will. Mr. Gottstein said yesterday that the information in the documents should be available to patients and doctors, as well as judges who oversee the hearings that are required before people can be forced to take psychiatric drugs. “The courts should have this information before they order this stuff injected into people’s unwilling bodies,” Mr. Gottstein said.
     Lilly originally provided the documents, under seal, to plaintiffs lawyers who sued the company claiming their clients developed diabetes from taking Zyprexa. Last year, Lilly agreed to pay $700 million to settle about 8,000 of the claims, but thousands more are pending. Mr. Gottstein, who is not subject to the confidentiality agreement that covers the product liability suits, subpoenaed the documents in early December from a person involved in the suits.
     The “Viva Zyprexa” documents also provide color about Lilly’s efforts to motivate its sales force as they marketed Zyprexa — whose generic name is olanzapine — to primary care doctors. At the 2001 meeting in Dallas with Zyprexa sales representatives, Mr. Bandick praised 16 representatives by name for the number of prescriptions they had convinced doctors to write, according to a script prepared in advance of the meeting. More than 100 other representatives had convinced doctors to write at least 16 extra prescriptions and thus “maxed out on a pretty sweet incentive,” he said. “Olanzapine is the molecule that keeps on giving,” Mr. Bandick said.



Baby in the Balance (#1 of five articles)
Mary Otto, Washington Post- 12/18/2006

The small blond woman who slumps before Judge Martin P. Welch seems to have been asleep for the past hour. "Ms. Coleman," the judge says to her, in his gentle way, "I don't want to jump to conclusions, but I have to ask you: Are you high right now?" "I'm tired. I've been up all night," Stacy Coleman says groggily. "My boyfriend kicked me out." Her boyfriend, Keith Cromwell, lean and neatly dressed, is also here before the judge. Welch has their files. He knows their stories. He has taken away so many babies from people like them. Addicts.
      Coleman, 28, is a high school dropout with tousled hair and a careworn face. She grew up in Baltimore's working-class suburbs in a family plagued by cocaine and started using at 13. When she got older she danced in bars, hustled for a living. She has had her brushes with the law. As has Cromwell, 41, a clean-cut high school graduate who grew up in Baltimore public housing, the son of a Vietnam veteran who drank and then disappeared. Cromwell is a steady worker who has had many jobs, a quiet man who struggles with his temper. He started drinking young, got into heroin, then crack. An unlikely couple perhaps, yet bound by their inheritance, the silent absences and secret customs passed down through addicted families. And now bound by a little girl.  Keyona Angel Cromwell is case No. 805206001, born July 19, 2005. Coleman tested positive for cocaine, so the baby was placed in foster care.
     On this day, Coleman and Cromwell find themselves among the first parents to take part in the Family Recovery Program, part of a growing movement of family drug courts throughout the nation. They are here because they want their baby back and know that conquering their addictions is the only way to accomplish that. This is an experimental court, and presiding over it is Welch, one of the first judges in the region empowered to order addicted parents into immediate drug treatment with the goal of dramatically limiting their children's stay in the foster system.
     In more than a decade overseeing the Family/Juvenile Division for the Circuit Court of Baltimore, Welch has taken thousands of neglected and abused children away from addicted parents. He has advised those parents that if they want their children back, they need to get clean and sober. But over and over, he has watched them disappear into anger or denial, or into a system with too few drug treatment slots available, especially for the poor and uninsured. And he has watched their children languish for years in Baltimore's troubled child welfare system.
     Then in August 2005, government, business and philanthropic leaders announced the Maryland Opportunity Compact, a public-private initiative that earmarked $2.5 million to establish the court's Family Recovery Program. When the state takes a child from an addicted parent, the judge refers the parent to the program. A caseworker from a private firm under contract to the court assesses the addict's needs and places the parent in a waiting slot for a drug treatment program paid for by the court. In the first year, 185 people will be referred to the program, 81 of whom will follow through to receive some treatment. The judge meets weekly to discuss their cases with a team of lawyers for the parents and children and with social service providers. Parents appear regularly before Welch in a closed courtroom Friday mornings, maintain steady contact with their case managers and submit urine samples. All the while, the clock is ticking. Decisions must be made.
     This is a year when Coleman and Cromwell's baby will begin to communicate, to walk, to bond, a year in which the parents will stumble repeatedly in their struggle to rise from their addictions. Welch knows relapses are inevitable. He isn't expecting miracles. But if children are to grow up with the capacity to trust and love, they need nurturing families. If Cromwell and Coleman fail to seize this chance, fail to develop the skills they need not only to raise a child but also to live life clean and sober, the state will move to terminate their parental rights. Keyona, with her elfin chin and big brown eyes, will be put up for adoption. "Ms. Coleman, we have to meet each other where we are," Welch tells her. "I'll take your explanation that you are not high, that you are tired. But next month, when you come back, get a good night's sleep. You are right on the cusp."



Temptations Counter Small Victories in Struggle to Regain Child (#2 of five articles)
Mary Otto, Washington Post- 12/19/2006

"Ms. Coleman, you look remarkably better. Like you are in this world,'' Judge Martin P. Welch says. Stacy Coleman is wearing a clean peasant blouse. Her short hair is shining. Keith Cromwell, her boyfriend and the father of her newborn, is there, too. Welch congratulates her. He sees in her file all the right developments: She is now living at a Recovery Network house for women in Baltimore. Making good progress. Urine tests show that she is staying away from drugs. "I wasn't sure what I was going to do with you if you had come back like you were last time," Welch tells her. "You've done a 180-degree turnaround." Case workers, lawyers, roughly a dozen other struggling mothers and two fathers in the courtroom applaud.
     Welch asks Coleman to come up to the bench. The judge awards her a "lifestyle certificate" commending her on her newfound sobriety and hands her a brightly wrapped gift. "A book to read to Keyona," explains the judge. The book is part of a larger boon that her progress brings. She will have a supervised visit with her daughter, now 3 months old and living in a foster home in the suburbs. The judge turns to Cromwell, Keyona's father. "I feel blessed," Cromwell tells the judge in his gruff voice. But inside, Cromwell is struggling.
     Cromwell started taking methadone to curb his cravings for heroin, but the regimen is taxing him. HIV-positive for more than a decade, he has maintained good health by taking antiviral medications faithfully. But as sometimes happens, the methadone interacted with his HIV drugs, so he has decided to stop the methadone. The withdrawal, done under the supervision of his program, has been powerful and painful. He describes the problem to the judge at a later hearing. "What should we do?" Welch asks. "I'm not sure how long it will take to get it out of my blood," Cromwell says. "Work with your case manager," the judge urges.
     After he leaves the courtroom that day, Cromwell redoubles his efforts. He decides to let go of his apartment on the rough end of Baltimore's St. Paul Street, where drugs are everywhere. He checks in for an eight-week stay at Hilltop Recovery Center in Owings Mills. He vows to make recovery a full-time job. Letting go of the apartment is momentous, not just for Cromwell but for Coleman, too. Their whole history is tied up in the place. It was four years ago when he first saw her on St. Paul Street arguing with a man. He intervened, invited her in, offered her a place to take her drugs, take a bath, take a nap. They formed an intense bond.
     Coleman was fierce and vulnerable. Cromwell was fastidiously neat and always working one job or another. Together they had drugs. But addiction sapped them of their patience, their ability to cope with the tensions that any relationship brings. They fought. Yet there were times when they pledged that somehow, together, they would leave behind the madness of addiction and build a real life for themselves.
     When Coleman became pregnant, she tried to stop using. Cromwell tried, too, or at least tried to hide his drug use from her. He would slip into the bathroom. But at the sound of his cigarette lighter, Coleman would rush in to share his crack, they recall. Keyona never came home to the nursery they had set up for her. The state took custody shortly after she was born when Coleman tested positive for cocaine. The day Cromwell moved their things out and put them in storage, he recalls, Coleman got permission to leave her treatment center and walk through the apartment one last time. But it was too much for her, being back in this place. For a minute, everything was quiet, Cromwell recalled. Then he realized Coleman was missing. Cromwell caught up with her out in the street, looking for crack.

 

Playing Down the Risks of a Drug
New York Times Editorial, 12/19/2006

It was bad enough when studies showed that the newest and most heavily promoted drugs for treating schizophrenia weren’t worth their high cost. Now the disturbing tale of their excessive use has taken a tawdry turn with revelations that Eli Lilly, a pharmaceutical giant, has consistently played down the risks of its best-selling antipsychotic drug, Zyprexa, and has promoted it for unapproved uses. The details were spelled out in The Times this week by Alex Berenson, who drew on hundreds of internal Lilly documents that have surfaced in legal proceedings. Although Lilly says the documents present an inaccurate picture, they offer persuasive evidence that the company engaged in questionable behavior to prop up its best-selling drug, which creates almost 30 percent of Lilly’s revenue.
      Zyprexa belongs to a class of drugs that were billed as a significant advance over the first generation of antipsychotic drugs but turned out to have serious flaws. Zyprexa, for example, has a tendency to raise blood sugar and to promote obesity, both of which are risk factors for diabetes. Some 30 percent of the patients taking Zyprexa gain 22 pounds or more after a year on the drug, with some gaining 100 pounds or more. Yet the documents show that Lilly encouraged its sales representatives to play down these adverse effects when talking to doctors.
      The documents also show that Lilly encouraged primary care physicians — far less sophisticated than psychiatrists in treating mental illness — to prescribe the drug for older patients with symptoms of dementia even though it was approved only for schizophrenia and bipolar disorder. It is illegal for companies to promote drugs for unapproved uses, but nearly every major drug company is under civil or criminal investigation for alleged efforts to do so.
     Lilly contends that it has never promoted Zyprexa for unapproved uses and has always shown its marketing materials to the Food and Drug Administration, as required by law. Both claims ought to be tested in Congressional hearings that should focus on how well the industry complies with existing laws and how effectively the F.D.A. regulates the industry’s marketing materials.



Sometimes, the Why Really Isn’t Crucial
Sally Satel, M.D., New York Times- 12/19/2006

“Why do I use drugs?” I am asked every few weeks by a patient in our methadone clinic. I take the query as a good sign; curiosity about oneself is usually healthy. But the premise behind the question — that a person can reliably identify the psychic roots of an addiction, or any other act of self-sabotage — is highly overrated.
     Research psychologists have known for decades that it is very difficult to determine causation in mental life and thus, of behavior. For one thing, we can never perform an experiment. Take my patient Karen, 50, who spent most of the 1990s smoking crack. She is certain that the decade-long binge would never have happened had her mother not died when she was 12. We will never know if she is right because we cannot rewind Karen’s life, play it again, and see what would have happened if her mother had lived.
     Reconstructing the story of one’s life is a complicated business for other reasons. What scientists call hindsight bias kicks in when we try to figure out the causal chain of events leading to the current situation. We may well come up with a tidy story but, inevitably, it will contain large swaths of revisionist history. It’s not that we bias ourselves deliberately; it happens because the mind tends to make events in the past appear comprehensible and orderly. We forget the uncertainties that might have beset us as we struggled in real time. Narratives are shaped also by a natural tendency to focus on information that confirms theories we already hold. These theories — for example, that molested children are likely to grow up to have sexual compulsions of their own — may be imbibed from the media, self-help books or therapists.
     If our own accounts of our actions are often so slanted and embellished, is composing them simply a misbegotten quest? Surely not. To a therapist, the attempt signals that patients are aware that they have a problem worthy of attention. And the narratives themselves can help them make sense out of confusion. This, in turn, can diminish anxiety and exaggerated guilt. Such relief might be sufficient in and of itself for some, or, depending on the goals of therapy, it could embolden a patient to make further healthy adjustments.
     But the grail-like search for insight can also backfire when it becomes a way for patients to avoid the hard work of change. This was my experience with Joe, a 24-year-old heroin addict. At every session, Joe would talk about his childhood relationship with his father, seeking new clues for how it damaged him and drove him to heroin. When I tried to change the topic to on-the-job stresses, which he linked to heroin craving, he said he’d rather “do psychotherapy.” Joe was forestalling the need to make practical changes. The many-layered drama with his dad doubled as an excuse for using heroin, absolving him of the responsibility to quit. When I proposed that possibility to him, he said, “Maybe you’re right.” But nothing really changed. He died of an accidental overdose a few months later.
     Finally, insight has no guaranteed relationship to change. A colleague of mine treated a 45-year-old woman, Joan, who came for therapy because she hated her chunky body. Joan firmly believed that once she discovered The Reason for her overeating she would stop. After a few months, Joan told my colleague that her father had developed cancer the year she went off to college. “You know, I never made the connection until now,” she announced triumphantly, “but I started overeating when he began to waste away. It’s like I was trying to nourish him through myself.” A poignant metaphor, yes, but months later she hasn’t lost a pound.
     It is time to retire the myth that insight is a prerequisite for change. For the patients in our clinic, change without hard-won insight is the rule. And who has time to wait? Not Natalie. This past month she and I worked on getting an abusive, shiftless boyfriend out of her apartment; finding tutoring for her son; and building a new social network to replace the drug users that she used to hang out with. At this stage in her treatment, awareness of what she needs to do will get Natalie further than insight. Less chaos in her life means less anxiety and that means less risk of relapse. Down the road she may ask, “Why did I use drugs?” But in the meantime, what’s important for Natalie and her son is that she is determined to stop.
     Frederic C. Bartlett, a British psychologist, coined the term “effort at meaning” to describe the human impulse to make sense of feelings and circumstances. Self-explorers be warned: it is an effort often fraught with distortion and even hazard, when it prevents one from making the changes that need to be made in the present.

Sally Satel is staff psychiatrist at the Oasis Drug Treatment Clinic and a resident scholar at the American Enterprise Institute.

Mental Health Parity Stalls Again in Michigan
David Eggert, Associated Press- 12/19/2006

LANSING - Lawmakers swiftly approved scores of bills during the frantic last week of their two-year session. But long and emotional debate was saved for a stalled Senate measure that didn't even get a vote; leaving the term-limited sponsor disappointed and supporters pledging to continue their efforts. The issue is mental health parity, an attempt to require health insurers to give as much coverage to mental illnesses as they do physical ones. "It's not a matter of `if' this is going to come, my friends, it's a matter of `when' it's going to come," said Sen. Beverly Hammerstrom, R-Temperance, who told senators she hopes they "do the right thing" in the next session.
     Hammerstrom has pushed the legislation for years. She had hoped to get it passed before her term runs out later this month, but was unsuccessful. She says a stigma against mental illness has created a discrepancy between physical, and mental health coverage, including fewer therapy visits, inpatient days and, allowable expenses along with higher copays and deductibles.
     By requiring better insurance coverage for depression and other disorders, advocates argue, people could be treated long before their illnesses become severe, allowing them to stay active and be productive citizens. The big obstacle is Michigan businesses, which say the bills would add to their already rising health care costs. Insurance companies also oppose requiring such coverage.
Wendy Block of the Michigan Chamber of Commerce says the group is "extremely sympatetic" to the issues facing the mentally ill, but businesses already are seeing double-digit percentage increases in their health costs. "They find it unacceptable, that government would pass somthing on that would add to those costs," said Block, the chamber's director of health policy and human resources. She said it would be difficult to define what mental illnesses should be covered and how the coverage must be on par with benefits for physical health.
     While the GOP-controlled Legislature has blocked the measure, some of its staunchest backers are Republicans who dispute claims that employers will pay higher premiums. Many Democrats-- including Gov. Jennifer Granholm -- support, mental health parity. "How the business community can claim that this is going to cost them more is just sheer ignorance or stupidity," said Sen. Shirley Johnson, R-Troy, who's also leaving because of term limits. "It's far more costly if that individual is not receiving the necessary care so that individual could lead a productive life," said Johnson, who has a family member with a severe mental illness.
     Michigan Partners for Parity, a Southfield-based advocacy group, says the costs of the legislation would be minuscule, increasing premiums by 1 percent or less. That would be offset by more productivity and less absenteeism by workers who have mental illnesses, according to backers. They say the legislation could help up to half of the 6 million people in Michigan with private health insurance. Large companles that self-insure are exempt from mental health parity requirements under federal law.
     Businesses note that higher health care costs under the legislation and inflationary pressures could cause cutbacks elsewhere in their workplaces. "Government should not be dictating to job providers what should and shouldn't be in their benefit packages," Block said. Thirty-nine states have some kind of a mental health parity law, and 26 are considered to have comprehensive statutes.

Many of the 'ADD Generation' Say No to Meds
Melissa Healy, Los Angeles Times- 12/20/2006

For Devin Barclay, life with attention-deficit disorder has been a winding road. And seven years after he quit taking medication for the condition, "it's still winding," he says with a laugh.
But as the 23-year-old navigates his way into adulthood, he's managed to pay the roadside distractions a little less attention. And he's learned a thing or two about getting himself from one destination to the next without taking major detours.
      In 1990, when Barclay was 7, he was diagnosed with ADD and began taking Ritalin — a stimulant medication that he and his parents referred to as "the thinking pill" — to help him sit still and pay attention in class. Over the next decade, almost 2 million American boys and girls were similarly diagnosed, an unprecedented growth of a medical condition that, before 1990, had been so rarely recognized that the national Centers for Disease Control and Prevention did not even track it.
      Today, the children on the leading edge of a wave dubbed by some "the ADD generation" have reached the cusp of adulthood. And as they take on jobs or college, care for themselves away from home, enter into adult relationships and become parents, these newly minted grown-ups are carrying out a massive natural experiment.
     It seems like only yesterday they were fidgeting in their seats, sprinting around their classrooms and daydreaming their way through addition and subtraction. Most, just like Barclay, struggled through elementary and middle school on Ritalin as the practice of medicating attention problems in children took off steeply in the United States: Between 1990 and 2005, production of the two stimulant compounds most used to treat ADD — methylphenidate and amphetamine — increased seventeenfold and thirtyfold, respectively.
     Now many are choosing to do without the drugs that profoundly affected their experience of childhood and school and, in many cases, made it possible for them to learn alongside other kids in mainstream classrooms. It is one of the first decisions of their adult lives. Mostly, it was parents who dictated whether and when they would start medications to sharpen their focus. But the decision to stay on or go off these drugs is one that these teens and young adults have made for themselves — with little research to guide them. Whether the results will be momentous or slight will be more than a personal test for each of them; it is uncharted terrain, also, to researchers in the field of attention problems who are watching intently for answers — and hoping for better guidance for future generations of ADD sufferers.
     American society remains deeply ambivalent about the diagnosis of ADD, a catch-all term used more commonly in the past that includes today's more well-known attention-deficit hyperactivity disorder. (Children diagnosed with ADD typically have difficulty focusing and paying attention. Those with ADHD are physically frenetic as well.) Almost three decades after the psychiatric profession first detailed the condition in its diagnostic manual, nagging questions remain: Does medicating a child with ADD help that child's well-being in the long term? Are there any negative consequences? And must it be a life-long prescription?
     Although most mental health professionals believe that about 2 in 3 children with ADD will continue to contend with the condition as adults, the truth is that "we have very few firm numbers," says Dr. Xavier Castellanos, a leading ADD researcher at New York University. In short, "There are more questions that are unanswered than are answered," says Lisa L. Weyandt, a psychologist at Central Washington University who studies college-bound kids with ADD. Nobody, she says, knows how these fledglings will fare away from home and neighborhood schools, and whether the medications that appeared to help them in grade school will continue to be of use to them as adults. "They are," Weyandt says, "in uncharted territory."

Schooling in adulthood
One reason that the terrain is unfamiliar is that this is the first generation of ADD kids for whom effective medication and accommodations for those with learning disabilities have made college a widespread possibility. "They're here and they're here in increasing numbers," Weyandt says. Barclay, now a freshman at Ohio State University, is typical of such youths in many respects. When he was little, he says, his energy was so prodigious that his father had to sit at his bedside at night and hold his eyelids shut to help him fall asleep. "I was always going at 100 miles per hour … and I was making bad decisions on a regular basis," Barclay says. "I just didn't think of the consequences. I just charged ahead."
     Looking back, he acknowledges that Ritalin did help him academically. But he also felt that it blunted his natural sociability, made it "hard to feel passionate about anything." And the same intensity of focus that helped him in class, he believes, impaired his instincts on the soccer field — a troublesome side effect for a rising soccer star. He quit Ritalin as a freshman in high school. Off the drug, he says: "I felt more like a happier person. I just felt more like myself," voicing an observation heard again and again among young adults who abandoned their ADD medication.
     He has no interest in going back. And he doesn't believe that he needs to. The symptoms that first prompted his parents to put him on Ritalin when he was 7 — the nonstop physical drive, the impulsiveness, the inability to focus in school — have abated with age, he says. A stubborn restlessness of mind remains, but the ADD has changed, and so has he. Adult life has a wider range of choices than grade school offered. He hopes that if he makes the right ones, he can make it all work.
     Barclay has got plenty of company, according to Mariellen Fischer, a professor of neurology at the Medical College of Wisconsin. Among the roughly 150 children she has tracked well into their 20s, "discontinuation of the medication has been by far the vast norm," she says. Of those diagnosed and medicated for ADD as children, she estimates, about 9 in 10 are off those medications by the time they reach 21. By high school, she adds, the most glaring of ADD symptoms — the inability to sit still — has typically eased. And, just like their peers without ADD, these young patients are driven to question the judgment of the people that have been in charge of their lives. Those challenges are naturally focused on the parents, teachers, physicians and therapists who played roles in labeling them different and putting them on medication that is a daily reminder of that judgment. They want, overwhelmingly, to feel normal, Fischer says — to be like other kids who can make it through a school day without being chided for daydreaming or sent to the nurse for a midday pill. Many, she says, are keen to try life without the medications to prove something: "to feel that your success, your accomplishments, your failures are truly your own and not the product of medication."
     For parents, this moment of awakening can be a frightening challenge. But experts warn that it's better to brace for change and have a plan than to dig in or — worse — be taken by surprise. "You can tell a 7- or 8- or 9-year-old to take his medication and he will. By 12 it starts to get tricky, by 14 it's difficult, and by 16, it's impossible," Castellanos says. "You get into issues of autonomy and charges like 'You're just trying to drug me.' "
     Castellanos says that a child often first questions his or her medication during the middle school years. When that happens, the child's parents and a counselor or physician should propose a "controlled break" of several weeks from medication, he recommends. During the break, the parents and counselor can nudge an adolescent to answer questions to determine whether there were benefits from the medication: Are classes less interesting than they were on medication? Does homework get done as readily? Is the child more forgetful about school assignments or appointments, and do friends and family notice a difference in personal interactions? "When they're on treatment for a period of time, they may forget what it's like being off treatment," says Sharon Wigal, a psychologist with UC Irvine School of Medicine whose research and clinical work focuses on adolescents and adults with ADD. Unless they're asked to cue in on the symptoms, she says, many adolescents are quick to believe that age has cured them of the disorder that has set them apart from peers and made life difficult.
     Yet there is reason to believe that adulthood is no cure for ADD, Wigal adds. In recent years, ADD diagnoses among adults have grown sharply, while the proportion of children diagnosed has held steady between 6% to 7% of the population. Though the numbers are uncertain, many ADD experts estimate that as many as 3.5% of adults could have the disorder.

A lingering issue
What few studies there are suggest that ADD often still causes problems after kids grow up. For 13 years, Fischer and her colleague Dr. Russell A. Barkley tracked 147 children who had been diagnosed with ADD by age 7. They compared them with a set of kids from the same neighborhoods without ADD. In 2005, they reported that the young adults with a childhood ADD diagnosis were more likely to have dropped out of high school and to have been fired from jobs. They were more likely to have had sex earlier and became parents at a younger age than their non-ADD peers. They had higher credit card debt and fewer savings, and were far less likely to attend college. Young adults with ADD also appear to have more motor vehicle collisions and traffic citations and are more likely to experiment with illegal drugs. But the data suggest that ADD sufferers who took prescribed medication were less likely than those who did not to use illegal drugs.
     Beyond that, the story is fuzzy because children that Fischer and Barkley tracked did not sort themselves into neat research categories. Some of the children diagnosed with ADD did not take medication. Others took medication steadily. Most took them for a while and then, at various ages, quit. And that leaves researchers in the dark. They don't know whether taking medication for some stretch of time, or during some critical period, will offer protection against these later, adult ills — even if, as adults, people decide not to medicate themselves any longer. In that sense, Devin Barclay's peers are writing the textbook on ADD as they go along.
     "We are the first generation of Ritalin kids," says 31-year-old David Cole who, as an undergraduate with ADD at Brown University, co-wrote "Learning Outside the Lines," a book about navigating college with a learning disability. (He's now an up-and-coming artist based in Rhode Island.) Certainly, such medication has made success in life a possibility for kids like himself, he adds — but once school is out, "it's whatever works for you," he shrugs.
     At 23, Devin Barclay has begun to learn how to harness his attention on tasks that he needs to accomplish. He wouldn't dream of bringing his laptop to a busy coffee shop to do homework, or to have the television on while reading. He plans to do his school work in short spurts of no more than an hour, and is careful to sequence his obligations — term papers, bill paying, soccer coaching duties — so they don't scramble his attention. And he recognizes the signs of a mind gone astray during a task. That's when he ties on his sneakers and takes a long run "to re-center" himself, as he puts it.
     In a nod to his ADD, Barclay says he accomplishes many of his grown-up tasks in pinball fashion, bouncing haphazardly from paying a bill to tending the home he owns to walking his dog. "I get things accomplished. It's probably not as efficiently or as quickly as other people, but it happens in my own way," he says.
     There have been detours. In 2000, one year after he quit taking Ritalin, Devin left high school after his sophomore year, intent on playing soccer professionally. At 18, he signed on with Major League Soccer and spent the next four years playing forward for teams in Tampa Bay, Fla.; San Jose; Washington, D.C.; and Columbus, Ohio. By 2005, he had earned his high school equivalency degree and also reached the end of his soccer career. Now he's a freshman at Ohio State University and older than most of his classmates — but much wiser, he says, for the winding road that has led him there.
     Dr. Lawrence Diller, a San Francisco psychiatrist and author of the 1998 book "Running on Ritalin," says that for children with ADD, the path into adulthood is seldom a straight line. In 25 years in practice, Diller has prescribed ADD medication to hundreds of kids. But in a new book, "The Last Normal Child," he raises concerns about the effect on society and children when parents, schools and the medical establishment reach too easily for such medication. Diller calls it "unduly pessimistic" to believe that two-thirds of kids with ADD will continue to suffer symptoms negative enough to require medication as adults. By a young adult's mid-20s or so, he believes that many who were diagnosed with ADD as children have developed strategies, as Devin Barclay has, to work around their weaknesses. And they are better equipped to answer the question — to medicate or not? — with a clear sense of their adult selves.
     Diller feels that those diagnosed with ADD — as well as their parents and counselors — should revisit "the bargain" that many made with Ritalin and other such drugs as children as they meander through their early adult years. In return for the often-reported side effects of the medication — sleep difficulties, appetite suppression, a "not quite me" feeling — children and their parents expected ADD medication to help them succeed in school at a time when sitting still and compliance with rules was highly valued. But in the adult world, young people with ADD have far wider choices, and they should make them with an awareness of their strengths and their weaknesses, Diller says — not what others expect of them. Using medication "to take octagonal kids and fit them into square holes" may be acceptable in grade school, he says. But "they will be patients for the rest of their lives," he adds, if they pursue fields that require enormous attention to detail or intense concentration on matters that do not fire their interest.
     It is a lesson that Barclay understands well by now. He is gravitating toward hospitality management or maybe psychology — both social fields that play to his outgoing nature. "The whole idea of doing what you love and finding what you enjoy doing is really important," he says. "But sometimes, there's pressure coming from your parents or thinking you need to make a lot of money." Those expectations, he says, can tempt someone with ADD to pursue a career or course of study that highlights weaknesses rather than playing to strengths that often come with the condition — such as creativity, gregariousness and quick response time. It can be a formula for disaster, he says. "If you have ADD, eventually that's going to really take hold. If you're doing something you don't enjoy, you're screwed."

Find out more
For more information on attention-deficit disorder and its treatment, consult these resources:
•  The National Institute of Mental Health. http://www.nimh.nih.gov/publicat/adhd.cfm and http://www.nimh.nih.gpv/healthinformation/adhdmenu.cfm .
•  "Taking Charge of ADHD: The Complete Authoritative Guide for Parents," by Russell A. Barkley (1995, Guilford Press).
•  "Driven to Distraction: Recognizing and Coping with Attention Deficit Disorder from Childhood Through Adulthood," by Edward M. Hallowell with John J. Ratey (1995, Touchstone Press). Also by Hallowell: "Delivered From Distraction: Getting the Most Out of Life with Attention Deficit Disorder" (with Ratey, 2005, Ballantine Books) and "Positively ADD: Real Success Stories to Inspire Your Dreams" (with Catherine A. Corman, 2006, Walker & Co.).
•  Children & Adults with Attention Deficit/Hyperactivity Disorder (CHADD) is the leading nonprofit patient group, providing support groups through local chapters, advocacy and research dissemination, conferences and a magazine. http://www.chadd.org