October 26

Part II– Mental Health Screening: A Form of Child Abuse–Mother Jones

Part II– Mental Health Screening: A Form of Child Abuse–Mother Jones
http://www.motherjones.com/news/feature/2005/05/medicating_aliah.html enter subscriber code MJZL6Y

Tue, 19 Apr 2005

This is a continuation of the earlier Infomail Re: Mental Health Screening expose by Rob Waters in Mother Jones – A detailed description of (what some would call) collusion by drug industry stakeholders whose activities and the TMAP marketing scheme were exposed by two public officials who blew the whistle on abuse of patients and major fraud and corruption.

Though antipsychotic drugs have not been approved for children, their use is mandated as first line treatment by the TMAP guidelines.

The numbers speak for themselves: “As the TMAP guidelines began to be adopted in 1997, Texas Medicaid spending on the five atypical antipsychotics skyrocketed from $28 million to $177 million in 2004.”

That bump in sales was not due to any evidence of these drugs constituting an improvement from the old cheap drugs at low doses:
“The largest study to date, a review of 52 clinical trials including more than 12,000 patients published in the British Medical Journal in 2000, found “no clear evidence that atypical antipsychotics are more effective or better tolerated than conventional antipsychotics.” A 2003 study comparing Zyprexa, the top-selling atypical antipsychotic, and Haldol, published in 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 skyrocketing increase in sales is the result of collusion by those groups and individuals that receive payments from the psychotropic drug industry.

The best allies drug manufacturers have are public officials–such as Dr. Steven Shon, the medical director for behavioral health for the Texas Department of State Health Services (DSHS)–and drug advocates who assume the guise of mental health advocates, declaring without a pang of conscience:
“the long-term disability of schizophrenia can come to an end.”

The heoes of the uncovered truth are Allen Jones who uncovered the money trail and complicity by state officials and drug marketers, and Dr. Stefan Kruszeuski who uncovered the human tragedies that resulted from the inappropriate, off-label use of antipsychotic drugs:
“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.”

They are courageous heroes who paid the price for speaking truth to power – both lost their jobs with the state of Pennsylvania. As they await their day in court, they have earned the respect and admiration of people with a moral and social conscience.

Contact: Vera Hassner Sharav


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.”

AS THE TMAP PANEL MEMBERS worked on the protocols, drug companies aggressively promoted the new antipsychotics across the psychiatric landscape. Their key selling point: that they were more effective and caused fewer serious side effects than the older antipsychotics, especially Haldol, the most widely used. Though it did approve six atypicals, the FDA was dubious of some of these claims. “We would consider any advertisement or promotional labeling for Risperdal false, misleading or lacking fair balance… if there is a presentation of data that conveys the impression that [Risperdal] is superior to [Haldol] or any other marketed antipsychotic drug product with regard to safety or effectiveness,” an FDA official wrote in a 1993 letter to Janssen Pharmaceutica. But the letter was only made public 53 years later, when journalist Robert Whitaker quoted it in his 2002 book, Mad in America. Most prescribing doctors were left in the dark. (For more on how drug companies manipulated clinical trials for atypicals see motherjones.com/spinningdoctors.)

The largest study to date, a review of 52 clinical trials including more than 12,000 patients published in the British Medical Journal in 2000, found “no clear evidence that atypical antipsychotics are more effective or better tolerated than conventional antipsychotics.” A 2003 study comparing Zyprexa, the top-selling atypical antipsychotic, and Haldol, published in 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 appear to be associated with higher suicide rates and to cause tardive dyskinesia, too, though perhaps at lower rates than the first-generation drugs. They can cause rapid weight gain and thus an increased risk of diabetes. In September 2003, the FDA required the makers of all atypicals to add to their labels a warning that the drugs can cause hyperglycemia, diabetes, and even death. Janssen was also made to send doctors a letter conceding it had misled them when it said that Risperdal does not increase the risk of diabetes. In fact, the company had to admit, it probably does.

When TMAP’s schizophrenia algorithm was finalized in 1997, however, it did exactly what industry representatives must have hoped for: It called for the newest, most expensive drugs – five atypicals – to be used first. If a patient does not respond well to one of those drugs, a second member of this group should be tried. If that drug also fails, a third drug should be tried, this time either another atypical or an older antipsychotic. The guidelines for major depression and bipolar disorder similarly favor new drugs.

“When [the drug companies] saw the newer medications were there, they liked that, of course,” says Shon. “I know that has raised questions in people’s minds: ‘Why are the newest, most expensive first?’ Well, the newest, most expensive are either the most efficacious and/or the safest.”

But that assertion is increasingly disputed. “When atypicals came out, they looked a little better in effectiveness and a lot better in terms of side effects,” says Mike Hogan, Ohio’s mental health director and former chairman of President Bush’s New Freedom Commission on Mental Health. “These days, they look perhaps a tiny bit better in terms of effectiveness, but increasingly it’s not clear whether the side-effect profile 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 prescribing doctors to consider. But in Texas, state officials put far more pressure on its physicians to follow the protocols. Under regulations codified by the legislature in 1999, doctors in state-owned and state-funded mental health entities must follow the algorithm, or justify a different course with a note in a patient’s file – a hurdle that sends the message that such deviation should be the rare exception. As the TMAP guidelines began to be adopted in 1997, Texas Medicaid spending on the five atypical antipsychotics skyrocketed from $28 million to $177 million in 2004.

MANY DOSES OF THESE DRUGS went to patients like Aliah Gleason. She was one of 19,404 Texas teenagers prescribed an antipsychotic in July or August of 2004 through a publicly funded program, according to ACS-Heritage, a medical consulting firm hired by Texas to investigate the use of psychotropic drugs on children. Nearly 98 percent were atypical antipsychotics-unapproved for children and prescribed “off-label,” a controversial practice in which doctors legally prescribe FDA-cleared drugs to patients, such as children, or for conditions, such as depression, for which they are not approved. The report found that more than half of the doses for antipsychotics appeared inappropriately high, that almost half did not appear to have valid diagnoses warranting their use, and that one-third of child patients were on two or more medications.

When she was transferred from Austin State Hospital to a residential facility on March 18, 2004, Aliah was on five different medications, putting her on the extreme end of a growing practice known as polypharmacy that worries many doctors. “This is a complicated regimen using powerful psychotropic medications in a barely adolescent girl, so I would be quite concerned about it,” says Dr. Joseph Woolston, a Yale University professor and chief of child psychiatry at Yale-New Haven Hospital. “It isn’t grossly, acutely dangerous, but it is sedating and would make it difficult for a child to experience the world in a normal way. If you or I were on that regimen we would have a lot of trouble attending to work or school. We don’t have any idea what that combination of medications does to a developing child. It may have a number of long-term side effects.” He also suspects that the drugs may have been used as much to control the angry 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 that while the hospital’s philosophy is to avoid using more than one member of any particular class of psychiatric medication, using multiple drugs from different classes is often the best way to treat a patient with multiple symptoms. While declining, for privacy reasons, to discuss Aliah’s treatment, he said medication and restraint would never be used for punitive purposes or merely to promote compliance with hospital rules, but only in the case of a “significant emergency behavioral situation.” He added that forced injection of an antipsychotic – which happened to Aliah several times – might be used “if there were a legal consent for an oral antipsychotic medication, which the patient refused.” Such consent was apparently provided, in Aliah’s case, by the Department of Protective and Regulatory Services.

The 46-bed child and adolescent wing where Aliah stayed was not, like the rest of Austin State Hospital, obligated to follow TMAP. Its treatment regimens were influenced more by CMAP, the children’s algorithm not yet mandated by the legislature. CMAP steers clear of providing protocols for schizophrenia and bipolar disorder – the disorders that atypicals were designed to address – in part, says DSHS’s Doug McBride, because there’s “little scientific evidence” as to what the appropriate regimen for kids would be. CMAP does, however, call for combining atypicals with antidepressants for children diagnosed – as Aliah was – as suffering from depression “with psychotic features.” McBride defends such off-label use of prescription drugs, saying that the FDA approval process “is not the end of clinical and other scientific evidence on the use of that medication.”

Beyond their technical dictates, the algorithms established a culture that affected which medications were prescribed. Steven Shon, who, along with his colleagues, had led training sessions for the staff of Austin State Hospital, argues that the algorithms were designed to prevent irrational and excessive medication. Yale’s Woolston agrees with the goal, though not necessarily the reality. “Algorithms are supposed to cut down on people using medications inappropriately and to take into account medication interaction,” he says. “Where they become a problem is when people use them as a mandate, forget their own clinical judgment, and believe that when you’re in doubt, you’re supposed to move forward in the algorithm and add more medication.”

Medications can be invaluable, and some patients say their lives have been transformed by atypicals. But algorithms reinforce the perception in both psychiatry and popular culture that mental problems always require drug treatment. “An algorithm may put blinders on a psychiatrist and create the presumption that the only clinical approach to problems is to use medications,” Woolston says. If a patient doesn’t respond to a particular medication, a doctor relying on an algorithm may think they need to use or add a different medication, he says. “But sometimes, the best approach is to say, ‘Medication isn’t working; let’s try something else.'”

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.

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