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For September 17, 2006

HERE AT THE MOSS REPORTS


The sheer volume and complexity of the medical information that the newly diagnosed cancer patient must quickly absorb can be overwhelming. Often, decisions must be made in a hurry, and under great stress. It is not easy under these circumstances to make a careful and fully informed decision.

I have made it my life's work to study the medical literature critically and to question the scientific basis for cancer treatments, many of which 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, and have compiled 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.

I also offer phone consultations to clients who have purchased a Moss Report. A phone consultation can be enormously helpful in drawing up an effective treatment strategy and getting one's options clearly prioritized.

A recent phone consultee wrote:

"My phone consultation with Dr. Moss was invigorating and left me feeling hopeful again about helping myself beat this cancer. He was extremely generous with his knowledge, personable and easy to talk to. It was evident that he had really thought through my particular circumstance before he called, so his recommendations were totally pertinent."

To schedule a phone consult appointment, please call 1-800-980-1234 (814-238-3367 from outside the US) or send an email to: Jacquie@cancerdecisions.com.

Also available from our website are the following in our Current Topics series, focusing on issues of interest in the field of cancer prevention and treatment:

We look forward to helping you.


NCI PRESS RELEASE DISTORTS RESULTS ON RALOXIFENE - PART TWO


(Last week we reported on the NCI's misleading press release and Web site on the Study of Raloxifene and Tamoxifen, or STAR trial. This landmark study compared these two drugs in healthy postmenopausal women to determine which was better at reducing these women's risk of breast cancer over a period of five years. NCI's statements on the positive effects of raloxifene {Evista} have now been shown to be exaggerated. We conclude the discussion, with references, this week.)


NCI's science-by-press-release strategy generated considerable controversy at the 2006 meeting of the American Society of Clinical Oncology (ASCO). The STAR results were supposed to have been reported first at ASCO so that there could be some form of peer review before general announcements were made. But instead, according to the Associated Press, NCI hastily called a press conference "and didn't disclose in materials sent to reporters that some key results were not statistically significant."

"It needs to be publicly vetted because it's not clear either way" which drug is better, said Dr. Roy Herbst, a well-known M.D. Anderson Cancer Center, Houston, researcher.

The trial's actual results thus differed substantially from the interpretation pushed by NCI's press release. This has also disturbed some reporters who bought into the earlier NCI version of the study. In April, for instance, the popular MSNBC Web site declared: "New, safer drug helps prevent breast cancer." The subhead, referring to Evista, held that the new drug "causes fewer side effects than tamoxifen, large study finds." But less than two months later, MSNBC's headline reads: "Surprising flip-flop in breast cancer drug study. Contrary to initial findings, raloxifene may not be better than old standby."

Robert Bazell, NBC's Chief Medical and Scientific Correspondent, really took NCI to task. He pointed out that the most disturbing aspect of the actual paper was that raloxifene was shown to be associated with a higher incidence of ductal carcinoma in situ (DCIS). Biologists may debate whether DCIS is truly breast cancer, a pre-cancerous condition or merely a risk factor. "But tens of thousands of women a year require surgery (often mastectomy) and radiation to treat DCIS so anyone would think twice before taking a drug that might increase the risk," said Bazell (2006).

American taxpayers spent $88 million paying for this trial, and raloxifene manufacturer Eli Lilly put in another $30 million, in order to arrive at the present ambiguous result. No wonder Lilly was so eager to try and rescue something positive from this debacle.

Bazell, who has won journalism's prestigious Peabody Award, scolded NCI for conducting science by press conference, rather than by peer-reviewed study. Or, as he trenchantly put it, "Impress the public before the messy facts get in the way."

NCI scientists have offered several rationalizations for issuing their misleading press release. For instance, they said it was necessary for the sake of "public health" and to inform the women who were in the trial.

But, as Bazell put it, "It is hard to see how either public health or the volunteers benefit from incomplete and confusing information released in a hurry."

According to this veteran reporter, "The NCI has faced a huge problem since 1971 when President Richard Nixon ordered the 'war on cancer.' Deaths from cancer - not only total deaths, but the death rate adjusted for the age of the population - have been climbing. Only last year for the first time did the death rate drop by a mere 1 percent."

Because of this, "NCI is always painting a rosy picture of progress." What he calls NCI's "optimism in the face of reality" reached its pinnacle in 2003 when Dr. Andrew von Eschenbach, then head of the agency, declared the unrealistic goal of eliminating all suffering and death due to cancer by 2015. Although many scientists privately derided the impracticality of this notion, few of them dared speak publicly for fear of losing NCI's financial support.

Bazell's eloquent conclusion is worth quoting:

"In the face of the enormous health burden of cancer, NCI should be spending even more to elucidate both the basic science and the clinical applications - including studies like the STAR trial. But a government agency with a charter to improve the public's health does not serve it by trying to put a positive spin on every result."

While it was encouraging to see this trenchant analysis on the MSNBC Web site, from a cynical point of view one could conclude that NCI calculated correctly. Its press release about the so-called "good news on Evista" was picked up by thousands of media outlets and has undoubtedly already influenced millions of potential consumers. The critical view represented by Robert Bazell and a few others will reach only a tiny fraction of eagle-eyed readers. Most journalists and headline writers drew their sound bites from the NCI statement, and even with publication of the full report on the STAR trial in the Journal of the American Medical Association, public perceptions are unlikely to change. Apparently, a billion dollars per year in sales buys you a lot of good will, facts notwithstanding.



Signature
--Ralph W. Moss, Ph.D.



References:

Bazell, Robert. When medical reality doesn't match the spin. Recent study shows the government is too eager to claim cancer success, MSNBC Web site, June 20, 2006. Available at:
http://msnbc.msn.com/id/13421277/

Consumer Affairs. Eli Lilly Fined $36 Million Over Evista Promotion, April 8, 2005. Available at:
http://www.consumeraffairs.com/news04/2005/evista_fine.html

Land SR, Wickerham DL, Costantino JP, et al. Patient-Reported Symptoms and Quality of Life During Treatment With Tamoxifen or Raloxifene for Breast Cancer Prevention: The NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 Trial. JAMA. 2006 Jun 5; [Epub ahead of print]. Available through:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=
pubmed&dopt=Abstract&list_uids=16754728&query_hl=2&itool=pubmed_docsum

NCI Web site on STAR trial:
http://www.cancer.gov/clinicaltrials/digestpage/STAR




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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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