Shaping Drug Safety Stories

What Does Drug Safety Mean from the Patient’s Perspective?

Rakesh Raman, M.D., Senior Director, Head of Medical Safety at REVOLUTION Medicines, joined the Safety Signals Podcast when he was in a similar position at Mirum Pharmaceuticals for a lively discussion about the importance of knowing everything possible about how a drug impacts a patient’s lifestyle.

The conversation covered a variety of topics, but central to the discussion was the idea that drug safety is really about patient stories. Dr. Raman explained how safety scientists must maximize safety signal detection, identify how a drug’s safety profile compares to its entire class of drugs, and understand how a patient’s life with a drug compares to the natural history of the disease being treated.

“You have to…determine what role, if any, your drug plays in some of these adverse events or adverse experiences that these patients have,” said Dr. Raman. He noted that if a regulator thinks a certain risk is involved but the sponsor doesn’t, “that’s…where you’re trying to prove the negative because what you want to do is create a label that you feel is representative and accurate.” 

According to Dr Raman, the trick for safety scientists is to construct a compelling story that explains the risk benefit analysis of a drug from the patient’s perspective.

Analyzing Data in the Proper Context

“When it comes to the work we do…the challenging part is always being able to go and tell the story of your patients in a way that you feel is done responsibly, ethically, and scientifically driven,” Dr. Raman said. 

Once a conclusion has been reached on a drug’s risk profile, Dr. Raman believes it’s important to “find a way to contextualize that with your actual background population…and whether or not this is below, above, or consistent with the actual disease.” 

He cautions pharmacovigilance professionals not to get bogged down in words and numbers, but instead try to look at data in terms of what it actually means for a patient taking a drug and living with a disease. “To give you an example, there are a lot of drugs out there that will cause adverse reactions, things like diarrhea, things like coughing, things like fatigue, nausea, or whatever,” he said. “When you work in the industry, it’s very easy to sort of be dismissive of those things and say, you know, well, we’re treating a major life threatening condition, that’s not a big deal, they can deal with that.”

But from the patient’s perspective, even with a life-threatening condition they might not be able to tolerate having to go to the bathroom 20 times a day just to manage it. To help patients deal with side effects, Dr. Raman said that a lot of health authorities are asking sponsors to provide management guidelines in protocols and labeling documents. 

This can require obtaining quality of life metrics from patients through questionnaires and other measures. “There’s another step that a lot of companies now are having to take, and justifiably so, to say that this is what the clinical experience looks like for…patients,” Dr. Raman said. “It’s not just about producing data and numbers, but being able to really justify what your risks are and how you manage them. And then how that impacts the patient.”

According to Dr. Raman, safety scientists owe it to patients to keep evolving. “The second you start to allow yourself to be a little bit stagnant with practices is when you quickly fall behind and you’re not doing the best for your patients,” he said. “If the motivation is always on doing what’s right and best for your patients, it sort of triggers that level of creativity and ambition to go and find the best possible sources and tools to be able to do our jobs the best that we can.”

This post is based on an episode of the Safety Signals podcast. To hear more, check us out on Apple Podcasts, SpotifyGoogle Podcasts or on our website.

The views of the hosts and guests featured on Safety Signals are their own and do not necessarily reflect the views of Saama or the individual companies for which the guests may work.