By Dr. Andrew Maniotis

Posted: 26 September 2005

Appeared in the "Paydirt," The Student Newspaper of New Mexico Tech on 21 September 2005, Volume 37 Number 5

There are hundreds of case histories and examples of corporate manipulation of the FDA approval processes, which are presently the subject of lawsuits. A product is pushed through the FDA approval process and gets approved. Then the product does some horrible physiological damage, someone dies, or a whole lot of people die, and the families go to court. Sometimes they win; sometimes they lose.

Th e recently adjudicated Vioxx case in Angleton, Texas, is an excellent example in which the widow won a judgment of a quarter of a billion dollars, which will no doubt be pared down to no more than $26 million, due to Texas limits on product liability awards.

Aspartame, an artificial sweetener, is a much better example, because it is a deadly neurotoxin which is ingested daily by perhaps as many as 175 million people in the United States; its effects are so insidious as a food additive rather than a prescribed medicine. Th ere were warning labels on tobacco products, even though the emphysema and lung cancer causation were really quite obvious; prescription pharmaceuticals might end up damaging you, but you have to go through a prescription process signed by a physician in order to get most of them.

The deadly neurotoxin Aspartame is on every grocery story shelf in the USA! Aspartame doesn't carry any warnings, other than in a very few products, which proclaim that phenylketonurics better avoid it, since it breaks down into, among other things, phenylalinine, a proven brain toxin. Phenylketonuria is a rare genetic condition, which is quite serious for those who have it, but most people think along the lines that they may be many things, but they are relatively sure that they are not a phenylketonuric, so why worry, it can't hurt them, because they believe that "Th e FDA is there to protect them, and if it were really bad, the FDA would have removed it from the market!"

What childish and naive balderdash! If the average person knew that aspartame's metabolized byproducts included formaldehyde, or that the FDA used to list 92 symptoms which were attributed to aspartame, would they continue to consume this product? I think not.

If they did use it for many years and came down with a host of neurodegenerative diseases from this witch's brew/formaldehyde cocktail, a few of them might still be solvent and intelligent enough to employ a lawyer to sue the manufacturers of the products containing the aspartame. Or, if a few dedicated and clever Attorney Generals in the United States began to recognize the similarities between the tobacco companies causing lung cancer and the aspartame companies causing neurodegenerative illnesses, some of these cases might actually end up in court in the very near future.

Companies continue to use their age-old excuse, that they had FDA approval for that particular product, and that the case should be thrown out because the FDA's pronouncements are considered inviolable and more powerful than any state consumer protection or tort law. Th is indeed was what Pfizer recently said in a Federal case in Minnesota (Witczak v. Pfizer) in which a widow, Kimberly Witczak, sued because her husband's suicide was attributed to Zoloft, a Pfizer product. Pfizer moved for a summary judgment of dismissal of the case, on the grounds that the FDA never required them to put a suicide warning on the side of the Zoloft box.

Fortunately, the Minnesota Attorney General, Mike Hatch, entered an amicus curie brief in March 2005 which essentially threw out the myths of federal preemption of FDA rulings and the FDA's approval processes. On July 20, 2005, US Chief District Court Judge, James M. Rosenbaum, completely rejected Pfizer's effort to dismiss Kimberly Witczak's Zoloft -suicide lawsuit.

Mrs. Witczak asserted that Zoloft induced her husband, Timothy Witczak, to commit suicide after suffering severe adverse reactions to the drug. Mrs. Witczak claims that Pfizer misrepresented Zoloft as safe and failed to provide warnings about Zoloft's propensity to increase the likelihood of suicide, despite Pfizer's knowledge of the risk, which was proven by internal memoranda and studies obtained through the discovery process.

In his ruling, Judge Rosenbaum stated: "State consumer-protection law compliments, rather than frustrates, the FDA's protective regime. This is especially apparent when one considers that prescription drugs were once marketed primarily to trained health care providers -- sophisticated and discerning intermediaries. Today, on the other hand, pill-rolling apothecaries and the mortar and pestle have disappeared. They have been replaced by drug manufacturers who urge the use of their drugs in massmarket print and television advertisements targeted directly at the public. Th e defendant, for example, advertises the drug involved in this case by personifying it as a happy, bouncing-oval cartoon character."

This is just one case, and there are many, many more. Eventually American leaders in science, in medicine, in legislatures, in jurisprudence, and in plaintiff law, are all going to wake up to the extent of the total folly implicit in the ruinous mythology, weak-minded acceptance, corporate capitulation by the American consumer, scientific flaws, and medical absurdities implicit in perpetuating the FDA's preemptive power, especially in matters where millions of people's health is involved.

There is no clearer case in this regard than the example of the neurotoxic artificial sweetener, aspartame. I encourage the members of the New Mexico Environmental Improvement Board to accept the rule change petition before them, filed August 22,to prohibit the sale of aspartame in New Mexico. This rule change reiterates the existing statutes on poisonous or deleterious food additives in New Mexico, even though they have been never used even once since their enactment in 1941!

I even more strongly recommend to the members of the New Mexico Legislature that they strengthen whatever the EIB decides, in the 2006 session regarding the whole class of neurotoxic food additives.

Above all, I urgently request Governor Bill Richardson of New Mexico to make getting rid of aspartame in New Mexico a high priority, to strengthen and deepen all of the state's consumer protection laws, and to begin to lead the nation as a leader to whom the health of his constituents is vastly more important than perpetuating the continued destructive actions of the legion of corporations producing the vast biochemical mayhem in thousands of products, which, I believe, has contributed enormously to the apparently inexorable demotion of the USA to 29th in the world in terms of international statistics on longevity.

For more information please contact Dr. Andrew Maniotis, Program Director in the Cell and Developmental Biology of Cancer Research at University of Illinois, Chicago, at or