Cancer Decisions - Free Newsletter

HERE AT THE MOSS REPORTS

People facing a diagnosis of cancer typically must make a series of crucial treatment decisions in very short order. It can be hard to choose wisely at a time when one is under such intense pressure. The widely praised Moss Reports are an invaluable source of information on the currently available conventional and alternative treatments. There are now well over 200 individual Moss Reports, each one on a different, specific kind of cancer. For the cancer patient, a Moss Report offers a truly comprehensive resource. These reports can be ordered and downloaded directly from our Web site, www.cancerdecisions.com.

For those who have already purchased a Moss Report on their specific cancer diagnosis, a phone consultation with Dr. Ralph Moss can be enormously helpful in narrowing down the options and arriving at a coherent treatment strategy. A recent phone consultee put it this way:

"I have found Dr. Moss to be an invaluable resource for historical as well as very current research information pertaining to cancer treatments. In my consideration, he is the most objectively knowledgeable authority to turn to when more information is absolutely necessary." — SRH

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 send an email to Jacquie@cancerdecisions.com.

CURRENT TOPICS

It is a modern day mantra, widely repeated and unquestioningly accepted, that screening mammography offers the best chance of reducing breast cancer deaths. But is this really true? What can a woman really hope to gain by regular mammography? Are there hidden dangers in the methods used to detect and diagnose breast cancer?

Our report, "Mammography, Biopsy and the Diagnosis of Breast Cancer" looks in depth at the largely unpublicized shortcomings of screening mammography and also discusses needle biopsies, with an explanation of the possible link between this type of breast biopsy and the spread of cancer to nearby lymph nodes.

This report, priced at $9.95, is one of our Current Topics series, and can be downloaded directly from our Web site, www.cancerdecisions.com. Other available reports include:

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

NCI PRESS RELEASE DISTORTS RESULTS ON RALOXIFENE - PART ONE

Tamoxifen (sold in the US as Nolvadex®) is a useful drug. It can reduce the chance of developing breast cancer in women who are at high risk of that disease, and can also diminish the chance of recurrence in some patients who have been successfully treated for breast cancer. Unfortunately, tamoxifen also has some serious side effects, the most significant of which are an increased risk of thrombosis (blood clots) and a heightened chance of a particularly aggressive form of uterine cancer. Scientists have therefore been looking for similar drugs that would have the benefits of tamoxifen but with fewer dangerous side effects.

In April 2006, it seemed as if that substitute had indeed been found – a newer drug called raloxifene (sold under the trade name Evista®), which was originally approved for the prevention and treatment of osteoporosis (a decrease in bone mass and bone density with an increased risk and/or incidence of fracture). Subsequent studies suggested that Evista had anti-breast cancer effects as well. To test the comparative merits of these two drugs, the US government initiated the Study of Raloxifene and Tamoxifen, or STAR trial. This study eventually enrolled 20,000 healthy postmenopausal women and compared these two drugs to determine which was better at reducing the risk of breast cancer over a period of five years.

In April, the NCI released the results of the study in a widely heralded press release and telephone briefing to reporters. While both drugs affected breast cancer incidence about equally, the study reported that Evista had fewer side effects. NCI was so excited about these results that it devoted an entire section of its popular Web site to just this one trial (http://www.cancer.gov/star).

According to NCI's current statement, "Initial results of STAR show that the drug raloxifene is as effective as tamoxifen in reducing the breast cancer risk of the women on the trial. In STAR, both drugs reduced the risk of developing invasive breast cancer by about 50 percent. In addition, within the study, women who were assigned to take raloxifene daily and who were followed for an average of about four years, had 36 percent fewer uterine cancers and 29 percent fewer blood clots than the women who were assigned to take tamoxifen."

Needless to say, this sounds great. The mainstream media seized on this story enthusiastically, as they so often do when they encounter anything that could be construed as reflecting progress in the war on cancer. And since Evista was already on the market, there seemed little reason why eligible women, who number around 30 million in the US alone, shouldn't begin taking the drug at once.

Evista is Eli Lilly's fourth bestselling drug: over $1 billion worth of Evista is sold per year. But, despite appearances, things have not been so good recently for the company. Evista's US sales have actually been falling since last year, and so the company rather urgently needed some positive news about the drug. Approval of Evista for breast cancer prevention would be a needed shot in the arm for the Indianapolis-based drug giant.

For some time now, Lilly has appeared almost desperate to get a cancer-related approval for Evista. In April 2005, the company pleaded guilty to illegal promotion of the drug and paid $36 million in fines. The US Justice Department said that the company had criminally violated the Food, Drug, and Cosmetic Act. The FDA's enforcement arm had charged that "Evista sales were so disappointing its first year on the market, Lilly started promoting the drug for unapproved uses – which is illegal. Once approved by the FDA, the drug may not be legally marketed or promoted for so-called ‘off-label' uses - any use not specified in an application and approved by the FDA," according to the official publication Consumer Affairs (2005).

For Lilly, therefore, NCI's laudatory press release and dedicated Web site concerning Evista might be just what the doctor ordered. After this positive spin on the STAR trial, John Boris, an analyst with the investment firm Bear Stearns predicted that Evista's sales could reach $1.2 billion by 2008. Similarly, Bank of America Securities analyst Chris Schott predicted the study's results "will likely reinvigorate Evista growth." But Boris cautioned that Evista's performance would not "meaningfully improve" unless the drug received FDA approval as a breast cancer preventative for women at high risk of the disease.

However, this summer, the other shoe dropped. The group that headed the STAR trial, the celebrated National Surgical Adjuvant Breast and Bowel Project, based in Pittsburgh, PA, finally published its paper detailing the study's results. Those results were significantly less positive than the earlier NCI press release had suggested.

Women in the Evista arm of the study reported more musculoskeletal problems, dyspareunia (pain during sexual intercourse), and undesired weight gain. By contrast, women in the tamoxifen group had worse gynecological problems, vasomotor symptoms, leg cramps and bladder control symptoms. This analysis clearly challenged the NCI's contention that Evista had a better adverse effect profile than tamoxifen. In reality, both drugs caused an array of problems for many patients.

While the NCI press release had emphasized that unlike tamoxifen, Evista was not associated with an increased risk of uterine cancer, this turns out not to be strictly true. According to the latest figures, differences between the two drugs on this issue were not statistically significant, and therefore could have been due to chance alone, although this fact was obscured in NCI's initial presentation.

What about the supposed reduction in the incidence of blood clots with Evista? Again, so few of these events occurred overall in the study that it was difficult to distinguish any meaningful difference between the two drugs. Furthermore, while tamoxifen imparts an anti-cancer effect that persists for several years after women cease taking the drug, it is not known whether the same is true of Evista.

Even the American Cancer Society (ACS) attempted to distance itself from the STAR-struck NCI. "There is some genuine controversy here," said Len Lichtenfeld, MD, deputy chief medical officer of the ACS. Not everyone agrees "that there was a clear winner in this study," he said.

(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.