December 28, 2018

Should Patients Engage in the Design of Device Trials? FDA Wants Your Views.

The device group at the Food and Drug Administration is seeking comments on Patient Engagement in Clinical Trials. Not just as trial subjects but as participants in the development of studies.

So far there are no comments. I'm willing to bet that people with diabetes have views on patients being involved in designing the trials for the devices that we use to manage our health. Now is the chance. Particularly as automated insulin delivery devices are poised to revolutionize diabetes care.

What do you think? Should FDA encourage device sponsors to include patients in the early process of defining trials? Where should devise sponsors be looking for patients with who to engage?  -  advocacy groups?

A full discussion of what they are seeking comments on can be found in the DOC or PDF files here. (1) The document runs around nine pages. But here are the reader's digest version of the discussion questions asked in the document.
• Define “patient engagement” in medical device clinical trials.
• Explain the value and positive impact of engaging patients in the design, conduct, and
communication of clinical trials.
• Describe barriers and challenges in engaging patients for clinical trials.
• Outline how and when sponsors can engage patients in the design and conduct of clinical trials.
You don't have to answer all the questions. All feedback is welcome.

Please comment into the docket at this link. (2)

I am a voting member of these Patient Engagement Advisory Committee (PEAC) to which FDA posed these questions in November. FDA has subsequently asked members of PEAC to share this docket. It is open to January 8.

They are listening, so say your 2¢ now!

(1)  Links to documents: download a PDF here:


December 13, 2018

Give Diabetes Gifts? Yeah of a kind.

My friend Will at Diabetes Mine asked about diabetes stuff and holiday gift giving. He broke possible D-gifts down into Medical gifts (tools and meds), practical gifts (diabetes-related gear, life, or kitchen supplies that aren’t purely medical), and diabetes humor gifts.

In general medical supplies including tools, possibly short of a new iPhone because it really isn't a medical device, aren't gifts. They fail the does this bring joy outside of diabetes test. That test probably should be a guide in all cases short of humor where diabetes should be the butt of the joke. While there are aspects of life with diabetes that are gifts, friendships, discovering personal strength and the like, a disease isn't grounds for a gift  - short of, I guess, an instantaneous cure.  

Practical life stuff is tough as a gift, diabetes or not. Try giving your spouse a frying pan. That is risky territory as you are likely to get hit upside the head with said pan. Practical gifts should be avoided by all but experts.  There is some nuance I would suggest the "Who Benefits?" test. If the frying pan is to make you - the giver - tasty burgers, hold off. So If the item is chore related, it is hard to see it as a gift. 

On the other hand if it something the recipient will see as fun in their scope of life then - maybe. Proceed With Caution. For example, I would like a good fry pan, but it would have to be one cool fry pan in my eyes, better for something I want to PLAY with cooking than my existing pans.  Since the key word there is play, not practical, possibly this test may invalidate Will's practical gift catagory. I think there are two important considerations in this situation. 1) Did the recipient specifically ask for the item and/or 2) is the item more hobby/joy than chore/work related. 

Other stuff disclaimer: There better be other non-chore stuff under the tree and in the stocking. 

Can you define any diabetes tool or meds as hobby/joy related? Not a chore? If so you are a ninja and don't need my advice because I can't see it. 

Humor is fair game as long as the health condition is the joke not the person with the condition. Just be sure everyone's sense of humor is aligned and see the other stuff disclaimer above. For example, my son gave me a stuffed plush toy prostate after cancer surgery. That was hysterical. 

I don't think the rules are much different with kids or adults. Maybe the sensitivity is different. Remember kids are kids. The holidays are BIG for them, and diabetes probably isn't their focus. Why bring it in? On the other hand, you can hurt an adult's feelings too. 

As a parent, any diabetes stuff needs to be outside the sibling
balance of gifts, with the possible exceptions of humor. Maybe diabetes humor should be in a balance of other fun poking humor with other kids. Cause if you poke fun at one kid's diabetes and don't poke fun at the other kids' challenges you could have more significant problems than holiday gift giving - you may be a dick.  

On the flip side of non-diabetes stocking stuffing, I was never a restrict holiday treats kind of a parent. I was always the guy packing in the Hershey's Miniatures and Reese cups; in my view - it isn't a holiday without them. It is the only time of the year I eat MrGoodbars, and I crave them Christmas morning. 

Be sure that there is parity in treat access. If the non-D kids get Hershey's kisses so do the D- kids, with the same freedom of access. Also if Reeses are low cures, from time to time they were here, then the other kids get'm too up to the last 15 carbs worth.

I don't recall any D-gifts. Years ago I put used insulin bottles on a chain of lights. They go in the tree every year.  Then I put the bacon ornament right next to them - that is our tradition.  

So, Will, my advice is that gifts are for the unique celebration of your family, tradition, and faith. Diabetes chronically sucks. Why bring suckage from any source into your individual celebration? As Bert and Earnie taught us, one of these things is not like the other. 

Of course, your diabetes may vary and it can bring gifts - the every cloud has a silver lining type. I see these a the friends that come from connection with the community. We have many, That is the kind of diabetes gift to give. 

So to all the lovely friends who help us get through the suckage of diabetes, we wish much joy with your families, revel in your traditions and find peace through your faith. While our holidays may vary, here is hoping our happiness does not. 

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

October 29, 2018

Patients, Data, Care, Research

Patients, our health information, and better care are in my email this morning. 

I was very much pleased to get an email from a specialist's office. It not only invited me to use their patient portal to manage my relationship with the office, they actually set up an account and gave me a one time use password. 


This is opposed to the deal at my primary doctor. I had a portal account there. It was great. I could see all the reports and letters other specialists sent about treatment.  For example, once I read the details of a specialist visit before we had the conversation that was written up. That was a little too proactive. I fired that doctor later in the day when we had our appointment.

My primary doctor's practice got bought up by a rapidly growing hospital system. My portal was closed pending a change to the new system's patient experience. Closed, not converted. Way to go Jefferson - quality care. And  - I have to go into the office to apply to join the new portal.

Also in my email today, Faster Cures aka the Milken Institute, sent a link announcing "new initiatives to engage the private sector, strengthen global partnerships and harness the power of data to save lives." Their stated priorities are:

  • Advance policies that break down regulatory and other barriers to getting scientific advances to patients more quickly;
  • Identify incentives to increase private sector investments in biomedical R&D;
  • Build global communities that expand capacity to treat disease;
  • Put patients – and their health data – at the center of biomedical research and analysis.
They go on to say: 
"Groundbreaking cures require access to, and analysis of vast amounts of health data. Researchers face obstacles to collecting these data because medical providers often fail to share information with patients, or because patients distrust a system that does not explain how the data will be used or ensure its privacy and security."  - (Emphasis added) 

The press release goes on to announce the new board of very impressive medical providers  - doctors, insurers, business people. One has a Nobel. That is impressive! 

While all of the very impressive people are at times patients - none is at the table with a portfolio explicitly representing patients. So who is gonna, "Put patients – and their health data – at the center of biomedical research and analysis?" Ya know - so that patients trust the system. 

Feels like the - I need to come into the office and apply - idea. Patient access as an afterthought. Maybe while we are there, you can address the distrust the system part too. Ideally in something other than an impressive if unreadable terms and conditions page.  

In fairness, I think the Milken Institute is doing good stuff. I just think it would be better if they could figure out how to do what they say is a priority - Putting patients at the center or at least in a seat at the table. 


October 25, 2018

PBM Without Rebates (aka Kickback?)

Pharmacy Benefits Manager Express Scripts has announced a program with 18 large employers where rebates are passed back to the employer, in total. The Blog Drug Channels says;
You should pay close attention to this b.i.g. news. It is structured so that Express Scripts will not profit from the flow of funds from a brand-name manufacturer to a plan sponsor. What’s more, the PBM’s compensation will be fully delinked from drug list prices.
Drug Channels sees this as a "PBM compensation approach could be an important step in our industry’s journey toward a world without rebates."

I hope so. I am not convinced. No rebates and lower prices make more sense to me. In the meantime is this a move to no rebates or a move to the employer getting all the money.

Rebate bucks are not clearly linked to the people and conditions that generate them. So chronic health issues can become a source of subsidizing healthcare at large employers that are not seen as connected. For example, insulin rebates flow to employers, even if the plan doesn't cover the insulin and the PWD pays full price. So the process transfers deductibles from people with diabetes to other employees in the system. I am sure the argument would be that all plan member face similar deductibles.

Drug Channels asks:
Will the funds be used primarily to offset total plan costs for the employer and premiums for everyone? Or, will the money offset the out-of-pocket costs incurred by the patients whose prescription activity generates the rebates and fees?
No rebates and lower drug prices are the best ideas. It seems to me that like rebates at the point of sale would be a better step in a move to a no rebate system for equitable reduction of rebate distortions. But any step to eliminating rebates is a step in the right direction IMHO.

Buried in here is something else to be concerned about. The PBM will get paid for managing care with a better spend. From Express Scripts press release:
Pay-for-performance for clinical and administrative plan management that improves patient and plan outcomes. Express Scripts will demonstrate, definitively, that it does not just buy better, but manages trend and spend better. Express Scripts' ability to deliver clinical and financial outcomes is directly tied to its compensation. Pay-for-performance means Express Scripts will take on more risk from clients, and be rewarded only when it delivers on agreed-to commitments. 
Is spend better, better care? Is it patient-focused care? It could be. It could also be more treat to failure restrictions. I have little confidence in middlemen working for patient-focused health-care. It didn't work for HMOs and PMB history isn't good. I could be wrong.

Stay tuned.


October 18, 2018

Of Adam, Appendixes, CGM, then AID in Hospitals

My friend Adam Brown just went through the maze of navigating blood glucose and a hospital stay. You can read about it in his post titled: My Appendix Ruptured: Scary Lessons Learned About Diabetes in the Hospital

Years ago my son had his appendix out. Like Adam, we were not willing to let the hospital manage his diabetes. Institutionally, they didn't like that idea. After all, had white coats. We prevailed. In the end, they were impressed. I came away convinced that PWD and their caregivers are WAY BETTER at insulin management than hospitals.

So did Adam.

I am in no way suggesting that hospitals, nurses, anesthesiologists, or surgeons don't know their stuff. They certainly know their stuff. I'm just saying that nothing like your diabetes is their stuff.

I wrote about our appendicitis adventure a post called, Poke a Finger on the Invisible Hand. I learned some lessons. While back then I prattled on about meter accuracy. I was fighting the current battle not the next.

Adam came away with a deep conviction that CGM is desperately needed for inpatient care. I agree with Adam. That is a battle to be won.

I think we need to go one step further. Adam spoke of needing to turn loop off for surgery.

Our experience was clinicians at the hospital were loquacious about insulin and had no real plan to administer it other than assuring us they had a sliding scale. That they couldn't answer what rates were in that scale gave us no comfort.

CGM is critical to better care. Full stop.

That includes those hopefully few times PWD are inpatient and under the knife.

I have seen academic presentations on the importance of managing post-op BG for non-PWDs. In fact, I spent a day in lofty, scholarly presentations on the matter. (I have had such adventures - you wouldn't believe.) Seems surgery is a shock to the system and high BG are a risk for complications, particularly infection. Not the kinda highs PWDs routinely see, by the way.

Bugs like sugar. Who'da guessed?

CGM isn't enough. The staff does not have the time or experience to manage diabetes' insulin needs even with CGM data. 

I think Automated Insulin Delivery is desperately needed in hospitals. OK, You are right to say, "Hey! Wait there isn't really automated insulin delivery other than DIY solutions in the wild."


But as systems come online, somebody needs to look at them for use in hospitals for T1s. Then T2 and finally for everyone who has had surgery and is a glucose risk.

Adam pointed out the horrifically inflated cost of finger sticks in his stay. He reports his appendix burst creating the need for infection care. But imagine the savings in those cases where infection could be minimized with automated BG control. Automating insulin could be a cost-effective driver of better post-operative care for some, maybe many.

In the meantime, better is better. If Adam Brown, possibly the most empowered patient in T1 history (or at least second to Kelly) cannot keep his automated insulin delivery system on in the hospital the rest of us are destined for trouble.

September 28, 2018

Is Your Work Getting Rebate Bucks from Your Chronic Condition

I have ranted about PGM rebates a lot. One big question is who gets the money? It may be the company you work for.

Quick Rebate Refresher.
When people with insurance get a drug at the pharmacy there is a lot of money changing hands behind the scenes. Your insurance policy doesn't pay the retail price. They get a rebate. It can be a big chunk of the price. They often get that rebate even if you haven't met the deductible and you pay the full retail. Some of that flows back to your insurance to 'help hold down the cost of coverage." A recent article suggests that most of it flow back. 

So you may have a high deductible to hold down the cost of coverage, and they get huge chunks of what you paid for medicine before meeting that deductible to help hold down the cost of coverage too. Double whammy or reverse insurance.

As Drug Channels Explained
Put another way, the PBMI data demonstrate that employers operate their pharmacy benefits like reverse insurance. Employees and their dependents taking medicines for chronic, complex illnesses generate the majority of manufacturer rebate payments. These funds are used primarily to offset total plan costs for the employer, not to offset the costs incurred by the patients whose prescription activity generates those rebates.
Paying rebates at the point of sale would put the rebate and the usage together so that patients benefit from the rebates paid on the drugs they use. Or the whole system could just be eliminated as the kickbacks they look like.

August 30, 2018

The Type 2 Medical Device that makes the Biggest Difference for Me - a Bicycle.

Two wheels, pedals, and spandex.  I know that the last thought is not a pretty image. - Sorry.

Biking helps with blood sugars (unless I have a massive Reese Cup craving after a long ride.) Time on the bike helps transfer weight from my gut to my leg muscles and maybe also shed a few pounds off.  I find a calm, meditative state when I ride. Particularly in a group ride where I don't need to think about navigation. Some folks get that in yoga, for me it kicks in around mile three of a long spin.

But even though I love biking, at times, I just don't want to go out. Last week I had 100 miles in five days. This week - zero. It is too hot, I told myself. The sofa is too comfy, whatever. It is super easy to swap being active for the shadow of being active.

I need some help keep at it. Peer pressure can be that nudge. I find knowing that my friends are out running or biking makes me feel I should 'keep up.', an activity tracking site helps me stay motivated.

I was invited to Stava years ago by a friend (thanks Adam) who is much younger, more fit than I am, and thinks about motivation more than I do (follow that link.) I was afraid Strava would put me in competition with him. That is something that I couldn't win. So it took me a while to join.

Turns out, we didn't complete we just gave each other 'attaboys. Who doesn't like a pat on the back?

Being part of a real-world group helps too. I don't socialize a lot on rides (see meditative above), but there is a comradery to groups, an implicit I'll show up and ride with you if you show up to ride with me. I have had rides where my ability/will to keep going broke. I hit the wall. Friends slowed down and helped me back. I have paid that forward for others.

Today Strava and real-world are colliding. I passed on riding on Tuesday. It was crazy hot. But there, on Strava, I see my friends showed up to ride anyway. That is enough to guilt me into a ride in the crazy hot tonight.

Thankfully, I have friends that help pull me back when I feel an excuse to not exercise. My type 2 device doesn't make a difference if I don't use it.

August 2, 2018

Call Lilly for Help with Insulin

The market for medicine in the United States is nuts. It is not always easy for patients to find the options that may help.

Navigating the process for Lilly insulin users is now easier with a newly opened helpline. They say:
Starting August 1, a new dedicated helpline called the Lilly Diabetes Solution Center will assist people who need help paying for their insulin – such as those with lower incomes, the uninsured, and people in the deductible phase of their high deductible insurance plans, Eli Lilly and Company (NYSE: LLY) announced today. A customized suite of solutions for all Lilly insulins, including for Humalog® (insulin lispro), will be used by helpline operators to find answers that best fit the personal circumstances of patients.*
Nothing in diabetes is perfect. Hopefully, this is one step towards better form many.  Better is Better.

*More at

April 24, 2018

Drug Prices Should Piss People Off, Maybe Not For The Obvious Reason

Drugs are expensive. Like death and taxes, drug list price increases seem inevitable. There is lots of room for justifiable ire.

I think maybe that anger gets aimed at the wrong target. We all feel we understand prices. We go to the store, see an amount for a product on the shelf and choose to buy or not. If the price goes up, we pay more. Sometimes we fill out a form and get a rebate that limits that price increase. But rebates typically are a pain in the ass, and most folks don't factor them in.

But the list price of drugs on the shelf is misleading. In part because few see it. For most, we make a copay and don't know what the actual price our insurance policy paid for the meds.

HUGE rebates are happening, and nobody sees it. How huge? More than $150 billion. Yeah with a "B." So the drug prices keep going up but so do the rebates to the invisible parts of the drug payment system.

In some cases the rebates more than equal the price increases. What that means is that the drug company nets less income even while they raise the price. Where does the money go? Rebates.

Remember back when nobody bought a car without a rebate? It is like that - on steroids. Plans do not buy drugs without rebates.

Those rebates may get back to the insurance plan and in theory, reduce premiums. But that is not true in all cases, and there is no way to know.

So be pissed that $150 billion in drug rebates seems to sift through the cracks of insurance coverage and we the insured patients may or may not get the benefit of that sifting.

What can be done?

Maybe the first thing to do is to start to understand that rebates exist and be pissed that $150 billion is getting shuffled around with nothing approaching transparency. Our anger at drug prices should be focused on this rebate scheme.

What is a good policy solution? Applying rebates at the point of sale for all plan members, whether or not they have met their deductible.

For the uninsured require the average rebate that drug pays insurers to be applied to the uninsured too.

Want to learn more?
This post at Drug Channels.