FDA, SLGT-2, EMDAC, T2D & DOC - Alphabet Soup

Last week I had the privilege of giving public comments at a FDA hearing of a proposed new type 2 drug in the class know as SLGT-2. These FDA meetings go by abbreviation EMDAC. So I was the DOC's, T2D, SLGT-2, FDA, ENDAC guy - Stick that in your soup bowl.

The drug in question is a new means of treating T2D. Instead of influencing insulin production or sensitivity, it prevents the kidneys from transporting glucose out of the urinary process, This recovery of glucose conserves energy in the body. DiaTribe has a nice little summary of the specific drug with links to more of their excellent and detailed reporting. If you prefer smaller bites of information here is a twitter search: https://twitter.com/search?q=Canagliflozin&src=typd.

Probably for most of the millenniums that humans have been around this conservation of energy was an important evolutionary advantage.  Not so much today.

By inhibiting this retention of glucose, patients on the medication excrete something like 100 to 300 calories of sugar a day. BG decreases. Significantly it only seems to happen at elevated BD levels.  When BG is in range the SLGT-2 isn't facilitating the excretion of BG or so I understood the presentation.

Readers digest version: SLGT-2s helps T2Ds pee out excessive sugar but doesn't make'm go low.

This may have a beneficial impact on weight. There are of course issues and the increase sugar in the urinary tract causes some increase in infections. YDMV.

There hearings follow a set agenda:

• The committee listens to at the drug sponsor's presentation (sponsor = company seeking approval.) 
• The FDA responds with a presentation of their review.  
• The committee then ask both a bunch of questions. 
• Most of the committee are physicians but there is one patient representative. 
• (The patient representative, at both the EMDAC sessions I attened, was fantastic. She did all patients proud. )
• The public chimes in after lunch. 
• The committee considers specific questions. 
• The committee votes a recommendation to the FDA.

This hearing had 5 people offering public comments, 2 were from the Diabetes Advocates, Kelly Close and myself. One was from the ADA, one was from the American Association of Clinical Endocrinologists. Finally one was with with a public interest group he helped start with Ralph Nader. (See my friend Scott Strumello's comment for more details, Thanks Scott for offering them.)With the exception of the public interest group affiliate, the public comments were about the need for drugs that get used, don't induce hypos and that while no drug is right for everyone, diabetes patients need options to consider with their health team.

I had the privilege of going last - batting clean up as it were. I tried to be slightly humorous with my inability to pronounce Canagliflozin to put an real world  face on the potential patient users of this drug who probably can't pronounce it either. I tried to be clear that I was there as a member of an e-patient and advocacy group. This to suggest that there are possibly a lot of us who may benefit from the drug, even if we cant pronounce it. I spoke about my family history with different Type 2 medications programs to also suggest that probably there is a bunch of us T2D for who it may not be the best choice. Either way that is a choice to make individually with one's physician,

My comments were influenced by listening to the sponsor and FDA presentation and my fellow public speakers. I mentioned Kelly Close by name and twice emphasized her points. 1) there are not enough diabetes specialist, as it took me 6 month to get an endo. appt. to confirm my T2D diagnosis and 2) we need drugs that people take, that work. I the speakers from the ADA and AACE about the fear of hypos that cause some patients to not take their all their meds. I mentioned that even those of us who know better may reduce our meds to avoid hypos, noting that a physician presenting in the morning said he himself did so and implied what do they expect form us civilians?

Both the patient representative on the committee and a member of the sponsor's team approached Kelly and I after the close of the meeting. They thanked us for our comments.  Which was very kind.

The room is a wee tad intimidating. I certainly don't yet feel totally comfortable speaking there. I will keep going and will become better at presenting there. I hope that other patients advocates continue to share views and I am happy to chat with anyone interested doing so at future sessions.

Alphabet soup helps.

Patient Voices

At a blogger event with a drug company one conversation turned to why they were engaging with diabetes people rather than patients from one of their other lines of business. The company folks replied it was because the diabetes online community (aka DOC) is significantly more active than the online patient communities of the conditions they serve.

Yay us! Right?

I had the chance to see another side of patient engagement this week. The FDA had an advisory committee considering a potential new basal insulin. There was a part of the meeting where 'we the people' could speak. Thanks to a little help with gas money from the Diabetes Advocates I drove down and spoke as a dad of T1d teens.

Comments about the DOC, like the one I started with, could make one think patients have more influence than maybe we do really do. Patients were not a significant voice in the FDA meeting room.

The majority of the committee discussion I heard was not about diabetes outcomes but about potential cardio vascular signals that may, or may not, be a potential risk. The talk around hypos and the possibility of reducing them seemed to me to be detached from the idea of hypos as a material health issue. In fairness I did not hear all the presentations.

A few physicians spoke in the public comment forum. God bless them. They were patient advocates. A doctor from the Endocrine society spoke very clearly to the fear of hypos as a barrier to good care. I found it particularly significant that he was talking about the role emotions play in the process of care, specifically the fear. Next time we complain that the care community doesn’t get the emotional side, I want to remember who spoke up to the FDA about the impact of the fear of hypos.

Hypos matter. The conversation about night time lows should be about the impact they have on how patients self manage, the fear of them and the complications of nocturnal hypos  - including dead in bed. Sadly a big part of the conversation was about what time frame counts as a nocturnal hypo; 10 p.m. to 6 a.m., 12 a.m. to 6 a.m., or 12 a.m. to 8 a.m..

While I found the time of a nocturnal hypos conversation inane for the most part this meeting was a serious science event. I freely admit it was a little intimidating to speak as a layperson, particularly following four very articulate physicians. However if we the DOC don’t show up to speak for patients who will?

We need better care options. Innovative insulins even incrementally innovative insulins are an area of better options. We would benefit form longer non-peaking basal insulin, faster bolus insulin and the holy grail of injectables glucose responsive insulins. So we need to be our own advocates making our case for benefits of better tools.

I felt there was a distinct under current in the conversation that there are perfectly serviceable insulins on the market now, so the process can hold possible innovations to a higher standard with more and longer trials without any adverse affect.

No.

Delaying or preventing access to better tools is an unfortunate outcome. These CV tests will cost more and so be barriers to new insulins making it into the butter compartments of people with diabetes. I am not sure Banting and Best could have had done CV studies. (Nor do I think there process is a model for modern safety and efficacy.)

Let me be clear. I am not advocating neglecting other safety issues such as CV risk. I am suggesting that we as patient community need to be part of the off line conversations that determine the medications and tools that are options for us to explore with our physicians. We need to be there to voice the value of better diabetes care. Maybe even introduce into the process a definition of better that not only looks at A1C but one that considers stability of glucose levels. That can include fewer or no night time hypos.

I am not saying there was no conversation about balancing better diabetes care with risks. I am saying from my perspective the value of better care appeared to be trivialized at times. In fairness I may be over stating my views.  (Raise you hand if you think I ever over state my views - ok, that is everyone who has ever read anything I ever have written.) The committee did recommend the insulin subject to ongoing CV consideration 8 to 4. Clearly the 8 felt there was benefits that were significant even with possible risks.

Still I think patient voices are needed to help balance the benefit side of consideration. We could even help the good doctor from the endo society make the case that the emotional parts of diabetes care are significant. I have been kicking myself the past two days for letting emotion breaks into my voice when I spoke about doing night time blood tests. In retrospect maybe that was a good thing. Maybe I helped him make his point. He did reach out and shake my hand as I retuned to my seat.

If we are not part of the process who will be our voice? How can we consistently do that?

Who Ya Gonna Call?

Ghostbusters if you have a free floating apparition.

But if you are in the media and are writing about diabetes where are you going to get an informed patient voice?

Diabetes Advocates Offer Assistance in Accurate Reporting in the Media
27 Mar, 2012 17:00 CET
”We want to help get it right,” states diabetes advocacy groupTuesday, March 27, 2012 (BERKELEY, CA) – Did you know there are more than five different types of diabetes? If your knowledge of diabetes is defined by what you hear and see on the news or in movies then you probably don't. Diabetes Advocates, a nonprofit program made up of influential members of the diabetes community has launched a media outreach campaign, designed to assist the media on all things diabetes.  

Kelly Kunik, a member of Diabetes Advocates, stated: “Today is Diabetes Alert Day in the US and we are trying to stress to all media sources that more due diligence is required on everyone’s part when reporting on diabetes. We want to help all sources ‘get it right’ but also stress the importance of explaining the differences among ‘all things’ diabetes.” 

See full press release here: http://www.cisionwire.com/diabetes-advocates-a-program-of-the-diabetes-hands-foundation/r/diabetes-advocates-offer-assistance-in-accurate-reporting-in-the-media,c9236817