Dr. Kessler decried the variety of health claims being made for evening primrose oil. He is perhaps unaware of the hundreds of studies in the literature supporting most of those uses. It is not surprising that a physician would be skeptical of something that seems to help so many illnesses. But it is a mistake to be blinded by skepticism from seeing the scientific evidence. Because GLA [from evening primrose and other oils] is a precursor to regulatory substances known as "prostaglandins," it has wide-ranging metabolic effects. It does help to lower blood pressure, reduce or cure atopic dermatitis, relieve PMS, reduce cholesterol and inflammation and help asthmatics and allergic patients. These are the many effects of the prostaglandins that are made from this important fatty acid. It is therefore not "incredible" to someone who bothers to look up the scientific documentation and who understands the metabolic rationale.
I want to reaffirm that these claims were not on the labels of these products, but they are in the medical literature. Also, I have observed in my practice the above-stated clinical effects, and have reviewed many of the studies substantiating some of the claims that the FDA agents heard from health food store clerks. The FDA should be doing everything in its power to disseminate this information and encouraging manufacturers to disseminate it also, as long as it is in the medical literature and not misleading. Instead, they are an obstacle to information exchange and are themselves misleading. This can only be changed if the FDA stops confusing its role of regulating real danger and fraud with the role of being the arbiter and promoter of truth as they see it. Passage of S. 784 will ensure a more sane approach to regulation, availability of dietary supplements and truthful health claims.
When Dr. Kessler says that they "plan to take no products off the market," that is a dramatic shift from what they have proposed in all their written material until now. With such waffling, confusion and misleading testimony, the FDA cannot be expected to take an honest and human approach to regulating such an important component of our health care.
I have read Dr. Linus Pauling's letter addressed to the committee supporting the Dietary Supplements Act. I hope it is included in the record because it is an eloquent statement that combines common sense, science, reason and compassion.
Linus Pauling's Testimony
Linus Pauling, the only person ever to have won two unshared Nobel prizes, died in 1994 at the age of 93. He pursued his research and directed the Linus Pauling Institute of Science and Medicine until shortly before his death from prostate cancer. He partially credited his long life (his parents had both died quite young) to his large doses of vitamin C (18 g per day) and other dietary supplements.
Here is the text of Linus Pauling's letter to the Senate committee, reprinted with permission of his family:
I am deeply concerned with the current state of affairs revolving around the issue of dietary supplements and related substances. The overwhelming body of evidence in the official medical and scientific indices regarding the efficacy and safety of vitamins, minerals, enzymes, amino acids, herbs, and other nutritionally related substances is obviously being ignored or, at best, misinterpreted to suit the special interests of a medical and political contingency. The volumes of respected historical data and conclusive current research in regard to these substances and their value in healthcare far outweigh single isolated instances of contamination, not to mention clinically and statistically unsubstantiated claims of toxicity. The manipulation of empirical credibility by political or economic egos is not to be tolerated or exonerated.
As a scientist, chemist, physicist, crystallographer, molecular biologist, and medical researcher, I have spent a lifetime in pursuit of expert knowledge. This issue involving the definition, regulation, and censorship of dietary supplements and associated information goes far beyond this hearing. It touches upon the very fiber of our human and constitutional rights. It mandates monopolization of the healthcare industry by creating an economic premise that will eventually eliminate those unable to meet its unrealistic requirements. These demands would require millions of dollars in research and excessive time constraints to prove the safety of substances already historically and statistically within considerable safety margins.
In the scientific and medical comunities, among those of reputable and significant knowledge, the votes have already been cast in favor of nontoxic therapies that are effective and affordable. This issue of agency determination of definitions and regulations overrides the individual's freedom of choice in healthcare, and inhibits free access to vitamin information that better enables a person to make an informed intelligent decision regarding services that could be of significant value in the prevention and treatment of disease, making it mandatory that they be made available only as "drugs," and under the jurisdiction therefore of the medical community. This ultimately enslaves a population to becoming chemically, psychologically, and economically dependent, rather than being actively responsible for its own well being. Billions of dollars and millions of lives are at risk of being jeopardized in this ruthless campaign to subjugate the health industry to being puppets of a legislated system of lobbying efforts.
It is imperative to maintain the highest quality of purity, safety, and performance in regard to consumer products and services. However, the subversive actions of raids at gunpoint, confiscation of patients' records and personal property, and warrantless censorship and banning of information and substances that are statistically proven to be of benefit are blatant violations of human and constitutional rights. As a scientist, I am appalled at the audacity of those challenging these rights; as a citizen, I am compelled to voice my indignation at being considered incapable of being in charge of my own health. The medical community needs to become a partner, not a dictator, in the healthcare system.
Over a quarter of a century ago, I became interested in nutrient compounds and their effects on human health. The old professors of nutrition who helped to develop the science of nutrition seemed complacent with their accomplishments and ignored the new discoveries that were being made in medicine, biochemistry, and molecular biology. They continued to teach their students the old ideas, many of them incomplete or incorrect, resulting in principles and practices that have denied the public proper access to new concepts and therapies.
Physicians themselves, though dedicated and intelligent, are virtually untrained in the area of nutritional science and metabolic therapy, other than conventional drug modalities and allopathic procedures. If there is to be a concerted effort to regulate and eliminate toxic substances, it would serve the issue far better to address the abuse of drugs and treatment procedures that are the cause of hundreds of thousands of medical catastrophies and deaths per year, which could possibly be avoided by improving medical education of the physicians and the public as to nutritional alternatives in healthcare maintenance.
At this hearing, I urge you to consider seriously the ramifications of crippling the full disclosure of information to the public regarding health research, and the unnecessary regulations and improper definitions of dietary supplements as drugs. This implies a direct infringemement of medical freedom of choice and the First Amendment, freedom of speech, allowing for a dangerous precedent of censorship that could generate epidemic problems not only in human health but human values. The Constitution of the World Health Organization, as mandated in conformity with the Charter of the United Nations, of which the United States is a signatory, states:
"Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. The enjoyment of the highest standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition. The health of all peoples is fundamental to the attainment of peace and security and is dependent upon the fullest cooperation of individuals and states. The extension to all peoples of the benefits of medical, psychological and related knowledge is essential to the fullest attainment of health. Informed opinion and active cooperation on the part of the public are of the utmost importance in the improvement of the health of the people." (Geneva, 1976)
This hearing is paramount to the determination of the Dietary Supplements Act, S-784. I submit to you the history-making moment that we are facing. As representatives of the people, consider not only the medical and scientific implications, but the humanity of your decisions. We are on the threshold of a new paradigm. The future of our self-determination as humankind depends upon our right to life and to live in freedom. Herophiles in 300 BC stated: "When Health is absent, Wisdom cannot reveal itself, Art cannot become manifest, Strength cannot be exerted, Wealth is useless, and Reason is powerless."
I trust that your reason will surpass the rhetoric, and that your wisdom will reveal the truth in support of the Dietary Supplements Act.
Unfortunately, in spite of the ultimate passage of a watered down version of the Dietary Supplement Health and Education Act, there are still political, behind-the-scenes maneuverings that make it unclear what will happen with regulation and oversight of dietary supplements by the FDA. The FDA officials and lawyers have been working tirelessly to "interpret" the language of the bill to try to maintain their inappropriate restriction on availability of supplements and on access to information about them.
If you want to help ensure the continued availability of dietary supplements and your access to information about them, you can contact your representatives in Washington and let them know you want their support for this. You can also support several organizations that, as of 1995, are working toward passage of a revision of the dietary supplement bill. This will surely still be an issue for the next few years. One of these organizations is the American Preventive Medical Association (see Appendix 2, "Resources"), which is working toward more health freedom in many ways.
Health Endangered In Canada
North of the border, dietary supplement consumers face similar problems to those in the US. And their regulations may be even worse. In 1995, the Canadian parliament has been considering a bill (C-7) which would make it difficult to find any over-the-counter dietary supplements. Because they have an effect on states of health, it is being proposed that access to supplements and information about them be restricted.
The Bill C-7 would technically criminalize anyone who sold any herbal remedy or natural supplement with stimulant or relaxant properties. Tryptophan is already a prescription drug in Canada, and its price has risen dramatically since losing its over-the-counter status. (At least it is available, unlike in the US.)
Other substances that are harmful to health are being specifically exempted from coverage by this bill. Thus, Canadians may be in the ridiculous position of being able to buy nicotine, alcohol and caffeine freely but not large doses of vitamin C or vitamin E. It can hardly be argued that the main goal of this bill is to protect public health. There is also an exemption for prescription drugs, which are at least 2500 times more dangerous than dietary supplements. There are Canadian associations that are working against this bill.