There is evidence that dangerous new psychiatric drugs are being over
promoted — especially for children. 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 (IRB's) that approve research protocols are
riddled with conflicts of interest.
A survey reported by Campbell et al. found that 36% 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%) thought that industry
relationships never affected the recommendations of fellow IRB members in an
inappropriate way. More than 40% of respondents reported that they did not
always disclose a conflict to an IRB official and 20% 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 (www.ahrp.org).
"Like the doctors, the researchers, the institutions, and government
agencies, IRB's are `on the takeı (thatıs the title of a book by Dr. Jerome
Kassirer, a former editor of the NEJM)," she states.
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-basedı 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 12/1/06).
"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). 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 insurersı 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.
Of greatest concern is that 2.5 million American children, some as young as
18 months, are being given antipsychotics. None of these drugs were 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% 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 Bushıs, "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.
Editor's Note: Michael Arnold Glueck, M.D., wrote this week's commentary
