Tuesday, March 04, 2008

YOUR Invitation to the NIH/NIDDK "Artificial Pancreas" Workshop

After 31 years of tolerating type 1 diabetes, I must admit that I'm just plain sick of it. Even moreso, while cheerleaders are fine for football teams, as a person with diabetes, I find many diabetes cheerleaders to be just plain annoying -- certainly not motivating. I need my job made easier, which does not mean motivation, a fact that seems to elude far too many diabetes researchers. The fact of the matter is that unlike other chronic diseases, type 1 diabetes never gives you a break (unlike MS, another chronic autoimmune disease, which sometimes gives patients a period of remission) and more often than not, diabetes will "act up" when you're least able to deal with it.

For example, even with "sick day rules", many people find it close to impossible to really manage their blood glucose levels when they are ill, and a sick person is really in no condition to increase their vigilance in managing it, are they? Furthermore, since the conclusion of the DCCT, the burden of managing the disease increased exponentially, the cost has ballooned even more, yet the reward for doing so has hardly changed.

While there's no doubt that the toxicity of hyperglycemia is a contributing factor to some complications, more recent evidence has also shown the source of inflammation which causes some complications is the immune system, at least in the case of type 1 diabetes. Therefore, we now have solid evidence that some forms of neuropathy as well as cardiovascular disease also appear to have an autoimmune basis. This means that ideal glycemic control may reduce the likelihood of these complications from occurring, but maintenance of glucose levels provides absolutely NO guarantee that you or your child be lucky enough to completely avoid complications completely. Hardly a source for ongoing motivation, is it?

Interestingly enough, I have read postings on the Café Pharma message board where ignorant (and pompus) drug sales reps actually make stupid comments suggesting that the avoidance of complications should be sufficient motivation to manage their diabetes. I think the words of the 2008 NIDDK Recent Advances & Emerging Opportunities, an annual document published by the NIDDK which highlights examples of the research advances published by NIDDK-funded scientists and their colleagues in the most recent fiscal year, says it best:

"Despite vigilance in disease management, with frequent finger sticks to test blood glucose levels and the administration of insulin, it is still impossible for patients to control blood glucose levels as well as they could if they had functional beta cells."

One of the most frequent criticisms of Government-funded (and too often, in charitably-funded, as well as for-profit) programs intended to address diabetes is that the patient is usually an afterthought when it comes to seeking input -- that is, when the patient is even considered! Instead, there is a mentality of "if we build it, the patients will come" seems to prevail among researchers and diabusiness leaders alike, instead of asking what it is patients actually want. One look no further than Pfizer's $2.8 billion write-down related to the decision to pull the plug on Exubera last year as an example of that.

Although it is now almost a decade old, I still think back to the 1998 Congressional testimony of Alastair T. Gordon, as President of The Islet Foundation, which sadly, remains as true today as it was when he gave the testimony. But as a friend of mine recently, noted, in science, in order to get the correct answer, one must ask the right question. As Mr. Gordon eloquently noted, "Now you, this well-informed diabetic consumer, read the NIH strategic plan and you see that millions of dollars are available for such high priority research goals as:

"Develop and evaluate strategies that address social and cultural barriers to adherence", "Study interventions to decrease psychiatric and social comorbidities in individuals with disease". And on and on and on. Now, if anybody had asked real live diabetics, they could have told you that even the most disciplined person in the world can never come close to the second-by-second metabolic adjustments made by living islets. And no amount of behavior modification or compliance analysis will ever change that.

An artificial pancreas is no cure, nor is it a guarantee of avoiding complications. By now, you're probably saying ... yeah, so what ... tell me something I don't already know. So here it is. There is actually an opportunity for you as patients to contribute something towards this project by representing real-life patient needs.

The first one is the ability to participate in the National Institutes of Health's (jointly sponsored by JDRF) Artificial Pancreas Workshop in Bethesda, Maryland on July 21 & 22, 2008. Although I personally believe there are still many unresolved issues with a so-called Artificial Pancreas, nevertheless, if you are in the Washington, DC area or can get there, you are welcome to submit a complete workshop registration form and potentially attend this workshop, offering the unique perspective of a patient to all the scientists who sometimes forget about who will ultimately be using this thing. Registrations will be accepted through June 20, 2008, and although there is no registration fee to attend the workshop, space is limited, so if you plan to attend, they ask that you submit your registration early to reserve a space.

The agenda is fairly lengthy and features a variety of so-called experts on the subject, including not surprisingly, JDRF's Aaron Kowalski of the JDRF Artificial Pancreas Project. Although I personally do not like the idea of an "artificial pancreas" for a host of different reasons (see my 2006 posting for some of them), nevertheless, I do think there should be patient representation at this meeting.

What are some of the issues that need resolution? No, its not insurance coverage, its the low level of accuracy at low (hypoglycemic) levels. Why is it that science has little if any problem developing testing equipment (test strips, meters, etc.) that can accurately test at levels of up to 1200 mg/dL (66.6 mmol/L), but cannot get anything under 70 mg/dL (3.8 mmol/L) accurate? Surely, this is just as important for a host of different reasons, yet for whatever reason, the issue barely registers in importance.

Then there is the issue of where to put all this crap they expect us to wear, and the subcutaneous tissue damage which is accompanied by all of it. Remember, children are smaller, and have less room to wear all of these gizmos, yet they are considered a primary target audience for all of these things.

Will you be able to attend? If you can, and you register, will you let the Diabetes OC know? I'm not sure I'll have the luxury of attending, but perhaps someone else can!

10 comments:

Jillian said...

So close to me, too bad the Artificial Pancreas is not my cup of tea. What I know about it doesn't sound like a "cure". I hope at least OCer can attend to report back to all of us.

Anonymous said...

It sounds as if it is time for Type 1 diabetics, who are probably better funded and regarded than AIDS patients were in the 80's, to start an organization similar to ACT Up. If the doctors, the researchers and so on will not take the needs of the patients into account, then BY GOD, maybe it's time for us to start attending these meetings with our concerns and start making some noise. And I'm not talking nice, quiet, civil 'let's not rock the boat' noise either. I'm talking LOUD, in-your-face confrontation with the people that keep wasting money and time on developing gadgets when what we really need are replacement beta cells and a way to turn off the inflammation that causes the problem in the first place. If Type 1 diabetics are sick and tired of being soaked for all of their spare cash, if they are tired of their fates being dictated by a money-grubbing healthcare machine that sees them not as patients to cure but dollars to be made, if they are tired of having their hopes dashed by the lack of progress and if they are mind-numbingly sick of 'being a brave diabetic' in the face of everything we have to endure, 24/7/365, then it is time to pull the big kid pants on. We need to start getting angry with those in the health care industry who use us as cash cows and patronize us by telling us that they know best.
I'd like some questions posed to Aaron Kowalski as to why he isn't funneling more money into Faustman's studies, which apparently are doing better research into the root causes of WHY this happens to us, rather than into developing another 'thing' we have to buy to hang off our bodies. I'd ask him why he seems to be such a friend of the pump and machine makers. I'd ask him if he was getting a kickback. I'd like to hear his answer on that one.

Folks, we are letting these companies take control of our lives by giving us the machines THEY make, rather than pressing them to do the right thing, work together for once and find the cure that WE want. And I'm bloody sick of it. But until we make our displeasure known in a manner that they CANNOT MISS, we will be stuck having machine after machine foiseted on us and having our wallets corespondingly drained. No one has ever received anything they needed by staying silent and being a good little boy or girl. You have to step up and make your demands known. Otherwise, you get what's handed to you.

Jenny said...

Isn't the problem with the blood sugar monitoring caused by the presence of interstitial fluid that causes that long lag behind fingertip blood and dilutes the concentration making it hard to evaluate?

A friend was just complaining to me that the new Dexcom is worse than the old ones for being unable to deal with lows.

As long as monitoring depends on expensive disposables this will be a huge problem. And as long as the equipment companies make their money ON disposables, there is no motivation to find alternative methods of evaluating blood sugar.

One note though. MS may have periods of remission, but people with MS can do NOTHING to improve their plight and they know that it is just a matter of time until they end up crippled and probably demented.

I have a friend with MS and after talking with her all I can say is how grateful I am to have a disease I can fight and where I have a good chance of improving the outcome through my efforts. There are no cheery biographies of 80 year old people with MS who were diagnosed in their 30s and are still doing well.

Scott said...

You're right about the CGMS monitoring interstitial fluid, but the issue goes beyond continuous monitors to meters and test strips, which vary in their degree of accuracy below 70 mg/dL. The main reason is because the FDA does not require it and the companies don't want to invest in it.

The most accurate system at the low end of the spectrum is the WaveSense Keynote system, but the system is not yet on the formularies of most healthplans (something the company tells me they are working on). The Abbott Freestyle system is the next best thing, but cannot reliably give a reading below 50 mg/dL. This means a reading may be 45 mg/dL and could be anywhere from 30 mg/dL to 75 mg/dL. With accuracy ranges like that, is it any wonder people cannot reliably treat hypos?!

Finally, I did not want to imply that MS is preferable, in fact you're right about that. I have a friend of the family who, over a span of 7 years, has gone from a vibrant, working woman to someone who can no longer even feed herself. I only meant that the relentlessness of managing diabetes is perhaps one of the most underappreciated burdens known to humanity. In some respects, type 2 has a marginal advantage in that regard, as glycemic variability has been proven to be much smaller, although it is anything but simple to manage.

As always, thanks for your feedback!

Anonymous said...

Scott—

Several years ago there was an advertising campaign soliciting CURE funds that featured a large, bulls-eye-centered target with an arrow/cure slogan for eliminating Type 1 diabetes. As you so aptly state, this has been replaced by using diabetics to CURE the bottom lines of pharmaceuticals, charities, medical community incomes, and even the institutions of higher learning research funding through government grants and charitable ‘hand-offs.’

There does come a time (I speak of 51 years of living with diabetes 24/7/365) that an individual certainly has to feel “there’s got to be a better way.” This constant ‘torture’ could eventually lead individuals to some rather drastic alternatives. Like you, I believe the whole charitable community, the NIH-NIDDK, and others who control our fate are primarily interested in propping up their bottom line as well as labeling us with NUMBERS which place us in either a “good little patient” or “bad little patient” group.

One of the places to start a pro-active agenda would be to demand from the FDA, from our doctors, and yes, even from our charities, a new set of guidelines that really MEAN something and can build on a future toward a more normal life while a CURE is found. I propose the following be instituted yesterday:

--Batch testing of ALL insulins that include not only insulin content (species and activity level) but also level of miscellaneous protein contaminants, levels and types of preservatives, and identification of diluents/carriers.

--All patients (new, old, or switching insulins) should be tested for insulin antibody response. Accurate guidelines for this should be developed in order to select compatible treatment protocols. In fact, content from insulin batch testing could also be compared to this insulin antibody response profile.

--A study should be done to incorporate all preservatives, carriers and miscellaneous ingredients in insulin vials to see whether 50 years of m-cresol, protamine, zinc, phenol, glycerine, etc. cause damage regardless of whether insulin is part of the treatment. The hypothesis would be: some or many of these products may actually cause arterial disease, kidney disease, eye damage, or many other things observed in long-term diabetes.

--Let’s encourage government and charities to use some of their funds to back INDEPENDENT inventors/researchers who probably already have a continuous, non-invasive monitoring device that would be a boon to parents of young children, and elder diabetics. Let’s have meter/strip-makers, with their inaccurate technology, go the way of buggy-whip makers.

--Let’s ask our charities to do something beneficial on our behalf by setting up a patient/doctor adverse events (reporting) data base that would be a more relevant and timely indicator of what is going on right now. These groups have our money, volunteers, and paid personnel who SHOULD be looking out for OUR best interest instead of their bottom line and corporate protection.

--In the world of insurance monopoly, let’s ask our corporate charities to underwrite legislation that would not allow doctors or the medical community to release ANY of our private information to insurance companies. This would include our NUMBERS (related to diabetes management).

--Let’s ask a group of leading medical practitioners in the field of diabetes management to subject themselves to wearing an insulin pump, taking regular doses of insulin, and frequent finger sticks to make sure they don’t become hypoglycemic. I do believe their perception of what a patient goes through 24/7/365 would be changed forever. BTW, we need a double-blind mode where they don’t know whether they’re receiving insulin or sterile water. If we could get them to do this for 6 months, just possibly one of the after-market, after-treatment results would be some doctors finding that they have actually become diabetic! Who says insulin doesn’t kill?

--The arsenal of drugs recommended to diabetics to improve NUMBERS is certainly overwhelming/complicated but nowhere near as insidious as the commonly recommended daily intake of SSRIs to “help control the diabetic’s emotional state.” Are we depressed? Hell, yes (sometimes)! The intent of medicine now appears to be to make all diabetics compliant robots through the use of SSRIs. This is, of course, after all the cheerleading has failed.

Short of compliance with most of the above requests, I would be very willing to join (see anonymous comment #1) a call to arms: “This may be time for a revolution.” The demands outlined above are not unreasonable unless you intend that a patient population be reduced to a status of unquestioning slavery. If and when we could finally get people who started JDRF and have become fully disillusioned to understand that their children, who were diabetics in the 1970s, are no better off today as adult diabetics than they were in the 1970s, maybe they would support another Boston Tea Party. Tell me where . . . tell me when . . . and I’ll be there.

--Brent

BetterCell said...

You are so right about everything that you have said Brent.
I applaud you LOUDLY and will include myself in "The Group."

Jenny said...

Scott,

Thanks for the elucidation. I did not realize that all meters were that inaccurate at low readings. If I didn't know it, with all the diabetes news I read, that information has been kept obscure indeed and that makes it an even larger problem!

Perhaps the huge increase in the number of people being diagnosed with Type 1 will help create a critical mass of people who can demand more of their elected representatives.

The frequency does seem to be rising at an alarming rate, but that gets you out of the "rare disease" bucket, at last.

Eric Link said...

My sister has MS and is unable to leave her home due to it, and unable to hold a job, get married, have kids, etc. I find your general reference to MS offensive.

Scott said...

Eric, I merely noted that MS sometimes gives patients a period of remission -- I never implied MS was a picnic as you seem to imply. The American Academy of Neurology claims that about 20% of MS patients do have periods of remission (ultimately, a majority will advance to a progressive phase of the disease, which is an unrelated conversation). But the comparison here is legitimate, not offensive: there is NEVER a period of remission for anyone with type 1 diabetes -- 0% vs. 20% is statistically significant. Furthermore, I would add that researchers have suggested that while glycemic control can slow the progression of diabetes complications, not a single scientific study has EVER eliminated complications with glycemic control alone, and new research has revealed that some complications long assumed to be attributed to hyperglycemia have an autoimmune basis in type 1 diabetes, including neuropathy and cardiovascular disease.

If you had even bothered to read my comments, you would have found further clarification on that position -- I also have a close friend of the family who has gone from over a span of 7 years, has gone from a vibrant, working woman to someone who can no longer even feed herself. But I noted that the relentlessness of managing diabetes is perhaps one of the most underappreciated burdens known to humanity.

PeggyEllen & Rich said...

Hi Scott,
Do you know of any sites or documents comparing the accuracy of the various meters currently on the market?
thanks,
PeggyEllen