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

Great minds must think alike! 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 monitoring systems for self-testing in diabetes mellitus", 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, 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 Consider the following statement given at the meeting by industry-consultant Barry Ginsberg, MD, PhD, (from the firm Diabetes Consultants, based in Wyckoff, NJ)<10 actually="" although="" and="" at="" based="" benefits="" br="" buyers="" can="" comment="" deviation="" do="" groups="" i="" insurers="" know="" least="" less="" managers="" manages="" much="" on="" other="" pay="" pharmacy="" price-competitive="" prices="" really="" remaining="" retail="" say="" so="" standard="" still="" t="" than="" that="" those="" to="" typically="" we="" while="" wholesale="">:

"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 can 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/ucm187406.htm. 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)