Why RCTs? Part 5

Mastectomies and Rigorous Evaluations

“In terms of reliable information about what works and what does not, United States law in 2016 is roughly where United States medicine was in the late 1930s, i.e., in the Dark Ages.”

2breastcancerblogpostcartoonThis quote will sound familiar if you read Jim’s most recent blog post. There have been astoundingly few RCTs and rigorous evaluations of what actually works when it comes to access to justice. So what can we learn from experiences in other fields? This is the first installment of Part 5 in a series called “Why RCTs?” which explores experiences with and without the benefit of randomized study across disciplines. In this post I examine what we can learn from the field of medicine, which has been transformed by its use of RCTs.

Cancer treatment has changed vastly over the past couple decades; for example, breast cancer mortality has decreased since the 1990s, thanks in large part of improved screening and testing. Huge gaps in knowledge have given way to using chemotherapy with varying degrees of success and unique approaches to combatting different kinds of cancer. How to treat cancer can be a difficult decision: should doctors and patients be aggressive with treatment or just focus on treating isolated areas? RCTs have played a hugely important role in determining the safest approaches and generating more successful outcomes.

While it makes logical sense to take more aggressive positions and be “safe rather than sorry” when combating invasive breast cancer (e.g., opting for mastectomies), RCTs have shed critical light on the best type of treatment. An RCT run in 1976 randomized women receiving lumpectomy, the removal of cancerous tissue, with or without radiation therapy versus a total mastectomy. The results suggested that lumpectomy with irradiation was the superior approach. The 25 year study did not show any significant difference in survival rate between those who underwent mastectomies versus those who were treated less invasively. In a previous randomized trial from 1973 those treated with lumpectomies had similar outcomes as those treated with mastectomies. These studies, as well as four others, “revolutionized local therapy for breast cancer,” showing how RCTs can help inform the choices that a patient and her doctor make for the best outcome.

These two RCTs were rigorous, comparing not just lumpectomies and mastectomies, but also lumpectomies with and without radiation to the more extensive surgery. Beyond revealing the favorability of less-extensive treatment against invasive breast cancer, they showed breast irradiation to be extremely important in decreasing recurrence in that breast. The results were mirrored in a 1995 meta-analysis by the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) which found no significant difference in survival between breast conservation with and without radiation therapy versus mastectomy with reconstructive surgery plus radiation. In order for the evaluation to be rigorous, the researchers committed themselves to carrying out the study for an extended period of time. Most of the breast cancer “events” that occurred were after five years of follow-up, and the study follow-up lasted for 25 years.

One oncologist notes, “[t]he science of clinical investigation has also evolved. In no field of oncology has the power of the properly conducted clinical trial contributed more than in breast cancer. Virtually all counsel that we provide to patients today is derived from evidence-based medicine, the direct result of a robust system of clinical investigation.” While this is an incredibly powerful statement, it also highlights how blind we are in other areas that do not benefit from such experimentation. When we craft legal services or provide litigants with different self-help materials, how can we be sure that our intentions line up with the desired outcomes? Or are as efficient as they could be? While breast cancer treatment has benefited an incredible amount from RCTs and rigorous testing, there are still roadblocks that plague the medical field- any any other, for that matter- when conducting RCTs. Stay tuned for a follow-up post that dives into more detail.

Subscribe to Blog via Email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.



Leave a Reply

Your email address will not be published. Required fields are marked *