Tamoxifen and Raloxifene for risk reduction

Problems and complications to be looked at carefully

Ann Fonfa's further thoughts on Tamoxifen as used for "risk reduction". These may possibly apply to Raloxifene as well.

Each cancer center or institution involved with a clinical trial creates its own Informed Consent form. This means some things are included in some and not in others. There is NO STANDARDIZATION. This can cause a problem, it has in the past.

I just read a paper disclosing the historical problems experienced with BCPT1 the trial used to justify Tamoxifen in healthy women. It was stopped twice for a period of time to allow new information about dangerous unwanted effects to be added to the consent form. According to Janette D. Sherman in her article "Tamoxifen and Prevention of Breast Cancer, published in Toxicology and Industrial Health, Vol. 14, No. 4, 1998, a Congressional committee looked at the problems of adequacy of the consent forms used in the trial(s) and found"68% of the forms either omitted or altered one or more key points from the NCI approved model form. Some of the forms did NOT MEET minimum legal requirement for informed consent". (Ann’s emphasis).

Using Tamoxifen to reduce risk for breast cancer has so many negative effects that critics have asked whether this is disease substitution. As Ann’s testimony stated, healthy women died from taking this drug. It causes pulmonary embolisms, deep vein thrombosis (these last two are blood clots), eye problems, liver damage, endometrial/uterine cancer, depression, fatigue, hot flashes and more.

Standards for health people have never been formally decided upon. It is the opinion of many activists that this should have been done prior to 1992 when the original trial was begun.

Another area of concern is the entry criteria for the trials. Women over the age of 60 were considered at high enough risk to enter the trial. But studies and statistics have shown that only 1 in 8 woman in her lifetime will develop breast cancer. If this is true, then a maximum of one women per 8 enrolled from that age group (If no other ‘risk’ factors are present), will actually be diagnosed. It follows that 7 women will not and are taking a very dangerous drug with NO benefit for them.

In BCPT1, a very small number of women developed breast cancer in either arm. Although the reduction of cases is expressed as 49%, it can also be shown that in the placebo arm, 98% of the women DID NOT HAVE CANCER while 99% of the women taking Tamoxifen DID NOT HAVE CANCER. Remember over 13,000 women were in this trial. The placebo (non-medicine) arm group had about 154 breast cancers develop, while the treatment arm had about half (85) of that. Not all that many for a high risk group anyway.

Women who developed breast cancer in the Tamoxifen arm tended to develop estrogen negative tumors which are harder to treat, as conventional therapy has targeted estrogen positive tumors.

If we accept that women from families with a strong family history (the trial has yet to publish data on whether or what proportion of these women are carriers of the BRCA1 or BRCA2 genes), at what age is it MOST appropriate to offer this method of ‘risk reduction’? If, as we strongly suspect, five years is the longest most women should take this drug, which five years should it be for a woman age 30-35. These women with a family history are said to develop earlier and pre-menopausal breast cancer. The good news is that studies continue to show that they develop exactly the same type of cancers as other women do. No better or no worse in most cases.

Women on Tamoxifen are told not to take birth control pills or hormonal therapy. If a woman becomes pregnant on Tamoxifen, it is likely that the fetus will be damaged. How long after Tamoxifen use must a young woman wait to conceive? Do we know?

The state of California actually listed Tamoxifen as a known carcinogen since it causes endometrial/uterine cancer. It is related to DES which has certainly been shown to cause trouble for women and their children (teratogenic).

Raloxifene is a drug we have less data on. In animal studies it was shown to induce ovarian cancer and tumors-two species. There was no evidence of endometrial/uterine cancers so this has enabled the company, Eli Lily to prominently state that everywhere. They tell the world and us that there was NO evidence of endometrial/uterine cancer but have always left out any discussion on ovarian issues. And ovarian cancer is MUCH harder to diagnose at an early stage.

It has been said many times as a defense that endometrial/uterine cancer is diagnosed early stage and is therefore treatable.

One other problem we have is the sloppiness of the media and some scientists in referring to the results as "prevention". FDA was very clear that prevention was NOT demonstrated (We activists believe this was our influence). Survival correlation WAS NOT demonstrated at all, nor was an attempt made. Women from the placebo arm have now been offered a place in the next trial-which is illegal anyway. So they are lost to follow-up and we cannot now know any true survival information.

These are some of the many reasons there continues to be strong debate against FDA approval of Tamoxifen for risk reduction, and concern over the addition of Raloxifene (with no placebo arm nor any test of nutritional intervention).

NOTE: Zeneca the makers of Tamoxifen (Novladex) are suing Eli Lilly Company. Supposedly the sales force of Lilly have been inappropriately (since it has yet to be proven) saying that Raloxifene prevents breast cancer. This should be interesting. I find out a lot of useful information from drug company salespeople who do not hesitate to say how badly their rivals products are doing as treatment.


Canadian Analysis Finds No Improved Survival

Br J Cancer, 11/01

Raloxifene:Benefits versus Risks

Therapeutics Initiative. BC Ministry of Health, Canada

Raloxifene May Block Thyroid Hormone Absorption
Raloxifene for Breast Ca Prevention: NWHN Analysis
Benefit Greatest to Prevent Hormone-Dependent Bca

Press Release, 1/15/03 National Cancer Institute


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