Here is an article discussing the Keystone Cops at the FDA suddenly
finding out that they just hired Ralph Nader's nephew instead of
Daffy Duck to audit them. About half way thruogh the article it
starts discussing how a panel advised a black box warning about the
cardio vascular risks of all ADHD meds and how it was ignored.

When you see an FDA panel split on a vote 8-7 for a black box warning
in reality it is worse than that. These panels are stacked with
pharm corp cronnies. There was a tragic vaccine that got approved
10-5 and rapidly pulled off the market after several infant deaths
and a few dozen surgeries. After the scandal broke it turned out
that 8 of the panel members had conflict of interest waivers and they
voted as a block to approve. There was another panel were 9 out of
ten had conflict of interest waivers. When the chairman(the only
one on the panel who was not conflicted) of the panel was asked way
don't you conveine a panel of experts without conflicts of
interest? He said, "The pharm corps have so much money and hire so
many people, it is imposible to find enough experts who are not
conflicted to make up a panel."
Nachum

Mutiny By An FDA Advisory Panel

Date: 10/14/06 Author: Byron Richards Source: NewsWithViews.com

By Byron J. Richards, CCN

October 12, 2006

NewsWithViews.com

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." The lead author is Curt D. Furberg, M.D., Ph. D., an expert
in epidemiology and biostatistics and current member 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 needed drug-
safety improvements. 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 among FDA advisory committees in
that it deals in a general way with 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 shocked when earlier this year the Drug Safety and Risk
Management Advisory Committee 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
children's market in ADHD meds, antidepressants, and atypical
antipsychotic meds. Americans are worried, and rightfully so, that
the true risks of these medications are being hidden and downplayed
thus placing an entire generation of children in danger.

The FDA thought the advisory committee was going to review depression
and suicide risk relating to ADHD medication. Instead, 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 prevent more fallout on their
already existing lax-on-safety image problem, especially when their
own appointed 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 FDA 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 cardiovascular deaths from ADHD
medication don't impress the FDA when Big Pharma blockbuster profits
are at stake.

However, safety 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 outlines the
significant cardiovascular risk of this class of medication and the
committee's plea for the FDA to act decisively. 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 Michael Enzi (R-WY) and Edward Kennedy (D-MA) 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. Big Pharma's illegal off-
label drug promotions to children, via the TeenScreen program,
require criminal investigation. All user fees paid by Big Pharma to
the FDA, which currently amounts to over half the FDA drug approval
budget, must be discontinued.

The current Bush-appointed FDA leadership, such as temporary head
Andrew von Eschenbach and second in command, Scott Gottlieb, must
have all their extensive 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