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Dr. Ed Tucker is vice president and head of pharmacovigilance operations, Global Medical Safety for Janssen Research & Development LLC, which is part of Janssen Pharmaceuticals, a Johnson and Johnson subsidiary. Janssen Pharmaceuticals itself produces pharmaceuticals for treating a wide range of diseases and disorders, including ADHD, gastroesophageal reflux disease, bipolar I disorder, schizophrenia, Alzheimer’s disease, epilepsy, pain management and a variety of other health concerns.
Tucker’s role at Janssen is to gather safety-related data to inform his company — and government regulators — about patient use of its products. His department sends Individual Case Safety Reports to national government regulatory agencies about adverse events experienced by patients using Janssen’s products, whether in clinical trials, physician-prescribed therapy, or over-the-counter purchases. Thus, it is important to his function that he communicates with patients about their use of pharmaceuticals.
Social media provides a new platform and opportunity for connecting with patients and learning about their safety concerns, questions or comments, and presents new opportunities for collecting key information. However, in such a highly regulated and sensitive area as pharmaceuticals, there needs to be extra care and vigilance in how such information is gathered, including an awareness of the legal requirements about reporting certain safety-related data.
In this interview, Tucker describes how social media is providing new opportunities in his own role as well as some of its promise for the pharmaceutical industry as a whole, and how the industry can take advantage of the potential of social media without violating safety, privacy and other regulatory restrictions.
How important is the social media business to your organization right now and what are some special challenges given your industry?
It is very important. In pharmacovigilance, we receive a lot of safety information that gives us insight into our products and the patients receiving our products. We are often one of the downstream recipients of information from other parts of the company that engage in social media activities.
One of the unintended consequences for a pharma company entering the digital media space is triggering certain regulatory requirements around the reporting of safety information. At an industry level, we have processes that can accommodate the receipt of safety information that is required to be sent expeditiously or periodically to the regulatory agencies.
When you’re talking about triggering a regulatory requirement, does that mean, for instance, somebody starts reporting “I took this drug and it gave me headaches” — is it that kind of information?
Yes. That’s precisely it. There are really three types of engagement. One is to utilize digital media tools to broadcast — that’s information that goes out on a website or a podcast akin to advertising or publishing. There’s no information that can come back with exception of a call center or email enquiry. So you’re literally promoting or broadcasting, which are subject to regulatory code compliance.
That’s one-way communication, yes.
Yes. Outward communication of details of a medicinal product or information about a disease awareness campaign are examples of promoting, so you should consider the regulations that cover direct-to-consumer advertising not only in the country of origin, but also in the countries where the information is disseminated.
The second type of digital media engagement is listening, where you can listen to open-access chats such as those you’d find on health advocacy group sites, Facebook, or Twitter. You can do what’s called Internet “scrapes” of information, where you draw down lots of various hits or posts from the Internet, and then analyze that data. You can listen to the chat essentially, the public sentiment, in the virtual environment. With these approaches you can capture patient data of interest; but you can also capture additional data that may include safety-related information, which will need to be transmitted to the safety group.
The third type of engagement, which is the most difficult, is where you have two-way communications. The pharma industry has struggled with this somewhat because two-way communication can be resource-demanding and great care has to be taken in providing appropriate advice and information to a diverse group of individuals from qualified company representatives.
With two-way communication, patient assistance may be centered around training on a device or on symptomology. It can also be focused on certain special populations, such as babies, whose parents are actually administering products to their newborns and want to know additional information or are seeking a route other than through their learned intermediary (doctor) or health care provider. (It is interesting to note that a patient has an almost-infinite amount of information from the digital space, but a pharma company has the most restrictions on communication despite its potentially being the most helpful or accurate.)
What are the big-picture goals for the pharma industry in general?
The pharma industry has a few examples of pilots conducted to reach goals for analysis, where we’ve managed to gain insight about patients and products in the market through information that’s been put into the digital media space by patients themselves. There are some structured areas like Jamie Heywood’s LLC, PatientsLikeMe, which is a very good example. PatientsLikeMe allows patients to volunteer their clinical information and as a result, collectively can reveal new insights that the industry is starting to use. Boehringer Ingelheim was the first company to engage Jamie Heywood’s organization to gain new insight into patient information.
But we’re still at the very infancy of analyzing big data. So when we’re doing big scrapes of data, what does that mean? When we’re listening on Facebook, how do we say, “What are the profiles of the patients and the products?” to understand better and improve patient safety? That’s the next piece in the Internet puzzle, the analytics. Do we understand the limitations of this data, and how can we take this data and compare with other data forms such as clinical trials and traditional spontaneous data? Can useful conclusions to data be derived from these digital activities? I believe we can make inferences that can be aligned with other forms of clinical data.
The third piece in pharmacovigilance is how we manage risk. How can we communicate, navigating those same compliance challenges of direct-to-consumer advertising, making sure we’re not in breach of any patient confidentialities? How can we communicate safety information to make patients safer as part of a well-defined risk management program? We’re some time away from that due to diverse and extensive regulatory expectations and the complex nature of healthcare. There are some examples of risk management plans in the virtual space, but these are the very early adopters. The industry has not gone mainstream with social media in risk management planning as there are still some key questions to be answered with regards to regulatory compliance, data privacy and promotion.
What are the issues from a regulated industries perspective?
The issues are many because there is no single agency that controls the Internet everywhere it exists.
The Internet doesn’t generally have national boundaries, so let’s look at the United States for instance. If you want to set up a social media site in the United States, then that data may be subject to the HIPAA if personal medical information is captured. It may be subject to promotional regulations of the FDA. It may be subject to safety reporting requirements. There may be questions around intellectual property rights, as you’re publishing potentially on Facebook or Twitter, related to use of trade names and brands in addition to the site requirements. And the very moment that you extend over more than one national boundary, you have transportation of health information across boundaries to consider.
In Europe, there are problems with direct-to-consumer advertising. You have to specify very clearly the separation between information that goes to health care providers and that which goes to patients. So again, you have to make provisions to avoid coming between the learned intermediary and the patient. It is the prescribing doctor who is the most important communicator with the patient.
Stepping back, what are some benefits from being involved in social media?
The first benefit is scale. Then there is accessibility and the instant data that can be generated. Those are plusses. Understanding market research, understanding sentiment and getting real-time information — these are some very positive upsides to the social media environment.
The downsides are that the data are not controlled, so it’s hard to analyze. It has confounders and biases, which include reporting bias, because not everybody has access to the Internet. Not everybody who does have access wishes to express their personal information. These issues can trigger major processing and analytical challenges in a large organization.
In your safety role in pharmacovigilance, you said you’re the downstream recipient. Does that mean you are in a listening mode? How do you as a downstream recipient derive value from social media?
At this moment in time, the science of social media in pharmacovigilance is extremely limited. So let me just back up to about 1970. Following the thalidomide disaster in the late ’60s, regulations were put in place to expedite the voluntary reporting of safety information to regulatory agencies. What that means is if a doctor wishes to report an adverse event, he or she may do so to the manufacturer, and that may trigger an obligation to report to a health authority where the product is registered.
Essentially, what that means is that if the thalidomide disaster were to occur again, then authorities would be aware of the new signal in five to seven days, if it were so obvious. That’s what was missing back in 1970.
Let’s move forward to the 2000s. We still have those reporting obligations. Now with a voluntary reporting system, we see anywhere between something trivial, where somebody says, “I’ve been on this drug and I’ve had a runny nose every third day,” to something serious. The former is a non-serious adverse event. The likelihood that it will be reported to a manufacturer is very, very low, probably less than 1%. But if a patient dies and the doctor believes that it could be related to a drug, there’s an 80% chance that it would be reported to the manufacturer and subsequently to a health authority. So there is a severity or a seriousness component to how much is reported from the patient and healthcare communities to those responsible for overseeing safety.
Overall, in the lifespan of all products in the world, the pharmaceutical industry and regulators receive information about 10% of all adverse events that occur. We can get insight into our products with that 10% because there’s a bias in reporting those events that are likely to be caused by the drug and likely to have a higher severity or seriousness. We can warn our patients and doctors in sufficient time with that 10% reporting, a conservatively biased sampling, which alerts the manufacturer and the regulatory agency to explore a potential safety signal further.
Now, in the social media space, what we have is a lot more written dialogue, reporting adverse events. So previously you might have been at a party or on a bus and describe an adverse event, which would not have been reported before. Today society utilizes the Internet to have those same conversations, where patients share their experiences and say, “Yes, I got a headache with my tablets last week.” Looking at the regulations from the last few decades, that kind of public comment may trigger a responsible company or regulatory agency to add it their safety database.
What we’ve got now are two things, which are correlated together. One is that the Internet has provided a tool for people to capture their adverse events, whereas before it was just the doctor who would report it to the manufacturer.
Two, the Internet is facilitating dialogue with other people, so there’s a lot more chatter. We have this whole new opportunity. Not only is there a new port for reporting, but there’s also more dialogue occurring, more experiences being shared, and each recorded experience may appear multiple times as messages passed (virally) from one person to another. Both of these things have dramatically increased the volume of documented adverse experiences, some associated with the drug and perhaps some associated with the disease. So we have to make good on that. This is a very new science for us all.
Do they use metrics to figure out the return on investment for what they’re doing in the social business space?
It’s really about the share of mind rather than some dollar amount. So the return is rather intangible. How do you measure share of mind?
Is there a use for social tools that you think the pharma industry hasn’t tackled yet, or taken advantage of?
Yes. It’s risk management. If permitted, the Internet could facilitate a dramatic improvement in healthcare information provision at the personalized level. This is an opportunity to transform from treatment provision to healthcare solutions and it’s a critical part of information and guidance because many patients go online to seek advice and clarity on their treatments and their conditions.
When I say “risk management,” I don’t mean business risk management. I mean patient risk management. I don’t think we’ve fully accommodated regulation yet and the regulation has not fully accommodated digital media, where we can give patients information without [it] being seen as promotion. And I think there’s a concern generally that if companies can communicate on safety, then they’ve got to tell them what drug it is without there being a feeling that it’s promotional. But there are some very entrenched biases there. I’m a physician first and foremost, and I think that if we [pharmaceutical companies] can be trusted as an industry, then the social media space is an excellent way to enhance the value of our treatments for patients around the world.
There’s a wonderful opportunity here to correct certain misinformation found on Wikipedia and the Internet and create a hierarchy of clinical data in the digital space for health care providers and patients to access. And I do feel that the regulators and the industry should be given the opportunity to be the source of information for products. I think that’s what patients need and deserve.
You mentioned earlier you thought that was about five years out. What could happen in those five years? Does that just increase dialogue with the regulatory agencies, or are there some technical things that need to occur?
At the moment, we’ve got very blunt instruments. I think if we can build confidence, then we can communicate to the right communities — the physician community is a good example, as it’s a closed community.
If the regulations converge and harmonize, that’s another opportunity as well. As some of these large social media organizations grow, they may see some opportunities to help society. So there could be convergence between Facebook and some of the large healthcare providers (I’m not speaking pharmaceuticals now) to try and improve health. I do see an opportunity there, because health improvement and disease prevention are the two things that, from a philanthropic perspective, we’re seeing with the Gates, Buffett and Clinton Foundations. We’ve seen a very large shift in focus in the past ten years.
Patients have a lot of places to look for healthcare information, but they don’t know where the reliable sources are. I would like to be part of that solution in the future. It’s a wonderful opportunity. The problem is, reputationally, the industry still has to build on being a trusted communicator of information and not seen to be the treatment providers as we are often characterized in the media. Confidence and trust takes a long time to build and only a second to break. The healthcare industry, including pharmaceutical companies and regulatory agencies, will not be given a second chance to build that trust, so the challenge is to enter this space carefully, trustfully, compassionately, honestly and most importantly with the planning and execution demanded by society, to get it right first time. This can only be achieved with cross-functional collaboration with the numerous stakeholders involved.