| Subject: |
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A message from Brent Hoadley, PhD Part 1 |
| Name: |
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Claudia French RN, LPHA |
| Date Posted: |
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May 21, 07 - 2:44 PM |
| IP Address: |
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72.186.110.244 |
| Email: |
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cfrench180@tampabay.rr.com |
| Website: |
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http://imva.info/diabetes.shtml |
| Message: |
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Below is the message I received today from Brent Hoadley, author of the book "Too Profitable to Cure" and a long time diabetic and advocate for the availability of natural insulins.
If a diabetic patient ONLY has his doctor for guidance, the pharmaco/medical line is ALL the patient will ever hear. A friend of mine told me this weekend he has never talked with a diabetic who, after brief conversation, doesn’t admit that he is less than satisfied with today’s treatment protocols. For example, a fellow diabetic may answer “How’re you doing?” with the succinct, “Fine.” A bit more conversation, however, elicits information that “the **** pump clogs” or “my blood sugars keep going out of site at night” or some other indicator that all is not truly “fine” and his doctor won’t listen.
This weekend I took the time to review a couple of important documents in my “library.” The 1982 Lilly application (to FDA) for approval of human insulin was truly an eye-opener. Nowhere in this document was there any indication of “NEED” for this product; in other words, they had new “science” and sought approval so they could explore ways to exploit it, with approval already under their belt. The NDA 18-781/S-036, S-033 revealed how few humans were involved in the pre-approval process. The most important feature seemed to be they were able to create a blood-sugar-lowering molecule through this process and claim it was human insulin—just like the body makes.
Compare this with what the FDA is being encouraged to use today as they consider generic rDNA insulin production (bioequivalency tests). If the guidelines being requested today by the market leaders were retroactive, the product they have foisted upon us for more than 20 years would not be approved.
Other interesting material, quoted next, are remarkable in the tolerance demonstrated by the reviewers. Again, they were being asked to participate in a cutting-edge advance in science and had (perhaps) inadequate tools, knowledge or experience to perform with expertise. From the NDA comes this:
HI, however, is prepared from E.coli K-12 into which genes specifying human insulin A and B chains have been introduced by recombinant-DNA techniques. Chains are purified from bacterial lysates and permitted to associate, forming human insulin. This is the actual wording used in the application. Doesn’t it seem strange that our well-being and/or our lives are predicated on the assumption that the A and B chains ARE PERMITTED TO ASSOCIATE, and will do so correctly. There was no technology to prove that the “proper association” occurred; scientists relied on “scientific studies” that showed the created HI did all the things that pancreatic pork insulin did—empirical studies were extrapolated to PROVE that the A and B chains were properly configured after this association. Today’s literature indicates that direct scientific proof is still unavailable, and that there are at least 15 locations where disulphide bridges can be formed—each, perhaps, providing an analog with unique properties that can only be “defined” through indirect observation.
Another direct quote: “The x-ray crystallographic studies (IND 24485) showed that the diffraction patterns of human insulin produced from human proinsulin are similar to those of pancreatic human insulin as well as of human insulin produced from combination of A and B chains. Although the authors claimed that the two were identical, the photographies in that article are not clear enough to confirm it. However, most likely the structure of human insulin derived from proinsulin is the same as that produced from chain combination.” Does this indicate to you that the reviewing “expert” was not totally convinced, but because the technology was so new felt he could qualify his opinion with “MOST LIKELY.” The terminology itself—“most likely”—disappears from subsequent consideration, and the “identical” issue became the accepted nomenclature.>
cont'd in part 2 |
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