Hearing the voices and learning the lessons
A conversation with Ramana Sonty, MBBS, PhD, Director of Strategy,
Janssen Global Medical Organization
Leaders from Janssen, Bristol-Myers Squibb and Sanofi recently participated in a panel on patient-centered leadership at an eyeforpharma Patient Summit. This is adapted from Ramana Sonty’s participation on that panel.
The primary topic was how companies can become aware of patient concerns and address them properly—not only for the benefit of the patients themselves, but for the efficiency and intelligence that ultimately make healthcare’s sales and marketing initiatives more successful.
Ramana Sonty is in the Global Medical Organization of Janssen at Johnson & Johnson, working on several different patient engagement and patient-centric activities, which is the mission of the office of the CMO. He says “most prominently I’ve worked in the expanded access space. Access in investigational medicine is something that we’ve been working on for the past couple of years and has brought us into the sphere of patients.”
On this topic, he reported that he remembered back in the initial AIDS crisis in the mid-80s that patient voices became very important. “These were either dying patients or seriously ill patients and the existing treatments didn’t work for them and they weren’t eligible for trials. I think the voices went to crescendo after social media came in.”
He recalled the story of a small boy who was likely to die very soon. It was very clear that he was fading and his physician said that there was a particular drug that was being produced by a small company that did not want to provide access to that drug. The parents worked with lawyers and then the social media folks, who mounted a very intense campaign. The result was the drug was provided to the child and he recovered.
“We all want access to these treatment options,” said Ramana. “When those voices came forward, one of the things that we discovered was that we engaged with patients and patient advocates. What they wanted were simple things, a single point of contact in the company. Where can we find more information, what drugs do you have, what is the process to apply, what is the decision criteria? None of this information is available on any kind of consistent basis.” In his role, he expanded access through improving the company website and providing the education with videos and other materials, gaining insights from patient advocates and trying to engage patient voices. “They certainly also asked for legislation to help them and they also asked for more innovative solutions and then we came up with a partnership with NYU.”
“One of the things we’ve heard from patients is a frustration about that they don’t know who to approach. Second is that there’s always the sense that there’s implicit bias—that you’ll get a better reception based on who you talk to.”
Ramana was reminded of specific changes he has seen. “One of the things we’ve heard from patients is a frustration about that they don’t know who to approach. Second is that there’s always the sense that there’s implicit bias—that if you go to the CEO you’ll get a better and warmer reception than if you go to the medical information line or just catch a security guard and ask him for the drug. And certainly we wanted to quell that kind of feeling among the patients so that they understood it’s a very fair process.”
“We’ve communicated that whether you’re a patient who is a king of a country or someone coming off the street, you’ll go through the same review process and you’ll be applying in the same place.”
He pointed out that trust is lacking because patients think the industry has interests contrary to those of the people being treated—that the primary concern is not necessarily medical evidence or treatment protocols.
“So to address all these pieces very tangibly over the past year we’ve gone ahead and built several principles based on which we set our policy. One of those principles is equity, so we’ve communicated that whether you’re a patient who is a king of a country or someone coming off the street, you’ll go through the same review process and you’ll be applying in the same place.” Second, he explained that it’s not just the internal company people who make that decision. There’s an initial screen of the application to look for issues on safety, or appropriate clinical trials, or a cohort program that the patient can go into. If that’s not available, they have a collaborative effort with NYU, an expert party independent of Janssen. It’s a group called CompAC, Compassionate Advisory Committee of NYU, that’s led by one of the world’s first and highly-regarded medical ethicists, Art Kaplan. The requests that come in after the initial screen are sent to NYU and they’re the ones that advise the company about whether this particular patient is an appropriate candidate and this one is not.
What’s impressive about all this is that it’s not something mandated by any regulatory body, and it’s an additional expense and screening process for Janssen. But they consider it a benefit overall, because it provides them with vital information that they might not get through traditional examination channels.
Ramana spoke of anecdotes he had heard about patients. “It was just very gratifying. Even being completely in the thick of it and designing the process and implementing it, I never for one day expected the kind of response that came back from the patients—that they were so grateful to us for doing this. In fact, one of the first responses that came back was about a family that had lost a husband and father. The son put up a campaign on social media trying to get medication for his dad, and unfortunately the father passed away because he couldn’t get access to the drug. The father’s widow wrote a letter to us saying ‘Thank you so much [for our programs]. I wish there was something like this when my husband was still alive.’ I think that’s an example of a very tangible change that we’ve made.”
“We just assume everybody knows certain facts. It was amazing that [the patient advocacy groups] were not aware of some of the policies that we had in place and the changes that were taking place in the landscape.”
This points to a sea change that has happened in just the last few years at companies. It forces everyone to think differently about their jobs, to change perspective, actions and programs. At first, there was a perception—probably true—that patient advocacy groups had a somewhat skeptical or even contentious relationship with the companies who make the drugs and devices. We now see that changing significantly: both are working toward the same goals, and therefore can operate in concert. The industry has never considered itself at odds with patient concerns, but it took a major shift in perspective to understand the gap between patient point of view and company point of view. Ramana said “It’s very interesting because you get so many insights from the advocacy groups. I’ve been working with some of them in the mental health area. As you know, depression is one of the areas that affects the most people, so this particular group had was training mental health professionals across the country. When it came to certain simple things about what pharma companies do, it was astonishing to see the level of awareness of things that we consider in our daily language, in our daily culture, that we just assume everybody knows certain facts. It was amazing that they were not aware of some of the policies that we had in place and the changes that were taking place in the landscape.”
Patients and professionals recognize the mutual benefits…and provide resources for each other.
In that case, it wasn’t even that the policies and programs weren’t available, but that even the patient advocates didn’t know about them. The company wasn’t aware of the education gap, and had to address that. Health literacy and education has to go hand-in-hand with the benefits provided by the companies. “This is one of the areas where the patient advocacy organization can let us know about the kinds of needs they have and the kind of insights that we can bring forward for them,” said Ramana. In other words, it’s a partnership, and that’s the new era we’re in: patients and professionals now recognize the mutual benefits of an ongoing conversation. They provide resources for each other: on the one side, information about disease states and therapies, and on the other side insights about what is understood or unknown. Access to each other is the bridge that makes this possible, and it’s the responsibility of healthcare companies to open the door to access. For instance, companies can help advocates organize their thoughts and formulate a plan of attack with a particular payer issue, or can align with them on things that are not branded.
Ramana said “One of the things I heard from the advocacy organizations was often times the advocacy organization will start with a very sick family member, and this person starts off a grassroots effort. It’s really teaching the advocacy organization how to advocate for themselves. So you really get them off the ground because we have a lot of experience that we can share and they can start representing a broader patient community. Very often they don’t know how to do that, but it’s just that they have unlimited passion because of a certain tragic story that they try to bring forward and help others in that space.”
It’s in this spirit that people like Ramana and many others have shown that, because we are all patients, we must also all be advocates. Not a difficult bridge to cross, and one that more companies are traversing every day. •
Ramana Sonty, MBBS, PhD
Director of Strategy Janssen Global Medical Organization Ramana is a leader on the J&J Pre-Approval Access Task Force in the Office of the CMO. The Task Force has delivered a new Janssen pre-approval access policy, a new SOP and implemented global tracking processes for expanded access/compassionate use requests. In addition, he has led engagement with multiple external stakeholders and is part of the team that launched an innovative compassionate use pilot with NYU, called CompAC, in 2015. The pilot has been featured in articles in Nature, JAMA and other publications. He has presented the work of the task force to diverse national and international audiences. Ramana has trained in medicine and neuroscience.