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[s] 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/levamisole 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:

"...[I]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, Ph.D.

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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