November 10, 2012

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?

1 comment:

Anonymous said...

It sounds like you definitely helped. Thank you so much for doing that, Bennett!