"We're from the government and we're here to help." -----Original Message----- From: Steven Foss [mailto:foss_ste...@yahoo.com] Sent: Sunday, February 22, 2009 1:31 PM To: silver-list@eskimo.com Subject: CS>B-6 and the FDA
Hi Silver List, The FDA did not say that one form of B-6 will become an illegal drug (LSD, Cocaine, Anabolic Steroids). Rather, one of "Big Pharma" has applied for a received approval and this one from will be only available as a prescription as a legal drug when approved for marketing. A North Carolina-based firm called Biostratum began manufacturing pyridoxamine-based drug called Pyridorin designed to prevent the progression of diabetic nephropathy (kidney disease). The company then petitioned the FDA to declare pyridoxamine a "new drug," clearing the way for them to hold an iron-clad monopoly on its sale. NephroGenex, a biotechnology company developing treatments for kidney disease utilizing molecular profiling, entered into licensing agreement with BioStratum Incorporated that acquires commercial rights to Pyridorin(TM) (pyridoxamine dihydrochloride) for diabetic nephropathy. http://www.nephrogenex.com PyridorinT has demonstrated a significant treatment effect in slowing the progression of diabetic nephropathy in two Phase 2 clinical trials, and it has been awarded Fast Track status by the FDA. PyridorinT is one of the leading drug candidates in advanced clinical trials for diabetic kidney disease.NephroGenex has recently initiated a new Phase 2b clinical trial (PYR-210) that is evaluating the safety and efficacy of PyridorinT in slowing the progression of nephropathy in patients with type 2 diabete The FDA agreed with Biostratum, and declared this most popular form of vitamin B-6 to indeed be a "new drug," using the argument that its medical qualities had been under investigation for years before it was ever used as a nutritional supplement under the DSHEA, which ironically was enacted in 1994 in order to protect nutritional supplements from excessive FDA regulation or removal from the market as drugs. Not to worry, said many observers in the nutritional supplement industry. After all, there are two other natural forms of vitamin B-6 that can still be used in multi-vitamin formulations. The problem is, another drug company has already petitioned the FDA to declare the second most popular form of B-6, pyridoxal 5'-phosphate, which is also called P5P, a "new drug," apparently for the very same reason pyridoxamine has been declared a drug, i.e., it's purely medical qualities have been investigated long before it was ever used as a nutritional supplement. How much longer until the third most popular natural form of B-6, pyridoxine will be declared a "drug"? You can bet your boots the pharmaceutical companies are racing to get in on the FDA's new fast-track for turning B-vitamins into drugs. If that is the case, then B complex formulas and Multi Vitamins will either have to remove B-6 from their formulations or become Rx drugs. There is a petition at https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id =245 You should also write and call your Congressmen and Senators immediately, and tell them you don't want the FDA banning any more vitamins by turning them into "drugs." Steve PS. There is less than 30 days to let the EPA know how you feel about regulating Colloidal Silver. See, http://colloidalsilversecrets.blogspot.com/2009/01/updated-contact-informati on-for.html for information where and how to post. -- The Silver List is a moderated forum for discussing Colloidal Silver. Instructions for unsubscribing are posted at: http://silverlist.org To post, address your message to: silver-list@eskimo.com Address Off-Topic messages to: silver-off-topic-l...@eskimo.com The Silver List and Off Topic List archives are currently down... List maintainer: Mike Devour <mdev...@eskimo.com>
