Fwd: [drugawareness] WASHINGTON POST-Keeping Doctors in the Dark

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atracyphd2

Wed, 24 Mar 2004 03:19:31 EST

[drugawareness] WASHINGTON POST-Keeping Doctors in the Dark

 

This is an excellent article from the Washington Post today detailing the

path which led us to the FDA warning on antidepressants.

 

In fact, Dr. Diller is beginning to sound like me! But then I have been

shouting this warning for 14 and a half years now. I know of no one who has been

working as an expert in antidepressant related court cases longer than I have

(including such high profile cases as Phil Hartman's murder/suicide, Columbine,

Andrea Yates, etc.).

 

What I mean to say by that is that, few have seen the downside of these drugs

to the extent I have, that is until Feb. 2, when the FDA got a glimpse into

my world - our world, because most of you on this list have " been there " as

well in your own SSRI-induced nightmare.

 

For years I have stated in interviews that if someone could follow me around

for a day to hear what I hear day in and day out they would do all they could

to stop the flood of antidepressants in this country. Feb. 2 an FDA Advisory

Panel moved to do just that after hearing what I have heard repeated over and

over again for all these years.

 

The politics in medicine in America are killing us at a very rapid pace. It

would be a good idea to take a hard look while we still can.

 

 

Ann Blake Tracy, PhD

Executive Director, International Coalition For Drug Awareness

Author: Prozac: Panacea or Pandora? - Our Serotonin Nightmare

& audio tape on safe withdrawal: " Help! I Can't Get

Off My Antidepressant! " (800-280-0730)

 

Cell: 801-209-1800

E-mail: atracyphd1

Website: www.drugawareness.org

 

 

http://www.washingtonpost.com/wp-dyn/articles/A19163-2004Mar23.html

 

Keeping Doctors in the Dark

 

By Lawrence Diller

Wednesday, March 24, 2004; Page A21

 

The Food and Drug Administration issued an official warning this week on the

increased risks of suicidal tendencies when taking antidepressants such as

Prozac. The makers of Prozac and of nearly every other major antidepressant used

in this country (Paxil, Zoloft, Wellbutrin, Effexor, Celexa, Lexipro) will

have to include a new warning on the package label. This action is the

culmination of more than 10 years of efforts to bring to light potential dangers

of

these medications.

 

The new warning alerts doctors and patients that in the first days and weeks

of treatment, side effects such as agitation, panic, irritability, insomnia

and severe restlessness may occur, contributing to an overall increase in the

risk of suicide. More than a decade ago similar concerns over Prozac were beaten

down in U.S. courts by an onslaught of " expert " testimony of

industry-sponsored researchers and legal arrangements that gagged victims and

their families

with large monetary settlements.

 

In fact, it's likely we still wouldn't have the information on the

antidepressants today, if it weren't for foreigners, specifically British

doctors, who

were more skeptical about the antidepressants' value in treating depression in

children. The Medicines and Healthcare products Regulatory Agency, Britain's

FDA, first issued a warning on Paxil and Effexor last summer. In October, all

the antidepressants known as SSRIs except Prozac were banned because studies

from the United States did not show they were effective in treating children

with depression, but did show that they were twice as likely as placebos to lead

to suicide.

 

The British decision led to the FDA's move to hold a hearing on Feb. 2 in

Washington. Until that time, of seven published studies of SSRI use for

childhood

depression, only three demonstrated positive effects as compared with

placebos. At the meeting, doctors and patients learned that the FDA had eight

additional drug company studies in its " back files " that also showed no positive

effects for the drugs but were never published. The drug companies had performed

these studies under the " pediatric rule, " which extended the patents of these

medications for the companies by six months. But the companies were under no

obligation to publish them, and so they languished in darkness until the British

government's action made us aware of them.

 

At the meeting, even researchers and academic psychiatrists who were

well-known proponents of psychiatric medication for children pleaded for

transparency

in research findings. How can doctors make sensible decisions when most of the

studies are withheld from public scrutiny? The companies responded that the

studies are proprietary company property and that publication of such data

could hurt their product and stockholders.

 

The lack of an economic interest also precludes any systematic follow-up on

drugs once they are approved by the FDA. Most studies required for FDA approval

last only a few months. Once approved, these drugs can be used forever, and

for whatever purpose a doctor sees fit to prescribe them. The drug companies

have little incentive to check whether the medicines are still working years

into a treatment. And it can take years of general use before side effects are

discovered to be associated with a drug.

 

It seems that only the trial lawyers have a vested economic interest in

following up on medications. That's a costly post-marketing surveillance system,

both to the society that absorbs the legal costs and to the people hurt by a

medication, before enough publicity or economic pain is felt by the manufacturer

to change the label or withdraw the drug. Nearly 80 percent of respondents to

a poll on my Web site said they'd pay at least a 1 percent surcharge on their

medications to fund independent, systematic follow-up on pharmaceuticals.

 

The FDA decision to issue its warning on antidepressants is a vindication,

albeit a much delayed " bitter pill " to the families that lost a child to suicide

as a result of taking what might have been no better than placebo treatment.

How many more children must die from other questionable drugs before our

government takes the necessary actions to " heal " the sick regulation of the

pharmaceutical industry?

 

The writer practices behavioral-developmental pediatrics in Walnut Creek,

Calif., and is the author of " Should I Medicate My Child? "