recent FDA decision puts drug profits before safety

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NewsTarget: recent FDA decision puts drug profits before safety

Tue, 6 Dec 2005 13:53:41 -0700

 

Big Pharma has manhandled the FDA once again, and this time it's all

about removing requirements for long-term safety testing of new

psychiatric drugs. Thanks to this latest decision, mind-altering drugs

can now be approved for a lifetime of use after merely two weeks of

safety testing.

 

It gives the phrase, " FDA approved " a whole new meaning...

 

Full story at:

http://www.newstarget.com/015406.html

 

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 unsuspecting

patients.

 

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 pre-approval studies.

 

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.

Kevin Trudeau's Natural Cures book review

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 says.

 

Works cited:

 

FDA Advisory Committee. " Committee Information: Psychopharmacologic

Drugs Advisory Committee. " 2005. http://fdaadvisorycommittee.com

FDA accused of suppressing drug safety information (commentary)

Laughren, Thomas P., M.D. " Memorandum to Members, PDAC. " 26 Sept.

2005. http://www.fda.gov

 

National Institute of Mental Health. " Statistics. " 15 Sept. 2005.

http://www.nimh.nih.gov

 

Vedantam, Shankar. " U.S. Alters Test Policy on Psychiatric Drugs. "

Washington Post. 26 Oct. 2005. http://www.washingtonpost.com