The Weeks Clinic
Report: Biogevity Spray Product Test Results
Date: 8-1-99
To:
Andrew Kochan, M.D.
Dear Andrew,
Greetings!
I told you that I
would get back to you with the results on my pilot study of the
Neways spray product when the company was prepared to release the
results. They have just now authorized me to do so and for your
personal use and for the sake of your patients, I wanted to get
these results to you right away.
As you know, I have been an early advocate for the use of HGH and
over the years have rigorously reviewed the anti- aging
literature on HGH analogues, secretagogues, homeopathics,
sublinguals and precursors. I had concluded (and advised my
patients accordingly) that only the injectable HGH was beneficial
(according to conventionally accepted anti-aging parameters such
s IgF.1 and changes in body morphology). I discouraged my
patients from using non- injectable alternatives to the Eli Lilly
product which most of us in the anti-aging field consider to be
the gold standard.
All that has changed now.
As you will see below, the pilot study I have done demonstrated
significant benefit and was met with very strong patient
satisfaction, Now I feel that I can offer both the injectable Eli
Lilly HGH to those who can afford it and offer the Biogevity
spray product to those who either can't afford injectable HGH it
or simply prefer the spray to the injection method. This is good
news as it makes the anti-aging benefits of HOH available to the
average person who can't afford the high price of the injectable
HGH.
Here is the study design and the results.
Please critique this and let me know your opinions.
PILOT STUDY DESIGN:
I looked at the changes in over 2 months of IGF-1 levels as well
as of chance in body morphology (changes in weight, body fat and
lean muscle in absolute and % numbers) in 44 patients of mine
using the Biogevity Spray.
The studies went quite well with only one out of 44 people not
completing the trial. (This is a very low number of cohort
dropouts and attributable I believe to the beneficial qualities
of the product and the test subjects' perceived loss from
dropping out. Note that the only drop out was also the youngest
member of the study.)
The study went quite well from a design point of view. I think
that we have results worth publishing. To be specific, the
product proved beneficial with significant increase in IgF-1
levels, the % weight loss and the % fat loss. As you can
appreciate, these changes represent major decreases in risk
factors for these patients and please me considerably. This is
anti-aging at it's finest.
Of note also is that NO ONE went out of the normal range which
speaks to the lack of potential for toxicity at the 2 sprays
three times a day dosage. No one reported ANY adverse side
effects. Therefore, the products appear both safe and beneficial
(objectively and subjectively) according to my pilot studies.
You will note as well that I chose to report the changes in %
changes, which is a far more precise and informative method than
simply focusing on the absolute changes. Who cares if a 250-pound
person loses 5 pounds of fat - that could be water shifting or
increased 3' spacing for reasons having nothing to do with
Biogevity. However, when we took at % fat changes or % weight
change, the numbers become more meaningful as the absolute
weights becomes less significant. All patients in the study
swapped fat for lean muscle. That means they preferentially
burned fat while sparing their muscle tissue. This is the goal of
anti-aging medicine. Note that the weight loss measured in pounds
is modest while the % drop in body fat is impressive. What
happened? Of course, these people GAINED muscles. This is an
important point to stress to your patients: weight loss is not
the critical parameter to watch. % body fat is. Remember, as
muscle weighs 3 times more than fat (the latter being hydroscopic),
some of the weight change in these people are actually an
understatement because, though they may not have lost as much
weight as would be expected, they did convert significant fat
into muscle. Therefore, by shifting weight from fat to muscle,
these people aided to a very significant degree the health of
their vital tissues such as heart, lungs and musculature. What
your patients will notice, however is more tangible: they fit
into their clothes better. Andrew, ask your wife. She will
confirm that weight is never the significant issue. % of body fat
and % of muscle are the critical measurements since they
determine SHAPE. Not surprisingly, most women whom I treat for
obesity in my Bariatrics Clinic don't care what they weigh as
long as they fit into a size 6 dress again.
As scientists, I want you to
review this study critically. In doing so, you will note a few
areas which may be criticized from the study design point of view.
First of all, 20-22 people in a study, while excellent for pilot
studies, is small for statistical significance. An N of 60 would
be more interesting. (I am planning a follow-up study with 30
males and 30 females in a double-blinded clinically controlled
trial).
I also suspect that the results might be skewed to the positive
by the fact that these people were not randomly chosen off the
street. They were all patients of mine who, by virtue of self-selecting
to my care at the Weeks Clinic, demonstrated that they have all
made life-style commitments towards health (including weight loss).
It would be more interesting from a marketing point of view to
place an ad and thereby find people off the street who have NOT
yet committed to healthy lifestyle habits. However, I anticipated
this factor, so I designed into the study the requirement that
the patients do nothing differently while in the studies such as
no extra workouts, no change in diet, etc. Not surprisingly, all
my patients reported that they, in fact, as requested did nothing
out of their ordinary routine. Therefore, I think we are looking
at "drug" effect and I conclude that the study really
tells us something of value.
Another caveat is that the Tanita machine, which made the body
morphology measurements, is very sensitive. What that means is
that if, for example, the % change in fat is only I digit change
(i.e. 23% down to 22% over a month's time) that can represent 5%
of someone's fat. This sounds large when in fact it might be
misleading. In the next study, I would correct for possible
artifact by having a research assistant do the Tanita body
morphology measurements 3 times and then plot the average of the
three results. Since I did all the measurements myself, I took
the time only to measure them once. The reliability of the Tanita
machine is not in question (it being the state of the art for BMI)
but three passes are better than one (just as your doctor ought
to take you blood pressure three times and average those values
for a more accurate measurement).
Finally, you both have asked me if this Biogevity product is as
beneficial as the Eli Lilly HGH that we are all using in our
practices. I can't answer that question yet. Those studies where
we compare Biogevity spray directly to the injectable HGH may be
done in the near future and should be very interesting. What I
can say now though, is that the Biogevity spray WORKS and that it
is far less expensive than the injectable HGH. That is great news
for our patients.
Summary
All that aside, this pilot study
impressed me and being skeptical by nature, I find myself
surprised at my enthusiasm for this spray product. The option
before us now is to offer the benefits of FIGH at a cheaper and
very effective form for our patients. The world's literature is
compelling responsible physicians to attend to anti-aging
measures for our patients and HGH is the crown jewel in any
physician's black bag.
These pilot studies demonstrated that the spray option works.
1) We see significant yet not excessive IgF-I levels indicating
that HOH is being stimulated to "youthful" levels.
2) We note significant loss of "toxic" body fat.
3) We appreciate an increase in lean muscle.
4) We note an overall loss in weight.
5) I can report that patient compliance and enthusiasm for this
product is gratifying both from the scientific and the clinical
point of view.
Let me hear from you re:comments on this study.
Best Wishes, Bradford S. Weeks, M.D.
Medical Director,
The Weeks Clinic Anti-Aging Division