Stephen T. Sinatra, M.D., F.A.C.C., C.N.S., C.B.T., speaks at a recent American Association of Anti-Aging Medicine International Congress about taking an integrative approach to degenerative disease, including cardiovascular disease and cancer. He speaks on his personal and professional use of Poly-MVA, sharing cases of patients with heart disease and cancer and the integration of Poly-MVA and CoQ10 into his treatments.

Board Certified Oncologist, Dr. James W. Forsythe M.D., H.M.D., at the Cancer Screening & Treatment Center of Nevada, has recently completed an outcome-based investigation on various (18 types) Stage IV Cancers with 212 patients over a 3-year period, observing a 56 % overall positive response rate with palladium lipoic complex (available as the dietary supplement Poly-MVA). Dr. Forsythe found that Poly-MVA appears to be a safe and effective natural food supplement for palliative assistance in Stage IV cancer patients either with or without concomitant chemotherapy. The safety profile for palladium lipoic complex is excellent and there were no treatment related deaths or any significant adverse reactions or negative interactions with chemotherapy or hormonal treatments.

Dr. Forsythe is Board Certified in Internal Medicine, Medical Oncology and Homeopathy. He has been a pioneer in integrative therapies and wellness medicine for more than thirty years. His Century Wellness Clinic and Cancer Screening and Treatment Center of Nevada have drawn thousands of patients from all over the world and have also turned Forsythe into an educator in his own profession.

Dr. Forsythe was recently vindicated in a 30-month investigation by the FDA into his use of integrative therapies. Not only was justice served, but for the first time in the history of the FDA a doctor in private practice has been asked to work with the FDA on integrative and alternative treatments.

Poly-MVA is a promising new, non-toxic dietary supplement that may assist in boosting immune response, and healing damaged cells. It is a uniquely formulated nutritional supplement containing a proprietary blend of Palladium and Alpha Lipoic Acid, Vitamins B1, B2 and B12, Formylmethionine, Acetyl Cystiene, and trace amounts of Molybdinum, Rhodium, and Ruthenium. While definitive studies on it’s effect in human nutrition and health are under way, early studies and anecdotal information indicate that the active ingredients in palladium lipoic complex may be beneficial in protecting cell DNA and RNA, assisting the body produce energy, and provide support to the liver in removing harmful substances from the body. Some studies indicate that ingredients of Poly-MVA can assist in preventing cell damage, and removing heavy metals from the bloodstream. As a powerful antioxidant, it can help to neutralize the free radicals within the body that are thought to influence the aging processes and convert them into energy. Other ingredients are involved in DNA synthesis, production of the myelin sheath that protects nerves, and red blood cell production, and playing an important role in immune and nerve function.

What makes Poly-MVA unique is the special, proprietary manufacturing process by which Lipoic Acid is bonded to Palladium. No other company produces any product similar to Poly-MVA because of the patented preparation and bonding process through which LAPd is manufactured. The proprietary formulation of LAPd with other vitamins, minerals, and amino acids provides considerable nutritional support, helping to enable optimum functioning of essential body systems.

Shari Lieberman, Ph.D., C.N.S., F.A.C.N.,
and James W. Forsythe, M.D., H.M.D.

According to The Prostate Cancer Institute in (Eden Prairie, MN) (1) an organization that maintains one of the leading websites on prostate cancer information and treatment, this disease:

• Is the single most common form of solid tumor in humans
• Is newly diagnosed every 2.6 minutes
• Is present in more than 9 million men
• Kills 1 man every 13 minutes
• Afflicts 1 in 6 men in their lifetimes
• Is second only to lung cancer in annual cancer deaths of U.S. men
• Is high risk for black men (they have incidence and mortality rates as much as 50 percent higher than other racial or ethnic groups)
• Strikes as many men (and causes almost as many deaths annually) as breast cancer does in women but lacks the national awareness and research funding breast cancer currently has
• Is nearly 100 percent survivable if detected early.

Us TOO Inc. (Downers Grove, Illinois; www.ustoo.com), an independent network of support group chapters for men who have the disease, recommends annual testing for prostate-specific antigen (PSA) and digital rectal examinations for all men 45+years old (and men at greater risk beginning at 40). And, while one can argue the accuracy of at least some of these statements, such as “is nearly 100% survivable if detected early,” any man reading this information would certainly be scared to death or at least scared into immediate treatment.

Cancer, in general, is rarely detected early because we simply do not have the technology to do so and is it generally asymptomatic. And there is little evidence to confirm that early prostate cancer detection will confer “100 percent” survival. This statement can give a false sense of security because it does not include the prognosis of hormone refractory prostate cancer, which is more difficult to treat and has a poorer prognosis. (2)

It is also misleading in that it could be argued that, because most prostate cancers are slow growing (as evidenced in autopsies of older men who did not die from prostate cancer and were untreated) that the progression time evidenced in 10, 12, or 15 years after treatment would be expected if left untreated.

While there are some limitations on the use of serum PSA to monitor patients after treatment for prostate cancer, this agent remains the “gold standard” for conventional treatment. (3)

Bio-chemical failure definitions in patients treated with radiation therapy appear to provide a 6–18 month lead time to clinical failure but there are only limited published data to suggest that early intervention of any type (androgen deprivation, radiation therapy, surgery, etc.) affects survival.

Conventional Treatments

What are men being told about the available treatments? A good deal of the information on the Prostate Cancer Institute’s website represents the conventional approach.

According to The Prostate Cancer Institute’s article on treatments, radical prostatectomy is said to have a “success rate” of 70–85 percent. (1) However, a very recent review revealed bio-chemical recurrence-free survival rates of 71 percent at 5 years and 63 percent at 7.5 years. (4) So, clearly, the survival rate decreases with years more distant from diagnosis.

What appeared most predictive of biochemical recurrence was a PSA level of > 10 ng/ml and the highest grades on biopsies, positive margins, perineural invasions, and Gleason score. But the side-effects of radical prostatectomy include incontinence (in about 10 percent of cases) and impotence in 79.6 percent of men reported at 2 years after the procedure. The Institute also reports that laparoscopic prostatectomy that is “less invasive” but still carries the risks of incontinence and impotence associated with the radical procedure. (1)

Watchful waiting is described on the Institute’s website (1) as the option for “a man who has chosen not to have immediate prostate cancer treatment. During the watchful waiting period, the physician keeps the cancer under close watch.” However, watchful waiting is appropriate for men who meet one or more of these criteria: short life expectancy; significant other illnesses; small tumors; low Gleason score; and low PSA level.

The article on the site goes on to say that “the major risk of watchful waiting is that without treatment, cancers can grow and spread quickly (metastatic cancer) so the cancer may escape the prostate capsule between doctor visits.” Finally, this section of the article concludes: “Even slow-growing tumors may suddenly become rapidly growing tumors if left untreated.” This message is clear treat the prostate cancer early regardless of the side-effects of treatment.

The site also describes cryotherapy for prostate cancer eradication. (1) This procedure was noted as conferring a major risk for impotence but the data show that 97.6 percent of patients are still cancer-free at 12 months.

There is also a section on the site on hormonal therapy that describes surgical castration, luteinizing hormone-releasing hormone therapy, and combined androgen blockage. (1) All three types of therapy can cause the following side-effects: impotence; loss of sexual desire; hot flashes; weight gain; fatigue; reduced brain function; and loss of muscle mass.
External bean radiation therapy (EBRT) is also described. (1) The article states that “EBRT can be curative if the cancer has not gone beyond the prostate gland.” However, an actual study is quoted on the website that states that, “after 5 years 67% of men with a pre-procedure PSA of 4.1 to 10.0 were still disease free when treated with EBRT alone. To improve success rate EBRT is often used in conjunction with other therapies.” The “other therapies” referred to are often hormonal blockades. Once again, some of the information seems a bit inflated compared to the actual data. The website correctly discloses the potential side-effect: “If the radiation damages nerves that control erections, the patient may lose his ability to get or keep an erection. . . .the probability was about 45 percent.”

Finally, brachytherapy (1) is described as a minimally invasive procedure that implants small radioactive pellets. . . .into the prostate.” And, once again statistics are given: “Long term clinical data supporting the use of brachytherapy has shown that over 87% of men are still free of cancer 10 years after brachytherapy treatment.” However, what is omitted is that high-dose brachytherapy is often combined with EBRT (or hormonal blockade).

A more recent study (5) shows a lower survival rate of 79 percent and suggests using EBRT with brachytherapy. Impotence rates are listed as 6–30 percent on the website but it says that this is the case “although patients receiving brachytherapy often report similar levels of impotence before treatment.” (1) The risk of impotence increases with age; impotence after brachytherapy can often be treated with prescription drugs such as Viagra (Pfizer, New York City).

There does not appear to be any conventional therapy for prostate cancer that does not carry an increased risk of impotence. According to a study on minimizing destruction of vessels that govern erection, (6) what actually causes impotence is radiation to the corpus cavernosum and the internal pudendal artery causing some vessel destruction. This study demonstrated that using coronal, sagittal, and axial magnetic resonance imaging data allows superior definition of the prostate apex so the radiation dose to critical erectile structures can be limited. However, this is rarely if ever done because this approach is costly.

The reasons why prostate cancer treatment is often delayed are fear, anxiety, and depression. I was personally depressed after reading the Institute’s website. (1) Although the website has nurses that one can consult with and an oncologist referral base - and complies with the HON code (Health On the Net Foundation; www.hon.ch/HONcode ) - there is no mention on that site of the hazards and risks associated with any radiation therapy (e.g., a secondary cancer) or the fact that all radiation is cumulative.

Nor was there any link to, or mention of, any alternative or complementary prostate cancer treatment resources on this website although several reports confirm that the prevalence of alternative and complementary medicine use by patients with cancer range from as little as 7 percent to as much as 64 percent. (7,8) Most patients who have cancer combine some form of alternative or complementary therapy with their conventional treatment while only 37.5 percent of patients with cancer surveyed in two studies expected complementary and alternative therapies to cure their disease. (8)

Poly-MVA: An Alternative Treatment

However, because of the overwhelming side-effect of impotence, some men refuse conventional treatment and seek safer, nontoxic alternative treatments instead such as garlic (Alliumsativum), soy (Glycine soja), lycopene, Haelan 951 (Haelen Products Inc., Woodinville, Massachusetts), or Poly-MVA® (see section called About the Product). In 1990, Larry Clapp, Ph.D., J.D., was diagnosed with prostate cancer and refused conventional treatment. Instead he embarked on a lifestyle program of nutrition, natural products, spirituality and detoxification. (9) Heremains in remission today.

Large-scale human studies on many of these natural treatments for treating cancer are simply cost-prohibitive. It costs at least $300 million to bring any cancer drug to market. This makes the “gold standard” validation for many of these therapies as a sole treatment impossible. However, well-documented case studies can serve as an excellent vehicle to explore the potential cancer-ameliorating effect of a natural agent when used as the primary treatment.

Three cases of patients using a proprietary product called Poly-MVA indicate that it may be a good alternative treatment for prostate cancer. The remainder of this article focuses on these cases.

About the Product

Poly-MVA contains a lipoic acid/palladium complex (LAPd) developed by Merrill Garnett, D.D.S. (founder and chief executive officer of Garnett McKeen Laboratory, Inc. Islip, New York).The formulation is sold as a dietary supplement under the trade name Poly-MVA and is distributed by AMARC Enterprises, San Diego, California. The formulation’s main active ingredient LAPd is being considered by the pharmaceutical industry under several patents as “synthetic reductase.” (10)

The initials “MVA” stand for “minerals, vitamins and amino acids.” The product is a proprietary formulation that contains palladium, alpha-lipoic acid, thiamine, riboflavin, and cyanocobalamin, formyl-methionine, and acetylcysteine. LAPd is the main active ingredient in both Poly-MVA and in synthetic reductase. 

LAPd complex has undergone extensive toxicologic study. (11) The study was conducted both intravenously and orally. Mice were given doses of 5000 mg/kg (a typical human dose is 20 mg/kg). No deaths or signs of organ damage occurred in the test animals. It was concluded that the LD50of LAPd exceeds 5000 mg/kg. The Ames Test was conducted by the same independent laboratory and yielded negative results. LAPd was also studied for its effectiveness in halting the growth of glioblastoma cells in vivo. (12) Tumors were allowed to grow in mice. The animals were then divided into 8 groups of 10 mice each. Four groups were given daily intravenous (IV) doses LAPd or placebo. Another four groups were given intraperitoneal doses of 0.05, 1.0, or 2.0 mg per mouse for a total of 4 weeks and tumor volume was measured throughout the study. Compared to the controls who received no LAPd, mice receiving the test material orally or IV at 0.5, 1.0, or 2.0 mg had a significantly reduced growth of the glioblastoma (a 50 percent or greater reduction in tumor size).

Mechanisms of Action

There are two proposed mechanisms of action of Poly-MVA. (13)

The formulation is an irreversibly-bound trimer of lipoic acid and palladium with a thiamine core and thus exists as a polymer rather than a single molecule. The product can therefore provide a unified redox (accept charge and donate charge) reaction. When glucose enters a cell it is broken down, in the absence of oxygen, into pyruvate, which subsequently enters the mitochondria and is quickly oxidized to acetyl-coenzyme A (acetyl-CoA). In aerobic respiration, acetyl-CoA is then channeled into the Krebs/citric acid cycle to create nicotinamide adenine dinucleotide (NADH). NADH is then oxidized to the electron transport chain. The electrons entering the chain are used to drive the phosphorylation of adenosinetriphosphate (ATP). The energy needs of the body are supplied by splitting ATP into adenosine diphosphate (ADP) and a free phosphate molecule.

Dr. Garnett created LAPd to shunt electron energy from itself to DNA and thus replace the electrons lost in normal cells as a result of the oxidative damage associated with radiation andchemotherapy. (10)

Further studies have demonstrated that the excess energy LAPd provides to the mitochondria, which travels down the electron transport chain, cannot be accepted by cancer cells. Because malignant cells function in a hypoxic environment, a local generation of free radicals occurs at the mitochondrial membrane. This activates apoptosis by facilitating cytochrome C release and activating caspase enzymes that destroy malignant cells. Given that healthy cells are richly oxygenated, LAPd is nontoxic to them and they actually benefit from the energy boost.

Another hypothesized mechanism of action is that LAPd can target tumor cells selectively by modulating pyruvate dehydrogenase (PDH). PDH is the bridge between anaerobic and aerobic metabolism. During anaerobic metabolism, glucose is broken down to pyruvate which nets 2 ATPs. The pyruvate molecule is then channeled into aerobic metabolism. Cellular metabolism results in the generation of 38 ATPs.

Because 2 ATPs are needed to initiate glycolysis, each glucose molecule will net 36 ATPs. Thus the vast majority of ATPs are generated during aerobic metabolism. Without PDH, aerobic metabolism cannot take place and the cells shift primarily to an aerobic metabolism. While PDH activity is altered in cancer cells, LAPd may also affect it. This would eliminate the primary means of ATP production in tumor cells (aerobic metabolism) and in doing so effectively kill cancer cells.

Data from Human Studies

Case reports have been cited by Milne and Block (14) appeared on the website www.polymvasurvivors.com and have been presented at several conferences. For example, a large case study was presented in 2004 at the American Academy of Anti-Aging Medicine.(15) This study followed patients who had Stage IV cancer with multiple origins, including breast, sarcoma, colon, lung, brain, bladder, stomach, and prostate, for 3–9 months.

In this large case study, there was a complete response rate of clinical remission in 14 of 66 patients (21 percent); a partial response rate of 39 of 66 patients (56 percent), and a progressive disease rate in 15 of 66 patients (23 percent) all of subjects who received conventional therapy together with LAPd. A partial response was defined as a 50 percent tumor mass or tumor maker reduction. The combined response rate (clinical remission + partial response) of patients who only received the formulation with other supportive nutrients was reported to be 10 of 24 (42 percent). I have colleagues who have also reported success using the formulation either alone or as an adjuvant to conventional cancer treatment. This product is sold for oral ingestion only. In order to give it IV, it must be filtered with a Millipore filter to remove any impurities such as parasites or bacteria.

Poly MVA in Three Case Studies

Patients gave written and verbal consent for the use of their medical records in the preparation of this report.

Case 1: R.Z.

R.Z. is a 73-year old man who was diagnosed with stage 4 adenocarcinoma of the prostate in January 2001. His biopsy revealed a Gleason score of 6. Tumor involvement was 25 percent of the right lobe and 15 percent of the left lobe. His PSA at the time of diagnosis was 7.8. His bones can showed 7th rib bone metastasis. A computed tomography (CT) scan of his abdomen and pelvis showed possible liver metastasis and liver cysts. He also was diagnosed with a dilated left ureter with tumor nodules around his ureter. His urinalysis was negative. R.Z. was getting up to urinate at least 4–5 times each evening and had difficulty in urinating (dysuria) because he had a partially obstructed ureter.

R.Z. adamantly refused any conventional treatment, including chemotherapy, radiation, or surgery. He was started on multivitamins, multiminerals, and an herbal supplement (PC-RES) similar to PC-SPES, which is a Chinese herbal combination. He adhered to this regimen from February 2001 to May 2004. Initially, his PSA started to decrease and by June 2001 it was 5.

However, close monitoring revealed that his PSA levels were erratic, with the levels going up and down over the course of time. In 2004 his PSA rose steadily. His highest PSA level was 11 in May 2004. R.Z. was given LAPd to add to his regimen in May 2004. He took 2 teaspoons of the formulation, q.i.d., for 6 months and then decreased the dose to 2 teaspoons t.i.d. His PSA levels came down progressively, reaching 8.7 in February 2005. This was the first time he experienced a consistent decrease in his PSA levels.

This patient has stage IV prostate cancer and has been stabilized on LAPd for the past 11 months and he remains physically, mentally and sexually active. During the 11 months he has been taking the formulation, his sexual function and libido have been good. As oft his writing, he is now waking 2–3 times each evening to urinate and no longer experiences obstructed urine flow. His performance scale results have been 100 percent perfect. He is also being treated for hypertension, which is under control with Diovan and Lotrel. His comprehensive metabolic panel has shown normal results.

Case 2: J.C.

J.C. is a 59-year-old man who was diagnosed with adenocarcinoma of the prostate with a Gleason score of 6 in September 2004. His left lobe was moderately differentiated and his right lobe was negative.

The lesion on his prostate was measured at 10 mm x5mm with a pelvic ultrasound and was palpable. A CT scan of the chest, abdomen, and pelvis showed no lesions and his virtual CT colonoscopy also showed no lesions. A bone scan and urinalysis also yielded negative results. His comprehensive metabolic panel results were also normal. His lymphocytes were very low at 3.9 (normal range is 24–44). He presented with dysuria and hematuria.

J.C. adamantly refused any conventional treatment, including chemotherapy, radiation, or surgery. He was started on IV LAPd initially, beginning on November 11, 2004. He then received the following treatment:

• Week 1—For 5 days, he received 20 mL of LAPd IV and took an additional 20 mL (two teaspoons b.i.d.) every day of the week including the non-IV days.
• Week 2—For 5 days, he received 30 mL of LAPd IV and took an additional 10 mL (2 teaspoons) every day of the week including the non-IV days.
• Week 3—For 3 of 5 days he received 40 mL of LAPd IV and took40 mL orally (2 teaspoons q.i.d.) on non-IV days.

He now remains on the oral dose he took during week 3. His PSA was 5.6 in November 2004 immediately after receiving the formulation. It is unknown whether this elevation was the result of the biopsy he had or the possible tumor killing effect of the product. His PSA level decreased to 4.01 by December 2004. His last PSA in March 2005 was 2.8 and his prostate nodules were no longer palpable. His dysuria and hematuria completely resolved after he took the formulation and he scored 100 percent on a performance scale. He was also diagnosed with chronic Epstein-Barr virus (EBV) and gastroesophageal reflux disease that has also improved during this time. Prior to starting the formulation, he was taking a multi-vitamin and multimineral supplement, fish oil, and a multiherbal supplement. None of these decreased his PSA level before starting the LAPd. His lymphocytes were 19.3 in January 2005. As of this writing, he remains mentally, physically, and sexually active.

Case 3: M.O.

M.O. is a 77-year-old man diagnosed with Stage 4 adenocarcinoma of the prostate in October 1996. At the time of diagnosis, his PSA was 69.2 with a Gleason score of 3. His bone scan revealed multiple bone metastases to various sites and he complained of back pain.

M.O. adamantly refused chemotherapy, radiation, or surgery but agreed to hormonal blockade treatment. He took Lupron and Casodex for 18 months. His PSA level decreased to 15.3 by November 2001. It then went up to 27.9 by December 2003. M.O. Stopped the hormonal blockade because he developed gynecomastia and continued to have back pain.

He agreed to take Zoladex intermittently for approximately 1 year and, by January 2002, his PSA was 32 and he decided to stop all hormonal treatment. He then sought an alternative treatment.

His PSA on December 2003 was still high at 27.9 after he had stopped all hormonal treatments. He had been taking a multivitamin supplement, a multimineral supplement, fish oil, and an herbal supplement for at least one year before he was started on the LAPd formulation.

He began taking the product in February 2004 and took 2 teaspoons q.i.d. for 6 months and continued to take 2 teaspoons b.i.d. there after. His PSA level decreased to 0.4 in July 2004 and rose to 0.5 in September 2004.

He was last seen in February 2005 and his PSA had risen to 9. During this last visit, it was noted that, despite the rise in PSA level, his back pain had resolved and his performance scale was 100 percent. His comprehensive metabolic panel showed normal results. However, his gynecomastia did not resolve.

As of this writing, he has been instructed to reinstate his oral dose of 2 teaspoons of the formulation q.i.d. and is being treated for mild hypothyroidism with synthroid. He is mentally and physically active but has not been sexually active for some time. He refuses further bone scans and ultrasounds.

Discussion and Conclusions

Conventional prostate cancer treatment carries significant risks for impotence, incontinence, and loss of sexual desire. (1–6) While other side effects are associated with these treatments the aforementioned side effects appear to create the greatest fear and anxiety in men and cause them to refuse conventional treatment.

Toxicology studies of the LAPd formulation have demonstrated that it is extremely safe and an LD50 was not induced even at extremely high doses that are far above what any human could take in via oral or IV administration. (13,14) Poly MVA’s mechanism of action appears to be a result of a crystalline polymer structure that promotes a more powerful redox than alpha-lipoic acid alone and induces apoptosis in cancer cells only. (15,16) Therefore, the product does not affect normal healthy tissue the way that radiation, chemotherapy, brachytherapy, or cryotherapy would. The formulation also does not make an impact on the hormonal system as does hormonal blockade.

It appears unlikely that the use of this formulation would lead to the significant risks associated with conventional treatments. These three case studies indicate that the product may stabilize prostate cancer and mitigate the very side effects that may be caused by conventional treatments or that may present at the time of diagnosis.

Two of these patients continue to have no intention of combining any conventional treatment along with LAPd and one subject refused further hormonal blockade as well as any testing other than for PSA. All of these men appear to be completely satisfied with their treatment, continue to be closely monitored by their physicians, and are willing to continue treatment with the formulation.

M.O. (Case 3) has reinstated his initial loading dose of LAPd (2teaspoons q.i.d.) to see if he can reduce his PSA level. Two of these cases appear to be stable and one case appears to be in remission at this time.

The most compelling feature of the treatment appears to be that all men scored 100 percent on a performance scale. J.C. was initially diagnosed with EBV and also appeared to have improvement in this condition as evidenced by his performance scale rating.

What is more, these three men remain physically and mentally active. Two of the 3 men remain sexually active at ages 59 and 73. The third man (age 77) had not been sexually active for sometime. R.Z. (Case 1) had significant reductions in nocturia and dysuria while taking the formulation. J.C. (Case 2) had complete reversal of dysuria and hematuria while using LAPd. It is feasible that this is the result of the hormonal blockade that he had previously received. However, according to his physician, the prior treatment is not an issue at this time.

While these cases are moderate in duration (7–12 months) they provide compelling evidence that this formulation may be a worthwhile alternative treatment for men who refuse any conventional treatment.
 
Other case studies are presently being gathered on a number of patients with cancer who have used the formulation, including but not limited to breast cancer, non–small-cell lung cancer, glioblastoma, and sarcoma. The goals of these case studies are to provide a clear protocol for the best dosing of the product and best route of administration of (IV versus oral), to determine which types of cancer are the most responsive, and to develop a timeline for the length of remission or stabilization of disease.

These and other cases will continue to be followed. Updates to published cases will be reported as addendums in case studies to be published in the near future.

References:

1.Prostate Cancer Institute. Online document at: www.prostate-cancer-institute.com
2.Moore CN, George DJ. Update in the management of patients with hormone-refractory prostate cancer. Curr Opin Urol 2005;15:157–162.
3.Vicini FA, Vargas C, Abner A et al. Limitations in the use of serum prostate specific antigen levels to monitor patients after treatment for prostate cancer. J Urol 2005;173:1456–1462. 4.Turpin-Wendling FN, Sahnoun A, Pariente A, et al. Oncological results of 117 consecutive radical prostatectomies. Prog Urol 2005;15:30–35.
5.Demanes DJ, Rodriguez RR, Schour L et al. High-dose-rate-intensity-modulated brachytherapy with external beam radiotherapy for prostate cancer: California endocurietherapy’s 10-year results. Int J Radiat OncolBiol Phys 2005;61:1306–1316.
6.McLaughlin PW, Narayana V, Meriowitz A et al. Vessel-sparing prostate radiotherapy: Dose limitation to critical erectile vascular structures (internal pudendal artery and corpus cavernosum) defined by MRI. Int J Radiat Oncol Biol Phys 2005;61:20–31.
7.Ernst E, Cassileth BR. The prevalence of complementary/alternative medicine in cancer: A systematic review. Cancer 1998;83:777–782.
8.Drisko JA, Chapman J, Hunter VJ. The use of antioxidants with first-line chemotherapy in two cases of ovarian cancer. J Am Coll Nutr 2003;22:118–123
9.Clapp L. Prostate Health in 90 Days without Drugs or Surgery. Carlsbad, CA: Hay House Inc, 1998.
10.Garnett M. Palladium complexes and methods for using the same in the treatment of tumors or psoriasis. U.S. Patent Nos. 5,463,093, October 31,1995; U.S. Patent, No. 5,679,697, October 21, 1997; and 5,776,973, July 7, 1998.
11.Pharmakon USA. Acute Oral Toxicity Study in Mice (14 Day) [pre-pared for Garnett McKeen Laboratories Inc.]. Waverly, PA: Pharmakon USA, May 16, 1995.
12.Pharmakon USA. Effect of a Test Article on the Growth of a Glioblastoma Tumor Cell Line in Nude Mice. [prepared for Garnett McKeen Lab-oratories Inc.]. Waverly, PA: Pharmakon USA, May 16, 1995.
13.Antonawich FJ, Fiore SM, Davis JN. The effects of a lipoic acid/palla-dium complex on hippocampal progenitor cells [abstr #857]. Society for Neuroscience 1998, Los Angeles CA.
14.Milne RD, Block ML. Poly-MVA: A New Supplement in the Fight Against Cancer. North Bergen, NJ: Basic Health Publications, Inc., 2004.
15.Forsythe J, Antonawich FJ. Poly-MVA clinical study. 12th Annual World Congress on Anti-Aging Medicine, Las Vegas, NV, December 2–4, 2004.

Shari Lieberman, Ph.D., C.N.S., F.A.C.N., is a research scientist and industry consultant based in New York City and Pompano Beach, Florida. She is also the Founding Dean of New York Chiropractic College’s (Seneca Falls, New York) MS Degree Program in Clinical Nutrition.

James W. Forsyth, M.D., H.M.D., is the medical director of the Century Wellness Clinic, Reno, Nevada, and an Associate Professor of Medicine and Pathology at the University of Nevada Medical School, also in Reno.
 

by Tony Isaacs

Western medicine, in contrast to at least 6000 years of natural medicine, treats the body as a collection of parts instead of as a synergistic organism. When it comes to treating broken bones and injured body parts, mainstream Western medicine is unequaled. When this same approach is used to treat illness and disease - fixing or repairing the parts where the symptoms of underlying illnesses manifest themselves, modern medicine fails miserably.

In the instance of cancer, instead of addressing the causes of cancer - toxins and a weakened immune system - we see instead treatments that either slash, burn or poison away the tumors and cancer cells, which further weakens an immune system cancer has already defeated and only worsens the conditions that led to cancer to begin with.

Even if initially successful at getting rid of existing cancer cells and tumors, the end result is a weakened body which may have major organ damage and which is more susceptible to the reappearance of the original cancer, as well as other forms of cancer and diseases.

For half a century or more, we have been told that a breakthrough or cure for cancer is just around the corner, yet the death rates for cancer remain virtually unchanged. Meanwhile, effective natural and alternative treatments which address and correct the actual causes of cancer continue to enjoy much greater success than the largely failed mainstream treatments - even as these natural alternatives suppressed and come under increasing attack by the medical establishment.

Profit plays a huge role in Western medicine and, because nature cannot be patented, there is no profit in conducting studies on natural remedies for cancer and illness. In fact, if studies were to prove the effectiveness of natural alternatives and those alternatives were to be approved for use in treating cancer and other illnesses, the result would be to admit cheaper, safer and more effective competition into a fiercely guarded market. Instead, such alternatives are heavily suppressed, discredited and passed off as “snake oil” and “voodoo medicine”.

The cold, hard fact is that cancer and other degenerative and chronic illnesses are big business - to the tune of hundreds of billions of dollars a year. When their only market place is our bodies, the vested interests of the trillion dollar world pharmaceutical empire, mainstream medicine and the institutions which depend on maintaining the status quo are not likely to allow such natural competition, even though the cost is millions of needless deaths and untold suffering.

A better plan for maintaining and increasing profit is to continue to bring new drugs into the market place which treat only symptoms and have serious side effects that lead to still more drugs in a never ending cycle so that by the time a male American reaches 65 years of age, he takes an average of 15 prescribed and over the counter medications every day - when it all started out with one or two conditions that could have been treated safely and effectively by natural means. A good model for profit, but a horrible one for humanity.

We now have over 15,000 patented and approved drugs, 95% of which have significant side effects. It is no accident that our doctors have been taught for generations, just as we have been, that the way to treat illness and disease is to prescribe approved medications – medications that are made by the single largest source by far of funding for medical education: the world pharmaceutical companies. What exactly has this mountain of medicine actually cured in the past half century? Certainly not cancer!

By far the most effective way to beat and avoid cancer is to remove the causes of cancer and to make your body as inhospitable to cancer and illness as possible. To understand what steps we should and can take, we should understand what we know about cancer:

We know that:

· The development of cancer indicates that our natural first line of defense, our immune system, has been defeated and that the presence of either toxins and pathogens, or some imbalance in our bodies have led to the development of cancer and enabled it to gain an upper hand.

· Cancer cannot develop without an impaired liver.

· Cancer cannot survive in an alkaline environment, nor can it survive in a highly oxygenated environment.

· Detoxing and cleansing our colons and liver helps restore balance, prepares our bodies to better be able utilize natural immune boosters and cancer fighters and paves the way to rebuilding our livers and immune systems.

· Cancer cells are diseased, impaired and/or beset by pathogens and have lost the ability to to be die naturally via cellular apoptosis and be replaced by healthy cells. These cancerous cells simply become abnormal and outlive the other cells in their normal cell life/replacement cycle and end up crowding out a territory over time.

· Iodine, vitamin D, and potassium are all vital to beat and ward off cancer.

· Fresh air, pure water and sunshine are also vital to maintain healthy bodies, which can fight off and beat conditions like cancer.

· A natural diet of uncontaminated raw vegetables and raw fruits, with plenty of omega-3’s and balanced nutrition has been proven to be effective in numerous natural anti-cancer protocols.

· A great number of natural botanicals and supplements, such as those containing beta glucans and other long-chain polysacharrides, the oleander remedy I have written about, Colloidal Silver, Inositol (IP-6), Poly-MVA, the ABM mushroom, South Africa’s “Cancer Bush” sutherlandia frutescans, cat’s claw, pau d’arco, corialus versicolor mushroom, and many others have been proven to boost the immune system, destroy pathogens, protect our cells, and beat cancer.

· Sugar feeds cancer.

And so, when we go to an oncologist and are diagnosed with cancer what is the prescribed treatment? Does it incorporate ANY of the above elements? No, sadly it does not. Our doctor prescribes what he or she has been taught: cut out, radiate or poison the symptom and do nothing to address the underlying causes and natural imbalances that enabled led to the symptom.

As a result, the way is paved for the return of the cancer or the introduction of another cancer or serious condition. Even worse, the road to further illness is often made easier due to the damage to the immune system and major organs caused by the treatment of the symptom.

Nature, on the other hand, gives us an array of tools to beat cancer and the underlying causes that lead to cancer, including foods, vitamins, minerals, supplements and lifestyle choices. Here is a suggested protocol based on what we know about cancer and its causes and what nature and lifestyle choices have offer:

· As soon as possible, cleanse your body to get rid of built up toxins like heavy metals and pesticides, as well as the undigested food, fecal matter and gallstones that build up in the body by cleansing your colon and liver and by chelation to rid the body of heavy metals. Such contaminations are breeding grounds for, and causes of, disease and illness. A toxic and unclean body weakens the body’s immune system that should be your first line of defense. Plus, once cleansed, the body is much more receptive to the good measures you take to rebuild your immune system and fight disease.

· Cleanse your environment to the greatest extent possible and eliminate bad habits. In an ideal world, you would move to the country where there was plenty of fresh air and sunshine and less stress. In the real world you may not find that possible, so eliminate common toxins in your household, workplace and other places you spend time.

· If you have mercury amalgam fillings in your teeth, have them replaced. In many instances, this step alone has led to elimination of cancer.

· Immediately eliminate bad habits and begin building build good ones so that you will make sure that you no longer have habits that weaken your immune system and that you will be able to build your body to fight and conquer illness. A sedentary lifestyle with a poor diet, lack of pure water, sunshine and fresh air, and constant exposure to toxins will in time lead to bad health conditions. Remember, bad health habits are open invitations for illness and disease to enter your body.

· Begin and maintain a healthy immune boosting and cancer fighting diet. A good balanced diet, pure water, fresh air, sunshine and exercise are some of the essentials. You will find that a good diet does not have to be a bad tasting diet – far from it! However, it should be noted that the very best and most healthy diet is one that is close to the diet our ancestors evolved to utilize: lots of fresh and uncooked vegetables, fruits, nuts, roots and tubers, and fish and meat uncontaminated by growth hormones, artificial fertilizers or pesticides – and little or no grain or dairy products. It should be noted that of all the foods, essentially only raw vegetables and fruits contribute to an alkaline pH.

· Rebuild and strengthen the body’s natural immune system. It is very likely that a weakened immune system contributed to your illness in the first place. It is absolutely certain that a rebuilt and strengthened immune system will help you beat your illness and keep it at bay. Again, good diet, nutrition and habits are all important – they lay the foundation for a strong and healthy immune system. However, they are not enough by themselves. You should build a good foundation and then make your body a healthy fortress against disease and illness. Quite simply, disease and illness hate healthy hosts. The stronger your immune system is, the harder it is for disease to survive and grow. And, to be the very strongest you can be, you need extra measures in the form of supplements as well as the healthiest foods. An oleander extractvery much like you get when you make oleander soup was tested in Europe in 1986 - 87 and found to have six times the immune stimulating activity of the most powerful immune stimulators known to man.

· Cleanse, restore and protect the liver before, during and after your anti-cancer and disease battle. Cancer cannot develop unless the liver is impaired to begin with. Plus, an effective cancer-fighting regimen will result in the release of a cascade of toxins that are released when cancer cells die. Such a release can overwhelm an already impaired liver and can even be fatal if measures are not taken to protect and regenerate the liver. Some of the very best anti-oxidants to used to protect and regenerate the liver are the ones used in the Berkson Clinical Study: Milk Thistle (silymarin), alpha lipoic acid and selenium.

· Maintain an alkaline pH and get plenty of oxygen to the cellular level. Cancer cannot survive in the presence of an alkaline cellular pH level, nor can it survive in the presence of highly oxygenated cells. Dr. Johanna Budwig of Germany has shown that for proper cellular utilization of oxygen to take place, our diets must contain adequate amounts of unsaturated fatty acids.

· Make sure you have plenty of iodine, potassium and Vitamin D. All have been proven to be essential in beating and avoiding cancer. As mentioned above, cancer cells have lost the ability to be shut off by the body in what is called cellular apoptosis. These cancerous cells simply become abnormal and outlive the other cells in their normal cell life/replacement cycle and end up crowding out a territory over time. Iodine goes in and both does away with the surrounding cyst where cancer has set up residence and then also goes in and allows the specific shut down of the individual cells that are abnormal, diseased, or beset w/ pathogens to make room for new cells.

· Drink plenty of pure water and get plenty of fresh air and sunshine. Water is essential for all healthy life; however, regular tap water contains trace amounts of hundreds to thousands of pesticides, carcinogens and other industrial pollutants. For that reason, the author recommends only the purest drinking water, such as reverse osmosis filtered water. Don’t overdo the sunshine, but sunshine is essential to the production of vitamin D, and, strange as it may sound, has been found to be essential in warding off melanoma as well as other cancers.

· Exercise in moderation. Regular exercise does not have to be grueling, but it is essential. Exercise stimulates the immune system, stimulates the production of natural human growth hormone, stimulates the production of hormones and pheromones that make us happier and healthier, and simply leads to a longer and happier life period. Innumerable studies have demonstrated the overall health benefits of exercise and the negative effects of a sedentary lifestyle lacking in exercise. It is not a coincidence that studies have shown up that those who exercise only a few hours each week have up to 50% less chance of developing many different kinds of cancer.

· The next element of beating your disease and keeping it at bay is to go on the attack. As a matter of fact, all of the elements of the this anti-cancer and disease protocol are elements of attack, because they make the body strong and inhospitable to disease. What I am talking about here is more than just making the body inhospitable to your disease – I am talking about going on the attack and wiping it out! In the case of cancer, there are many very potent anti-cancer supplements, such as the ones listed above and several others.

§ One such supplement, named OPC (not to be confused with the European anti-oxidant of the same name), based on a remedy I have researched and written about , has been used for the past three years in South Africa to treat HIV and cancer. Of approximately 350 HIV patients, all are still alive and well with their symptoms either reversed orstabilized. Of 80 cancer patients, some in very late stages, 72 are alive and well and either cancer free or with their cancers in remission and tumors shrinking. Of the 8 that did not survive, 5 were in their very final days and could not hold down the supplement. Another three succumbed to organ failure as a likely result of prior traditional Western treatment via chemo. Compare that with the results of any mainstream medicine or treatment!

§ Perhaps the supreme cancer destroyer I have found is Inositol/IP6, such as is found in the product Cell Forte. A one to two month intensive regimen is best - and it seems to just melt away tumors according to several users I have spoken with. One caution - Inositol/IP6 may deplete minerals unless you make sure to take a mineral supplement such as plant-derived minerals (a good thing to do anyway). Be sure to get plenty of Calcium and Magnesium (a second good thing to do anyway). Also, I feel it is good to only take a maintenance dose most of the time and even give it an occasional month break, with only one or two yearly intensive regimens.

§ Colloidal Silver is another must in my opinion - it has been shown to be deadly to single cell organisms and pathogens. The caution with Colloidal Silver is that it is not specific and you need to supplement with pro-biotics (another good thing to do anyway).

§ Poly MVA is widely reported to have excellent results in beating cancer and is an excellent immune booster as well.

· Remember, what you avoid can be just as important as what you consume: Avoid sugar to the greatest extent possible. Sugar feeds cancer and other illnesses and causes a myriad of other health problems. Refined sugar is also the number one single cause of health problems in the entire world! Likewise avoid bread and other items containing bleached white flour, which is essentially empty and harmful calories that convert to sugar once ingested. Other items to avoid include non-fermented soy, pork, MSG, ALL charredfoods and foods cooked at high temperature, aluminum and coated cookware, micro-waved food, food in plastic containers and styrofoam.

· The final key to winning your battle is your mental attitude. Remove as much stress from your life as you can and believe that you are going to win. Stress and worry accomplish nothing – worse, they are actually allies of illness and disease. You have surely heard the term “stress, the silent killer”? It’s true! So you must do whatever it takes to remove stress from your life and make your mental attitude your ally. Meditate, take yoga, change jobs, retire, go fishing, find a pleasant hobby – do whatever you must to remove stress and have a positive mental outlook. Just remember, anyone who introduces orkeeps worry and stress in your life is neither a friend nor an ally during this fight. And make no mistake, it is a fight - likely the most important one of your life. But it is a fight you can and will win.

Think it, believe it and live it!

Some in the field of natural health will tell you that you can beat cancer through diet alone, or through diet and de-toxing. In many instances that is true, and some of the most effective and popular natural anti-cancer protocols, such as the Budwig Diet, are based on such a premise.

However, in my opinion, the more weapons you have in your natural arsenal, the greater your chances of success will be. That is why I advocate including one or more of the powerful natural supplements that have been proven to beat cancer and boost the immunes system, and which address what we know about cancer.

Our depleted soils and the introduction of modern industrial toxins and contaminants makes it hard to build a strong enough immune system through diet alone. Our immune systems were not designed to handle the multitude of modern toxins they now face, which is why cancer is largely a modern disease.

As a final note: for those of you who continue to believe the big lie that the harsh and ineffective options offered by mainstream medicine (and its half century record of broken promises to deliver a cure or significant breakthrough) are superior to nature, I ask: When did God become a quack?

Live long, live healthy, live happy!

You can read more of Tony’s writing at:

http://www.tbyil.com

http://www.rose-laurel.com
 

Recording is of Frank Antonawich, PhD, Senior Scientist and Clinical Research Administrator at Garnett McKeen Laboratory, Inc., speaking at a previous American Academy of Anti-Aging Medicine International Congress. Dr. Antonawich discusses the role of Lipoic Acid Palladium Complex (LAPd) in the use of energy in the regulation of cell death in cancer. LAPd is the complex used commercially as Poly-MVA, a unique nutritional supplement that assists in boosting immune response, healing damaged cells and providing energy for compromised body systems.

Poly MVA: Energy to Get the Job Done

Frank Antonawich, Ph.D.

Over fifty years ago, most scientific and medical therapeutic approaches focused on cellular metabolism.  With the advent of genetics a concentrated shift toward genomics, and subsequently proteomics (protein profiles), dominated the therapeutic stage.  The area of metabolism (metabolomics) is now being revisited as an attractive target. 

One such regulatory approach is via the manipulation of cellular energy.  Cellular energy is synonymous with metabolic power.  As we age there is a decrease in metabolism, furthermore, numerous disease states involve metabolic dysfunction (i.e. ischemia/stroke, cancer).  As we all know, the major power plant of the cell is the mitochondria.  It utilizes high energy intermediates (NADH and FADH) to donate electrons and drive the production of ATP, our functional energy source.  Can we alter metabolic fitness by providing an alternative electron source?

WHAT IS POLY-MVA?

Poly-MVA is a dietary supplement that contains a patented palladium lipoic acid complex (LAPd).  LAPd is a composed of the element palladium irreversibly bound to the antioxidant lipoic acid in a trimer about thiamine (B1).   The name Poly-MVA was coined by Dr. Albert Sanchez since Poly MVA is composed of minerals, vitamins, and amino acids (MVA).  In addition to the LAPd complex, the proprietary formulation contains riboflavin, cyanocobalamin, formyl-methionine and acetyl-cysteine.  Dr. Sanchez became its principle proponent in his search for non-invasive support/treatment for cancer patients, following his wife’s tragic battle with colon cancer.

The LAPd family of compounds was discovered by Dr. Merrill Garnett.  While Dr. Garnett was formally trained as a dentist, this was followed by substantial graduate work in biochemistry and electrochemistry, followed by over 40 years of scientific bench work.  His inquiry and screening into thousands of organo-metallic compounds, led to the discovery of the non-toxic LAPd chemotherapeutic agent.  The principles that led to this finding in the early 90s still drive Dr. Garnett’s principle laboratory interests today; that ultra-low frequency  electrical currents are at the heart of all physiological processes and determine such events as the polarization, charge and folding of enzymes, nucleic acids and membrane phospholipids.  He believes that the regulation of charge transfer may form the basis of several new methods of medicinal management.

Q & A

I am frequently contacted at my laboratory, on the radio, or approached at conferences with common questions regarding Poly MVA. 

• A number of people are under the impression that Poly MVA is merely a cocktail of palladium, alpha-lipoic acid, thiamine, riboflavin, cyanocobalamin, formyl-methionine and acetyl-cysteine.  There is no free lipoic acid or palladium in Poly MVA, it is bound irreversibly with thiamine.  Therefore, comparisons to free palladium or lipoic acid are irrelevant.  This was done by Dr. Garnett to create a metallic polymer that is both fat and water soluble.  Furthermore, it is prepared in a unique fashion so it does not metabolize, dissociate, and liberate the metal, which could accumulate in tissues and eventually become toxic like most chemotherapeutics.

• Is Poly MVA safe? LAPd complex has undergone extensive toxicology study (Calvert Laboratories, Inc; Pharmakon USA, Inc.). The toxicology was conducted both intravenously and orally with LAPd.  Mice were administered doses of 5,000 mg/kg (a typical human dose is 20 mg/kg).  No deaths or signs of organ damage occurred in the test animals.  It was concluded that the LD50 of LAPd exceeds 5,000 mg/kg. The Ames test was conducted by the same independent lab and demonstrated not to cause any mutations.  LAPd was also studied for its’ effectiveness in halting the growth of glioblastoma cells in vivo.  Tumors were allowed to establish and mice were divided into 8 groups of 10.  Four groups were given daily intravenous (IV) doses LAPd or placebo; four groups were given intraperitoneal doses of  .05, 1.0 or 2.0 mg per mouse for a total of four weeks and tumor volume was measured throughout the study.  Compared to the controls who received no LAPd, mice receiving the test material orally or intravenously at 0.5, 1.0 or 2.0 mg had a significantly reduced growth of the glioblastoma (50% or greater reduction in tumor size).

• Palladium is a precious metal and quite expensive.  Why was it used?  Dr. Garnett discovered during his electrochemistry studies that DNA (and other biological cellular entities) has select electrical frequencies that it resonates at.  After testing thousands of chemicals, Dr. Garnett found that only a limited few metals shared the same resonance frequencies with DNA.  This characteristic facilitates electron flow between them.  This is analogous to the propulsive energy provided to a surfer by a wave.  If the surfer is in “sync” with the wave he can ride it all the way in to the beach.  However, if he or she isn’t, they will crown right over the top of the wave.  Palladium is important since this is the only one that Dr. Garnett could “cook” with the lipoic acid and thiamine to form this irreversible crystal polymer.

• Why are the other components added to the dietary supplement?  Most people feel the other components are added without regard to the LAPd complex, but this is not true.  Any molecule that transfers electrons has the ability to generate heat.  In very early studies, patient temperatures elevated.  The proprietary blend in Poly MVA is not inert, but plays a role in buffering the temperature alterations.
  
• Is Poly MVA just a super free radical scavenger?  This was my initial thought after my first transient global ischemia experiments with the LAPd complex in Poly MVA.  However, the LAPd complex is a liquid crystal polymer.  There is extensive data supporting the dramatic redox potential of polymers versus monomolecular structures, such as vitamins.  Any redox molecule can certainly absorb electrons, but it also donates them.  Dr. Garnett’s electrochemistry papers demonstrate LAPd’s significant redox potential versus its monomolecular competition.  After my initial ischemia research findings, I sent some Poly MVA to Brunswick Labs, Inc. (Wareham, MA) for an ORAC analysis.  An ORAC assay measures the oxygen radical absorbance capacity of a compound as compared to Trolox (vitamin E).  The table below demonstrates the potent anti-oxidant capacity of Poly MVA (expressed as Trolox equivalent per gram):

Vitamin A = 1.6 (2,800)
Vitamin C = 1.12 (1,890)
Vitamin E = 1.0 (1,700)
Melatonin = 2.04 (3,468)
Lipoic Acid = 1.4 (2,400)
Poly MVA = 5.65 (9,605)
 
• Why is this supplement often credited or associated with providing energy? While Poly MVA does indeed have the ability to be a highly effective free radical scavenger.  Its ability to donate electrons to the mitochondria of the cell is critical to explaining its dramatic benefits.  Anecdotal clinical evidence of the reports of additional energy, led to my early hypotheses regarding its possible benefits in stroke and ischemia.  Following an interruption of blood flow to any tissue, in my particular case it is the brain, there is deprivation of oxygen and glucose.  Providing an alternative energy source can maintain the integrity of the electron transport chain within the mitochondria.  The LAPd complex was demonstrated, by Dr. Garnett, to shuttle electrons to oxidized DNA, however, this energy flow does not appear to proceed directly to DNA.  By conducting a competition assay with lipoic acid, which works at complex I of the mitochondria as a cofactor as pyruvate is converted to acetyl CoA, one can attenuate the beneficial effects.  This is critical since mitochondrial health is a major concern during myocardial and cerebral ischemia.  By providing this alternative energy source, the electron transport chain components do not readily dissociate (coenzyme Q-10 = ubiquinone; cytochrome C).  In a normal cell this would obviously provide a boost, but serve as a supplement to an ischemic cell.
 
• Can Poly MVA be taken with other vitamins and free radical scavengers?  Since LAPd is a highly efficient redox molecule, normal daily recommended values of vitamins have not been of consequence in our laboratory studies.  However, excessive doses of anti-oxidants may attenuate Poly MVA’s benefits.  As mentioned above, administration of alpha lipoic acid in our competition assay hindered the redox benefits of Poly MVA.  However, alpha lipoic acid alone only offers a fraction of the ischemic protection offered by the polymer. 

MECHANISMS OF ACTION

Poly MVA’s proposed mechanisms of action directly related to its structural formulation.  Dr. Garnett’s complex is a liquid crystal polymer and provide a unified redox.  Redox polymers more efficiently accept charge, and therefore serve as potent anti-oxidants.  Furthermore, they can also donate charge and serve as alternative energy sources.  This electron transfer appears to be the key to its physiological effectiveness.

When glucose enters a cell it is broken down under anaerobic conditions (absence of oxygen) into pyruvate.  Pyruvate subsequently enters the mitochondria, via complex I, and is quickly oxidized, in the presence of alpha-lipoic acid, to acetyl-CoA.  In aerobic respiration, acetyl-CoA is then channeled into the Krebs/Citric Acid Cycle to create the reduced form of nicotinamide adenine dinucleotide (NADH).  NADH donates its electron to the electron transport chain to drive the phosphorylation of adenosine triphosphate (ATP).  The energy needs of the body are supplied by splitting ATP into adenosine diphosphate (ADP) and a free phosphate molecule. 

Studies have demonstrated that LAPd provides electrons to DNA (to replace the electrons lost in normal cells as a result of the oxidative damage associated with radiation and chemotherapy) via the mitochondria.  This electron transfer will provide an additional energy source to normal cells.  However, cancer cells are metabolically challenged, as well as, function in a hypoxic environment.  Since excess electrons have less oxygen to accept them in the cancer cell, a local generation of free radicals occurs at the mitochondrial membrane. This activates apoptosis by facilitating the release of cytochrome C from the inner mitochondrial membrane, allowing the formation of an apoptotic complex in the cytoplasm.  This complex, results in the subsequent activation of the caspase cascade of enzymes that destroy the malignant cells.  Given that healthy cells are richly oxygenated, LAPd is nontoxic to them and they actually benefit from the energy boost. 

Recent findings have focused on the role of Poly MVA and a malignant cell’s ability to physiologically adapt to a hypoxic environment.   These physiological changes are mediated by a molecule called HIF-1 (hypoxia inducible factor-1), which increases in hypoxic conditions to promote an increases in: Vascular Endothelial Growth Factor (VEGF) - a promoter of angiogenesis; Glucose Transport 1 (GLUT1) and glycolytic enzymes – critical components in anaerobic respiration; and Erythropoietin (EPO) – responsible for the differentiation of red blood cells).   Poly MVA appears to decrease the production of HIF-1 thus restricting the ability of the cells to adapt to its environment and subsequently making it more vulnerable to the apoptotic cell death discussed above.

Increased use of dietary supplements in the

US could save healthcare consumers more than $24 billion over 5 years, a study commissioned by the Dietary Supplement Education Alliance has reported. The study focused on calcium-vitamin D combinations, folic acid, omega-3 fatty acids, and lutein-zeaxanthin combinations. The study updated research conducted by The Lewin Group, a national health care and human services consulting firm, from 2004 and 2005 that included a systematic literature review of the most rigorous scientific research available. Researchers found that consumers could save on healthcare costs by increasing their use of supplements in the following ways:

• Supplementing with calcium-vitamin D could help seniors avoid hospitalization for hip fractures, as well as prolonged stays in nursing facilities. Five-year savings: $16.1 billion.

• If 25 percent of the 44 million American women of childbearing age not currently taking folic acid began taking 400 mcg daily, neural tube defects could be prevented in 3,000 babies. Five-year savings: $1.4 billion.

• Elderly people taking 1800 mg of omega-3 fatty acids per day could help them avoid approximately 374,301 hospitalizations for coronary heart disease. Five-year savings: $3.2 billion.

• About 191,000 people with age-related macular degeneration could prevent loss of vision and the dependent care related to it by taking 6-10 mg of lutein-zeaxanthin every day. Five-year savings: $3.6 billion.

For the last several years The New York Times has run articles almost every week exposing abuses by the prescription drug industry. The stories usually document indirect payoffs to doctors for prescribing drugs, such as exorbitant speaker fees, expense-paid trips to industry-sponsored seminars at resort locations, or excessive fees for participating in clinical trials. In some cases the articles document outright kickbacks, as when the NYT reported that doctors who administer an anemia drug in their office could receive tens of thousands of dollars annually in rebates from the manufacturer.

The abuses also affect the research that is used to establish a drug’s safety and effectiveness. There have been many incidents in which drug companies have concealed evidence that their drugs may not be more effective than cheaper alternatives. In some cases, they have concealed evidence of negative side effects from the public and the Food and Drug Administration. And, there is the problem that drug companies often pay researchers to sign their names to articles touting the benefits of their drugs, which the researchers did not write.

Such abuses should not be surprising to anyone who appreciates the value of a competitive market. The root cause of all of these problems is government-granted patent monopolies that allow the pharmaceutical industry to sell drugs at prices that can exceed the cost of production by a factor of a hundred, or more. Last fall, Wal-Mart began selling hundreds of generic drugs for $4 per prescription. The vast majority of brand drugs could also be profitably sold for $4 per prescription, if it were not for the patent monopoly granted by the government. 

As a result of patent monopolies, drug companies can sell drugs for hundreds of dollars that cost them a few dollars to manufacture. This situation invites the sort of corruption that NYT documents regularly in its pages. 

Drug patents do serve a purpose: they provide an incentive to the industry to develop new drugs. However, there are other ways in which this research can be financed. The federal government already spends nearly $30 billion a year on biomedical research conducted through the National Institutes of Health. By doubling this amount, it could probably replace the research conducted by the pharmaceutical industry, most of which currently goes to develop copycat drugs (another problem of the patent system). 

As another possible alternative, Nobel Laureate Joe Stiglitz has suggested a prize system, in which the government would buy out patents at prices determined by their usefulness. The patents would then be placed in the public domain so that all new drugs could be sold as generics.

The United States spends almost $240 billion a year on prescription drugs, which comes to $800 per person. The cost of prescription drugs are a major burden to millions of low and moderate income households as well as to the government itself, which now picks up much of the tab through Medicare and Medicaid. In addition, hundreds of millions of people in the developing world are denied access to prescription drugs because they cannot afford to pay patent-protected drug prices.

The time has long passed when we should be seriously considering alternatives to patent financed research for prescription drugs. However, the power of the pharmaceutical industry has largely kept any such discussion off the political agenda.

A recent article in The Nation triggered a debate in the blogosphere as to whether the methodology of mainstream economics prevents it from considering important issues. In the case of patent financing of prescription drug research, there are no methodological issues at stake. Economists could use the exact same models that show the losses from trade barriers on shoes and shirts to quantify the much larger economic harm from patent monopolies on prescription drugs. 

Unfortunately, the political force behind protection for prescription drugs is much greater than the political force behind protection for shoes and shirts. Therefore, we can look forward to reading many more articles in the NYT about abuses in the prescription drug industry.

By Dean Baker
t r u t h o u t | Columnist 
 
 

*Reprinted from CancerWire, a monthly newsletter distributed by Cancer Monthly (www.cancermonthly.com)

Research is revealing that diet can help prevent cancer and may help treat it too. When will we see the clinical trials?

Today, most people know that lifestyle choices can affect the risk of getting cancer. While many authorities are quick to argue that lifestyle choices are wholly responsible, this is not true. We cannot control the pesticides, herbicides, fungicides and other carcinogens that we are exposed to on a daily basis from the food we eat, the water we drink, and the air we breathe. Yes, smoking can lead to lung cancer, but what about the diesel fumes we breath as we drive behind an 18-wheeler?

The arguments about the causes of cancer are as much political as they are scientific. Once a cancer cause has been accepted by science and law there is an immense and dramatic change in fortunes. Take for example, the asbestos industry. Asbestos was manufactured and used by some of America’s largest corporations which kept quiet the fact that this mineral was carcinogenic and potentially deadly. Once it became known, the eventual litigation bankrupted many of these companies and changed the way this mineral was used forever.

Although our environment is full of carcinogens their existence is often tied to the status quo of industry and production. This means that politics, power, and wealth, not science alone, ultimately determine what is considered cancer causing and what is removed and when.

We do not believe in blaming the victim for their cancer because of their lifestyle choices. This seems to be a popular and convenient approach to the subject. For example, in the recent ABC News story “Eating Healthy Cuts Cancer Risk, Too” the writer explains that being overweight and obese is connected to an increased risk of several different types of cancers, such as breast cancer in post-menopausal women, as well as cancers of the colon, endometrium (uterus), esophagus and kidney.

While there are studies that support such a relationship, blaming cancer solely on obesity, smoking and other lifestyle choices keeps the focus off the elephant in the room - namely the millions of tons of toxins that are poured into our environment as a by-product of industry and mass agricultural practices. So why write about cancer and diet? It is an important subject for at least two reasons:

1) Given how little each of us can control our total environment (i.e. what is in our food, water, and air) we should seek to create a diet that gives us the best opportunity to maintain or regain our health;

2) The connection between diet and cancer prevention is now being expanded into understanding the connection between diet and cancer treatment and this is an important subject for any cancer patient.

Diet and Cancer Risk

The fact that diet can help prevent certain cancers has been known for decades. For example, in a recent case-control study from Taiwan, the researchers stated, “A reduced risk for lung cancer was found to be associated with increased intakes of vitamin A, alpha-carotene, and beta-carotene from 13 food items.” The study concluded that “higher consumption of vitamin A-rich vegetables, especially garland chrysanthemum and sweet potato leaves might provide potential protection from lung cancer.”

As human studies continued to accumulate on the relationship between diet and cancer risk, current research within the human genome is now explaining how it works.

The Biological Mechanisms of Diet and Cancer Risk

How do specific dietary ingredients actually prevent cancer? The pathways and biological mechanisms are being mapped now and it appears that some of these substances may actually work at the genetic level. A recent article from the Department of Medicine at Flinders University in Adelaide, Australia, summarizes the current state of scientific knowledge on this topic:

“Dietary factors might interact in several ways with the genome to protect against cancer. An agent might interact directly with the genome and regulate expression (as a genetic or epigenetic regulator) or indirectly by influencing DNA ‘repair’ responses and so improve genomic stability. Research now shows that diet-genomic interactions in cancer go beyond interactions with the normal genome and involve enhancement of normal cellular responses to DNA damage such that genome stability is more effectively maintained. Activation of apoptosis may be a key to protection.”

And this is likely a two-way street - while certain dietary factors may protect against cancer at the genetic level other dietary factors can contribute to cancer within the gene. For example, in this recent study published in the World Journal Gastroenterology people who ate diets rich in nitrosamines had a greater likelihood of developing esophageal cancer. Obviously, the relationship between ingesting carcinogens and cancer is not new. What is new is that scientists reported that this correlation was due to the effect this unhealthy diet had at the genetic level - specifically on chromosomal mutations in exon 6 of Tp53 gene. This gene is known as a tumor suppressor gene and its lack of proper functioning has been implicated in most cancers.

Diet as a Cancer Treatment

Research on the biological mechanisms between cancer prevention and diet suggest a critical and obvious question - if dietary ingredients such as specific foods, herbs, etc., working at the cellular or genetic level can help prevent cancer, can they also help to manage, control or treat a cancer that already exists? The alternative community has argued for decades that it can based on a combination of clinical research, in vitro studies, and anecdotal information from long-term cancer survivors. Many of these survivors had rejected conventional therapies (chemotherapy, surgery, and radiation) and had instead relied on dietary factors, supplements and other alternative regimens.

Current research continues to support this proposition. For example, one recent study that appeared in the Journal of the American Medical Association (JAMA) demonstrated that a higher intake of a Western dietary pattern after cancer diagnosis was associated with a significantly worse disease-free survival in patients with Stage III colon cancer. According to an article written about this study that appeared in the August 15th edition of Voice of America, “The high fat diet chosen by many people in developed countries — and a growing number of those living in developing countries — is called the Western Pattern Diet. In the study, those cancer patients who ate fattening foods had almost four times the risk of reoccurrence or death. Dr. Jeffrey Meyerhardt (one of the study’s authors) adds, ‘The biggest surprise is actually the impact that a western pattern diet seems to have.’ Patients who switched to greater quantities of fruits, vegetables, poultry and fish appeared to fare better.”

And in a study from Ohio State University, researchers tested the anti-cancer effects of anthocyanin-rich extracts from a variety of fruits and vegetables on colon cancer cells. Anthocyanin pigments are responsible for the red, purple, and blue colors of many fruits, vegetables, cereal grains, and flowers. Researchers retrieved these anthocyanins from fruits and other plants, including grapes, radishes, purple corn, chokeberries, bilberries, purple carrots and elderberries. Science Daily reported, “The plants were chosen due to their extremely deep colors, and therefore high anthocyanin content…The researchers found that the amount of anthocyanin extract needed to reduce cancer cell growth by 50 percent varied among the plants. Extract derived from purple corn was the most potent, in that it took the least amount of this extract (14 micrograms per milliliter of cell growth solution) to cut cell numbers in half. Chokeberry and bilberry extracts were nearly as potent as purple corn. Radish extract proved the least potent, as it took nine times as much (131 µg/ml) of this compound to cut cell growth by 50 percent. ‘All fruits and vegetables that are rich in anthocyanins have compounds that can slow down the growth of colon cancer cells, whether in experiments in laboratory dishes or inside the body,’ said Monica Giusti, the lead author of the study and an assistant professor of food science at Ohio State University.”

Like the relationship between cancer and prevention, the biological mechanisms that explain how dietary elements, herbs and other ingredients can actually slow or arrest cancer is beginning to be understood. And, like prevention, these molecules appear to act on the cells at the genetic level and within our immune systems.

For example, in a recent study from Japan, the ingredients in ginger were found reduce the viability of gastric cancer cells in vitro. Scientists were able to trace exactly how this worked and found that tumor necrosis factor (TNF)-related apoptosis-inducing ligand or “TRAIL” induces apoptosis of tumor cells but not most normal cells. Ginger has been used throughout the world as spice, food and traditional herb. Now, there is evidence that 6-gingerol, a phenolic alkanone isolated from ginger affects a complex biological mechanism that reduces the viability of gastric cancer cells.

And in another recent study, the herb Saw Palmetto was found to induce growth arrest and apoptosis in androgen-dependent prostate cancer cells in vitro by:

· Inducing apoptosis of LNCaP cells in a time- and dose-dependent manner.
· Increasing the expression of p21waf1 and p53 protein in LNCaP cells.
· Down-regulating DHT- or IL-6-induced expression of prostate specific antigen in conjunction with down-regulation of the level of androgen receptor in the nucleus.
· Down-regulating the IL-6-induced level of the phosphorylated form of STAT 3 in LNCaP cells.

This technical terminology can be quite confusing. But, the point is that there is hard science accumulating that certain dietary ingredients and medicinal herbs have efficacy in reducing cancer through genetic, cellular and immune pathways.

Where are all the clinical trials for food and herbs?

Clinical trials are expensive to run and there is an expectation that a profit can be made from a new drug or therapy. However, because ginger, saw palmetto, low-fat diets, anthocyanins and other naturally occurring molecules are difficult to patent, drug companies are hesitant to invest in them. Nonetheless, research into human biology is beginning to illustrate that the statement by Hippocrates, the ancient Greek physician and the Father of Medicine, “Let your food be your medicine, and your medicine be your food” was likely correct. Unfortunately, until economic incentives are altered it is unlikely that cancer patients will be given the option of a clinical trial based wholely or partly on diets, herbs, and other naturally occuring substances. Patients interested in dietary approaches will have to continue to perform their own research by reading and speaking to professional health practitioners experienced in this area.

A new presidential report on cancer takes on not only tobacco companies but the food industry while calling on the federal government to “cease being a purveyor of unhealthy foods” and switch to policies that encourage Americans to eat vegetables and exercise.

The report, issued on Thursday, also urged changes in public and private insurance policies to encourage doctors to spend more time counseling patients on how to stay healthy by eating right, exercising and avoiding tobacco.

Federal, state, and local policies have actually made healthful foods more expensive and less available, have limited physical education in schools and created an environment that discourages physical activity, the report said.

“Ineffective policies, in conjunction with limited regulation of sales and marketing in the food and beverage industry, have spawned a culture that struggles to make healthy choices - a culture in dire need of change,” said the report, available on the Internet at http://pcp.cancer.gov.

Margaret Kripke of the University of Texas M.D. Anderson cancer center, a member of the President’s Cancer Panel, said in a telephone interview, “What became clear to me is that we simply don’t have the political will to protect the public health.”

Several reports have shown that a third of all cancers are caused by tobacco use, and another one-third by obesity and inactivity.

“This country must not ignore its moral obligation to protect the health of all Americans. We can and must empower individuals to make healthy choices through appropriate policy and legislation, and the panel urges you to use the power of your office toward this life-saving goal,” the panel, chaired by Howard University’s Dr. LaSalle Leffall, wrote in a letter to Bush.

Purveyor of Unhealthy Foods

The report recommended much stricter control of the tobacco industry and urged Congress to authorize the U.S. Food and Drug Administration to regulate tobacco.

“The report also supports increasing the federal cigarette tax, which is currently 39 cents per pack,” American Cancer Society Chief Executive Officer John Seffrin said in a statement.

“The panel’s recommendation runs counter to the president’s public opposition to a tobacco tax increase.”

The federal government also should “require the elimination of unhealthy foods from school breakfast and lunch programs” and “must cease being a purveyor of unhealthy foods that lead to disease and increased health care costs,” the report said.

This includes regulation of food advertising and changing agricultural support policies, it said.

“We heavily subsidize the growth of foods (e.g., corn, soy) that in their processed forms (e.g., high fructose corn syrup, hydrogenated corn and soybean oils, grain-fed cattle) are known contributors to obesity and associated chronic diseases, including cancer,” the report reads.

“The people who are doing the U.S. agricultural subsidies need to connect their subsidies with the policy on public health and I don’t think that has been done,” Kripke said.

Yet fresh fruits and vegetables are not subsidized in the same way. “And physical education classes in school have almost disappeared,” Kripke said.

The American Cancer Society predicts more than 1.4 million Americans will be diagnosed with cancer in 2007 and that 559,650 will die.

This is unacceptable. This is changeable. Eating right, engaging in physical activity, keeping a healthy state of mind, and incorporating nutritional supplements into your diet are all ways you can assist your body in the fight against disease. Be informed and take control of your health, and the health of the ones you love!