The Douglass Report December 2002

December 2002 PDF

Making a deal with the devil: The costs of the latest cancer "miracle"

Great news! You no longer "have to take" chemotherapy if you have breast cancer. The latest news from the official cancer battlefield is that chemotherapy isn't so hot after all and "all you need" is surgery, maybe a little radiation, and tamoxifen.

Richard D. Gelber, a biostatistician at the Dana-Farber Cancer Institute in Boston, and numerous co-authors have concluded that "chemotherapy may offer no benefit" for post-menopausal women with breast cancer that is made worse by the presence of estrogen. Instead, they recommend a five-year course of tamoxifen after surgery. Since tamoxifen blocks estrogen, it may be the only treatment needed after removal of the cancer, they say.

But let's look at what the latest Associated Press report left out concerning tamoxifen. This piece is quite typical of articles on cancer treatment in that the possible serious consequences of taking tamoxifen are not mentioned at all. Don't get me wrong: I'm not pointing the finger at the reporters (this time). I think it's instinctive for anyone covering cancer treatment to try to present a happy face. Generally, people like to read bad news-calamities like ferry sinkings, tornados, murder, and mayhem. But they don't need any more bad news about cancer. It just doesn't sell after 50 years of little progress against the disease. Up until now, chemotherapy was the only option-and people have caught on to the fact that it isn't pleasant, or all that effective.

Dr. Gelber gave the following lowdown on chemotherapy: "There is a quality of life burden associated with chemotherapy," he said. "It is not a free ride. It should not be given frivolously." The quality of life burden Gelber is referring to involves hair loss, nausea, vomiting, and persistent tiredness.

So the major thrust of this report is to get people to buy into the idea that tamoxifen can eliminate the need for chemotherapy. But is tamoxifen any better?

Tamoxifen isn't technically called chemotherapy, because it's an anti-hormone agent that blocks the effect of estrogen--whereas a "chemotherapeutic" drug is one that attacks cancer cells. The rationale is that the chemotherapy agent will kill the bad cells before it kills enough of the good cells to kill YOU. But if you ever take tamoxifen, I doubt you will be able to tell the difference: It will seem like chemotherapy, because it has plenty of side effects as well.

In this case, I have a legion of support from concerned medical experts from all over the world. It's nice to have some company once in a while.

The dark side of tamoxifen- it's worse than just ineffective

As long ago as 1998, the reports were coming in on the dark side of tamoxifen. Prominent medical journals like Lancet published studies from Britain, the U.S., and Italy indicating tamoxifen's ineffectiveness-and worse.

More recently, on July 29 of this year, the Department of Health and Human Services (HHS) released The 9th Report on Carcinogens, prepared by the National Toxicology Program. And guess what's been added to the already staggering list? Tamoxifen makes its debut as an official carcinogen, based on sufficient evidence from studies in humans indicating a causal relationship between exposure to tamoxifen and cancers of the uterine endometrium. These aren't animal studies where you always run into the "rats aren't humans" argument. No, this evidence is unequivocal. Tamoxifen is carcinogenic to humans.

But that hasn't stopped the medical establishment from pushing it on the public.

"While there is clear evidence," one article reports, "that tamoxifen increases the risk of uterine cancer in women taking the drug, there is also conclusive evidence that tamoxifen therapy is effective in the treatment of breast cancer, reduces the risk of recurrence of breast cancer when administered after breast cancer surgery, reduces the risk of contralateral (opposite) breast cancer in women with a previous diagnosis of breast cancer, and reduces the incidence of breast cancer in women at high risk of this diagnosis."

Well, I beg to differ. There is not "conclusive evidence" at all that tamoxifen does those positive things.

Two studies, one in England and the other in Italy (performed by the world-famous Italian scientist U. Veronisi), reported that the incidence of breast cancer among the women participating in the trials was the same whether or not they took tamoxifen.

Trading in one risk for another

The Breast Cancer Prevention Trial, from the University of Pennsylvania and Allegheny College, has received a lot of attention from the cancer establishment. But as Dr. Richard Klausner, director of the National Cancer Institute, expostulated: "We don't have a chance every day to tell you about such remarkable progress."

They've got themselves all worked up about the latest findings that point to an apparent 45 percent reduction in incidence of breast cancer among women taking tamoxifen. "This is the first time that we have evidence that breast cancer not only can be treated, but prevented," said researcher Bernard Fisher, M.D..

Dr. Fisher predicted that these findings will trigger an intense medical debate "over who should be prescribed tamoxifen." Well, I wouldn't want to disappoint him. Though you won't hear any debates from Dr. Fisher: He's very enthusiastic about tamoxifen. But keep in mind he is the source of the studies that have led to such widespread use (and some say abuse) of the drug.

What the researchers aren't making a big deal of is the fact that the apparent 45 percent reduction in breast cancer was accompanied by an increased risk of some serious-potentially fatal-health problems. Cancer of the endometrium, the lining of the uterus, is twice as common in patients who have taken tamoxifen. And blood clots in the lungs (pulmonary emboli) are three times more likely to occur in the tamoxifen-treated patients. In fact, two women, both in the tamoxifen group of one study, died from pulmonary emboli.

Dr. Fisher emphasized that women and their physicians must weigh tamoxifen's benefits against identified risks, and he expressed hope that, "rather than demanding tamoxifen immediately, many women will participate in an upcoming trial comparing tamoxifen with a similar drug that may have fewer side effects."

In other words, don't just settle for being a tamoxifen guinea pig. Instead, hurry to reserve your spot as a guinea pig for this new drug, the safety of which they have no idea about just yet.

Maybe he doesn't mean to, but Dr. Fisher is waging classic psychological warfare against cancer patients: In essence, he is saying: "There is no doubt that tamoxifen is for you; it's just that we may have another drug that could be even better. After a few experiments-er, trials-we will know which is the lesser of the evils."

Action to take:

Forget Dr. Fisher's cajoling. It's like I always say-you don't want to be the first one to take a new drug. And as for tamoxifen, I'll continue to keep you updated on my findings via my Daily Dose e-letter service. (To sign up, send an e-mail to But for now, I say steer clear of it. With all of it's risk-swapping, taking tamoxifen just seems too much like making a deal with the devil. RH


"Studies question tamoxifen as breast cancer preventive," Star Tribune, 7/10/98

"Prevention of breast cancer with tamoxifen: preliminary findings from the Italian randomised trial among hysterectomised women," Lancet 1998; 352 (9,122): 93-97

"Interim analysis of the incidence of breast cancer in the Royal Marsden Hospital tamoxifen randomised chemoprevention trial," Lancet 1998; 352 (9,122): 98-101

"Endocrine responsiveness and tailoring adjuvant therapy for postmenopausal lymph node-negative breast cancer," J Natl Cancer Inst. 2002: 94(14):1,054-1,065.

"Study Looks at Chemo, Breast Cancer," Associated Press, 7/16/02