Written by:
Kathleen Wilkinson
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this Issue of Curve:
Vol. 10#2
“Evil comes with a name and a home address. ... Evil is not abstract.” — Poet and activist June Jordan, quoting Bertolt Brecht, at the 1998 Breast Cancer Action Town Meeting
In the early 1990s, as the breast-cancer epidemic continued to affect more than 2 million American women a year and activists’ cries for prevention and cure became louder and more insistent, the National Cancer Institute (NCI) decided to throw a pill at the problem, and launched the Breast Cancer Prevention Trial.
Because the drug tamoxifen had been shown to be somewhat effective in staving off a recurrence in the “healthy” breast of women who had already been diagnosed with breast cancer, the NCI decided it would be a good idea to test the drug on 16,000 healthy women who were at “high risk” for breast cancer.
The NCI embraced the new drug despite its serious and even fatal side effects, despite the fact that it is known to cause endometrial cancer and despite the fact that tamoxifen should be taken for only five years, after which time it may be more harmful than helpful.
A TERRIBLE WASTE OF LIVES
As part of the federal government, the NCI is responsive to political pressure. In the Breast Cancer Prevention Trial it worked with the multibillion-dollar pharmaceutical company AstraZeneca, which manufactures tamoxifen under the trade name Nolvadex®. Tamoxifen is one of the new “selective estrogen receptor modulators,” or SERMs, often referred to as “designer estrogens” because they mimic some of the effects of estrogen in the body.
“Giving pills for prevention is just a bad idea,” says Sharon Batt, author of Patient No More: The Politics of Breast Cancer and Nancy’s Chair of Women Studies at Mt. St. Vincent University in Halifax, Nova Scotia. “We’re really interested in promoting nontoxic approaches to prevention, getting rid of toxins in the environment.
“Hormones added to beef feed, which raises the level of estrogen, may be partly responsible for the early onset of menstruation, which is always cited as a risk factor for breast cancer,” Batt points out. “What are the factors contributing to that? The hormones we’re consuming, which are added to increase profits, not because they have any health benefit, may play a role. We’d like to see other approaches looked at more, too; for example, strengthening people’s support networks has been shown to reduce the risks of many diseases.”
Judy Norsigian, program director of the Boston Women’s Health Book Collective and co-author of Our Bodies Ourselves for the New Century, has little praise for the scientists at the NCI: “They have this fixed idea that this is the approach they want to take to prevention and they’re going to shoehorn the data into their notion that this benefits women despite the fact that the evidence doesn’t support that.”
And shoehorn they did. The trial was already a failure before it began. The NCI was unable to enroll enough patients to conduct the trial as it was designed. Still, it persevered. Four years into the five-year study, the agency, under the leadership of director Richard Klausner, announced results early, claiming a 45 percent reduction in breast cancer — without releasing any of the scientific data to the public.
“If you take any clinical trial or statistics or ethics class, you learn that you’re bound to tell clinical trial patients they’ve been on placebo and allow them the benefit of a proven treatment,” says Cindy Pearson, executive director of the National Women’s Health Network in Washington, D.C. Pearson has been actively following this trial from its inception. This, she says, was the ostensible reason that the NCI ended the tamoxifen trial early.
But, Pearson queries, “Is a benefit proven the first month you can see that fewer women have developed breast cancer? Or is it after five years, or is it some years after the treatment, because women can’t keep taking this drug indefinitely?”
Out of 6,694 women who did not take the drug, 154 were diagnosed with invasive breast cancer. Of the same number of women who took tamoxifen, 85 were diagnosed with the disease. These are the numbers on which the 45 percent reduction is based.
At the same time, 18 more women who were on the drug than those who were not developed endometrial cancer, 11 more women developed deep vein thrombosis (blood clots in a major vein), and nine more women developed pulmonary embolism (blood clots in the lung). Two women died of pulmonary embolism attributable to taking tamoxifen.
Add it all up, and you’ve got only a 20 percent reduction in disease, and this for only a four-year period. So, in the end, only 31 women on tamoxifen are “disease-free.” And that doesn’t encompass how quality of life is impacted by a myriad of other side effects, such as memory loss, weight gain, eye damage, uterine bleeding and hot flashes, to name a few. All in all, the numbers are awfully small to bet your life on.
The worst part is that we still don’t know if this reduction in breast cancer diagnoses lasts more than five years. Why? Because when the NCI released its data on the Breast Cancer Prevention Trial it “unblinded” the study, alerting the 6,694 in the control group that they had been on the placebo and giving them the “opportunity” to take tamoxifen.
“For this to have a lasting impact, it’s going to have to show benefit after five years,” Pearson says. “We’d like to know that it lasts forever. But we don’t know that about tamoxifen and because of the [NCI’s] decision we may never know. Unfortunately, stopping the trial then meant that women couldn’t get the answers that they really wanted: Would tamoxifen actually prevent breast cancer or just delay it? Would there be any long-term complications from [taking the drug for five years] that would emerge years later? That’s a terrible waste of the lives of the women who volunteered for that study.”
NEW TRIAL CALLED “UNETHICAL”
Because the powers-that-be at the NCI were so happy with the results (and, more importantly, because most of the mainstream media offered unqualified praise) of the tamoxifen trial, the Institutes immediately began plans for its next “pill for prevention” study.
The new candidate is raloxifene, Eli Lilly’s Evista®, another SERM, or “designer estrogen,” which is already approved by the FDA for the treatment of osteoporosis. The new trial, for which the NCI is attempting to enroll some 22,000 healthy women, will compare tamoxifen and raloxifene and is known as the Study of Tamoxifen and Raloxifene, or STAR trial.
“The STAR trial is born flawed because it’s based on the tamoxifen trial that didn’t take long enough to get the answers that women really need,” Pearson says.
The biggest flaw is that the trial will not include a placebo control group. Apparently, the NCI is so convinced of its success with the tamoxifen trial it has deemed a control group unnecessary.
“Some 22,000 healthy women will be given powerful, potentially dangerous drugs for five years and the ensuing information will be useless,” says Barbara Brenner, executive director of Breast Cancer Action in San Francisco. “The only beneficiaries will be drug manufacturers AstraZeneca and Eli Lilly, who will inevitably use the results to market their products. The trial design is, in a word, unethical.”
Many women living with breast cancer and other women who fear the disease know of tamoxifen’s built-in five-year obsolescence and have already begun taking raloxifene, hoping it will prevent the development of breast cancer.
Unfortunately, a good many of these women may be basing their decision on advertising, not empirical data. Eli Lilly (which engaged in an all-out ad war with AstraZeneca) has been promoting the breast cancer-reducing benefits of its product even though the research the company undertook was designed to study osteoporosis and included only women at low risk for breast cancer.
“A lot of women have the impression that raloxifene does have a positive benefit,” Pearson says. “They hear reports that say Evista cuts breast cancer by 70 percent in thousands of women. The very preliminary studies were done on women at low risk for breast cancer and were funded by the manufacturer. These trials are not designed to find out if raloxifene reduces the risk of breast cancer, and they can’t know if it does.”
Norsigian agrees: “There has been a real problem recently with exaggeration of the benefits of drugs like raloxifene. Drug companies and the media, generally speaking, are very quick to promote the benefits and tend to pay very little attention to long- and even short-term problems. This is disease substitution, not disease prevention.”
Many organizations, like Breast Cancer Action and the National Women’s Health Network, have called for women not to enroll in the trial. Unfortunately, it seems that activists will not succeed in shooting down the STAR trial.
There is one high note in the din of misinformation surrounding the STAR trial. “In a twisted way, it’s good that someone is trying to prove whether raloxifene reduces the risk of breast cancer,” Pearson concedes.
But as Brenner notes, an alternative design including a placebo and perhaps a phyoestrogen product, such as a soy compound, would have been much better. “This would provide information about the relative merits of several approaches and might have given women some really useful information.”
Clearly, this is only the latest skirmish in a long battle for timely and accurate information. For now, the truth is that there is no cure for breast cancer. No one knows what causes most cases of the deadly disease, and therefore, no one knows how to prevent it.
Unfortunately, until research into true prevention yields more concrete results, when we hear the words “cure” or “prevention” in relation to breast cancer, we’re hearing a lie, whether intentional or inadvertent. This deadly act of deception only helps, as Brenner says, “delay the day when the breast cancer epidemic will be only a painful memory.”
To get involved, contact the Nat’l Women’s Health Network at (202) 347-1140 or http://www.womenshealthnetwork.org; Breast Cancer Action at (415) 243-9301 or http://www.bcaction.org; or the Boston Women’s Health Collective at http://www.ourbodiesourselves.org/.
Don’t Be Fooled — Even Detected Early, Breast Cancer Is Not 100 Percent Curable
A number of organizations, including the American Cancer Society (ACS), the Susan G. Komen Breast Cancer Foundation, and other breast-cancer charities, have adopted the NCI’s “industry standards” in communicating about breast cancer.
The American Cancer Society, for example, continues to publish only five-year survival rates for breast cancer in its Cancer Facts and Figures, even though longer-term survival rates are available. Instead, it reports that 95 percent of women who detect breast cancer early will survive five years.
In ACS lingo, that translates into early detected breast cancer being almost 100 percent curable. Without mincing words, Barbara Brenner, executive director of Breast Cancer Action in San Francisco, says, “The difference between the ACS statements about 100 percent curable and the facts are a lot of funerals.”
What’s especially pernicious is that much of the media and many policy makers use these figures when discussing survival rates. “It’s practically criminal to let that information go around. It’s pacifying women, that if they catch it early they’re going to be okay,” says Cindy Pearson, executive director of the National Women’s Health Network in Washington, D.C.
Further clouding the understanding of “prevention” and “diagnosis,” both the ACS and the Komen Foundation tout the benefits of mammograms as prevention. Yet mammograms are only a screening device, and an unsatisfactory one at that.
“The ‘breast health’ message, which is essentially three things — mammograms, breast self-exam and clinical exam by a doctor — are all detection methods. None of them will make your breasts healthy,” Brenner says. — KW |
