Efficacy of antioxidants
Antioxidants neutralize harmful chemicals called free radicals that occur in the body and constantly arise from fatty foods, smoking, alcohol, environmental pollutants, toxins, carcinogens, iron, smog, and radiation. Free radicals attack vital cell structures and cause damage contributing to the development of certain disease (i.e., cancer, cardiovascular, arthritis, cataracts).

Antioxidants protect normal cells and other tissues by fighting free radicals and the oxidative reaction that is caused by free radicals. Antioxidant nutrients include beta-carotene, vitamins C and E, selenium, copper, zinc, bioflavonoids, and cysteine. There are now more than 200 studies that shown antioxidants can help decrease the risk of developing cancer.

One of the most recent investigations took place in Linxian, China. Researchers from the Cancer Institute of the Chinese Academy of Medical Sciences teamed up with researchers at the United States National Cancer Institute and studied nearly 30,000 adults, randomized over a five-year period into four different groups receiving different nutrients during that period. Here is a brief summary of the study:

• It was the first large-scale intervention trial in a prospective randomized fashion to demonstrate that three antioxidant nutrients together-beta-carotene, vitamin E, and selenium-significantly reduced total mortality (9%) especially from all cancers (13%) and particularly stomach cancer (21%).
• These antioxidant nutrients also prevented the risk of cancer in humans.
• These antioxidant nutrients substantially reduced the prevalence of cataracts in the oldest patients (aged 65 to 74 years).
• These antioxidant nutrients also reduced the mortality from stroke. Many other studies demonstrated similar findings, including the Finland Study, the Switzerland Study, the Hawaiian Study, and studies involving people at high risk for developing endometrial cancer, breast cancer, cervical cancer, small cell lung cancer, oral pharyngeal cancer, and others. All studies show that protection is conferred to those who consume antioxidants and other nutrients.

Studies of pre-cancerous conditions
Scores of studies, from all over the world, have shown that antioxidants can decrease the risk of pre-cancerous lesions from developing into a full-blown cancer.

The Linxian, China study investigated 3,300 patients with esophageal dysplasia which is a precursor to developing esophageal cancer. The same team of researchers from China and the United States examined the results of the study, which was an intervention study, the best type of clinical design. The group that received the multiple vitamin-mineral supplement daily for six years had:

• lower mortality from esophageal and upper stomach cancers (8%)
• lower mortality rate in general (7%)
• lower rate of death from cancer in any site (4%)
• lower risk of dying of a stroke (38%)

While the duration of this trial was very short (six years) and the doses of the nutrients were far too low compared to other trials, the patients who took the supplements had much better results than the control group of patients who took no supplements. Other studies show that people who have colon polyps, abnormal cervical Pap smears, or other pre-cancerous conditions, all do better and can reverse the trend toward a cancer if they take certain antioxidants and other nutrients.

But what about beta-carotene specifically? There have been reports from the CARET and ATBC studies that beta-carotene increased the incidence of lung cancer in heavin heavy smokers who drank alcohol and were exposed to asbestos. I want to address this issue with the following thoughts:

• Over 200 studies have demonstrated that beta-carotene is safe and can lower the risk of developing cancer and cardiovascular disease.
• All intervention studies show that beta-carotene and other nutrients can decrease cancer rates and cancer progression.
• A total of 22 epidemiological studies that included 400,000 smokers and nonsmokers have shown those who had a high blood level of beta-carotene had a lower incidence and mortality of lung cancer. None of these studies reported any association with an increased incidence of lung cancer. In fact, the reduction in risk was even more pronounced in smokers than in nonsmokers.
• The principal investigator has publicly said that the findings are too preliminary to discuss and the data were not statistically significant.
• The smokers in these studies who had high beta carotene serum levels at the start of the study had the lowest incidence of lung cancer.
• Most of the study participants were alcoholics, and all of them ate a high fat diet – both risk factors dramatically and independently increase the risk of developing cancer..
• beta carotene did not increase the risk of lung cancer for those who smoked less than 20 cigarettes a day and drank little or no alcohol.
• To my knowledge, no information was gathered concerning other lifestyle risk factors that also would contribute to a poor outcome.
• Beta-carotene works most efficiently at the early stages of carcinogenesis, not at the later stages when a cancer is already formed – as was the case with the patients in the CARET and ATBC studies. Cancers are started between 10 and 20 years before symptoms occur or our technology can detect them.

The fact remains, beta-carotene:

• is the most powerful antioxidant.
• neutralizes singlet oxygen, a powerfully damaging chemical.
• enhances immune system function.
• is very safe and nontoxic.

It is important to rely on the synergism of all the antioxidants, including the carotenoids, and also the B’s, etc., as well as lifestyle changes to decrease one’s risk of cancer and heart disease. it is foolish to expect that a single nutrient can give the “green light” to continue lifestyle behavior that will cause disease.

Conclusion
Nutrition and lifestyle factors can profoundly reduce toxic side effects and improve the results of conventional treatments. In a recent study of 50 patients with early stage breast cancer, I evaluated the treatment side effects of radiation alone, or radiation combined with chemotherapy, while the patient took therapeutic doses of nutrients. Patients also followed the Simone Ten Point Plan (see Table 1). The patients were asked to evaluate their own response to the treatment in terms of impacts of treatment on their quality of life. The major rationale behind our nutritional plan is that it contains a well-rounded supply of antioxidants and immune enhancing nutrients. The results of the study were impressive:

• More than 90% of both groups noted improvement in their physical symptoms, cognitive ability, performance, sexual dysfunction, general well-being, and life satisfaction.
• Not one subject in either group reported a worsening of symptoms. Patients who follow the Ten Point Plan and use certain vitamins andminerals report few side effects from chemotherapy and radiation therapy. Twenty studies with more than 2,700 patients that investigated lifestyle modification that includes dietary changes, nutrient supplementation, and other lifestyle changes demonstrated a lower recurrence rate and an increase in survival. The patients in these studies had the following cancers: breast, ovarian, cervical, uterine, head and neck, lung, pancreatic, prostate, and bladder.

Cancer patients should modify their lifestyles using the Ten Point Plan, which includes modifying nutritional factors and taking certain vitamins and minerals, especially if they are receiving chemotherapy and/or radiation. The studies indicate that it is important to take the correct nutrients to reduce side effects, enhance conventional therapies, and increase outcomes (table 2).

Table 1
The Simone Ten Point Plan:

1. NUTRITION. Maintain an ideal weight-lose even 5 or 7 pounds if needed. Follow a low-fat (about 20%), high-fiber (25 gm) diet. Take specific nutrients (see table 2). Eliminate salt, food additives and preservatives, and caffeine.
2. TOBACCO. Do not smoke, chew, snuff, or inhale other's smoke.
3. ALCOHOL. Avoid alcohol.
4. RADIATION. Avoid unnecessary X-rays and use sunscreens when in the sun. Avoid electromagnetic fields.
5. ENVIRONMENT. Keep air, water, and work place clean.
6. HORMONES/DRUGS. Avoid all estrogens and unnecessary drugs.
7. KNOW THE SEVEN WARNING SIGNS OF CANCER. Lump in breast, non-healing sore, change in wart/mole, change in bowel or bladder habits, persistent cough or hoarseness, indigestion or trouble swallowing, unusual bleeding.
8. EXERCISE.
9. STRESS MODIFICATION, SPIRITUALITY, AND SEXUALITY.
10. HAVE AN EXECUTIVE PHYSICAL ANNUALLY.

Table 2
Dr. Simone's recommended nutrients/dosages:

• Beta carotene = 20 to 30 mg per day
• Lutein = 10 TO 25 mcg per day
• Lycopene = 10 TO 25 mcg per day
• Vitamin E = 400 to 600 IU per day
• Vitamin C = 350 to 6,000 mg per day
• Bioflavonoids = 10 to 20 mg per day
• Selenium = 200 to 300 mcg per day
• Zinc = 15 to 20 mg per day
• Copper = 3 to 5 mg per day
• Cysteine = 20 to 500 mg per day
• Vitamin A = 5,000 to 7,500 IU per day
• Vitamin D = 400 to 600 IU per day
• Vitamin B1 = 10 mg per day
• Vitamin B2 = 10 mg per day
• Vitamin B6 = 10 mg per day
• Vitamin B12 = 18 mcg per day
• Niacinamide = 40 mg per day
• Biotin = 150 mcg per day
• Pantothenic acid = 20 mg per day
• Folic acid = 400 mcg per day
• Iodine = 150 mcg per day
• Chromium = 125 mcg per day

FDA’s REVIEW PROCESS STRUCK DOWN
Princeton, NJ – Charles B. Simone, M.D., a medical oncologist, immunologist and radiation oncologist at the Simone Protective Cancer Institute, continues to be a leader in health care matters and Food and Drug Administration reform. In 1993 he was called upon to write the language that led to the compromise in the US Senate and finally the House ensuring that all Americans have free access to food supplements – the Dietary Supplement, Health and Education Act of 1994 (DSHEA).

Wins Landmark Case Against FDA

Charles B. Simone, M.D. was again called upon to help Emord and Associates win a landmark case against the Food and Drug Administration. On January 15, 1999, the United States Court of Appeals for the D.C. Circuit ruled as invalid the FDA's interpretation of the term "significant scientific agreement" for pre-screening nutrient-disease relationship claims of nutritional supplements - [Pearson v Shalala]. The Court found that the FDA’s interpretation of the term "significant scientific agreement" has been "arbitrary and capricious" and "in violation of the Administrative Procedure Act."

FDA Violates First and Fifth Amendments

The Court also held that FDA's four sub-regulations [21 C.F.R. § 101.71(a), (c), (e); and § 101.79(c)(2)(i)(G)] as invalid and in violation of the First and Fifth Amendments to the United States Constitution. The First, because producers of dietary supplements are assertedly subject to a ‘prior restraint’ on their protected speech the labeling of products. The Fifth, because the agency’s approach is so vague as to deprive the producers of liberty (and property) without due process.

The U S Court of Appeals further stated: "It simply will not do for a government agency to declare - without explanation - that a proposed course of private action is not approved. The agency must articulate a satisfactory explanation for its action. To refuse to define the criteria it is applying is equivalent to simply saying no without explanation. Accordingly, on remand, the FDA must explain what it means by ‘significant scientific agreement’ or, at minimum, what it does not mean."

Do we always need to tell patients the truth?
Charles B. Simone, M.D., Nicole L. Simone, B.S.E.,
Charles B. Simone, II Lancet. 1998; 352: 1787.

Hassn and Hassan wrote their opinion that "the wish of patients to know the whole truth about their illness does not mean that it is right for them... on the contrary, it harms many of them"(1). However, a survey found that 96 percent of Americans wanted to be told if they had cancer and 85 percent wanted to know how long they would live if their cancer usually led to death in less than a year (2).

Moreover, a legal case involving ethical informed consent (Arato v. Avedon [3]) asked whether the law should force physicians to report statistical life expectancy information to patients. Mr. Arato had pancreas cancer that was treated surgically, then with experimental chemotherapy and radiation because there "is no effective treatment." The surgeon and oncologist never told Mr. Arato and his wife that only 5 percent survive for 5 years, nor did they give a prognosis or estimate of his life expectancy, nor were they asked. A recurrence occurred and the physicians knew he would die within a few months, but did not tell the patient about life expectancy. The patient died and his wife sued the physicians claiming that the doctors were obligated under California’s informed consent law to tell the patient about survival figures before asking him to consent to chemotherapy. The court decided Mr. Arato should have been informed. The physicians said if the patient knew of the high mortality rate, he would have no hope. And during the 70 visits, the patient did not ask questions about his life expectancy indicating to the physicians that he did not want to know. The patient’s wife said had the patient known the facts, he would have declined all treatment and attended to his business affairs. His wife incurred tax losses due to poor business planning.

The lower court favored the physicians. The appeal court reversed the decision. The California Supreme Court upheld the decision in favor of the wife because of the doctrine of informed consent based on four tenets:

1. Patients are generally ignorant of medicine.
2. Patients have a right to control their own bodies and thus to decide about medical treatment.
3. To be effective, consent to medical treatment must be informed.
4. Patients are dependent upon their physicians for truthful information and must trust them (making the doctor-patient relationship a "fiduciary" or trust relationship rather that an arm’s length business relationship).