February 2

Polypharm & New Antipsychotics Not More Beneficial-Just More Expensive

“The sky is falling, the sky is falling!” The harsh light of reality is shattering the psychiatric profession’s drug-dependency sending alarm bells throughout the mental health community. The truth is tumbling out faster than psychiatry’s PR firms can come up with spin to deflect the impact from the demise of a belief system contrived by marketers.
First to be stripped of their allure were the antidepressants which were knocked out of their “safe and effective” packaging mold. Assurances from psychiatry’s leadership to the contrary, the fact is,  FDA’s Patient Information Sheet reiterated  drug-induced suicide warnings (July 2005):  “Taking antidepressants may increase suicidal thoughts and actions in about 1 out of 50 people 18 years or younger.”
Next on the chopping block are the most toxic of all psychotropic drugs—the neuroleptics—a.k.a. atypical ant-psychotics. Though approved for very limited uses, the drugs are used as chemical restraints; they are mainly prescribed off-label, which explains their market share of about $9 billion in the U.S.

The myth about the “safety and effectiveness” of antipsychotics was blown first by the government-funded CATIE schizophrenia study (New England Journal of Medicine, September, 2005) and now a second study, STEP-BD (The American Journal of Psychiatry, 2006)  found the drugs not to be effective for bi-polar disorder.  

The Pink Sheet reports that an AJP editorial by J. Raymond DePaulo (Johns Hopkins University) concludes: "modern pharmacological treatment may be no more beneficial than older ones, despite their added cost."

Bloomberg New reports that a report by Dr. William Honer, (University of British Columbia) in the current issue of the NEJM found:
“ Six of 34 chronic schizophrenia patients taking the antipsychotic drug clozapine improved when Johnson & Johnson’s Risperdal was added to their treatment regimen.” However, “nine improved when a placebo was added.”

Joseph Woolston, acting chief of child psychiatry at Yale-New Haven Hospital, confirmed that the use of multiple psychiatric drugs has become extremely common'' in children.The vast majority of kids…are on at least two different medications and many are on three or four or five different medications.”

This is a powerful example illustrating how remote “evidence-based” treatment is from prevailing practices in psychiatry. Using more than one psychoactive drug to treat mentally ill patients has no therapeutic basis—it has a strong financial basis.
To understand how psychiatry’s prescribing guidelines are arrived at, one needs to examine TMAP—the Texas Medication Algorithm Project. The TMAP prescription guidelines (and their clones) are industry’s Fifth Column—they have infiltrated clinical practice and corrupted the research literature.
Rob Waters (Bloomberg News) reports that an editorial in the NEJM by John Davis (Psychiatric Institute of the University of Illinois at Chicago), claimed that the results reported by Dr. Honer were contradicted by two earlier studies which showed a clear benefit for (Risperdal) augmentation.''<br /><br />However, when challenged with the fact that the two previous studies were split, Dr. Davis acknowledged that the error wasa bad mistake.” He said Honer’s study raised substantial doubt as to whether (polypharmacy) is useful.'' <br /><br />Once again, the editors of the NENM are shown asleep at the helm as misinformation enters its pages.&nbsp; Waters reports that, in an e-mailed statement, the editors said they &ldquo;had been made aware of the error this week but did not believe it affected the substance of the editorial.&rdquo;<br /><br />&nbsp;<br />Contact: Vera Hassner Sharav<br />212-595-8974<br />veracare@ahrp.org<br /><br /><br /><br />BLOOMBERG NEWS<br />&nbsp;For Schizophrenia, Two Drugs No Better Than One, Study Finds<br />2006-02-01 17:03 (New York)<br /><br />By Rob Waters<br />&nbsp;&nbsp;&nbsp;&nbsp; Feb. 1 (Bloomberg) -- Schizophrenia patients taking one antipsychotic medication get little benefit from adding a second, researchers said.<br /><br />&nbsp;&nbsp;&nbsp;&nbsp; Six of 34 chronic schizophrenia patients taking the antipsychotic drug clozapine improved when Johnson &amp; Johnson's Risperdal was added to their treatment regimen, said a study in the Feb. 2 New England Journal of Medicine. Nine improved when a placebo was added.<br /><br />&nbsp;&nbsp;&nbsp;&nbsp; Using more than one drug to treat mentally ill patients, a practice known as polypharmacy, has grown in recent years though it greatly increases costs and there's little evidence it improves outcomes. It also may raise the risk of side effects, said lead author William Honer, a psychiatric researcher at the University of British Columbia.<br />&nbsp;&nbsp;&nbsp;&nbsp;The study is a call for all of us who treat patients with schizophrenia to exercise more caution when combining antipsychotics,” said Leslie Citrome, of the Nathan S. Kline Institute for Psychiatric Research in Orangeburg, New York, who was not involved in the study. Other strategies need to be considered first.''<br /><br />&nbsp;&nbsp;&nbsp;&nbsp; Newer drugs are far more expensive than older, first-generation antipsychotics such as haloperidol or chlorpromazine. Monthly costs for the newer drugs can run $300 and more for each medication, according to online drug retailer Drugstore.com.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; That cost has been a key cause of soaring drug expenditures in state Medicaid programs, prompting some states to try to restrict access to them, Citrome said.<br /><br />&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 3.2 million patients<br /><br />&nbsp;&nbsp;&nbsp;&nbsp; About 3.2 million Americans suffer from schizophrenia, a severe mental illness that causes hallucinations and delusions and leaves many unable to care for themselves. The $14 billion global market for schizophrenia drugs is competitive. Lilly's Zyprexa, with annual sales of $4.8 billion, for instance, has lost market share in recent years to rivals claiming fewer side effects.<br /><br />&nbsp;&nbsp;&nbsp;&nbsp; Last year, a $44 million study funded by the National Institute of Mental Health found that the newer antipsychotics were neither more effective nor safer than the older drugs, which are now rarely used. Nearly three of four patients enrolled switched drugs before the 18-month study was completed because they failed to work or caused intolerable side effects.<br />&nbsp;&nbsp;&nbsp;&nbsp;I think the results are a measure of the frustration that psychiatrists have with the limited response that we see with antipsychotic drugs,” said Honer in a Jan. 31 telephone interview.

                        `Basic Principles’

     The alternative is to use good old basic principles of medical practice,'' he said.If one drug isn’t working, ask why not? Is the person hearing voices because they’re smoking marijuana or using crack cocaine? Is the psychosocial support that’s available to the person optimized?”

     Last year, a study of 796 adult schizophrenic patients found that nearly 60 percent spent at least 60 days on more than one antipsychotic drug.
     Clozapine is the most rarely used of the newer antipsychotics, most of which entered the market in the past decade, because it is known to cause agranulocytosis, a drop in white blood cells. Other antipsychotics are more commonly used and combined, including Lilly’s Zyprexa, Pfizer Inc.’s Geodon, Bristol-Myers Squibb’s Abilify and AstraZeneca Plc’s Seroquel and Risperdal.

     The use of multiple psychiatric drugs has also become extremely common'' in children, says Joseph Woolston, acting chief of child psychiatry at Yale-New Haven Hospital.The vast majority of kids who are seriously psychiatrically disturbed are on at least two different medications and many are on three or four or five different medications.”

                          Side Effects

     The new treatments were seen as an improvement over the earlier antipsychotics, which caused serious side effects including sedation, social withdrawal, and muscle and facial tics like those in people with Parkinson’s disease. But the newer drugs have been found in recent years to cause rapid weight gain and diabetes in many patients.
     An editorial accompanying Honer’s article by John Davis, a researcher at the Psychiatric Institute of the University of Illinois at Chicago, claimed  Honer’s results contrasted with two earlier studies which showed a clear benefit for (Risperdal) augmentation.''<br /><br />&nbsp;&nbsp;&nbsp;&nbsp; In fact, the two previous studies were split. Davis, in a Feb. 1 telephone interview, said the error wasa bad mistake.” He said Honer’s study “raised substantial doubt as to whether (polypharmacy) is useful.” Editors of the New England Journal, in an e-mailed statement, said they had been made aware of the error this week but did not believe it affected the substance of the editorial.

–Editor: Gale.
To contact the reporter on this story: Rob Waters in San Francisco at (1) (415) 743-3549 or Rwaters5@bloomberg.net.

To contact the editor responsible for this story: Robert Simison at (1) (202) 624-1812 or rsimison@bloomberg.net.

"The Pink sheet"
Number 008
Atypical Antipsychotics Falter In STEP-BD Study
A series of articles in the February issue of the American Journal of Psychiatry provide further evidence that second-generation antipsychotics are not necessarily more effective than older drugs.

In an editorial accompanying the publication of the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) study, J. Raymond DePaulo (Johns Hopkins University) concludes that "modern pharmacological treatment may be no more beneficial than older ones, despite their added cost."

The STEP-BD study, authored by Roy Perlis (Massachusetts General Hospital) et al., suggests that "in spite of modern evidence-based treatment," additional treatments are needed to control bipolar disorder.
The results are similar to the findings of the Clinical Antipsychotics Trials of Intervention Effectiveness (CATIE) study comparing four atypical antipsychotics and a conventional antipsychotic in treatment of schizophrenia, which was published in the New England Journal of Medicine Sept. 22, 2005.
While Lilly’s Zyprexa (olanzapine) was found to have some advantages in CATIE, particularly in terms of low incidence of side effects, second-generation antipsychotics were in general not found to be more efficacious than the older, cheaper option (1"The Pink Sheet" DAILY, Sept. 19, 2005).

The National Institute of Mental Health-sponsored STEP-BD trial, the largest bipolar disorder treatment study to be conducted, monitored 1,469 patients up to two years. Although 58.4% of patients subsequently achieved full remission, nearly half of them (48.5%) had recurrences.
Of the recurrences, the study found that more than twice as many relapses involved depressive episodes (34.7%) than manic, hypomanic, or mixed episodes (13.8%).

The results of the STEP-BD study demonstrate that "mood episodes in bipolar disorder, and particularly depressive episodes, are prevalent and likely to recur in spite of guideline-based treatments," Perlis et al. write.
In addition, the nearly 50% relapse rate "highlights the need for development of new interventions in bipolar disorder."

"It is not at all clear therefore whether clinicians could get better results with the treatments now available to them," DePaulo writes in the editorial.

The February issue of the American Journal of Psychiatry also includes an analysis comparing the results of head-to-head studies of several atypical antipsychotics. The study, by Stephan Heres (Technical University of Munich) et al., demonstrated "a clear link between sponsorship and study outcomes…as 90.0% of the abstracts were rated as showing an overall superiority of the sponsor’s drug."

Further, the study found that "different comparisons of the same two antipsychotic drugs led to contradictory overall conclusions, depending on the sponsor of the study."

[Editor’s note: Additional coverage of the AJP studies will appear in the Feb. 6 issue of "The Pink Sheet."]
A third study compared the efficacy of three treatments for treatment-resistant bipolar depression. Used as adjunct therapy to antidepressant treatment, there were no statistically significant differences between GlaxoSmithKline’s Lamictal (lamotrigine), J&J’s Risperdal (risperidone) or inositol, Andrew Nierenberg (Massachusetts General Hospital) et al. concluded.
– Jonathan Block

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