Month: July 2014

A message from diaTribe’s editor Kelly Close

/ rivagreenberg / Leave a comment

Screen Shot 2015-02-06 at 3.43.53 PM

Kelly Close if you don’t know is a tireless diabetes advocate and on the front lines of diabetes information and its dissemination. A highly respected financial analyst, as well as someone who’s lived with type 1 diabetes for more than 25 years, Kelly runs Close Concerns and keeps an eagle eye on research, product development, pharma and the FDA.diaTribe is her free every other month e-newsletter. 

The July issue had a message from Kelly I wanted to pass along. Given the FDA’s risk-averse policy to new drugs and devices, many products that could help the many linger and languish. Kelly’s inviting any and all of us to chime in to the FDA at their public hearing August 11th. Here’s the article below and here’s the plea: please email us on what you would like the FDA to know at: 

We want our diabetes treatments to be effective, but we also want them to be safe, and it is up to the FDA to decide if the benefits of a given medication outweigh the risks. Our concern, is that the pendulum has swung too far in favor of caution and safety at the expense of innovation. Much-needed new products are being delayed or even shelved entirely. the good news is theta FDA will be considering these risk-benefit tradeoffs at a meeting in August, and you have a chance to make your voice heard.

Determining whether a new diabetes drug should be approved has never been easy, but the turning point in this debate occurred in 2007, when Avandia was implicated for apparently increasing the risk of heart attacks. The FDA revised its guidelines so that drug companies would need to demonstrate cardiovascular safety before approval, adding huge costs to the process ($100 – $300 million). The FDA tried to ease this burden by allowing the companies to submit so-called interim data, or data midway through the cardiovascular (CV) trial that demonstrated safety, and the companies could complete the trial after the d rug was approved.

Unfortunately, that hasn’t worked out too well. Once the drug has been approved, participants want that drug and are motivated to abandon the trial. It’s logical behavior, but it negates the very costly study.

The result? Companies are giving up on diabetes. Bristol-Myers Squibb left diabetes entirely in 2013, and Genentech is out too. The cardio trials can delay drugs (like degludec) and follow up drugs (IDegLira) for years. Takeda said it won’t develop its once-weekly DPP-4 inhibitor in the US because trials are too expensive, while delays with Sanofi’s GLP-1 agonist Lyxumia slowed development of entire new classes of diabetes drugs.

In sum, there are benefits to the trials, but we believe we are sacrificing innovation at the altar of safety. (And by the way, Avandia was ultimately found to be safe).

The FDA is holding a public hearing on August 11 to discuss how to address interim data in trials. This is a real opportunity for our community to make our voices heard. Registration to attend is open until July 28; those who can’t make it to Silver Spring, Maryland, can submit a comment right here at Kelly@diaTribe.org. Every comment submitted before July 28 will be considered, but you can submit all the way up to October 10. We would love to thank the FDA for giving patients and families and healthcare providers the option to comment. 

When our response is ready, we’ll tweet it and make it widely available – we’re working on it now! This issue is complex, and it’s only part of a much larger question about how we should handle drug development and approval. But for now, let’s tell the FDA that the status quo isn’t working. We also look so forward to following up November 3 in a conversation with FDA – read our new now next for more on this!

very best,

Kelly

Patients learn something invaluable from each other

/ rivagreenberg / Leave a comment
Screen Shot 2015-02-06 at 3.55.59 PM

I am not medically trained, yet there’s a lot I can give another person with diabetes that a health provider can’t. From 42 years of living with diabetes I know a lot more about medication and food and blood sugar than most.

One thing I am however is a peer-mentor with the A1C Championprogram, and I am among 80 people living with diabetes who speak across the country to other people who have diabetes.

When someone with diabetes, either recently diagnosed or having had it for years, hears from their doctor what they have to do to manage it, they’re usually looking back in the face of someone who doesn’t have it. Someone who thinks what’s the big deal about changing how you eat, taking up an exercise program, taking pills with every meal or six injections a day? Just get on with it.

But when we talk as fellow patients those we talk to look back in the face of someone who gets it. Who knows how frustrating it is when even though you’ve been “good”- eaten the right foods and walked around the mall – your blood sugar is “bad” – not in your target range.

The hour-long programs we present as peer-mentors provide information and education, but largely provide inspiration through our own personal stories of struggle and success.

Patients learning from patients is a very different kind of education than patients learning from medical professionals. And it’s happening more and more. Patients go online, follow diabetes bloggers and volley what they know back and forth. Patients learning from patients is about a shared bond and experiences.

This led me to reflect on an early A1C Champion presentation I gave in Buffalo, New York. It was the first time I was double billed with a diabetes educator. Her talk preceded mine, so I leaned back and listened. What I heard was forty-five minutes of numbers: A1Cs, blood pressures, weight and weight control, exercise, portion control, and carb-counting.

While all this is important information, I also heard what she left out. That these goals are not easy. That we have to find a way to fit it all into our day. That a small step in the right direction is to be applauded. That we should pat ourselves on the back for every good effort.

The purpose of my talk I quickly saw would be to say what she did not: to talk about how we hold diabetes in our lives and if necessary how holding it differently can help. Taking the stage I shared my own shock and fear upon diagnosis, my subsequent denial, and my early complications from that denial.

The room quieted. I was they saw like them. I see the same landscape they see. I tramp through the same darkness trying to figure out half the time why my blood sugar’s doing what it’s doing. I look for solace when diabetes rains down upon me or drains me out.

“When you’re so busy testing your blood sugar every day,” I said to my audience, “reading labels, counting carbs, and calculating everything, do you stop to think why you’re doing all this work? Isn’t it to see the grandkids grow up, start that second career, create the best vegetable garden in town, contribute something to the world, or have another million days with your spouse?”

Heads nodded and people leaned forward. They turned from silent witnesses into curious involved participants. Someone had brought humanity back into the room. Someone had understood and acknowledged this piece of living with diabetes where their heart resides, along with their struggle.

My predecessor, warm and personable though she was, didn’t have diabetes. That put her not just on the other side of the projector, but on the other side of our experience, where so many healthcare providers sit.

We patients, however, are the experts of our diabetes and we are in the daily business of chronic illness. We have life adjustments to make, and since we have precious little help to make them, we are reaching out to each other.

Here are my 5 recommendations for a better tomorrow:

1.    Learn all you can about diabetes, and about your diabetes

2.    Pace your efforts, forgive your mistakes

3.    Appreciate what you hold dear

4.    Spend more time doing what you love. While we’re living with diabetes let’s not short-change the “living” part.

5.    Consider yourself “more than” not “less than.”  We’re all doing a second job.

After the program, people crowded around to thank me, and they were smiling. Well, if anyone can leave a diabetes meeting with a smile then I figure I’ve done something right

Life with Diabetes Update 2014

/ rivagreenberg / Leave a comment

Screen Shot 2015-02-06 at 3.58.00 PM

This poster was created last year by the American Recall Center with the help of several diabetes bloggers to help educate people about diabetes. I just found it and thought it worth updating you on several things it says here and explaining a little further.

So starting at the top of the maze and going down, “Keeping my blood sugar under control requires both meal planning and exercise.” True. It also requires knowing stress often raises blood sugar as well as being sick.

“Diabetes has to be a factor in every decision I make.” Well, most decisions, and I do spend an exceptional amount of time thinking about it. Except maybe when I’m deciding what color bedspread to buy.

DID YOU KNOW? “Warning signs are excessive thirst & urination, weight loss and lethargy.” Another key sign of diabetes is often blurry vision.

“Sugar alone does not cause diabetes.” Actually sugar does not cause diabetes, period. Best we know, type 2 diabetes is caused by genetics,  being sedentary and overweight. Of course if you eat too many foods with sugar, it’s easy to gain weight. The jury is still out on what causes type 1 diabetes.

“I can quickly go from perfectly fine to dangerously low or high blood sugar.” Yes, one’s blood sugar fluctuates all day – and all night. But “quickly” is debatable. It may not take hours, but it also doesn’t take seconds.

“Diabetes can happen to people who have no apparent risk factors.” Likely the risk factor that’s not apparent is genetics. And, few people know, but 1 in 5 people with type 2 diabetes are slim or normal weight.

DID YOU KNOW? “25 million people in the US have diabetes?” Unfortunately, that’s gone up to 29 million people and currently 86 million people have pre-diabetes (or Stage 1 of Type 2 diabetes.) That’s gone up from 79 million. And, one-fourth of people in both populations don’t know they have diabetes.

“We are capable of achieving anything that a regular person can.” Well, yes and no. Like everyone with diabetes, I want people to know it doesn’t define or limit me, but it does at times influence what I can do. If I’m having a low, you would not want me to do your taxes. And, hmmm…I think you still can’t be a commercial airline pilot.

“Diabetes needs more research & funding to find a cure.” Absolutely.

“There is no such thing as a diabetes diet. Different things work for different people.” True, there is no such thing as a diabetes diet. Not like 42 years ago when they handed me one and told me I could no longer eat candy bars. The diet recommended today for all Americans is also recommended for people with diabetes: lots of vegetables, some fruit, whole grains, low fat dairy, lean meat, healthy fats, occasional sweets. Personally, it’s easiest to keep my blood sugar relatively stable when I eat low-carb, which I do.

DID YOU KNOW? “People with Type 1 diabetes must have insulin to survive.” Absolutely. I’d also add having a loving spouse, furry pet and work or hobby you love is pretty important too.

“My family plays an important role to help me maintain my health.” Hmmm…seems to speak to my point above. However, if you don’t have family or that family, do it for yourself.

The more we educate ourselves, and the public, about diabetes, the better off we’ll all be. If you really want to know about diabetes and how to take care of yourself, out of the goodness of my heart I can only tell you to get a copy of two of my books, “50 Diabetes Myths That Can Ruin Your Life and the 50 Diabetes Truths That Can Save It” and“Diabetes Do’s & How-To’s.”

As Oprah  says, and I agree, absolutely, “The more you know, the better you do.”