ONCE THE DEVELOPMENT of the algorithms was largely complete, Shon began hitting the road, making about one trip a month—often at the expense of drug companies—to spread the TMAP gospel to officials in other states. This close relationship between TMAP and the pharmaceutical industry raises disturbing questions about whether the drug companies were wielding undue influence or profiting at the expense of patients. But no one raised these questions until 2002, when Allen Jones, an investigator for the state of Pennsylvania's Office of Inspector General (OIG) began to look into a complaint that mental health officials had set up an unorthodox bank account to collect money from 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 of 2002 when he began investigating this case. Over several months, he interviewed state officials, traveled to New York and New Jersey to question pharmaceutical company executives, and learned all he could about TMAP. He soon felt that something inappropriate, and possibly illegal, was going on. "It just did not pass the smell test," he says.
Jones learned that in early 2000, Dr. Steven Karp, who was then medical director of the state's Office of Mental Health, had become interested in implementing a Pennsylvania version of TMAP. Karp discussed his interest with executives of Janssen Pharmaceutica, Jones found, and the company paid for Shon to come to Pennsylvania in late 2000 to meet with Karp and Steven Fiorello, the state's chief pharmacist. Shon returned in March 2001 to train state medical personnel, according to records Jones obtained and provided to Mother Jones. To cover Shon's travel expenses, Janssen made an "educational grant" of $1,765.75. A Janssen funding request form notes that the grant was to support the "TMAP initiative to expand atypical usage and drive Steve Shon's expenses." A box marked "Risperdal" is checked on the form. Janssen's check was sent to Fiorello and placed in the account where other donations from pharmaceutical companies were deposited.
Two months later, Janssen provided $4,000 for Fiorello and a state psychiatrist to travel to New Orleans for meetings with Dr. Madhukar Trivedi, a UT-Southwestern psychiatrist and TMAP project team director. The funding request form for this payment listed the "deliverable" as the "successful implementation of PennMAP." A Janssen representative also attended and paid for $80-per-person dinners for the Pennsylvania and Texas officials. Fiorello and the psychiatrist made another trip to New Orleans later that year, also paid for by Janssen, according to Jones. Such perks, while of no great consequence to a company the size of Janssen, did forge a friendly relationship with Pennsylvania officials whose decisions carried enormous financial stakes for the company.
Fiorello told Jones he was the state's "point man" for selecting drugs for the state formulary—those used in state hospitals—and that industry representatives visit him often "to ensure access of their drugs to the state system," Jones wrote in a file memo as he pursued his investigation. In April 2002, Fiorello and Dr. Frederick Maue, clinical director for the state's Department of Corrections, spoke at a Janssen-sponsored symposium for prison doctors and nurses on treating mentally ill offenders. They were paid $2,000 by Comprehensive NeuroScience, a marketing firm working for Janssen that helped shape their presentation. Another marketing company hired by Janssen appointed Karp to its advisory board, flying him to meetings in Seattle and Tampa. Pfizer put Fiorello on an advisory council and twice paid his expenses to come to New York.
Jones became convinced that, as he puts it, "the pharmaceutical companies were buying influence with key decision makers in state government, trying to turn their drugs into blockbusters." But as he brought these findings to his boss, Daniel Sattele, he was told to stop pushing so hard. After he was barred from investigating whether state officials had received inappropriate payments from drug companies, Jones sued in federal court, alleging that "major public corruption investigations were being delayed, obstructed, or otherwise hindered by officials in the OIG." Sattele subsequently conceded in a deposition taken in 2003 that he asked Jones if he were "a salmon," telling him, "go with the flow, don't swim against the current." Sattele also said that after Jones came to him with his concerns for the fourth or fifth time, he reminded Jones of the industry's power and influence. "I said, 'Allen, pharmaceutical companies are very aggressive in their marketing…. They probably donate to both sides of the aisle,'" he recalled in the deposition.
When Jones continued to pursue the case he was removed 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 British Medical Journal. In April he was suspended. In May he again sued in federal court, charging that his superiors were harassing him to "cover up, discourage, and limit any investigations or oversight into the corrupt practices of large drug companies and corrupt public officials who have acted with them." He was then fired. He is now working as a bricklayer; both his actions are pending.
A spokeswoman for the Pennsylvania Office of Inspector General declined to comment on Jones' allegations or his termination. A representative of the Department of Corrections told Mother Jones that Maue donated the honorarium he was given by Comprehensive NeuroScience to the state's general fund. And Stacey Ward, a spokeswoman for the Department of Public Welfare, said that the state "did not receive contributions of any kind from any pharmaceutical company to study or support the implementation of PennMAP." [Ed note: After the print edition of this story went to press, the Pennsylvania State Ethics Commission fined Steven Fiorello, the state’s chief pharmacist, $27,000 for using his position to earn extra income from sources that included Pfizer.]
Meanwhile, another Pennsylvania official was becoming increasingly alarmed with how drugs being pushed by the pharmaceutical industry were actually affecting patients. Dr. Stefan Kruszewski, a Harvard-trained psychiatrist working for the state's Department of Public Welfare, was charged with reviewing psychiatric care provided by state-funded agencies to identify cases of waste, fraud, and abuse. In the summer of 2001, he began documenting examples of what he calls "insane polypharmacy" and widespread use of drugs for reasons not approved by the FDA. Most shocking to him were the cases of children placed in state-funded residential treatment facilities, sometimes for years, and heavily drugged on the new antipsychotics and anticonvulsants, including some of the same medications given, off-label, to Amanda.
"These kids were on multiple medications without the clinical diagnoses to support the medications," Kruszewski says. One drug, Neurontin, approved for controlling seizures, "was being massively prescribed for anxiety, social phobia, PTSD, social anxiety, mood instability, sleep, oppositional defiant behavior, attention deficit disorder. Yet there's almost no evidence to support these uses in adults and no evidence for kids whatsoever."
Last year a Pfizer 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 estimate that off-label uses account for some 90 percent of its sales. New York attorney Andrew Finkelstein says he's been enlisted by the relatives of 425 people who committed suicide while on Neurontin, and thus far has filed 46 lawsuits against Pfizer.
Kruszewski sent memos to his bosses about dangerous off-label uses of these medications but says they were ignored. He also looked into the deaths of four children in residential programs and submitted a report on an Oklahoma facility, where Pennsylvania children were sometimes sent. He found that many of the kids "were severely overmedicated" with atypical antipsychotics, antidepressants, and anticonvulsants, and he theorized that the death of at least one child could be attributed to a culture that combined polypharmacy and neglect.
His report earned him no plaudits. The day after submitting it, he says, he was yelled at for "trying to dig up dirt." The next day he was fired and escorted to the street. He has since filed suit in federal court against the state officials who fired him, along with several drug companies that, he charges, have "distorted statistics, violated regulations… and misrepresented the effects of the use of their psychotropic drugs… simply to make money." (The Pennsylvania Department of Public Welfare declined to comment on Kruszewski's charges because of his pending lawsuit.) Months after he was fired, Kruszewski alternates between anger and sorrow as he thumbs through documents piled in the dining room of his Harrisburg home. "I get very emotional about these reports," he says. "The people who were paid to protect consumers did exactly the wrong thing."
UNLIKE SOME OTHER HEAVILY medicated children, Amanda survived. In June 2004, more than five months after she was taken from school, Chad and Malika saw their daughter for the first time—in a courtroom. "I was so excited," Amanda recalls. "I hid under the table so I could surprise them. I started crying when I saw them. I thought I would never see them again."
It would take another four months of legal wrangling with the state before a district court judge ordered Amanda released into her parents' custody. Finally, the family was allowed to choose the people who would treat their daughter. They selected Austin psychologist John Breeding, a well-known critic of the overuse of psychiatric medications, and soon the whole family began meeting with him.
The first priority, Breeding said, "was to get her off the medication." Working with the family's doctor, he helped design a program for tapering her off her final drugs, Risperdal and Depakote, a process that was completed by the end of last year. He says the goal now is to help her recover from the emotional wounds she suffered as a result of her time under the state's care. She also needs to lose all the weight she gained while on the atypicals.
The good news, he says, is that "the family is reunited, she's doing well in school, and is even participating in extracurricular activities." Like her sisters, Amanda plays in the school band and also takes part in a drill team. "She's coming back, starting to get that gleam in her eye," Breeding says.
Amanda found herself at the intersection of a capricious child-protection system and a health care system that's all too ready to medicate. As doctors dispense ever-greater quantities of potent psychiatric drugs, and the industry spends ever-greater amounts of money promoting them, how can consumers be confident that decisions about their care are truly informed and in their interest? Whatever the stakes for the drug companies, the stakes for patients are infinitely higher.
Update: The names of "Amanda" and her parents have been changed to protect their privacy.