FDA Rule Would Create Pharmaceutical Dictatorship

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Mon, 16 Jan 2006 07:49:55 EST

FDA Rule Would Create Pharmaceutical Dictatorship

 

 

 

http://rense.com/general69/bdnk.htm

 

 

FDA Rule Would Create

Pharmaceutical Dictatorship

Exempting Redress By Victims And State Consumer Protection Laws

 

 

From Dr. Betty Martini, D.Hum

Bettym19

1-15-6

 

As states line up to follow in the footsteps of New Mexico where

Stephen Fox has petitioned for the ban of aspartame,and a bill has

been written, it looks like this is an effort to prevent action to

save consumers from this toxin.

 

Obviously, if we can get aspartame banned state by state, millions

will wake up well from afflictions they may not correlate with the

neurotoxic drug, aspartame. And then the world will know the aspartame

manufacturers have poisoned the world as Dr. James Bowen told the FDA

years ago:

 

http://www.dorway.com/drbowen.txt

 

In Georgia, Return to Eden, an organic food market and health food

store, gave out 16,000 Killer Kola brochures on the dangers of

aspartame. Thousands got off of it because the reports were so damning

and about 60 days later woke up well from afflictions they had

suffered for years. The cases were incredible. Two people who were

blind regained their sight, as Dr. Morgan Raiford said would happen if

vision was still in the wet stage. Many who were crippled with

fibromyalgia could walk again. Headaches, insomnia, memory loss, brain

fog, and neurological symptoms disappeared. Two people diagnosed with

MS walked out of their wheelchairs.

 

The manufacturers are doing everything they can to stop this from

happening in New Mexico. We want it to be a precedent for the world to

follow. Already a member of Parliament, Roger Williams, has called for

a ban on aspartame.

 

The Bill of Rights tells us they cannot take away the rights of the

people and of the states:

 

http://en.wikipedia.org/wiki//wiki/Ninth_Amendment_to_the_United_States_Constitu\

tion

 

Ninth Amendment Protection of rights not specifically enumerated in

the Bill of Rights.

 

The enumeration in the Constitution, of certain rights, shall not be

construed to deny or disparage others retained by the people. *

<http://en.wikipedia.org/wiki//wiki/Tenth_Amendment_to_the_United_States_Constit\

utionTenth

 

Amendment Powers of states and people

 

The powers not delegated to the United States by the Constitution, nor

prohibited by it to the states, are reserved to the states

respectively, or to the people. __

 

Big Pharma would like to have a dictatorship and prevent the rights of

the people from having legal redress, and the FDA, the handmaiden of

the pharmaceutical industry would be delighted to help.

 

They have given their loyalty to Big Pharma and betrayed the public trust.

 

On May 17, 2001, Ed Horton, Editor of the prestigious Lancet wrote the

FDA is compromised because it receives so much funding from industry,

and endangers the lives of the people. When those responsible to solve

the problem ARE the problem the rights of the people must be addressed

and served. Those who compromise the right of the people to life,

liberty and the pursuit of happiness should be stopped. As Ed Horton

said, the FDA actions have led to many deaths. In the case of

aspartame because it causes cancer

 

http://www.wnho.net/new_aspartame_studies.htm

 

triggers degenerative diseases, diabetes and other fatal problems as

well as abortions and birth defects, consider the deaths in the

millions. (Aspartame Disease: An Ignored Epidemic, H. J. Roberts,

M.D., and Excitotoxins: The Taste That Kills, Russell Blaylock, M.D.)

Aspartame interacts with all drugs and vaccines:

 

http://www.wnho.net/aspartame_interacts.htm

 

As long as it remains on the market no drug is safe.

 

The FDA has proven they are not the SERVANT of the people. Their

actions show them to be more of a corporate SERPENT who slithers and

attacks the lives and rights of the population.

 

Their hissing is aimed at removal of safe vitamins and herbs, and the

protection of Big Pharma. They rubberstamp just almost everything that

industry wants. To help in the New Mexico effort you can go to

www.wnho.net and click on aspartame to read the releases.

 

To help ban aspartame in your state contact Stephen Fox or myself

(stephen and bettym19).

 

To prevent this FDA rule against the rights of the people forward this

on to those who can help and to your congressman.

 

Dr. Betty Martini, D.Hum, Founder,

Mission Possible International

9270 River Club Parkway

Duluth, Georgia 30097

770 242-2599

http://www.wnho.net and www.dorway.com

 

Aspartame Toxicity Center, http://www.holisticmed.com/aspartame

 

Subscribe to Aspartame Information List, front page banner, www.wnho.net

 

 

Wall St. Journal: FDA Pre-empts All State Law

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

 

Promoting Openness, Full Disclosure, and Accountability www.ahrp.org

Consumers beware!

 

FDA political appointees have embarked on a plan to divest the

American consumer of the right to seek compensation for defective

prescription drugs. The Wall Street Journal reports that the agency's

plan for revamping drug labeling rules would carve in stone the

agency's former chief counsel, Daniel Troy''s pre-emption argument.

The pre-emption argument holds that the authority of the FDA (and

other federal regulatory agencies) pre-empts any state consumer

protection laws. In the case of drugs companies like Merck would be

free from liability even as the body count from its pain killer,

Vioxx, reaches tens of thousands.

 

The White House, pharmaceutical giants, lobbyists and sycophants are

attempting to frame the argument in terms " tort reform " falsely

creating the impression that the only ones who would lose would be

plaintiff attorneys. In truth, the FDA, whose legal mandate is to

protect the public from drugs that have not been scientifically proven

safe and effective, is proposing a rule to protect the manufacturers

of hazardous drugs instead. Indeed, FDA's plan would encourage Big

Pharma to continue to use corrupt marketing practices--including

flooding the airwaves with misleading advertisements for prescription

drugs-- instead of enforcing truth in advertising laws.

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

http://online.wsj.com/public/article/SB113720623594046758-2WU_h2b

weo8Wdurc2Sbuca_2_yw_20070114.html?mod=tff_main_tff_top

 

 

FDA Plan Would Aid Drug Makers In Liability

Suits Agency's Approved Labels Would Pre-empt

State Law; Plaintiffs' Lawyers Object

 

 

By Anna Wilde Mathews

Wall Street Journal - Page A1

1-14-6

 

The Food and Drug Administration is preparing to declare that

federally approved medication labels pre-empt state law, a move that

could strengthen pharmaceutical makers' defenses against lawsuits

claiming injury by the companies' products. The policy could help

companies argue they weren't required to warn consumers about a

potential risk when the FDA had determined that the safety issue

didn't warrant inclusion on a medicine's label. The new policy, which

would address state liability statutes, has been written into a broad

new drug-labeling rule that is likely to be issued shortly, according

to people with knowledge of the matter, though the rule has been

repeatedly delayed.

 

Product-liability suits have become a huge problem for drug makers. In

one of the more high-profile cases lately, Merck & Co. faces dozens of

lawsuits across the country over its withdrawn painkiller Vioxx. Merck

pulled that hugely popular drug from the market in 2004 following a

study that linked the drug to an increased risk of heart attacks and

strokes in patients taking it for 18 months or longer. Merck and other

companies have often struggled to explain the scientific nuances of

their drug-safety defenses to juries. As yet, it isn't clear whether

the new FDA policy would affect the Merck cases. Kent Jarrell, a

spokesperson for Merck, said, " We really can't get into discussing

language of a proposed rule that we have not seen. "

 

A spokesman for drug maker Pfizer Inc. declined to comment.

Plaintiffs' lawyers, however, oppose the policy. " If the proposed

changes were to be enacted, drug-product safety in the U.S. would

suffer a major setback at a time when the conduct of pharmaceutical

companies and the FDA have been called into question, " said Thomas R.

Kline, a plaintiffs' attorney with Kline & Specter and a key player in

Vioxx litigation.

 

The controversial policy has been written into the preamble of an

important FDA rule that is supposed to reform how drugs are labeled,

according to people with knowledge of the matter. It could still be

toned down or even removed before the rule becomes public, though it

has already survived years of internal debate. The FDA has asserted

similar arguments in briefs filed in legal cases, but the federal rule

would be broader and likely have more impact on individual judges'

decisions. Courts may still choose to reject the reasoning, however.

 

The policy would mesh with the White House's focus on tort reform.

Indeed, other federal agencies have made similar moves toward helping

to shield businesses from certain forms of legal action.

 

The National Highway Traffic Safety Administration last August

proposed a new rule on car-roof strength that would grant legal

protection to car makers that adhere to the safety standard. The U.S.

Office of the Comptroller of the Currency issued a sweeping regulation

in early 2004 that said federal banking laws take precedence over a

number of state consumer-protection statutes when applied to national

banks.

 

The agency challenged an investigation of potentially discriminatory

lending practices by New York Attorney General Elliot Spitzer, arguing

that his probe impinged on federal enforcement turf. Inclusion of the

new FDA policy in the long-awaited drug-labeling rule has sparked

disagreements between FDA career officials and Bush administration

appointees, according to people with knowledge of the matter. Some FDA

career staffers have argued internally that it isn't relevant to the

rule's focus on drug-labeling reform, and may draw controversy to an

important regulatory improvement that isn't itself politically divisive.

 

In addition, career officials believe debate over the matter has

helped delay the labeling change from taking effect. The new rule is

expected to specify circumstances under which the legal shield would

apply, though it may not limit the protections solely to those

situations, according to people with knowledge of the matter. The drug

company must have provided all its data to the FDA, these people said.

The drug-labeling rule's language pertaining to the new policy is

likely to contribute to the growing clash over the proper bounds of

state and federal regulatory authority.

 

Big companies have long fought patchworks of laws that differ from

state to state, and federal efforts to assert authority in various

regulatory areas have drawn testy responses from state officials. In

the case of the new FDA rule, states argue that they weren't

adequately informed that it was coming. Yesterday, the National

Conference of State Legislatures protested the move in a letter to

Health and Human Services Secretary Michael Leavitt, calling it a

" thinly-veiled attempt on the part of FDA to confer upon itself

authority it does not have by statute " and an " abuse of agency process. "

 

Past FDA briefs arguing that agency guidelines pre-empt state law

haven't always been accepted by courts. Last July, a federal judge in

Minnesota turned down a Pfizer request to bar a suit over the

antidepressant Zoloft, writing that " federal labeling laws are minimum

standards; they do not necessarily shield manufacturers from state law

liability. ... state-law protections reinforce and enhance " federal

efforts to protect the public.

 

Defenders of the FDA's pre-emption briefs have argued that they simply

articulate a stance that is implicit in federal law. If state

lawmakers and courts can second-guess the FDA, some drug-industry

officials say, it could lead to a morass of conflicting rules and

undermine the decisions of the government's most qualified experts.

" You want the FDA to have the last word if you believe in the FDA's

expertise, " said Daniel Troy, the former FDA chief counsel who filed

several of the briefs and who represents industry clients in private

practice.

 

The new drug-labeling rule, a major regulation that has been in

development for years, will update the format of the FDA-approved

documents that provide the definitive account of each medicine's uses

and risks. They can stretch for dozens of pages, and even doctors

often find them difficult to navigate. The new layout is expected to

clarify the most important information at the top of the label in a

standardized " facts box " format. It is the centerpiece of a broader

FDA initiative to make drug information more accessible.

 

--Heather Won Tesoriero and Barbara Martinez contributed to this

article. Write to Anna Wilde Mathews at anna.mathews