Tell the FDA +/- 20% Is Not "Good Enough" ... Today!

Great minds must think alike! As I was posting this on my personal blog, Scott's Web Log" (sstrumello.blogspot.com), another diabetes blogger, in this case, Kelly Kunik wrote about this very same topic as I was going to publish this posting. Read her post here.

Last June, the U.S. Food and Drug Administration's new Commissioner Dr. Margaret A. Hamburg wrote a formal letter of response to the American Association of Clinical Endocrinologists (AACE), which had formally asked that the regulatory agency act on the issue of clinical accuracy of home blood glucose testing supplies. The New York Times reported that the group had requested the FDA to push for greater accuracy in a letter sent to the FDA in May 2009.

The standards used in the U.S. (and elsewhere) today for blood glucose tests were actually established in 2003 by the Switzerland-based multinational organization known as The International Organization for Standardization (ISO), and those standards permit manufacturers +/- 20% deviation from actual clinical laboratory tests for blood glucose levels. (The formal document number is ISO 15197:2003 entitled "In vitro diagnostic test systems - requirements for blood-glucose m...", but be advised that the organization will charge you a hefty 130 Swiss Francs to download a copy of the lengthy document, or about $122 U.S. based on current exchange rates).

The AACE was prompted, in part, to ask the FDA to step in to tighten standards when a study undetaken by government researchers actually revealed when comparing tests from 5 different brands of widely-used blood glucose meters/test strips showed the results varying from lab values by as much as 32%. What's more, the study controlled for a number of different factors that might impact readings in a real-world clinical environment, such as ensuring that subjects washed and dried their hands before each test, for example.


Dr. Hamburg asked the FDA's Center for Devices and Radiological Health, the unit of the FDA responsible for reviewing, approving and establishing standards for blood glucose self-testing supplies sold in the U.S., to respond to the AACE. In their response, the Center for Devices and Radiological Health did cite a number of different statistics that seemed to suggest tighter standards were probably appropriate, including the number of adverse events attributed inaccurate blood glucose test readings from these devices, a number to FDA readily acknowledges is most likely under-reported because reporting is voluntary. Then, in June 2009, the FDA formally pressed ISO to tighten the standards for self-monitoring devices for blood glucose, believing that ISO has the ability to act much more quickly and broadly than the FDA does all by itself, although the FDA did hint that if ISO refused to act on the request, then the FDA "may instead recognize other (higher) performance standards" on its own. For the FDA to act on it's own would likely be more time-consuming because Federal regulations mandate that the Agency must have a formal public comment period announced in the Federal Register, a minimum period of time to collect responses, followed by a formal review of the comments gathered before even reaching a conclusion. Collectively, the process can take well over 18 months at a minimum, which would then need to be followed by a sufficient time period to enable manufacturers to comply with tighter new standards.

At a two-day meeting held to review blood glucose meters held by the FDA on March 16-17, 2010 (see here for the FDA's notice on that meeting) held at a Hilton Hotel located the Maryland suburbs just outside of Washington, DC, the FDA solicited input from a number of relevant stakeholders including: physicians, nurses, healthcare providers who work in intensive-care settings, industry representatives, diabetes educators, professional societies, consumers and even patient advocate groups to determine whether FDA review criteria for these blood glucose meters/strips devices should be changed "in order to promote greater public health". Among the attendees representing the industry was Alan Cariski, MD of Johnson & Johnson's LifeScan, Inc. unit and Mike Flis of Roche's home diagnostics unit.

Although the manufacturers claim to support tighter standards in much the same way as the tobacco industry supports smoking "prevention" programs and education, the industry tried to suggest that changes to tighten standards to within 15% were technologically feasible, while tighter standards were not. However, if one reads the FDA-mandated inserts included with a vial of test strips, the literature in a number of popular brands suggests those products are already compliant with +/- 15%, therefore such a mandate would require the manufacturers to do absolutely nothing! Meanwhile, reducing the industry claims that reducing the variance from lab values to a margin of +/- 10% (or even +/- 5% as some would like to see) is not possible using current technology. Of course, that argument is a tad ironic considering at least one manufacturer, in this case AgaMatrix, Inc. already meets the <10% deviation standard and still manages to do so while remaining price-competitive (at least based on retail prices, although I can't really comment on wholesale prices that insurers and pharmacy benefits managers actually pay, other than to say we know those groups typically pay much less than retail buyers do).

Consider the following statement given at the meeting by industry-consultant Barry Ginsberg, MD, PhD, (from the firm Diabetes Consultants, based in Wyckoff, NJ):

"How much accuracy you need depends on who you are. Those with type 2 diabetes who treat their condition with diet changes and oral drugs don't need to monitor their blood levels as closely as those with type 1 diabetes who take insulin", he said.

What does Dr. Ginsberg's statement mean, exactly? Allow me to translate:

In effect, he's saying "Look, 90-95% of patients have type 2 diabetes and they don't require insulin, so the current standards are more than adequate for the vast majority of users".

That's a lame excuse. Why should anyone with diabetes, regardless of type, have to deal with such inaccuracies? The industry has repeatedly suggested that more stringent mandates will result in higher prices. To some extent, that's true, and we need to realize that retail prices for testing supplies are higher than most payers (meaning insurance companies, and/or Medicare) actually pay. The FDA estimates the pricing differential to range from 20-40%, depending on the drug or device.

All I can say in response to Dr. Ginsberg is: "Oh my God, the industry is claiming that the minority should not be dictating tighter standards for everyone else and threatening that doing so will possibly raise Medicare costs!" Sorry, but that smells like an excuse to avoid doing anything more. As they say "Why buy the cow when you get the milk for free?" This business is a cash cow, plain and simple.

Reuters reported (see here) on the meeting phrased it a bit differently:

"At issue is whether incorrect meter readings stem from problems with the technology or other issues such as patients or doctors and nurses not using the devices properly. Other problems can include trouble with test strips, blood samples, hand washing and other factors that can impact results."

Unfortunately, my impression is that representatives with a direct, vested financial interest in the fortunes of the blood glucose self-monitoring device and supply industry seemed to rely on an all-too-common yet pathetic practice that has always existed in diabetes care: to try and deflect any criticism away from the treatment (or in this case, the device/strip manufacturers) and instead shift the blame to the end-users of their products, notably patients and to a lesser extent, doctors, nurses and hospitals which now routinely use the devices even if they are not formally approved for clinical use in those non-individual settings. The industry does claim to support the FDA in establishing standards to for blood testing devices that are used by doctors and nurses, but FDA regulators should be asking: "why wouldn't they?" Support for that effort translates into more users and buyers of their products, thus more earnings for their shareholders!

Claims that users aren't washing hands which can indeed impact test results was, from a patient's perspective, a pretty lame effort to suggest user error is the biggest issue, when the fact is, it isn't. This is a less-than-blatant attempt to discredit a legitimate need for greater precision even while claiming that they really "support" greater precision, but the FDA shouldn't buy it!!

Fortunately, Ellen Ullman actually attended the FDA meeting, and was there to represent the needs of patients and/or their caregivers (such as parents of children with diabetes), rather than the more typical style of FDA meeting where there's a conference room full of "experts" consisting of scientists, doctors, nurses and industry reps basically discussing the issues amongst themselves because it's required by law, but then do pretty whatever industry wants anyway. That helps explain why the diabetes industry, especially under the previous Commissioner, usually got what it wanted from the FDA. For those of you who don't know Ellen, her son Zach was diagnosed as an infant less than 2 years old if memory serves me correctly (he's now in college), and she has long been very actively involved in the online diabetes community, including the Children with Diabetes website, DiabetesTalkFest and many others. Ellen sat on the far right-hand side of the panel table for the DRI's Diabetes 2.0 Conference in Miami last November (see here for the video of that panel discussion). Ellen presented the results of a survey she conducted (Kelly Kunik of Diabetesaliciousness(TM) wrote about the survey here), and although Ellen told me she felt she could have done a better job than she did at the meeting, I really think she did very well! More importantly, I believe her mere presence there was far more important than what was actually included in her presentation.

The FDA notes that transcripts of the workshop may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the public workshop (on or around March 29, 2010) at a cost of $0.10 cents per page. In your request, you should specify the docket number for the event (which is "FDA-2009-N-0604") and the title "FDA/CDRH Public Meeting: Blood Glucose Meters - March 16-17, 2010". A transcript of the public workshop will also be available (which should be free, if I'm not mistaken) on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/u.... There you'll be able to read all of the details from this important meeting, including the formal positions expressed by the various parties in attendance. From what I can discern, it appears that most practicing doctors and patients were on the side of tighter standards for BG meters and strips (the tighter the standards, the better as far as I'm concerned, although I do not want this the manufacturers to use it as an excuse to jack up prices, which they likely will).

Submit Your Own Comments on Whether You Think Current Accuracy Standards for BG Meters are Sufficient -- Online!

There's a BIG opportunity for the Diabetes O.C. (Online Community) to take part in this discussion even if we could not attend the meeting. First, I should note that the FDA has been migrating to the Federal Dockets Management System, which is a U.S. Government-wide system for posting documents, arranging meetings and seeking public commentary on issues such as accuracy standards for blood glucose monitoring systems. According to the Federal Register, the deadline for submitting comments regarding this public meeting is Tuesday, April 20, 2010 by 5:00 PM EST (about 2 1/2 weeks from today), so do not delay ... Act Now!! Click on the FDA Comments Docket for details! (If the link is not working, visit: www.regulations.gov, and search for Docket No. FDA-2009-N-0604)

Views: 142

Comment by nel on March 19, 2010 at 12:14pm
I hope, what I add here is appropriate to the discussion : I had a glucose random done at the lab : 7.6 ( x 18 ) , one meter , which links to my pump , tested finger poke : 4.1 ( x 18 ) , another meter, not a link ( same brand ) finger poke 5.3 ( x18 ) ...A1C result 7.0 ( finger pokes av. of 9.4 ??( x 18 ) ...31 day averages of both meters , CGMS about 6.5 ( X 18 ) ...maybe another story ?
I called the meter company, because of the numbers being off by more +/- 20 percent , the way I calculated and I am confused.
This is what I understood being said : do a meter test at the Lab and use venous blood and you will find a closer relationship between the results .This is the first time , I heard about this and it seems very unrealistic; been poking for about 23 years . For me , if I have a finger poke result of 7.0 prior to a meal , I like to give a correction with no insulin on board ; am I at 4.1 , with insulin on board, I may require some glucose .
PS my simple observation .
Comment by Olaf R Saugen on March 20, 2010 at 10:47am
The 20% error rate is way too high for today's more sophisticated Diabetes management and the industry's wishy-washy response is infuriating. I have written my state senators to urge them to support the FDA's efforts to imrpove the standards, but have little hope that anything meaningful will be done. In a somewhat perverse sense it may well be that the rapidly improving CGS technology will make the blood glucose monitor industry will find iself out of business. But please support the efforts referenced in this discussion and support the FDA effort to improve the standards.
Comment by Sylvie on March 20, 2010 at 9:11pm
So I wonder then, why would we not ALL start using the AquaMatrix brand of meter. That would certainly get the other companies to rethink their unacceptable stand on meter accuracy...
Comment by Scott Strumello on March 21, 2010 at 7:45am
Hey everyone, thanks for your comments -- sorry I haven't had the opportunity to respond to every individaul comment, but I do appreciate your thoughts on this subject. For example, DuckFiabetes had some interesting comments, and while I know all brands on the market today have patents, I'm not a patent attorney so that's not really my expertise. But I do know that the industry routinely makes files what are sometimes called "evergreening" patents which enable them to extend the lives of existing patents by making marginal, and I would argue insignificant, changes to the original patents. Recent examples include reductions in the time required for a test, reduction in sample sizes, or even design changes to the strips themselves by adding a clear overlay "window" or using a different type of plastic. Fundamentally, however, the same core technology has been used for a number of years without core technological changes.

For Sylvie, in particular, the reality is that there's more to it than everyone switching brands. The biggest issue is the fact that 80% of the testing products sold in the U.S. today are actually paid for by insurance companies who manage the approved brands with preferred brands and/or lack of coverage for non-approved brands. Usually, pharmacy benefits managers (PBMs) such as Caremark, Express Scripts or Medco play a role here. Alternatively, Medicare, Medicaid or the Veterans Administration (VA) pick up another large piece, and AgaMatrix does not (yet) have widespread coverage in getting themselves on the approved formularies yet (part of this is the fact that "approved" vendors will cut prices further to prevent other brands from being covered, making this a challenge for a startup company).
Comment by Tim on March 24, 2010 at 5:16am
I was diagnosed about 30 years ago, before the widespread availability of home bg testing. Very shortly after diagnosis I was taught home bg testing at the state's research hospital and benefited greatly.

What was diabetes like before home bg testing? Well, you had urine testing. Pee on a strip and if it turns dark, then you had a bg over 180 in the past 6 or 12 hours. What's my bg right now? No way to know.

Home bg testing is such humongous improvement over no home bg testing.

If we get the government to put their heavy hand in and require 5% or 10% accuracy, and no manufacturer has such a product, then guess what? They're not allowed to sell any bg meters. And I'm back to the days of urine testing. I'm not going back, I won't!
Comment by Scott Strumello on March 24, 2010 at 5:37am
Tim, I don't think you have a full understanding (BTW, I also used urine testing for my first 15 years of life with type 1). At issue is the fact that manufacturers CAN meet tighter standards, but they don't want to make the investments necessary when they can continue selling technology that is at least 10 years old, the very definition of a cash cow. There is already a single manufacturer (as noted in my post above) who already meets the <10% variance (AgaMatrix, Inc.). The government and the FDA work for U.S. taxpayers, not the medical device industry, so the obligation is to ensure that standards are meeting the needs of patients. We should indeed be pushing for higher standards, because clearly, the industry isn't going to volunteer to do it by themselves.
Comment by Tim on March 24, 2010 at 6:28am
I think my standards for what a meter has to do, are not as demanding as some others.

It has to tell me if I'm hypo. I don't care too much if it reads 30 when I'm 20 or 20 when I'm 30. Both are hypo, and I need to know that. BTW: That's a 50% inaccuracy that I regard as acceptable there. To be honest I don't care much if it tells me I'm 30 when I'm 50 or 50 when I'm 30. Those are too low too.

It has to tell me if I'm high. I don't care too much whether it says 280 when I'm 350 or 350 when I'm 280. Both are too high. BTW: That's a 25% inaccuracy that I regard as acceptable there.

It certainly has to tell me if I'm a little too low (60) or a little too high (140). It's nice to distinguish those numbers from 100. That's a 40% inaccuracy that I regard as acceptable there.

It'd be cool to be able to distinguish 80 from 100, or 120 from 100. That's not really a hard and fast need, but it's a "I'd like too". That's a 20% inaccuracy that I regard as just fine with me.

"We need more accurate meters" is a bit like my boss playing "bring me a rock". (Google it.) No meter is going to be perfectly accurate. We need good enough. We need good enough when it's cold outside, we need good enough when it's hot outside, we good enough when it's a humid day, we need good enough with a new tube of test strips, we need good enough with a nearly expired test of test strips.

BTW, I always test my bg with my meter, minutes before and minutes after having lab bloodwork done. I find my meter (Accu-Chek Compact) to be within 5% all the time, IF the test is done indoors and my hands aren't too cold. What I find diminishes the accuracy of my meter is if I do it when it's below freezing and I do it outdoors (tends to lower the result by 10%), or on a very humid day (tends to raise the result by 10%), etc. Remember, when you ask a meter company to make a meter for me, I demand that it work in the rain, in the cold, in the hot, etc. Demanding high precision in the face of all the environmental variations is probably possible, but will cost a lot more.

I'm not a shill for the meter companies. I actually remember life as a T1 diabetic 30 years ago before I had bg testing. Today, we're living in a world of luxury compared to the stone knives and bearskins days.
Comment by BadShoe on March 24, 2010 at 6:20pm
Anyone interested can read what I sent here. It is really wordy.

http://www.ydmv.net/2010/03/dear-fda.html

Please go to the FDA site and add you comment. I bet you can be a lot briefer than I was. Here is a quick little adlib you can use to make you own. Feel free to swipe it. Please sent a comment.


I am the (a PWD/mother/father/sister/brother/next door neighbor/school bus driver/dog walker) for (name). (I/She/He/It/They/None of the above) has had type (I,II,II and a half,III) diabetes for (number) years.

I(we/she/it) rely on a blood glucose meter to measure (My/Her/His/Their/None of the above) blood sugar and dose insulin. Meter accuracy matters in our home.

We believe that more accurate meters would reduce the number of (hypo/hyper/psychotic/in range) episode in our home. We work hard to avoid (hypo/hyper/psychotic/in range) episodes and we hope our meters would too.

(Thank you/pound sand/respectfully/Jane you ignorant sl*t)

Your Name

__________________
Bennet
Comment by Daniel Oliva, RRT RPFT AE-C on March 25, 2010 at 8:27pm
Lets all face the truth....THE FDA IS FOR SALE TO THE HIGHEST BIDDER! They do not protect consumers at all! It is BIG Business that wine and dines them...the lobbyist are just doing the job that medical manafactures pay them and the hell with the recipients! The FDA does nothing!
Comment by Bradford on March 27, 2010 at 1:45pm
Scott,

Thanks for talking about this. Here's the letter I submitted to them earlier today. I hope that others will continue to contact them so that change will be forthcoming.

To the FDA,

Thank you for the opportunity to comment on the blood glucometer accuracy. I have had type I diabetes for nearly fifteen years. My father has had type II diabetes for nearly seven. I am writing today not only as a person living with diabetes, but also as a family member of a loved one with diabetes. It is safe to say that my life has been affected by diabetes.

Per the regulations.gov Web site, the supplementary information provided regarding the March 16 & 17 meetings states, “Glucose meters are used by millions of people with diabetes every day. These devices have become smaller, faster, and more accurate over the past 3 decades and now allow for better glycemic control by diabetics than in the past.” This statement is undoubtedly true, but the current regulation that requires that these meters only be accurate to a person’s blood glucose to +/- 20% is unacceptable. The current standard of was defined by ISO 15197, established in 2003.

As a person living with type I diabetes, I require the administration of insulin to regulate my blood glucose, as my body no longer produces any of its own. I make insulin dosage calculations based on the food I plan to consume, my activity levels, and of course, my current blood glucose reading. Because every person is unique in the way his or her body utilizes insulin, it is imperative that the most accurate information possible is utilized. Requiring more stringent regulations that would provide for glucometer accuracy to be within +/- 10% would provide a great service in helping to minimize the amount of nearly uncountable variables that need to be taken into consideration prior to administering insulin or carbohydrates (depending on the current glucose level).

The FDA’s supplementary information also notes,

Blood glucose meters are being used in clinical settings and at home in ways that are not within the intended use of the devices as evaluated by FDA. For example, glucose meters are increasingly being used to achieve tight glycemic control despite the fact that these devices have not been cleared for this use. There is currently no consensus that blood glucose meters currently on the market are accurate enough to be used in this way.

This is extremely unfortunate, as every day, the pharmaceutical and durable medical device companies that manufacture and distribute these glucometers are marketing them as devices that can be used to manage accurately one’s diabetes. The danger lies in this +/-20% inaccuracy. If I attempt to have a blood glucose of 112 mg/dL, and the glucometer I use says 112, I am content and continue with my normal daily activities. However, given the accuracy may be up to 20% off, that means while the glucometer states 112, I could really have a blood glucose of 140 mg/dL. This is not a life changing value, unless I keep my glucose at 140 (or above) all the time. If I unknowingly trust my meter that continues to tell me my glucose is appropriate, I am at an increased risk for complications such as retinopathy, neuropathy, heart attack, cerebrovascular accidents, or worse. So as a person living with this disease every day, my ability to manage my disease is undercut by the very makers of the products that are supposed to be helping me in this process.

This disease is a 24/7/365 disease, and I receive no breaks. With the technological advancements made that have allowed for smaller, faster, and more accurate glucometers, I am sure that more can be done to continue to reduce this margin of inaccuracy. Please help me in this fight by requiring more a stringent standard of +/- 10% accuracy. The technology is already available to meet this increase in standards. I urge you to make it mandatory for all companies to commit fully to making the lives of persons with diabetes better. Thank you again for the opportunity to comment, and I look forward to the FDA continuing the fight to maintain the safety and well-being of all persons with diabetes.

Respectfully,

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