Medicare and the FDA (Food and Drug Administration) are choosing to lower costs at the expense of your health. They are allowing cheap and faulty diabetes test strips into the marketplace. Test strips that have been proven — the FDA admits — to give inaccurate glucose readings.
This is dangerous for anyone who has diabetes, no matter what your age. We cannot allow this to continue and, together, we can stop it — and we must.
I want you to write a letter to the FDA to keep bad strips out of the market. That’s it, that’s all, that simple. Go, as soon as you read this, and use one of the sample letters that has already been created for you at StripSafely.com.
StripSafely was created by the diabetes online community with a single mission. To have the FDA create a plan to best ensure test strips’ accuracy. A plan that holds test strip manufacturers accountable to meet minimum accuracy standards — and reviews test strips’ accuracy after they enter the marketplace, when new lots are often found to be unreliable.
Gary Scheiner, certified diabetes educator and author, says, “The 4 million plus people in the U.S. who take insulin typically base doses on meter readings. Inaccurate readings can lead to inappropriate dosing. This greatly increases the likelihood of severe hypoglycemia (low blood sugar) and long-term hyperglycemia (high blood sugar).”
Meaning, each blood sugar reading I get throughout the day tells me my starting point for every decision I make about eating, activity and how much insulin to take. Each of my daily diabetes decisions is based on that reading. If my reading is falsely high or low I will take an action that can cause me to fall into a coma or die or suffer diabetes complications.
Another problem, says Scheiner, is if patients lose faith in their meter and strips due to inaccuracies, they are likely to stop testing altogether.
Why is this a problem now?
Because this month Medicare rolled out its price-slashing program on blood sugar test strips. After requesting competitive bids, Medicare now limits the test strips a beneficiary can receive to 18 selected manufacturers, mostly from overseas.
Several of these manufacturers’ strips failed accuracy tests or their accuracy was deemed uncertain. In one study of 34 blood glucose systems, more than one-fifth did not meet the minimal accuracy requirements of the ISO standard.
The FDA acknowledges there are strips in Medicare’s new program that give inaccurate results and they have no way of removing them. Further problematic is the FDA reviews manufacturers’ test strips before the strips are marketed, but not after. Strips can, and do, vary after they’re in the marketplace.
And while this is currently being imposed on Medicare members, this may hurt us all. David Edelman reports in “Can You Trust Your Test Strip’s Accuracy?” that the winners of our government’s bidding war may price U.S. manufacturers out of the market as they are held to the FDA accuracy standard.
Or U.S. manufacturers may have to drop their prices so low, they will abandon the other essential things their test strips fund — new product development, innovation, customer service support, educational programs, and oh yes, accuracy.
Mike Hoskins, at DiabetesMine.com says all “PWDs (people with diabetes) will have less choice (of meters and strips) and an even harder time getting coverage for the best brands.”
Medicare’s cost-cutting strategy is clearly save now, pay later. You, or someone you love, may pay with heart disease, kidney disease, an amputation, neuropathy or retinopathy, all diabetes complications. Or the payment may be the co-morbidities of diabetes: cancer, obesity, hypertension, fatty liver disease, sleep apnea and fractures. You may pay in health care costs for surgeries, drugs, medications and not being able to work. Inaccurate blood sugar readings will contribute to all of these.
Write a Letter, It’s Easy-Peasy
Take just a few minutes, use one of the sample letters on the site and add your voice to urge the FDA to protect you or someone you love by ensuring test strips meet regulatory requirements — both before and after they’re in the marketplace.
My letter is on the site as well and here’s the beginning:
Jeffrey Shuren, MD JD Director, Center for Devices and Radiological Health Food and Drug Administration 10903 New Hampshire Avenue, WO66-5442 Silver Spring, MD 20993
July 2, 2013
Dear Dr. Shuren:
I’ve had type 1 diabetes for 41 years and I’m turning 60 next month. Two weeks ago my A1C was 5.5 percent, yes, normal. How is that possible? I adhere to a healthy diet, exercise every day, and check my blood sugar diligently using a meter and strips recognized among those with the tightest accuracy.
I am writing to you because while I might have said as a teenager, “I’d die if I don’t get that!” I actually could die if I don’t have accurate test strips…
Hold the FDA to their job
Many would argue the most basic job of government is to protect its citizens. Yet, the federal government is causing seniors to lose out and set the ball in motion for U.S. strip manufacturers to get priced out of the market. If this happened it would deny nearly a third of American citizens, the population with diabetes and pre-diabetes, accurate glucose meters and test strips — the most essential tool to manage our diabetes and our health.
FDA accuracy standards are already low, and I have been among the many fighting to increase accuracy of meters and strips. But now all of us may face strips that don’t even meet those standards.
Can massive organizations like Medicare rob us of our health? Not if we don’t let them.
Write your letter please. Help urge the FDA to pursue a plan to keep us healthy. This is too important. And pass this on to anyone you know with diabetes.
They’ll thank you for it — as does my aunt, my downstairs neighbor, hundreds of my friends and acquaintances, and my husband — who doesn’t have diabetes, but if we don’t fix this, one day soon may not have me.
Originally published in The Huffington Post.