We received the following letter this week:

"Thanks again and my warmest praise for the great moral courage you originally showed in publicly going against the greed-mongering establishment; plus your continuous and serious efforts, and time-consuming work, in opening the minds of so many people, both patients and professionals, to the realities behind the multitude of cancer truths and falsehoods within our all-too-often corrupt institutions. You deserve to be nominated for a Nobel prize in Medicine, and I do NOT say that to make you feel good."
--Richard M.

Well, we doubt if a Nobel prize is in our future. But we would be very happy to increase the subscribers to our newsletter by January 1. Please, if you haven't done so already, send a copy of this free newsletter to all of your friends who are concerned about cancer. We have never advertised this letter and so it grows exclusively by word of mouth. Please help us to spread accurate information on the effectiveness of cancer treatments, conventional and alternative.

Also, please remember that we offer Moss Reports on about 200 different cancer diagnoses. If you or a loved one needs help in making choices please check out our service at www.cancerdecisions.com

A FRIENDLY SKEPTIC LOOKS AT POLYMVA

In December 1998, I had the pleasure of receiving a visit from Dr. Merrill Garnett. Dr. Garnett is a former naval dentist who took up medical research in 1959 and directs a small center in Long Island, NY, called the Garnett McKeen laboratory.

On the day in question we had lunch, listened to his son playing the piano, and spent time talking about the nature and origin of his research. There is no doubt in my mind that Dr. Garnett is a highly original thinker.

He told me how he had experimented with thousands of compounds before coming up with a proposed anticancer agent which he dubbed PolyMVA. PolyMVA contains the rare metal palladium, whose behavior is not unlike that of platinum, the source of major anticancer drugs. He also presented me with copy of his autobiography, "First Pulse: A Personal Journey in Cancer Research." This little book was illustrated with oil paintings by his daughter, Joy. I enjoyed reading it and came away convinced that Dr. Garnett was both an affable person and a serious scientist, who had dedicated a long career to finding useful treatments for cancer. I say all this to emphasize that in the "friendly skeptic" equation I incline more towards friendliness than skepticism.

However, what do we really know about the clinical effects of Dr. Garnett's compound? Not much. The name PolyMVA is intended to convey that the substance is composed of a combination of minerals, vitamins and amino acids (i.e., MVA). PolyMVA contains various such agents, but its distinctive core is a combination of palladium and the antioxidant lipoic acid. Another name for this combination is "LAPd," which is humorously appropriate for an agent whose purpose is to "arrest" cancer cells. (It is also known as synthetic DNA reductase or Polydox.)

Dr. Garnett was granted a patent on PolyMVA in 1995. At the time of his visit, he was offering his agent free to any patient whose doctor would enroll in a clinical trial then underway. It was a generous offer, which has since been withdrawn. Five years later, PolyMVA has become a pricey and increasingly popular supplement, full-page ads for which regularly appear in alternative medicine magazines such as the Townsend Letter for Doctors & Patients (October 2003), Integrative Cancer Therapies (September 2003) and the ICHF newsletter (Autumn 2003),

At the 31st annual Cancer Control Society meeting in Universal City, CA, this Labor Day weekend, PolyMVA was the "show stealer" according to a long-time observer of alternative medicine, Michael Culbert. At one point, people who had reputedly survived fatal diseases through the use of unconventional methods were asked to come on stage. Of the 30 who appeared, 13 (by Culbert's count) ascribed their recovery in whole or in part to PolyMVA.

In promotional materials proponents say that more than 300 physicians around the world are using PolyMVA either by itself or in conjunction with other treatments. This figure may be exaggerated, but even so it is clear that some physicians are indeed using PolyMVA. Among the practitioners who are now praising it are the dentist and homeopathic physician David Korn, whom Culbert describes as medical director of the Aeris Cancer Treatment Center in Tempe, Ariz. (This information is outdated, since the Aeris clinic recently closed its doors.) Dr. Korn is quoted as saying that he has seen "complete recoveries" in cases of prostate cancer and lymphoma, and that PolyMVA is "the drug of choice for brain cancer." He also says that it is "wonderful for prevention," at a dose of half a teaspoon to one teaspoon daily.

In his own newsletter, Mr. Culbert reprints an opinion piece by the cardiologist Stephen Sinatra, MD, FACC, medical director of the New England Heart and Longevity Center in Connecticut, director of www.DrSinatra.com and editor of the Sinatra Health Report newsletter. According to this commentary, Sinatra and his personal "circle of physicians" ward off illness by employing a healthful life style. In particular, these doctors prevent cancer by taking "the most powerful nutrients known to man for prevention. And if we ever get cancer (the odds are slim), we have cancer's strongest natural enemies ready and waiting."

The centerpiece of Dr. Sinatra's prevention strategy is PolyMVA. Dr. Sinatra is quoted as making some extraordinary statements about the agent. For example: "We've finally won the war against cancer…It's the biggest breakthrough in the war against cancer." He further claims that PolyMVA can help stop breast, brain, lung and many other forms of cancer. If he himself had cancer, he says, he'd take PolyMVA "without hesitation." PolyMVA is supposedly effective for animal tumors as well.

Where's the Proof?

At a promotional website, it is said that Pharmakon Laboratories performed studies in mice using PolyMVA. The animals were first injected subcutaneously in the scruff of the neck with the agent. When the tumors reached a certain size (200 to 400 cubic millimeters), the mice were treated with either PolyMVA or an inert substance, either by mouth or intravenously. The test lasted 4 weeks and the volume of each tumor was determined twice per week. Necropsies were performed on all animals at the termination of the study. A reduction in tumor size compared to the control group was seen in all cases. "This reduction was statistically significant in the orally treated animals when the dose was 1 mg/mouse," the report read. "It was significant in all the intravenous treated group."

"Based on the data from this study," the site reads, "this synthetic reductase [i.e., PolyMVA] administered orally at 1 mg/mouse or IV [intravenously] at 0.5, 1 or 2 mg/mouse significantly reduced the growth of the glioblastoma tumor cell line" in these laboratory animals.

This is all well and good. Animal studies are necessary to lay the groundwork for clinical trials in humans. But there is no author or citation given for this mouse study. To my knowledge, no write-up of such a test has ever been published except in this informal report on the Internet.

At another promotional website, www.polymvasurvivors.com, mention is prominently made of what are called "clinical studies." But what is discussed there are not formal clinical studies at all, nor even an academic paper, but a talk delivered by Rudolf E. Falk, MD, at the Adjuvant Nutrition in Cancer Treatment Symposium, held on March 10th 1994. Dr. Falk is described as an "ontological surgeon" at the University of Toronto. (The authors obviously mean "oncological surgeon.") In fact, Dr. Falk left the University of Toronto in 1985 to form his own private Falk Oncology Centre in that city, specializing in alternative treatments. I can find no record of this speech, or any other writings of his on PolyMVA, as having been published in any journal.

To quote from the summary attributed to Dr. Falk, "95 patients were treated in a modified Phase 2 study." It is not at all clear what he means by this and unfortunately we cannot ask him, since he died in 1998. However, referring to a "Phase 2 study" implies a formal clinical trial, yet there is no record of such a trial in the standard databases. I suspect that these were simply patients that Dr. Falk treated in the course of his busy daily practice. Patients in this "study" included those with "breast, lung, colorectal, prostate, pancreatic, ovarian, malignant melanoma and primary brain neoplasia." Ninety percent of the patients had supposedly "failed all available therapy." At the time of the speech, 88 were described as surviving on the therapy with a mean survival time of 9 months. According to Dr. Falk, the anticipated survival time of this group from available statistics would vary from 20% to 60% at 6 months. However, it is important to note that all of these patients also received what Dr. Falk describes as "moderate doses of chemotherapy."

It was certainly understandable that Dr. Falk gave these patients a more established treatment in addition to the experimental one, PolyMVA. But since these patients also received chemotherapy, one cannot exclude the strong possibility that any temporary improvement in tumor size and patients' clinical status was due to the effect of chemotherapy rather than to the PolyMVA treatment. Also, where is the follow-up on these patients? Nine months is usually not enough time to draw any conclusions concerning the effectiveness of a cancer treatment. Patients sometimes experience transient benefit, only to decline rapidly a few months later.

In addition, the 20 to 60 percent survival figures that Falk gives are essentially uninterpretable, not only because it is impossible to separate out the effects of chemotherapy from those of PolyMVA, but also because the patient sample itself was inherently so diverse. It is simply not possible to draw conclusions from such a 'study' when there has been no attempt to standardize the patients by making sure that they all had the same, or closely comparable, disease and stage, and all had similar performance status at the outset. Furthermore, the effect of something as seemingly nebulous as patient motivation can itself be profound. Highly motivated patients who have sought out a treatment represent effectively a different sample from the more passive, fatalistic, stay-at-home patients who provide the raw material for many statistical tables.

In short, there is a powerful selection bias at work in putting together such groups. Patients who traveled to Dr. Falk's Toronto clinic for treatment came imbued with determination and hope. (I saw this first hand when I visited him in the mid-1990s.) A recent study by Elizabeth Lamont, MD, of the Massachusetts General Hospital, Boston, showed that patients who travel to receive treatment survive much longer than those who simply accept treatment at their local clinic, even when the two treatments are the same in all formal aspects.

Click or go to these two web pages for my previous articles on Dr. Lamont's findings:

http://www.cancerdecisions.com/092003.html

and

http://www.cancerdecisions.com/092703.html

At the www.polymvasurvivors.com website it is further stated that "the first 27 patients…were all considered terminal, and all refused to continue with chemotherapy." They were therefore placed on a "health promotion program" as outlined in chapter 23 of book "The Definitive Guide to Cancer," published in 1997 by Burton Goldberg, founder of Alternative Medicine magazine.

"The cancers involved brain, tongue, esophagus, lung, breast, stomach, colon, pancreas, prostate, lymph, blood, and marrow," the website continues. "All had metastasis. All were given 5 drops [of PolyMVA, ed.] four times daily as a loading dose. 13 reported improvements in either appetite, weight gain, increased energy or reduction in pain within the first 7 days of starting PolyMVA. At the end of 14 days, 6 additional patients reported improvement. None of the 27 patients reported adverse reactions. We learned from this small study (1) that the initiating dose was inadequate, (2) rapid improvements can be expected in patients with a variety of malignant conditions, (3) LAPd is non-toxic. When given this low dose, some patients demonstrated clinical changes indicating early improvement."

I am not sure who the author of these astonishing words is supposed to be. One clue is that the subject of the cited chapter in the Goldberg book is Lawrence H. Taylor, MD, of Chula Vista, California. In that popular book he is quoted as saying that "research on PolyMVA is ongoing in the United States and Mexico." He further describes PolyMVA in glowing terms as a "new concept in nutritional supplements….It repairs the abnormally altered gene that is believed to set the cancer mechanism in motion." According to the same chapter, "preliminary indications are that PolyMVA is effective against brain tumors, glioblastomas, and lung, ovarian and breast cancers."

About brain tumors, Dr. Taylor is quoted as saying that "even in the late stages with extensive symptoms of partial paralysis, memory changes, and ambulatory abnormalities, there was a quick and prolonged return to normal function." (p. 508). As to breast cancers, Dr. Taylor states that "late stages with extensive bone metastasis have reported resolution of the bone loss and reduction in pain" (ibid.).

All of these are extraordinary claims and therefore deserve the closest scrutiny. Who exactly is Lawrence Taylor? According to the Goldberg book, Dr. Taylor is a "top physician" whose experience includes "four decades of studying the problem of cancer." Yet according to the website of the California Medical Board, on March 1, 1996, Lawrence H. Taylor, MD, had his medical license revoked as a result of disciplinary action rendered by the Board. No further practice by him is permitted in that state. Oddly enough, the Goldberg book, which was published in the following year, failed to mention this salient fact, although it did state that Dr. Taylor's patients were being treated in Tijuana, Mexico.

The fact that "none of these patients reported adverse reactions" in 14 days is hardly definitive proof that PolyMVA is non-toxic! It should be obvious that serious adverse effects can and do emerge beyond an arbitrary two-week mark. And the author (whoever he or she is) has apparently never heard of the placebo effect. I also cannot see how one can conclude that "rapid improvements can be expected in patients with a variety of malignant conditions" from the above so-called study.

TO BE CONCLUDED WITH REFERENCES NEXT WEEK.

--Ralph W. Moss, Ph.D.

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The news and other items in this newsletter are intended for informational purposes only. Nothing in this newsletter is intended to be a substitute for professional medical advice.

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