Cancer Decisions - Free Newsletter

HERE AT THE MOSS REPORTS

Our thanks, as always, to all those readers who have taken the time to provide us with comments about current or past newsletters and suggestions for future topics. Your input is greatly valued, and is often the impetus for important new projects.

For example, it was at the suggestion of several readers that we began writing and publishing our Current Topics series. Over the coming months, we plan to publish more of these useful reports. Their concise length (they average around 30 pages) and their modest cost ($9.95) make them both affordable and readable. We currently have the following Current Topics reports for sale at our Web site, www.cancerdecisions.com:

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

Meanwhile, we continue to publish this free weekly newsletter as we have for the past five years. Please remember to email your friends with copies of this newsletter. We want to build a worldwide community of people devoted to the rational and evidence-based examination of all cancer treatments, conventional and alternative.

And of course we continue to publish more than 200 different diagnosis-specific Moss Reports. Each Moss Report offers a thorough overview of the best available conventional and alternative treatments for a particular cancer diagnosis. For cancer patients and their families a Moss Report offers a truly comprehensive resource. These reports can be ordered and downloaded directly from our Web site, www.cancerdecisions.com. Ordering over the Internet means instant access to the fully searchable 400+ page report, and a $50 savings over the printed version.

For those who have already purchased a Moss Report on their specific cancer diagnosis, a phone consultation with Dr. Moss can be enormously helpful in narrowing down the options and arriving at a coherent treatment strategy.

A recent phone consultee wrote:

"After stumbling around in the jungle of alternative cancer treatments for some frustrating months, I ordered the Moss Report. Finally I had found information that I knew was absolutely trustworthy! Dr. Moss clearly has the depth and breadth of knowledge in this field that I was looking for. In addition he clearly has the worldwide medical contacts to keep up-to-date on all the latest research. The Moss Report quickly became the anchor in my quest for solutions. It gave me the perspective that I needed to make decisions.

"The subsequent telephone conversation with Dr. Moss was of equally vital importance to me in that Dr. Moss gave me advice and direction regarding my own specific personal situation. The conversation was not only highly informative but simply delightful. I just might ask for another consultation real soon, that's how valuable it was to me. I'm truly grateful. Thanks and best regards." — KR

If you are a Moss Report client and would like to schedule a consultation with Dr. Moss, please call 1-800-980-1234 (814-238-3367 from outside the US) or email Jacquie@cancerdecisions.com.

IS FDA ADVISORY COMMITTEE TIGHTENING THE RULES FOR DRUG APPROVAL? - PART I

In September, the FDA's Oncologic Drugs Advisory Committee (ODAC) refused to approve Abraxane, a new drug for the treatment of breast cancer, because of the weakness of the supporting data that was presented to the committee.

It is by no means certain that the FDA will go along with this decision. At one time, the FDA bowed unquestioningly to the decisions of ODAC, the agency's top scientific advisory committee on cancer, but this is no longer the case. For example, in July, 2006, ODAC recommended against the approval of Gemzar (gemcitabine) for the treatment of advanced ovarian cancer because of a lack of evidence of its effectiveness. However, the top leadership of FDA (under acting head Andrew C. von Eschenbach, MD) overrode the committee's decision and granted approval for this indication in spite of the absence of evidence of substantial patient benefit from the drug.

In the case of Abraxane, it remains to be seen whether FDA officials will abide by the decision of ODAC, or whether it will once again override the committee, and grant approval to a drug for which there is scant evidence of effectiveness.

Abraxane is already approved for use in patients with advanced, metastatic breast cancer for whom all other treatments have failed. Although Abraxane has been shown to cause temporary tumor shrinkage in a larger percentage of patients than the very similar drug, Taxol (24 percent versus 11 percent), there is no evidence whatever that Abraxane prolongs life in these patients. Abraxis BioScience, Inc., the drug's manufacturer, is strongly motivated to obtain approval for the drug as a treatment for node-positive breast cancer in its earlier stages since approval for use in this setting would greatly increase the market for the drug. And at $4,200 per dose, the drug stands to make a great deal of money for Abraxis BioScience.

Because of investor enthusiasm for Abraxane, the stock market value of Abraxis is currently $4.6 billion. The company had a profit of $86 million last year on sales of $519 million. According to the New York Times, Patrick Soon-Shiong, MD, the company's chairman, who owns 84 percent of the stock, is now worth about $3.8 billion, and annual sales of Abraxane could reach $1 billion within the next four years (Berenson 2006).

ODAC's refusal to expand approval for Abraxane without further clinical trials therefore represents an unwelcome setback for Abraxis. ODAC concluded that although Abraxane is closely modeled on Taxol (paclitaxel) it is basically a separate and new entity, and should therefore not be approved without the same clinical trial procedure that is required for all new drugs. This ruling came despite the intensive lobbying effort conducted by Abraxis, employing the help of at least one top name in American oncology. Arguing on behalf of the drug before the committee was Clifford Hudis, MD, chief of the Breast Cancer Medicine Service at Memorial Sloan-Kettering Cancer Center, New York. The panel, however, rejected his argument that since Taxol is known to be active in breast cancer, Abraxane should be approved as well. By a vote of 13-1, ODAC ruled that Abraxane was indeed a separate drug that will require independent proof of safety and efficacy.

Dr. Soon-Shiong remains staunchly enthusiastic about his company's product, despite the lack of evidence of its ability to prolong life. "We have a breakthrough," he is quoted by the New York Times as saying.

In its excellent analysis the Times points out that in at least one way, Abraxane is indeed a breakthrough, if only in that it costs about 25 times as much as Taxol. "Because of the odd economics of the cancer drug market, though, Abraxane's price does not seem to be hurting its popularity. About 20,000 people have now been treated with the drug, and Dr. Soon-Shiong expects its sales to approach $200 million this year" (Berenson 2006).

Worldwide, the money spent on cancer drugs is skyrocketing and is expected to more than double from 2004 to 2009, to $55 billion, with most of that in the United States (ibid.).

To be concluded, with references, next week.

--Ralph W. Moss, Ph.D.

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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.