This is not a story about statistics, yet I have to start there. It is not a story about a shocking ad that ran in the New York Times and Washington Post, yet the uproar started there.
This is the story of how approximately 150,000 people with type 1 diabetes will die, and one among them, a vibrant, healthy and lovely 17-year-old girl who did die, due to a side effect of insulin.
Insulin, which many think is a cure for type 1 diabetes, is not a cure but a medicine that lowers blood sugar. Sometimes so much, that you die. Did you know that?
This ad ran on Nov. 2 and touched off seismic aftershocks among diabetes bloggers and online advocates.
Most who read the ad were stunned. Parents who have a child with diabetes were terrified or angered. The emotional-hit prompted many to question such an unbelievable figure: 1 in 20 people (an estimated 2-4 percent and 6 percent in patients younger than 40 years old) will perish from severe hypoglycemia.
Of the estimated 3 million people in the U.S. with type 1 diabetes, that's approximately 150,000 people. That's like wiping out Chattanooga, Tenn. or Rockford, Ill. -- wiping them right off the map.
Aaron Kowalski, Juvenile Diabetes Research Foundation (JDRF) vice president, who's been in charge of hypoglycemia research funding and helped launch, and still oversees, the Artificial Pancreas Project immediately responded to the uproar online.
He said JDRF ran the ad because they want the FDA to understand that tools and technologies, such as artificial pancreas technologies, exist to minimize dangerous low blood sugar; that research shows predictive algorithms can minimize hypos by up to 80 percent.
Yes, life-saving and life-changing tools are, even as you read this, being used in other countries, but not here. Take the Medtronic Veo insulin pump. It suspends insulin delivery
 when a person is already suffering from low blood sugar and is non-responsive. More insulin will drop their blood sugar dangerously further. The Veo has been available for more than two and a half years in over 40 countries. Yet here it is still waiting FDA approval.
Stacy Goodman Died in Her Bed
Four years ago the idea that you could die from low blood sugar became real for me. It was a chilly fall day when I took a train from Grand Central station in New York City to meet Marc Goodman. We sat across from each other in stark daylight in a quiet conference room at his company. He told me about his 17-year-old daughter, Stacy, who upon the precipice of starting her life didn't wake up one morning.
"Stacy was diagnosed with type 1 diabetes a month shy of 4 years old," Goodman began. "We immediately took her to the hospital where she was in intensive care for 10 days. The endocrinologist in the hospital told us how lucky we were that she had diabetes, and that it was going to be cured in three years.
"We raised Stacy to believe she could do anything as long as she did the things that were necessary to have that. When she was young we sent her to a camp for girls with juvenile diabetes. She came back so confident. Stacy played tennis and softball and she was getting ready for college."From the day she left the hospital after her diagnosis she was never back in the hospital. She knew her body, knew how to manage it and she had no complications. We were so thankful.
"It's like there never was an event in her 13 years with diabetes and then one morning she didn't wake up. I had seen her that Sunday and we had a great day. The next morning my ex-wife found Stacy in bed not breathing. They said she had a hypoglycemic reaction and her heart seized. They called it 'dead in bed.'"I had to do something to make some sense out of why someone so young and nice and intelligent, who wanted to be a doctor and find a cure for diabetes, died for no reason. I had to make Stacy's life count, so I created the Stacy Joy Goodman Memorial Foundation. I have only two hopes. That I will be alive when there's a cure, and that my son never gets diabetes."
Jessica Apple, who like her husband has type 1 diabetes, wrote in her post, "This Diabetes Awareness Month Tell the World You Aren't Equal." "I've always known the stakes are high. That's the reason when I wake up in the middle of the night, I sometimes touch my husband's forehead to see if there is sweat on his brow. If there is, I wake him to check his blood sugar. That's the reason I cried when I first injected insulin into my thigh before I went to sleep. It wasn't the pain. It was the thought of the two of us sleeping on insulin (and maybe not waking up)."
There's rarely a night a parent of a child with diabetes sleeps without fear. Meri Schuhmacher, a mom of three boys all with type 1 diabetes said, "The world has no understanding of the daily grind and worry that accompanies us day in and day out. One of my boys was throwing up from ketones (a dangerous by-product of the body burning fat instead of glucose) last night and another's blood sugar was 43 mg/dl at 2 a.m." [Below 70 mg/dl is low blood sugar, below 50 mg/dl dangerously low.]
Diabetes blogger Barbra Wagstaff, also a mom of a child with diabetes wrote:
Those who have (type 1) diabetes living in their house are well aware of its dangers. We remind our loved ones to test (their blood sugar) and be in range before driving anything from a bicycle to a motor vehicle. We wake up multiple times throughout the night to test (our children's blood sugar) and make sure that our loved ones are safe. We know that diabetes is a deadly disease.Impassioned entrepreneur Robert Oringer, who's constantly searching for and bringing to market innovative technologies to make life more manageable for people with diabetes -- and father of two sons with type 1 diabetes -- told me he has a hope and a vision. That first responders -- paramedics, police officers, fire people, schoolteachers -- and the world at large, understand the dangers of low blood sugar so well that anyone will know how to help someone with diabetes who's having a low blood sugar episode.
Those of us who live with type 1 diabetes, and those of us who work as advocates, are mystified at the FDA's slow and disengaged response to medicines, devices and technologies that can help us save our lives.
I haven't spoken to the FDA but if someone wants to contact me, I'd love to hear from you.
Next time you see an ad for diabetes I want you to think about what you're not seeing. The 3 million of us with type 1 who go to bed every night with a faint thought in the back of our head, "Will I wake up tomorrow?" The parents who no longer sleep soundly.
That's why we're anxious for a cure. And until a cure is found, we're still waiting for the tools that will help us and everyone we know with type 1 diabetes not be "1 in 20."
Riva is a requested speaker and the author of "50 Diabetes Myths That Can Ruin Your Life and the 50 Diabetes Truths That Can Save It" and "The ABC's Of Loving Yourself With Diabetes." Visit her website DiabetesStories.com.
Follow Riva Greenberg on Twitter: www.twitter.com/diabetesmyths
1. The stats, which are false (http://www.ncbi.nlm.nih.gov/pubmed/10490436 and other follow up studies show on the right side of the page indicate a .2 percent rather than a 20% statistic- perhaps the JDRF misplaced a decimal) scare people, esp church youth group leaders, educators, coaches and parents - they dont want the responsibilty.
2.They my child look like a victim. That is so upsetting.
3. We are on MDI and dont want an AP
4. Even if we wanted to use the AP, no way would I want the FDA pushed into approving it before they made sure it was safe. And I mean safe!!
5. Why should the JDRF be paying a huge pharma company cash to produce this? They are already rolling in profit
6. Why isnt the JDRF concentrating on Smartinsulin, or Research
7. Why isnt the pushing Insurance to let people have more tests strips or at least pushing for them to be cheaper? They cost about a buck each if you dont have insurance and cost 25 cents each if you do.
8.Why isnt the JDRF pushing for the Public Option or socialized medicine in countries that dont have it like the USA? My husband has a great job with great insurance. But it strikes great fear into my heart if thinking what we would do if he lost his job and insurance. The system we have is barbaric!
The FDA wants full-blown trials of this first stage device, in part to level the playing field and in part to provide a road map for manufacturers to follow, in part to make sure a "thalidomide-like" disaster doesn't occur. This approach is great in a theoretical world, where it doesn't cost lots of dollars, lots of time and lots of hospital visits, long-term health loss and yes, possible death to those waiting. There are real world issues that the FDA seems to be ignoring.
Who cares about the statistics? 1 in 20 or 1 in 500? Tonight, I will test @ midnight, 3AM and 6AM and hope I wake up. LGS could provide a life-saving benefit to American T1D's like me tonight, tomorrow night and every night thereafter, but the FDA can't move fast enough even though it is available in 40 other countries. Why?
How will the FDA respond to this ad? Will they respond?
What strikes me about this political ad (face it, this ad hopes to generate enough public support that either our elected officials will ask the FDA to act, or the FDA will feel enough pressure to act before being called on the proverbial carpet) is that the JDRF felt like they had to run it. Never mind the fact that there is NOT a direct call to action (e.g., "Contact the FDA/Congress/JDRF"). I would have thought the JDRF and the FDA would be pretty close, perhaps having regular contact/meetings to discuss what's being done to cure and/or manage the disease better. Apparently not?
Regardless, from what I have read on the FDA website (yes, I have left the FDA my comments). It appears that their process for investigating and evaluating "new" technologies is broken.
No, I don't want untested and unsafe products on the market, but I also don't want tested and safe products kept off the market because the regulatory hurdles are too high. If the FDA feels the safety testing for products like the Veo has not been adequate, they should specifically state what those objections are. Instead, they are treating this as something brand new, untested, untried and unknown.
The current end result is a very high price. Too high for some diabetics.
I am not shocked. I am thrilled that the truth as sad as it is, will be told to the public at large
It was only about a week ago that another 17 year old girl here in Sydney passed away, and her parents have now set up a memorial fund, and are lobbying the govt here to include an alarm device as a benefit on the PBS (Pharmaceutical Benefits Scheme).
In the US, we are not free to make that choice.
It's likely someone in the FDA saw the cost, and worried about that cost being passed on to insurance companies. You see, over here, those FDA people likely worked in the Insurance companies, cool their heels a few years at the FDA, making rules covering their former employee, and then return to the insurance industry, to be rewarded for a job well done.
While the Dexcom 7+ CGM has been available in the USA for years, it's not available here. It would go a long way to helping. No CGM is covered by any insurance here (despite a public system and additional private insurance), so death-prevention is for the rich in this country.
I live alone and I'm glad to wake up every morning. It's such a fine line with insulin, despite my life-changing insulin pump (also only covered by private health insurance here).
Thanks for highlighting this most important issue, Riva! I'm so sick of reading all the nonsense out there about diabetes, all kinds, that when a meaty issue like this comes along, public awareness is often drowned out by a lack of understanding of what it really takes to manage this awful disease.
Sadly, technology for diabetes is so tied up with money and politics that it's shameful! Lives are being lost and there's no excuse for that!