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Medicating Amanda

When state mental health officials fall under the influence of Big Pharma, the burden falls on captive patients. Like this 13-year-old girl.

Amanda* is a big, 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 is the second of four daughters of Chad and Malika, an African American couple who run a struggling business taking people on casino bus trips.

In the early part of seventh grade, Amanda was a B and C student who "got in trouble for running my mouth." Sometimes her antics went overboard—like the time she barked at a teacher she thought was ugly. "I was calling this teacher a man because she had a mustache," Amanda recalled over breakfast with her parents at an Austin restaurant.

School officials considered Amanda disruptive, deemed her to have an "oppositional disorder," and placed her in a special education track. Her parents viewed her as a spirited child who was bright but had a tendency to argue and clown. Then one day, psychologists from the University of Texas (UT) visited the school to conduct a mental health screening for sixth- and seventh-grade girls, and Amanda's life took a dramatic turn.

A few weeks later, the family got a "Dear parents" form letter from the head of the screening program. "You will be glad to know your daughter did not report experiencing a significant level of distress," it said. Not long after, they got a very different phone call from a UT psychologist, who told them Amanda had scored high on a suicide rating and needed further evaluation. The family reluctantly agreed to have Amanda see a UT consulting psychiatrist. She concluded Amanda was suicidal but did not hospitalize her, referring her instead to an emergency clinic for further evaluation. Six weeks later, in January 2004, a child-protection worker went to Amanda's school, interviewed her, then summoned her father to the school and told him to take Amanda to Austin State Hospital, a state mental facility. He refused, and after a heated conversation, she placed Amanda in emergency custody and had a police officer drive her to the hospital.

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The family would not be allowed to see or even speak to their daughter for the next five months, and Amanda would spend a total of nine months in a state psychiatric hospital and residential treatment facilities. While in the hospital, she was placed in restraints more than 26 times and medicated—against her will and without her parents' consent—with at least 12 different psychiatric drugs, many of them simultaneously.

On her second day at the state hospital, Amanda says she was told to take a pill to "help my mood swings." She refused and hid under her bed. She says staff members pulled her out by her legs, then told her if she took her medication, she'd be able to go home sooner. She took it. On another occasion, she "cheeked" a pill and later tossed it into the garbage. She says that after staff members found it, five of them came to her room, one holding a needle. "I started struggling, and they held my head down and shot me in the butt," she says. "Then they left and I lay in my bed crying."

What, if anything, was wrong with Amanda remains cloudy. Court documents and medical records indicate that she would say she was suicidal or that her father beat her, and then she would recant. (Her attorney attributes such statements to the high dosages of psychotropic drugs she was forcibly put on.) Her clinical diagnosis was just as changeable. During two months at Austin State Hospital, Amanda was diagnosed with "depressive disorder not otherwise specified," "mood disorder not otherwise specified with psychotic features," and "major depression with psychotic features." In addition to the antidepressants Zoloft, Celexa, Lexapro, and Desyrel, as well as Ativan, an antianxiety drug, Amanda was given two newer drugs known as "atypical antipsychotics"—Geodon and Abilify—plus an older antipsychotic, Haldol. She was also given the anticonvulsants Trileptal and Depakote—though she was not suffering from a seizure disorder—and Cogentin, an anti-Parkinson's drug also used to control the side effects of antipsychotic drugs. At the time of her transfer to a residential facility, she was on five different medications, and once there, she was put on still another atypical—Risperdal.

Amanda's case raises troubling—and long-standing—questions about the coercive uses of psychiatric medications in Texas and elsewhere. But especially because Amanda lives in Texas, and because her commitment was involuntary, she became vulnerable to an even further hazard: aggressive drug regimens that feature new and controversial drugs—regimens that are promoted by drug companies, mandated by state governments, and imposed on captive patient populations with no say over what's prescribed to them.

In the past, drug companies sold their new products to doctors through ads and articles in medical journals or, in recent years, by wooing consumers directly through television and magazine advertising. Starting in the mid-1990s, though, the companies also began to focus on a powerful market force: the handful of state officials who govern prescribing for large public systems like state mental hospitals, prisons, and government-funded clinics.

One way drug companies have worked to influence prescribing practices of these public institutions is by funding the implementation of guidelines, or algorithms, that spell out which drugs should be used for different psychiatric conditions, much as other algorithms guide the treatment of diabetes or heart disease. The effort began in the mid-1990s with the creation of TMAP—the Texas Medication Algorithm Project. Put simply, the algorithm called for the newest, most expensive medications to be used first in the treatment of schizophrenia, bipolar disorder, and major depression in adults. Subsequently, the state began developing CMAP, a children's algorithm that is not yet codified by the state legislature. At least nine states have since adopted guidelines similar to TMAP. One such state, Pennsylvania, has been sued by two of its own investigators who claim they were fired after exposing industry's undue influence over state prescribing practices and the resulting inappropriate medicating of patients, particularly children.

Thanks in part to such marketing strategies, sales of the new atypical antipsychotics have soared. Unlike antidepressants—which have been marketed to huge audiences almost as lifestyle drugs—antipsychotics are aimed at a small but growing market: schizophrenics and people with bipolar disorder. Atypicals are profitable because they are as much as 10 times more expensive than the old antipsychotics, such as Haldol. In 2004, atypical antipsychotics were the fourth-highest-grossing class of drugs in the United States, with sales totaling $8.8 billion—$2.4 billion of which was paid for by state Medicaid funds.

At a time when ethical questions are dogging the pharmaceutical industry and algorithm programs in Texas and Pennsylvania, President Bush's New Freedom Commission on Mental Health has lauded TMAP as a "model program" and called for the expanded use of screening programs like the one at Amanda's middle school. The question now is whose interests do these programs really serve?

 

THE TEXAS MEDICATION ALGORITHM PROJECT got under way in the mid-1990s just as the new generation of antipsychotic drugs was coming on the market. For some 40 years before, medications like Thorazine, Haldol, and Mellaril were given to patients with schizophrenia or psychosis to silence their voices and calm their agitation. But they caused terrible side effects, including sedation, social withdrawal, and tardive dyskinesia, which causes muscle and facial tics and strange jerking movements like those in people with Parkinson's disease. Many patients would refuse to take them—when they had a choice. Some sued drug companies and doctors for failing to warn them about the side effects and won large awards.

Into that environment, drug companies brought out the new atypical antipsychotics and began describing them in almost miraculous terms. The drugs—including Janssen Pharmaceutica's Risperdal, Eli Lilly's Zyprexa, Pfizer's Geodon, AstraZeneca's Seroquel, and Bristol-Myers Squibb's Abilify, as well as a slightly older drug, Clozapine by Sandoz—were said to be more effective than the first-generation antipsychotics and less likely to cause motor problems and other side effects. "A potential breakthrough of tremendous magnitude," Stanford University psychiatrist Alan Schatzberg gushed to the New York Times. Laurie Flynn, executive director of the National Alliance for the Mentally Ill, added that now "the long-term disability of schizophrenia can come to an end."

Despite the hoopla, not all doctors immediately embraced the new drugs, and many patients bounced haphazardly between the old and new antipsychotics. "They complained that whenever they got new doctors, their whole medication regimen usually changed," says Dr. Steven Shon, the medical director for behavioral health for the Texas Department of State Health Services (DSHS).

In 1995, Shon began talking with researchers at the UT-Southwestern Medical Center in Dallas about the use of algorithms to address these random prescribing practices. From the start, the process of creating the algorithms reflected the extensive ties between academic psychiatrists and the pharmaceutical industry. UT-Southwestern was a major research center stocked with investigators conducting drug trials paid for by pharmaceutical companies.

One of Shon's key collaborators was Dr. John Rush, a nationally known psychopharmacologist who has extensive ties to industry. Rush declined to speak for this article, but according to a disclosure statement appended to one of his published articles, he has received grant and research support from 14 pharmaceutical companies, has served as a consultant to 11, and has been a member of 10 drug company speakers' bureaus. Together, Shon, Rush, and the then-chair of UT-Southwestern's psychiatry department convened panels of experts who drew up "consensus guidelines" for schizophrenia, bipolar disorder, and major depression—blueprints on which drugs to give patients in what order and combination. Of the 46 members of the three panels, 27 have conducted research on behalf of pharmaceutical companies, served on drug company speakers' bureaus, or served as consultants to a drug company, according to a review conducted for Mother Jones by the Center for Science in the Public Interest, a watchdog group that maintains a database on the financial links of researchers.

For the drug companies, TMAP represented an opportunity. Their products were given a high priority in the algorithm, and if the algorithm was widely followed, it could mean thousands of prescriptions and millions of dollars in revenue. The industry didn't miss the chance. "We went to the pharmaceutical companies or, actually, they approached us because they are always dropping by," Shon told Mother Jones. "Once we created the algorithms, they said, 'Could you use any financial help for any materials?' And we said, 'Yeah,' because we have to publish manuals. We have to create training videotapes."

Shon says the initial creation of the TMAP guidelines was underwritten by state funds, along with $3 million in grants from foundations, including $2.4 million from the Robert Wood Johnson Foundation, a charity set up by the estate of a former chief executive of Johnson & Johnson, the parent of Janssen. Shon insists that no industry money went into the creation of the guidelines, though a 1999 paper he coauthored outlining the "development and implementation" of TMAP acknowledged grant support from seven pharmaceutical companies.

Shon also told Mother Jones that his department received only $285,000 from drug companies for TMAP's training materials in the program's "feasibility testing stage." But Nanci Wilson, an investigative reporter for KEYE-TV in Austin, reviewed the DSHS accounts, and her analysis indicates that gifts from pharmaceutical companies totaled $1.3 million from 1997 to July 2004, at least $834,000 of which was earmarked for TMAP. For example:

  • Janssen Pharmaceutica, the maker of Risperdal, gave $191,183 "to help support further developmental activities of TMAP" or in general support of TMAP.
  • Eli Lilly, the maker of Prozac and Zyprexa, gave $47,000 to "help fund the collaborative effort to develop medication best practices for the treatment 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.

While not refuting Shon's statement, DSHS spokesman Doug McBride says he is "aware" that industry donated $1.3 million. Representatives of pharmaceutical companies contacted by Mother Jones denied that their contributions were intended to shape TMAP. "We didn't participate in the development or influence the content," said Janssen spokesman Doug Arbesfeld. "It was an arm's-length contribution." Heather Lusk, an Eli Lilly representative, said contributions to TMAP were "educational" grants made by a company grants office that "is completely independent of any kind of sales and marketing function."

Pfizer's Jack Cox pointed out that nonprofit mental health advocacy groups also raise and spend money to influence policy. "There's an assumption that our money is dirty and corrupt," he said. "I beg to differ."

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