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Tidepool, Eli Lilly, and the Big Picture

February 6th, 2018

TL;DR

Tidepool has entered into a partnership with Eli Lilly to provide a) use of the Tidepool Clinical Study Platform and b) access to anonymized datasets made possible via the Tidepool Big Data Donation Project. Our partnership has been driven by the team at the Lilly Cambridge Innovation Center, which is developing new and novel insulin delivery products.

  • We didn’t enter into this partnership lightly; we are keenly aware of the challenges with insulin pricing, affordability and access. We have engaged deeply with Eli Lilly on this topic, with multiple teams, at every organizational level up to and including the President of Lilly Diabetes. We have provided clear, concise and specific feedback on how we think Eli Lilly can and must do much better, and we will continue to do so.
  • As always, Tidepool is committed to openness and transparency in everything we do, and to always making decisions that we believe are in the best interest of the diabetes community.
  • We will be making some datasets available for free or at greatly reduced cost to nonprofit, academic, and citizen scientist researchers. You can contact bigdata@tidepool.org to learn more.
  • We will be sharing 10% of the proceeds of the Tidepool Big Data Donation Project with Tidepool’s nonprofit partners. The rest of the revenue we’ve earned directly supports Tidepool and our mission to deliver great, free software to the diabetes community.

Transparency at Tidepool

One of the core tenets of Tidepool is openness and transparency. It’s at the heart of everything we do. You can see that in our open source code, our project planning, our work with the FDA, our employee handbook, and much more.

In May 2017, we announced the Tidepool Big Data Donation Project, which allows Tidepool users to opt-in to donating their anonymized diabetes data. One of the goals of this project is to make these donated, anonymized datasets available to researchers and industry innovators so that they can develop novel software, devices and therapies that will benefit the diabetes community.

Our first partner for this program was Dexcom, and we’ve recently added a new name to that list: Eli Lilly and Company.

We’re committed to being transparent about every partner of the Tidepool Big Data Donation Project, so that data donors know what organizations are benefiting from their data and what new innovations their data are impacting. Since Eli Lilly has been at the center of a heated conversation around insulin pricing and access, we want to address our decision to partner with them head on.


The System is Broken

To state the obvious: The healthcare system in the U.S. is broken. The complexity of the topic is well beyond the scope of this blog post. However, for those of us living with chronic conditions like insulin-requiring diabetes, these issues hit close to home. Here are a few examples of how the system is failing us:

  • Twisted rebate schemes. The current model of rebates and incentives provided by pharmaceutical companies to insurance companies and pharmacies through Pharmacy Benefit Managers means that the people who can least afford it, those with no insurance or poor insurance, often have to pay full list price for their insulin. Meanwhile, those with good insurance only contribute a co-pay toward the steeply rebated list price that their insurer pays.
  • Lack of price transparency. A lack of price transparency means that you may not know how much you are going to pay until you are standing at the pharmacy counter. Worse, your insurance plan may only cover one brand of insulin.
  • High deductibles and high expenses. Current trends towards high-deductible health care plans mean that people pay very high out-of-pocket expenses at the beginning of the year before their deductible is met, which means paying a high, no-rebate list price for a vial of insulin.
  • Employer-provided healthcare limits options. The typical U.S. model of employer-provided healthcare often means that you may not get a choice of plan, or may only have access to plans that aren’t suitable for someone who uses insulin every day.
  • Medicare Part D coverage gaps. The Medicare Part D “Donut Hole” means that many people fall into a coverage void where insulin is not covered.
  • Barriers to generic alternatives. With only minor improvements, pharmaceutical companies have extended patents on rapid-acting insulins, which creates a barrier for lower cost generic alternatives, which is exactly the opposite of what the discoverers of insulin intended.

And these issues barely scratch the surface.

While we believe that there are many things that Lilly can be doing better to help address these issues (see below), we also don’t believe this is exclusively Eli Lilly’s fault. The system is broken and in need of dramatic overhaul that will require substantive legislative, regulatory and industry courage and energy. That will be a topic for another day.


Our Conversations with Eli Lilly

We believe in supporting the work that Eli Lilly, and specifically the Lilly Cambridge Innovation Center, is doing to innovate for people living with diabetes. We need more companies like Eli Lilly to invest in building innovative insulin delivery devices, especially at a time when some pump makers are getting out of the market (e.g., Animas) and others are struggling to be profitable. We need companies like Eli Lilly to continue to invest in innovative insulins, for example faster acting, more predictable insulin and smart glucose-sensing insulin.

We are aware of the challenges that many people face in accessing insulin and other life-saving diabetes supplies. We are also aware of the role Eli Lilly has played in some of these public conversations, and actions they have taken, that have eroded trust with the community.

When it became clear that the Lilly Cambridge Innovation Center was interested in working with us, we began conversations in parallel with other parts of Eli Lilly, including their “Insulin Access and Affordability” team. Unfortunately, we were disappointed with what we heard:

  • We feel the team did not do good job of clearly and concisely expressing the issues that affected insulin affordability and access.
  • We feel they did not clearly convey what steps Eli Lilly was taking to address the issues.
  • We feel they did not demonstrate a commitment to act as a leader in the pharmaceutical industry to improve insulin access and affordability.
  • We feel there was not a clear, vocal demonstration of empathy for insulin-requiring people that these issues affect.

Fortunately, the team was open to concrete suggestions on things that Eli Lilly could do to set the tone for the industry and, in their actions, be an example that other pharmaceutical companies could follow:

  • They can help educate the public with a clear and concise expression of what the issues are.
  • They can invest in search engine optimization and marketing (SEO/SEM) so that when people Google “I can’t afford my insulin” they quickly find helpful resources provided by Eli Lilly.
  • They can invest in a trained coaching program and online expert systems that ask direct questions of people to help them find affordable, accessible insulin.
  • They can support efforts from nonprofit organizations like JDRF, Beyond Type 1 and Diabetes Patient Advocacy Coalition (DPAC) to establish cross-industry programs that help people understand what steps they can take to get access to affordable insulin and lobby employers to provide access to health plans with low or no deductible for chronic disease medication.
  • They can make a commitment not to raise prices for a product that has changed very little for 20 years, and to make a commitment to a lower-cost alternative.
  • They can commit to releasing appropriate patents on rapid-acting biosimilar insulin, allowing generics to emerge, or even support the Open Insulin Project (as I’m sure Banting and Best would have encouraged).
  • They could use a more human-centered approach to addressing issues. Writing in a clearer, more empathetic tone when describing problems or sharing changes will help to begin rebuilding trust. For example: “This a real problem, and we would like to walk you through the steps we are taking to address it, including what we have learned from mistakes we’ve made in the past when trying to address the issues publicly.”

We gave all of this feedback to many people at Eli Lilly over many meetings, and have escalated these views and recommendations all the way to the President of Lilly Diabetes. We believe that Tidepool is in a unique position to work with industry partners in a forward thinking, collaborative manner without leaving anyone behind. We will continue to be as helpful and constructive as we can be, and we hope we will see more demonstrable forward progress soon.


How is Tidepool working with Eli Lilly?

As with Dexcom, we have licensed donated, anonymized diabetes datasets to Eli Lilly. We also plan to continue this approach with other device makers, pharmaceutical companies and industry researchers. We will also be making some datasets available for free or at greatly reduced cost to nonprofit, academic, and citizen scientist researchers.

In order to fulfill our mission to make diabetes data more meaningful, accessible, and actionable, Tidepool must support research and innovation that will bring new tools and technology to the diabetes community. We think this is the right thing to do because it will help catalyze innovation at Dexcom, Eli Lilly, and hopefully across the diabetes community.

Also, as promised when we launched the program, we are sharing 10% of the proceeds from licensing these datasets to other diabetes non-profits like Beyond Type 1, Children with Diabetes, College Diabetes Network, Diatribe Foundation, JDRF, Nightscout Foundation and many others. Over the course of the upcoming months, we expect to share over $80,000 with these organizations.

The remaining proceeds help Tidepool sustain itself, to continue on our mission to make diabetes data more accessible, actionable, and meaningful by liberating data from diabetes devices, supporting researchers, and providing great, free software to the diabetes community.

Please share your thoughts below or via email to info@tidepool.org. Thank you again for your support.

Cheers,
Howard


The No Bull$#it FAQ

What are Tidepool’s goals for the Big Data program, and specifically with Eli Lilly?

Our overarching goal with the Big Data program is to give people living with diabetes an opportunity to donate their data to researchers, and in turn to help catalyze research and development of innovative devices and therapies. Since large, for-profit companies are willing to pay for access to these data sets, we also intend to use the proceeds to support Tidepool and other diabetes nonprofit organizations.

Eli Lilly intends to use access to these anonymized datasets to help further their development of novel insulin delivery devices and as to explore new forms insulin therapy. Tidepool’s goal is to support these efforts – we feel strongly that more companies should be innovating in these areas.

Whoa, seriously? People pay you money for these anonymized data sets?

Yes. Tidepool goes to great lengths to anonymize these datasets (read more here) and qualify them to meet our partners’ needs. The dataset licensing fees we charge help support our mission and help Tidepool towards becoming a self-sustaining nonprofit organization so we can continue to deliver our software to the diabetes community for free.

I think the Tidepool Big Data Donation Project is awesome and I would like to donate my data. How do I sign up?

Awesome, thank you! Instructions for how to sign up for the Tidepool Big Data Donation Project are here.

I think this is unacceptable and I want to opt out of donating my data.

That’s cool, too. It’s your data, you get to choose. Instructions to opt out are here. If you have any questions or concerns send an email to info@tidepool.org to get in touch.

How will we know what innovations occur based on these donated data sets?

Part of our deal with these partners is that they will publicly share how the data sets get used. For starters, we are posting short summaries from our partners here. As we learn more, or any research is published, we will share their findings with all of you.

Will you ever give my data to someone without my permission?

Nope. Never. Not even anonymized data unless you give us permission to do so. You must OPT IN to donating or sharing your data in anyway. We’re pretty proud of our readable Privacy Policy – please check it out or let us know if you have any questions.

Isn’t this just like the Nightscout and OpenAPS Data Commons?

We are huge fans (and users) of Nightscout and OpenAPS. Our programs are similar in some ways. You can read more about them Nightscout and OpenAPS Data Commons here and here respectively.

How can my company or organization get access to these datasets?

Email us at bigdata@tidepool.org and let’s talk about your needs.

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