THE MOSS REPORTS Newsletter (09/19/04)

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19 Sep 2004 19:50:24 -0000

 

 

THE MOSS REPORTS Newsletter (09/19/04)

 

 

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

Newsletter #150 09/19/04

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NEW DOUBTS ABOUT ADJUVANT CHEMOTHERAPY FOR COLON CANCER, PART TWO

 

 

Last week we revealed that a definitive clinical trial has shown that

a regimen containing 5-FU conveys no long-term survival benefit, when

given after surgery, in stages II and III colon cancer. This week we

conclude our discussion. –Ed.

 

 

CAM Comparisons

 

 

When an alternative cancer treatment fails in a clinical trial it is

generally finished—that failure is quickly made the basis for official

scorn or even a government clampdown. Anyone who doesn't accept the

negative results of such a clinical trial is considered recalcitrant.

By contrast, notice with what kid gloves the chemotherapy

establishment handles its own treatments, even when clinical trials

prove beyond doubt that the treatments in question do not prolong life.

 

These latest findings have additional importance when considered in

their historical context. At the time that 5-FU-based adjuvant therapy

was approved, alternative cancer treatments such as Laetrile and

high-dose vitamin C were presenting a determined challenge to

mainstream medicine. Oncology was a relatively new discipline and was

struggling to fend off the competition from alternative clinics in

Mexico and elsewhere.

 

Dr. Moertel, of the Mayo Clinic, was an outspoken critic of alternative

medicine. He called Laetrile one of the " dominant unresolved

problem for American medicine today " (Moertel 1978). Many cancer

leaders were less than enthusiastic about doing clinical trials, which

are apt to have uncertain outcomes. But Moertel passionately argued

that clinical trials be done on Laetrile, not in order to arrive at

the truth about its efficacy—he knew that already—but as a political

weapon. Laetrile, he told his fellow doctors, " can only be

successfully combated if we fight on familiar grounds, using the tools

that we have known to be most trustworthy: a tightly controlled

clinical trial performed in competent and experienced hands " (Moertel

1978).

Not surprisingly, it was Dr. Moertel who supervised the " tightly

controlled " clinical trials of these alternative treatments and

announced to the world that they had proven to be abject failures

(Creagan 1979, Moertel 1982, Moertel 1985).

Yet his approach to 5-FU/levamsiole was just the opposite. He

prematurely claimed that this treatment was highly beneficial to

patients and lobbied for its adoption by the general medical

community. It was hard to avoid the implicit message that whereas

alternative treatments such as Laetrile and vitamin C did little but

generate false hope, 5-FU based chemotherapy genuinely saved lives.

Some readers may feel that Dr. Moertel (who himself died of cancer a

few years ago) may have sincerely believed that chemotherapy worked

well, while alternative treatments were mere quackery. There certainly

are many in oncology who sincerely believe in chemo, just as there

many practitioners who are convinced of the efficacy of alternative

treatments.

However, in the New England Journal of Medicine in 1978, Dr. Moertel

revealingly wrote:

" ...t must be concluded that there is no chemotherapy approach to

gastro-intestinal carcinoma valuable enough to justify application as

standard clinical treatment. By no means, however, should this

conclusion imply that these efforts should be abandoned.

Patients...and their families have a compelling need for a basis of

hope. If such hope is not offered, they will quickly seek it from the

hands of quacks and charlatans " (Moertel 1978).

Read these words carefully. As Dr. Moertel saw it, chemotherapy should

be prescribed for its political, socio-economic and psychological

benefits, since by his own admission there was no solid medical

justification for its use as an adjuvant to surgery in colon cancer.

He was not the only one to voice such sentiments. Stanford University

surgeon Victor Richards, MD, put it still more bluntly. In 1972, he

wrote that even ineffective chemotherapy " serves an extremely valuable

role in keeping patients oriented toward proper medical therapy, and

prevents the feeling of being abandoned by the physician...Judicious

employment...of potentially useful drugs may also prevent the spread

of cancer quackery...Properly based chemotherapy can serve a useful

purpose in preventing improper orientation of the patients " (Richards

1972:215).

So positive news about 5-FU-based chemotherapy had more than medical

significance: it had great propaganda value in conventional medicine's

war on alternative approaches.

The medical establishment continues to this day to prescribe

chemotherapy even in circumstances in which they know it does not work

well.

Consider the clinical practice guidelines for stage II colon cancer

proposed by Dr. John McDonald, Professor of Medicine at New York

Medical College and chief of the division of medical oncology at St.

Vincent's Catholic Medical Center, New York. In a 2004 review of

adjuvant chemotherapy in colon cancer, written for the medical website

Medscape, Dr. McDonald candidly admits that there is " no convincing

evidence that therapy with adjuvant cytotoxic chemotherapy benefits

patients with stage II disease. " But that's not the end of the story.

He concludes:

" ...[F]or clinicians dealing with individual patients, the reason to

treat or not to treat is based upon a panoply of factors, most of

which are not associated with hard evidence-based data. These include

.... the desire of the patient in many instances to `do something,'

even if the benefit is small " (McDonald 2004).

In other words, if people opt for chemotherapy, they should be given

it, despite the fact that oncologists professionally acknowledge that

this is an unproven treatment that might harm or even kill their

patients.

When it comes to chemotherapy, oncologists show an unfamiliar

solicitousness and respect for their patients' freedom of choice.

However, as readers may have discovered, it is a different story when

patients request something as innocuous as antioxidant supplements.

Then many oncologists adopt a censorious or openly hostile approach.

Accepting Negative Results

A past director of the National Cancer Institute once complained to me

that CAM advocates lose scientific credibility when they refuse to

accept the conclusions of negative clinical trials. But the same

criticism can certainly be leveled against many advocates of

chemotherapy. Notice what happens when a proposed chemotherapy regimen

does not make the grade. Numerous friends of the pharmaceutical

approach rush to its defense, parsing statistics and splitting hairs

in an attempt to wrest the slimmest suggestion of benefit from stark

evidence of its ineffectiveness.

They point to short-term gains (in the absence of long-term benefit);

to the " outdated " nature of the regimen in question (yet 5-FU

continues to be a commonly used colon cancer drug); to the need for

changes in " surrogate markers " (which can be deftly foreshortened when

the data on overall survival prove negative over the long haul).

Role of Media

Medical ethicists do not censure these gross violations of scientific

protocol. The mass media fail to provide the public with even a

rudimentary understanding of chemotherapy's failures and limitations.

Experts -

including biostatisticians, who certainly know better - say nothing

that might upset their clinical colleagues. When favorable news about

5-FU and levamisole was triumphantly announced by Dr. Moertel, the

media were all over the story like white on rice. For example, Time

magazine called the Mayo Clinic treatment " death defying, " and said

Moertel's drug therapy could hold cancer " at bay " (October 16, 1989).

Since then, the mass media have continued to report favorably on the

supposed benefits of chemotherapy to the exclusion of more nuanced

interpretations of the treatment's worth.

For example, when I scoured the 4,500 sources in Google News to gauge

media coverage of the recent NSABP report on colon cancer, I found a

total of four articles on the topic, none of which had appeared in a

major newspaper or media outlet. The National Cancer Institute (NCI)

has not featured the NSABP study in its News Highlights, despite the

fact that it was published in the NCI's own medical journal.

Is it any wonder, then, that the general public continues to think

that great progress is being made in the war on cancer, since only

positive news about chemotherapy filters down through the mass media?

The British politician Arthur Ponsonby observed in 1928, " When war is

declared, truth is often the first casualty. " Welcome to the war on

cancer.

Please note: This discussion does not attempt to answer the question

of what one should do after surgery for stages II-III colon cancer. To

answer this would obviously entail a longer and more detailed discussion.

A good starting point for such an inquiry is the professional PDQ

statement on the treatment of colon cancer available free of charge at

www.cancer.gov

Regardless of the choices one finally makes in regard to chemotherapy,

more attention needs to be paid to immune modulators. These are the

sorts of issues that are dealt with in my comprehensive Moss Report on

colon cancer, which can be ordered online at www.cancerdecisions.com,

or by calling Diane at 1-800-980-1234 (814-238-3367 from outside the US).

--Ralph W. Moss, PhD

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References:

Boice JD, Greene MH, Killen JY Jr, Ellenberg SS, Fraumeni JF Jr, Keehn

RJ, McFadden E, Chen TT, Stablein D.Leukemia after adjuvant

chemotherapy with semustine (methyl-CCNU)--evidence of a dose-response

effect. N

Engl J Med. 1986;314:119-20.

Creagan ET, Moertel CG, O'Fallon JR, Schutt AJ, O'Connell MJ, Rubin J,

Frytak S. Failure of high-dose vitamin C (ascorbic acid) therapy to

benefit patients with advanced cancer. A controlled trial. N Engl J Med.

1979;301:687-90.

Grem, Jean. Adjuvant therapy for colon cancer: a historical

perspective. J Natl Cancer Inst 2004;96:1116-1117,1128-1132.

Laurie JA, Moertel CG, Fleming TR, et al. Surgical adjuvant therapy of

large-bowel carcinoma: an evaluation of levamisole and the combination

of levamisole and fluorouracil. The North Central Cancer Treatment

Group and the Mayo Clinic. J Clin Oncol. 1989;7:1447-56.

McDonald, John S. Adjuvant Therapy for Stage II Colon Cancer: A review

of clinical practice guidelines. Posted August 5, 2004. Retrieved

August 14, 2004 from:

http://www.medscape.com/viewarticle/484429

Moertel CG, .Schutt AJ, Hahn RG, Reitemeier RJ. Therapy of advanced

colorectal cancer with a combination of 5-fluorouracil,

methyl-1,3-cis(2-chlorethyl)-1-nitrosourea, and vincristine. J Natl

Cancer Inst

1975;54:69–71.

Moertel, CG, et al. Current concepts in cancer: chemotherapy of

gastrointestinal cancer. New England Journal of Medicine 1978;299:1049-52.

Moertel, CG, et al. A clinical trial of amygdalin (Laetrile) in the

treatment of human cancer. New Engl J Med 1982;306:201-206.

Moertel CG, Fleming TR, Creagan ET, Rubin J, O'Connell MJ, Ames MM.

High-dose vitamin C versus placebo in the treatment of patients with

advanced cancer who have had no prior chemotherapy. A randomized

double-blind comparison. N Engl J Med. 1985;312:137-41.

NIH. Adjuvant Therapy for Patients with Colon and Rectum Cancer. NIH

Consensus Statement Online 1990 Apr 16-18 [cited year month

day];8(4):1-25. Retrieved August 12, 2004 from:

http://consensus.nih.gov/cons/079/079_statement.htm

Richards, Victor. Cancer: The Wayward Cell. Berkeley: University of

California Press, 1972.

Smith RE, Colangelo L, Wieand HS, Begovic M, Wolmark N. Randomized

trial of adjuvant therapy in colon carcinoma: 10-year results of NSABP

protocol C-01. J Natl Cancer Inst 2004;96:1128–32.

Wolmark N, Fisher B, Rockette H, Redmond C, Wickerham DL, Fisher E, et

al. Postoperative adjuvant chemotherapy or BCG for colon cancer:

results from NSABP protocol C-01. J Natl Cancer Inst 1988;80:30–36.

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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.

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