Evidence-based medicine is an approach to medical practice intended to optimize decision-making by emphasizing the use of evidence from well-designed and well-conducted research. It is what guides medical practice today.
The standard of care is most often based on evidence-based medicine as it should be in many cases. My brain understands this, but my heart does not. I recently declined a case because evidence-based medicine says that we did not have a case, but my heart tells me that in this case EBM leads to an unjust result.
I recently declined a case for my client, Samantha Ramirez, because EBM and the standard of care would not allow us to pursue her case. Her position is logical, but statistics and economics don’t support her position. She gave me permission to tell her story.
Samantha is 32 years old and a single mother of three children, twins who are 2 and a 10-year old. In May 2015, she was diagnosed with ductal carcinoma in situ, or DCIS, a cancer confined to the breast and that now comprises approximately 25 percent of newly diagnosed breast cancers. Samantha’s cancer was confined to one breast but after consulting with her breast surgeon, she decided to have a double mastectomy on the advice of her surgeon.
Her thought process was to eliminate any possibility of recurrence by eliminating her breast tissue. She underwent surgery in June 2015. Her breast surgeon told her that her prognosis was excellent and that there was no need for radiation therapy or chemotherapy because they had removed her cancer.
A diagnosis of breast cancer is never good, but if you are going to have it, DCIS is the one to have. Samantha recovered from her surgery and was planning to live happily ever after – until she found out last June that the cancer had returned and had now spread to her liver. She was understandably very upset, and she contacted us to investigate the matter about six weeks ago.
The statute of limitations expires in June of this year. Because the events happened in Kansas and they have a two-year statute of limitations that can be extended to a maximum of four years if you did not reasonably determine that negligence had been committed in the first two years, we still had time. Since she learned in June of last year of the recurrence, she had until the fourth anniversary of her breast surgery to possibly pursue a case.
Normally, when we are contacted so close to the expiration of the time limit, we put our track shoes on and run the opposite direction because of the tremendous stress it causes. However, Samantha told me a compelling story and so I decided to investigate her case. I told her that the only possibility for her was that the pathologist who examined her breast tissue might have erred and we should have the pathology slides reviewed by another pathologist, so I contacted one in California who agreed to review the slides. The pathologist called two weeks ago, and he agreed with the original pathologist that there was no evidence of cancer in the lymph nodes, which is where you would look to see if something was missed. I then informed Samantha of his findings, but she had more questions.
She wanted to know why they did not treat her anyway. In the analysis done in 2015, they determined that there was a biologic marker in her cancer tissue called Her2/neu. This is a protein that when found can be a target of therapy. Samantha had a positive Her2/neu marker. Her thought was that with this marker, she should have received ongoing monitoring in case there was recurrence. This is called post-operative surveillance. The problem is that there is a debate among oncologists as to whether this should occur in a diagnosis of DCIS. According to our review of the literature it is not the standard of care to do further imaging, laboratory tests and tumor markers for patients who have had a bilateral mastectomy for DCIS. Evidence-based medicine in action. The statistics just don’t support Samantha’s argument.
Samantha’s position is that unless you can tell her with absolute certainty that there will be no recurrence, why not do post-operative surveillance with blood tests and tumor markers? Sounds logical to me. The risks of recurrence are potentially catastrophic, as it was in her case, so why not eliminate all risks. The thought is that if the cancer returns and you catch it quickly the prognosis is much better.
Samantha is understandably quite upset. She is undergoing treatment for the cancer that has spread to her liver and intends to fight the cancer vigorously, but she wonders endlessly why the standard of care does not require further testing and monitoring. The sad reality is that statistics do not support further testing and monitoring.
The old saying that there are three lies applies to Samantha: There are lies, damn lies and statistics. Why do statistics and money dictate the quality of health care? Samantha has earned the right to ask this question.
Samantha’s case haunts me. I would like to help her, but I can’t create a standard of care. She wants to change the standard of care for DCIS, and she is willing to be the poster child for this insidious disease.
It is an uphill battle she fights, but don’t count her out. I have not known her long, but she is a fighter and while she fights for her life, she wants to make sure that this does not happen to anyone else. Let us help her with our prayers.
Bob Buckley is an attorney in Independence, www.wagblaw.com . Email him at firstname.lastname@example.org