“There’s been a neglect of women in this area,” says Marianne Sutcliffe, vice president, women’s health, AbbVie. “There hasn’t been enough investment or emphasis on endometriosis, and there’s not the support that these women need.”
Sutcliffe wonders if this is partially due to societal expectations of women.
“I think as women, we suffer and muddle through it, because that’s what people expect us to do,” she says. “Women are out there suffering on their own, going from doctor to doctor trying to get answers, and not only is it frustrating, but the pain is impacting their lives – their social lives, their time with their families, and their ability to go to school or work.”
Dawn Carlson, vice president, general medicine, AbbVie, agrees. Now leading the AbbVie team striving to find treatments for endometriosis, she previously worked to bring medicines to market in the areas of immunology and oncology.
Ask her about her current role, and she’ll tell you about the disparities inherent in women’s health, the stigma of talking about a reproductive condition, the fact that medicine had long considered endometriosis a “surgical disease,” and – mostly disturbingly for Carlson – that women often feel their endometriosis-related pain isn’t taken seriously.
“I met a patient who had really heavy bleeding. She’d been told that unless she passed clots larger than her head, it was nothing to worry about. When she finally had (investigative laparoscopic) surgery, and she woke up and was told she had endometriosis, she was actually happy because that meant she wasn’t crazy, and someone believed her,” Carlson says.
Under Carlson’s leadership, a group of Illinois-based scientists, physicians, clinical trial specialists and more have been working to change the status quo for endometriosis and related conditions.
Their journey began eight years ago and a thousand miles west, when a California-based biotech called Neurocrine Biosciences found itself with a novel compound and the need for a clinical partner to help turn it into a medicine.
The company had ample data showing the promise of their compound for the treatment of endometriosis-related pain, but needed a partner for the large-scale development program they felt the compound deserved. AbbVie was looking to expand its endocrinology business and hone in on unmet needs in women’s health.
“Neurocrine Biosciences came to us with some incredibly innovative ideas about the potential of this medicine… [and] it was our job to make these possibilities a reality,” Carlson says.
One of the first steps in designing a clinical program for a new medication is developing the endpoints – the primary outcomes measured by a clinical trial, used to show the value the medication might bring to patients, physicians and other stakeholders. These endpoints are often straightforward; for example, lower levels of disease in the blood, number of episodes, or clearance of lesions.
But developing endpoints for a medication used to treat endometriosis is a different animal altogether, says Ahmed Soliman, associate director, Health Economics and Outcomes Research (HEOR), AbbVie, who works with Carlson on the women’s health team.
This is a disease where everything is patient reported. We do measure estrogen levels but what really matters is the pain that patients report,” he explains. “We also wanted to measure how that pain impacts multiple dimensions of someone’s quality of life and productivity.”