[In a letter posted in the Health Sentinel on February 8, 2010, Nicholas J. Gonzalez, M.D., wrote to Sen. John McCain, R-Ariz., co-sponsor of the Dietary Supplement Safety Act of 2010. The following is an abridged form of Gonzalez’ letter.]

Dear Senator McCain:

Though I am a resident of New York, not Arizona, I suggest that someone on 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 that you would want their deaths on your conscience.

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 that the Party, including you, had strayed significantly from its mission of limited government, deficit reduction and, ultimately, protection of individual liberty.

A former journalist (Time Inc.), I am currently a physician and cancer researcher. I was educated at three Ivy League schools (Brown undergraduate, Columbia post grad, Cornell for medical school) and finished a fellowship in cancer immunology under Robert A. Good, for ten years president of Sloan-Kettering. Under Dr. Good’s direction, 29 years ago I began researching the use of diet, nutrients and proteolytic enzymes against advanced cancer.

Though some consider my work “alternative,” and although in the past I have 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-Ind., has long been a vocal supporter; and I have met with Sen. Tom Harkin, D-Iowa, at his invitation, to discuss this treatment. My research was featured in a lengthy profile published in The New Yorker magazine (Feb. 5, 2001) and more recently in the actress Suzanne Somers’ best-selling book Knockout about innovative new approaches to cancer. My colleague Dr. Linda Isaacs and I recently published the first book in a projected series, The Trophoblast and the Origins of Cancer, which 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

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

Though I suspect you and your staff created this new bill with the intention of protecting the public, as I read information about the bill, it appears to give the FDA near-dictatorial control over the manufacture and availability of supplements, allow it at its own discretion to remove legitimate nutritional supplements from the marketplace, file arbitrary complaints against legitimate supplements and impose drug-testing standards on each supplement. Testing of a single product to meet FDA standards for marketing of a new drug can cost hundreds of millions of dollars. To my knowledge, no supplement company has the resources to fight or meet such regulatory impositions. As a result, ethical supplement companies 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 these organizations are trying to shift blame from their athletes to the supplement industry. Regardless, the FDA already possesses the power to investigate and punish companies marketing and selling steroids improperly. It certainly does not 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. 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.

On the surface, your bill sounds innocent enough, requiring manufacturers to provide the FDA with ingredients, etc. But current Good Manufacturing regulations already require supplement companies to provide proof of ingredients and quality. This proposed bill, whatever your stated goal, appears to play into the FDA’s longstanding animus against the supplement industry at large, which to date — under the Dietary Supplement Health and Education Act (DSHEA) — has had some protection from capricious regulatory harassment. Based on years of study, I believe that the FDA’s 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, which it alone could control and market and for which it could charge enormous prices. 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 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, the American people have repeatedly fought back in vigorous campaigns, 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 and provide considerable health benefits. We see this daily in our own practice, 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.

On a personal note, I will tell you that since your press conference announcing the introduction of your bill, hundreds of my very sick patients have been very distraught, 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 these people are not part of some supplement company conspiracy against safe manufacturing practices: They are Americans with terrible diseases, many of them veterans, 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 on your staff about the unintended consequences apparent in this bill. As I read the information, 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 repeatedly shown over the decades that 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 daily lives as they fight their life-and-death battles.

Sincerely,

Nicholas J. Gonzalez, M.D.

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