Long-term Testing Requirement for Psychiatric Drugs Abandoned Due to Big Pharma Pressure on the FDA
Originally published December 4 2005
Long-term testing requirement for psychiatric drugs abandoned due to Big
Pharma pressure on the FDA
The bipolar medication lithium is so toxic that it often causes major kidney
damage, yet most patients must use it for lifetime maintenance of
manic-depressive disorder. Similarly, schizophrenics often spend lifetimes
on neuroleptics with long-term side effects such as tardive dyskinesias, or
uncontrollable movement of the face, tongue, lips and extremities.
The point here? Side effects almost always go hand-in-hand with taking a
medication for a long duration in order to treat a chronic condition. With
that in mind, it seems outrageous that on Oct. 25, 2005, a panel voted to
defeat the FDA's proposal to extend pre-approval testing of psychiatric
drugs from two short-term studies to six-month trials. In layman's terms,
psychiatric drugs will not be tested for a long enough time to determine
their safety for long-term use before they are approved. Now, they can be
tested for as little as two weeks, then given the stamp of safety approval
by the FDA after which they will be used for years, if not decades, on
In a Sept. 26 memo, Dr. Thomas P. Laughren, acting director of the FDA's
Division of Psychiatry Products, gave solid reasons for the FDA's desire to
extend its required testing time. In fact, he begins the memo with a simple
fact that makes the need for long-term testing clear: "Most psychiatric
illnesses are chronic." He later goes on to explain that current short-term
testing methods advocate stopping treatment of subjects who are responding
to the drug after only a few weeks, something that would be considered
"ethically questionable" in actual clinical treatment. In other words,
real-world patients with mental disorders may have to stay on these drugs
for months, years, decades and possibly even a lifetime, so why should
clinical testing be limited to the short term?
The current short-term tests also present a problem for psychiatrists who
are prescribing a newly-approved drug. As Dr. Laughren explains, "Since most
treatment guidelines for chronic psychiatric illnesses recommend continuing
patients for four to six months or longer after response during short-term
treatment, clinicians have generally not had a sufficient evidence base
(from pre-approval studies) to support what is the standard practice of drug
treatment of psychiatric illnesses."
When a psychiatric drug first hits the market, prescribing physicians are
largely left in the dark about treatment issues after a patient stays on the
medication longer than the six to 12 weeks tested during approval trials.
Yes, the FDA generally asks for longer-term studies to be completed after
approval, but it can be years before this is done. During this time patients
are put at risk for side effects that did not emerge in the short
How Big Pharma overrules the FDA
Though Dr. Laughren rightly petitioned for testing standards to change, Big
Pharma once again flexed its muscles and defeated the FDA's acting director
and other supporters of longer safety testing requirements. Pharmaceutical
industry executives from Merck, Wyeth and Eli Lilly gathered with academic
researchers and presented the 11-member Psychopharmacological Drugs Advisory
Committee with 15 presentations, all against extending the duration of
pre-approval trials to six months.
Their argument? According to Eli Lilly's David Michelson, executive director
for neuroscience medical research, half of all patients switch psychiatric
medications after three months of treatment, with the figure reaching as
high as 70 percent after six months. According to this logic, conducting
six-month pre-approval tests will not benefit enough psychiatric patients to
warrant the policy change. In other words, Big Pharma is saying we should
ignore the potential health risks posed to psychiatric patients who take
these drugs on a long-term basis because they don't make up a large consumer
group. This perspective is alarming in itself, but given the scandals
surrounding Vioxx and other prescription drugs, it comes as no surprise.
The facts are clear: Mental illness is presently an epidemic in modern
society, a result of our chronic malnutrition and ingestion of metabolic
disruptors (ingredients that disrupt normal brain function, such as refined
sugars, trans fatty acids, chemical sweeteners, artificial colors, etc.).
According to statistics from the National Institute of Mental Health, about
one in five American adults suffer from a diagnosable mental illness.
To make matters worse, our population's desire for "magic pill" solutions
has made us look to chemical cures for nutritionally- and
environmentally-based problems. Because of this trend, drugs that we don't
fully understand are being prescribed to an ever-increasing percentage of
our population. The long-term effects of this could be disastrous.
In this case, the FDA tried to take a positive step in protecting the
public, but failed under the pressure from Big Pharma. It's now up to
concerned consumers like you to make your voice heard. Tell the FDA that you
want psychiatric medication adequately tested, no matter what Big Pharma
FDA Advisory Committee. "Committee Information: Psychopharmacologic Drugs
Advisory Committee." 2005. http://fdaadvisorycommittee.com
Laughren, Thomas P., M.D. "Memorandum to Members, PDAC." 26 Sept. 2005.
Vedantam, Shankar. "
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