FDA Rule Would Create
Pharmaceutical Dictatorship

From Dr. Betty Martini, D.Hum
Bettym19@mindspring.com
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_Constitution

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_ConstitutionTenth

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@santafefineart.com and bettym19@mindspring.com).

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@ahrp.org
http://online.wsj.com/public/article/SB113720623594046758-2WU_h2b
weo8Wdurc2Sbuca_2_yw_20070114.html?mod=tff_main_tff_top

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.