Memorandum

LEADER: How this data will change – and save – lives – FDA OPH by Kelly Close – June 20, 2017

Executive Highlights

Good afternoon, everyone. My name is Kelly Close, and I am the founder of the diaTribe Foundation, a diabetes patient advocacy nonprofit formed in 2013 to improve the lives of people with diabetes and with obesity. Donors to the diaTribe Foundation include the Helmsley Charitable Trust and many other organizations including today’s sponsor. By way of disclosures, I also founded and help lead Close Concerns, a healthcare information organization that chronicles diabetes’ scientific and clinical progress and challenges. I also was a co-founder of dQ&A, the diabetes market research firm. My colleagues will review the disclosures of Close Concerns and dQ&A later this afternoon.

I would like to talk about three things – mean sentiment, collaboration, and understanding.

I’ve learned a lot since I first started coming to these hearings. I’ve learned a lot globally from the voices of patients, and I want to salute the FDA for giving us this chance to be able to connect with you. I want to step back and say, it was a pretty intense morning, and I want to encourage everyone to hopefully not lose the forest for the trees.

Second, collaboration – we feel strongly at the diaTribe Foundation that researchers and clinicians and patients should work together better. We have to be in better alignment – and patients and clinicians need to follow research better and the research must be translated better. We want more people to read and understand labels, and we want clinicians to feel more successful in translating research and patients to feel successful and engaged in understanding it.

And, third, understanding – these are once-a-decade results, and I want to acknowledge that. This is a BIG deal to take a drug to prevent CV disease – it’s a different mindset. When the topline results of LEADER came out 15 months ago, I remember reading about it in bed. I jumped out of bed and woke my husband – Johnny!!!!! There are going to be fewer heart attacks. I ran into the bedroom that our children share and said Coco! Lola! Valentino! WAKE UP!!!!!! This is a new dawn for SO many people with diabetes! We can do BETTER!!!!!!!!!!!!!!!!!! My husband was already at the door, saying, patients at very high risk can do better. YES – people at high risk. These numbers are profound and we want to thank the researchers and patients who helped figure out this analysis.

Type 2 diabetes and cardiovascular disease are inextricably linked – we know that. Think about that…people are living longer and longer with this disease thanks to smarter and better therapies, but that only means that the global cardiovascular disease burden will increase DRAMATICALLY – people are living longer, but we don’t want them to be unwell in their older years.

We’d like to suggest that adding a CV indication to the Victoza label will help to open up discussion of complications and get the important things out there to discuss.

The sheer presence on a diabetes drug label could kick start the necessary conversations: Physicians will be reminded to establish that CVD is the main cause of death and disability for people with type 2, and people with diabetes may be inclined to ask about THEIR risk when they see the words peering back at them from the label.

And when people are more conscious about CV risk, that can only be a good thing. The CV burden at a population level could decrease.  We’d love to see this happen. Long term consequences are often poor motivators of behavioral change, particularly if a person feels like there is nothing he or she can do. Having a proven therapy to turn to in combination with good access and advice about healthy living (which they’ll have more time for since they don’t have to talk about hypo, weight gain, etc.), this could empower patients and clinicians in many ways. But it has to start with awareness.

And finally, I know value-based care is still somewhat a thing of the future, but that IS the direction we’re heading. Taking a drug with the goal of prevention, that’s not something patients are used to, but if any drug can claim on its label that it reduces risk of CV events, that’s a big step. With the availability of drugs able to reduce CV risk, with value-based care, health care systems could begin to think about prevention, and that may motivate them to reorganize around a value-based framework. There are so many compelling reasons this should happen.

Thank you very much.

 

-- by Kelly Close