September 13, 1995 intelisoft multimedia, INC. Owen R. Fonorow 2880 Sun Valley Road Lisle, IL 60532 The Honorable Dr. David A. Kessler, M.D. Commissioner of Food and Drugs United States Federal Food and Drug Administration Rockville, MD 20857 Dear Dr. Kessler:
It is my impression after watching you on television recently that you are a dedicated public servant, a capable leader, and a man of integrity. I would like to bring a very important scientific development to your attention.
You are aware that the two most commonly used cardiac medical procedures, i.e., Coronary By-Pass Graph (operations) and Angioplasty, are inherently dangerous procedures with high recurrence rates. For example, the re occlusion rate for Angioplasty is 25% - 45%. You must also be aware that neither procedure was "proven" by clinical trial before coming into widespread use. This is understandable with heart disease as the number one cause of premature death in this country, and is not to imply that these procedures have not prolonged lives.
A very important recent scientific discovery holds the promise of being an extremely safe method for reversing occlusive heart disease. Scientists have apparently pin-pointed a peculiar form of LDL (bad) cholesterol and are now calling it the leading cause of heart disease. Although not well publicized, this strange form of LDL is called lipoprotein(a) or Lp(a) in the medical literature. Lipoprotein(a) is an LDL particle with an additional adhesive (apo) protein wrapped around it.
According to heart disease researcher Dr. Matthias Rath, M.D.:
"High cholesterol, specifically LDL (bad) cholesterol, is not the cause of cardiovascular disease. The newest research tells us that lipoprotein-(a) will cause cardiovascular disease ten times more likely than high LDL (bad) cholesterol. This fact was revealed during a recent revaluation of the Framingham Heart Study, the largest cardiovascular risk factor study ever conducted. Today lipoprotein-(a) has been confirmed as the leading risk factor for many forms of cardiovascular disease."
This is exciting, but only one half the story. Even more interesting is the work of the late Nobel prize winning scientist Linus C. Pauling. Based on the lipoprotein(a) discoveries, Dr. Pauling developed a "unified theory" of occlusive cardiovascular disease. From this work of several years ago, he postulated that a "drug free" treatment for the condition could be devised. This treatment is based on Nobel prize winning discoveries in medicine, i.e., the knowledge of the "cholesterol binding" mechanism. Clinical studies have shown the new therapy prevents Lp(a) from adhering to the walls of blood vessels and forming plaque "in vivo".
Linus Pauling's "drug free" therapy was first tried by a retired member of the National Institute of Health suffering advanced heart disease; a world renowned biochemist, member of the National Academy of Sciences, and National Medal of Science winner. Dr. Pauling reported: "His condition cleared as if by miracle." This therapy is now in use in clinics in the United States.
Linus Pauling became convinced that this thorough understanding and new treatment of cardiovascular disease would prevent the condition and save many lives. When Pauling and Rath were able to demonstrate that plaque build-up could be dissolved "in vivo" they were awarded U. S. patent 5,278,189. In response to a reporter's question as to whether or not "the new [recommended therapy] can really reverse the atherosclerotic process?", Dr. Pauling replied:
"I think so. Yes. Now I’ve got to the point where I think we can get almost complete control of cardiovascular disease, heart attacks and strokes by the proper use of [the recommended therapy]. It can prevent cardiovascular disease and even cure it. If you are at risk of heart disease, or if there is a history of heart disease in your family, if your father or other members of the family died of a heart attack or stroke or whatever, or if you have a mild heart attack yourself then you had better be taking [the recommended therapy]"
Dr. Kessler, I submit that we now have within our grasp a $200/year therapy for occlusive cardiovascular disease composed of essential amino acids and vitamins that, when applied in therapeutic amounts, can prevent Lp(a) build-up. More importantly, this new therapy seems to be able to reverse Lp(a) build-up. Naturally, all thinking persons would welcome significant clinical studies in human beings that support this claim, but like Coronary By-Pass and Angioplasty before it, what justification can there be for depriving people of this inherently 'safe' therapy, based on solid theory, while waiting for more "proof" than already exists? (A serious question is: why haven't there been more studies since 1987 when this discovery was first made?)
Other than perhaps Dr. Matthias Rath, there are very few experts in lipoprotein(a) or this new therapy. As with any new and important discovery that promises to revolutionize the field of medicine, their will be honest people who oppose it. However in this case, I have personally brought the lipoprotein(a) developments to the attention of top scientists at our best universities throughout the country, many via the internet, others by U. S. mail. I do not know any of these ladies or gentlemen personally. Not one has written to me disputing the facts, or even expressing their opposition. (All reservations are with the apparent lack of controlled trials.)
I have included two supporting letters. One, from distinguished professor Varro Tyler of Purdue University. Professor Tyler states that after reading the Pauling/Rath patent on reversing heart disease: "it appears there is a theoretical basis for treatment of [heart disease] with ascorbate and substances that inhibit lipoprotein(a) binding." Dr. Wayne B. Jonas, Director of the Office of Alternative Medicine, National Institute of Health, is also well aware of the recent developments regarding lipoprotein(a).
Furthermore, according to Dr. Rath, "Vitamins belong to the most powerful agents in the fight against heart disease. This fact has been established by studies on thousands of people over many years. Here are some important results of recent clinical studies:
No prescription drug has ever been shown to help prevent heart disease similar to [vitamins A, C and E]. These results and those of countless other studies are so clear that anybody questioning the value of vitamins in the prevention of heart disease can safely be considered uninformed."
Dr. Kessler, I believe this serious development requires your personal attention. I would very much appreciate a personal response from the commissioner. Not only is the new therapy inherently safer than the CABG or Angioplasty alternatives, but it is affordable. No longer will heart treatments be restricted to persons of means or those with comprehensive health insurance.
Some would say that the FDA feigns interest in protecting the public, but in reality protects the vested interests of organized medicine and the pharmaceutical industry. Here is the perfect opportunity to silence such cynical critics forever. The FDA has every reason to endorse and support this new therapy -- over the risky alternatives. This would be a dramatic demonstration that the FDA places the public interest first.
In review:
We are entering a new era in health. I implore you sir, please do not let silly bureaucracy and ill advised policy stand in the way of recognizing the value in this wonderful new approach to heart disease. The public needs to hear about this. What better way than for the FDA to bring it to their attention!
Dr. Kessler, If you would like a copy of the video tape, in which Dr. Pauling speaks informally regarding the lipoprotein(a) discovery and therapy, I would be happy to supply you with one at our cost. It is hoped that you will find the Pauling/Rath lipoprotein(a) discoveries warrants further investigation. I look forward to hearing from you. I hope you will make me proud that my country has a Federal Food and Drug Administration.
Sincerely,
Owen R. Fonorow President Cc: President Clinton Senator Carol Mosley-Braun Senator Paul Simon Representative Harris Falwell Tom Brokaw, NBC Peter Jennings, ABC Dan Rather, CBS Larry King, CNNBack to Intelisoft Multimedia, Home Page