Reputation of the FDA in shambles after Vioxx scandal; calls for wholesale FDA reform gain momentum.

[Guest guest]

Sunday, November 07, 2004 commentary:

 

Reputation of the FDA in shambles after Vioxx scandal; calls for

wholesale

FDA reform gain momentum.

"...the agency’s senior management is more concerned with external

appearance

than rigorous science." -- Dr. Richard Horton, editor, The Lancet

The reputation of both the FDA

http://www.ReformTheFDA.org/001731.html

and Merck lies in shambles today after evidence continues to surface

that

shows the FDA knowingly approved, promoted and refused to recall a

dangerous

drug that caused an untold number of fatalities among the American

population:

Vioxxhttp://www.Newstarget.com/002155.html

.. As readers of this website have long known, the FDA sees its job as

promoting

drugs and the financial

interests http://www.Newstarget.com/001783.html

of pharmaceutical companies, not in protecting the public

health http://www.PublicHealthNews.org/001513.html

.. We've known, all along, that it would take a scandal to reveal the

true

nature of the FDA and see serious calls for reform. Well, folks, the

scandal

is here, and the FDA is now under intense fire by the international

medical

community for its role in covering up the truth about Vioxx for four

years.

 

Perhaps the most relevant criticism of the agency comes from Dr.

Richard

Horton, editor of The Lancet, a well respected medical journal. After

reading

the Merck insider

emails

published in the Wall Street Journal showing how Merck sought to

distort

drug

trials http://www.Newstarget.com/001690.html

to hide evidence of heart

disease http://www.HeartDiseaseReport.org/002046.html

, and after reviewing the same clinical

trials on the drug that the FDA reviewed before approving it, Dr.

Horton

was outraged and called for FDA

reform http://www.Newstarget.com/000151.html

:

 

"In the case of Vioxx, the FDA was urged to mandate further

clinical

safety testing after a 2001 analysis suggested a 'clear-cut excess

number

of myocardial infarctions'. It did not do so. This refusal to engage

with

an issue of grave clinical concern illustrates the agency’s in-built

paralysis,

a predicament that has to be addressed through fundamental

organizational

reform."

 

But Dr. Horton didn't stop there. He also explained, "...with

Vioxx,

Merck and the FDA acted out of ruthless, short-sighted, and

irresponsible

self-interest." In other words, Merck and the FDA were playing the

classic "cover your ass" game in trying to hide the destructive health

consequences of Vioxx from the public for as long as possible. And they

managed to pull it off for four years thanks to the gullibility of

conventional

doctors

http://www.Newstarget.com/001754.html

and the ignorance of the American public, who continue to believe in prescription

drugs http://www.PharmaceuticalNation.com/001352.html

as "miracle cures" for just about every symptom or disease, even though

the facts reveal that prescription drugs heal no one. More often than

not,

they actually kill people.

 

The FDA, godfather of the U.S. drug

racket http://www.DrugRacket.org/001866.html

For decades, the public has blindingly trusted the FDA, despite the

growing

evidence that the agency acts more like a 1920's Chicago mob than an

organization

dedicated to protecting the public health. The FDA is far more

interested

in protecting the profits of Big

Pharma http://www.PharmaceuticalNation.com/002042.html

, it seems. In a very real sense, the FDA is the godfather of the U.S.

drug racket, where dangerous chemicals are hyped, approved and sold to

the American people, regardless of their true dangers. I've been

shouting

this message for years, and now, finally, people around the world are

starting

to listen.

One thing we've learned with the Vioxx scandal is that the FDA

routinely

suppresses any information from its own scientists that might have

something

negative to say about drugs the agency has already approved. One

scientist

the FDA suppressed was Dr. David Graham, associate director for science

in the Office of Drug Safety at the FDA. He had directly warned the

agency

about the cardiovascular risk presented by Vioxx, and yet his

supervisors

essentially told him to sit down and shut up. Dr. Anne Trontell, one

such

supervisor, called the studies showing heart damage from Vioxx,

"nothing

more than a scientific rumor." That's how the FDA and people in the

medical

community shut down critics: they just declare anything they don't like

to be "unscientific."

 

The FDA censors its own scientists

Another FDA researcher, Dr. Andrew Mosholder, was censored and not

allowed

to testify in February, 2004 about his study that found antidepressants

http://www.PharmaceuticalFraud.com/001118.html

increase the risk of suicides

in children http://www.Newstarget.com/001104.html

.. There was a war within the FDA between the scientists who recognized

the clear health risks of drugs like Prozachttp://www.Newstarget.com/001465.html

and Vioxx, vs. the top administrators who wanted to keep pushing drugs

to the public regardless of their health risk. As Dr. David Graham

explained,

"the

review and clearance process had been turned into a battleground, full

of contention and intimidation because our managers, the people who

fill

out our performance evaluations, had created a system where it was

taking

a great risk to stand firm in our scientific beliefs."

That's how the FDA operates: censor any scientists who speak out

against

prescription drugs. Better yet, just fire them and blackball the whole

lot. Only positive information about drugs is accepted by the FDA, and

if you work for the agency, you're encouraged to understand that

message

as quickly as possible through a system of intimidation and censorshiphttp://www.Newstarget.com/001691.html

..

 

Today, the FDA's reputation is in shambles. Finally, the world is

getting

the picture: the agency cannot be trusted. It has now proven, yet

again,

that it will co-conspire with drug

companies http://www.DrugCompanies.info/000476.html

to distort the truth, lie to the American public, and blatantly promote

dangerous

drugs http://www.Newstarget.com/001502.html

that it knows are killing people.

 

Blatant criminal behavior at the FDA

These actions are not mere "administrative oversight," folks. These

actions

represent a pattern of criminal behavior on the part of FDA

employees

and drug company executives. Promoting these toxic drugs,

distorting

the clinical trials, and burying the negative evidence are criminal

actions

and should be treated as such. In a sane world, the FBI would march

into

the FDA offices tomorrow and arrest these white-collar felons for the

crimes

they have committed. Executives at Merck should do prison time -- plus

pay billions in fines -- for the pain, suffering and death they have

unleashed

upon the population.

Quite clearly, Big Pharma is a highly corrupt industry, and it is

backed

and promoted by a federal agency that needs to be wiped clean and

rebuilt

from scratch (along with a new office of Internal Affairs that would

investigate

FDA employees for precisely these sort of crimes).

 

Regardless of what happens next, it's evidence that the public

trust

in the FDA has been destroyed. "...the most important legacy of

this

episode," writes Dr. Horton, "is the continued erosion of trust

that public-health institutions will suffer. Failure to act decisively

on signals of risk might minimize short-term political criticism for

regulators,

or shareholder unrest for company chief executives. But the long-term

consequence

of prevarication is a tide of public skepticism about just whose

interests

drug makers and regulators truly represent."

 

That's a very polite way of saying the FDA is in bed with the drug

companies

-- a fact that's as obvious as the fingers on your hand to anyone who

has

actually been following the FDA's actions over the last few years.

There's

no question about it: the FDA knowingly and willingly places the

financial

interests of Big Pharma as its highest priority. And in doing so, it is

causing the needless death and suffering of American citizens.

 

By any definition, that is criminal.

 

Action Items:

1) Support the movement to charge FDA officials and drug company

executives

with the crimes they have committed against humanity. If they are not

held

responsible for their actions, there's no reason why they won't keep

repeating

them.

2) Write your political representatives in Washington and demand

real reform at the FDA.

 

3) Steal this article and post it on your website or send it to

your

friends via email.

Spread the word about NewsTarget.com so that more people can get

involved

in our leading effort to call for FDA reform and the prosecution of

drug

company executives for their crimes against the people.

 

--------------------------------

 

About the author:

 

Author Mike Adams is a holistic nutritionist with over 4,000 hours

of study on nutrition, wellness, food toxicology and the true causes of

disease and health. He is well versed on nutritional and lifestyle

therapies

for weight loss and disease prevention / reversal. View

Adams' health statistics http://www.newstarget.com/AdamsHealthStats.htmlshowing

LDL cholesterol of 67 and outstanding blood chemistry. Adams uses no

prescription

drugs whatsoever and relies exclusively on natural health, nutrition

and

exercise to achieve optimum health. He serves as the executive director

of the Consumer Wellness

Research

Center and is author of several books about health and nutrition,

including

The Five Soft Drink Monsters

http://www.TruthPublishing.comand

Superfoods For Optimum Health

http://www.chlorellafactor.com.

In his spare time, Adams engages in pilates, cycling, strength

training,

gymnastics and comedy improv training. In the technology industry,

Adams

is president and CEO of a well known email

marketing software company http://www.arialsoftware.com.

 

Related Reading:

 

Reputation of the FDAhttp://www.ReformTheFDA.org/001731.html

in shambles after Vioxxhttp://www.Newstarget.com/002155.html

scandal; calls for wholesale FDA

reform http://www.Newstarget.com/000151.html

gain momentum

 

Source:

http://www.newstarget.com/002157.html

 

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