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[IP] Nothing but the truth

I received this from a fellow pumper. Pretty interesting.
$$ Nothing But The Truth $$
)February 28, 2001.-- Hoadleygold, Inc. Brent Hoadley, Ph.D.
 The 4 million insulin-using diabetics in the United States are becoming
nothing more than a human population of guinea pigs. They represent the
money tree for 'Diabusiness.'

 In his book 1984, George Orwell wrote about "newspeak.' This is now the
language used by the pharmaceuticals to create billions of dollars in profit
from genetically engineering insulin-like molecules.

When is an insulin molecule a 'foreign' protein? Pharmaceuticals will tell
you the foreign protein insulin source is the pancreas of a pig or cow. When
given names such as Humalog, Lantus or NovoRapid by giant corporations, a
foreign protein becomes a wonderful 'analog' of human insulin. The truth is
all three of these substances are foreign proteins-in some cases not even an
insulin molecule. All could be considered new growth hormones with very
little being known about long term effects. Diabetics need to apply for
long-term guinea pig status.

Over the last 30 years, there have been over 2000 patents approved for
various chemical compounds or processes used to normalize blood sugar
metabolism. This enormous interest is a 30-year ride on the money train
called diabetes. It's also a good insight into the lack of progress in the
treatment of diabetes over the last 70-plus years. We have replaced proven
insulin protocols with less effective insulins.

 In a 1999 U.S. Pat. #5,922,675, related to a "better" basal insulin,  Eli
Lilly Corporation researchers state:
"in order to achieve normal glycemia, therapy must be designed to parallel
as closely as possible the pattern of endogenous insulin secretion in normal
individuals. The daily physiological demand for insulin fluctuates and can
be separated into two phases: (a) the absorptive phase requiring a pulse of
insulin to dispose of the meal-related blood glucose surge, and (b) the
post-absorptive phase requiring a sustained amount of insulin to regulate
hepatic glucose output for maintaining optimal fasting blood glucose.
Accordingly, effective therapy involves the combined use of two types of
exogenous insulin: a fast-acting meal time insulin and a long-acting basal

The '(b)' phase of the above statement is a widely accepted necessary
component to normalize blood glucose metabolism. However, earlier (1996),
Hoffmann wrote in Lilly patent #5,534,488:
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 ideal basal time action, the best parenteral product that fits
this description is commercially available beef Ultralente insulin. Injected
just once per day, it gives a low, steady release of insulin into the
bloodstream without any noticeable insulin peak.

 Beef Ultralente is no longer available in the marketplace because Lilly and
NovoNordisk arbitrarily decided this only-known ideal basal insulin was an
immunogenic foreign protein for some diabetic patients. They said this could
lead to alteration in insulin time action (their words). Even noted diabetes
researcher Irl Hirsch, in a 1993 review of diabetes insulin treatment called
Beef Ultralente the only true basal insulin, with no peak. He also made
reference to Human UL Ultralente as being something less than ideal (my

 U.S. Patent #5,534,488, in discussing  Human Ultralente and Beef
Ultralente, states (1996):
"However, several years of clinical experience led to definite indications
that these products were not identical. In fact, clinical reports indicated
that human Ultralente was faster acting than the beef Ultralente formulation
while pork Ultralente was shown to be intermediate in time action between
the other two species. In clinical practice this has led many physicians and
diabetologists to recommend a twice a day injection protocol for human
Ultralente. In addition, a significant peak of insulin absorption into the
bloodstream is observed about 12 hours after subcutaneous administration.
This phenomena not only diminishes the ability of this product to counteract
the steady basal glucose output of the liver, it also results in
hyperinsulinemia which itself may lead to macrovascular complications.
 The reasons for the differences in time action between human and beef
Ultralente products are not completely understood."

The above patent is for new analogue formulations of human insulin which
more closely mimic basal levels of insulin found in the normal human body.
Beef insulin is also a naturally occurring analogue of human insulin. Lilly
admits that they do not know whether it is the actual amino acid arrangement
of beef insulin or the resulting manipulated beef crystalline structure that
provides the 'ideal basal insulin.'

 In order to speed up approval and acceptance of Human UL Ultralente, the
product was placed before the FDA, the American Diabetes Association
(financed by diabusinesses), and pushed by the pharmaceutical
representatives to doctors because it was just like beef Ultralente without
antibody response. The ADA even made a statement in the Wall Street Journal
in 1992, claiming that all human insulin was just like animal insulin in
activity curves. Recently, the ADA has been forced to recognize activity
curve differences.

Eli Lilly's Ultralente Human Insulin insert (PA6364AMP) states: this product
has a longer and less intense duration of activity up to 28 hours. This does
not imply a peak at 12 hours or the fact that, as stated in their patent,
the product is found to last only 18 hours. Diabetic patients are warned to
be aware of individual patient differences.

 A significant peak at 12 hours and a greater risk of macro blood vessel
damage could put the diabetic patient in harm's way if the UL Human is split
into two doses. That is NOT just like Beef Ultralente.

 Novo Nordisk stated in 1995 U.S. Pat. #5,157,021:
"In the case of Insulin-Dependent Diabetes a frequently used therapy
consists in two daily injections of a protracted insulin preparation, one in
the morning and one in the evening just before bedtime, in order to create a
basal insulin level. Additionally, three injections of a fast acting insulin
preparation are given prior to the principal meals. The disadvantage of this
therapy is that the late injection of the protracted preparation may result
in a dangerously low blood glucose level in the course of the night."

 Does this also point the finger at Human (UL) Ultralente or does it mean
that intermediate duration insulins like NPH and Lente, used as split doses,
are dangerous preparations in the course of sleep hours.

 A fact not widely known is that Human R insulin does not cover the
post-prandial (after meal) rise in blood glucose in the expected manner for
many diabetics. In U.S. Pat. #5,474,978 (1995) Lilly researchers wrote:
"However, this therapy has not yet been optimized. The most rapid-acting
insulin commercially available peaks TOO LATE AFTER INJECTION AND LASTS TOO
LONG  to optimally control glucose levels."

 This admission is made in several patents: "Human regular when deposited
under the skin in a depot reacts too slow to cover post prandial blood sugar
rise in some patients. Secondly and just as important it may last too long."
"LAST TOO LONG" from personal experiences can mean a plateau (or peak) in
the middle of the night. Combine this with an "unawareness", and you have a
recipe for disaster. Perhaps this is the reason for an increase of the "dead
in bed" syndrome, especially among the younger and older diabetics..

Even as early as 1986, NovoNordisk recognized a need for a better
rapid-acting insulin solution. In U.S. Pat. #5,504,188, it is again stated
that "commercially available rapid acting insulins peak too late."

In the past few years a new rapid acting insulin has been marketed by
Lilly-Humalog. NovoRapid has been approved for sale by NovoNordisk in
Europe. Lantus has been approved for sale as a basal insulin. The only
natural basal insulin is beef ultralente.

Aventis Pharmaceuticals, in a press release for the new product Lantus,

"Safety Information:
Human insulin therapy may be associated with hypoglycemia, worsening of
diabetic retinopathy, lipodystrophy, skin reactions (such as injection site
reaction, pruitus, and rash) allergic reactions, sodium retention, and

NovoNordisk, in the announcement regarding NovoRapid.:

"In long-term, large-scale clinical trials, NovoRapid. significantly
improved glycemic control compared to that of soluble human insulin and
significantly reduced the risk of major nocturnal hypoglycemia.

Historically, improving glycemic control with soluble human insulin has been
associated with an increase of hypoglycemia."

 rDNA Human insulin was pushed through the FDA in the early 1980s in a
period of about 5 months. Lilly was a well-known pharmaceutical, with the
only U.S. expertise in insulin production. This product was fast-tracked
through the approval process with the false premise that there were many
diabetics dying from allergic reactions to animal insulins and the
possibility that future supplies of animal insulins would be in decline.
We now see from the above rush to patent new insulins that the human insulin
product so quickly approved was not even equal to the beef and pork insulin
products which have proven safe over a period of 70 years of use. The only
advantage of human insulin is the fact that the product is considerably less
expensive to produce than animal insulins and results in greater
profitability for diabusiness.

The pieces of the human-insulin puzzle slowly being put together as the
truth includes the following:

a) After 17-18 years of human insulin usage, the truth is beginning to
emerge. Human R is NOT fast acting and may have a delayed peak. Human UL
basal is NOT REALLY basal, and two shots to cover 24 hours could lead to
nighttime hypoglycemia and macro blood vessel disease. Intermediate
formulations given as two more shots cause unexpected night-time lows in
some patients. Where's the advantage?-PROFIT!

b) Then we note in a press release the occurrence of rashes, worsening of
diabetic retinopathy, allergic reactions, sodium retention, and improved
glycemic control with soluble human insulin is associated with increased
incidence of hypoglycemia.

In a 1995 Patent #5,422,339, Joslin Diabetes Ctr. States that immune systems
of the patient produce antibodies which interfere with insulin related
function. Human insulin and animal insulin antibodies are an immunological
response to insulin treatment.

Animal insulins were replaced because they were immunogenic to a small
percentage of the insulin-taking diabetic population.  Now, it is admitted
that human insulin causes the same problem. Where's the advantage? PROFIT!

c) The naming of Humalog was meant to indicate it is a human insulin
analogue, and somehow better than pork or beef. Considering the A and B
chains of human insulin have 51 amino acids, there are millions of analogues
of this growth hormone that could be considered using natural amino acids.
Remember beef and pork are just analogues of human insulin. Where's the
advantage? PROFITABLE new insulins with no proven record of better control.

d) An Aventis product-Lantus--has added 2 additional amino acid molecules
(glargine), for a total of 53 amino acids, and essentially have created a
foreign growth hormone structure. ATTENTION DIABETICS1 Step right up. Be a
human guinea pig for determining long term results.
There is no proof it is better than Beef UL. Even plant scientists worry
about the impact of creating new hormones.

e) The patent examiners sit on one side of government, knowing the truth
about new and "old" insulin products. The FDA is lied to about the efficacy
of new insulins while the diabetic patient is put in harm's way. Meanwhile,
profits for diabusinesses increase.

f) Once a 'wonderful new insulin' hits the marketplace, the pharmaceutical
companies-with high-priced public relation campaigns-convince the ADA,
doctors, hospitals, noted clinics and patients that the diabetic life will
now be "much better." All of these, except the diabetic patient, often
benefit from an inflow of corporate dollars in the form of contributions,
advertising, research grants, sponsorship, and other unqualified perks.
Therefore, their promotion and/or endorsement of a 'wonderful new insulin.'
is not necessarily unbiased or fact-based, but is certainly profit-driven.

Lilly's answer to problems has always been to blame the patient and/or blame
the disease. The perfect insulin has not been invented. Any problems
suffered by a diabetic on human insulin protocols will be attritubed to the
patient's noncompliance and/or negligence.

Proven protocols for some diabetic patients were destroyed when animal
insulins-PARTICULARLY BEEF IN ALL FORMS-were taken off the market.

It is not just coincidence that there has been an increase in diabetic
deaths, increased emergency room visits, increased automobile accidents due
to hypoglycemia, and increased "dead in bed" syndrome. A large percentage of
the diabetic population could maintain lower glycohemoglobin levels (A1c's),
have less incidence of hypoglycemia and have lower maintenance costs using
animal insulin protocols.

Let us have all the tools available, including the analogues of beef and
pork insulin. Let the doctor-patient relationship work out the best
protocols for each individual to obtain an acceptable A1c.

    Brent Hoadley, Ph.D.
    Plant Scientist and Inventor
    Diabetes Survivor, 45 years

Author's note: Now the FDA and the pharmaceuticals use the threat of
BSE-infected cattle to scare patients away from adding beef insulin to their

In an article related to Bovine Vaccines Currently Safe, the FDA stated they
could not infect susceptible mice with BSE after exposure to pancreas and
skeletal muscle tissue of infected cattle. BSE is found in central nervous
system tissue.

If you really want to consider risk, think about gelatin, which is a
component of many foods and drugs we consume daily.  This is a polygelic
product of ground up cattle remnants, some of which may even be used in the
broth of bacterial or yeast brew which produces "human insulin."

During any process involving high pressure liquid chromatography, all
insulins should be totally safe.

Ask any diabetic whether he would rather die tomorrow because he can't take
human insulin or face the "fake risk" of BSE and the educated answer would
always be free choice of protocols. Profit again drives diabetic patients to
stay away from the proven product.
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