Blog Entries With Tag: fda


Posted: Nov 30, 2010

I was one of the many bloggers asked to post a guest blog at the DSMA (Diabetes Social Media Advocacy) website during the month of November.  You can read some of the great discussion that followed there after my post. 

 

Being a Type I diabetic and/or having a Type I child can be extremely demanding, both mentally and physically.  I never really thought about this before joining up to DOC’s (diabetic online communities). I didn’t realize that others were in the same boat - I basically dealt with my diabetes on my own, and it’s been a roller coaster ride.  Yes, I do have an endocrinologist that I see every 6 months, but all he is concerned about is my A1C reading.  Sometimes we’ll discuss the ongoing research that has come across my desktop, but basically, he feels I do a good job managing my diabetes, and leaves me to it.  That’s where the DOC has played an important role in my life, as it has for many other diabetics around our big blue marble.  I can talk about the day-to-day issues, the ones we all have to live with.

The ability to adapt to this chronic disease is really a testament to the human spirit and our ability to adapt to difficult situations.  However, as we adapt I think we can lose some of our perspective.  I have read in blogs and/or forums where diabetics are struggling with issues and looking for help.  The responses they get from other diabetics are sometimes so self-righteous and insensitive that they are downright hurtful, and honestly sometimes have made me want to no longer be involved in the DOC.   Because we are all so different (e.g. age, metabolism, activity level, and other medical issues), the level of difficulty in maintaining ones diabetes varies from individual to individual.  When a parent writes that they are struggling with their child’s diabetes, do we step back and consider that they may be a stressed out single parent who work long hours to support their family?  Or perhaps that active child may have other health issues impacting their overall diabetes care?  If you have near perfect control but do not exercise and/or maintain an active lifestyle, you may think we have it all figured out!  The question that goes through my head at that point …  

Are you really doing what is best for your overall health, and how can I or someone else judge you? “ 

One specific subject that really bothers me, is when someone blogs about pump related problems; they are either immediately dismissed as to not knowing what they are doing - “go read the manual you dummy, I don’t have this problem!”  or “it’s a one in a million chance” and “it can’t happen to me” type of response.   That is BS as far as I’m concerned – especially with some of the emails I’ve received in confidence ever since I blogged and opened up forum discussions about the pump and Stephen Krueger at Diabetes1.org and a few at Tudiabetes.  Stephen's insulin pump primed the whole contents of his insulin cartridge into his body while he was sleeping, resulting in his untimely death.   

We have to realize that  insulin pumps do malfunction, perhaps more often then we are willing to admit.  Earlier in the Springtime the FDA called a meeting to discuss the numerous reported problems with insulin pumps – and since then – the ball has started to roll (more information can found at this link.  I understand the desire to not want to confront this issue, but it is ultimately better for all of us to take each story seriously, to encourage those that may have had a bad experience to come forward, and to hold the manufacturer’s accountable.  

Yes, we all do dumb things sometimes, and unfortunately diabetes is not very forgiving when this happens.  Let’s have some empathy towards our fellow humans who are impacted by this disease, and always show our civility when we are in forums or responding to a heart-felt blogger.  We are bigger than this disease, and lets help each other beat it!

 

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Posted: Oct 29, 2009

Well, I'm finally getting my life back to order.  Don't think Mike, my husband appreciated my being away at the IDF Diabetes World Congress for 5 days (I averaged 12 hour days there), as my Domestic Engineering duties sort of went the way of the dodo bird.  I am back on track, almost, just don't pay me a surprise visit right now, as it still looks like a bomb went off in my house (I need a housekeeper as one of my friends says - treat yourself).

So, below you will find a rather amusing picture of me.  It was a way to let off some steam I think for all the delegates that were there, as attending seminars, learning new ideas of coping with diabetes can sometimes make for a tired brain.  It was fun seeing people from all over the world, putting on the RCMP uniform and standing with the Canadian Rockies behind them!  Of course, I had to do something different didn't I? Being the animal lover, I had to go and pet the moose.  He was very bristly, incase you are wondering! The staff had no problem the next day remembering my picture, no number required - just had to tell them - "I'm the moose lover!"

Novo Nordisk FatCatAnna

I went to the Novo Nordisk booth because I was interested in learning about Victoza, which Type 2 diabetics can inject once a day.  They can either use it alone, or combine it with their Metformin or sulphonylurea treatment.  The big thing with this insulin that they are thumping their chests about is that it helps patients gain better blood glucose control WITHOUT the weight gain, which often happens when going on insulin therapy.  According to one of the documents I have on hand, visceral fat (this is fat that surrounds our internal organs) was reduced by 13% to 16% in patients treated with Victoza + Metformin.  I know for a few diabetics diagnosed with Type 2, weight can be an issue, and of course, the sooner we shed it, eat sensible and exercise, the better our diabetes is controlled!

So in a nutshell it'll be able to do the following -

  • Reductions in A1C of up to 2.74%
  • Reductions in weight by up to 2.8 kg
  • Reduction in blood pressure readings
  • Improvement is beta-cell function (makes me wonder with time, if you start early enough - you might reverse diabetes as your pancreas start to produce insulin).

Not sure when it will be coming to the market in North America as all the information I am finding  is based in Europe - therefore I'm unable to post the Novo Nordisk link for you to check it out for yourself unless you register there yourself.  I've done abit of research on Victoza and there seems to be some problems with bringing it to the market due to labeling of the product believe it or not in the United States!  We'll just have to wait and see and be patient with FDA, but the forecast is for sometime in 2010. 

Also, if there are any of my friends from abroad reading my scribbles, and you've got some insight into Victoza, please feel free to share with us!

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Posted: Sep 2, 2009

Some of you may have read about the FDA's recent warning about the inaccuracy of certain test strips while taking certain medications.  Honestly, I didn't pay much attention since I already accept they are inaccurate and I wasn't using any of the interfering products mentioned by the FDA.  However, since it affects anyone receiving dialysis I realized I might be negligent in dismissing the problem.

Today, Diabetes in Control published more information on the topic including stating that Wavesense (Agamatrix) products are of a new technology and thus do not have this interference problem.  Bayer also says their meters don't use the old technology.  HOWEVER - several meterrs that are used to calibrate CGMSs do use this older, inaccurate technology.  So ... use a product that is inaccurate to calibrate another inaccurate product and you get double inaccurate.  Nice.  This article is primarily about the few number of people affected by the problem but nonetheless being an informed consumer is forewarned. 

I've always known that many sweeteners (primarily sugar alcohol) can mess up a blood sugar.  This article states particular products that inaccurately skew blood sugar results.

I've also heard people with kidney problems say their blood sugar drops quite a bit and believe it's because of the kidney problems.  They have different sensitivity levels.  Scratch the head.  Well, apparently that's only partially true.  It seems that the drugs they are taking cause the meters to read incorrectly and thus they OD on insulin in an attempt to correct a supposed high.  So it's not the kidney problems or the insulin or their sensitivity.  It's the inaccuracy of the meters.  Big oops! 

Again, I realize apparently small numbers of people are affected by this but it is another reason to demand not request that meter manufacturers spend some of that $1-$1.25 per test strip and find new technology that works.  AgaMatrix has .... why can't the others?

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Posted: Jan 12, 2009

The FDA wants drug manufacturers to be more cautious in the approval process of type 2 drugs as noted in this Healthday News article.  They want to know about cardiovascular risk which in and of itself is not a bad thing.

It means that more information will have to be provided to the FDA before approval is granted and that studies will have to be longer and larger, especially on older at risk patients.  This obviously means it will take longer for new drugs to reach market.  That will also mean more cost to pharmaceutical companies and a longer period before they see any return on their investment.

Now ... one question I have is are these people really at more risk by taking the drugs?  Or is the higher risk actually caused by the non-normalized targets and attainment and years at damage levels?  Are they just in really crappy condition anyway?  Or is the problem an aging population with poor eating habits, huge percentages of overweight or obese people and total inactivity? 

The bottom line is there is only one way to know ... properly geared studies of appropriate populations, not studies gear to prove the meds won't hurt people in totally out of control populations.  I'm not sure we'll ever see "proper" studies because of where most study funding seems to originate. 

Take a look at clinical trial detail ... who is paying, the target population, the goal of the trial, what they do to steer the trials/studies in the desired direction.  It's quite appalling.

Doris J. Dickson

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Blog: Gizzz

Posted: Jul 18, 2008

Finally FDA declared that the cause of Salmonella was not tomatoes - my FAVORITE tomatoes.

I eat a lot of them - of different sizes and shapes - but def. the tastiest veg. in the world - tomatoes. I am so glad they are back in all the stores and restaurants. The summer vegetable - red juicy TOMATO!

Please try my summer salad I make frequently:

You need (for one portion and about 120-150calories):

1. 2 small fresh tomatoes or 1 medium tomato

2. 2 small cucumbers

3. 1 medium radish

4. 3 table spoons of sour cream + salt

OR

olive oil + pepper + salt

The salad is very refreshing and filling at the same time. Take a try and you will love it forever!

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