Most women know about breast cancer awareness month and its pink ribbons, but those same women may not be aware of an important trait that boosts their personal risk. Currently, there is no national law requiring that women with dense breasts be notified that having this status increases their breast cancer risks and makes their mammograms harder to read.

Though a dozen states have breast density inform laws on the books, and several other states have legislation in the works, letters are inconsistent, with some states providing clearer information than others. In December, the U.S. Food and Drug Administration will release a draft for a nationally standardized breast density notification letter for comment. Dr. Richard Frank, CMO at Siemens Healthcare, spoke with DOTmed News about why standardization is so important, and how current inconsistencies hurt women.

DMN: Tell me about your background in this area.
RF: I started at Siemens in July. My role here as CMO is to be the medical voice of the company, both in discussions like this in which I'm talking about topics of importance for Siemens, and also what I see going on in the external space. Historically, I had a similar role at another company. They had a group focusing on mammography across the various modalities, and so whether it was during the RSNA meetings over the last few years, or approaching legislatures and so on, I have a long history and involvement in showing the clinical applications for the various modalities involved in breast cancer. Before that I worked 20 years in the therapeutic pharmaceutical industry developing drugs, including anti-cancer agents.

DMN: I've heard that the language in breast density inform in some states is confusing. What are some examples of that?
RF: The variability from state to state includes such things as a letter that says "if" you have dense breasts, and the woman will look at that and think 'oh this doesn't tell me that I do have dense breasts, maybe this is not actionable, this isn't speaking to me'. This should be something that says, here is your circumstance that may call for additional thinking. Go see your doctor. This "if" word is a very serious one because it sort of neuters the whole effort.

DMN: What other differences have you noticed between the various laws?
RF: The other differences have to do with whether specific imaging modalities are mentioned or not. This can result in people over-thinking things, or feeling that there's some sort of vested interest, so they get cynical about the stuff. The simple matter is, they should be referred to their physician to ask a specific question: does the fact that I have dense breasts, despite having a normal mammogram, mean that I should receive some additional screening? That should be the long and the short of it. The woman needs to be empowered with the information that she does have dense breasts, and what that means is the following, because of that you should ask your doctor if more is necessary.

DMN: Besides notifying the woman that she has dense breasts, do you think there's any other information the letter should include, or should it just say to talk to your doctor for more information?
RF: It should say talk to your doctor for more information. Because, ultimately, there are always many different factors involved here. There's what we would call an index of suspicions. It could be family history, it might be the palpation of a lump, it might be some symptoms. It's very difficult for a letter to take all of this into account.

DMN: Are there any other issues surrounding breast cancer that you think are worth mentioning?
RF: It certainly is the case that the industry has been innovating for dose reduction for many years. I'll try to avoid speaking of specific products. It's not only Siemens. The industry has been working hard not only to make imaging more effective in detecting lumps and assessing whether they're benign or cancerous, and then directing biopsy needles and all the various roles that imaging plays in making sure women get the best care, including staging for nodes and following up on treatment. In addition to all of those efficacy roles, there always is the safety issue. Dose reduction is something the industry takes seriously, and I could point to any number of innovations as part of the standard mammogram as well as downstream, which reduces exposure as part of the standard mammogram. PET scanning for scanning of metastases and so on.

DMN: Any final thoughts?
RF: It's crucial that people like you keep this in the news, because FDA will be coming out in December with this proposed language. We need to show that incorporating notification into federal standard is seen to have value despite the fact that various states have made their efforts. There's a qualitative enhancement of the effectiveness of this notification if it is unified and at the federal level.