The Intersection of Access: Part II
05/15/2018
From Clinic to Court; From Real-World to Research
In fall 2017, on the seventh floor of Scott Hall, students in the Legal Clinics sought to improve access to a life-saving medical cure through litigation, while students in a Food & Drug Law Seminar did original research to formulate new solutions to other access issues.
The Classroom as Solution
In a Food & Drug Law Seminar taught by visiting professor Elizabeth McCuskey of the University of Toledo College of Law, health law students explored complex health issues that do not yet have solutions. The seminar provided students with a “deep dive” into the regulation of health-related products, as well as a chance to do original research and put forward solutions in a format reflecting real-world legal practice in that area.
While the final stages of the hepatitis C lawsuit wrapped up in the Legal Clinics’ office, involving students who had learned about a particular health access problem within the walls of law school and gone out to fix it, a few feet away down the hall, students who had worked in the health care field prior to law school returned to the realm of academia to explore solutions to problems they had seen firsthand.
Pushing the Boundaries
One of these students was 2L Michelle Rodman, who spent 15 years as a surgical technologist
at a hospital in Seattle, Washington, before coming to law school. Rodman drew on
this experience as well as on the experience of a colleague she’d had, a doctor who
was diagnosed with glioblastoma multiforme and served as the first human in a breakthrough
immunotherapy trial. She wrote a white paper on his case study and explored the Right
to Try Act that has been debated in recent months in Congress.
“The premise of the paper was how this technology and that legislation can work together to promote new possibilities for patients being able to have access to treatments that maybe aren’t FDA-cleared yet or are still in the trial phase,” Rodman said. “So looking at, ‘Where is this going to go now?’”
Besides the groundbreaking nature of the case study she was exploring, she was also compelled by the circumstances that led to it.
“How do you have someone in the medical community who’s very knowledgeable help patients who don’t have as much access to that get treatment that they could have? Or how do you prevent people from getting treatment that may not be the best for them, just because they hear about it on TV?” she asked. “I thought he would be a great example of how you have access to information but use it in a very practical way.”
Rodman recently sent a copy of her white paper to SLU LAW alumni working in D.C. who do FDA regulatory work, hoping to get their feedback.
And while she remains interested in new cancer treatment technologies, her real passion is orthopedic technology, such as total joint replacements, implants and screws for broken bones.
“Especially as baby boomers are living longer and the population is growing, I think everyone wants to be healthy, so those are the kinds of devices that I really love.”
Ensuring Effectiveness
Another student in McCuskey’s seminar, 2L Lauren Pair, took an opposite tack. Before
coming to law school, Pair had spent five years as a clinical researcher for a pediatric
oncology group at UAB Hospital in Birmingham, Alabama, while getting her master’s
degree in public health, serving as a “behind-the-scenes data person.”
“When patients were eligible for research studies, I was the person submitting their eligibility data and then keeping track of them throughout the course of their treatment,” Pair said. When she read about how new FDA leadership was prioritizing accelerating the approval process for certain drugs, she was intrigued.
“Having had the practical experience of knowing patients who go through that process but, too, knowing the behind-the-scenes data that goes into actually making sure that the drugs are safe and effective, that was fascinating for me to see. Of course everyone wants access to new drugs if they’re safe and effective, but what measures are they taking to ensure that they’re not compromising on those requirements to meet their goal of getting drugs approved more quickly?”
Speeding up the process — instead of taking seven years, for example, only taking three — runs the risk of not ensuring enough time to accurately tell if the drug is truly effective, she said.
“You don’t want to tell parents ‘Here’s this new drug, it’s been approved more quickly, it’s going to be great,’ and then it turns out it doesn’t actually have that beneficial effect that takes time to tease out through clinical research.”
A lot of people think of ‘access’ in terms of policy, so you’ve got to work for the government, but there’s the business side and the health care industry side, as well — how can you assist hospitals or physician practice groups and make their lives easier? Because that’s where the access is."
Lauren Pair ('19)
In addition, the new regulation for accelerated approvals does not mandate that follow-up studies be in place.
In a citizen petition to the FDA, Pair analyzed the new regulation and then used evidence from prior studies conducted by physicians and public health researchers to support why she felt the change was not enough.
“My suggestion to the FDA was to change the language of the statute so that instead of saying ‘These are studies that are likely already to be in place,’ to change it to ‘These studies shall be already in place [in order] for you to get accelerated approval.”
McCuskey commented that Pair’s petition was a “superlative combination of her science background, her research on drug-approval regulation and the real-world application of administrative law in drafting a petition for rulemaking.”
“What drove me to come to law school after spending time in the field was improving access,” Pair said. “That’s very broad and there are a lot of different ways to attack that problem. A lot of people think of ‘access’ in terms of policy, so you’ve got to work for the government, but there’s the business side and the health care industry side, as well — how can you assist hospitals or physician practice groups in their day-to-day and make their lives easier? Because that’s where the access is. Even if you work at a big firm and you’re assisting insurers or health care providers, you’re still helping with access.”
Synthesizing Systems to Save Lives
And fourth-year student Jeremey King, who is pursuing a dual-degree master’s in health
administration, conducted original research on state prescription drug monitoring
programs (PDMPs), a leading tool in the fight against prescription opioid abuse.
King became interested in exploring PDMPs as an intern in 2016 for the National Health Law Program, and in 2017, Missouri Governor Eric Greitens signed an executive order to initiate a PDMP for the state as the 50th in the nation. King compared state-by-state features of these programs and proposed best practices for PDMPs, including aspects such as privacy and interoperability.
“There’s been a lot of research into the problems [surrounding opioid abuse] but not a lot of solutions proposed, and it kind of synergized with a project I was working on in the M.H.A. program for a health information systems class,” King said. “So this is kind of the health information system response for how to fix the problem.
“Before I started, I didn’t realize how bad the problem was,” he continued. “There are these [prescription drug monitoring] programs, but they’re not really effective, in that they don’t capture many of the issues that everyone knows to be the issues.”
Some of the programs, King explained, do not require administrators to enter a form of payment, so if a person is paying for a prescription drug with cash, that may not be picked up as a potential abuse situation. Some states’ databases only update every seven days. Some capture who picks up the prescription, such as a parent or spouse, and some do not.
“From the research I did, there’s a consensus on what data needs to be collected, but hardly any databases actually do capture all of the data points.”
In his paper, King advocated for a federally managed but state-operated approach similar to Medicaid, in which a federal program mandates broad outlines and facilitates interoperability, and then the states can fill it out, while having to meet minimum standards.
After graduation, King plans to join the Missouri Department of Social Services as an assistant special counsel, working on the Medicaid and public benefits programs.
“The FDA seminar gave me some insight into, in my view, what good regulation would look like, which I think is useful. And it gave me an idea of what bad regulation looks like and the issues that could arise if it looks good on paper, but down the line there are all these holes that just create more problems than good.”
“The profound tension between scientific innovation, product safety and patient access to treatment makes drug regulation extraordinarily complex,” McCuskey said. “I am so impressed with my seminar students’ willingness and ability to embrace that complexity and seek new legal solutions.”
— By Maria Tsikalas