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from veracare@...:
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability
www.ahrp.org
FYI
The long-denied, hidden truth about the deadly risks of antipsychotic drugs
is about to be disclosed to the public. The New York Times reports that the
FDA will now require Black Box warnings about the increased risk of death on
the labels of some of the most aggressively marketed, hence widely
prescribed drugs such as Zyprexa (Eli Lilly) Risperdal (Johnson & Johnson)
Abilify (Bristol-Myers Squibb), Clozril (Novartis), Geodon (Pfizer) for
non-life-thereatening conditions, increase the risk of death.
In 17 placebo-controlled trials involving elderly patients with dementia,
the drugs were found to kill 1.6 to 1.7 times as many patients as were on
placebo. The elderly are not the only ones at risk of death. Mental health
professionals have long-observed but kept silent about the fact that
patients prescribed the new antipsychotic drugs are dying from drug-induced
heart failure, stroke, and other debilitating chronic physical illnesses,
such as diabetes.
These are the very drugs recommneded by the Texas Medication Algorithm
Project (TMAP) as first line treatment. TMAP is praised as a drug
prescribing model by the President's New Freedom Commission for Mental
Health report.
Is it the intended policy of the governement to support the promotion of
increased use of drugs that increase the risk of death and other
debilitating conditions?
Psychiatrists have been encouraged to prescribe these very toxic drugs in
irresponsibly in cocktails--mixing SSRIs and antipsychotics. The deadly
consequences have often been attributed to "natural causes." However, AHRP
board member, Dr. Stefan Kfruszeuski, has documented evidence of
patients--including children--in state care who suffered, some died as a
result of antipsychotic drugs.
Antipsychotics,SSRIs, COX2 painkillers, and cholesterol lowering are the
most agressively marketed drugs that help the pharmaceutical industry
maintain an unprecedented 7% profit increase (in 2004, and 2003)--which is
two and a half times greater than the rate of inflation. See: AARP Rx
Watchdog Report
http://www.usatoday.com/news/nation/2005-04-12-drug-prices_x.htm?POE=NEWISVA
Contact: Vera Hassner Sharav
212-595-8974
veracare@...
http://www.nytimes.com/2005/04/12/health/12dement.html?pagewanted=print&posi
tion=
THE NEW YORK TIMES
April 12, 2005
Popular Drugs for Dementia Tied to Deaths
By GARDINER HARRIS
WASHINGTON, April 11 - Older patients with dementia who are given
antipsychotic medicines are far more likely to die prematurely than those
given dummy pills, federal drug regulators said Monday. The warning adds to
growing worries about the safety of the widely prescribed drugs.
The Food and Drug Administration said that it would now require
manufacturers of the medicines to place black-box warnings - the agency's
most severe - on the labels of all the drugs. In 2003, the agency required
manufacturers to add a warning about an increased risk of diabetes from
antipsychotic medications.
Zyprexa and Symbyax from Eli Lilly, Risperdal from Johnson & Johnson,
Seroquel from AstraZeneca, Abilify from Bristol-Myers Squibb, Clozaril from
Novartis and Geodon from Pfizer are all affected by the warning.
The drugs belong to a class of medicines developed since 1989 that are
supposed to be safer than the older class of medicines for psychosis, like
Haldol. In high doses, Haldol and drugs like it can cause a debilitating
condition called tardive dyskinesia, a lifelong affliction that can involve
uncontrollable trembling, tics and jerky movements.
Doctors have become so comfortable with the safety of the newer medicines
that they are now among the biggest selling in the world, with some
physicians using them to treat a wide range of conditions, including
schizophrenia, depression and dementia in the elderly. Indeed, some
psychiatrists prescribe cocktails of antipsychotics to patients with
persistent mental problems.
Zyprexa is the biggest drug expense for many state Medicaid programs, the
health insurance for the poor.
But the safety of the pills has come under increasing scrutiny. Studies now
suggest that the newer drugs are only slightly less likely to cause tardive
dyskinesia, and worries about other side effects are mounting.
The Food and Drug Administration said that it had analyzed the results of 17
placebo-controlled trials involving the drugs, which are known as atypical
antipsychotics. The agency found that elderly patients with dementia who
were given the pills were 1.6 to 1.7 times as likely to die as those given
placebos.
The causes of death varied, although most died of heart-related problems
like heart failure or infections like pneumonia, the drug agency said.
Representatives for Eli Lilly, AstraZeneca and Johnson & Johnson said the
companies were reviewing the F.D.A.'s requirement and would work with the
agency to develop new warnings.
The representatives from Eli Lilly and Johnson & Johnson noted that the
companies put warnings on their labels about an increased risk of stroke
more than a year ago.
The drug agency said it was considering adding the new warning to the older
class of medicines "because limited data also suggest a similar increase in
mortality for these drugs."
Copyright 2005 The New York Times Company
from fdaadvisorycommittee.com
Adverse Events Definition Should Be Narrower, IRB Groups Tell FDA
The Consortium of Independent Review Boards is calling for a more
restrictive definition of suspected adverse drug events observed during
clinical trials.
The definition of an adverse event that needs to be reported to an IRB
should be "probably or definitely" related to the study drug, CIRB President
John Isidor said March 21 during an FDA public hearing on "Reporting of
Adverse Events to Institutional Review Boards."
Current regulations stipulate that adverse events must be reported to an IRB
if they [are] "at least possibly related" to use of the drug under investigation,
FDA Office of Medical Policy Director Robert Temple said.
The hearing was held to address the concern that IRBs have become
overwhelmed with adverse event reports due to the substantial increase in
the number of large multicenter clinical trials.
Meeting participants suggested that over-reporting of adverse events may be
due to the fear of litigation.
"However we craft that definition" of which adverse events must be reported,
"it appears to me that people are going to push the envelope to over-report
because there's a tremendous fear in this society that if we're going to be
guilty of under-reporting, we're going to be penalized in the worst possible
way," Isidor said.
University of Pennsylvania Associate Director of Human Research Yvonne
Higgins pushed for regulation that would reduce IRB burden by shifting the
responsibility for evaluating adverse events to clinical trial investigators
and sponsors.
"What I want is clear guidance from a federal regulatory memo that puts the
responsibility for interpreting these things back on the sponsor and the
investigator and allows the IRB to do its job of protecting patients,"
Higgins said.
FDA issued a proposed rule in March 2003 (dubbed "the Tome") that would
require companies to file expedited reports of suspected adverse drug
reactions unless the company is sure the product did not cause the reaction.
At the public hearing, the Association of Clinical Research Organizations
suggested that the use of partially blinded analyses of study data to detect
overall trends in data could also help reduce the burden on IRBs.
To watch a webcast of this meeting, click the button below. To order
videotapes & DVDs, email webcasthelp@... or call 800-627-8171.
Posted: Friday, March 25, 2005
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