NIH INSTITUTE ABANDONS
NCI'S TAMOXIFEN STUDY

From The Cancer Chronicles #30
© Dec. 1995 by Ralph W. Moss, Ph.D.

A major part of the National Institutes of Health (NIH) has withdrawn support from the National Cancer Institute's (NCI) controversial trial of the drug, tamoxifen. This is the $68 million study to find out whether this drug, a powerful agent commonly used to treat advanced breast cancer, can reduce the risk of various diseases in healthy women.

Although the primary focus of the study is to find out if the occurrence of breast cancer can be prevented, another goal was to find out if the same drug could be used to reduce osteoporosis or fatal heart disease. Tamoxifen is already the top selling cancer drug in the world: a positive result in this study would result in an unprecedented bonanza for the drug's manufacturer, Zeneca (a branch of the giant ICI).

However, the director of the National Heart, Lung and Blood Institute (HNLBI), Dr. Claude Lenfant, has informed the new NCI director Richard Klausner that there were simply not enough minority women or women over age 55 in the study. "The way the study is going," Lenfant told Science, "we will get some information, but not what we were expecting" (11/10/95). Behind this mild statement may lurk a fierce struggle over the most controversial "prevention" study NIH has ever undertaken.

Tamoxifen is not a harmless or non-toxic supplement. It is a powerful and unpredictable agent, with complex and little understood effects on the body's hormonal balance. For these reasons, the test has generated controversy from the start, especially after patients learned that the drug itself cause endometrial cancer and cancer of the liver in animals. The word on the street is very negative. Thus, although NCI aimed to recruit 16,000 patients by June, 1994, the total recruitment was only 11,500. And only 3 percent of these were minority women, in whose communities skepticism of the medical establishment runs high.

The heart institute had originally pledged $3 million, but only $1.8 million of that has been spent. From the outside, NHLBI's complaints seem remediable.

"Frankly, I think [NHLBI] has been looking for a way out for a long time," an NCI staffer told Science.


Even more damaging to NCI's plan may be California Proposition 65, under which the state must maintain and publish a list of all known carcinogens. In 1994, the state's advisory group, the Carcinogen Identification Committee (CIC, headed by Dr. Thomas Mack, identified tamoxifen as a carcinogen: women who have used it have an increased risk of endometrial cancer. The state called an unprecedented hearing to review the CIC's finding on October 10. At that point, NCI grantees and officials, including Leslie Ford, NCI's coordinator of the tamoxifen trial, began a phone and letter campaign to protest the CIC's decision.

Zeneca flew its staffers as well as a group of "independent" oncologists to Sacramento, CA to lobby against the CIC's finding. Dr. Mack, an epidemiologist at the University of Southern California, courageously refused to attend the forum, called it a "reprehensible" attempt to interfere with his panel's deliberations. Mack says, "Unless something comes along that's a complete surprise, tamoxifen will be listed" as a carcinogen in California. And that may be the death blow to a widely feared NCI study.

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Ralph W. Moss, Ph.D. is director of the The Moss Reports for cancer patients. Dr. Moss is the author of eleven books and three documentaries on cancer-related topics. He is or has been an advisor on alternative cancer treatments to the National Institutes of Health, the National Cancer Institute, the American Urological Association, Columbia University, the University of Texas, the Susan G. Komen Foundation and the German Society of Oncology. He wrote the first article on alternative medicine for the Encyclopedia Britannica yearbook. He is listed in Marquis Who's Who in America, Who's Who in the World, Who's Who in the East, and Who's Who in Entertainment (as a film documentarian). This Web site does not advocate any particular treatment for cancer. We urge you to always seek competent medical advice for all health problems, especially cancer. Before consulting our site please read our full Disclaimer statement.



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