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Biotech / Medical : ADVR - Bulls no Bears

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To: garden_man who wrote ()3/5/1997 2:20:00 PM
From: Bernie Bildman   of 913
 
I received this as a fax, from an anonymous stockholder who is not a member of SI, I post it in its entirety::

-------------------------

Advanced Viral Research's (AVR) decision to restrain unauthorized
releases of company information by having principals and associates sign a
disclosure agreement, seems to have fostered unwarranted internet attacks
against the company and its management. Attacks have run the gamut from
the sincerity and honesty of the management and associated principals to
the worth of Reticulose. In essence, the internet has provided a medium
for opponents of AVR and/or Reticulose to write derogatorily about the
company with little cause and with incomplete knowledge or substance. Of
course, these type of attacks are nothing new, they have been going on for
years. All seem to follow the same format as used by Mr. Savitz in his May
20, 1996 Barron's 'Wonder Drug' article where he employed the same tact as
did former Senator Joe McCarthy when he held his infamous 1950 Senate
hearings, that is,"if you can't attack the facts attack the man". If you
take careful notice, most internet postings concerning AVR and/or
Reticulose are highly negative - never if ever supportive of AVR and its
management. So to balance things off a bit, here are some positive and
supportive thoughts on AVR.

How is it possible for a drug which was developed during the 1930s and
successfully used for some 20-years prior to 1962, by organizations such as
the U.S. Army, to have been disapproved by the FDA for the past 34-years?
How could this have occurred after twelve doctors experienced in
administering the drug attested to its effectiveness against numerous viral
infections, with no reported toxicity, during a symposium held on 1
September 1960 in Miami, FL? (see Proceedings)
* Is Advanced Viral Research, the present manufacturer of Reticulose, at
fault? Why would a small company with under ten employees formally
headed
by two septuagenarian men go through the aggravation of restoring the
availability of Reticulose to the American public when they knew that
the
FDA was instrumental in taking the drug off the market? This is akin to
jumping into a fire. Would they have done it primarily for financial
gain
so that they could spend the remaining 10%-to-20% of their lives
living in
opulence and skiing the slopes of Aspen? Or, could it be remotely
possible
that a dedicated former employee [Bernard Friedland] of the initial
Reticulose manufacturer [Chemico] is honestly trying his best for the
benefit of mankind to right a possible grave mistake made by the FDA in
1962? Is it not self evident that Advanced Viral has been trying its
best
to meet FDA requirements. Especially so with the hiring of Dr.
Shalom Z.
Hirschman, former director of the division of infectious diseases at
Mount
Sinai School of Medicine, to conduct basic research and controlled
testing
of Reticulose as well as develop even newer compounds based on the
quintessence of Reticulose? Could there be a remote possibility that
the
requirements put on AVR by the FDA for approval of the drug may be
unreasonable, unwarranted and even impossible to satisfy?
* Is the FDA at fault? Why did they, in 1962, deem a 1930s developed,
effective anti-viral drug as being new? Does it not seem extreme for
the
FDA to have seized the remaining supply of Reticulose from Chemico so
that
it could not continue to be used by the U.S. public? In doing so,
did the
FDA really have the interest of the Americans in mind or could there
have
been an ulterior power-struggle agenda to the FDA's actions? Also,
is it
not ironic that the FDA continues to suppress the dispensing of
Reticulose
even when an expert within the FDA, Christopher Tseng, Phd, has found
Reticulose to be safe and effective against Influenza A (see NIH
report ARB
No. 89-048 of 12 October 1989)?
* Or is the U.S. Congress at fault? Has Congress given too much
autonomy to
the FDA where they answer only to themselves and never to the U.S.
public.
Assuming there is merit to Reticulose, would it not have been better for
Mr. Savitz to have suggested in his May 20, 1996 Barron's article that
Congress intervene in the interest of mankind and find some way to
mediate
this unfortunate 34-year 'stand-off' between the FDA and Advanced Viral
Research and get at the truth about the effectiveness of Reticulose
against
viral infections?

Why is it that when Mr. Savitz could not refute Dr. Hirschman's
scientific findings he chose to revert to the old Joe McCarthy ploy by
attacking Dr. Hirschman's character based on someone else's statement that
he had sold the stock he received in compensation for his work? Why did
Mr. Savitz imply that Dr. Hirschman's scientific reports were deliberately
made optimistic so that he could unduly profit from the sale of his stock?

Further, Mr. Savitz reported that AVR's William Bregman was trying to
discourage other associates of the company from putting information
concerning Reticulose on the internet. Could this desire to keep
information off the internet be caused by Mr. Bregman's determination not
to instigate a possible reprimand from the FDA and SEC for allowing
information about Reticulose to be put on the internet? Have FDA [and
possibly SEC] pressures reached such proportions that they tend to
intimidate organizations [like AVR] and individuals [like William Bregman]
from providing the truth [like the effectiveness of Reticulose against
viral infections] to the U.S. public.

Mr. Savitz insisted that he was simply reporting the facts in his 20
May 'Wonder Drug' article when he responded to Bernard Friedland's views of
Advanced Viral's SEC and NSDA difficulties, as outlined in Barron's July 8,
1996 Mailbag. However, when Mr Savitz referred to one of his facts that
"the FDA repeatedly has refused to let Advanced Viral conduct even
early-stage human clinical trials", he never addressed the question - "why
has the FDA refused to allow clinical trials"? Regrettably, he chose not
to, or was not able to address the reason(s) why the FDA has been reluctant
in sanctioning trials for Reticulose.

One of the more obvious reasons may be that AVR has refused to divulge
the composition of Reticulose and/or the procedures for its production in
order to protect their interests and investment and those of the AVR
shareholders. Thus, AVR may never be able to fully respond to FDA demands.
If the FDA's refusal to sanction trials is based strictly on AVR following
FDA requirements, regulations and procedures to the 'letter of the law',
the delay or refusal to allow clinical trials is, unfortunately, the
consequence of 'tunnel vision'. If their refusal centers around a
deliberately hidden agenda, whether it be based on an abuse of power within
the FDA or pressures from outside the FDA, the consequence of the FDA's
repeated refusal to let Advanced Viral conduct human clinical trials has
resulted in undue suffering, and even death, of numerous Americans.

It appeared to me that Mr Savitz in his May 20 article only wanted to
provide facts that diminished the sincere efforts of the AVR management and
not to provide facts that support their quest to satisfy FDA requirements.
For instance, he did not point out that substantial evidence abounds
supporting the efficacy of Reticulose. Examples of this evidence are
contained in:
* The Proceedings of the September 1960 "Clinical Symposium on Viral
Diseases Demonstrating the Anti-Viral Biotic Properties of the Drug
Reticulose Lipoprotein-Nucleic Acid Complex".
* The October 1989 Christopher Tseng, Phd., report on the safety and
effectiveness of Reticulose against Influenza A, NIH report ARB
No. 89-048.
* The September 1992 Angelo A. Chinnici, M.D., report on the efficacy of

Reticulose in the treatment of ten AIDS patients conducted by the

Infectious Disease Institute of the Dominican Republic.
* The December 1992 Matthew Cohen, M.D., PhD., report on "The Efficacy
of a Peptide-Nucleic Acid Solution (Reticulose_) for the Treatment of
Hepatitis A and Hepatitis B in a Controlled Human Clinical Trial",
Journal of the Royal Society of Health.

Mr. Savitz did acknowledge the findings reported in Dr. Hirschman's
abstract - "Peptide Nucleic Acids Stimulate Gamma Interferon and Inhibit
Replication of Human Immunodeficiency Virus" -presented on 5 May 1996 at
the Biomedicine '86 meeting. Unfortunately, he did not try to counter the
negative opinions he solicited from Martin Delaney [Project Inform] and
Dave Gilden concerning the abstract by
also soliciting an opinion from a peer of Dr. Hirschman. Such an opinion
could, most probably, have been positive as to the scientific findings
presented at the Biomedicine '86 meeting. [The associated article to Dr.
Hirschman's abstract appear in the August issue of the Journal of
Investigative Medicine].

Even though I support AVR and Dr. Hirschman, there is one negative
aspect that is disturbing to me. After approximately one year, no one at
AVR nor at Mount Sinai School of Medicine has addressed the press regarding
the Savitz article - not even to say that they are fully supportive of Dr.
Hirschman. Their attitude seems to be - "why should we say something about
the Savitz article, the truth will come out in the end". It does make one
wonder exactly what it is that is being presently hidden by AVR from the
American public. It has been well established and documented that
Reticulose can not harm anyone - never has, never will. Who and/or what
organization(s) have such power and desire or need to suppress the truth
about Reticulose - its effectiveness against viral infections, its
efficacy, its non-toxicity, its potential use with protease inhibitors in a
'cocktail' at, most likely, a much lower cost compared to using AZT or 3TC
with the protease inhibitors?
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