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Also, check out this exciting bit of news which Scott Strumello has just brought my attention to:
Exsulin Corporation Announces Publication Of Phase 2 Trial Results For Novel Islet Regeneration Treatment In Type 1 & Type 2 Diabetes
I've been hearing about INGAP almost as long as I have been following diabetes. This INGAP trial (the drug has been renamed) involves a peptide that appears to actually regenerate islet cells in both Type 1 and Type 2 diabetes. Most importantly, the increased C-peptide values remained "after washout" i.e. after the drug was discontinued.
The company behind INGAP has had a lot of trouble getting funding over the years, probably because a cure would rob big pharma of its chronic disease cash cows.
Let's pray that the next stage of testing of this drug finds it to be safe and that some company that cares more about your health than its profits will get behind it.
12 comments:
Thanks for keeping us up to date on the latest news.
Back in July you mentioned something about non-invasive BG monitor technology having been developed but not yet made available to diabetes patients probably because of the lucrative business of selling test strips for the blood spot monitor models.
I mentioned what you said to a friend who is an optical engineer for a biotech startup and he said he is familiar with the noninvasive BG monitor technology and it isn't promising/effective enough and that's why it hasn't hit the market yet.
Could you shed some light on your position on this sometime?
Could you post on this
Anna,
There have been quite a few noninvasive technologies that have been tested and discussed in the press over the years. It is hard to believe none of them was worth further development.
The technique of buying up competing patents to keep them from being developed is well-known in the business world, so it is hard to know what to think about this topic.
Given how poor a job the strips do one has to wonder at just how bad the noninvasive techniques would be.
The cost of strips prevents people of limited income and just about everyone in the developing world from testing blood sugar at all. An affordable test device that did not use consumables would save literally millions of lives.
Jenny, thanks for the credit! As far as Exsulin is concerned, Lisa Jansa said in an interview with David Mendosa last year [http://www.healthcentral.com/diabetes/c/17/51864/regenerating-islet], we learned:
In David's words, "Something as big as INGAP won't come cheap." Lisa Jansa told him "We don't anticipate that it will exceed $20,000 for a single course of treatment," Lisa told him. Later, however, she is confident that as they scale up production they will be able to bring the cost down." Also, "If and when we are able to use INGAP, it won't be a single shot. It's like that at least when it first comes to market it will be daily injections for up to 3 months. However, they don't know yet if we would have to take booster shots after that."
The mantra in the pharma industry these days, at least according to Forbes: The drug industry has transformed from a business that tries to sell pills to the masses to one that markets very expensive treatments to small groups of sick people--and that changes everything. (In other words, the age of the "blockbuster" seems to be history, hence the move to smaller but more lucrative markets). Forbes also adds "An expensive medicine that serves a small population can mint money--and it's pretty tough for even the harshest government system to say no to it."
That's not to say that it can be too costly; but it does need to be a better value for payers than current treatments, which considering how little they've evolved over the last 80 years, may not be too hard to justify. Only time will tell. The other issue that still needs to happen is the treatments to address inflammation, and there are several in trials at present. There might actually be competition in that market!
Scott,
Reading the release what struck me was there was no quantification of the improvement. "Significant" improvements are all too often statistically significant, which can mean only 2 or 3% over placebo.
Re cost. They are charging $10K a month for the only treatment that seems to stall MS, which seems criminal to me especially when people with MS are routinely denied access to insurance drug coverage.
The model where we only treat the wealthy and privileged is highly immoral. I hope we don't see that with islet regeneration.
I have become very disenchanted with pharma and their approaches to developing drugs over the years as well. However, don't forget the recession and credit disaster- in my business I see many small companies (including biotech and pharma), most of which have struggled, floundered or given up entirely over the last few years due to lack of funding. Many potential cures and approaches to treatment have gone the way of bankruptcy of late, and who knows if they will ever be revived. I understand your criticisms of the industry and your cynicism, but there are usually business reasons behind all drug/device development, or lack thereof. It may be very short sighted business thinking, as we are wont to do, but unlikely to be due to conspiracies. That said, don't stop advocating and encouraging new development. Sometimes businesses need a hand getting past the hurdles, and if some sort of tax incentive or grant would help, then your social responsibility and educational efforts could help.
By the way, have you ever heard of health insurance being run as a nonprofit? That seems like a reasonable middle ground ...
Cynthia
Cynthia,
All the plans available to me in Massachusetts, which has the most progressive insurance laws in the US are nonprofit plans. They were all started by hospitals and are PPOs.
They are a lot less abusive than the private insurance I had in Connecticut years ago. They cover what they say they cover with no arguments, and of course, since this is Massachusetts, everyone is able to buy coverage no matter what their pre-existing conditions.
Wonder if you have seen this study?
Type 1 Diabetes Linked To Immune Response To Wheat
http://www.sciencedaily.com/releases/2009/08/090820124038.htm
Dr. Davis will find this interesting.
I had seen the wheat article.
The rise in gluten allergies parallels the rise in other autoimmune diseases. My guess is that it doesn't CAUSE it, because humans have been eating wheat for a very long time and this explosion of autoimmune conditions happened within the past 20 years.
I think this is due to the invasion of our food supply by soy products, which haven't been a standard part of human diet. Soy contains compounds known to change the permeability of the gut. When the gut permeability changes, proteins like gluten seep through and generate immune attacks.
I wouldn't be surprised if the huge rise in the use of soy formula in babies was linked to the beginning of the Type 1 epidemic.
Thanks Jenny for that insight. I guess the same could be said for dairy and the claim that it may have been the cause of Type I.
Did not realize there has been an explosion of auto immune diseases in the last 20 years. I would have chalked it up to better diagnosis.
I don't disagree with you about the soy, but I wouldn't let wheat off the hook, either.
It kills me to see people sticking a bun or cracker in the hand of a teething infant. Of course, I did the same thing before I knew better, in fact, I made gobs of bread with a bread machine when my son was very young. Many bread machine recipes called for "hard winter wheat" flour and added "vital wheat gluten" (the high gluten content boosts fast rising and dough performance).
I'm sure other environmental factors contribute (including rampant Vit D deficiency, higher sugar/fructose consumption, excessive omega 6 fatty acids, etc.), but the wheat itself is partly to blame, too.
Americans and many other populations around the world increased their wheat gluten consumption dramatically about 20+ years ago when the low fat/high carb diet became the standard advice for all (and pasta consumption took off, too). Wheat derivative ingredients are now ubiquitous in the processed foods that line our store shelves and grace casual restaurant menus so anyone (everyone?) on the SAD has a very high gluten exposure unless they completely avoid prepared foods.
In modern life I don't think it takes much to trigger expression of the HLA genes (more common than previously thought) that predispose to gluten sensitivity and celiac sprue. Gluten sensitivity is even harder to recognize than celiac, because the symptoms may be very mild, often do not include GI issues, and are hard to connect to the gluten-loaded modern diet that is the norm.
New wheat hybrids have been developed to fit industrial food production requirements - high gluten wheat doughs rise faster, therefore make cheaper products. Many people have less issue with the ancient varieties of wheat, like spelt.
Additionally, wheat (and other grains) are no longer sprouted or fermented as they were in earlier times. Sprouting/fermenting activates enzymes that neutralize the phytic acid (which is an anti-nutrient and binds minerals and potentially contributs to mineral deficiencies). True sourdough bread (a la "Little House on the Prairie", not the sourdough-flavored commercial bread that most people are familiar with) is a very slow and highly variable food and isn't profitable in a high production context. Long fermentation breaks down the gluten protein into peptides that are somewhat less likely to trigger problems, especially if other inflammatory factors aren't present.
Industrial commodity wheat also isn't freshly ground in many/most cases, so it is likely rancid (one of the reasons food manufacturers love refined flours without the fast-spoiling bran). Bakers who mill their own flour right before using the grain (there are home mills available) know the incredible difference that freshly ground flour makes in their breads and other baked goods.
"Whole grain" is heavily promoted for health (based on shaky epidemiological grounds), but the bran in whole grain also contains some problematic compounds such a lectins. I view the advice to consume "whole grains" with a lot of skepticism. I feel "no grain" is probably far healthier than either whole grain or refined grain. The 10,000 years or less of wheat consumption hasn't been enough time for us to truly adapt to eating a lot of wheat, not when you consider how long humans didn't eat prior to the adoption of agriculture. And the modern wheat versions are probably even less easy for our bodies to handle than the ancient versions.
The bottom line is that wheat, far more than other grains, isn't an inherently healthy food to consume (it certainly isn't essential), especially in the ways we consume it now.
JD,
There has been an explosion in diagnoses of Type 1 in children of the past generation. This is not a diagnosis doctors ever missed as the children end up in the ER.
In the 1950s-1960s Type 1 diabetes was extremely rare. It has become far more common. This is accepted by mainstream medicine, but the explanation is up for grabs.
Re bread. I don't believe that Americans increased their bread consumption over the past decades. We ate bagels, rolls, coffee rolls, pizza, crackers etc all the time when I was growing up in the 1950s. Everyone did. Their parents had too. In fact, most European cultures ate a lot MORE bread in the 19th century because of the inability to store other foods. Bread was the food of the poor. Bread shortages caused riots.
People of European ancestry who couldn't cope with grains probably didn't live to reproduce.
It's the soy that has been added to bread, crackers, etc, etc that I'd fault, not the wheat.
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