This excellent investigation about drug company influence on “mental health screening” shows that some kids are getting drugs over the wishes of their own parents.
Mother Jones May/June 2005
When state mental health officials fall under theinfluence of Big Pharma, the burden falls on captive patients. Likethis 13-year-old girl.
by Rob Waters
ALIAH GLEASON IS ABIG, lively girl with a round face, a quick wit, and a sharp tongue.She’s 13 and in eighth grade at Dessau Middle School in Pflugerville,Texas, an Austin suburb, but could pass for several years older. She isthe second of four daughters of Calvin and Anaka Gleason, an AfricanAmerican couple who run a struggling business taking people on casinobus trips.
In the early part of seventh grade, Aliah was a B andC student who “got in trouble for running my mouth.” Sometimes herantics went overboard — like the time she barked at a teacher shethought was ugly. “I was calling this teacher a man because she had amustache,” Aliah recalled over breakfast with her parents at an Austinrestaurant.
School officials considered Aliah disruptive, deemedher to have an “oppositional disorder,” and placed her in a specialeducation track. Her parents viewed her as a spirited child who wasbright but had a tendency to argue and clown. Then one day,psychologists from the University of Texas (UT) visited the school toconduct a mental health screening for sixth- and seventh-grade girls,and Aliah’s life took a dramatic turn.
A few weeks later, theGleasons got a “Dear parents” form letter from the head of thescreening program. “You will be glad to know your daughter did notreport experiencing a significant level of distress,” it said. Not longafter, they got a very different phone call from a UT psychologist, whotold them Aliah had scored high on a suicide rating and needed furtherevaluation. The Gleasons reluctantly agreed to have Aliah see a UTconsulting psychiatrist. She concluded Aliah was suicidal but did nothospitalize her, referring her instead to an emergency clinic forfurther evaluation. Six weeks later, in January 2004, achild-protection worker went to Aliah’s school, interviewed her, thensummoned Calvin Gleason to the school and told him to take Aliah toAustin State Hospital, a state mental facility. He refused, and after aheated conversation, she placed Aliah in emergency custody and had apolice officer drive her to the hospital.
The Gleasons would notbe allowed to see or even speak to their daughter for the next fivemonths, and Aliah would spend a total of nine months in a statepsychiatric hospital and residential treatment facilities. While in thehospital, she was placed in restraints more than 26 times and medicated– against her will and without her parents’ consent — with at least12 different psychiatric drugs, many of them simultaneously.
Onher second day at the state hospital, Aliah says she was told to take apill to “help my mood swings.” She refused and hid under her bed. Shesays staff members pulled her out by her legs, then told her if shetook her medication, she’d be able to go home sooner. She took it. Onanother occasion, she “cheeked” a pill and later tossed it into thegarbage. She says that after staff members found it, five of them cameto her room, one holding a needle. “I started struggling, and they heldmy head down and shot me in the butt,” she says. “Then they left and Ilay in my bed crying.”
What, if anything, was wrong with Aliahremains cloudy. Court documents and medical records indicate that shewould say she was suicidal or that her father beat her, and then shewould recant. (Her attorney attributes such statements to the highdosages of psychotropic drugs she was forcibly put on.) Her clinicaldiagnosis was just as changeable. During two months at Austin StateHospital, Aliah was diagnosed with “depressive disorder not otherwisespecified,” “mood disorder not otherwise specified with psychoticfeatures,” and “major depression with psychotic features.”
Inaddition to the antidepressants Zoloft, Celexa, Lexapro, and Desyrel,as well as Ativan, an antianxiety drug, Aliah was given two newer drugsknown as “atypical
antipsychotics” — Geodon and Abilify — plus anolder antipsychotic, Haldol. She was also given the anticonvulsantsTrileptal and Depakote — though she was not suffering from a seizuredisorder — and Cogentin, an anti-Parkinson’s drug also used to controlthe side effects of antipsychotic drugs. At the time of her transfer toa residential facility, she was on five different medications, and oncethere, she was put on still another atypical — Risperdal.
The case of Aliah Gleason raises
troubling– and long-standing — questions about the coercive uses ofpsychiatric medications in Texas and elsewhere. But especially becauseAliah lives in Texas, and because her commitment was involuntary, shebecame vulnerable to an even further hazard: aggressive drug regimensthat feature new and controversial drugs — regimens that are promotedby drug companies, mandated by state governments, and imposed oncaptive patient populations with no say over what’s prescribed to them.
Inthe past, drug companies sold their new products to doctors through adsand articles in medical journals or, in recent years, by wooingconsumers directly through television and magazine advertising.Starting in the mid-1990s, though, the companies also began to focus ona powerful market force: the handful of state officials who governprescribing for large public systems like state mental hospitals,prisons, and government-funded clinics.
One way drug companieshave worked to influence prescribing practices of these publicinstitutions is by funding the implementation of guidelines, oralgorithms, that spell out which drugs should be used for differentpsychiatric conditions, much as other algorithms guide the treatment ofdiabetes or heart disease. The effort began in the mid-1990s with thecreation of TMAP — the Texas Medication Algorithm Project.
Putsimply, the algorithm called for the newest, most expensive medicationsto be used first in the treatment of schizophrenia, bipolar disorder,and major depression in adults. Subsequently, the state begandeveloping CMAP, a children’s algorithm that is not yet codified by thestate legislature. At least nine states have since adopted guidelinessimilar to TMAP. One such state, Pennsylvania, has been sued by two ofits own investigators who claim they were fired after exposingindustry’s undue influence over state prescribing practices and theresulting inappropriate medicating of patients, particularly children.
Thanksin part to such marketing strategies, sales of the new atypicalantipsychotics have soared. Unlike antidepressants — which have beenmarketed to huge audiences almost as lifestyle drugs — antipsychoticsare aimed at a small but growing market: schizophrenics and people withbipolar disorder. Atypicals are profitable because they are as much as10 times more expensive than the old
antipsychotics, such as Haldol. In 2004, atypical antipsychotics were the
fourth-highest-grossingclass of drugs in the United States, with sales totaling $8.8 billion– $2.4 billion of which was paid for by state Medicaid funds.
Ata time when ethical questions are dogging the pharmaceutical industryand algorithm programs in Texas and Pennsylvania, President Bush’s NewFreedom Commission on Mental Health has lauded TMAP as a “modelprogram” and called for the expanded use of screening programs like theone at Aliah Gleason’s middle school. The question now is whoseinterests do these programs really serve —
THE TEXAS MEDICATIONALGORITHM PROJECT got under way in the mid-1990s just as the newgeneration of antipsychotic drugs was coming on the market. For some 40years before, medications like Thorazine, Haldol, and Mellaril weregiven to patients with schizophrenia or psychosis to silence theirvoices and calm their agitation. But they caused terrible side effects,including sedation, social withdrawal, and tardive dyskinesia, whichcauses muscle and facial tics and strange jerking movements like thosein people with Parkinson’s disease. Many patients would refuse to takethem — when they had a choice. Some sued drug companies and doctorsfor failing to warn them about the side effects and won large awards.
Intothat environment, drug companies brought out the new atypicalantipsychotics and began describing them in almost miraculous terms.The drugs — including Janssen Pharmaceutica’s Risperdal, Eli Lilly’sZyprexa, Pfizer’s Geodon, AstraZeneca’s Seroquel, and Bristol-MyersSquibb’s Abilify, as well as a slightly older drug, Clozapine by Sandoz– were said to be more effective than the
first-generationantipsychotics and less likely to cause motor problems and other sideeffects. “A potential breakthrough of tremendous magnitude,” StanfordUniversity psychiatrist Alan Schatzberg gushed to the New York Times.Laurie Flynn, executive director of the National Alliance for theMentally Ill, added that now “the long-term disability of schizophreniacan come to an end.”
Despite the hoopla, not all doctors
immediatelyembraced the new drugs, and many patients bounced haphazardly betweenthe old and new antipsychotics. “They complained that whenever they gotnew doctors, their whole medication regimen usually changed,” says Dr.Steven Shon, the medical director for behavioral health for the TexasDepartment of State Health Services (DSHS).
In 1995, Shon begantalking with researchers at the UT-Southwestern Medical Center inDallas about the use of algorithms to address these random prescribingpractices. From the start, the process of creating the algorithmsreflected the extensive ties between academic psychiatrists and thepharmaceutical industry. UT-Southwestern was a major research centerstocked with investigators conducting drug trials paid for by
Oneof Shon’s key collaborators was Dr. John Rush, a nationally knownpsychopharmacologist who has extensive ties to industry. Rush declinedto speak for this article, but according to a disclosure statementappended to one of his published articles, he has received grant andresearch support from 14 pharmaceutical companies, has served as aconsultant to 11, and has been a member of 10 drug company speakers’bureaus.
Together, Shon, Rush, and the then-chair ofUT-Southwestern’s psychiatry department convened panels of experts whodrew up “consensus guidelines” for schizophrenia, bipolar disorder, andmajor
depression — blueprints on which drugs to give patients inwhat order and combination. Of the 46 members of the three panels, 27have conducted research on behalf of
pharmaceutical companies,served on drug company speakers’ bureaus, or served as consultants to adrug company, according to a review conducted for Mother Jones by theCenter for Science in the Public Interest, a watchdog group thatmaintains a database on the financial links of researchers.
Forthe drug companies, TMAP represented an opportunity. Their productswere given a high priority in the algorithm, and if the algorithm waswidely followed, it could mean thousands of prescriptions and millionsof dollars in revenue. The industry didn’t miss the chance. “We went tothe pharmaceutical companies or, actually, they approached us becausethey are always dropping by,” Shon told Mother Jones. “Once we createdthe algorithms, they said, ‘Could you use any financial help for anymaterials?’ And we said, ‘Yeah,’ because we have to publish manuals. Wehave to create training videotapes.”
Shon says the initialcreation of the TMAP guidelines was underwritten by state funds, alongwith $3 million in grants from foundations, including $2.4 million fromthe Robert Wood Johnson Foundation, a charity set up by the estate of aformer chief executive of Johnson & Johnson, the parent of Janssen.Shon insists that no industry money went into the creation of theguidelines, though a 1999 paper he coauthored outlining the
“development and implementation” of TMAP acknowledged grant support from seven pharmaceutical companies.
Shonalso told Mother Jones that his department received only $285,000 fromdrug companies for TMAP’s training materials in the program’s”feasibility testing stage.” But Nanci Wilson, an investigativereporter for KEYE-TV in Austin, reviewed the DSHS accounts, and heranalysis indicates that gifts from pharmaceutical companies totaled$1.3 million from 1997 to July 2004, at least $834,000 of which wasearmarked for TMAP. For example:
*** Janssen Pharmaceutica, themaker of Risperdal, gave $191,183 “to help support furtherdevelopmental activities of TMAP” or in general support of TMAP.
***Eli Lilly, the maker of Prozac and Zyprexa, gave $47,000 to “help fundthe collaborative effort to develop medication best practices for thetreatment of major depression, schizophrenia and bipolar disorders.”All together Lilly contributed $103,000 to support TMAP.
*** Pfizer, the maker of the antidepressant Zoloft and the new antipsychotic Geodon, contributed at least $146,500 for TMAP.
Whilenot refuting Shon’s statement, DSHS spokesman Doug McBride says he is”aware” that industry donated $1.3 million. Representatives ofpharmaceutical companies contacted by Mother Jones denied that theircontributions were intended to shape TMAP. “We didn’t participate inthe development or influence the content,” said Janssen spokesman DougArbesfeld. “It was an arm’s-length contribution.” Heather Lusk, an EliLilly representative, said contributions to TMAP were “educational”grants made by a company grants office that “is completely independentof any kind of sales and marketing function.”
Pfizer’s Jack Coxpointed out that nonprofit mental health advocacy groups also raise andspend money to influence policy. “There’s an assumption that our moneyis dirty and corrupt,” he said. “I beg to differ.”
AS THE TMAPPANEL MEMBERS worked on the protocols, drug companies aggressivelypromoted the new antipsychotics across the psychiatric landscape. Theirkey selling point: that they were more effective and caused fewerserious side effects than the older antipsychotics, especially Haldol,the most widely used. Though it did approve six atypicals, the FDA wasdubious of some of these claims. “We would consider any advertisementor promotional labeling for Risperdal false, misleading or lacking fairbalance if there is a presentation of data that conveys the impressionthat [Risperdal] is superior to [Haldol] or any other marketedantipsychotic drug product with regard to safety or effectiveness,” anFDA official wrote in a 1993 letter to Janssen
Pharmaceutica. Butthe letter was only made public 53years later, when journalist RobertWhitaker quoted it in his 2002 book, Mad in America. Most prescribingdoctors were left in the dark. (For more on how drug companiesmanipulated clinical trials for atypicals seemotherjones.com/spinningdoctors.)
The largest study to date, areview of 52 clinical trials including more than 12,000 patientspublished in the British Medical Journal in 2000, found “no clearevidence that atypical antipsychotics are more effective or bettertolerated than
conventional antipsychotics.” A 2003 study comparingZyprexa, the top-selling atypical antipsychotic, and Haldol, publishedin the Journal of the American Medical Association, found the new drug”does not demonstrate advantages compared with [Haldol] in compliance,symptoms or overall quality of life.”
The new drugs now appearto be associated with higher suicide rates and to cause tardivedyskinesia, too, though perhaps at lower rates than thefirst-generation drugs. They can cause rapid weight gain and thus anincreased risk of diabetes. In September 2003, the FDA required themakers of all atypicals to add to their labels a warning that the drugscan cause hyperglycemia, diabetes, and even death. Janssen was alsomade to send doctors a letter conceding it had misled them when it saidthat Risperdal does not increase the risk of diabetes. In fact, thecompany had to admit, it probably does.
When TMAP’sschizophrenia algorithm was finalized in 1997, however, it did exactlywhat industry representatives must have hoped for: It called for thenewest, most expensive drugs — five atypicals — to be used first. Ifa patient does not respond well to one of those drugs, a second memberof this group should be tried. If that drug also fails, a third drugshould be tried, this time either another atypical or an olderantipsychotic. The guidelines for major depression and bipolar disordersimilarly favor new drugs.
“When [the drug companies] saw thenewer medications were there, they liked that, of course,” says Shon.”I know that has raised questions in people’s minds: ‘Why are thenewest, most expensive first?’ Well, the newest, most expensive areeither the most efficacious and/or the safest.”
But thatassertion is increasingly disputed. “When atypicals came out, theylooked a little better in effectiveness and a lot better in terms ofside effects,” says Mike Hogan, Ohio’s mental health director andformer chairman of President Bush’s New Freedom Commission on MentalHealth. “These days, they look perhaps a tiny bit better in terms ofeffectiveness, but increasingly it’s not clear whether the side-effectprofile is better or just different.”
Ohio adopted a TMAP-like algorithm in 2001 but with a critical difference. According to Hogan, it’s merely a guideline for
prescribingdoctors to consider. But in Texas, state officials put far morepressure on its physicians to follow the protocols. Under regulationscodified by the legislature in 1999, doctors in state-owned andstate-funded mental health entities must follow the algorithm, orjustify a different course with a note in a patient’s file — a hurdlethat sends the message that such deviation should be the rare exception.
Asthe TMAP guidelines began to be adopted in 1997, Texas Medicaidspending on the five atypical antipsychotics skyrocketed from $28million to $177 million in 2004.
MANY DOSES OF THESE DRUGS wentto patients like Aliah Gleason. She was one of 19,404 Texas teenagersprescribed an antipsychotic in July or August of 2004 through apublicly funded program, according to ACS-Heritage, a medicalconsulting firm hired by Texas to investigate the use of psychotropicdrugs on children. Nearly 98 percent were atypical antipsychotics –unapproved for children and prescribed “off-label,” a controversialpractice in which doctors legally prescribe FDA-cleared drugs topatients, such as children, or for conditions, such as depression, forwhich they are not approved. The report found that more than half ofthe doses for antipsychotics appeared
inappropriately high, thatalmost half did not appear to have valid diagnoses warranting theiruse, and that one-third of child patients were on two or moremedications.
When she was transferred from Austin State Hospitalto a residential facility on March 18, 2004, Aliah was on fivedifferent medications, putting her on the extreme end of a growingpractice known as polypharmacy that worries many doctors. “This is acomplicated regimen using powerful
psychotropic medications in abarely adolescent girl, so I would be quite concerned about it,” saysDr. Joseph Woolston, a Yale University professor and chief of childpsychiatry at Yale-New Haven Hospital. “It isn’t grossly, acutelydangerous, but it is sedating and would make it difficult for a childto experience the world in a normal way. If you or I were on thatregimen we would have a lot of trouble attending to work or school. Wedon’t have any idea what that combination of medications does to adeveloping child. It may have a number of long-term side effects.” Healso suspects that the drugs may have been used as much to control theangry reactions of a girl who was hospitalized against her will
as to treat any mental and emotional problems.
Dr.Clifford Moy, clinical director of Austin State Hospital, says thatwhile the hospital’s philosophy is to avoid using more than one memberof any particular class of psychiatric medication, using multiple drugsfrom different classes is often the best way to treat a patient withmultiple symptoms. While declining, for privacy reasons, to discussAliah’s treatment, he said medication and restraint would never be usedfor punitive purposes or merely to promote compliance with hospitalrules, but only in the case of a “significant emergency behavioralsituation.” He added that forced injection of an antipsychotic — whichhappened to Aliah several times — might be used “if there were a legalconsent for an oral antipsychotic medication, which the patientrefused.” Such consent was apparently provided, in Aliah’s case, by theDepartment of Protective and Regulatory Services.
The 46-bedchild and adolescent wing where Aliah stayed was not, like the rest ofAustin State Hospital, obligated to follow TMAP. Its treatment regimenswere influenced more by CMAP, the children’s algorithm not yet mandatedby the legislature. CMAP steers clear of providing protocols for
schizophreniaand bipolar disorder — the disorders that atypicals were designed toaddress — in part, says DSHS’s Doug McBride, because there’s “littlescientific evidence” as to what the appropriate regimen for kids wouldbe. CMAP does, however, call for combining atypicals withantidepressants for children diagnosed — as Aliah was — as sufferingfrom depression “with psychotic features.” McBride defends suchoff-label use of prescription drugs, saying that the FDA approvalprocess “is not the end of clinical and other scientific evidence onthe use of that medication.”
Beyond their technical dictates,the algorithms established a culture that affected which medicationswere prescribed. Steven Shon, who, along with his colleagues, had ledtraining sessions for the staff of Austin State Hospital, argues thatthe algorithms were designed to prevent irrational and excessivemedication. Yale’s Woolston agrees with the goal, though notnecessarily the reality. “Algorithms are supposed to cut down on peopleusing medications inappropriately and to take into account medicationinteraction,” he says. “Where they become a problem is when people usethem as a mandate, forget their own clinical judgment, and believe thatwhen you’re in doubt, you’re supposed to move forward in the algorithmand add more medication.”
Medications can be invaluable, and some patients say their lives have been
transformedby atypicals. But algorithms reinforce the perception in bothpsychiatry and popular culture that mental problems always require drugtreatment. “An algorithm may put blinders on a psychiatrist and createthe presumption that the only clinical approach to problems is to usemedications,” Woolston says. If a patient doesn’t respond to aparticular medication, a doctor relying on an algorithm may think theyneed to use or add a different medication, he says. “But sometimes, thebest approach is to say, ‘Medication isn’t working; let’s try somethingelse.'”
ONCE THE DEVELOPMENT of the algorithms was largelycomplete, Shon began hitting the road, making about one trip a month –often at the expense of drug companies — to spread the TMAP gospel toofficials in other states. This close relationship between TMAP and thepharmaceutical industry raises disturbing questions about whether thedrug companies were wielding undue influence or profiting at theexpense of patients. But no one raised these questions until 2002, whenAllen Jones, an investigator for the state of
Pennsylvania’s Officeof Inspector General (OIG) began to look into a complaint that mentalhealth officials had set up an unorthodox bank account to collect moneyfrom drug companies.
Jones, a lanky, 50-year-old chain-smoker,had spent several years with the OIG in the late ’80s and early ’90s,but left to pursue real estate investing to pay for his daughters’college tuition. He had only just rejoined the agency in the summer of2002 when he began investigating this case. Over several months, heinterviewed state officials, traveled to New York and New Jersey toquestion pharmaceutical company executives, and learned all he couldabout TMAP. He soon felt that something inappropriate, and possiblyillegal, was going on. “It just did not pass the smell test,” he says.
Joneslearned that in early 2000, Dr. Steven Karp, who was then medicaldirector of the state’s Office of Mental Health, had become interestedin implementing a Pennsylvania version of TMAP. Karp discussed hisinterest with executives of Janssen Pharmaceutica, Jones found, and thecompany paid for Shon to come to Pennsylvania in late 2000 to meet withKarp and Steven Fiorello, the state’s chief pharmacist. Shon returnedin March 2001 to train state medical personnel, according to recordsJones obtained and provided to Mother Jones. To cover Shon’s travelexpenses, Janssen made an “educational grant” of $1,765.75. A Janssenfunding request form notes that the grant was to support the “TMAPinitiative to expand atypical usage and drive Steve Shon’s expenses.” Abox marked “Risperdal” is checked on the form. Janssen’s check was sentto Fiorello and placed in the account where other donations from
pharmaceutical companies were deposited.
Twomonths later, Janssen provided $4,000 for Fiorello and a statepsychiatrist to travel to New Orleans for meetings with Dr. MadhukarTrivedi, a UT-Southwestern psychiatrist and TMAP project team director.The funding request form for this payment listed the “deliverable” asthe “successful
implementation of PennMAP.” A Janssen representativealso attended and paid for $80-per-person dinners for the Pennsylvaniaand Texas officials. Fiorello and the psychiatrist made another trip toNew Orleans later that year, also paid for by Janssen, according toJones. Such perks, while of no great consequence to a company the sizeof Janssen, did forge a friendly relationship with Pennsylvaniaofficials whose decisions carried enormous financial stakes for thecompany.
Fiorello told Jones he was the state’s “point man” forselecting drugs for the state formulary — those used in statehospitals — and that industry representatives visit him often “toensure access of their drugs to the state system,” Jones wrote in afile memo as he pursued his investigation. In April 2002, Fiorello andDr. Frederick Maue, clinical director for the state’s Department ofCorrections, spoke at a Janssen-sponsored symposium for prison doctorsand nurses on treating mentally ill offenders. They were paid $2,000 byComprehensive NeuroScience, a marketing firm working for Janssen thathelped shape their presentation. Another marketing company hired byJanssen appointed Karp to its advisory board, flying him to meetings inSeattle and Tampa. Pfizer put Fiorello on an advisory council and twicepaid his expenses to come to New York.
Jones became convincedthat, as he puts it, “the pharmaceutical companies were buyinginfluence with key decision makers in state government, trying to turntheir drugs into blockbusters.” But as he brought these findings to hisboss, Daniel Sattele, he was told to stop pushing so hard. After he wasbarred from investigating whether state officials had receivedinappropriate payments from drug companies, Jones sued in federalcourt, alleging that “major public corruption investigations were beingdelayed, obstructed, or otherwise hindered by officials in the OIG.”Sattele subsequently conceded in a deposition taken in 2003 that heasked Jones if he were “a salmon,” telling him, “go with the flow,don’t swim against the current.” Sattele also said that after Jonescame to him with his concerns for the fourth or fifth time, he remindedJones of the industry’s power and influence. “I said, ‘Allen,pharmaceutical companies are very aggressive in their marketing. Theyprobably donate to both sides of the aisle,'” he recalled in thedeposition.
When Jones continued to pursue the case he wasremoved as lead investigator, then pulled off altogether, he says.Nonetheless, over the coming months, he quietly copied documents and,on his own time, gathered more information.
In February 2004,Jones laid out his charges for the New York Times and the BritishMedical Journal. In April he was suspended. In May he again sued infederal court, charging that his superiors were harassing him to “coverup, discourage, and limit any investigations or oversight into thecorrupt practices of large drug companies and corrupt public officialswho have acted with them.” He was then fired. He is now working as abricklayer; both his actions are pending.
A spokeswoman for thePennsylvania Office of Inspector General declined to comment on Jones’allegations or his termination. A representative of the Department ofCorrections told Mother Jones that Maue donated the honorarium he wasgiven by Comprehensive NeuroScience to the state’s general fund. AndStacey Ward, a spokeswoman for the Department of Public Welfare, saidthat the state “did not receive contributions of any kind from anypharmaceutical company to study or support the implementation ofPennMAP.” [Ed note: After the print edition of this story went topress, the Pennsylvania State Ethics Commission fined Steven Fiorello,the state’s chief pharmacist, $27,000 for using his position to earnextra income from sources that included Pfizer.]
Meanwhile,another Pennsylvania official was becoming increasingly alarmed withhow drugs being pushed by the pharmaceutical industry were actuallyaffecting patients. Dr. Stefan Kruszewski, a Harvard-trainedpsychiatrist working for the state’s Department of Public Welfare, wascharged with reviewing psychiatric care provided by state-fundedagencies to identify cases of waste, fraud, and abuse. In the summer of2001, he began documenting examples of what he calls “insanepolypharmacy” and widespread use of drugs for reasons not approved bythe FDA. Most shocking to him were the cases of children placed instate-funded residential treatment facilities, sometimes for years, andheavily drugged on the new antipsychotics and anticonvulsants,including some of the same medications given, off-label, to AliahGleason.
“These kids were on multiple medications without theclinical diagnoses to support the medications,” Kruszewski says. Onedrug, Neurontin, approved for controlling seizures, “was beingmassively prescribed for anxiety, social phobia, PTSD, social anxiety,mood instability, sleep, oppositional defiant behavior, attentiondeficit disorder. Yet there’s almost no evidence to support these usesin adults and no evidence for kids whatsoever.”
Last year aPfizer subsidiary pleaded guilty to criminal fraud and agreed to pay$430 million in fines for promoting off-label prescribing of Neurontin,which racked up $2.8 billion in U.S. sales in 2004. Officials estimatethat off-label uses account for some 90 percent of its sales. New Yorkattorney Andrew Finkelstein says he’s been enlisted by the relatives of425 people who committed suicide while on Neurontin, and thus far hasfiled 46 lawsuits against Pfizer.
Kruszewski sent memos to hisbosses about dangerous off-label uses of these medications but saysthey were ignored. He also looked into the deaths of four children inresidential programs and submitted a report on an Oklahoma facility,where Pennsylvania children were sometimes sent. He found that many ofthe kids “were severely
overmedicated” with atypical antipsychotics,antidepressants, and anticonvulsants, and he theorized that the deathof at least one child could be attributed to a culture that combinedpolypharmacy and neglect.
His report earned him no plaudits. Theday after submitting it, he says, he was yelled at for “trying to digup dirt.” The next day he was fired and escorted to the street. He hassince filed suit in federal court against the state officials who firedhim, along with several drug companies that, he charges, have”distorted statistics, violated regulations and misrepresented theeffects of the use of their psychotropic drugs simply to make money.”(The Pennsylvania Department of Public Welfare declined to comment onKruszewski’s charges because of his pending lawsuit.) Months after hewas fired, Kruszewski alternates between anger and sorrow as he thumbsthrough documents piled in the dining room of his Harrisburg home. “Iget very emotional about these reports,” he says. “The people who werepaid to protect consumers did exactly the wrong thing.”
UNLIKESOME OTHER HEAVILY medicated children, Aliah Gleason survived. In June2004, more than five months after she was taken from school, Calvin andAnaka Gleason saw their daughter for the first time — in a courtroom.”I was so excited,” Aliah recalls. “I hid under the table so I couldsurprise them. I started crying when I saw them. I thought I wouldnever see them again.”
It would take another four months oflegal wrangling with the state before a district court judge orderedAliah released into her parents’ custody. Finally, the Gleasons wereallowed to choose the people who would treat their daughter. Theyselected Austin psychologist John Breeding, a well-known critic of theoveruse of psychiatric medications, and soon the whole family beganmeeting with him.
The first priority, Breeding said, “was to gether off the medication.” Working with the family’s doctor, he helpeddesign a program for tapering her off her final drugs, Risperdal andDepakote, a process that was completed by the end of last year. He saysthe goal now is to help her recover from the emotional wounds shesuffered as a result of her time under the state’s care. She also needsto lose all the weight she gained while on the atypicals.
Thegood news, he says, is that “the family is reunited, she’s doing wellin school, and is even participating in extracurricular activities.”Like her sisters, Aliah plays in the school band and also takes part ina drill team. “She’s coming back, starting to get that gleam in hereye,” Breeding says.
Aliah found herself at the intersection ofa capricious child-protection system and a health care system that’sall too ready to medicate. As doctors dispense ever-greater quantitiesof potent psychiatric drugs, and the industry spends ever-greateramounts of money promoting them, how can consumers be confident thatdecisions about their care are truly informed and in their interest?Whatever the stakes for the drug companies, the stakes for patients areinfinitely higher.
Rob Waters has writtenextensively on the use of psychiatric medication by children. Last yearhe revealed in the San Francisco Chronicle that the FDA suppressed aninternal report linking antidepressants to an increased risk of suicideamong children, a story that led to congressional hearings and warningsbeing issued for the drugs.
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