Threaders - Here's the BioFIT overview. At the end, I offer my own interpretation of a key passage.
(1) Quality Assurance. The Company researches the scientific literature to
determine the mechanisms of action for herbal or botanical products and develops
assays to determine the range of activity for each of the biological functions
the product could affect. The Company then uses its proprietary technology to
evaluate these products based on how they perform in a scientifically selected
battery of functional tests. If the product generates activity within the proper
range for each of the activities being tested, the product is certified as
BioFIT(TM), or "Bio Functional Integrity Tested," the Company's trademarked
designation. BioFIT(TM) assays confirm consistent in vitro biological activities
within a carefully defined range, closely associated with the benefit claims on
the product's label. The Company intends to market the BioFIT(TM) designation to
producers of herbal medicines and dietary supplements which the Company believes
will enable these producers to (i) differentiate their products from similarly
labeled products based on their products' consistent delivery of the benefits
claimed by their producers; (ii) ensure "batch to batch" consistency in the
production of their products; (iii) eliminate consumer confusion as to "which
product to buy?"; and (iv) provide more "consistent" products and information in
the herbal and dietary supplement market. The Company is completing initial
BioFIT(TM) certifications for five herbal products. Assays to test these
products are in the final stages of development. The Company is also working
with the trade associations of the herbal and dietary supplement market to test
product functionality.
The Company entered into an agreement with R.P. Scherer North America in July
1998 that established R.P. Scherer as the exclusive marketing and distribution
agent for the BioFIT(TM) Certification program in North America. In a related
agreement, R.P. Scherer was also granted the worldwide rights to use the
BioFIT(TM) program with its soft-gel products in the dietary supplement and OTC
markets. The agreements allow R. P. Scherer exclusive use of the BioFIT(TM)
Quality Assurance Certification program for a line of herbal supplements to be
offered in a softgel capsule form. R. P. Scherer, acting as a contract
manufacturer, will market the product line to wholesale customers worldwide. The
initial roll out of five herbal products, along with the commencement of revenue
to the Company is anticipated to begin in the first quarter of 1999. The Company
anticipates that the agreement will result in the payment of significant
development fees and licensing revenues to the Company in 1999.
One of the herbal supplements being evaluated for the R. P. Scherer Agreement is
Echinacea. In the dietary supplement industry, claims have been made that
Echinacea acts as an immune system enhancer. R. P. Scherer provided 5
commercially available Echinacea products for the Company to evaluate using the
BioFIT(TM) Certification program. The results of the evaluation are
illustrative. 4<PAGE>
After conducting a literature search and performing direct research, the Company
scientists identified the TNF-alpha protein as the "mechanism of action" or
biomarker for the stimulation induced in human immune cells. Company scientists
then tested each supplement with the BioFIT(TM) Echinacea Assay to see which
product was more effective in stimulating the TNF-alpha marker. The results of
the test are summarized in Table 2.
Table 2 clearly indicated that Brand C has the greater effect on the TNF-alpha
marker. The evaluation also shows the wide range of bioactivity found in the
different samples. Ordinarily, there would be no way to test the effect of a
complex herbal compound on the TNF-alpha response. Researchers would have to
identify the compound in the herb that they thought stimulated the immune
response in humans. They would then test their product for the concentration of
that compound and compare it to a benchmark concentration.
In the case of Echinacea, some manufacturers standardize their product against a
phenolic acid that is found only in Echinacea under the assumption that it is
the active ingredient which results in the benefits claimed for the herbal
supplement. Paracelsian scientists have found that it is possible to standardize
the product for its concentration of the phenolic acid and have no bioactivity
that would affect the human immune system.
The BioFIT(TM) Assay allows R. P. Scherer to identify the herb samples which
have an effect on human immune cells without having to conduct human or animal
clinical trials and offers an inexpensive way of accurately identifying sources
of raw material which have high levels of the relevant bioactivity. In addition,
R.P. Scherer can evaluate, quickly and easily, its competitors herbal
supplements. Echinacea - Preliminary Testing
Immune Support Product-Induced Stimulation
Macrophages to Produce TNF
Product
----------------------------------------------
Brand Brand Brand Brand Brand
A B C D E
----- ----- ----- ----- -----
TNF-alpha Response 0.249 0.145 1.054 0.057 0.717
This new BioFIT(TM) Certification Program which utilizes a unique "functional"
approach to quality assurance will provide the natural products consumers more
accurate information when purchasing herbs and other botanical products.
BioFIT(TM) Certification is based on demonstrated biological activity in the
product and goes beyond current analytical techniques that only measure the
presence or absence of certain marker compounds.
BioFIT(TM) Quality Assurance Certification bridges the gap between chemical
assay methods of validation versus the use of animal and human clinical trials
to validate the effectiveness of natural products relative to the structure and
function claims being made.
Read this part carefully:
In the case of Echinacea, some manufacturers standardize their product against a
phenolic acid that is found only in Echinacea under the assumption that it is
the active ingredient which results in the benefits claimed for the herbal
supplement. Paracelsian scientists have found that it is possible to standardize
the product for its concentration of the phenolic acid and have no bioactivity
that would affect the human immune system.
My own interpretation: This is the QA method of PharmaPrint: checking for a particular compound. As I read it, this says that some stuff that passes the PharmaPrint test does not help the immune system. They are checking for the wrong stuff, and in the wrong place. (If the consumer can buy a product that's been PharmaPrinted, but may have no effect on one's immune system, or else a product that is BioFIT Certified, which does have an effect on one's immune system . . ..) |
