$$ Nothing But The Truth $$

      • ©February 28, 2001®-- Hoadleygold, Inc. Brent Hoadley, Ph.D.

        • Brent Hoadley's Lilly, Novo, Genentech and
          other Insulin Patent Research and Findings

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

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 insulin.”

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

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 words).


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, stated:

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 edema.”

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

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 attributed 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 protocols.

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.

Brent Hoadley,patents,accidents, beef insulin, pork insulin, animal insulin, diabetes, diabetic, FOX, Diabetes, IDDT, Hypoglycemia Unawareness, Synthetics, USDA, FDA, DIF, Suzan Kawulok, Glenn Selig, CP Pharmaceuticals, class action, law suit, Litigation Diabetes, Lilly, Glucose, Foundation, FDA, Diabetics, DIABETES-MELLITUS, Diabetes, CP, Accidents, Videos Humulin, Iletin, USDA Fees, Beef insulin, BSE, Brain, Tamblyn, FDA