Thursday, September 29, 2005

Monthly Rant on Diabetes Care

I posted the following in the Yahoo Group "DiabetesPortal", which is a group I started primarily for users of the original family of websites who have been displaced with the recent decision to discontinue operations. Outside users are welcome in the new group, and you can join by visiting the following URL:

If everyone in this group would indulge me, I am planning to post what I am calling my "Monthly Rant" on the state of diabetes treatment and research each month. This marks my inaugural post:

Last Tuesday (9/20/2005), a study revealed that annual U.S. spending on medical research had doubled over the past decade to more than $94 billion in 2003, but the additional dollars yielded only disappointing results.

"There aren't a lot of diseases where we can point to and say we have an answer today that we didn't have a decade ago," according Dr. Hamilton Moses of The Alerion Institute, a North Garden, VA think-tank that evaluates research policy. He noted that doctors were frustrated at not having cures to offer patients suffering from Alzheimer's disease or childhood afflictions such as autism and juvenile diabetes. "It raises the question ... are we getting our money's worth? Are we capturing the full value of that significant investment?" Moses said.

Although these results may be shocking to policymakers and medical researchers, many patients with diabetes -- especially those of us who have lived with this condition for a number of years, are not at all shocked by the findings. When one examines much of what has been done in diabetes research especially, the fact is that a tremendous amount of research dollars are foolishly wasted on studies that prove that which has already been proven.

For example, the DCCT was supposed to be the definitive study on the subject of diabetes control and complications, yet over the past decade, countless additional studies and trials were done yielding results that told us that, surprise, improved blood glucose control has lasting benefits - no kidding! True, many have been conducted by pharmaceutical companies and other diabetes vendors hoping to tap into this lucrative market, but regardless, we do not need any more duplicative studies to show that HbA1c improves, for example, by using an insulin pump, nor do we need any more studies on how to "improve patient compliance".

Dr. Eliott P. Joslin was among the very first the first to acknowledge that insulin alone was insufficient to effectively treat this condition, and I suspect that Joslin was thinking even beyond patient education. However, clinicians simply interpreted this to mean that increased education must be the "missing piece" of the puzzle, often at the expense of physiological issues with current treatments. The principle underlying this belief is that more diabetes education will improve a person's ability and/or desire to practice intensive insulin therapy, which is grounded in the assumption that it is reasonable to expect a person to take 3 or more daily injections of insulin (or insulin pump therapy), conduct 4 or more daily blood glucose tests (at a cost of $1 per test), and follow dietary instructions and restrictions every day for the rest of his or her life.

Diabetes education combined with insulin is not a panacea -- or a cure. A study published in the January 21, 2004 issue of Journal of American Medical Association (JAMA) revealed that only 37% of diabetes patients achieve the American Diabetes Association's (ADA) goal for blood glucose control -- a hemoglobin A1c (HbA1c) blood test result of less than 7%. Moreover, the percentage of people who achieve these targets has changed little in the last decade, according to the same study.

When will the medical community finally acknowledge that education, while an vital element, is simply not sufficient? The limitations of insulin replacement therapy are painfully evident to anyone actually trying to live with type 1 diabetes. The uncertainty and imprecision of properly dosing insulin make it difficult to achive optimal results even under ideal circumstances. Closed-loop systems are widely heralded as the next big advance in treatment, but there is legitimate concern that their promise is already being overhyped.

The "adverse effects" of insulin therapy, namely hypoglycemia, seem to be routinely written off by doctors and diabetes educators, many of whom shift blame to patients for mistakenly counting the carbohydrate content of their meals or not taking one of the dozens of other factors that influence blood glucose levels into account rather than acknowledging genuine physiological issues with faulty counterregulation. A closed-loop system will only deliver the glucose-lowering hormone insulin, but does absolutely nothing to correct faulty counterregulatory systems. Hypoglycemia is vastly underestimated as a diabetes treatment complication. The root of this issue traces back to the widely-heralded DCCT.

The DCCT reported that the incidence of severe hypoglycemia increased threefold in intensively treated patients. Less frequently acknowledged is the fact that the DCCT began in 1983 with only 278 participants and the first 2 years were devoted to planning and feasibility studies. Of the original 278 participants in the DCCT, 8 dropped out (3%) and 11 died (4%) caused in large part by severe hypoglycemia. Changes were subsequently made to the eligibility criteria for the full-scale trial to exclude anyone with this very common short-term issue with today's insulin replacement therapy. This suggests that in spite of a statistically significant increase in the incidence, severe hypoglycemia is severely underestimated as an "adverse effect" even today, especially considering that intensive treatment is the standard treatment for virtually everyone with Type 1 diabetes.

Ironically, in spite of spending billions on more research into the benefits of improved blood glucose control, there have been virtually no new treatments for Type 1 diabetes since the discovery of insulin in 1921. True, there have been marginal improvements to insulin, such as the 1996 introduction of rapid-acting insulin analogs and improved delivery methods, including portable insulin pens and insulin pumps. But the Congressionally-appointed Diabetes Working Group summarized the current situation better than anyone else:

"Genetic engineering of the insulin molecule and new methods of delivery have improved insulin therapy, but in essence, the treatment for Type 1 diabetes has changed little since insulin was discovered."

Very recently, there have been a few bright spots in diabetes treatment, and I hope that clincal practice and results encourage more research dollars towards these innovations. Recently, San Diego-based Amylin Pharmaceuticals received FDA approval to market Symlin, a synthetic version of another missing hormone secreted by the disease-ravaged beta cells in Type 1 diabetes. The company is understandably marketing this as a treatment primarily aimed at the enormous Type 2 market, but this appears to be the first new treatment for Type 1 since the discovery of insulin 84 years ago. Some of you may have also read my editorial published in the Summer 2005 edition of Insulin-Free TIMES entitled "Why Big Pharma's Nanotech Efforts Should Fail", which I have also uploaded into the "Files" section in this group. If you haven't, I encourage you to read it, as I discuss Smart Cells, Inc.'s efforts to introduce a new form of insulin that eliminates hypoglycemia as an "adverse effect". Personally, I am eagerly awaiting SmartCells' IPO, which I believe could be a good investment. The company already has inside access to leaders of the Danish pharmaceutical giant Novo Nordisk, although I'm less clear whether this would be an exclusive deal (I would hope not.) Further information on Symlin, Smart Insulin and others can be found in the following "Links" directory location:

Links/Type 1 Diabetes Information/Type 1 Diabetes Research/Treatment Advances

For your reference, I am also including the article I noted in the first paragraph of my rant below, although I'm not certain how long the articles will be accessible on Reuter's website, so I've included the full text of the article below.

Scott Strumello
DiabetesPortal Group Moderator

US Medical Research Spending Rises
Tuesday, September 20, 2005 4:21PM ET

CHICAGO (Reuters) - Annual U.S. spending on medical research doubled in the past decade to more than $94 billion in 2003, but the additional dollars have yielded only disappointing results, a study said on Tuesday.

"There aren't a lot of diseases where we can point to and say we have an answer today that we didn't have a decade ago," said Dr. Hamilton Moses of The Alerion Institute, a North Garden, Virginia, think tank that evaluates research policy.

Doctors were frustrated at not having cures to offer patients suffering from Alzheimer's disease or childhood afflictions such as autism and juvenile diabetes, he said.

"It raises the question ... are we getting our money's worth? Are we capturing the full value of that significant investment?" Moses said.

Total U.S. spending on medical research derived primarily from corporate, government and charitable sources doubled to $94.3 billion in 2003 versus 1994, after adjusting for inflation, according to the report published in this week's issue of the Journal of the American Medical Association.

Industry funded about 57% of the total, the U.S. government provided 28% and charities and foundations about 5%.

"Foundations have a vital role to play," the report said. "They are able to support research that is risky scientifically (and politically) for scientists who are going in a very new area that may be extremely important."

The development of useful new drugs has lagged compared to research results produced by the biotech and medical device industries, the study said. Pharmaceutical companies created an average of 23 new molecular compounds between 2001 and 2004, down from 35.5 per year from 1994 to 1997.

The report said pharmaceutical companies frequently decide that compounds approved by regulators are not worth bringing to market because they would compete with existing drugs that are safe and effective.

"For all sponsors, the challenge is patience. Biomedical research is an inherently high risk and lengthy process," Moses said. While the United States spends nearly 6% of its health expenditures in biomedical research, more than any other nation, the report criticized the minimal outlays for research on evaluating the new cures.

(c) Reuters 2005. All rights reserved.


Scott S said...

For patients with type 1 (immune-mediated) diabetes, Lilly has a decided limited product line, as the company does not even offer a complete line-up of insulin analogs unlike rivals Novo Nordisk and Sanofi Aventis. While I am very sorry to hear of your issue with Zyprexa, its unclear to me how this issue has anything to do with patients with the autoimmune variety of diabetes. I would suggest that you take the issue up with the U.S. FDA.

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