Years After Surgery,
a Patient’s Search for Her Specimen

Diane Balma, J.D.

Director of Public Policy
The Susan G. Komen Breast Cancer Foundation

I was diagnosed with an invasive form of breast cancer in 1995 at the young age of 30. At the time, I was practicing law in the San Francisco Bay Area, and breast cancer was not top of mind. I was aggressively treated with surgery and chemotherapy. Initially, the pathology of my tumor was negative for HER-2, a very important prognostic indicator in breast cancer – HER-2 patients do not respond well to standard treatments. Several years later, while working at the Susan G. Komen Breast Cancer Foundation, and after the testing for HER-2 had improved, my oncologist recommended that my tumor specimen be tested again to determine whether, in the event I recurred, I would be a candidate for a specific targeted therapy used in the treatment of HER-2-positive cancers. This time the test revealed that my type of cancer was highly positive for HER-2.

I joined the Susan G. Komen Breast Cancer Foundation in 1998 as legal counsel, and I now serve full time as director of public policy for the Foundation. A few years ago, while sitting at my desk, I was reading about the retention and handling of tumor specimens. I hadn’t formerly devoted much time and attention to this issue because there are so many other issues facing breast cancer patients and their families today. As I continued to read, I learned that there are no national standards for the retention and preservation of tumor specimens. Some such specimens are retained for clinical use, while others are discarded or consumed for research. It struck me that the only reason I now know that I have HER-2 breast cancer is because my tumor specimen was available for testing and could be located, with some effort on my part.

As breast cancer therapies become more specialized and targeted, the pathology from the specimen becomes increasingly important. I had a moment of panic when I considered that treatment for breast cancer begins with the tumor specimen, and I had no idea where my specimen was or whether it still existed, whether it was being used for research or whether it had been dubbed “hazardous waste” and tossed out with the “trash.”

I knew from my legal background that I had waived any rights I had to my tumor specimen before my surgery, and I began to consider how I could access my specimen, and in a hurry. The best legal argument I could think of was that I had signed the informed consent forms under duress. “Duress” is a legal defense to the formation of a contract. I figured that the informed consent forms were, in essence, a contract, and that since I was required to sign the forms as a prerequisite to receiving life-saving surgery, I had signed the consent forms under duress. What I didn’t know was that even if I prevailed on the theory of duress, I had virtually no rights to my specimen anyway. In addition, I still didn’t know whether it even existed.

I decided to make some calls to California to see if I could track it down. I called the community hospital where the original lumpectomy was performed. They didn’t have possession of the specimen. I then called the comprehensive cancer center in San Francisco where my mastectomy was performed. They didn’t have possession of the specimen either. I called the community hospital back and played the “Komen card.” Yes, I admit it. I told them that I was “counsel for the Susan. G. Komen Breast Cancer Foundation” and that I needed my specimen back. The woman on the other end of the phone sounded like she had never received such a request. She told me that she would immediately look into it and get back with me. The next morning I received a call confirming that my tumor wasn’t at either of the institutions that performed my surgeries. Rather, it had been tracked down in a commercial lab in South San Francisco, and it was being sent to my office via Fed Ex.

While I won’t use this as an opportunity to debate the legalities of air mailing my specimen to my office, I will say that I was quite relieved, and a bit taken aback, when my tumor arrived. I viewed it, and for several days, I couldn’t stop looking at it. I found it ironic that the thing that nearly killed me could now hold the key to my long-term survival. As they say, “It’s a thin line between love and hate.” For more than a year, I kept my tumor in my office in the same box in which it arrived in all its paraffin glory. I simply didn’t know what else to do with it. My colleagues and I joked that I could keep it in the box and use it as a paper weight. They also warned me that if I ever took it home, I had better remember not to leave it in my car because the Texas heat would surely melt the paraffin. My tumor specimen now sits in its box, in my closet, next to my shoes. Odd, isn’t it?!

I want something better for breast cancer patients (and for all patients). That’s why I am so passionate about this issue and why the Komen Foundation has identified tissue information access and related issues as a top public policy priority. The Komen Foundation commends the FasterCures team, led by Greg Simon, for its leadership in this field and for bringing attention to this area. This emerging issue has major implications for the thousands being diagnosed every day with breast and other cancers and diseases. The Foundation recognizes that there is a balance – we must work to ensure that patients have access to information from their specimens for clinical use but, at the same time, we must not impede the research through which innovative therapies are developed.

I don’t believe research and access are mutually exclusive. The Komen Foundation views its role as serving as the patient voice on these issues and to raise the dialogue on behalf of patients. There are numerous stakeholders, and a thoughtful solution will require public-private partnerships, collaboration and compromise. It will take commitment, and we are in it for the long haul.