HERE AT THE MOSS REPORTS

Constantly monitoring the scientific literature pertaining to the prevention and treatment of cancer is an essential part of my work. By keeping a watchful eye on the medical journals I am able to discern emerging research ideas and pass along to my readers the latest developments. It also enables me to keep the library of Moss Reports on more than 200 different cancer diagnoses updated.

Each Moss Report is an even-handed and thorough analysis of the available conventional and alternative treatments for a particular kind of cancer. The reports also discuss such topics as participation in clinical trials, how to change one's diet in order to maximize one's chances of recovery, and how to detect and avoid unsafe and unsound remedies.

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).

Also downloadable from our website are our Current Topics reports on important cancer-related subjects. These reports are priced at $9.95 each.

Choose from the following:

•  Mammography, Biopsy and the Diagnosis of Breast Cancer
•  Do Antioxidants and Chemotherapy Conflict?
•  Herceptin – or Deceptin? (An evaluation of the use of Herceptin in breast cancer)
•  Avastin – Your Money or Your Life (A clear-eyed look at the 'targeted' drug Avastin)
• The Politics of Hope: Andrew von Eschenbach and the Decline of the National Cancer Institute
•  Mexican Cancer Clinics in the Era of Evidence-Based Medicine

I am also available for phone consultations with those clients who have purchased a Moss Report. 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 circumstances before he called, so his recommendations were totally pertinent."— A.B

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

We look forward to helping you.

IN MEMORIAM

I note with great sadness the passing of three significant figures in the world of complementary and alternative medicine.

Wolfgang Woeppel, MD, founding director of the Hufeland hospital in Bad Mergentheim, Germany, passed away on July 10, 2006.

Alexander (Alex) S. Sun, PhD, 67, founder of the Connecticut Institute for Aging and Cancer and of the Sun Farm Soup Co., Milford, CT, passed away several weeks ago. According to his son, Linus Sun, PhD, the cause was a sudden and fatal cardiac arrhythmia while exercising.

Dr. Fikrat Abdullaev, author of over 120 scientific papers and probably the world's leading expert on the medicinal uses and anti-cancer properties of saffron, died suddenly this week.

All of these men were personal friends as well as long-term colleagues. They were good people who fought hard for the benefit of cancer patients everywhere. I have requested details about their lives from the respective families. When these are forthcoming, I intend to write obituaries for each of them.

Dr. Woeppel, Dr. Abdullaev and Dr. Sun will all be greatly missed.

COMPANY KILLS NEGATIVE CLINICAL TRIAL

In late June, the pharmaceutical company, Genentech, Inc., abruptly halted a large phase III clinical trial of its drug Avastin. This trial was designed to test whether Avastin (whose scientific name is bevacizumab) could prolong the lives of patients with pancreatic cancer. The trial was halted at the recommendation of an independent data monitoring board because the addition of Avastin to an approved drug, Gemzar (gemcitabine), failed to improve overall survival. Significant improvement in Avastin's performance was deemed unlikely given the results that had already been seen.

Avastin is a so-called 'targeted' form of chemotherapy. It is a synthetic antibody that is designed to seek out and inhibit a specific cell surface protein called VEGF (vascular endothelial growth factor). VEGF is a signaling protein that is crucial to the ability of tumors to generate and maintain new blood vessels, a process called angiogenesis, which is essential for tumor growth.

Paradoxically, the premature halting of the clinical trial is likely to work in Genetech's - and Avastin's - favor. Genentech's losses have effectively been cut before worse damage could be inflicted by all the negative publicity that would follow publication of such mediocre results. The possibility that patients who received Avastin plus Gemzar might actually have fared worse than those receiving Gemzar alone has now been avoided. Genentech simply stated that significant differences in overall survival were "highly unlikely" between the two treatment arms.

But if such differences were so unlikely, why not let the trial play out? The purpose of a clinical trial is supposed to be the generation of new knowledge, even when that knowledge is detrimental to the financial interests of the sponsor. The company promises that the results will eventually be published in a medical journal, but this will probably receive next to no publicity when and if it finally happens. Early closure of the trial precluded any new revelations about Avastin's adverse effects. The company has asserted that the trial was not halted for safety reasons and that no new safety concerns related to this product were observed in the trial. However, a complete and thorough peer-reviewed report might have also added new knowledge about the drug's potential toxicity.

Despite this setback, Avastin remains a huge profit center for Genentech and its majority stockholder, the Swiss pharmaceutical giant, Roche. US sales of Avastin in the first quarter of 2006 jumped 96 percent to $398 million, from the $203 million mark for the corresponding period a year earlier. For Roche, Avastin contributed $1.67 billion to its $27.27 billion 2005 revenue from prescription drugs. This is not bad for a drug that, so far, has had only a minimal effect on advanced cancers of any type, including its original approved indication, colorectal cancer.

Click or go here to order my recent Current Topic report on Avastin:
http://www.cancerdecisions.com/031906.html

The cancelled trial was sponsored by the US National Cancer Institute (NCI) and involved 602 patients at approximately 200 sites around the world. It was initiated based on some hopeful results in a single-arm phase II study that combined Avastin with Gemzar in pancreatic cancer. This study concluded that "The 6-month survival rate was 77 percent and that "the combination of bevacizumab [Avastin] plus gemcitabine is active in advanced pancreatic cancer patients. Additional study is warranted" (Kindler 2005).

The larger phase III trial was carried out by a network of researchers organized by the Cancer and Leukemia Group B (CALGB). Patients were randomized to receive treatment with gemcitabine (Gemzar) plus Avastin or gemcitabine plus placebo as their first-line therapy.

The U.S. Food and Drug Administration (FDA) had previously approved Avastin in combination with intravenous 5-FU-based chemotherapy as a first-line treatment for patients with metastatic colorectal cancer. In June 2006, the drug was also approved as a second-line treatment of colorectal cancer (i.e., for use in patients whose cancer has progressed despite having already received one course of chemotherapy). The company has also requested licenses from the FDA for Avastin for advanced non-small cell lung cancer and for the treatment of women with advanced breast cancer.

In colorectal cancer trials, the drug has been shown to extend the lives of patients by approximately 3.3 months (Kabbinavar 2005). In lung, breast and now pancreatic cancer, however, there is not yet any proof of life extension from rigorous trials.

Perhaps the most startling thing about Avastin is its price - around $100,000 per year for some indications. Genentech has staked much on the success of this billion-dollar earner. The South San Francisco-based company is currently funding 130 clinical trials in 25 different types of cancer. According to MarketCancer.com, this decision to stop the pancreatic cancer trial will not affect any existing filings or approvals in colorectal, lung and breast cancer. For Roche-Genentech, the termination of this trial is only a minor setback, according to Hernani de Faria, analyst at Zuercher Kantonalbank. "The Avastin program is huge and broadly-based, as they're investigating more than 20 types of cancer," he said (RTT 2006). Wall Street analysts still estimate that the drug could eventually reap revenue of up to $10 billion from these expanded indications.

It seems extraordinary that a drug with such a weak general performance record could earn so much money and garner such positive publicity. The two phenomena are related, as patients and their doctors opt for specific treatments largely because of favorable media coverage. Here are some typical headlines over the past year. The first two come from the manufacturers of the drug, while other equally adulatory statements come from influential journalistic sources, whose ostensibly objective reporting adds weight to an essentially commercial agenda:

"Breakthrough cancer treatment Avastin receives first approval in the US" –Roche.com

"Avastin is a breakthrough drug..." –Gene.com (Genentech's Web site)

"Avastin May be Cancer Wonder Drug for Pancreatic, Renal, Ovarian and Prostate Cancers" –Medicalnewstoday.com.

"90% of Cancer Patients Completely Unaware of New Breakthrough Cancer Therapy" –antara.co.id

"Biotech Breakthrough for Colorectal Cancer."—imshealth.com.

"Amazing Avastin. This innovative colorectal cancer drug has the potential to revolutionize cancer therapy."—PharmaLive.com.

Meanwhile, this abruptly halted clinical trial, with its unequivocally negative results, has received little publicity, and certainly nothing like the intensely positive attention that surrounded the drug's approval last year. This kind of selective reporting helps to foster the illusion that targeted drugs such as Avastin are steadily improving the treatment and outcome of cancer. The truth, as revealed by the curtailed Genentech study, is very much less rosy. With a few notable exceptions, so-called 'targeted' drugs are still not targeted enough to make much of a difference to the outcome of the most common forms of cancer.

References:

Kabbinavar FF, Hambleton J, Mass RD, Hurwitz HI, Bergsland E, Sarkar S. Combined analysis of efficacy: the addition of bevacizumab to fluorouracil/leucovorin improves survival for patients with metastatic colorectal cancer. J Clin Oncol. 2005 Jun 1;23(16):3706-12. Epub 2005 May 2.

Kindler HL, Friberg G, Singh DA, Locker G, Nattam S, Kozloff M, Taber DA, Karrison T, Dachman A, Stadler WM, Vokes EE. Phase II trial of bevacizumab plus gemcitabine in patients with advanced pancreatic cancer. J Clin Oncol. 2005 Nov 1;23(31):8033-40.

RTTNews. Genentech Stops Avastin Pancreatic Cancer Trial As Results Fail To Meet Endpoint – Update., June 27, 2006. Available at:
http://www.tradingmarkets.com/.site/news/TOP%20STORY/290927/

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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