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withdrawn support from the National Cancer Institute's (NCI)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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