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Senator John McCain
United States Senate
241 Russell Senate Office Building
Washington, DC 20510

Re:Strong Opposition to the McCain-Sponsored Dietary Supplement Safety Act (DSSA)

Dear Senator McCain:

Though I am a resident of New York, not Arizona, I suggest that someone in your staff read my letter very carefully as I believe you are unwittingly sponsoring a bill with potentially onerous consequences, one that might, if I read the information about it properly, lead to the death of hundreds of my patients fighting advanced, terminal cancer. I do not think, if I am correct in my interpretation, that you would want their deaths on your conscience.

As some background, I am a registered Republican, and in the past have donated many thousands to Republican causes, including your reelection, even when it became clear to me the Party, including you, had strayed significantly from its mission of limited government, deficit reduction, and ultimately protection of individual liberty. In terms of my professional activities, I am a former journalist (Time Inc.), currently a physician and cancer researcher, who was educated at three Ivy League schools (Brown undergraduate, Columbia postgrad, Cornell for medical school). I finished a fellowship in cancer immunology under Robert A. Good, for ten years president of Sloan-Kettering, and the most published author in the history of medicine. Under Dr. Good's direction, 29 years ago I began researching the use of diet, nutrients, and proteolytic enzymes against advanced cancer.

I am a serious scientist working seven days a week trying to help those for whom there is no other help. Though some consider my work"alternative" and though in the past my treatment has generated controversy since my therapy does not conform to the drug company model, I have been funded by very mainstream corporations and institutions including Procter & Gamble, Nestle, and the NIH. Congressman Dan Burton (R-IN) has long been a vocal supporter, and I have met with Senator Tom Harkin at his invitation to discuss this treatment. My research has been featured in a lengthy profile appearing in the New Yorker magazine (Feb 5, 2001) and more recently in the major best-selling book Knockout about innovative new approaches to cancer, written by the actress and writer Suzanne Somers. I appear regularly in the media, which increasingly have taken a very positive view of my work. In addition, my colleague Dr. Linda Isaacs and I recently published our first book in a projected series, The Trophoblast and the Origins of Cancer, that discusses in some detail the scientific support for our treatment approach. You can learn more about my background and therapy at our website: www.dr-gonzalez.com.

In our New York practice, we are currently treating hundreds of patients diagnosed with terrible advanced cancer for whom no conventional options exist. Many are successfully battling their disease with our regimen of diet, nutritional supplements, and proteolytic enzymes – which are currently available legally as over-the-counter items. We use only high-quality products, manufactured to my stringent specifications.

Though I suspect that you and your staff created this new bill with the good intention of protecting the public, as I read information about the bill, it appears to give the Food and Drug Administration (FDA) near-dictatorial control over the manufacture and availability of supplements, allow them at their own arbitrary discretion to remove legitimate nutritional supplements from the marketplace, file complaints against particular legitimate supplements at their whim, and impose drug-testing standards on each supplement. Testing of a single product to meet FDA standards for marketing of a new drug alone can cost hundreds of millions of dollars. No supplement company to my knowledge has the resources to fight or meet such regulatory impositions. As an end result, ethical supplement companies as they currently exist would, again if I read the bill correctly, be forced to shut down.

I have read that you are motivated by recent scandals involving the doping of athletes with illegal steroids, certainly a terrible tragedy, and have been approached by various professional athletic organizations such as Major League Baseball. I believe that these organizations are trying to shift blame from their athletes to the supplement industry. Regardless, the FDA already possesses power to investigate and punish companies marketing and selling steroids improperly – the issue at stake here – and requires no additional authority to do so. It certainly does not now need added control over properly manufactured and properly marketed supplements or food substances and the companies that provide these products, in order to regulate illicit steroid spiking.

 I suppose that, on the surface, the bill sounds innocent enough, requiring manufacturers to provide the FDA with ingredients, etc. But current Good Manufacturing regulations to my understanding already require that supplement companies provide proof of ingredients and quality. This proposed bill, whatever your stated goal, appears to play into the FDA's long-standing animus against the supplement industry at large, which to date has some protection from capricious regulatory harassment under the Dietary Supplement Health and Education Act (DSHEA). I believe, based on years of study, that such FDA antagonism even against ethically manufactured supplements stems from its close working relationship with the drug company giants. Like the FDA, the drug industry has sought for years to have supplements removed from the over-the-counter marketplace and transformed into prescription drugs that they alone could control and market and for which they could charge enormous prices, as is the case with any other drug. You seem to have played right into this effort.

In your press conference, you alluded to expected opposition to your bill from the supplement industry. I suspect that such opposition will be small compared with the opposition of the American public at large. In past decades, as the FDA, working with the drug industry, tried to gain complete control over the supplement industry, repeatedly the American people have fought back in vigorous campaigns, in true American fashion expressing their opinions to their elected officials in Washington. But the regulatory agencies in Washington never give up their dream of removing most if not all supplements from the free marketplace and turning them into restricted and expensive drugs, all to the benefit of the pharmaceutical industry and to the ultimate detriment of the public.

Ethically manufactured nutritional supplements when used appropriately are extraordinarily safe with considerable health benefits. We see this in our own practice daily, even with the most advanced, deadly of diseases. Furthermore, nutrients – again when manufactured and used appropriately – have in my long experience none of the terrible side effects of prescription items or even over-the-counter drugs. For example, it is estimated that 10,000 Americans die each year from bleeding resulting from intake of aspirin or over-the-counter anti-inflammatory drugs, yet the FDA does nothing to ban these products, which bring in untold profits to the drug industry. Nor to my knowledge have you ever held a press conference expressing your outrage over thousands of Americans tragically dying from aspirin use each year.

Certainly everyone would agree that an unethical company marketing potent drugs as supplements should be prosecuted to the full extent of the law, but again, the FDA already has such authority. It hardly seems reasonable, as could now be possible should your bill pass, to punish and perhaps even eliminate an entire industry because of a few renegade manufacturers.

Your bill, furthermore, seems to unravel the Dietary Supplement Health and Education Act (DSHEA) that provides protection from regulatory harassment for the many legitimate small supplement companies. In a flurry of misguided efforts to protect consumers, the FDA should not be given what it has long sought, the ability to regulate and control – and eventually, possibly even bankrupt – the supplement industry, all to the benefit of the drug companies. I believe that your bill would allow the FDA to do just that.

I am astonished that without much apparent thought of the consequences, you would consider introducing such legislation. The American people, by and large, want their nutritional supplements, and they want these products freely available without FDA interference. Yes, of course they also want scientifically sound and ethically manufactured products, but the FDA and FTC can already act against improperly marketed supplements and supplements deliberately contaminated with drugs. And a company determined to spike their products will do so whatever the additional regulations imposed.

We do not need yet another power grab in Washington, all intended for our alleged "good," and to help protect us from ourselves. On a more personal note, I will tell you that hundreds of my very sick patients are very distraught about this bill since your press conference announced its introduction, angry that you, of all people, would sponsor legislation that might possibly eliminate their life-sustaining supplements from the marketplace, and essentially condemn them to death – all in the name of consumer protection. The mere possibility of such a turn of events has upset them enormously. I will also tell you that as we learn more about this proposed legislation, however you may position it, my patients are already considering mobilizing to support your opponent in every way possible, financially, as volunteers – even perhaps holding a "sit-in" at your offices for the benefit of the press. That is how seriously they are taking this situation. And let me assure you that these people are not part of some supplement company conspiracy against safe manufacturing practices; they are Americans – many of them, incidentally, veterans – with terrible disease who do not want interference with their treatment choice. I can understand their dismay. Perhaps I am wrong in my interpretation, but if this bill were ever to pass, the repercussions do seem potentially disastrous, in ways far beyond your assurance that this issue is a "no-brainer."

I would be happy to talk to anyone in your staff about the unintended consequences apparent in this bill. As I read the information, in my opinion it appears that ultimately it protects nobody except the drug industry and provides professional athletes with a convenient scapegoat. It certainly would not protect the American public that has over the decades repeatedly shown it wants free access to nutritional supplements without FDA interference. Certainly, it will not protect my patients, who, frankly, did not need to hear of this bill, the thought of which has added enormous stress to their lives as they daily fight their life-and-death battles.

Sincerely,

Nicholas J. Gonzalez, MD