By Tonia Twichell
(December 2015) Bray Patrick-Lake addresses a standing room only meeting of White House and government agency staff,
No one would guess that Patrick-Lake, a co-chair of President Obama’s Precision Medicine Initiative advisory committee and founder of a patient advocacy organization, just seven years ago was a jilted research subject, angry and confused that a clinical trial intended to help patients with her heart condition announced to the media that it had closed without telling patients.
Patrick-Lake and other trial participants wanted answers. The Erie resident approached John Carroll, MD, the University of Colorado physician who had inserted a device in her heart as part of the clinical trial. Over the next several months, Carroll patiently helped Patrick-Lake understand the complex world of clinical research.
“It was a very unique thing,” she says. “Most investigators would say ‘I’m not seeing you anymore. You’re not my patient.’ Dr. Carroll had a different mindset. He wanted to know what we could do together to make this situation better.”
Those conversations set the stage for a large-scale career shift for Patrick-Lake, a former police officer and homeless advocate, placing her at the forefront of a national movement that has changed the role of patients in clinical trials throughout the country.
“People don’t know how much one clinician can change things,” Patrick-Lake says. “Of all of the 25 things I’ve worked on since 2008, none of this would have happened, if the first time I went to him and said, ‘I don’t understand,’ he had said, ‘I don’t have time.’”
An Accidental Advocate
Patrick-Lake considered herself healthy and athletic until one day in 2004 when she collapsed at a shopping mall while six months pregnant with her second child.
“I went from being someone who saw the doctor once a year to a person paralyzed and unable to speak,” she says. While the paralysis lasted only about 10 minutes, it was the beginning of life-altering health issues.
Diagnosed with patent foramen ovale (PFO), meaning she has a hole between two chambers in her heart, she suffered debilitating pain, migraines
“At the age of
“So I did what people do now. I went straight to the Internet. Online, I found people like me and learned what was working and what wasn’t.”
Patrick-Lake discovered a clinical trial at
“I woke up with a 100 percent cessation of migraines,” she says. Unfortunately, she also suffered severe side effects. But she learned who would support her during those dark times.
“When I had complications, Dr. Carroll would be there. He once met me on a Friday night in the emergency room when I was in trouble. And then he followed up to make sure I was OK.”
Within four months the medical device company, citing lack of enrollment, shuttered the trial, which was taking place at 30 hospitals around the country. Infuriated that the trial had been aborted without timely notice to patients, she was also upset that federal law prohibited the release of trial results. Additionally, the company that funded the trial was under no obligation to continue providing care or tracking patients.
Patrick-Lake, who at this point knew she’d been given the experimental device, says: “I thought, ‘This should never happen to anyone ever again. I’m not ever going to get the data and I’m going to live with this device the rest of my life.’”
Carroll, director of interventional cardiology at the CU School of Medicine, had not been involved in an aborted study before or since. In time, their patient-physician relationship evolved; they partnered to convene a PFO
“We talked about how these clinical trials could be done better, what’s wrong with some of them and what barriers are there to changing them,” Carroll says. “And she made the evolution from being angry at the company to saying, ‘How can things be improved?’ That was the beginning of the most amazing transformation I’ve ever seen in a patient becoming an activist in the field.”
Soon Patrick-Lake began working with patient groups, researchers and government officials. Along the way, she got a lot of constructive criticism from Carroll.
“Dr. Carroll was honest in saying, ‘If you say it this way it sounds inflammatory.’ He was really a mentor as far as helping me understand how to make systematic changes constructively.”
Carroll knew that tone was critical. “There’s always the danger of being seen as an angry young person who doesn’t know what they’re talking about. I got called early on when she started making national connections from people asking whether she was a reasonable person. I told them ‘She is the real deal. This is someone we need in the field.’”
In 2009, she was invited to Washington, D.C., to a town hall meeting of the U.S. Food and Drug Administration before the transparency task force.
“I was thinking of it like it was some small town meeting. I walked in and it was a panel with Consumer Reports, the Pew Foundation, the Medical Device Safety Institute and me, just off the plane from Colorado, a mom of two kids with peanut butter and jelly on her shirt.
“I had no idea what I was getting into. I never intended to do this. It was a very accidental journey … But there are some things that need to change and not just for me. We need a systematic change in this country, and I think everyone knows it. “
‘The Match that Lit the Fuse’
Patrick-Lake’s advocacy helped lead a change in perspective about the role of patients in research trials.
“This was before the age of patient centricity,” Patrick-Lake says. “Now everyone talks about how to work with the patient and patient-centered research outcomes. Back then, there was no mindset of working in partnership with patients around clinical trials.
“Millions of dollars were wasted, patients got no answers and no new product reached the market. All parties lost.”
She believes that the PFO trial she enrolled in might have been successful if patients had been involved from the beginning in designing the study. As a patient advocate who has worked with several organizations including National Institutes of Health, the Patient-Centered Outcomes Research Institute, and the Clinical Trials Transformation Initiative (CTTI), she advocates patient input in the design and conduct of research, and improved communication so patients can make informed decisions about their care.
“Now for many
In earlier trials, patients rarely saw results of research trials,
“We think so much deeper now about patient involvement,” says Larry Wood, corporate vice president of Transcatheter Heart Valves at Edwards
“She’s the first person who comes to mind when I think about patient advocacy and maybe the last person who comes to mind, too.”
Now patient groups often design and fund clinical trials or develop their own trial networks.
“Patients today want information,” Patrick-Lake says. “If we can’t get it from research or our health care provider we pop up a Facebook group, so you end up with information sharing outside of systems.”
But she believes splintering the system doesn’t work well and that patients and researchers get better results if they collaborate. So she has dedicated herself to making the system more inclusive. The results from a CTTI project she has been leading recently released evidence-based recommendations on effective engagement with patient groups. Now Patrick-Lake is leading work to measure the value and impact of patient engagement in clinical trials.
“It started with me knocking on the door and asking a lot of questions. It was me saying ‘I don’t like these things.’ Had that first door not opened when I knocked, it’s possible none of this would have happened.”