THE MOSS REPORTS Newsletter (01/08/06)

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8 Jan 2006 23:55:33 -0000

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THE MOSS REPORTS Newsletter (01/08/06)

 

 

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Ralph W. Moss, Ph.D. Weekly CancerDecisions.com

Newsletter #218 01/08/06

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THE MOSS REPORTS – CANCER DECISIONS NEWSLETTER

 

 

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.

 

 

http://www.cancerdecisions.com/010806.html

 

 

For January 8, 2006

 

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.

 

 

Signature

--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/

 

 

 

IMPORTANT DISCLAIMER

 

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.