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Breast Health? Breast Cancer Drug as Preventive Called into Question

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Breast health? Breast cancer drug as preventive called into question
by Bill Sturgeon

The National Surgical Adjuvant Breast and Bowel Project of 1992 has been represented as a flagship study that produced astonishing good results from tamoxifen (also see "Conflict of interest," next page) in "preventing breast cancer." In fact this massive scientific study, supported by both government and industry, was curtailed early so that the women in the control group could then also receive the benefit of this new preventive treatment instead of the ineffective placebo they would have otherwise received.

Credibility of study in question

* Others in Europe tried to replicate these results without success. The July 11, 1998 issue of Lancet reported that two European research teams found no such protective effect derived from tamoxifen.

* World cancer expert, Samuel Epstein, M.D., wrote in 1992, "The evidence that tamoxifen can prevent breast cancer is largely wishful thinking. To make matters worse, the risks to healthy women of a wide range of serious complications, including uterine cancer, fatal liver cancer, liver failure, life-threatening blood clots and crippling menopausal symptoms are unacceptable. This trial must be halted in its tracks."

* The World Health Organization formally designated tamoxifen as a human carcinogen (cancer causing agent).

* C. Pierson of National Woman's Health Network wrote, "It doesn't make sense to use something that's listed as a carcinogen to try to prevent cancer."

* T. Bush of Johns Hopkins University said, "I'm questioning the philosophy of chemoprevention in healthy women using a toxic agent."

What do the figures say?

The incidence of breast cancer discovered in the study's large population after four years was 1.3 percent instead of the expected 2.3 percent, thus the reported 45 percent reduction in breast cancer rate. Much publicity was given to this finding.

This could reflect with equal validity that the study resulted in a 1 percent reduction in breast cancer incidence (2.3 minus 1.3 equals 1 percent). Incidence means that a woman does not have cancer until she has had a positive biopsy and cytology report. (See "When do you get cancer" below.) Accordingly, in a population of 100 healthy at-risk women taking prophylactic tamoxifen for four years, we can expect that one of them will, as a result of the drug's action, be spared - not from breast cancer - but from the discovery of breast cancer, during that time period only.

If that is the benefit, what is the cost? The cost is the exposure of all 100 women in the test population to greater risk of liver failure, liver cancer, eye problems, deadly blood clots and endometrial cancer (for women who still have a uterus). Liver cancer takes about ten years to be noticed, and some experts warn of a forthcoming epidemic of liver deaths in women taking this drug today.

But what is the cost measured in dollars? In 1999 prophylactic tamoxifen for 100 at-risk women for four years would cost $86.64 for a patient's single month's supply, or $415,872 total. Add to that the treatment costs of exposing all the women to the additional uterine and liver cancer it is known to cause. This single benefit would be obtained at the cost of nearly half a million dollars spent on tamoxifen! Is it worth it?

I ask whether this drug is about creating corporate wealth or creating public health?

In the Aug. 7 Boston Globe, Bernard Sanders, US representative from Vermont, was quoted: "Tamoxifen, a widely prescribed breast cancer drug, sells for one-tenth the price in Canada it sells for in the United States."

More questions

Does a person with an unnoticed five year old malignant tumor have cancer? What if that tumor were so slow-growing that it was not noticed before the person died of something else? Did she have cancer? Not according to the tamoxifen study's authors. To them only diagnosed cancers were real.

What of the tumors that failed to show up on schedule because tamoxifen evidently changed their growth rate? Did the tamoxifen destroy these breast tumors or just slow down their growth enough so that the five- and six-year-old tumors didn't show up on schedule?

After tamoxfen is discontinued do these slowed-down tumors once again increase their pace until of discoverable size? It undoubtedly buys a few women some time, but how many and how much? (See graph above for recent updates of the tamoxifen study after six years.)

Is there a healthier alternative?

Tamoxifen may buy a few women a few years of evident health. But there may well be an effective alternative to its use with no adverse side effects-dietary soy!

To oversimplify a bit, soy and tamoxifen each serve the same useful function in the female body-they are both estrogen receptor binders. We need more studies to learn about this link but who would fund it? Soy, being a natural product, cannot be patented.

Estrogen is a big villain in breast cancer. It causes rapid cell growth and hence nudges cell behavior closer to the uncontrolled cell growth that we call cancer. Anything that reduces your exposure to estrogen will reduce your chances of developing breast cancer. With each monthly period a woman's cells are exposed to estrogen as her body prepares for possible motherhood. That which reduces a life-time number of menstrual periods will reduce your chances of developing breast cancer-many pregnancies, longer breast feeding, early menopause.

Another strategy for reducing estrogen exposure is to tie up your body's estrogen delivery system. Estrogen, free flowing in your blood, connects to your tissue physically not unlike a key in a lock. When a key occupies the lock, another key cannot occupy the same space. An estrogen receptor (the lock) connects with estrogen (the key) and it enters your system. If an estrogen receptor binder, such as tamoxifen or soy is already in the lock, you are healthier than if an estrogen molecule were there.

Clearly we need to champion more research into breast cancer prevention.

When do you get cancer?

You undoubtedly have cancer cells in your body as you read this. In the process of cell replication constantly taking place in your body, some percentage - perhaps dozens each day - are bad copies, defective cells. These have all the earmarks of cancer cells-left to their own devices, they would grow into a malignant tumor. However, your healthy immune system routinely seeks them out and takes care of them.

When your cellular insults increase and your immune system weakens beyond tolerance, one of these cells may prevail, become a malignant tumor and grow exponentially in size. This growth will continue for seven or eight years, on average, until the tumor is large enough to be noticed by palpating fingers or X-rays or thermogram. So a woman will carry a growing breast tumor long before it is noticed and diagnosed.

Bill Sturgeon is a medical science writer and medical device manufacturer who lives in Petrolia. In 1958 Bill lost both his wife and only child to cancer. Since then, he has closely watched the national cancer industry which dedicates only one percent of its income toward cancer prevention efforts. If you have feedback please direct it to him at sturgeon@asis.com, or 707-629-3434

Editor's note: during the past few years we have wanted to bring you alternative voices in the breast cancer industry. In October 1997, Sturgeon wrote "How safe are mammograms?" In October 1998 his story was about Thermograms as an alternative to mammograms. In 1999, his October story was called "Breast cancer detection-trick or treatment." Senior News appreciates Bill Sturgeon for his ongoing research and writing in this field.

One-time article Copyright 2000 by Humboldt Senior Resource Center .