Cancer Decisions - Free Newsletter -June 10, 2007

GARDASIL - NEW CAUSE FOR CONCERN

An editorial published two weeks ago in the New England Journal of Medicine (NEJM) raises serious questions concerning the effectiveness of Gardasil, Merck's cervical cancer vaccine, and explicitly calls for a more cautious approach toward public policy decisions on Gardasil vaccination.

The NEJM editorial accompanied the publication of a study in the same issue that found that the effectiveness of the vaccine was greatest when it was administered to girls and young women who had not previously been exposed to any of the four major types of human papillomavirus (HPV) that are associated with cervical cancer. Among this highly selected population, Gardasil was 98 percent effective in preventing infection with these four strains of HPV. However, the vaccine's effectiveness fell dramatically - to only 17 percent - when it was administered to girls and women in the broader population who had previously been exposed to HPV, and who already had very early signs of cervical pre-malignant change (Sawaya 2007).

Not only is the vaccine far less effective in the general population than Merck's publicity blitz had initially suggested, it may also be far less safe than originally assumed. According to documents obtained last month from the Food and Drug Administration under the Freedom of Information Act, more than 1,600 adverse reactions to the vaccine have already been documented by the FDA's Vaccine Adverse Event Reporting System (VAERS), including three deaths which were related to blood clotting (thrombosis). Among 42 women who were vaccinated with Gardasil while pregnant, 18 experienced reportable adverse events ranging from miscarriage to fetal abnormalities.

Concern and caution over this vaccine is therefore amply justified. Our Current Topics report "On Guard - Gardasil" is a full-length discussion of the vaccine and the deeply flawed clinical trials that led to its approval. Click here to purchase this report: http://cancerdecisions.com/030407.html

HERE AT THE MOSS REPORTS

We are dedicated to bringing our readers and clients the latest and most interesting developments in the field of cancer research, treatment and prevention.

The Moss Reports is a comprehensive series of detailed individual reports on more than 240 different kinds of cancer. Each Moss Report analyzes the most promising current treatments, both conventional and alternative, for a particular cancer type, and offers the cancer patient a clear-eyed, truthful assessment of the available options. If you would like to purchase a Moss Report for yourself or someone you love, you can do so securely from our Web site (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 bought a Moss Report. A phone consultation can be enormously helpful in drawing up a treatment strategy and getting one's options clearly prioritized. I was honored to receive the following comment from a husband and wife who had a joint consultation:

"We felt that speaking to Dr. Moss was a great gift. He has a wealth of information, which we were able to receive because the person we were speaking to was unbiased and had such an obvious concern for humankind." - Clients O. and S. L.

To schedule an appointment for 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.

CURRENT TOPICS

Also available from our Web site are our Current Topics reports - a series of in-depth reviews of cancer-related subjects and controversies. Currently available are the following:

On Guard - Gardasil (An in-depth discussion of the anti-cervical cancer vaccine Gardasil)
Do Antioxidants and Chemotherapy Conflict?
Mammography, Biopsy and the Diagnosis of Breast Cancer
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
The Mexican Cancer Clinics in the Era of Evidence-Based Medicine

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ASCO 2007 - NEWS FROM THE FRONTLINES IN THE WAR ON CANCER

I recently returned from the 2007 meeting of the American Society of Clinical Oncology (ASCO). There were about 30,000 attendees at this 43rd annual meeting, held in Chicago. A total of 21,188 presentations were offered - plenary lectures, clinical science symposia, oral and educational seminars, poster sessions, and 10,000 publications that were listed in the proceedings but not actually presented in an oral form.

ASCO is considered a pivotal annual event for the worldwide oncology community. Although it is called the "American" Society for Clinical Oncology, it is a very international meeting and you are as likely to hear German, Chinese or Spanish being spoken in the corridors as English.

One cannot help but be impressed by the tremendous organizational effort it takes to produce a meeting of this size and scope, as well as the phenomenal amount of time and money that is needed to produce these many papers and discussions. In the face of so much irrationality, not to mention madness, in the world, it is heartening to see science making such an effort to cure one of humanity's worst scourges.

That said, let me give you my admittedly subjective impression of the mood of ASCO 2007: the community seemed to me to be rather dispirited and discouraged, especially compared to the upbeat tone of previous meetings. This year, there were no major announcements to match the excited cheering that greeted news from the clinical front on drugs such as Gleevec and Herceptin at previous meetings. I kept waiting for the big announcement to come, but it never happened. It was all very low key. Even as I sit here at my desk, recovering from jet lag and what turned out to be a two-day trip home, I find it hard to identify any particular item that stirs the blood.

It is somewhat ironic that the top stories that were highlighted at ASCO this year concerned complementary and alternative (CAM) treatments, including shark cartilage, flaxseed and ginseng. The report on shark cartilage was negative, while those on flaxseed and ginseng were positive - the first time I can remember that ASCO has publicized the benefit of natural methods at a major meeting. But it is my perception that the number of papers on innovative forms of treatment is diminishing, or at least not increasing appreciably.

Although the New York Times (June 3, 2007) described shark cartilage as a "widely used alternative therapy for cancer," this characterization is decidedly dated. My perception - and that of other close observers of the field to whom I spoke - is that shark cartilage has largely been superseded as a cancer treatment. In fact, I cannot remember the last time that a cancer patient told me s/he was using it, or asked me about this treatment. William Lane's once-notorious book on shark cartilage ("Sharks Don't Get Cancer") was published 15 years ago. It, and a follow-up book, has been out of print for many years. These books - and shark cartilage itself - are mainly of historical interest.

It was therefore not important news - nor was it even truly news - that shark cartilage did not seem to help patients with lung cancer live longer. A 2005 clinical trial had in fact already shown that "there was no difference in overall survival between patients receiving standard care plus a shark cartilage product versus standard care plus placebo" (Loprinzi 2005).

The reason for highlighting CAM treatments was the acknowledgement by ASCO leaders that many of their patients are taking these supplements - widely available in health food stores - and asking their doctors about them. So, an ASCO spokesperson told the Times, "well-designed clinical trials are needed to determine whether these approaches are helpful or harmful."

"One of the most common questions patients ask me is about these things they have snookered away in their purses and pocketbooks," said Dr. Bruce Cheson, a hematologist at Georgetown University, who moderated an ASCO news conference on the studies of the therapies.

Dr. Charles Lu of the M.D. Anderson Cancer Center in Houston, the shark cartilage trial's lead investigator, said he thought there were grounds to believe that shark cartilage might work. That is because it was an early contender in the field of anti-angiogenesis. It contains factors that can slow formation of blood vessels. However, this is not the first time that agents that exhibit anti-angiogenic potential in the laboratory have failed to perform well in a clinical setting. Lung cancer patients who received shark cartilage lived a median of 14.4 months. Those who got placebo had a median survival of 15.6 months.

In another highlighted study, this one focusing on flaxseed and its possible role in controlling prostate cancer, taking flaxseed was found to reduce the aggressiveness of prostate cancer by 20-40 percent.

The ginseng study found that the powdered root helped fight fatigue. The study involved 282 patients with various kinds of cancer. About one-quarter of the patients who took 1,000 or 2,000 milligrams a day of a powdered extract of ginseng root reported that their fatigue had become "moderately" or "much" better. That contrasted with only one-tenth of those who took either a smaller amount or a placebo.

Debra L. Barton, the oncology professor at the Mayo Clinic who was lead investigator of the ginseng study, cautioned that many commercial ginseng supplements do not use the same Wisconsin ginseng that the study did.

There was nothing particularly remarkable about either the ginseng or flaxseed study. What made them unusual was that they were so prominently featured at ASCO. However, do not expect the posture of the average oncologist to change any time soon. I had the pleasure of spending some time at the booth of the Annie Appleseed Project, an organization that promotes the fair testing of dietary and nutritional supplementation in cancer. My observation was that most American oncologists simply ignored this alternative information as they made a beeline towards the elaborate and expensive displays of the largest pharmaceutical companies, some of which were offering gifts to doctors in exchange for listening to lectures on their products or filling out questionnaires. (Foreign oncologists, especially those from Asia, were more receptive to CAM and often stopped to chat.)

Overall, ASCO 2007 gave a good impression of the enormous amount of work being done in oncology by thousands of dedicated professionals. On the other hand, it was surprising that, while there were incremental improvements for a number of cancers, there were no important breakthroughs to be announced. This undoubtedly had an effect on the overall mood of the conference.

I hope to have a more complete discussion of results from the 2007 ASCO meeting available at our cancerdecisions.com Web site in the next few weeks.

--Ralph W. Moss, Ph.D.

References:

Loprinzi CL, Levitt R, Barton DL, et al. Evaluation of shark cartilage in patients with advanced cancer: a North Central Cancer Treatment Group trial. Cancer 2005 Jul 1;104(1):176-82

Sawaya GF, Smith-McKune K. HPV vaccination - more answers, more questions. N Engl J Med. 2007 May 10;356(19):1991-3.

VAERS reports on Gardasil adverse events available through the public interest group Judicial Watch®, www.judicialwatch.org. Accessed June 12 2002 from:
http://www.judicialwatch.org/6299.shtml

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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.