HERE AT THE MOSS REPORTS

Most people believe that all medical treatments are solidly grounded in science, and that in order to be made available to patients, such treatments must be unequivocally proven to be effective by rigorous clinical trials. Yet, surprisingly, this is by no means always the case: some treatments are simply "grandfathered in" ­ i.e., accepted on the basis of having been around for a long time, and are just assumed - wrongly in some cases - to be effective. Last week I began a discussion of a paper, written by three Australian oncologists and published in the journal Clinical Oncology, showing that the contribution of chemotherapy to the five-year survival of adult cancer patients was just over 2 percent. I conclude that discussion this week.

I have made it my life's work to study the medical literature critically and to question the basis for cancer treatments that have become universally adopted without ever having been shown to prolong life. I have written and published extensively on the subject of cancer and its treatment, including compiling a comprehensive series of individual reports on more than 200 different cancer diagnoses – The Moss Reports – each one of which examines both the standard treatment options that are likely to be offered for a particular cancer diagnosis, and the possible alternative and complementary approaches to that disease.

If you would like to order a Moss Report for yourself or someone you love, you can do so from our website, www.cancerdecisions.com, or by calling 1-800-980-1234 (814-238-3367 from outside the US).

I also offer phone consultations to clients who have purchased a Moss Report on their particular cancer type. A phone consultation can be enormously helpful in drawing up an effective treatment strategy and getting one's options clearly prioritized. To schedule an appointment, please send an email to Jacquie@cancerdecisions.com.

In addition to the 400-page diagnosis-specific Moss Reports, we also have a growing list of shorter reports on cancer-related topics. Currently available are:

• Mammography, Biopsy and the Diagnosis of Breast Cancer
• Herceptin – or Deceptin?
• Do Antioxidants and Chemotherapy Conflict?
• Mexican Cancer Clinics in the Era of Evidence-Based Medicine

These reports, priced at $9.95 each, can be ordered and downloaded from our website at www.cancerdecisions.com.

We look forward to helping you.

AUSTRALIAN ONCOLOGISTS CRITICIZE CHEMOTHERAPY, PART TWO

To their credit, the Australian authors of the study on the effectiveness of chemotherapy address the issue of relative versus absolute risk. They suggest that the apparent gulf between the public perception of chemotherapy's effectiveness and its actual mediocre track record can largely be attributed to the tendency of both the media and the medical profession to express efficacy in terms of relative rather than absolute risk.

"The minimal impact on survival in the more common cancers conflicts with the perceptions of many patients who feel they are receiving a treatment that will significantly enhance their chances of cure," the authors wrote. "In part this represents the presentation of data as a reduction in risk rather than as an absolute survival benefit and by exaggerating the response rates by including 'stable disease.'"

As an example of how chemotherapy is oversold, they cite the treatment of breast cancer. In 1998 in Australia, out of the total of 10,661 women who were newly diagnosed with breast cancer, 4,638 women were considered eligible for chemotherapy. Of these 4,638 women, only 164 (3.5 percent) actually gained some survival benefit from chemotherapy. As the authors point out, the use of newer chemotherapy regimens including the taxanes and anthracyclines for breast cancer may raise survival by an estimated additional one percent – but this is achieved at the expense of an increased risk of cardiac toxicity and nerve damage.

"There is also no convincing evidence," they write, "that using regimens with newer and more expensive drugs is any more beneficial than the regimens used in the 1970s." They add that two systematic reviews of the evidence been not been able to demonstrate any survival benefit for chemotherapy in recurrent or metastatic breast cancer.

Another factor clouding the issue is the growing trend for clinical trials to use what are called 'surrogate end points,' as a yardstick by which to measure a chemotherapy regimen's effectiveness. This is instead of using the only real measures that matters to patients – prolongation of life as measured by overall survival and improved quality of life. Surrogate end points such as 'progression-free survival,' 'disease-free survival' or 'recurrence-free survival' may only reflect temporary lulls in the progression of the disease. Such temporary stabilization of disease, if it occurs at all, seldom lasts for more than a few months at best. The cancer typically returns, sometimes with renewed vigor, and survival is not generally extended by such interventions. However, trials reported in terms of surrogate end points can create the illusion that the lives of desperately ill patients are being significantly extended or made more bearable by chemotherapy, when in reality this is not the case.

In summary, the authors state:

"The introduction of cytotoxic chemotherapy for solid tumors and the establishment of the sub-specialty of medical oncology have been accepted as an advance in cancer management. However, despite the early claims of chemotherapy as the panacea for curing all cancers, the impact of cytotoxic chemotherapy is limited to small subgroups of patients and mostly occurs in the less common malignancies."

Splitting Hairs

In view of the highly controversial nature of the study's findings, one might have expected it to receive enormous international attention. Instead, media reaction has been largely limited to the authors' native land of Australia; the study received almost no coverage whatsoever in the US. In fact, although the paper appeared in December 2004, there was limited coverage even Down Under. The authors were interviewed for the Australian Broadcasting Corporation (ABC) program The Health Report in April 2005. But their landmark paper did not come to most doctors' attention until a widely distributed medical practice periodical, the Australian Prescriber, ran an editorial on the study early in 2006.

On ABC's The Health Report, Prof. Morgan, the paper's principal author, reiterated the study's conclusions that chemotherapy had been oversold, and pointed to the fact that relative risk reduction is being used as the yardstick of efficacy, with its deceptively large percentage differences.

For balance, the show host, Norman Swan, interviewed Prof. Michael Boyer, chief of medical oncology at Australia's Royal Prince Albert Hospital, Sydney. Unable to deny the validity of the study's essential findings, Prof. Boyer instead attempted to nitpick the authors' methodology. He suggested that the figure for chemotherapy's efficacy was actually somewhat higher than the study had concluded. Yet even so, when pushed, the most favorable figure he could come up with was that chemotherapy might actually be effective in 5 or 6 percent of cases (instead of around 2 percent).

Interviewed by Australian Prescriber, Prof. Boyer similarly commented: "If you start...saying how much does chemotherapy add in the people that you might actually use it [in], the numbers start creeping up...to 5 percent or 6 percent" (Segelov 2006).

In my opinion, this sort of hair-splitting damns chemotherapy with faint praise. It actually confirms the central message of the three critics' study. If the best defense of chemotherapy that orthodox oncology can come up with is that it may actually be effective for 5 or 6 percent of cancer patients, rather than merely 2 percent, then surely it is high time for a radical reassessment of the widespread use of this toxic modality in cancer treatment. Either figure - 2 percent or 6 percent - will come as a shock to most patients offered this type of treatment, and ought to generate serious doubt in the minds of oncologists as to the ethics of offering chemotherapy without explicitly warning patients of its unlikely prospects for success.

It was also astonishing that the orthodox Prof. Boyer complained that one of the major shortcomings of the study was that it insisted on measuring absolute instead of relative benefits. Asked by the interviewer whether there weren't violations of informed consent implicit in the way that benefits of treatment were usually presented, Prof. Boyer defended the use of the more impressive-sounding relative risk reduction:

"One of the problems of this [Morgan, ed.] paper is it uses absolute benefits rather than relative benefits," he protested: "...the relative benefit is about a one third reduction in your risk of death."

This, of course, is precisely the reverse of the argument made by the study's authors, who clearly demonstrated the misleading nature of relative risk reduction as a means of describing the efficacy of chemotherapy.

Other Critics Emerge

Prof. Morgan and his Australian colleagues are not alone in criticizing the pervasive use of relative risk as a means of inflating treatment efficacy. There have been others in recent years who have also voiced concern about this trend. For example, in a letter to the editor of the medical practice journal American Family Physician, James McCormack, PharmD, a member of the faculty of Pharmaceutical Sciences, University of British Columbia, made this same point about relative vs. absolute risk with great clarity.

Dr. McCormack took as an example the prescription of the bisphosphonate drugs in the treatment and prevention of osteoporosis...but identical issues apply to the use of anticancer drugs. The journal in question had written that one of those drugs produced almost "a 50 percent decrease" in the risk of new fractures. Addressing himself to a hypothetical patient, Dr. McCormack reinterpreted this statement in terms of absolute risk: "Mrs. Jones, your risk of developing a...fracture over the next three years is approximately 8 percent. If you take a drug daily for the next three years, that risk can be reduced from 8 percent to around 5 percent, or a difference of just over 3 percent." Of course that sounds far less impressive than saying that taking the drug will decrease the risk of fracture by almost half, even though technically both are mathematically accurate ways of expressing the benefit to be gained by the therapy.

The Good News and the Bad

News concerning conventional cancer treatments seems to come in two varieties: good and bad. Good news, meaning that conventional treatments work well, often generates widespread press coverage and enthusiastic statements from health officials. On the other hand, bad news, such as the fact that conventional treatments have generally been oversold, usually comes and goes unseen, attracting no media attention whatsoever.

An example of the first kind is the recent announcement that for the first time in 70 years, the absolute number of US cancer deaths had fallen. Andrew C. von Eschenbach, MD, director of the US National Cancer Institute (NCI), called this "momentous news." Similarly, Dr. Michael Thun, head of epidemiological research for the American Cancer Society, said it was "a notable milestone." How big was the celebrated decline? As we reported in a recent newsletter, deaths actually fell by a total of 370, from 557,272 in 2003 to 556,902 in 2004. Expressed as a percentage of the total, it represents a drop of seven hundredths of one percent (0.066 percent).

Contrast the wildly enthusiastic coverage given to this tiny improvement in the annual cancer death rate with the almost total media blackout (at least in North America) on this critical paper from Australia. Yet nothing can obscure the fact that chemotherapy, for most indications, has far less effectiveness than the public is being led to believe. Dr. Morgan and his colleagues deserve every reader's gratitude for having pointed this out to their colleagues around the world.




--Ralph W. Moss, Ph.D.

References:

Australian Broadcasting Corporation (ABC) Health Report – Available from:
http://www.abc.net.au/rn/talks/8.30/helthrpt/stories/s1348333.htm

Bucher HC, Weinbacher M, Gyr K. Influence of method of reporting study results on decision of physicians to prescribe drugs to lower cholesterol concentration. BMJ. 1994;309:761-764.

Chao C, Studts JL, Abell T, et al. Adjuvant chemotherapy for breast cancer: how presentation of recurrence risk influences decision-making. J Clin Oncol. 2003; 21 (23):4299-4305.

Morgan G, Ward R, Barton M. The contribution of cytotoxic chemotherapy to 5-year survival in adult malignancies. Clin Oncol (R Coll Radiol). 2004;16(8):549-60.

Segelov, E. The emperor's new clothes – can chemotherapy survive? Australian Prescriber. 2006; 29 (1):2-3

For copies of my book, Questioning Chemotherapy, click or go to:
http://www.amazon.com/exec/obidos/dt/assoc/tg/aa/xml/assoc/-/188102525X/cancerdecisio-20/ref%3Dac%5Fbb6%5F%2C%5Famazon/104-1661683-0762302

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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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