You are using an outdated browser. Please upgrade to the latest version for the best experience. Upgrade your browser now.
Skip Navigation

Breast Cancer Awareness Month: Blue Shield Drives Cutting-Edge Study to Battle Breast Cancer

Dr. Laura Esserman is leading the WISDOM study, a massive research study that combines genetics and traditional methods to identify those at risk
Breast Cancer Awareness Month: Blue Shield Drives Cutting-Edge Study to Battle Breast Cancer

October is Breast Cancer Awareness Month. Blue Shield of California is a leading supporter of early detection and treatment of breast cancer. The plan also supports, and provides coverage for, the WISDOM study.

Over the last half century, we’ve come to accept annual mammogram screenings as the most effective tool for detecting breast cancer.  But questions have persisted about its benefits since the first large-scale screening trials were conducted in 1963 in New York City.

A nationwide study, now underway by University of California scientists and physicians, is seeking to provide clarity through a clinical trial testing breast cancer detection in standard annual mammograms versus breast screenings tailored to an individual’s risk.

“Our modern science tells us every breast cancer is not the same. We shouldn’t treat them all the same,” said Laura Esserman, MD, a renowned UC San Francisco breast cancer specialist who is leading the large-scale trial.

Esserman, who is director of the Carol Franc Buck Breast Cancer Center and professor of surgery and radiology at UCSF, said the study intends to identify “who is at risk for what kind of breast cancer and what’s the best thing we can do about it.”

Esserman and her collaborators, as part of the Athena Breast Health Network, launched its recruitment process two years ago after receiving a $14 million federal grant for the study, called “Women Informed to Screen Depending on Measures of Risk,” or WISDOM. Blue Shield of California was the WISDOM study’s first partner in the trial.

The study is recruiting 100,000 women between the ages of 40 and 74, without a history of breast cancer. Participants are either part of the randomized controlled trial cohort or they can self-select to take part in the annual mammograms or the personalized screening. The cohort in the personalized screening group will be evaluated based on several factors: individual risk, biology and preference. They will undergo genetic testing and will not necessarily have an annual mammogram, although some could have the screening more than once a year if considered high risk. No participant receives less screenings than is recommended by at least one guideline. To date, more than 16,000 women from California and the Midwest are participating in the trial.

This month, in National Breast Cancer Awareness Month, marks a new phase of the study, as Esserman and Athena expand their enrollment efforts with new recruitment programs in Illinois, North Dakota and New Jersey through Blue Cross Blue Shield Association plans.

The trial’s goal is to determine whether a personalized screening approach is better than the standard annual mammogram to improve detection while reducing overdiagnosis and false positives that lead to unnecessary biopsies.  At the same time, the study seeks to show that personalized screening for high-risk women could lead to earlier detection of cancer. 

Creating a study of WISDOM’s size and significance, with collaboration among researchers, physicians, policy makers, patients and health insurers, is a complex undertaking that Esserman has been diligently working toward now for decades.

Much medicine 'doesn't change in a timely way'

Her mission has its roots in her undergraduate years at Harvard University, where she studied the history of science, and how it intersected with culture and politics. After graduating in 1977, she dug into health policy at Stanford Medical School. “I got into this notion of being more thoughtful and smarter about organizing our resources,” she said.

Esserman initially focused on cervical cancer, questioning the screening frequency. She then turned to breast cancer, while doing her surgical residency and a research fellowship at Stanford.

Soon as she finished her medical school education and training in 1991, Esserman was persuaded to go back to school by a mentor, Stanford professor emeritus and health care policy expert Alain Enthoven. This time, it was Stanford business school, which was a “life changing experience,” she said. Esserman learned about organization behavior and management, and importantly, Andy Grove’s innovation model in the semiconductor industry and Michael Bloomberg’s data systems transformation in the financial industry. It led to a rethinking of her approach to healthcare.

“There’s so much in medicine that doesn’t change in a timely way. We need to have a different rhythm, said Esserman, a mother of two whose groundbreaking approach (and serenading of patients) has been profiled in the New York Times and published in academic journals.

Esserman has pursued a steady succession of initiatives to drive change in breast cancer screening, treatment and trials (including I-Spy 2 that seeks to accelerate drug development and approval processes.)

In October 2009, Esserman and prostate cancer specialist Ian Thompson teamed up to co-publish a critical piece in the Journal of American Medicine Association, better known as JAMA. The essay called into question annual screenings for both breast and prostate cancer, and stated that some screening came at the cost of overtreatment. In both cases, the screening identified a “reservoir of indolent disease,” but it was not driving a decrease in cancer rates, Esserman said. By contrast, colon cancer rates decreased with screening.

“We were doing something wrong. We had not found the right precursors for invasive breast cancer and we had to make a change,” she said.

The essay’s timing was serendipitous: Within weeks, an influential independent group, U.S. Preventive Services Task Force, recommended annual screening start at 50, not 40 years old.

That same year, Esserman and her UC health colleagues started the Athena Breast Health Network to coordinate care across the UC’s five medical campuses – and to collect valuable scientific data. The foundation was now in place for a bigger study, and Esserman subsequently won a Robert Wood Johnson grant for a study pilot in 2013. Importantly, the personalized screening trial pilot provided the seed money that led to the then federal grant for what is now the WISDOM study.

The screening trial, however, was at a standstill. The grant only covered administrative costs; Esserman needed funding for participants’ genetic tests. In 2014, Esserman held a stakeholders meeting with insurers and others - Blue Shield stepped up and subsequently developed a new policy to cover the genetic tests.

Why Blue Shield covers WISDOM participation

Typically, healthcare insurers approve coverage of a new procedure and/or treatment only after it has been proven clinically effective and safe. For genetic testing, evidence-based guidelines require a systematic assessment of their clinical utility that showed a screening or diagnostic test could prevent or improve health outcomes with treatment. Moreover, in many cases, genetic testing is not covered at all by health insurers because it is considered investigational or experimental. However, genetic tests, like BRCA 1 and 2, and genetic expression tests for early stage breast and prostate are gaining wide spread adoption.

Henry Garlich, director of Blue Shield’s Healthcare Value Solutions and Enhanced Clinical Programs said Blue Shield recognized the study could lead to better individual health outcomes. He said the insurer partnered with Esserman so they could responsibly evaluate whether genetic testing could play a new role as part of the breast cancer screening protocol for all members, not just those in the trial.

 “If a new screening procedure or new type of diagnostic test changes the clinical paradigm to improve upon existing standards of care, we want to support it and provide access,” Garlich said. 

The national Blue Cross, Blue Shield Association soon followed, adopting a policy to encourage coverage nationwide of the WISOM study tests. “I hope it will usher in a new way we practice medicine to get better outcomes and better values,” Esserman said.

 

 

 

 

 

 


Related Stories