Please Register for #DOCasksFDA. NOW!

FDA and diaTribe invite you, her, him and all the rest of the DOC to join an unprecedented patient dialogue on November 3 from 1-4pm EST - you can register for the online webcast at:  

www.cvent.com/d/z4qgt1/1Q. 

Even if you are only available for part of the conversation, I strongly encourage you to sign up and join the virtual discussion based on our recent collective feedback.

As a community, it is essential that we show the FDA how committed we are to more open communication. Please register and join as a signal to the Agency that you are interested in dialogue, have valuable input to share, and want to advocate for better treatment options for diabetes.

Thanks so much to everyone at FDA and diaTribe for making this possible!

Hey Adam needs a hand, Little help?

This is from my good friend and inspiration to bicycle, Adam Brown at diaTribe. Help him out OK? Just to be clear, diaTribe is asking to help better focus on what matters to PWD when we do the next round of #DOCasksFDA, not FDA asking. Go us!

Hello DOC friends! 

On November 3, the FDA will host an unprecedented discussion between the diabetes community and senior agency leadership (both drugs and devices). The event will be live webcast from 1 - 4 pm. We want this to be nothing short of a home run. The event will include a panel of patients (T1 and T2), as well as representatives from ADA, JDRF, and diaTribe. As a community, our job is to present the numerous challenges we as patients face each day, and we need as many opinions as possible to be a part of this discussion! With FDA, ADA, JDRF, and dQ&A input, we have created a survey posted at www.diaTribe.org/survey. We are asking the entire diabetes community (T1 and T2!) to please fill out this short survey and share thoughts on what's important when it comes to living with diabetes. This feedback will go DIRECTLY to FDA and help influence the conversation on November 3. 

FDA is currently working on the registration to sign up for this webcast event; as we understand it, this should be posted within the week. We will be in touch with that information and a finalized agenda as soon as we have it. For now, it is mission critical to have a massive response to the survey. We need to show the FDA that patients care about these issues, that patients have valuable input to share, and that the treatment options we have are still not good enough.

Thank you on behalf of our entire team for your help in spreading the word on the survey and about the event. We’re truly excited about the potential to open the lines of communication with the FDA, which for too long has been a black box. We need more patient input into the drug and device approval process, and we see November 3 as a very key avenue to making that happen. Let’s show the FDA how committed our community is.

very best wishes,

Adam

Mark Your Calendar - Nov 3 diaTribe Town Hall Meeting with FDA

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.