tag:blogger.com,1999:blog-16774010.post52071871597129116..comments2024-01-25T17:58:34.297-05:00Comments on Scott's Web Log: More Exposure of Trouble at the FDAScott Shttp://www.blogger.com/profile/03286529314567223617noreply@blogger.comBlogger6125tag:blogger.com,1999:blog-16774010.post-48583439298334989502008-08-27T12:14:00.001-04:002008-08-27T12:14:00.001-04:00Scott—As you know, much of this problem with the F...Scott—<BR/><BR/>As you know, much of this problem with the FDA had its early beginnings in the journeymen politicians left over from Tricky Dick in the early 1970s. They ended up as henchmen, responsible for all this grief that is firmly rooted in the Reagan administration. Trickle-down economics was just THAT for the middle class—a trickle. At the same time, Reagan employed these henchmen to de-regulate as many business/regulatory systems as possible. <BR/><BR/>The best example for many of us who are diabetic is the FDA’s looking the other way thanks to the likes of Henry Miller and Vice President George Bush (Sr.) when Lilly’s new rDNA insulin was approved. Of course, there was a gentleman named Donald Rumsfeld, who was a G.D. Searle executive, and (contemporaneously) saw HIS golden opportunity to bring us all the neurologic toxin aspartame, better known by diabetic and weight-control enthusiasts as NutraSweet. These two products alone, approved by the FDA, have probably killed more people than any terrorists will ever kill in the U.S. Add to that the chronic disease symptoms that these products exacerbate and extend, and you have a double whammy (can you say ‘profit-profit-profit’) CAUSED by de-regulation and politicization. It was no fluke that Dan Quayle, tied to Indianapolis and Lilly, was selected to be George H.W. Bush’s vice president. As you aptly pointed out, the present (Bush Jr.) leader has also done everything possible to de-regulate the regulatory guidelines used by our FDA. This also serves the Republican party, when they claim that ‘government can’t do the job, it needs to be done by private/corporate structures.’ So far, Bush’s administration has done nothing but sabotage regulatory with asinine appointments and non-scientific ideologies. <BR/><BR/>Whether or not embryonic stem-cell research will lead us to a cure . . . just think how much further along we would be in this determination if roadblocks had not delayed the research for the past 8 years. The Thoreau-FDA site which you reference is a very good starting point for all of us to secure our bearings and support those in middle and lower ‘management’ positions at the FDA—you know, those civil servants who actually seek to SERVE. This debacle could be fairly titled, “Follow the money.”<BR/><BR/>--BrentAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-16774010.post-65695749021596177372008-08-27T12:14:00.000-04:002008-08-27T12:14:00.000-04:00Scott—As you know, much of this problem with the F...Scott—<BR/><BR/>As you know, much of this problem with the FDA had its early beginnings in the journeymen politicians left over from Tricky Dick in the early 1970s. They ended up as henchmen, responsible for all this grief that is firmly rooted in the Reagan administration. Trickle-down economics was just THAT for the middle class—a trickle. At the same time, Reagan employed these henchmen to de-regulate as many business/regulatory systems as possible. <BR/><BR/>The best example for many of us who are diabetic is the FDA’s looking the other way thanks to the likes of Henry Miller and Vice President George Bush (Sr.) when Lilly’s new rDNA insulin was approved. Of course, there was a gentleman named Donald Rumsfeld, who was a G.D. Searle executive, and (contemporaneously) saw HIS golden opportunity to bring us all the neurologic toxin aspartame, better known by diabetic and weight-control enthusiasts as NutraSweet. These two products alone, approved by the FDA, have probably killed more people than any terrorists will ever kill in the U.S. Add to that the chronic disease symptoms that these products exacerbate and extend, and you have a double whammy (can you say ‘profit-profit-profit’) CAUSED by de-regulation and politicization. It was no fluke that Dan Quayle, tied to Indianapolis and Lilly, was selected to be George H.W. Bush’s vice president. As you aptly pointed out, the present (Bush Jr.) leader has also done everything possible to de-regulate the regulatory guidelines used by our FDA. This also serves the Republican party, when they claim that ‘government can’t do the job, it needs to be done by private/corporate structures.’ So far, Bush’s administration has done nothing but sabotage regulatory with asinine appointments and non-scientific ideologies. <BR/><BR/>Whether or not embryonic stem-cell research will lead us to a cure . . . just think how much further along we would be in this determination if roadblocks had not delayed the research for the past 8 years. The Thoreau-FDA site which you reference is a very good starting point for all of us to secure our bearings and support those in middle and lower ‘management’ positions at the FDA—you know, those civil servants who actually seek to SERVE. This debacle could be fairly titled, “Follow the money.”<BR/><BR/>--BrentAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-16774010.post-36869005289796300062008-08-27T11:07:00.000-04:002008-08-27T11:07:00.000-04:00Lilly was returning to the drawing board to develo...<I>Lilly was returning to the drawing board to develop a Lantus-like product, but even under ideal circumstances, it will be years before any such product is introduced.</I><BR/><BR/>I would suggest that Lilly direct its research toward finding a medicine to cure STUPID. I would then recommend that their corporate leaders comprise the base for clinical trials. If they could CURE corporate stupidity, they might once again be a leader in diabetes healthcare.<BR/><BR/>Like a dog chasing its tail, they seek to only to embrace "new technology" to find that next great blockbuster. All they truly have to do is look in their own CORPORATE ARCHIVES. Per their own research scientists and patent-holder, [patent #5,534,488]:<BR/><BR/>"The ideal insulin formulation to deal with this basal glucose output would be one that resulted in a slow, steady infusion of insulin into the bloodstream that matched the low level of glucose output from the liver. In terms of this <B>ideal basal time action</B>, the <I>best parenteral </I>[non-oral administration] <I>product that fits this description is commercially available beef Ultralente insulin.</I> Injected just once per day, it gives a low, steady release of insulin into the bloodstream without any noticeable insulin peak."<BR/><BR/>Lilly is spending untold amounts of money and inexcusable time delays to re-invent the wheel. They HAD the 'gold standard' insulin for basal control, it WAS commercially available--and they TOOK IT AWAY FROM US! How smart is that? Indeed--they need a pill for CORPORATE STUPIDITY.<BR/><BR/>Lilly might also take note that this NATURAL INSULIN PRODUCT, when highly purified, would not need further testing or FDA approval. <BR/><BR/>Couple this with the fact that they could literally name their price (up to a point), because it is generic, those pharma/insurance 'selector' groups would see this as a huge price advatage over analog pricing. In fact, if the GENIUSES at Lilly wanted to, they could probably add a vitamin/supplement, creating a patented product that would gain further price advantage. For example--consider what BAYER just did with their low-dose aspirin. They added a phytosterol. Though 'aspirin' was not patentable, I expect their new heart-friendly product is patent-protected. Think what a low-dose insulin with a supplemental bG moderator could do for the diabetic population and the corporate bottom line.<BR/><BR/>Yes indeed, I think Lilly's leaders could use a high-dose pill to reduce STUPID.<BR/><BR/>--MelodyAnonymousnoreply@blogger.comtag:blogger.com,1999:blog-16774010.post-17182207903460843682008-08-27T09:55:00.000-04:002008-08-27T09:55:00.000-04:00I agree Jenny ... Januvia is a drug that is overpr...I agree Jenny ... Januvia is a drug that is overpriced and far more dangerous, but I think the issue of corruption at the FDA is simply undeniable in whatever case. Its time for radical reforms, the question is whether anyone in Washington is really listening. Whose bright idea was to add tobacco to the FDA's responsibilities? I think splitting food and drugs would be a better decision, not adding to their responsibilities, but instead we see more of the same, which is indicative of a much larger problem with corporate-owned influence.Scott Shttps://www.blogger.com/profile/03286529314567223617noreply@blogger.comtag:blogger.com,1999:blog-16774010.post-6183688754007938162008-08-27T09:47:00.000-04:002008-08-27T09:47:00.000-04:00Unfortunately, all this negative press about the 6...Unfortunately, all this negative press about the 6 cases of pancreatitis linked with Byetta will cause MORE prescribing of a far more dangerous drug, Januvia.<BR/><BR/>Dr. Mark R. Goldstein who publishised a letter about this in Annals of Internal Medicine (<A HREF="http://www.annals.org/cgi/eletters/147/6/386#33297" REL="nofollow">Read it HERE</A> estimates that <B> Januvia is causing 30,000 excess cancer deaths a year.</B> But because the only cancer tests the FDA requires do not track human cancers longer than 1.5 years and hence did not track the long term effect of blocking the protease, DPP-4, which is essential to killing metastasizing cells, these excess deaths will not even be linked to Januvia.<BR/><BR/>The FDA's tests only look for drugs that cause cancer in the test tube by damaging DNA or in rodents, not cancer caused by turning off cancer-preventing mechanisms. The latter is what Januvia does. <BR/><BR/>And Januvia is the single most heavily promoted non-psychiatric drug in the U.S. right now and the one with the most new prescriptions.<BR/><BR/>Byetta is a LOT safer in contrast, not to mention more effective.Jennyhttps://www.blogger.com/profile/17384082448952856117noreply@blogger.comtag:blogger.com,1999:blog-16774010.post-11564692594463852442008-08-27T09:18:00.000-04:002008-08-27T09:18:00.000-04:00Good reporting, Scott. While Byetta may or may not...Good reporting, Scott. While Byetta may or may not be headed for more serious problems, the MEAT of the problem is the flawed FDA, and its equally flawed AE reporting system.<BR/><BR/>Thoreau-FDA is to be commended for shining the light on systemic failures within the agency . . . but the public is asleep. As the pre-emption (for medicines) debate is heating up, the public MUST WAKE UP. The fox has--for way too long--been in charge of the henhouse.<BR/><BR/>Thanks for blogging and keeping us informed.<BR/><BR/>--MelodyAnonymousnoreply@blogger.com