November 16, 2018

Verily (Google) Halts Glucose Sense Contact Lens

It made a lot of news stories since it was first announced but Verily aka Google has put the breaks on the glucose-sensing contact lens. You can read their statement here.

In part they say:
Our clinical work on the glucose-sensing lens demonstrated that there was insufficient consistency in our measurements of the correlation between tear glucose and blood glucose concentrations to support the requirements of a medical device.

Meanwhile, regular old school continuous glucose monitoring has advanced in accuracy, coverage, and its place in automated insulin delivery systems. 

The Patient Engagement Meeting Was Different

The Center for Devices and Radiological Health, the Food and Drug Administration device group, held their second Patient Engagement Advisory Committee on November 15, 2018.*

I am a voting member. I attended. Here are some of my impressions on the meeting process, which was different, in a good way.

To be clear - these are my views, not in anyway an official report of proceedings. The appropriate people will do that in due course.

What struck me is that the agency wants to engage patients. They worked hard to fit working with patients into their mandated process of public meetings. Maybe the most visible sign of that desire is the time commitment the director of the boss, Dr. Jeffrey E. Shuren gave to the meeting. He was the opening speaker and was there all day.

Less visible was the time that staff put into preparing for the meeting. They cleverly adapted existing meeting processes to patient engagement. One change was there were more opportunities for people in the audience to engage. Yes, there was the typical public comment period. Same as at other advisory committee hearings. But there were also calls from the Chairman for public comment throughout the day. That is good. What was different were roundtable discussions of questions asked of the audience.

All the people attending were invited to break up to randomly assigned tables to address questions pertinent to the day’s topic. The tables are moderated by agency staff who then summarised and reported out each tables conversations. While participation was voluntary the idea of having everyone in the audience join together and be part of the proceedings was pretty unique.

These breakout conversations were a bit of struggle to fit into the advisory meeting process. A process was in part designed to ensure that advisors on any given panel are kept separate from inappropriate influence. Like from industry or other parties. You know, no private meetings in the hallway.

That what we the panel saw and heard was through the open public process. Good meeting design - Particularly for meetings where the regulators seek advice on a device approval. The panel isn't meant to be talking privately with pharma sponsors or anyone else. In this case, since every comment at every table wasn’t publically reported out, as panel members, we couldn’t participate in those roundtable conversations. 

I would have loved to hear those conversations. I respect that Center for Devices and Radiological Health found a way to have everyone engage and that the price of that was that committee members couldn't just jump in. 

All voices = better.

Devices are critical in diabetes care. So I suggest that people with diabetes take the time to join in these meetings. You will be heard, even if I can't chat you up in the hallway.

* Two cents on acronyms. I'm finding them wearying, and I tried to edit them out.

My friend Ginger writes on early work on T2 Treatment to increase insulin production.

Interesting piece by my friend Ginger Viera at Healthline about stimulating insulin production in type 2. She writes the procedure stimulates regrowth of cells on the surface of the small intentions that are responsible to trigger insulin production. While the work is in the early stages it is potentially an interesting path for future care. The article interviews Dr. George Grunberger about the process and similarities to gastric bypass in the timing of the return of insulin production.

Good read.

I encourage you to read Ginger's piece here and the full article in Diabetes Care

November 9, 2018

Pay Attention to the Man Behind the Curtain on Drug Prices

I'm enough of a nerd that I'm a fan of the blog Drug Channels.  It is written by Adam J. Fein, Ph.D. and consistently brings smart analysis to the drug marketplace. By smart, I mean pealing back the layers of the onion and getting to the root causes of market distortions, like spiraling list prices while manufacturers face stagnant net revenue.

I found this recent piece a particularly good example of why I like it. Drug Prices After the Midterms: Five Crucial Implications of Pharmacy Benefit Design

Going beyond complaining about drug prices, Fien seeks to explain some of what is going on behind the curtain in the mostly invisible drug middle market. This is where the big companies that manage drug benefits (not make medicine or dispense it) do their thing.  The whole post is a good read but here are a few highlights.

This quote should send chills down the spine (bold text added):

Coinsurance amounts are typically based on the negotiated rate between a pharmacy and payer. These amounts typically approximate a drug’s undiscounted, pre-rebate list price. Though patients pay the list price, their employer can still collect a rebate that is not reflected in that pharmacy pricing. For some high-list/high-rebate drugs, the patient’s out-of-pocket costs can even exceed the net cost of the drug to the employer.  
That’s right: Employers can actually profit from certain drugs. Plan sponsors can hoard rebates rather than share the savings with the employees whose prescriptions generated the rebate funds.

Who is likely getting screwed over in these cases?
Employers and their PBMs typically place therapies for such chronic, complex illnesses as cancer, rheumatoid arthritis, multiple sclerosis, and HIV on the fourth and specialty tiers of benefit plans.

So IMHO, PBM reform that applies rebates at the point of sale seems like a really good place to start the conversaton on drug price reform. If anyone is serious about it. 

November 8, 2018

OmniPod & Samsung Working Together

OmniPod announced they are working with Samsung to control the Pod with select Galaxy phones.* It is an announcement of working to that end not an approval, yet. But that is good news none the less.

The announcement says they will be using Samsung security at hardware and operating system levels. Sounds positive. I'm no expert.

No word on other phones.

For the announcement details see:

From the release:
*Capabilities will be limited to select Samsung Galaxy smartphone models. Information on exact model availability will be shared at a later date.

November 2, 2018

Omnipod Announces Tidepool Loop Agreement

This very cool news from the Omnipod earnings call:

“As a first step in our support of interoperability, we are pleased to share that Insulet is the first pump partner for Tidepool’s Loop Program. For those who aren’t familiar, Tidepool is a non-profit organization that is working to get an open source, iOS-based Looped app and algorithm, approved by the FDA. Together, we are developing an interoperable, automated insulin delivery system that allows Omnipod DASH to be controlled by the Tidepool Loop algorithm from an iPhone. This partnership is additive to our internal Omnipod Horizon program and offers a potentially faster avenue to market, an automated insulin delivery system with iPhone control for our Podders, and a terrific way for us to support the DIY diabetes community.” (About 23 minutes into earnings call starts getting more interesting for PWD aka less businessy at about 20:00)

At first blush, it seemed to me that the Bluetooth Omnipod DASH offered little more than an evolutionary step for the Pod, particularly without smartphone control. Nicer new controller but still something extra to carry.

Well, now revolutionary is more accurate. They announced the path to phone control and interoperability aka multiple Automated Insulin Deliver algorithms.


(listen to) the earnings call