September 20, 2013

No True Government Support for Test Strip Safety

This is a take off on Ann Bartlett's blog of July 17. I have held this too long, but with what has happened with the Society of General Internal Medicine (SGIM) and their list for Choosing Wisely, I feel that this needs exposure again. Ann is very confident that our medical insurance needs to stay out of the way when it comes to our medical supplies.

Unfortunately, they will be hitting type 2 patients on oral medication very hard probably around the first of the year. When Dr. Robert Ratner, chief scientific and medical officer for the ADA that says, “Many people with type 2 diabetes who are on medications don't need to do home glucose monitoring at all." This is followed by the SGIM putting this statement at the top of their “Choosing Wisely” list, "Don't recommend daily home finger glucose testing in patients with Type 2 diabetes mellitus not using insulin,” patients with type 2 diabetes on oral medication will be in the dark about the management of diabetes. Yes, bold is my emphasis, but apparently is having little in the way of getting people upset.

Our local support groups have had a meeting about this including a support group from a neighboring community. I appreciate the action of the support group I belong to for their actions, but for other emails, I have only had one from a doctor that I have had discussions with and worked with on setting up shared medical appointments. See my blog here.

David Klonoff, MD, from the University of California, San Francisco had the only positive comments at the meeting held the week of September 9. He also said, "Our organization is very interested in this public-health issue, which is to see that safe blood glucose monitoring systems are available for patients." Yes, some of the representatives from the online diabetes community were positive, but only about the desire to promote test strip safety and reliance.

Even the FDA was dragging their feet to delay action. Yes, you can claim that it takes time for them to act, but without funds to back up the request for action, the FDA will continue to side step on the issue time after time.

Courtney H. Lias, PhD, director of the division of chemistry and toxicology devices at the FDA, said, “Some advantages of a surveillance system include its potential ability to identify sources of error for further investigation and to deter/discourage detrimental manufacturing or design issues.” She continued, “However, some of the downsides are that such a system won't identify the source of the error — additional investigation would be required; it might be expensive and difficult to oversee; and small sample sizes might not detect outliers among the billions of glucose tests conducted every year.”

Translation, It isn't going to happen. This is confirmed by her statement, “And to make such a program mandatory, either Congress would have to pass a new law or the FDA would have to engage the rule making process, which is typically incredibly lengthy and, at best, takes 5 to 6 years. "This is not an overnight scenario."”

So between the FDA and CMS, we can forget about increased accuracy or correcting problems in the supply of faulty test strips. Yes, the FDA will support a voluntary program that requires no funds from them. However, the program must be a credible surveillance program and if it is, it can be a very powerful tool. (If the FDA chooses to back it.) Surprisingly the members of most manufacturers in attendance endorsed to proposal.

CMS does not agree.

No comments: