Pharmacology & Pharmacy, 2013, 4, 1-8
http://dx.doi.org/10.4236/pp.2013.46A001 Published Online September 2013 (http://www.scirp.org/journal/pp)
1
Gene-Eden-VIR Is Antiviral: Results of a Post Marketing
Clinical Study
Hanan Polansky*, Edan Itzkovitz
The Center for the Biology of Chronic Disease (CBCD), Rochester, USA.
Received July 3rd, 2013; revised August 3rd, 2013; accepted August 12th, 2013
Copyright © 2013 Hanan Polansky, Edan Itzkovitz. This is an open access article distributed under the Creative Commons Attribution
License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
ABSTRACT
Introduction: This paper reports the results of a post marketing clinical study that tested the antiviral properties of
Gene-Eden-VIRTM. Specifically, the clinical study tested the effect of Gene-Eden-VIR on the severity, duration, and
frequency of symptoms reported by individuals infected with various viruses. The viruses included the Human Papillo-
mavirus (HPV), Herpes Simplex Virus (HSV), Epstein Barr Virus (EBV), Human Cytomegalovirus (HCMV) and
Hepatitis C Virus (HCV). The symptoms included abnormal Pap smear, low and high grade cervical dysplasia, warts,
blisters, cold sores, hives, skin tabs, panic attacks, depression, kidney problems, sleeping problems, liver problems, fe-
ver, fatigue, sore throat, swollen lymph nodes, diarrhea, and weight loss. Treatment: A capsule of Gene-Eden-VIR in-
cludes five natural ingredients: 100 mg of quercetin, 150 mg of green tea extract, 50 mg of a cinnamon extract, 25 mg
of a licorice extract, and 100 mcg of selenium. The dosage was 1, 2, 3, or 4 capsules per day. The duration of treatment
was 2 to 54 weeks. Population: The study population consisted of 60 infected individuals, ages 20 to 66. Results: The
participants reported no side effects after taking Gene-Eden-VIR. Seventy three percent of the individuals treated with
Gene-Eden-VIR reported a decrease in their symptoms. Specifically, they reported a decrease in the severity (p = 0.006,
n = 45), duration (p = 0.009, n = 34), and frequency of their symptoms (p < 0.001, n = 31). Following treatment, the
participants also reported an increase in their physical abilities (p < 0.001, n = 47), energy levels (p < 0.001, n = 54),
mental abilities (p < 0.001, n = 44), and general health (p < 0.001, n = 46). The results showed that Gene-Eden-VIR has
a duration effect (p = 0.044, n = 32), that is, those treated for a longer time reported a larger decrease in their symptoms.
The results showed no interviewer bias, no selection bias, and a surprising response shift. The results also showed that
Gene-Eden-VIR has therapeutic consistency under varying manufacturing conditions. Conclusions: This post market-
ing clinical study showed that Gene-Eden-VIR is a safe and effective antiviral treatment. Specifically, the clinical study
showed that Gene-Eden-VIR is a safe and effective treatment against the Human Papillomavirus (HPV), Herpes Sim-
plex Virus (HSV), Epstein Barr Virus (EBV), Human Cytomegalovirus (HCMV), and Hepatitis C Virus (HCV). There-
fore, health care practitioners should recommend Gene-Eden-VIR as a safe and effective antiviral treatment against
these viruses.
Keywords: Human Papillomavirus (HPV); Herpes Simplex Virus (HSV); Epstein Barr Virus (EBV); Human
Cytomegalovirus (HCMV); Hepatitis C Virus (HCV); Gene-Eden-VIR
1. Introduction
This paper reports the results of a post marketing clinical
study that tested the antiviral properties of Gene-Eden-
VIR. Specifically, the clinical study tested the effect of
Gene-Eden-VIR on the severity, duration, and frequency
of symptoms in individuals infected with the Human
Papillomavirus (HPV), Epstein Barr Virus (EBV), Her-
pes Simplex Virus (HSV), Human Cytomegalovirus
(HCMV), and Hepatitis C Virus (HCV).
The following section describes the standard treat-
ments against these viruses and notes their limitations.
HPV: There are no drugs approved against the HPV
[1]. Current treatments include procedures, such as cry-
otherapy, conization, and the Loop Electrosurgical Exci-
sion Procedure (LEEP). These procedures use liquid ni-
trogen, a surgical knife (scalpel), a carbon dioxide (CO2)
laser, or electrical current to remove the abnormal
growths caused by the HPV. These growths include cells
*Corresponding author.

Gene-Eden-VIR Is Antiviral: Results of a Post Marketing Clinical Study 2
that harbor the active virus. The procedures do not target
cells with the latent virus. Since they do not remove the
latent virus, these procedures only produce a temporary
remission.
EBV: A few antiviral drugs are available that were
shown to inhibit EBV replication in cell culture. These
drugs include the acyclic nucleoside analogues aciclovir,
ganciclovir, penciclovir, and their respective prodrugs
valaciclovir, valganciclovir and famciclovir, the acyclic
nucleotide analogues cidofovir and adefovir, and the py-
rophosphate analogue foscarnet. However, clinical stud-
ies have shown that these drugs are mostly ineffective in
humans [2].
HSV: Two types of antiviral treatments against HSV
are available: topical and oral. The treatments include pe-
nciclovir, acyclovir, famciclovir, and valaciclovir. How-
ever, their effectiveness is limited. For instance, a meta-
analysis of five placebo-controlled and two dosecom-
parison studies evaluated the effect of aciclovir, fam-
ciclovir or valaciclovir on symptoms. The meta-analysis
showed that oral antiviral therapy decreases the duration
and the associated pain of an outbreak by merely one day
[3].
HCMV: Several drugs are approved for the treatment
of HCMV infections in immunocompromised individuals.
These drugs include ganciclovir, its oral prodrug valgan-
ciclovir, cidofovir, foscavir and fomivirsen. However, the
use of these drugs in immunocompetent individuals is
limited by their toxicity, poor oral bioavailability, modest
efficacy, and the development of drug resistance [4].
HCV: The combination of a pegylated interferon
(IFN)-α and ribavirin is the standard treatment for chro-
nic HCV infections. This combination is effective in
about 80% of the individuals infected with the HCV
genotype 2 or 3, and in about 40% - 50% in those in-
fected with genotype 1 or 4. Lately, two new drugs were
approved, telaprevir and boceprevir, with better results.
However, the combinations of pegylated interferon
(IFN)-α and ribavirin and telaprevir or boceprevir are
associated with additional side effects, increased costs,
and more complex treatment strategies [5].
There are also some dietary supplements that claim to
be effective against viruses. However, the law does not
consider dietary supplements as drugs, and therefore,
does not require the FDA to evaluate the effectiveness of
these supplements [6]. As a result, the sellers of most
dietary supplements do not conduct clinical studies to
test the effectiveness of their products.
The scientists, who developed Gene-Eden-VIR, used a
unique scientific tool, Computer Intuition, a proprietary
psycholinguistic-based, data-mining program that ana-
lyzes scientific text [7]. The scientists’ objective was to
identify natural ingredients mentioned in the scientific
literature that have a strong antiviral effect against the
most common viruses. To achieve the objective, they
used Computer Intuition to analyze more than 50,000 pa-
pers. Based on the computer’s results, they selected five
ingredients: green tea extract, quercetin, licorice extract,
cinnamon extract, and selenium.
A manual search on these five ingredients found stud-
ies that supported the computer’s results. For instance,
some studies showed that catechins, found in green tea,
are effective against viruses such as Epstein-Barr Virus
(EBV), Herpes Simplex Virus (HSV), Hepatitis Virus B
(HVB), and other viruses [8-11]. Other studies showed
that quercetin inhibits EBV-EA activation in latently in-
fected cells [12-14]. Some studies showed that glycyr-
rhizin and glycyrrhizic acid, found in licorice, have an
antiviral effect [15-18]. A few studies showed that the
active compounds in cinnamon, cinnamaldehyde, terpe-
noids, eugenol, and ethyl cinnamate, have a strong anti-
viral effect [19-21]. Finally, some studies reported that
selenium also has an antiviral effect [22-24].
After selecting the five ingredients, the scientists used
Computer Intuition again to analyze the thousands of
papers published on these five ingredients. Table 1 lists
the number of scientific papers published on each ingre-
dient according to PubMed as of September 1, 2009 (Ta-
ble 1).
Based on the new computer’s results, the scientists de-
termined the final formula of Gene-Eden-VIR: quercetin
100 mg, green tea extract 150 mg, cinnamon extract 50
mg, selenium 100 mcg, and licorice extract 25 mg. Gene-
Eden-VIR was introduced in the marketplace at the end
of 2009.
This paper reports the results of a post-marketing clini-
cal study that tested the antiviral properties of Gene-
Eden-VIR. Specifically it tested the effect of Gene-Eden-
VIR on the severity, duration, and frequency of symp-
toms reported by individuals infected with the HPV, EBV,
HSV, HCMV, and HCV.
2. Methods
2.1. Ethics Statement
An informed consent was obtained from all participants
Table 1. Scientific papers per ingredient on PubMed.
Ingredient Number of Scientific Papers
Green Tea Extract 3413
Quercetin 6753
Licorice Extract 2215
Cinnamon Extract 913
Selenium 2004
Total 15,298

Gene-Eden-VIR Is Antiviral: Results of a Post Marketing Clinical Study 3
prior to conducting the phone interviews.
2.2. Objective and Framework
We used this post marketing study to test the efficacy,
safety, and optimal use of Gene-Eden-VIR during viral
infections. Specifically, we tested the effect of Gene-
Eden-VIR on the severity, duration, and frequency of
symptoms reported by individuals infected with the HPV,
EBV, HSV, HCMV, and HCV.
2.3. Treatment
The dosage was 1, 2, 3, or 4 capsules of Gene-Eden-VIR
per day. The duration of treatment ranged from 2 to 54
weeks.
2.4. Outcome Measures
We used a self-developed questionnaire called the Natu-
ral Origin Treatment Clinical Questionnaire (NotCiq).
The NotCiq questionnaire is a patient reported outcome
(PRO) instrument. The purpose of a PRO instrument is to
capture the patient’s experience. Our main endpoint was
symptoms associated with viral infections. Meaning, the
objective of the study was to measure the effect of the
treatment with Gene-Eden-VIR on the symptoms of the
viral infection as they are reported by the treated partici-
pants.
To develop a reliable and valid questionnaire, we con-
sidered the purpose of study, the research question, the
response format, the phrasing of tested items, and the
statistical tests. At the end, we created a five section
questionnaire. The first section measured the changes in
general health. A second section centered on the changes
in the severity, duration, and frequency of the symptoms
during a viral infection. A third section centered on
changes in physical abilities, a fourth on energy, and a
fifth on mental abilities. The general health section in-
cluded 5 questions. The section explored areas such as
current disease and the change in general health. The
symptoms section included 5 questions, two questions on
severity, two questions on duration, and one question on
the frequency of symptoms. The physical abilities section
included 5 questions, the energy section included 5 ques-
tions, and the mental abilities section included 6 ques-
tions. NotCiq included both open and closed-ended ques-
tions. The answers to the closed-ended questions were on
a scale of 1 to 7, where “1” corresponded to “Poor
health”, “Very Severe”, “Extremely Interfered”, “All the
time”, “No relief”, or “Frequently appeared”, and 7 to
“Unnoticeable”, “Not at All”, “Constant Relief”, or
“Never Appeared”, etc.
The study collected the answers to the NotCiq instru-
ment by phone interviews. We used two independent
companies that specialized in outbound call services for
performing the interviewers, one company from the US
and one from Israel. The interviewers were blinded to the
objective of the study. All interviews were recorded.
The instrument was pre-tested on a small sample of
Gene-Eden-VIR users to evaluate both the sensitivity and
clarity of the questions.
2.5. Population
We randomly selected participants from the Gene-Eden
VIR customer database that includes all Gene-Eden-VIR
current and past customers. We used a computerized sys-
tem to randomly create a call list of 1000 customers. Out
of these customers, 100 agreed to participate. From these
participants we excluded customers who were using
Gene-Eden-VIR for other purposes, such as treatment for
cancer, chronic diseases, hypertension, etc. The final list
of participants consisted of 60 Americans of both sexes,
ages 20 to 66, infected with the HPV, EBV, HSV, HCMV,
and HCV. The diagnosis was done by the participant's
physician. Each participant reported as having specific
symptoms (e.g. for HPV participants reported genital
warts, low and high grade cervical dysplasia, abnormal
Pap smear results) and general symptoms (blisters, cold
sores, hives, skin tabs, panic attacks, depression, kidney
problems, sleeping problems, liver problems, fever, fa-
tigue, sore throat, swollen lymph nodes, diarrhea, and
weight loss). Since the objective of the study was to test
the effect of Gene-Eden-VIR on symptoms associated
with viral infections, we excluded participants who re-
ported no symptoms. That is, we excluded participants
who reported a 7 point score on the pre-treatment ques-
tion. Such a score indicates that the participant does not
suffer from the symptom represented by the question
regardless of the treatment the participant actually re-
ceived. This exclusion still preserves the intention to treat
(ITT) principle.
We considered participants who stopped taking Gene-
Eden-VIR for a month or more before data collection as
past users. All other participants were considered as pre-
sent users.
2.6. Controls
The Gene-Eden-VIR post marketing study includes a
pre-treatment concurrent control and an historical control.
To create an historical control, we divided the original
test group into two subgroups, present users and past
users. Generally, an historical control is a separate group.
However, since we did not have a separate group of
non-users, we used the past users as a proxy for an his-
torical control.
2.7. Statistical Analysis
We tested the statistical difference between the score of

Gene-Eden-VIR Is Antiviral: Results of a Post Marketing Clinical Study 4
pre-treatment, which is the numeric answer each partici-
pant used to describe his symptoms before the treatment
started, to the score of post-treatment, which is the nu-
meric answer each participant used to describe his sym-
ptoms after the treatment was completed. We also calcu-
lated the delta (Δ), that is, the difference in scores be-
tween the answer to the pre-treatment and post-treatment
question. Then, we tested the statistical difference be-
tween the deltas. These tests were performed in a then-
test model for both present and past users. Statistical
analysis was performed using a two-tail t-test assuming
unequal variances.
The research defined the primary endpoint as a statis-
tically significant increase in the score from pre-trea-
tment to post-treatment on the raw answers and on the
deltas.
3. Results
The participants reported no side effects after taking
Gene-Eden-VIR.
Out of the 60 infected participants, 7 reported perfect
general health and no symptoms (that is, a score 7 out of
7 on the pre-treatment questions on both the general
health question and the symptoms questions), and 7 par-
ticipants reported perfect general health with some
symptoms. Fifty four percent (25/46) of the individuals
that reported less then perfect health reported an im-
provement in general health.
Out of the 60 infected participants, 41 reported having
some symptoms. Seventy three percent (30/41) of the
individuals treated with Gene-Eden-VIR reported a de-
crease in their symptoms. Specifically, they reported a
decrease in the severity of their symptoms (p = 0.006, n =
45), a decrease in the duration of their symptoms (p =
0.009, n = 34), and a decrease in the frequency of their
symptoms (p < 0.001, n = 31) (Table 2).
Although 73% of the participants with symptoms re-
ported a decrease in their symptoms, only 54% reported
an improvement in their general health. These numbers
Table 2. Pre-treatment vs. post-treatment symptoms as re-
ported by the participants.
Questions N of P*# Pre-T
Score
Post-T
Score P Value
A5 General Health 46 4.67 5.59 < 0.001
B1-B2 Severity 45 4.90 5.49 0.006
B3-B4 Duration 34 4.79 5.46 0.009
B5 Frequency 31 2.42 5.23 < 0.001
*The statistical analysis on the Severity of Symptoms, and on the Duration
of Symptoms, was conducted using one score per participant. The score was
equal to the average answers of the participant to questions B1 and B2, and
B3 and B4, respectively. #N of P is Number of Participants, Pre-T is Pre
Treatment, Post-T is Post Treatment.
suggest that some participants do not perceive a decrease
in symptoms associated with viral infections as an im-
provement in general health. In their mind, viral symp-
toms and general health are somewhat unrelated (Table
2).
Following treatment with Gene-Eden-VIR, the parti-
cipants also reported an increase in their physical abili-
ties (p < 0.001, n = 47), an increase in their energy levels
(p < 0.001, n = 54), and an increase in their mental abili-
ties (p = 0.042, n = 44) (Table 3).
To test for a duration effect, we compared the change
(Δ) from pre-treatment to post-treatment in participants
who took Gene-Eden-VIR for less then two months and
those who took Gene-Eden-VIR for two months or more.
The results showed that participants who took Gene-
Eden-VIR for the longer period reported a 220% larger
decrease in their symptoms (p = 0.044, n = 32) (Table 4).
We could not test for a dose effect since the number of
participants who took 1, 3 or 4 capsules per-day was too
small for statistical analysis.
To test for a possible interviewer bias, we compared
the answers to the pre-treatment questions collected by
the American and the Israeli call centers. We also com-
pared the answers to the post-treatment questions be-
tween the two call centers. In both cases, the difference
between the answers was not statistically significant (p =
0.30, n = 154, for pre-treatment, and p = 0.36, n = 154,
for post-treatment, Table 5). This means that although
the centers included different interviewers from different
cultures working at different times of day, Americans
working during the day and Israelis working during the
night, the answers were similar. Hence, the results
showed no interviewer bias. Similar results were obtained
Table 3. Pre-treatment vs. post-treatment, physical abilities,
energy level, and mental abilities.
Question N of PPre-T Score Post-T Scorep Value
Physical Abilities47 4.90 5.55 < 0.001
Energy Level 54 4.57 5.53 < 0.001
Mental Abilities44 5.03 5.42 0.042
*Statistical analysis was performed using a single score for each participant.
The score was equal to the average of all answers in the relevant block of
questions.
Table 4. Duration of treatment.
Duration of TreatmentN of P* Change (Δ) from
Pre-T to Post-T Statistics
Less than 2 Months 13 0.43
2 Months or More 19 0.95
p = 0.044,
n = 32
*Statistical analysis was performed using the change in scores from pre-
treatment to post-treatment reported by present users only. The analysis used
one score per participant. The score was equal to the average of the answers
to questions B1 - B5.

Gene-Eden-VIR Is Antiviral: Results of a Post Marketing Clinical Study 5
for the other sections of the questionnaire (physical abili-
ties, energy, and mental abilities, data not shown) (Table
5).
To test for a possible selection bias, we compared the
answers to the pre-treatment questions by the past and
present users of Gene-Eden-VIR. We also compared the
answers to the post-treatment questions between the two
groups, and the change (Δ) from pre-treatment to post-
treatment. In all three tests, the difference between the
answers was not significant (p = 0.18, n = 154, for pre-
treatment, p = 0.72, n = 154, for post-treatment, and p =
0.47, n = 154, for the change (Δ), Table 6). This means
that, statistically, the answers by the present users are the
same as the answers by the past users, and therefore,
show no selection bias (Table 6).
An issue unique to natural products is the concern
about the therapeutic consistency of marketed products.
See discussion on this issue in the FDA guidelines for
botanical New Drug Applications (NDA) [6]. To test the
therapeutic consistency of Gene-Eden-VIR, we com-
pared the two batches used by the participants. The cap-
sules in these batches were produced at two different
manufacturing sites, and completed about 10 months
apart. The results showed that the answers given by the
participants who used the capsules from Batch 1 were the
same as those given by the participants who used the
capsules from Batch 2 (p = 0.988, n = 160, Table 7).
Hence, the results indicated that, although Gene-Eden-
VIR is a natural product, its formula has therapeutic con-
sistency (Table 7).
4. Discussion
This post marketing clinical study showed that individu-
Table 5. USA vs. Israel call centers.
USA Israel
N of A* Score N of AScore
Statistics
Pre-T 81 3.03 73 2.74 p = 0.30, n = 154
Post-T 81 5.04 73 5.36 p = 0.36, n = 154
*The data may include up to five answers per participant.
Table 6. Past vs. present users.
Past Present
N of A* Score N of A Score
Statistics
Pre-T 46 3.17 108 2.77
p = 0.18,
n = 154
Post-T 46 5.28 108 5.16
p = 0.72,
n = 154
Change (Δ) 46 2.11 108 2.39 p = 0.47,
n = 154
*N of A is Number of Answers. The data may include up to five answers per
participant.
Table 7. Batch 1 vs. Batch 2.
Batch N of A*Change (Δ) from
Pre-T to Post-T Statistics
1 81 2.20
2 79 2.20
p = 0.988
n = 160
*Note that the data may include up to five answers per participant.
als infected with the HPV, EBV, HSV, HCMV, or HCV
reported a safe decrease in their symptoms following
treatment with Gene-Eden-VIR. The participants also re-
ported an increase in their physical abilities, an increase
in their energy level, an increase in their mental abilities,
and an improvement in their general health.
The results are consistent. We observed a statistically
significant decrease in the severity, duration, and fre-
quency of symptoms. The results also showed a duration
effect. Participants treated for two months or more re-
ported a larger decrease in their symptoms compared to
those treated for less then two months.
The results are robust. They showed no interviewer
bias, no selection bias, and therapeutic consistency of the
Gene-Eden-VIR formula under varying manufacturing
conditions.
This post marketing clinical study does not include a
placebo control, that is, it is not a double-blinded study.
Placebo controlled studies are the gold standard in medi-
cal research in pre-marketing clinical studies. However,
except in rare cases, post marketing studies do not use
placebo controls. They use other controls recommended
by the FDA.
The FDA guidance lists five types of controls for both
pre marketing and post marketing studies: 1) Placebo
Concurrent Control, 2) Pre-treatment Concurrent Control,
3) Dose-response Concurrent Control, 4) Active (Positive)
Concurrent Control, 5) External Control (Including His-
torical Control). The External Control “can be a group of
patients treated at an earlier time (historical control)”
[25].
The Gene-Eden-VIR post marketing study is a change
from baseline study that includes a pre-treatment con-
current control and a proxy for an historical control.
The results are not likely to be a placebo effect. The
current predominant and well-proven theories on the pla-
cebo effect suggest that its main mechanisms are condi-
tioned reflexes and patient expectations [26]. The Gene-
Eden-VIR product literature does not mention the possi-
bility of a change in symptoms, and specifically, the se-
verity, duration, and frequency of symptoms. Hence, the
participants in this study could not have been primed for,
or expect the reported effects. This lack of conditioned
reflexes and patient expectations minimizes the possibil-
ity of a placebo effect, and supports the possibility of a
physiological effect.

Gene-Eden-VIR Is Antiviral: Results of a Post Marketing Clinical Study 6
All participants who started the study completed it;
therefore, the study has no follow-up bias.
It should be noted that although we tested for some
biases, others are still possible, for instance, the non-re-
sponsive bias.
This study relies on patient reported outcomes (PROs).
Past studies showed that PROs had a significant role in
the development and evaluation of new medicines [27].
According to the FDA, PROs are a valid and valuable
source for measuring the efficacy of new drugs. They are
reliable enough to warrant an approval of a label claim
for a new drug. From the years 1997 to 2002, the FDA
approved 23 new drugs based on PRO endpoints only.
They include six anti-migraine products (Amerge®, Ax-
ert®), several anti-epileptics (Gabitril®, Keppra®), and a
variety of other therapy classes (Tamiflu®, Relenza®)
[27].
The FDA regards this source of data as valid and va-
luable. The scientific community also believes that PROs
are valid and useful. Many major journals published
clinical studies that use patient reported outcomes. The
trust of the FDA and the scientific community in PROs
should convince the medical community, and specifically,
doctors, to consider studies that use PROs when recom-
mending medical treatments to their patients.
A possible limitation of this type of study is the sub-
jective report of symptoms. One might argue that the
participants’ have evaluated the effect of Gene-Eden-VIR
on symptoms, which are unrelated to their infection. To
address this question, we compared the symptoms re-
ported by the participants to the standard signs and
symptoms reported in the literature (“Harrison’s princi-
ples of internal medicine”, 18th edition). The comparison
clearly showed that the reported symptoms and the major
standard symptoms of viral infection as found in the lit-
erature overlapped (data not shown).
The size of the study group is a major concern in
clinical studies. A group that is too small may fail to
show a positive effect of the treatment. In addition, a
small group could also misrepresent the diversity in the
population. The standard principle for multivariate be-
havioral research is at least 10 patients at endpoint per
dependent measure [28]. This study included one end-
point dependent measure (the change in symptoms from
pre-treatment to post-treatment). This study population
included 60 individuals. Hence, the size of the study
group in this study is adequate.
One might also question the reliability of the partici-
pants recall period due to the long duration of the period
under investigation (up to 54 weeks). This study used a
“then-test” method. This method, also known as the ret-
rospective pre-test-post-test design method, asks partici-
pants at the post-test period to think back to the pre-test
period and retrospectively rate their condition. The “re-
sponse shift” is defined as the difference between the
“pre-test” and the “then-test” ratings. Currently, the re-
sponse shift is a well documented and extensively re-
search phenomenon [29]. According to the literature on
“response shifts”, participants may alter their internal
standards, values, or conceptualization of their quality of
life when experiencing changes in health states. These
response shifts can affect or distort the reported scores
and undermine the credibility of the observed medical or
psychosocial effects. Many studies reported that after
participants experience an improvement in their health, a
then-test tends to show a decrease in the initial assess-
ment of the original level of well being.
Since this clinical study uses the “then-test” method,
we tested for a possible response shift by comparing the
answers to the pre-treatment question at less then two
months and at two months or more. The results showed a
statistically significant increase in the pre-treatment score
over time. The results indicated that the participants ex-
perience a response shift, however, in the opposite direc-
tion from what was expected. This response shift sug-
gests that the participants do not tend to exaggerate, but
tend to forget how bad their symptoms were before tak-
ing Gene-Eden-VIR. The tendency to forget adds support
to the statistical significance of the results in this study.
Our research also shows an important and unique de-
velopment process that may influence future develop-
ments in medicine. Gene-Eden-VIR was formulated by
analyzing thousands of scientific papers with Computer
Intuition. The basic premise of the computer program is
that every future event is preceded by hints, and that the
key to predicting these events is recognizing the signifi-
cance of these hints.
In 1996, the first author of this paper completed a pro-
totype of a psycholinguistic-based data-mining program
that analyzes scientific text and assigns a rating to all
ideas found in the text. The higher the rating, the more it
hints on future events.
The following is a description of one prospective ap-
plication of Computer Intuition. In 1995, Frederiksen
published a paper entitled: Diagnostic Imaging in Dental
Implantology [30]. At the time, Frederiksen was one of
the world leading experts on the subject. To test the pre-
dictive power of the Computer Intuition analysis, Almog
and Heisler from the University of Rochester devised a
test. They conducted a Medline search for papers pub-
lished between 1980 and 1996 using keywords relevant
to the subject of diagnostics, imaging, and dental im-
plantology. The search identified 34 papers. The content
of these papers was analyzed with Computer Intuition.
The analysis produced three ideas. Two ideas were
identical to the main conclusions described in Frederik-
sen’s paper. This, by itself, was an impressive achieve-
ment. By using Computer Intuition, Almog and Heisler

Gene-Eden-VIR Is Antiviral: Results of a Post Marketing Clinical Study 7
duplicated the results of a world leading expert quickly
and inexpensively. However, while it took Frederiksen
decades to build his expertise, Almog and Heisler ac-
quired similar expertise within weeks.
The third idea suggested a new technology. This tech-
nology was not mentioned in Frederiksen’s paper. The
three ideas were published in 1997 [7].
How predictive was the Computer Intuition analysis?
In 2006, Almog, Frederiksen, and four colleagues, pub-
lished a survey of the academic and commercial field of
diagnostic imaging in oral implantology [31]. In their
paper, they reported an interesting observation. Begin-
ning in 2000, three years after the publication of the
Computer Intuition paper, “numerous companies from
technology-transfer and commercial standpoint have in-
troduced technology platforms that offer planning and
guidance systems to facilitate dental implant placement
procedures”, the same technology proposed by the third
idea three years earlier. This observation confirms the
Computer Intuition based prediction.
The scientists who developed Gene-Eden-VIR pre-
dicted that Gene-Eden-VIR will have an antiviral effect.
This post marketing clinical study shows that, as pre-
dicted by the Computer Intuition analysis, individuals
infected with viruses report a safe decrease in the severity,
duration, and frequency of symptoms following treat-
ment with Gene-Eden-VIR. As in the Almog and Heisler
research, the results of this research confirm the Com-
puter Intuition based prediction. The difference between
the two studies is that Almog and Heisler predicted a new
medical device. In this research, the scientists who de-
veloped Gene-Eden-VIR predicted the safety and effi-
cacy of a new treatment. Both Computer Intuition based
predictions were right.
5. Conclusions
The scientists who developed Gene-Eden-VIR used
Computer Intuition to design a natural product that tar-
gets latent viruses in infected individuals. This post mar-
keting clinical study showed that, as predicted, individu-
als infected with HPV, EBV, HSV, HCMV, and HCV
reported a safe decrease in their symptoms following
treatment with Gene-Eden-VIR. These results prove that
Computer Intuition, a psycholinguistic-based data-mi-
ning program of scientific text, can predict the safety and
effectiveness of medical treatments, and, therefore, has
the potential to revolutionize the R & D process in the
pharmaceutical industry.
Finally, this study showed that the natural product
Gene-Eden-VIR safely and effectively decreases symp-
toms in individuals infected with the HPV, HSV, EBV,
HCMV, and HCV. Therefore, health care practitioners
should recommend Gene-Eden-VIR as a safe and effec-
tive antiviral treatment to individuals infected with these
viruses.
REFERENCES
[1] M. A. Stanley, “Genital Human Papillomavirus Infections:
Current and Prospective Therapies,” Journal of General
Virology, Vol. 93, No. 4, 2012, pp. 681-691.
doi:10.1099/vir.0.039677-0
[2] E. Gershburg and J. S. Pagano, “Epstein-Barr Virus In-
fections: Prospects for Treatment,” Journal of Antimicro-
bial Chemotherapy, Vol. 56, No. 2, 2005, pp. 277-281.
doi:10.1093/jac/dki240
[3] L. A. Jensen, J. D. Hoehns and C. L. Squires, “Oral Anti-
virals for the Acute Treatment of Recurrent Herpes Labi-
alis,” Annals of Pharmacotherapy, Vol. 38, No. 4, 2004,
pp. 705-709. doi:10.1345/aph.1D285
[4] G. Andrei, E. De Clercq and R. Snoeck, “Novel Inhibitors
of Human CMV,” Current Opinion in Investigational
Drugs, Vol. 9, No. 2, 2008, pp. 132-145.
[5] J. M. Pawlotsky, “New Antiviral Agents for Hepatitis C,”
F1000 Biology Reports, Vol. 4, No. 5, 2012.
[6] US Department of Health and Human Services, Food and
Drug Administration, Center for Drug Evaluation and
Research (CDER), “Guidance for Industry. Botanical
Drug Products,” 2004.
http://www.fda.gov/downloads/Drugs/GuidanceComplian
ceRegulatoryInformation/Guidances/ucm070491.pdf
[7] D. M. Almog and E. M. Heisler, “Computer Intuition:
Guiding Scientific Research in Imaging and Oral Implan-
tology,” Journal of Dental Research, Vol. 76, No. 10,
1997, pp. 1684-1688.
doi:10.1177/00220345970760101001
[8] A. Singal, S. Kaur, N. Tirkey and K. Chopra, “Green Tea
Extract and Catechin Ameliorate Chronic Fatigue-Induced
Oxidative Stress in Mice,” Journal of Medicinal Food,
Vol. 8, No. 1, 2005, pp. 47-52. doi:10.1089/jmf.2005.8.47
[9] S. Y. Lyu, J. Y. Rhim and W. B. Park, “Antiherpetic Ac-
tivities of Flavonoids against Herpes Simplex Virus Type
1 (HSV-1) and Type 2 (HSV-2) in Vitro,” Archives of
Pharmacal Research, Vol. 28, No. 11, 2005, pp. 1293-
1301. doi:10.1007/BF02978215
[10] L. K. Chang, T. T. Wei and Y. F. Chiu, “Inhibition of
Epstein-Barr Virus Lytic Cycle by (-)-Epigallocatechin
Gallate,” Biochemical and Biophysical Research Com-
munications, Vol. 301, No. 4, 2003, pp. 1062-1068.
doi:10.1016/S0006-291X(03)00067-6
[11] L. C. Lin, Y. C. Kuo and C. J. Chou, “Anti-Herpes Sim-
plex Virus Type-1 Flavonoids and a New Flavanone from
the Root of Limonium sinense,” Planta Medica, Vol. 66,
No. 4, 2000, pp. 333-336. doi:10.1055/s-2000-8540
[12] Y. Iwase, Y. Takemura, M. Ju-ichi, et al., “Inhibitory
Effect of Flavonoid Derivatives on Epstein-Barr Virus
Activation and Two-Stage Carcinogenesis of Skin Tu-
mors,” Cancer Letters, Vol. 173, No. 2, 2001, pp. 105-
109. doi:10.1016/S0304-3835(01)00615-2
[13] B. Ozcelik, I. Orhan and G. Toker, “Antiviral and Antim-
icrobial Assessment of Some Selected Flavonoids,” Zei-
tschrift für Naturforschung C: A Journal of Biosciences,

Gene-Eden-VIR Is Antiviral: Results of a Post Marketing Clinical Study 8
Vol. 61, No. 9-10, 2006, pp. 632-638.
[14] A. Arena, G. Bisignano and B. Pavone, “Antiviral and
Immunomodulatory Effect of a Lyophilized Extract of
Capparis spinosa L. Buds,” Phytotherapy Research, Vol.
22, No. 3, 2008, pp. 313-317. doi:10.1002/ptr.2313
[15] C. Fiore, M. Eisenhut and R. Krausse, “J Antiviral Effects
of Glycyrrhiza Species,” Phytotherapy Research, Vol. 22,
No. 2, 2008, pp. 141-148. doi:10.1002/ptr.2295
[16] G. J. Kapadia, M. A. Azuine and H. Tokuda, “Inhibitory
Effect of Herbal Remedies on 12-O-tetradecanoylphorbol-
13-Acetate-Promoted Epstein-Barr Virus Early Antigen
Activation,” Phytotherapy Research, Vol. 45, No. 3, 2002,
pp. 213-220. doi:10.1006/phrs.2001.0936
[17] J. C. Lin, “Mechanism of Action of Glycyrrhizic Acid in
Inhibition of Epstein-Barr Virus Replication in Vitro,”
Antiviral Research, Vol. 59, No. 1, 2003, pp. 41-47.
doi:10.1016/S0166-3542(03)00030-5
[18] T. Sekizawa, K. Yanagi and Y. Itoyama, “Glycyrrhizin
Increases Survival of Mice with Herpes Simplex En-
cephalitis,” Acta Virologica, Vol. 45, No. 1, 2001, pp. 51-
54.
[19] F. Benencia and M. C. Courreges, “In Vitro and in Vivo
Activity of Eugenol on Human Herpesvirus,” Phytother-
apy Research, Vol. 14, No. 7, 2000, pp. 495-500.
doi:10.1002/1099-1573(200011)14:7<495::AID-PTR650
>3.0.CO;2-8
[20] Y. Tragoolpua and A. Jatisatienr, “Anti-Herpes Simplex
Virus Activities of Eugenia caryophyllus (Spreng.) Bul-
lock & S. G. Harrison and Essential Oil, Eugenol,” Phy-
totherapy Research, Vol. 21, No. 12, pp. 1153-1158.
doi:10.1002/ptr.2226
[21] Y. Orihara, H. Hamamoto, H. Kasuga, et al., “A Silk-
worm-Baculovirus Model for Assessing the Therapeutic
Effects of Antiviral Compounds: Characterization and
Application to the Isolation of Antivirals from Traditional
Medicines,” Journal of General Virology, Vol. 89, No. 1,
2008, pp. 188-194. doi:10.1099/vir.0.83208-0
[22] S. W. Jian, C. E. Mei, Y. N. Liang, et al., “Influence of
Selenium-Rich Rice on Transformation of Umbilical
Blood B Lymphocytes by Epstein-Barr Virus and Ep-
stein-Barr Virus Early Antigen Expression,” Ai Zheng,
Vol. 22, No. 1, 2003, pp. 26-29.
[23] H, Wojtowicz, K. Kloc, I. Maliszewska, et al., “Aza-
analogues of Ebselen (Selenium-Containing Agents) as
Antimicrobial and Antiviral Agents: Synthesis and Prop-
erties,” Il Farmaco, Vol. 59, No. 11, 2004, pp. 863-868.
doi:10.1016/j.farmac.2004.07.003
[24] G. N. Schrauzer, “Effects of Selenium and Low Levels of
Lead on Mammary Tumor Development and Growth in
MMTV-Infected Female Mice,” Biological Trace Ele-
ment Research, Vol. 125, No. 3. 2008, pp. 268-275.
doi:10.1007/s12011-008-8172-1
[25] US Department of Health and Human Services, Food and
Drug Administration, Center for Drug Evaluation and
Research (CDER), “Guidance for Industry, E 10 Choice
of Control Group and Related Issues in Clinical Trials,”
2001.
http://www.fda.gov/downloads/RegulatoryInformation/G
uidances/ucm129460.pdf
[26] M. Breidert and K. Hofbauer, “Placebo: Misunderstand-
ings and Prejudices,” Deutsches Ärzteblatt International,
Vol. 106, No. 46, 2009, pp. 751-755.
[27] R. J. Willke, L. B. Burke and P. Erickson, “Measuring
Treatment Impact: A Review of Patient-Reported Out-
comes and Other Efficacy Endpoints in Approved Prod-
uct Labels,” Controlled Clinical Trials, Vol. 25, No. 6,
2004, pp. 535-552. doi:10.1016/j.cct.2004.09.003
[28] P. D. Harvey and R. S. Keefe, “Studies of Cognitive
Change in Patients with Schizophrenia Following Novel
Antipsychotic Treatment,” American Journal of Psychia-
try, Vol. 158, No. 2, 2001, pp. 176-184.
doi:10.1176/appi.ajp.158.2.176
[29] C. E. Schwartz, R. Bode, N. Repucci, et al., “The Clinical
Significance of Adaptation to Changing Health: A Meta-
Analysis of Response Shift,” Quality of Life Research,
Vol. 15, No. 9, 2006, pp. 1533-1550.
doi:10.1007/s11136-006-0025-9
[30] N. L. Frederiksen, “Diagnostic Imaging in Dental Im-
plantology,” Oral Surgery, Oral Medicine, Oral Pathol-
ogy, Oral Radiology and Endodontology, Vol. 80, No. 5,
1995, pp. 540-554. doi:10.1016/S1079-2104(05)80153-2
[31] D. M. Almog, B. W. Benson, L. Wolfgang, et al., “Com-
puterized Tomography-Based Imaging and Surgical Guid-
ance in Oral Implantology,” Journal of Oral Implantology,
Vol. 32, Vol. 1, 2006, pp. 14-18.