FDA – DiabetesDad

NEWSBREAK WARNING: Do not—DO NOT Let our Voices Go Unheard. Read, Act, and Share.

Posted on September 1, 2013 | by tomkarlya | 6 Comments

Sometimes things are done that just leave me scratching my head. Today is such a day. The best part is that you can do something about it, and to be honest–this just makes no sense to me whatsoever.

The FDA is planning a series of ‘patient meetings’ over the next five years to better understand specific diseases. It astounds me, and is a glaring mis-step, that diabetes is not on that list. That’s correct. Diabetes will not be included. My guess is that diabetes is not on the list (and my guess only) as I look at the list of the other diseases included is that someone at the FDA believes that they have all the necessary information needed to make decisions moving forward.

This is a mistake.

In the Diatribe sponsored petition, they state;
“We need to tell our story to the FDA: about the need for accurate strips, more physiologic insulin, a broader range of drugs, and the Artificial Pancreas.”

These issues should be listed as very important to all of us and if you add Ed Damiano’s Bionic Pancreas (which is somewhat different from the AP utilizing both insulin AND glucagon) and those many organizations looking at biological cure possibilities that may, and will absolutely, be up against hurdles in the FDA process; everyone who has a loved one with diabetes, or has diabetes, should sign this petition.

We need to be given the opportunity for not only us as the general public; but experts like Ed Damiano, Dr. Camillo Ricordi, Dr. Aaron Kowalski, Dr. Bernhard Hering, and so many more to join together to be heard and stress the importance of both treatment options and cure related focus that needs to be addressed by the FDA in a manner that is both expeditious and comprehensive in scope.

The examples given in the Diatribe (owned and operated by DOC’s own and wonderful, Kelly Close) petition are only but a few issues in the ever-changing diabetes landscape that will be facing the FDA over the next five years, we cannot; and should not; allow our collective voices to go unheard.

If diabetes has any importance to you whatsoever (and it is my hope that just reading that sentence annoyed you because we all know that it is hugely important to all of us) in better management tools, medications, insulins, and cure related research—I urge you to sign this petition.

This is crucial for all of us to join together. Type 1; type 2; LADA, Gestational and any other form of diabetes you know of; our voices MUST BE HEARD.

Under the comment section of the petition, I wrote:
With so many aspects of diabetes that will be before the FDA in the near future; it is too crucial to be detached from those who are in the know about matters of treatment and potential cures. It makes no sense to omit those active in this disease state to assist the FDA. The diabetes community should be included in the upcoming FDA ‘patient meetings’.

If we can not convince the FDA how crucial it is that our voices be heard; the silence will be deafening. Period.

Click here and sign today.

I am a diabetes dad.

A Crucial Issue That You Should Know About….Read, Share, and Follow THIS Issue.

Posted on August 9, 2013 | by tomkarlya | 2 Comments

Over the last few days I have been at the American Association of Diabetes Educators Conference in Philadelphia.

I have been coming to this conference for years. It is great to meet up with those who support the DRI in so many different ways and to meet colleagues who are deep into the fight for PWDs and their caretakers. I have written many times how crucial the diabetes educator is as we navigate the diabetes obstacle course.

It is an education to meet so many educators who are also here and listen; to learn and to share. It is an atmosphere that is always filled with many new things being added to the diabetes landscape. Positive things.

This year was different.

It was certainly great to see so many people who I only see a few times a year but this year there was a new guest at this conference and it was “I Just Don’t Know.”

Never before do I remember so many issues that face us as parents, that face those with diabetes, that have me concerned as I am now. The profile of our healthcare world is heading to an area that will impact us in ways that has not been seen before. I’m not trying to alarm anyone but I highly suggest you stay informed. To those asked, the response was the same many times, “we just don’t know”.

Three different diabetes educators shared that their hospital was cutting back and the diabetes program was at the top of the list to be cut. What? It amazes me that with so many people impacted by diabetes that this would even be a thought and all three said the same thing; there is no money allocated to education. Financial concerns for diabetes is at an all time high.

Another issue, which is turning out to be a big issue, is the accuracy of test strips. A very detailed explanation made shorter is this: the cost of strips is based on the price that Medicaid and medicare will pay for reimbursement which has just been set at an all time low. One would think that is good news because it should translate that the bigger companies would just drop their cost to match that number, right? Well not necessarily because the companies that the government chooses to supply the strips is based on cost. So if a supply company overseas, that has much less accuracy standards is chosen, and the FDA chooses not to make sure the standards of accuracy are met; we may have a real problem.

Bennet Dunlap, a d-dad, is about as straight-shooter you will ever meet. He is incredibly passionate and it takes much to see Bennet concerned; and Bennet is concerned over this issue, very concerned. And so are many of us. PLEASE join his site and stay informed. This is an issue that is evolving as we speak and Bennet and many others of our good friends in the diabetes community are going to fight this, and fight it hard. Click here and join his Strip Safely site. Also make sure you click the ‘issue’ tab after you join so you can read in more detail what I have touched upon here.

There are many issues in the heath care world that are changing. I heard it so many times this week that the diabetes world of next year will be vastly different from the one from this year. Again not to scare anyone but to implore you to stay educated. Read. Learn. And for goodness sake if action is needed and people will inform you as to when and how, please take it.

We may very well be the only controller of our collective fates; we need to be educated, armed, and ready as we come to this cross-road.

I am a diabetesdad

Please visit my Diabetes Dad FB Page and hit ‘like’.

Good-bye to Blogging as We Know It??? I Surely Hope Not.

Posted on December 3, 2012 | by tomkarlya | 9 Comments

There is a very interesting article being circulated online, written by ‘NPR‘. The article entitled:
Social Media Help Diabetes Patients (And Drugmakers) Connect
begins by stating how the diabetes community is connected but quickly turns to the fact that pharma companies are getting involved with many of the bloggers and that involvement needs to be regulated, or guidelines better set by the FDA, according to advocate groups.

People living with diabetes have created a vibrant online community. Big drug companies are certainly taking notice — and some advocacy groups feel that the Food and Drug Administration should as well.

But there is a disconnect here which I believe the writer misses altogether. In as much as there are people out there claiming various ‘cures’ and ‘potions’ that will rid you of your diabetes (that should be vetted), taking all bloggers and stating that there should be a regulating body over them is a dangerous and slippery slope to be navigating.

My guess is that there are far more writers inspiring and connecting people than there are those specifically ‘on contract’ with a specific agenda. Those who blog in this community who write about subjects where they receive any sort of compensation are also very quick to also add that they receive that compensation from a particular company.

Bloggers are writers. Writers speak from experience to lend a voice of experience. In life; in diabetes; as a parent; as a person with diabetes; and yes to even state that they tried a product and it was great (or sucked for that matter).

The article quotes Jason Bonner who states:
“There’s no proof in diabetes that social networking is helpful,” says Jason Bronner, a doctor at the University of California San Diego Medical Center. He’s leading a study that will help determine whether social networking can actually help patients manage diabetes.

Now there are two different positions here—-social networking being helpful and social networking actually helping patients manage their diabetes. It might have helped if the writer wrote a longer article to clarify the difference and what might or might not need the influence of a federally governing body.

If it is all the same to the NPR writer, I may not consider a particular writer helping to better manage my children’s diabetes but I would be lost if I did not have some writers to clarify my sanity from time to time. Bloggers are bloggers…..I can differentiate the ones I want to be part of my life as credible and so can mostly everyone else.

I just think we need to be very careful trying to censor, or federally control, a world of writers that are crucial to those who live with diabetes every day, or are caretakers to the same.

This is a large community that is very intelligent and informative. To be honest, should someone write or say something that is bogus, untrue, or off the mark……believe me the diabetes community would be there before anyone else to correct and clarify any point made that was off-base. But I find it dangerous for someone to say to all writers, “You must stay within these parameters”.

How one differentiates between me reading about life and again about cinnamon curing diabetes……I am not too sure. But I think most of us know or would be quickly informed by others in the diabetes online community.

Perhaps the advocacy groups (the writer does not mention which ones) that thinks the FDA should be more involved may want to start with an easy one; why not start with asking the media to ‘get it right’ when it discusses diabetes.

I love the diabetes community. I also respect all of the great things the diabetes community accomplishes with the written word on blogs, FB, print media, or otherwise. DO we really want the FDA to set guidelines? Really?

I also do not believe anyone should just come out there and say what they want about a product or medicine……but what I know is this community will speak up very quickly when a line is crossed, but remember this; there are many lines. It would be dangerous and harmful to think any one agency could set one hard and fast rule across the board to govern; would anyone really want that?

I don’t, do you?

Thoughts?

I am a diabetesdad.

Disclaimer: I am a blogger; and love that I am.