Wednesday, January 10, 2007

Red Flag for Pediatric Drugs

Red Flag for Pediatric Drugs
    Michael Arnold Glueck, M.D., and Robert J. Cihak, M.D., The Medicine Men
    Wednesday, Dec. 13, 2006

There is evidence that dangerous new psychiatric drugs for children are being over promoted.
So cautions a number of medical journals, institutions, researchers, and a recent American Association of Physicians and Surgeons news perspective.
According to an article in the New England Journal of Medicine, the institutional review boards (IRBs) that approve research protocols are riddled with conflicts of interest.
Conflicts of Interest
A survey reported by Campbell et al. found that 36 percent of IRB members had at least one relationship with industry in the preceding year (New Engl. J. Med., 2006, 355: 2321-2329). Most (85.5 percent) thought that industry relationships never affected the recommendations of fellow IRB members in an inappropriate way.
More than 40 percent of respondents reported that they did not always disclose a conflict to an IRB official and 20 percent said they always voted on a research protocol submitted by a company with whom they had a relationship.
This study "shatters the last myth about the integrity of the system of checks and balances in medical research," writes Vera Hassner Sharav of the Alliance for Human Research Protection (
"Like the doctors, the researchers, the institutions, and government agencies, IRBs are `on the take,'" she states. (Coincidently, that¹s the title of a book by Dr. Jerome Kassirer, a former editor of the NEJM.)
Sharav has been especially critical of over-promotion of drugs for mental illness. "Antipsychotic drug manufacturers created a marketing blockbuster cash cow with the help of influential psychiatrists from the University of Texas," she states.
"Together they manufactured [evidence-based] consensus promoting psychotropic drug prescription guidelines that requires use of these drugs as first-line treatment."
The Texas Medication Algorithm Project (TMAP) turned what Sharav calls "the most toxic drugs in medicine,"(approved for limited indications of schizophrenia and bipolar disorder) into blockbuster sellers.
Newer drugs, including Risperdal, Zyprexa, and Seroquel, now account for more than 90 percent of the $10.5-billion-a-year U.S. market for antipsychotics, largely paid for by federal and state governments, reports Rob Waters (Bloomberg News, Dec. 1, 2006).
"Newer drugs are no more effective than the older drugs they have largely replaced, although they cost 10 to 20 times more," writes Waters, citing the federally funded, $42 million CATIE study, "Clinical Anti-psychotic Trials in Intervention Effectiveness," (Am J Psychiatry 2006;163: 563-565).
Troubling Side Effects Loom
The new drugs also cause another set of troubling side effects, including weight gain and metabolic changes that can lead to diabetes. In an editorial, Robert Freedman, editor in chief of the journal, expressed worry that the study might result in insurers dictating the choice of drug, with decreased flexibility for clinicians (Washington Post 12/1/06).
It is alleged that adverse effects were concealed in ghostwritten journal articles signed by academic psychiatrists paid by drug companies to advocate the new drugs as first-line therapies in TMAP formularies. Also, there is allegedly evidence to suggest that government officials were bribed to put expensive and toxic drugs as first-line treatment on state formularies.
Steven Fiorello, former chief pharmacist for the State of Pennsylvania, has been arraigned on charges related to too-cozy relations with drug companies (Business Week 11/22/06).
Eli Lilly, Sharav writes, has signed a $690 million settlement in suits charging that Zyprexa caused hyperthermia and diabetes.
Suffer the Children
Of greatest concern is that 2.5 million American children, some as young as 18 months, are being given antipsychotics.
None of these drugs was approved for use in children until Risperidal was recently approved, without a public hearing, as a chemical straitjacket for autistic children, writes pediatrician Karen Effrem, M.D.
She noted that 45 deaths from toxic effects of these drugs had been reported, with the FDA admitting that this may represent only 10 percent of the total.
Dr. Effrem believes there is a, "mental health dragnet," seeking young children for testing with psychoactive substances. The blueprint, implemented in President Bush's, "New Health Freedom Commission Report," is being implemented even as the evidence demonstrates that psychiatric treatment guidelines are being corrupted by industry.
Now, that's total insanity that needs to be treated immediately.
Unfortunately there are no medications for federal foolishness.
Editors' Note: Michael Arnold Glueck, M.D., wrote this week's commentary.
* * *
Contact Drs. Glueck and Chehak by e-mail.
Michael Arnold Glueck, M.D., comments on medical-legal issues and is a visiting fellow in Economics and Citizenship at the International Trade Education Foundation of the Washington International Trade Council. Robert J. Cihak, M.D., is a senior fellow and board member of the Discovery Institute and a past president of the Association of American Physicians and Surgeons.

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