That's great, you know about Type I diabetes, doesn't mean you know a thing of which you claim regarding the business sect in research. If anything is ********, it's your complete ignorance regarding the pharm industry.
I'm calling you out. Just because someone with experience disagrees with you doesn't mean "they don't know a thing" about pharma-- quite the contrary, in fact. Who was your employer. Place and time of employment. See how it's easy to throw around accusations? While were at it, lets talk about your friends/contacts in the industry. What's their positions? Business development? Market research? Marketing? Clearly NONE of them are from the research side of things. I know Merck, Lilly, and Novartis R&D firsthand. While the business development side of things tends to imagine control over pipeline research, it's not how it's done lab-side. Business development only grabs onto projects that are in the hit-side of things, but even there most projects stall in the hit to lead to due poor PK/PD and ADME. Upper management only takes note during preclinical.
As I said before, all possible angles are looked at during R&D, especially nowadays where big pharma isn't afraid of biologics. Hell, even combichem has finally gotten the boot. Product development is not some strict delineation of therapy types. While we're on that topic, I'm also calling you out on your total scientific ignorance. You claim to know something, yet keep spewing this "cure" nonsense. More below.
I didn't even read through your comment, it was right out of a high school biology text book.
OK. I get it. The real reason you didn't "read" it is you didn't like my answer. As I said, right now there's not a feasible "cure" using SM or biologics. If you had any iota of scientific knowledge and/or reading comprehension you'd understand this. But hey, what do I know, I only make drugs for a living. Since your so clearly competent (citation please), let's step up the level of conversation and take off the kiddie gloves, shall we?
There have been many advances, such as infrared blood monitoring devices that require no blood test strips, and have repeated results that are on par with current OneTouch and Bayer systems. I was a part of this study many years ago. Why isn't it on the market? Because no one would need test strips, that's money lost to the pharm companies. Why do you think a OneTouch Ultra test kit costs $19 at CVS, or is free? The strips out of pocket cost $50-100, for a 25-50 vial box.
From what I understand, there were a few issues, but I'm not an expert on medical devices (although those strips are quite neat electrochemical cells):
1) Device size (why NIR is only in ICUs)
2) Light source intensity and range. From what I understand the device sweeps a broad range of spectra at the moment. Near IR excites molecule vibrational rotations, although I have to question whether its actually NIR. Glucose -OH vibrate up near 3000 cm-1, but thats not true NIR which is 14000-4000 cm-1. If they're looking for higher freq overtones, how would this method differentiate between sugars? I see it being quite noisy at best given how ****** FTIR are even in lab settings.
3) Analytical low-level detection thresholds. Your strips are analytical electrochemical masterpieces, as I've said before. In order to get FDA approval you need reproducibility and accuracy, especially in a life critical device.
4) Lack of hypoglycemia patients in the trial
Fortunately, most of the patent apps seem to be from 2001, meaning that there's still some time for market exclusivity. Make no mistake -- if they did get it to work, they would be selling it. Your strip cost would just be averaged out and adjusted to be the unit price adjusted for unit lifetime. Hell, there'd probably be a hefty premium for the convenience. For supposedly understanding the market you seem to know quite little -- it's an intense area of competition, and any device such as that would claim a large share of the market. Companies like Novo or Lilly would jump on such an opportunity, and I know for a fact one of those two has not expressed any interest.
The only recent trial I could find (admittedly with 5 minutes of searching) was from a Japanese study published in Appl Spectrosc in 2006. Were you a part of that?
How about coating the beta-cells in seaweed? Research has shown this to be a highly effective, yet young, advancement in keeping the immune system from attacking the beta cells necessary for insulin. Funding was cut.
I'm sorry, but your lack of knowledge is showing. Immensely. You do not "coat" beta cells in an organism to potentially deliver cells. Assuming for a second that this is actually what you meant.... it would never, ever work. You'd have an immune response from a non-native organism. If you mean orally....
By seaweed, you probably mean a sugar based resin... alginates, agaroses, hyaluronan, chitin, pullan... etc. The thing is, you don't "coat" these cells, even with these sugar resins. Any sort of flow processing or microfludic LBL assembly would kill the beta cells which are already fickle enough as is. You likely meant hydrogels, which are macroporous non-soluble crosslinked resins that behave much in the manner of most SEx resins. The reason why these work? They're biocompatible and (mostly) non immunogenic (I say mostly because even PEG has an immune response, contrary to popular myth); the beta cells are suspending in the um pores in the resin, thus immobilized. The resin is then inject subcu or locally during surgery, and the cells are released by a combination of passive diffusion and/or slow breakdown of the resin. (As a side note, computational passive diffusion for hydrogels suck, even when considering the most basic of brownian motions).
Here's the reason why it's a stupid idea in this case: in either surgical or subcu scenario, you're releasing beta cells either in serum or locally, and since you have an auto immune response, these beta cells too will be cleared by your immune system, just like your native ones. Therefore you'd have to repeat dosage ad infinium, just like insulin. How is this any better than insulin? This is of course assuming the best case scenario -- that these beta cells are yours. If not you'd potentially have dose-limited toxicity from a foreign immune response going absolutely *******.
Recently, Canadian researchers found evidence to suggest Type I diabetes to be a result from a viral infection brought on by a genetic anomaly, very different from the immune system attacking the beta cells necessary for insulin production.
Again... your ignorance is showing, this time about the immune system. How's it any different? The cause is, but the end result is the same. Viral infection WILL induce an immune response... which induces the exact same result of the immune system attacking the beta cells. I don't have time to explain the entire immune system, but please look up Toll like receptors and the IL family, as well as the MHC class of proteins. The immune response is the side effect of the root cause; the immune system is functioning as intended.
I don't know why everyone is so obsessed with modality when it comes to causality. There's many different causes for everything from diabetes to cancer; the observed phenotypes, ala symptoms, are what generally define a disease state. In this case, it's autoimmune destruction of b-cells, which exhibits the phenotype of insulin modulation.
Type I diabetes is polygenic; there's likely many, many genes implicated, although IDDM1 seems to be the primary culprit. HLDA-DQB1 is part of the DQ heterodimer that forms a cell surface receptor. Mutations in this protein obviously inhibit self tolerance, thus allowing these cells to present self-antigens. The immune response machinery recognizes the DQ heterodimer, meaning that any displayed peptide will illicit an immune response. This is the basis for the disease state. Different mutations in antigen presenting heterodimers can induce the same result, and opportunistic viral infection could also ilicit immune response (albeit through a different mechanism), giving the same result.
As a Type I diabetic since 12, and my father since 6, taking insulin is not a "cure". A cure means there is no longer any evidence of the disease in the system, or that further treatments are no longer necessary.
If you actually read what I said before--instead of acting like a child and getting angry that someone disagreed with you--you would have noticed I said EXACTLY this. A cure is not a treatment. Treatments fix symptoms, not the root cause. As I said before, for a disease state such as diabetes, there is effectively no "cure" with todays technology. Using the term "cure" is misrepresentation of the greater complexity in modulating human biology.
As I said before, if you don't want repeat treatments, the only "cure" to genetic diseases (or autoimmune) is to re engineer the original system with genetic modification. That's not currently possible and faces a whole host of technological and ethical challenges which would take at least another 30 years to chew through. I worked in this area for a few years -- if you want to have a more in depth discussion of the underlying science I'm game.
Per month out of pocket costs:
$300 for 5 Humalog pens
$600 for 300 OneTouch Ultra test strips
$75 100/Ml bottle of Lantus insulin
~$200 for syringes for my Lantus insulin and other supplies
That's over $1,000 per month, not counting the Medtronic supplies for my insulin pump (I only use that to monitor my BG's, but I still need to test to ensure the system is properly calibrated, and the pump cost $3000 of which I had to fight Blue Cross Blue Shield to cover as they attempted to dodge it), A1C blood tests, doctors visits, etc.
Hey, don't get me wrong, that does suck, but a lot of your troubles center around BCBS and insurance companies. I know the pain there; to be quite frank they suck. That's another topic for another day in terms of reform, but keep in mind the reason for the cost: science is expensive, and reagents are also expensive. Take a 20L pail of ether: ~$250. Want that building block? $1000/100 mg. How about that cell line? Thousands to priceless. Animals? 12 monkeys for $1.5 million (for a ****** job, too). It goes on and on. Clinical trials? Tens of millions +. Now account for the cost of 40,000+ employees, global manufacturing and distribution, marketing, a 20% preclinical success rate, and low clinical success rate (under 10%), and you have a recipe for high cost.
Those costs need to be recuperated, and the money stockpiled to pay for R&D and operations until the next big drug(s). Factor in VC wanting 300%+ returns in unreasonable timescales and you have a recipe for a fiscal *****torm. Believe it or not but us scientists are on your side -- most are in for the job, not the pay.
It's great you know the medical background of Type I Diabetes, my ex's brother in law is a VP at Medtronic, I have friends in the industry, it all boils down to what the pharmaceutical companies, etc want - money. There is more money in treating diseases than curing. Period.
Again with the "cure" word. Can't you read? Also, I don't consider Medtronic pharma -- they're a device company. Different ballgame entirely. Also read what I wrote above.
I sincerely hope you put down the tinfoil hat and consider the larger economic implications that give rise to the cost.
I appreciate your personal interest in this matter.
It's a bit more than personal interest... it's what puts the bread on the table.
