Zyprexa Takes Major Hit In Alaska - October 2, 2006

Image: Google Images


Zyprexa Takes Major Hit In Alaska

First published October 2, 2006

A major legal victory recently occurred in the highest court in the state of Alaska, for all people who oppose forced psychiatric drugging. In a resounding affirmation of personal liberty, the Alaska Supreme Court issued a decision in the case of Myers v Alaska Psychiatric Institute and found Alaska's forced drugging regime to be unconstitutional.

One of the drugs that the Institute tried to force on the plaintiff was Zyprexa and from here on in, the state cannot force people to take Zyprexa, or any other psychiatric drug, without first proving it to be in the patient's best interests and that there are no less restrictive alternatives available. The ruling is specific to psychiatric drugs.

"By requiring the least intrusive alternative to forced psychiatric drugging," says Jim Gottstein, the triumphant attorney in the case, "this decision has the potential to change the face of current psychiatric practice, dramatically improving the lives of people who now find themselves at the wrong end of a hypodermic needle.“

Mr Gottstein acknowledges that the ruling will effect drug company profits. "The issue of Big Pharma profits is a big one, of course," he says, "and the Myers decision is perhaps most relevant where it states, "a valid debate exists in the medical/psychiatric community as to the safety and effectiveness of the [drugs]."

"This is judicial confirmation," he explains, "that the safety and efficacy of these psychiatric drugs has not really been established and can be used to support that contention."

While acknowledging that some people find psychiatric drugs helpful, Mr Gottstein said he pursued this case because, in addition to the drugs' serious physical health risks, he is concerned about the rights of those who find the drugs both unhelpful and intolerable.

"No other field of medicine allows this sort of forced treatment," he points out. 

“For people who want to try non-drug approaches," he explains, "the research is very clear that many will have much better long-term outcomes, including complete recovery after being diagnosed with serious mental illness."

"This decision restores the rights of those people to pursue that potential," he states.

"Of course," he says, "there are many people who see psychiatrists and voluntarily, even eagerly, take psychiatric medications." 

And he "has absolutely no complaint about this," he states.

It is the unwarranted forced treatment that he objects to, "using the force of law (court orders) to compel people to submit to unwarranted psychiatric treatments they do not want," he says.

After being involuntarily committed to the Alaska Psychiatric Institute, Ms Meyers appealed a superior court order approving the administration of psychotropic drugs by the hospital. She argues that the statutes relied on in approving the medication violated the Alaska Constitution’s guarantees of privacy and liberty.

The Supreme Court agreed. "In keeping with most state courts that have addressed the issue," it said, "we hold that, in the absence of emergency, a court may not authorize the state to administer psychotropic drugs to a non-consenting mental patient unless the court determines that the medication is in the best interests of the patient and that no less intrusive alternative treatment is available."

The High Court noted the trial court's concern that the statute does not allow the court to consider the problems with the drugs even though "a valid debate exists in the medically/psychiatric community as to the safety and effectiveness of the proposed treatment plan."

With the Supreme Court's decision, trial courts are not only allowed to consider, they are required to consider the safety and effectiveness of the medications in deciding whether the proposed drugging is in the patient's best interest.

The Court specifically points out that Alaska Statutes require a hospital to honor a patient's previously expressed desires regarding psychiatric medications.

Ms Myers has suffered with mental illness for over 20 years and her symptoms have at times included paranoia, dizziness, and hallucinations. She has been hospitalized a number of times and placed on psychotropic drugs in the past.

In 2001, she weaned herself off psychotropic drugs, believing that they actually worsened her condition and since then, has described herself as an advocate for the mentally ill.

During Ms Myers’s hearing in the lower court, two API psychiatrists testified that administering drugs to Ms Myers would be appropriate.

Ms Myers responded with testimony from her own two expert psychiatrists. The first testified that medication is not the only available treatment for schizophrenia. While acknowledging that drugs played an accepted role in the “standard of care for treatment of psychosis,” he testified that, because such drugs “have so many problems,” they should be used “in as small a dose for as short a period of time as possible.”

Ms Myers’s second expert specifically testified that Zyprexa, despite being “widely prescribed,” was a “very dangerous” drug of “dubious efficacy.” He based his testimony on a “methodological analysis” of the studies that led to the approval of Zyprexa by the FDA.

At the end of the hearing, the lower court found that Ms Myers “lacked . . . insight into her own condition” and did “not appreciate that she suffers from a mental disorder.”

On appeal, Ms Meyers argues that the provisions governing authorization of treatment with psychotropic medications violate the Alaska Constitution’s guarantees of liberty and privacy and the Supreme Court agrees.

"In our view," the Court wrote, "before a state may administer psychotropic drugs to a non-consenting mentally ill patient in a non-emergency setting, an independent judicial best interests determination is constitutionally necessary to ensure that the proposed treatment is actually the least intrusive means of protecting the patient."

In reaching its decision, the Court noted that Alaska law recognizes and addresses a distinct class of drugs called “psychotropic medications.”

"Because psychotropic medication can have profound and lasting negative effects on a patient’s mind and body," the Court said, "Alaska’s statutory provisions permitting nonconsensual treatment with psychotropic medications implicate
fundamental liberty and privacy interests."

The right to choose or reject medical treatment, the Court noted, finds its source in the fundamental guarantees of liberty and privacy. "The constitution itself requires courts, not physicians," the Court noted, "to protect and enforce these guarantees."

Psychotropic drugs, the Court said, “affect the mind, behavior, intellectual functions, perception, moods, and emotions” and are known to cause a number of potentially devastating side effects.

"Side effects aside," it stated, "the truly intrusive nature of psychotropic drugs may be best understood by appreciating that they are literally intended to alter the mind."

"We conclude," the Supreme Court wrote, "that the Alaska Constitution’s guarantees of liberty and privacy require an independent judicial determination of an incompetent mental patient’s best interests before the superior court may authorize a facility like API to treat the patient with psychotropic drugs."

The Court also said that "in future non-emergency cases a court may not permit a treatment facility to administer psychotropic drugs unless the court makes findings that comply with all applicable statutory requirements and, in addition, expressly finds by clear and convincing evidence that the proposed treatment is in the patient’s best interests and that no less intrusive alternative is available."

A number of other states have also ruled that the right to refuse psychotropic drugs is fundamental. For instance, in Rogers v. Commissioner of the Department of Mental Health, the Supreme Court of Massachusetts held that a committed mental patient could not be forcibly drugged with antipsychotics unless a court determined both that he was incompetent and would have consented to the drugs if he was competent.

The court emphasized that mentally ill patients have dignity and worth equal to other individuals and said that a committed patient is entitled to an independent judicial determination of whether the patient would have consented to receive psychotropic drugs.

In Rivers v Katz, the New York Court of Appeals found a person’s right to control his medical treatment in state common law but went on to declare that “[t]his fundamental common-law right is coextensive with the patient’s liberty interest protected by the due process clause of our State Constitution."

In our system of a free government, the court wrote, where notions of individual autonomy and free choice are cherished, it is the individual who must have the final say in decisions regarding medical treatment. If the court concludes that the patient lacks the capacity to determine his own treatment, it states:

"the court must determine whether the proposed treatment is narrowly tailored to give substantive effect to the patient’s liberty interest, taking into consideration all relevant circumstances, including the patient’s best interests, the benefits to be gained from the treatment, the adverse side effects associated with the treatment and any less intrusive alternative treatments."

The Minnesota Supreme Court reached a similar decision in Jarvis v Levine and ruled that the constitutional guarantee of privacy “begins with protecting the integrity of one’s own body and includes the right not to have it altered or invaded without consent. Commitment to an institution does not eliminate this right. When intrusive treatment is proposed, the ‘professional judgment’ of medical personnel insufficiently protects this basic human right.”

Most recently, the Ohio Supreme Court ruled in Steele v. Hamilton County Community Mental Health Board that the state could forcibly medicate a mental patient only after a court had found, “by clear and convincing evidence, that:

(1) the patient does not have the capacity to give or withhold informed consent regarding his/her treatment, (2) it is in the patient’s best interest to take the medication, i.e., the benefits of the medication outweigh the side effects, and (3) no less intrusive treatment will be as effective in treating the mental illness.”

Given the nature and potentially devastating impact of psychotropic medications, the court said, "the right to refuse to take psychotropic drugs is fundamental."

This right, the court said, must extend “equally to mentally ill persons,” so that the mentally ill are not treated “as persons of lesser status or dignity because of their illness.”

(1) Interview and court documents provided by Jim Gottstein

November 10, 2006

DSM Billing Bible - Big Pharma Best Seller

One-hundred percent of the experts involved in writing diagnostic criteria for mood disorders and schizophrenia for the, "Diagnostic and Statistical Manual for Mental Disorders (DSM)," have undisclosed financial ties to the pharmaceutical companies whose drugs are used to treat those conditions.

The April 2006 study in the journal, Psychotherapy and Psychosomatics, also determined that more than 80% of the members on the panels involved in decisions related to "anxiety disorders," "eating disorders," "medication-induced movement disorders" and "premenstrual dysphonic disorder" have financial ties to the pharmaceutical industry.

..Experts say the importance of the "Psychiatric Billing Bible," cannot be understated, especially for the Big Pharma. The FDA will not approve a drug to treat a disorder that is not included in the DSM and public and private health insurance programs will not pay to treat a disorder that is not listed in the manual.

The April study, led by Dr Lisa Cosgrove, a clinical psychologist from the University of Massachusetts, is the first of its kind, and was conducted in part, by sifting through legal files, conflict of interest databases, patent records, journal articles, and other records.

Dr Cosgrove told the Washington Post that she began the research after learning that 5 of six panel members deciding whether certain premenstrual problems should be considered a psychiatric disorder had ties to Eli Lilly, a company that was at the time seeking approval to market Prozac to treat those problems.

"I don't think the public is aware of how egregious the financial ties are in the field of psychiatry," she told the Post.

"The very vocabulary of psychiatry is now defined at all levels by the pharmaceutical industry," according to Dr Irwin Savodnik, assistant clinical professor of psychiatry at the University of California, in a statement to the Chicago Tribune.

A co-author of the study, Sheldon Krimsky, a science policy specialist at Tufts University and author of, "Science in the Private Interest," told the Washington Post, "When someone is establishing a clinical guideline for the bible of psychiatric diagnosis, I would argue they should have no affiliation with the drug companies in those areas where the companies could benefit from those decisions."

Critics say the pill-promoting list of bogus "mental disorders" in the DSM apparently has no end and kids appear to be the most sought after customers. For instance, in the DMS, a child's behavior become an "oppositional defiant disorder," if a child exhibits at least four of eight behavior patterns, four of which are "often argues with adults," "often loses temper," "often touchy or easily annoyed by others" and "often spiteful or vindictive."

And to treat these alleged "disorders" the drug companies have doctors prescribing the strongest, most expensive psych drugs on the market. On November 11, 2006, the New York Times reported that 13-year-old Paul Williams "has had almost as many psychiatric diagnoses as birthdays."

"The first psychiatrist he saw, at age 7," the Times said, "decided after a 20-minute visit that the boy was suffering from depression."

A string of office visits with psychologists, social workers and psychiatrists led to labels with disorders such as “compulsive tendencies,” “oppositional defiant disorder,” and “pervasive developmental disorder,” or some combination of the others.

Each diagnosis was accompanied by a different regimen of drugs. By the time Paul was 11, his mother said, it was bipolar "with it a whole new set of drug prescriptions."

In June 2006, a study in the Archives of General Psychiatry, said the use of antipsychotics to treat children for problems with aggression and mood swings had increased more than 5-fold between 1993 to 2002, even though none of the drugs are approved for children.

The study found that about a third of the kids who received antipsychotics were diagnosed with behavior disorders, such as attention deficit; another third listed psychotic symptoms or developmental problems; and the others were for mood disorders.

In addition to antipsychotics, the study found that more than 40% of the children were also taking one or more other psychiatric drugs.

Experts say the rise in prescribing antipsychotics to children corresponds with the introduction and heavy promotion of the new generation of antipsychotics known as "atypical" antipsychotics which include Risperdal, Zyprexa and Seroquel, promoted as superior to older and much cheaper antipsychotics like Haldol.

Atypicals are FDA approved for very limited uses in the treatment of adults with schizophrenia, psychosis, and bipolar disorder.

..The drugs have been shown to be less effective with children than the old. An August 2006 study by the New York Psychiatric Institute, found that the average response rate in children enrolled in 8 studies taking the new antipsychotics was only 55.7%, compared to 72.3% with children in 13 studies who were taking the older drugs.

The over-prescribing of the atypical drugs to children is found to be most rampant when the cost of the drugs is covered by government health care programs. For instance, a study in the August 3, 2004, Archives of Pediatric Adolescent Medicine, found the number of children in Tennessee covered by the state's Medicaid program, who were prescribed antipsychotics nearly doubled in six years.

The age group with largest increase was children aged 13 to 18 at 116%, followed by a 93% increase in children aged 6 to 12, and perhaps the most alarming was a 61% increase in the use of antipsychotics with preschool children.

In the wake of budget busting costs, the state of Texas hired ACS-Heritage, a medical consulting firm, to investigate the prevalence of psychotropic drugs prescribed to children and billed to the state, and learned that during the months of July and August, 2004, more than 19,400 teens were prescribed antipsychotics, with nearly 98% prescribed for conditions not approved.

In fact, ACS said that almost half of the children did not appear to have a valid diagnosis warranting the use of the drug, and that one-third of the children were on 2 or more drugs.

The drug companies promote the life-long use of antipsychotics. For instance, a Relapse Prevention Booklet (2004), by the Manic-Depression Fellowship, sponsored by Eli Lilly, for Zyprexa states that “bipolar disorder is often a lifelong illness needing lifelong treatment; symptoms come and go, but the illness stays; people feel better because the medication is working; almost everyone who stops taking the medication will get ill again and the more episodes you have, the more difficult they are to treat.”

Many states have filed lawsuits against the drug makers to recoup the costs incurred by the over-prescribing of the atypicals for conditions not approved by the FDA, as well as the cost of medical care for citizens injured by the drugs.

Referring to a study published in the New England Journal of Medicine, on September 21, 2005, The Age.com, reported that a "US Government-financed study of drugs used to treat schizophrenia has confirmed what many psychiatrists long suspected: newer drugs that are highly promoted and widely prescribed offer few — if any — benefits over older medicines that sell for a fraction of the cost."

As for pushing pills for the mood disorders, with the help of President George Bush's New Freedom Commission on Mental Health, put in place by an executive order as a gift to the drug companies in return for the millions of dollars in contributions, Big Pharma is zeroing in on children, even infants, as customers for Paxil, Zoloft, Prozac, Lexapro, Effexor, and Celexa, by setting up mental health screening programs in schools and daycare centers.

In a 2003 speech, the director of the Substance Abuse and Mental Health Services Administration, Kathryn Power, reported that mental health assessments are increasingly being conducted in "non-mental health settings," and she praised one community for "placing mental health consultants in child care settings."

She also bragged about the federal "Prevention and Early Intervention Grant Program," and noted that the program's goal is to reach children, and babies, before they have a diagnosable problem. At that time, Ms Power said that more than half of the administration's programs were focused on infants and preschoolers.

Mental health screening programs for kids as young as age 0, are being implemented in states all across the country. For instance, in Minnesota an early childhood program is being integrated to ensure all children ages 0 to 5 are screened "early and continuously" and to link children and their families to mental health services.

In Florida, the Florida Strategic Plan for Infant Mental Health Plan is to develop a system to prevent children from 0 to age five from developing emotional and behavioral disorders.

In Illinois, "all children" are to receive social and emotional screens and the schools are to incorporate social and emotional standards as part of the state's learning standards.

Its not as if infant recruitment schemes are necessary considering the record breaking sales of these drugs.

But then, Big Pharma would be out of the psych drug business in no time if not for the cooperation of the doctors writing the prescriptions. On August 17, 2005, the Wall Street Journal said, "If the icon of American psychiatry was for years a couch, it is now arguably a pill."

"And that change in focus," the Journal reports, "has brought to prominence a new type of psychiatrist: the psychopharmacologist."

According to the Journal, "these doctors frequently prescribe complex cocktails of drugs for patients with multiple diagnoses of mental illnesses and sometimes prescribe other drugs to counterbalance side effects from the primary drugs."

A 2003 study by the American Psychiatric Association, on "financial disincentives" for psychotherapy found doctors could earn about $263 an hour for holding three 15-minute medication management sessions per hour, compared to about $156 for a single therapy session, which boils down to an hourly pay cut of 41% for doctors doing therapy.

According to Dr Juan Riestra, associate director of medicine in the department of psychiatry at Mountainside Hospital in Montclair, NJ, a psychopharmacologist is often someone "using a trendy word as a marketing device."

When a psychopharmacologist sees 30 or 40 patients a day, as some do, Dr Riestra told the Journal, "it becomes like a factory."

Sources

(1) Study Finds a Link of Drug Makers to Psychiatrists, April 20, 2006, New York Times

(2) McGraw gets Alaskan help in Zyprexa case, The West Virginia Record, August 4, 206

(3) Manic-Depressive Fellowship (2004) Staying well…with bipolar disorder. Relapse Prevention Booklet. London: Produced in Association with the Manic-Depressive Fellowship Sponsored by Eli Lilly and Company. p 17.

(4) Healy D (2006) The Latest Mania: Selling Bipolar Disorder. PLoS Med 3(4): e185

(5) August 17, 2005 Wall Street Journal

EVELYN PRINGLE
Award Winning Investigative Journalist and Researcher