The Inmates are running the asylum
“If an idea can survive a bureaucratic review and be implemented, it [isn’t] worth doing” –
Mollison’s Bureaucracy Hypothesis
To illustrate just how far out of touch the FDA is with the real world take a look at letter the agency sent to manufacturers of blood glucose monitoring products – the entire letter and all its various attachments can be found at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm227935.htm?sms_ss=email&at_xt=4cd4835558d9946c,0
It seems the FDA is concerned that patients are sharing their monitors with other patients, just as heroin users share needles with other addicts. The FDA is worried that somehow the patient who is sharing their glucose monitor isn’t properly cleaning the monitor after using it and somehow infected blood is being somehow transferred to another patient who ends up infecting themselves with Hepatitis or HIV, and no we are not making this up.
This concern by FDA clearly shows that the agency has no clue how BGM units are used in the real world or even a basic understanding of BGM technology. As everyone knows Diabetic Investor is a strong proponent of diabetes education and given the FDA’s lack of understanding on how BGM units are used we thought it’s time the FDA was the beneficiary of some diabetes education of their own.
First the FDA should know that the “infected” blood they are worried about is collected and stored in the test strip and not the monitor. Unlike heroin addicts, patients with diabetes don’t go around sharing used test strips. Even if someone found a used test strip and picked it up, it would be difficult, if not, impossible for any blood to find its way onto the person who goes hunting for used glucose test strips. About the only way blood could be exposed would be for this person to take apart this used test strip. Why anyone, even a person on heroin, would take apart a used test strip is a stretch even for the FDA.
While it is possible that a small amount of blood could make its way on to the monitor itself, patients with diabetes are not heroin addicts and don’t go around swapping their monitors with other patients. Even if they did, and this is a real leap into fantasyland, it is difficult to imagine a scenario where “infected” blood would make its way onto the person using the monitor.
In the real world, somewhere the FDA seems to be barred from, a patient with diabetes inserts a test strip into their monitor, lances their finger, places blood onto the test strip and then throws away the used test strip after the test is complete. In the real world this same patient wipes the blood from their fingertip with tissue. In the real world if any blood makes its way onto the monitor the patient will also wipe this blood off the monitor. In the real world patients with diabetes don’t hang out on street corners sharing their monitors, test strips and lancing devices they way heroin addicts share needles.
Now Diabetic Investor is pretty sure that there is someone at the FDA who found some obscure study that concluded that .00001% of patients with diabetes share their monitors, test strips and lancing devices. While Diabetic Investor is not aware of any such study, it more than likely concluded that of these .00001% of patients that share their monitors, test strips and lancing- 1 patient actually became infected with HIV or Hepatitis. Therefore the FDA concluded they must make glucose monitor manufacturers jump through another hoop, conduct even more studies and spend even more money to protect the public.
Diabetic Investor can only imagine the new requirements that come from this push to protect. We can see the FDA requiring manufacturers to devote entire sections of the product manuals, manuals that no one reads, about how to properly clean their monitors after use. Given the craziness going on at the agency, we can even see them requiring warning labels that tell patients not to share their monitors or to clean their monitors before sharing. It wouldn’t surprise Diabetic Investor at all if the agency asked for more money to launch an advertising campaign so they could warn the public not to share their glucose monitors. We’ll even wager that some researcher is currently conducting a study that is trying to correlate heroin addicts sharing their needles and patients with diabetes sharing their monitors. Diabetic Investor can hardly contain ourselves as we wait for the groundbreaking conclusions of that study.
Would it be too much to ask for the FDA to sit down with a real person who actually has diabetes and watch them perform a glucose test? Is it really necessary to ask companies to spend even more money, wasting even more time to study an issue that impacts a minuscule portion of the patient population? Is there anyone who seriously believes this is an issue that even needs to be addressed by the FDA? Talk about killing a house fly with a nuclear weapon, my goodness.
As Woodrow Wilson wrote; “In public affairs, stupidity is more dangerous than knavery.”