WASHINGTON POST-Keeping Doctors in the Dark

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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? "