Psychiatrists , Children and Drug Industry ’ s Role Fabrizio Costantini for The New York TimesAnya Bailey is among a growing number of children given antipsychotic drugs by doctors who are paid by the makers of those drugs . By GARDINER HARRIS , BENEDICT CAREY and JANET ROBERTSPublished : May 10 , 2007 When Anya Bailey developed an eating disorder after her 12 th birthday , her mother took her to a psychiatrist at the University of Minnesota who prescribed a powerful antipsychotic drug called Risperdal . Prescription for InfluenceBeyond the Label The New York Times Created for schizophrenia , Risperdal is not approved to treat eating disorders , but increased appetite is a common side effect and doctors may prescribe drugs as they see fit . Anya gained weight but within two years developed a crippling knot in her back . She now receives regular injections of Botox to unclench her back muscles . She often awakens crying in pain . Isabella Bailey , Anya ’ s mother , said she had no idea that children might be especially susceptible to Risperdal ’ s side effects . Nor did she know that Risperdal and similar medicines were not approved at the time to treat children , or that medical trials often cited to justify the use of such drugs had as few as eight children taking the drug by the end . Just as surprising , Ms . Bailey said , was learning that the university psychiatrist who supervised Anya ’ s care received more than $ 7 , 000 from 2003 to 2004 from Johnson & Johnson , Risperdal ’ s maker , in return for lectures about one of the company ’ s drugs . Doctors , including Anya Bailey ’ s , maintain that payments from drug companies do not influence what they prescribe for patients . But the intersection of money and medicine , and its effect on the well - being of patients , has become one of the most contentious issues in health care . Nowhere is that more true than in psychiatry , where increasing payments to doctors have coincided with the growing use in children of a relatively new class of drugs known as atypical antipsychotics . These best - selling drugs , including Risperdal , Seroquel , Zyprexa , Abilify and Geodon , are now being prescribed to more than half a million children in the United States to help parents deal with behavior problems despite profound risks and almost no approved uses for minors . A New York Times analysis of records in Minnesota , the only state that requires public reports of all drug company marketing payments to doctors , provides rare documentation of how financial relationships between doctors and drug makers correspond to the growing use of atypicals in children . From 2000 to 2005 , drug maker payments to Minnesota psychiatrists rose more than sixfold , to $ 1 . 6 million . During those same years , prescriptions of antipsychotics for children in Minnesota ’ s Medicaid program rose more than ninefold . Those who took the most money from makers of atypicals tended to prescribe the drugs to children the most often , the data suggest . on average , Minnesota psychiatrists who received at least $ 5 , 000 from atypical makers from 2000 to 2005 appear to have written three times as many atypical prescriptions for children as psychiatrists who received less or no money . The Times analysis focused on prescriptions written for about one - third of Minnesota ’ s Medicaid population , almost all of whom are disabled . Some doctors were misidentified by pharmacists , but the information provides a rough guide to prescribing patterns in the state . Drug makers underwrite decision makers at every level of care . They pay doctors who prescribe and recommend drugs , teach about the underlying diseases , perform studies and write guidelines that other doctors often feel bound to follow . But studies present strong evidence that financial interests can affect decisions , often without people knowing it . In Minnesota , psychiatrists collected more money from drug makers from 2000 to 2005 than doctors in any other specialty . Total payments to individual psychiatrists ranged from $ 51 to more than $ 689 , 000 , with a median of $ 1 , 750 . Since the records are incomplete , these figures probably underestimate doctors ’ actual incomes . Such payments could encourage psychiatrists to use drugs in ways that endanger patients ’ physical health , said Dr . Steven E . Hyman , the provost of Harvard University and former director of the National Institute of Mental Health . The growing use of atypicals in children is the most troubling example of this , Dr . Hyman said . “ There ’ s an irony that psychiatrists ask patients to have insights into themselves , but we don ’ t connect the wires in our own lives about how money is affecting our profession and putting our patients at risk , ” he said . The Prescription Anya Bailey is a 15 - year - old high school freshman from East Grand Forks , Minn . , with pictures of the actor Chad Michael Murray on her bedroom wall . She has constant discomfort in her neck that leads her to twist it in a birdlike fashion . Last year , a boy mimicked her in the lunch room . “ The first time , I laughed it off , ” Anya said . “ I said : ‘ That ’ s so funny . I think I ’ ll laugh with you . ’ Then it got annoying , and I decided to hide it . I don ’ t want to be made fun of . ” Now she slumps when seated at school to pressure her clenched muscles , she said . It all began in 2003 when Anya became dangerously thin . “ Nothing tasted good to her , ” Ms . Bailey said . Psychiatrists at the University of Minnesota , overseen by Dr . George M . Realmuto , settled on Risperdal , not for its calming effects but for its normally unwelcome side effect of increasing appetite and weight gain , Ms . Bailey said . Anya had other issues that may have recommended Risperdal to doctors , including occasional angry outbursts and having twice heard voices over the previous five years , Ms . Bailey said . Enlarge This Image Fabrizio Costantini for The New York TimesAnya Bailey has a painful nerve condition called dystonia , in which the muscles in her back clench as a result of taking an antipsychotic drug . Prescription for Influence Fabrizio Costantini for The New York TimesAnya Bailey with her younger sister , Melanie , and her mother , Isabella . Dr . Realmuto said he did not remember Anya ’ s case , but speaking generally he defended his unapproved use of Risperdal to counter an eating disorder despite the drug ’ s risks . “ When things are dangerous , you use extraordinary measures , ” he said . Ten years ago , Dr . Realmuto helped conduct a study of Concerta , an attention deficit hyperactivity disorder drug marketed by Johnson & Johnson , which also makes Risperdal . When Concerta was approved , the company hired him to lecture about it . He said he gives marketing lectures for several reasons . “ To the extent that a drug is useful , I want to be seen as a leader in my specialty and that I was involved in a scientific study , ” he said . The money is nice , too , he said . Dr . Realmuto ’ s university salary is $ 196 , 310 . “ Academics don ’ t get paid very much , ” he said . “ If I was an entertainer , I think I would certainly do a lot better . ” In 2003 , the year Anya came to his clinic , Dr . Realmuto earned $ 5 , 000 from Johnson & Johnson for giving three talks about Concerta . Dr . Realmuto said he could understand someone ’ s worrying that his Concerta lecture fees would influence him to prescribe Concerta but not a different drug from the same company , like Risperdal . In general , he conceded , his relationship with a drug company might prompt him to try a drug . Whether he continued to use it , though , would depend entirely on the results . As the interview continued , Dr . Realmuto said that upon reflection his payments from drug companies had probably opened his door to useless visits from a drug salesman , and he said he would stop giving sponsored lectures in the future . Kara Russell , a Johnson & Johnson spokeswoman , said that the company selects speakers who have used the drug in patients and have either undertaken research or are aware of the studies . “ Dr . Realmuto met these criteria , ” Ms . Russell said . When asked whether these payments may influence doctors ’ prescribing habits , Ms . Russell said that the talks “ provide an educational opportunity for physicians . ” No one has proved that psychiatrists prescribe atypicals to children because of drug company payments . Indeed , some who frequently prescribe the drugs to children earn no drug industry money . And nearly all psychiatrists who accept payments say they remain independent . Some say they prescribed and extolled the benefits of such drugs before ever receiving payments to speak to other doctors about them . “ If someone takes the point of view that your doctor can be bought , why would you go to an E . R . with your injured child and say , ‘ Can you help me ? ’ ” said Dr . Suzanne A . Albrecht , a psychiatrist from Edina , Minn . , who earned more than $ 188 , 000 from 2002 to 2005 giving drug marketing talks . The Industry Campaign It is illegal for drug makers to pay doctors directly to prescribe specific products . Federal rules also bar manufacturers from promoting unapproved , or off - label , uses for drugs . But doctors are free to prescribe as they see fit , and drug companies can sidestep marketing prohibitions by paying doctors to give lectures in which , if asked , they may discuss unapproved uses . The drug industry and many doctors say that these promotional lectures provide the field with invaluable education . Critics say the payments and lectures , often at expensive restaurants , are disguised kickbacks that encourage potentially dangerous drug uses . The issue is particularly important in psychiatry , because mental problems are not well understood , treatment often involves trial and error , and off - label prescribing is common . The analysis of Minnesota records shows that from 1997 through 2005 , more than a third of Minnesota ’ s licensed psychiatrists took money from drug makers , including the last eight presidents of the Minnesota Psychiatric Society . The psychiatrist receiving the most from drug companies was Dr . Annette M . Smick , who lives outside Rochester , Minn . , and was paid more than $ 689 , 000 by drug makers from 1998 to 2004 . At one point Dr . Smick was doing so many sponsored talks that “ it was hard for me to find time to see patients in my clinical practice , ” she said . “ I was providing an educational benefit , and I like teaching , ” Dr . Smick said . Dr . Steven S . Sharfstein , immediate past president of the American Psychiatric Association , said psychiatrists have become too cozy with drug makers . one example of this , he said , involves Lexapro , made by Forest Laboratories , which is now the most widely used antidepressant in the country even though there are cheaper alternatives , including generic versions of Prozac . “ Prozac is just as good if not better , and yet we are migrating to the expensive drug instead of the generics , ” Dr . Sharfstein said . “ I think it ’ s the marketing . ” Atypicals have become popular because they can settle almost any extreme behavior , often in minutes , and doctors have few other answers for desperate families . Their growing use in children is closely tied to the increasingly common and controversial diagnosis of pediatric bipolar disorder , a mood problem marked by aggravation , euphoria , depression and , in some cases , violent outbursts . The drugs , sometimes called major tranquilizers , act by numbing brain cells to surges of dopamine , a chemical that has been linked to euphoria and psychotic delusions . Suzette Scheele of Burnsville , Minn . , said her 17 - year - old son , Matt , was given a diagnosis of bipolar disorder four years ago because of intense mood swings , and now takes Seroquel and Abilify , which have caused substantial weight gain . “ But I don ’ t have to worry about his rages ; he ’ s appropriate ; he ’ s pleasant to be around , ” Ms . Scheele said . The sudden popularity of pediatric bipolar diagnosis has coincided with a shift from antidepressants like Prozac to far more expensive atypicals . In 2000 , Minnesota spent more than $ 521 , 000 buying antipsychotic drugs , most of it on atypicals , for children on Medicaid . In 2005 , the cost was more than $ 7 . 1 million , a 14 - fold increase . The drugs , which can cost $ 1 , 000 to $ 8 , 000 for a year ’ s supply , are huge sellers worldwide . In 2006 , Zyprexa , made by Eli Lilly , had $ 4 . 36 billion in sales , Risperdal $ 4 . 18 billion and Seroquel , made by AstraZeneca , $ 3 . 42 billion . Many Minnesota doctors , including the president of the Minnesota Psychiatric Society , said drug makers and their intermediaries are now paying them almost exclusively to talk about bipolar disorder . The Diagnoses Yet childhood bipolar disorder is an increasingly controversial diagnosis . Even doctors who believe it is common disagree about its telltale symptoms . Others suspect it is a fad . And the scientific evidence that atypicals improve these children ’ s lives is scarce . One of the first and perhaps most influential studies was financed by AstraZeneca and performed by Dr . Melissa DelBello , a child and adult psychiatrist at the University of Cincinnati . Dr . DelBello led a research team that tracked for six weeks the moods of 30 adolescents who had received diagnoses of bipolar disorder . Half of the teenagers took Depakote , an antiseizure drug used to treat epilepsy and bipolar disorder in adults . The other half took Seroquel and Depakote . The two groups did about equally well until the last few days of the study , when those in the Seroquel group scored lower on a standard measure of mania . By then , almost half of the teenagers getting Seroquel had dropped out because they missed appointments or the drugs did not work . Just eight of them completed the trial . In an interview , Dr . DelBello acknowledged that the study was not conclusive . In the 2002 published paper , however , she and her co - authors reported that Seroquel in combination with Depakote “ is more effective for the treatment of adolescent bipolar mania ” than Depakote alone . In 2005 , a committee of prominent experts from across the country examined all of the studies of treatment for pediatric bipolar disorder and decided that Dr . DelBello ’ s was the only study involving atypicals in bipolar children that deserved its highest rating for scientific rigor . The panel concluded that doctors should consider atypicals as a first - line treatment for some children . The guidelines were published in The Journal of the American Academy of Child and Adolescent Psychiatry . Three of the four doctors on the panel served as speakers or consultants to makers of atypicals , according to disclosures in the guidelines . In an interview , Dr . Robert A . Kowatch , a psychiatrist at Cincinnati Children ’ s Hospital and the lead author of the guidelines , said the drug makers ’ support had no influence on the conclusions . AstraZeneca hired Dr . DelBello and Dr . Kowatch to give sponsored talks . They later undertook another study comparing Seroquel and Depakote in bipolar children and found no difference . Dr . DelBello , who earns $ 183 , 500 annually from the University of Cincinnati , would not discuss how much she is paid by AstraZeneca . “ Trust me , I don ’ t make much , ” she said . Drug company payments did not affect her study or her talks , she said . In a recent disclosure , Dr . DelBello said that she received marketing or consulting income from eight drug companies , including all five makers of atypicals . Dr . Realmuto has heard Dr . DelBello speak several times , and her talks persuaded him to use combinations of Depakote and atypicals in bipolar children , he said . “ She ’ s the leader in terms of doing studies on bipolar , ” Dr . Realmuto said . Some psychiatrists who advocate use of atypicals in children acknowledge that the evidence supporting this use is thin . But they say children should not go untreated simply because scientists have failed to confirm what clinicians already know . “ We don ’ t have time to wait for them to prove us right , ” said Dr . Kent G . Brockmann , a psychiatrist from the Twin Cities who made more than $ 16 , 000 from 2003 to 2005 doing drug talks and one - on - one sales meetings , and last year was a leading prescriber of atypicals to Medicaid children . The Reaction For Anya Bailey , treatment with an atypical helped her regain her appetite and put on weight , but also heavily sedated her , her mother said . She developed the disabling knot in her back , the result of a nerve condition called dystonia , in 2005 . The reaction was rare but not unknown . Atypicals have side effects that are not easy to predict in any one patient . These include rapid weight gain and blood sugar problems , both risk factors for diabetes ; disfiguring tics , dystonia and in rare cases heart attacks and sudden death in the elderly . In 2006 , the Food and Drug Administration received reports of at least 29 children dying and at least 165 more suffering serious side effects in which an antipsychotic was listed as the “ primary suspect . ” That was a substantial jump from 2000 , when there were at least 10 deaths and 85 serious side effects among children linked to the drugs . Since reporting of bad drug effects is mostly voluntary , these numbers likely represent a fraction of the toll . Jim Minnick , a spokesman for AstraZeneca , said that the company carefully monitors reported problems with Seroquel . “ AstraZeneca believes that Seroquel is safe , ” Mr . Minnick said . Other psychiatrists renewed Anya ’ s prescriptions for Risperdal until Ms . Bailey took Anya last year to the Mayo Clinic , where a doctor insisted that Ms . Bailey stop the drug . Unlike most universities and hospitals , the Mayo Clinic restricts doctors from giving drug marketing lectures . Ms . Bailey said she wished she had waited to see whether counseling would help Anya before trying drugs . Anya ’ s weight is now normal without the help of drugs , and her counseling ended in March . An experimental drug , her mother said , has recently helped the pain in her back .