December 11, 2008

Jane Zones, Board Member

Army of Women

The first event at SABCS, for me, was a delicious dinner hosted by the Alamo Breast Cancer Foundation for advocates arriving for the conference. Susan Love, everyone’s favorite breast cancer surgeon, and author of the Breast Book and the Menopause and Hormone Book, held court among the 120 or so attendees.

Susan, with an assist from the Avon Foundation, has organized an “Army of Women”, which seeks to enlist a million women to become potential participants in clinical research to assess causes of breast cancer. Enrollees sign up with a brief set of descriptors, including contact information, and then receive occasional emails notifying them about upcoming studies in which they might wish to participate.

Over a quarter of a million women have already sent in their names, and quick response to two requests for help has been remarkable. The Sisters’ study got over 3000 responses in a matter of days, for a study that has been enrolling women, slowly, for years. Using the Army notification they were able to locate the particular types of women they needed—including Pacific Islanders, younger women, and older women who had completed only a high school education. Another study, which sought breastfeeding women who had been scheduled for a breast biopsy, had thirty hits in just one day—a group which would have been painfully difficult to accumulate without this internet system. We had a discussion of the common military symbolism used in breast cancer (I suggested “mob” rather than “army”), but the brochure is all ready out!

Milk Fat and DDT

This morning, Barbara, Allison and I had an early breakfast with Stefanie Jeffrey, another favorite breast surgeon, BCA supporter, and cancer researcher at Stanford. The restaurant only provided whole milk, which led to a discussion of Bill Goodson’s research on progesterone in milk fat. Goodson’s work makes note that the dairy industry keeps cows pregnant with much greater frequency than in the past, in order for them to produce more, and milk from pregnant cows has more progesterone than milk from non-pregnant ones.

Another Bill G— Bill Gates—came up as well. In his focused quest to eradicate malaria in Africa, he wants to bring back the use of DDT, which has been banned in the US since the 1960’s because of its horrific impact on the environment (thank you Rachel Carson). Barbara mentioned that mosquito netting effectively reduces malaria, without the environmental and health costs, and is inexpensive to purchase and distribute with the type of aid Gates has been investing on the African continent. Gates’ mother died of breast cancer.

Endpoints and Reality

And then the meeting began. One good aspect of SABCS is that there is only one talk going on at a time, but this means that they are given in a cavernous hall, with a dozen huge screens to show the speakers and their accompanying slides. The hall holds thousands of people, and there is a spill-over area nearby.

The morning talks mostly compared endocrine therapies (mostly tamoxifen) with aromatase inhibitors, and combinations thereof, which Barbara will cover. In one of those talks, the speaker noted that one treatment altered participants’ Her-2 status from negative to positive, which would presumably allow treatment with Herceptin. This got me to thinking about outcomes in these studies.

At BCA, we are most concerned about survival, and treatments most likely to enhance that—by length of life or quality of life. But in the clinical trial world, researchers are increasingly using much more modest outcome criteria, frequently time to disease progression. Using intermediary study endpoints makes it possible to end the study in less time, enroll fewer people (progression is more common than death, so you don’t have to accrue as large a sample), and is much less expensive. Also, manufacturers and the researchers they fund are pressuring the FDA to reduce the standard endpoints that have been used to evaluate new drugs for approval.

The talk this morning was the first I’ve seen that discussed alteration in biomarkers as a possible study goal, and it reminded me of a number of parallels. Statins are being urged on middle-aged and older people to lower their cholesterol, with the assumption it will reduce heart disease, but without evidence to that effect. (Remember Hormone Replacement Therapy? Same thing.). Osteoporosis drugs have been marketed to older women to reduce osteoporosis, with the expectation that they will reduce bone fractures, but without good evidence for that. Taking these drugs, which have known and serious side effects, for many years, is no trivial enterprise.

Safe Cosmetics Issues at SABCS

Near the BCA booth, hidden with the other non-profits’ booths in back of the exhibition hall, we ran into Adrienne Olson, a doctor of Pharmacy from Southern California, who will be presenting a poster (a smaller, less formal presentation) on Saturday that looks at unwitting use of estrogens by women using topical moisturizers. Adrienne notes that topically applied estrogens are absorbed more easily by the body than oral estrogen (pills).

Estrogen-receptor-positive breast cancer patients need to avoid estrogen exposure to minimize their chance of recurrence. She and her colleagues analyzed sixteen different topical moisturizers, none of which listed any estrogen content among their ingredients. They found that six of the 16 contained forms of estrogen, some in significant amounts. Because women cannot determine estrogen content and potential systemic exposure, the researchers suggest that advocacy groups work with FDA to have them identify products containing estrogens, including exotic “designer” estrogens.

Talking About Risk—In Real Terms

Joann Elmore, Head of General Internal Medicine at University of Washington’s Harbor View Medical Center, and an epidemiologist, gave a very good presentation addressing the question, How does a clinician answer a patient who asks “What is my risk of getting breast cancer?”

Elmore reviewed the literature on the Gail Model, which has been used now for many years to assess breast cancer risk, and showed that while it worked well at the population level (predicting what proportion of people in a very large set of people would develop breast cancer based on their combined risk), it had no predictive value for individuals. Furthermore, of every 47 women classified as high risk by the model, only one will subsequently be diagnosed with breast cancer over five years’ time.

Elmore’s talk reminded me of a painful lesson I learned when a friend of mine, then in her late 30’s, asked me whether she should start getting mammograms. I asked her if she had close relatives who had had breast cancer (no), and then proceeded to tell her that her risk was very low. I told her about the BCA mammography policy statement, which reviews the evidence that mammography is relatively ineffective for premenopausal women. My friend was diagnosed with cancer less than two years later, and most unhappy with me, understandably. What I learned there is that what’s good for the population as a whole, is not necessarily applicable to any single individual, and that we all have to figure out for ourselves what decisions we are going to make under conditions of great uncertainty.