tag:blogger.com,1999:blog-16774010.post8909143989727084091..comments2024-01-25T17:58:34.297-05:00Comments on Scott's Web Log: ADA Scientific Sessions: Biodel Announces Regular Insulin Beats AnalogsScott Shttp://www.blogger.com/profile/03286529314567223617noreply@blogger.comBlogger8125tag:blogger.com,1999:blog-16774010.post-55716569642119320532007-10-04T11:57:00.000-04:002007-10-04T11:57:00.000-04:00Amalas, the fact of the matter is that its REQUIRE...Amalas, the fact of the matter is that its REQUIRED by the U.S. Food and Drug Administration for approval, AND the study must be done in comparison to Regular insulin, not an insulin analog. There was some debate at the ADA Scientific Sessions in Chicago this year about whether Regular should be considered the current "gold standard" of treatment, but for the time being, that remains the case.<BR/><BR/>The company may choose to conduct additional testing in comparison to Humalog or Novolog, but that is optional, not required by the FDA.Scott Shttps://www.blogger.com/profile/03286529314567223617noreply@blogger.comtag:blogger.com,1999:blog-16774010.post-84868629402175060892007-10-04T11:43:00.000-04:002007-10-04T11:43:00.000-04:00I find that study to be mostly worthless. Why com...I find that study to be mostly worthless. Why compare VIAject(TM) to Humulin(R) R? I would much rather see a study that compares VIAject to say, Humalog or Novolog.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-16774010.post-17995325607754420762007-06-25T13:12:00.000-04:002007-06-25T13:12:00.000-04:00Wow this post was really eye opening. For my mast...Wow this post was really eye opening. For my master's in political economy I had to write full academic reviews before any term paper - I can't believe the ADA doesn't have as tight controls. <BR/><BR/>As a newly diagnosed Type I, I agree that the information on the ADA's website is awful. It gives you just the bare minimum of what you need to know and it seems that in the medical community doctor's/ researchs are too affraid to make the patient "feel bad". It's like there is something wrong with those of us who want the tightest control possible.Wingmanhttps://www.blogger.com/profile/00867789638868481704noreply@blogger.comtag:blogger.com,1999:blog-16774010.post-37042298965984433782007-06-25T08:48:00.000-04:002007-06-25T08:48:00.000-04:00Thank you all for your feedback. To Jenny, I whol...Thank you all for your feedback. To Jenny, I wholeheartedly agree with you on regular insulin, and the best logic is there's a reason that's what is in the body to begin with! You're right about press releases, however, to comment on Viaject, I should note that it is not dramatically faster than rapid-acting analogs (in fact, its only minutes faster, but as one analyst said, in this business, time is money). However, the fact that it is from a structural standpoint, identical to regular human insulin gives it a big advantage over analogs which are neither human, nor insulin. It will be interesting to see how this plays out!<BR/><BR/>Barry, I certainly agree with you re: the ADA, and that also applies to Melody's comment as well. The ADA's credibility among patients is pretty low to begin with (except newly diagnosed patients, unfortunately), but I think the issue of duplicative research is harming their reputation within the scientific community as well. I just take issue with them when they refer to themselves as the diabetes authority, yet they cannot even police the articles that appear in their own publications! I have traditionally supported JDRF over the ADA anyway (their current leadership has made me rethink that), but its really unfortunate when so many patients and doctors alike look to that organization for leadership. Oh well!<BR/><BR/>Chrissie, I completely agree re: older medicines over newer medicines that have proven themselves. Personally, I believe I attained control that was comparable (if not better) using animal-derived, purified insulins, and did not suffer from issues with hypoglycemia unawareness at any point when I used them, but have had continued problems with synthetic "human" insulin which is blamed on the patient for not correctly counting carbs or some other issue. The reason I find Biodel's Viaject attractive is that it is structurally identical to regular human insulin. The big deal is that none of the ingredients are new invention, rather they are already approved by the FDA for use in other applications, so we're not talking about untested substances here! Biodel is about to go public, and I would consider an investment in this company ... although they could ultimately be acquired, shareholders will likely get a rich premium for their shares!Scott Shttps://www.blogger.com/profile/03286529314567223617noreply@blogger.comtag:blogger.com,1999:blog-16774010.post-27389308411675110152007-06-25T07:51:00.000-04:002007-06-25T07:51:00.000-04:00When the ADA "morphed" from a patient-focused char...When the ADA "morphed" from a patient-focused charitable organization to a charitable CORPORATION, the mission changed. To remain "a player," the ADA had to please it "shareholders" (contributors and advertisers) rather than diabetic patients.<BR/>The "new mission" has become perpetuating the organization rather than serving and advocating for patients.<BR/><BR/>MelodyAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-16774010.post-51796254860391335912007-06-25T02:31:00.000-04:002007-06-25T02:31:00.000-04:00YES, sifting through all the junk is enough to fin...YES, sifting through all the junk is enough to finish you off! About the new insulins - don't get me wrong, I like progress, but I also prefer an older medicine over a newer medicine so that it has proven itself over time. So often one hears, "ooops this medicine wasn't quite as safe as we thought!"Chrissie in Belgiumhttps://www.blogger.com/profile/02556806942193998413noreply@blogger.comtag:blogger.com,1999:blog-16774010.post-28034284705877421112007-06-23T22:47:00.000-04:002007-06-23T22:47:00.000-04:00The ADA is a Top-Heavy organization loaded with to...The ADA is a Top-Heavy organization loaded with too much Politics and Buracracy.<BR/>What kind of good can develop from such a place?BetterCellhttps://www.blogger.com/profile/13667917240368089110noreply@blogger.comtag:blogger.com,1999:blog-16774010.post-9682526647124728972007-06-23T18:36:00.000-04:002007-06-23T18:36:00.000-04:00Scott,Excellent point about the ADA's failure to c...Scott,<BR/><BR/>Excellent point about the ADA's failure to consider previous research.<BR/><BR/>Even worse, in my opinion, is the way that in its journals the ADA funds the publication of well-conducted research that makes it very clear how bad the advice they are giving patient really is, but they ignore it and keep on giving out the "carbs are good for you", "tight control means blood sugars of 180 mg/dl 2 hours after a meal" advice that is causing blindness, nerve damage and kidney failure. <BR/><BR/>==<BR/>I'd read the PR release about VIAJect yesterday, too--that's what you copied in your blog. I hope this stuff is real. PRnewswire releases aren't entirely credible as they are written by the company's marketing department and may just be an attempt to manipulate the company's stock. <BR/><BR/>But I am a big fan of R because the strange responses I've had to two different analogs make me concerned that they aren't good for my body.<BR/><BR/>My concern is that this R+GRAS stuff will be as expensive or even more expensive than the analogs and that, worst case, this kind of formulation may cause the cheap R to go the way of UL (which worked very well for me.)<BR/><BR/>It would be nice if it worked, though. OTOH, I can see some problems with a much too fast insulin too. What I like about R is that it lasts over enough time that it eventually meets up with my food rather than hitting all at once with the potential of missing it.Jennyhttps://www.blogger.com/profile/17384082448952856117noreply@blogger.com