January 14, 2013

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 AdvocatesKelly 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.

3 comments:

Scott S said...

You should clarify when you say "one was affiliated with Ralph Nader" is not technically correct. Dr. Sidney M. Wolfe was formerly with Public Citizen, an organization which Ralph Nader helped start, and he is the only patient-advocate on the FDA advisory panel. However, Sidney Wolfe actually co-founded the Public Citizen's Health Research Group along with Mr. Nader (prior to that, Public Citizen had no involvement with the FDA), hence his role was as influential as Mr. Nader's was when it comes to the FDA, and Dr. Wolfe fought for over a decade to get a seat on the FDA review panel before succeeding in 2009. Prior to that, Dr. Wolfe helped push the FDA to get 16 [dangerous] drugs off the market and impose restrictions on several multibillion-dollar drug products.

Bennet said...

Fair enough Scott. Some adjustment made. I was going by how he introduced himself to me when we chatted. I certainly got a little lost in the relationship but he certainly was pleasant enough and I appreciated his perspectives My post was getting a little long to go into to in detail and I already was running off on tangents.

Mike Hoskins said...

Bennet - thanks for being there, not only covering the meeting but particularly for speaking and representing the community. I very much appreciated hearing your comments and think you did great! Now, we'll see what the FDA does with this committee's recommendation...