The FDA has created its own monster. Could it be that an FDA
advisory panel actually has enough impartial members to be truly
concerned about the health and well being of all Americans? No
doubt, the top FDA officials were squirming in their boots as
five current and past members of the Drug Safety and Risk
Management Advisory Committee went public with their call for
sweeping changes at the FDA.
The
October 9, 2006, issue of the
Archives of Internal Medicine contains
the article:
FDA and Drug
Safety: A Proposal for Sweeping Changes.
Lead author is
Curt D. Furberg, M.D., Ph. D., an expert in
epidemiology
and biostatistics and current member of of the
FDA safety committee. He is a professor at the
Department of Public Health Services, Wake
Forest University School of Medicine. In an
interview by
Amanda Gardner, HealthDay reporter, Dr.
Furberg states:
"Congress cannot leave them [the FDA] on
their own….What's missing is a strong, dynamic leadership to
make some changes….The main problem is the voice of drug safety
is not heard….There's a lot of unhappiness, low morale, people
don't communicate….The leadership does not get the message….For
a decade, they've [the FDA] had problems, and they've done very
little. They deny their problems, and they can't fix them. We're
saying Congress has to step in to give them authority, give them
money, oversee their operations and make sure drug safety is a
priority.”
This criticism comes from a collection
of experts that the FDA assembled to give them advice on the
safety of drugs. Numerous experts on the Drug Safety and
Risk Management Advisory Committee felt the FDA was not
following their advice regarding the improvement of drug
safety. The message is loud and clear: The FDA, an agency that
maintains a cozy and profitable relationship with Big Pharma, is
incapable of protecting the American public from harm.
Drug Safety and Risk Management Advisory Committee
This particular committee is unique amongst FDA advisory
committees in that it deals with the FDA in general on the topic
of drug safety, including the need for post-marketing
surveillance. Other FDA advisory committees usually focus on
one drug or topic area. The importance of this committee has
been elevated since the Vioxx scandal.
Grumbling
from committee members has been going on for some time. While
the committee feels they have made some inroads, progress has
been on simple issues that can be acted on in a short period of
time. On the tough issues, the core problems of drug safety at
the FDA, the FDA has been
slow to adopt committee recommendations that would protect
Americans from harm.
Why Won’t the FDA Protect Our Children?
The FDA was stunned and shocked when the Drug Safety and Risk
Management Advisory Committee earlier this year voted 8 to 7 to
place a black box warning for cardiovascular risk on all ADHD
medications. Such a move would cost Big Pharma dearly, eroding
the ten billion dollar market that is currently damaging the
nervous systems of millions of our children with ADHD meds,
antidepressants, and atypical antipsychotic meds.
The
FDA thought the committee was going to review depression and
suicide risk. The meeting spun out of FDA control and resulted
in a major catastrophe from the perspective of the FDA. In no
way, shape, or form did the FDA want the committee delving into
cardiovascular risk in the manner they did. Of course, the FDA
does not have to follow the advice of their advisory panels.
But how could they protect their image of being lax on safety
when a panel of experts is telling them to act quickly to
protect children? Stunned, FDA spokesperson Robert Temple
offered this lame explanation, “You don’t want to over scare
people with data that aren’t very solid.”
In
high-level damage control the FDA shunted the issue to a
different advisory panel, one that would water down the
recommendations. One month later the new panel stated a black
box warning for cardiovascular risk was not warranted. The
strategy is clear; if one panel warns of a need for safety,
another panel can be used to quell concern. After the cover up
meeting
Temple stated, “The committee was not impressed with the
level of cardiovascular risk to children.” Twenty-five reported
deaths doesn’t impress the FDA when Big Pharma blockbuster
profits are at stake.
However, advisory panel member Steven E. Nissan, M.D., was not
going to take this insult lying down. After all, the safety of
our children was at stake. Dr. Nissan launched his attack in
the New England Journal of Medicine. On April 6, 2006,
his article was published,
ADHD Drugs and Cardiovascular Risk. In it, he blasts the
FDA for covering up safety issues and clearly outlines the
significant cardiovascular risk of this class of medications.
To this day, the FDA ignores the severity of the problem, which
in my opinion is simply to protect the profits of Big Pharma.
Americans Must
Respond
The unusual and public call for
reform by members of the Drug Safety and Risk Management
Advisory Committee tells us the FDA is hopelessly broken. When
members of their own committees feel the agency is not listening
and putting the well being of Americans in jeopardy, it is time
to act.
Americans must wake up before it is too late. The FDA, the
White House, and elite leaders of both parties are owned by Big
Pharma. True reform at the FDA must occur, and will not occur
unless American citizens demand it and actually know what is
going on.
Already, Senators Enzi and Kennedy have
introduced a sham safety bill (S3807) that is a gift to Big
Pharma and actually intends to make part of the FDA a drug
company! It is clear that politicians will work deceptive spin
under a pretense of safety.
Big Pharma must be banned from all lobbying and drug
advertising. The 80,000 drug reps that routinely bribe doctors
with perks, as well as their “free” samples, must be stopped.
The FDA needs total reorganization with a focus on drug safety.
All user fees paid by Big Pharma to the FDA, which currently
amounts to over half the FDA drug approval budget, must be
stopped.
Current FDA leadership, such as temporary head Andrew von
Eschenbach and second in command, Scott Gottlieb, must have all
their Big Pharma connections fully exposed. There is a reason
they want to speed drugs to the market, reduce safety testing,
and prevent Americans from suing drug companies when drugs
injure and kill our people.
© 2006
Truth in Wellness, LLC - All Rights Reserved
Byron J.
Richards, Founder/Director of
Wellness Resources, is a Board-Certified
Clinical Nutritionist and nationally-renowned
health expert, radio personality, educator, and
author.
Richards
encourages individuals to take charge of their
health, stand up for their health rights, and
not blindly succumb to propaganda from the
vested-interests who profit from keeping
Americans sick. Author of
Mastering Leptin and
Fight for Your Health, Richards is now
joining forces with
health freedom leaders in the U.S. and
throughout the world. Visit his
health blog for up to date happenings.
www.truthinwellness.com
As founder of
Wellness Resources, Inc. of Minneapolis, MN
(since 1985), he has personally developed 75
unique nutraceutical-grade nutritional formulas.
www.wellnessresources.com
Charter Member of
the
International and American Associations of
Clinical Nutritionists (IAACN) (since 1991)
Richards has presented hundreds of educational
classes to health professionals and individuals
who want to take charge of their health!
E-mail: byron@truthinwellness.com
