From the Executive Director: Meeting the Needs of Patients: BCA’s Survey on Aromatase Inhibitors

by Barbara A. Brenner

I was at the San Antonio Breast Cancer Symposium in 2001 when the first results of a trial looking at an aromatase inhibitor (AI)—the ATAC trial (Arimidex, Tamoxifen Alone or in Combination)—were presented. I knew from the buzz at the meeting that these results would change practice overnight and that, by the following week, postmenopausal women with breast cancer would be encouraged to take an AI instead of tamoxifen.

I knew a few other things as well from BCA’s work, particularly based on what the organization had heard from women when tamoxifen was the treatment of choice. Again, women would want—and need—to know the short- and long-term side effects of this new class of drugs. They would want to know how long the drugs should be taken. They would want to know whether symptoms they were experiencing were truly side effects of the drugs.

Because Arimidex was approved by the Food and Drug Administration (FDA) under its fast track approval system, the kind of information that women need is not available.1 FDA rules require drug companies that make products approved under the fast track system to continue to monitor the drug effects once the drug is on the market. But the fact is that very few of these “post-market” trials are actually completed. One reason is the lack of FDA resources.2 Another is that the pharmaceutical industry is usually more interested in getting drugs to market than in having a complete side effect picture to present.

In late 2002, drug maker AstraZeneca received FDA approval to market Arimidex as adjuvant therapy for estrogen-receptor or progesterone-receptor-positive breast cancer in postmenopausal women. Very soon thereafter, BCA started hearing from women (whose doctors were recommending the drug) who wanted to know both the side effects and how long they should stay on it.

Knowing that the FDA couldn’t, and the drug industry wouldn’t, collect this information, we decided to do it ourselves. Having been an informal repository for side effect information of tamoxifen, BCA decided to systematically ask women about their experiences on Arimidex and the two other AIs, letrozole (Femara) and exemestane (Aromasin). After all, patients almost always know before the medical community what side effects they are experiencing as a result of the drugs they are taking. If, in the case of AIs, we could get them to tell us, we could use the power of BCA to communicate that information to women, their doctors, the FDA, and the pharmaceutical industry.

With the help of wonderful volunteers like Diane Tompkins, who helped us design our survey, and Marilyn Zivian, who analyzed the data, BCA created the survey, reached out to other advocacy organizations to encourage participation in it, and quickly collected a lot of responses.

With this issue of the BCA Source, we report on the preliminary results from our AI survey. We will continue to collect, analyze, and release data from the survey so that women one day will know all of the short- and long-term side effects of these treatments, and doctors will know how best to prescribe these drugs.

Information allows people to make informed choices about their care. In the current environment, nonprofit organizations like BCA take on the responsibility to provide this information when government agencies and drug companies don’t. While we do so, we also work for the day when, in the interest of patients and those who care for them, both federal agencies and the pharmaceutical industry provide complete drug information before extensive marketing occurs.

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1 List of Fast Track Approved Drugs from 1998 to 2006 is available online atwww.fda.gov/cder/rdmt/internetftap.htm.

2 Government Accountability Office, Drug Safety: Improvement Needed in FDA’s Post-Market Decision-Making and Oversight Process. Available online at www.gao.gov/new.items/d06402.pdf.

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