DR. SHANTHA INDICTED

The Moss Reports ^ | 01.08.06 | Ralph Moss, Ph.D.

[Coleus]

DR. SHANTHA INDICTED

A Stockbridge, Georgia doctor, Dr. Totada R. Shanthaveerappa, better known as T.R. Shantha, MD, PhD, has been indicted by a grand jury in Atlanta on 84 counts: 16 counts of health care fraud; five of introducing an unapproved drug into interstate commerce; one of introducing a misbranded drug into interstate commerce; and scores of counts of money laundering, totaling US $4.78 million.

Dr. Shantha is primarily accused of using unproven medications, such as dinitrophenol (DNP), a banned, hazardous substance commonly found in weed killers, as a treatment for cancer. This "weed killer" charge has provided a sensational handle for most of the mainstream stories on the indictment. Dr. Shantha also has used insulin potentiation therapy (IPT) and hyperbaric oxygen (HBO) in his cancer work.

The 70-year-old former anesthesiologist is also charged with using Ukrain®, which is an Austrian-manufactured cancer drug that, despite a considerable body of scientific literature, remains unapproved by the Food and Drug Administration (FDA).  At this writing Dr. Shantha's "Integrated Chemotherapy Specialists" clinic apparently remains open (although the clinic has failed to return our phone calls). A number of his patients have come forward to defend him, claiming that they are in remission from their cancer because of his treatment.

At his Web site, Dr. Shantha claims: "Although there is no guaranteed cure for cancer, there are safe and effective, non-toxic, scientifically based alternative and traditional methods that can cure and control most cancers and other chronic diseases." One could certainly argue with the use of the word "most" in that context, but this is little different from what many complementary and alternative medicine (CAM) practitioners claim.  It is possible that the validity of CAM itself may become an issue at this trial. If the government broadens its attack to include CAM approaches in general, it may trigger a society-wide battle over patients' right to use such unconventional treatments as Ukrain® and immune modulators. The debate on this question has been rather quiet since Dr. Stanislaw R. Burzynski, MD, PhD, of Houston was acquitted of similar charges in the 1990s, but this current controversy may well rekindle it.

It will be considerably harder to defend Dr. Shantha's use of dinitrophenol, or DNP.

There are over 9,000 citations in the standard medical literature for dinitrophenol. Five hundred sixty two of these relate specifically to cancer. But as far as I can see, none of these citations contains any clinical trial results, much less positive indications for the use of DNP as a cancer treatment.  Dinitrophenol is a poison that can cause fever as part of a general pattern of adverse effects. According to one standard peer-reviewed article on DNP poisoning:

"In man, the classic syndrome consists of lassitude, malaise, headache, increased perspiration, thirst, and dyspnea [difficulty breathing, ed.], which may progress to hyperpyrexia [elevation of body temperature, ed.], profound weight loss, respiratory failure, and death. Because dinitrophenol compounds are widely used [i.e., as herbicides], it is likely that some patients with unexplained fever have unrecognized dinitrophenol poisoning" (Leftwich 1982).

This description is hardly reassuring as a basis for using DNP as a cancer treatment, least of all in an unapproved setting outside the context of clinical trials in which patients' rights are meticulously observed.  I have followed Dr. Shantha's activities for a number of years. We met and had lunch about one year ago at the 2004 Cancer Control Society (CCS) meeting in Los Angeles. I found him to be quite personable, with a lively sense of humor. What most distinguishes him is undoubtedly his prior career as an anesthesiologist at Emory University and a Clinical Professor at the Medical College of Georgia in Augusta, a position he held from 1990 to 1997. During that orthodox phase of his career, Dr. Shantha published articles in some of the best medical journals, including the New England Journal of Medicine. But these articles were in his special field of training, anesthesiology, and not on cancer treatment per se.

Dr. Shantha is anything but a narrow specialist. He has - to put it mildly - a wide-ranging mind. For instance, his many patent applications include natural formulas for diaper rash cream, vaginal tampons, antiperspirants, lock systems, kitchen utensils, vehicle covers, safety air bags, transdermal patches, and the production of energy under bridges, to name just a few. According to one of his Web sites, www.iptmd.com , his forthcoming books include a discussion of insulin potentiation therapy and the anatomical basis for regional anesthesia. Also forthcoming, apparently, are diverse works entitled variously Sleep on the Left Side and Live Longer, The Water of Life, 365 Rice and Tofu Cooking Menus, and The Last 20 hours of Jesus' Life.

To read Dr. Shantha's resume click or go to:
http://www.iptworks.com/new_page_1.htm

Dr. Shantha's methods of cancer treatment are equally unconventional. I have alluded to his interest in insulin potentiation therapy, itself a controversial approach. Heat treatment is another one of his interests and DNP was apparently used as part of what he calls "intracellular hyperthermia." (One of his former Web sites had the self-explanatory address www.heatkillscancer.com .)

The term "hyperthermia" refers to a form of treatment that makes use of elevated temperatures to induce the death of cancer cells. It is a well-researched procedure practiced at many academic centers in Europe, the US, Asia, etc. It would not be difficult to defend conventional local-regional hyperthermia in any court of law. However, while traditional hyperthermia relies on various devices for heating the body from outside, or introducing heated chemotherapeutic agents into the body, Dr. Shantha's method is based on his theory that DNP is capable of creating heat within the cells themselves - i.e., from the inside out - ostensibly by harnessing the heat generated by biochemical processes within the cell.

The Stockbridge doctor has hypothesized that his method would work by uncoupling the chain reaction of oxidative phosphorylation, the biochemical process by which cells generate energy. According to Shantha, an "uncoupling agent" is administered so as to create a futile short circuit by shuttling protons back into the mitochondrial matrix (mitochondria are energy producing organelles within the cell that utilize 95 percent of all oxygen). Shantha further proposes that such short circuits would increase heat production at the expense of useful energy. Because the uncoupling agent used in intracellular hyperthermia therapy is lipophilic (i.e., it seeks out and attaches itself to cell membranes), it would thus able to penetrate every cell in the body, including those in the brain. The net result of this, Shantha suggests, would be the conversion of mitochondria from efficient powerhouses of energy production to chemical furnaces that were capable of heating cancer cells from the inside out.

Or so, at least, he says. I find this description obscure and scientifically tenuous. Leaving aside the safety of this particular drug or procedure, it is not at all certain that one can truly heat cells from the inside out before the normal homeostatic mechanisms of the body (shivering, sweating, etc.) take over and restore normal temperature. I have been unable to find anything in the standard medical literature to support this concept.  The idea apparently originated with Nicholas Bachynsky, MD, whose medical license was revoked in the early 1990s. In 2003, Dr. Bachynsky created a clinic, now defunct, at the Villa Preziosa Medical Facility in Italy. In 2004, the US Securities and Exchange Commission (SEC) charge Bachynsky, three other individuals, and their company, Helvetia Pharmaceuticals, Inc. with a fraudulent securities offering. Helvetia, through Bachynsky and others, was said to have raised more than $3 million from approximately 50 investors in 2001 and 2002 through the sale of unregistered Helvetia stock and promissory notes. Bachynsky was the company's medical director.  To read more on the Bachynsky case, please click or go to:
http://www.sec.gov/litigation/litreleases/lr18756.htm

Although Dr. Shantha has disavowed any recent connection with Dr. Bachynsky, the description of Shantha's intracellular hyperthermia treatment at his Web site is practically word for word identical with Dr. Bachynsky's.  In addition, Dr. Shantha's charges for his treatment are also very steep. One week of intensive therapy costs between $12,500 and $17,500. Standard (2-3 week) treatment costs between $25,000 and $45,000.  It is important not to confuse this Bachynsky-Shantha form of "intracellular hyperthermia" with more established forms of hyperthermia, which are well described in the medical literature. Nor is it the same as a similarly named procedure using magnetite nanoparticles. The latter is a promising experimental approach that has nothing in common with the Shantha's "Heat Kills Cancer" treatment (Ito 2003).  Because of doubts about the validity of Dr. Shantha's approach, over a year ago we began including a warning in our Moss Reports that in the absence of firm clinical data showing its effectiveness, patients should avoid Shantha's "Heat Kills Cancer" treatment and consider better established forms of hyperthermia instead.

We sympathize with those patients who feel that they have been provided with hope in desperate circumstances. And we certainly worry whenever the government (never known for its sensitivity in these matters) starts to prosecute doctors for using unconventional cancer treatments. However, readers should realize that Dr. Shantha was on very shaky ground in his choice of treatments, especially the dubious DNP. This government prosecution should come as no surprise to anyone, least of all the good doctor himself.


--Ralph W. Moss, Ph.D.

References:

Ito A, Shinkai M, Honda H, et al. Heat shock protein 70 expression induces antitumor immunity during intracellular hyperthermia using magnetite nanoparticles. Cancer Immunol Immunother. 2003;52:80-8

Leftwich RB, Floro JF, Neal RA, Wood AJ. Dinitrophenol poisoning: a diagnosis to consider in undiagnosed fever. South Med J. 1982 Feb;75(2):182-4.

Shantha's Web site: http://www.iptmd.com/

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[indcons]

"It will be considerably harder to defend Dr. Shantha's use of dinitrophenol, or DNP."

You can say that again!!

[SunkenCiv]

I wonder if his defense will be based on patient testimony? With such a litigious environment in the US, I'd be surprised if his patients were dropping like flies.