If it's good for OraVax, is it also good for you?
By RICHARD JANNACCIO
How do you sell a vaccine to protect people from an innocuous virus
blamed for killing seven people in
a metropolitan area of more than 10 million? Thatís the challenge
facing OraVax, the Cambridge,
Massachusetts company that is licensed to profit from a West Nile Virus
vaccine developed by the
U.S. Army using our tax dollars.
Of those seven whose deaths were blamed on the WNVówithout proofóall
were over 68 years old,
three of whom were debilitated from chemotherapy, a fourth tested HIV+,
and the other three weíll
probably find out more about later.
The fact remains that most people, even those in their 70s and 80s,
recovered without treatment. Not a
single infant, child or young or middle-aged adult was claimed by this
ìdeadly virusîóincluding those
suffering from leukemias, lymphomas, AIDS and other diseases associated
with weakened immune
systems and vulnerability to infection.
Deception is the buzzword. The virus must be characterized in the most
frightening terms, and the
vaccine must be described as safe and effectiveóas a godsend.
Moreover, certain truths must be
hidden.
Weíve all heard comments about how frightening WNV is, and seen
the extraordinary effort madeóas
if this ìpublic health crisisî were on a par with the
Black Plague. The facts, however, justify neither the
panic nor the Herculean efforts being made. Very few people exposed
to WNV even develop
symptoms, and of those few who do, most recoverówithout treatment!
Contrast the established facts
with the following quote:
ìThe West Nile Virus is one of the most frightening to have emerged
in recent years and there is no
vaccine available to protect against the disease.î
That ominous statement comes from Dr. John Brown, chief executive of
Peptide Therapeutics, British
parent company of WNV vaccine licensee OraVax. Dr. Brown did not indicate
why he felt the virus is
ìthe most frightening to have emerged in recent years,î
but his job may have something to do with it.
The facts certainly do not support his statement. And he had to say
thereís no vaccine available,
because our government just gave his company $3 million to ìdevelopî
the already-developed vaccine.
The vaccine was developed by the U.S. Army with our tax dollars.
Now consider this quote:
ìIt will cause a very mild infection with no symptoms and leave
the person immunized against West
Nile.î In this case, ìitî refers to the WNV vaccine,
and the statement was made by Col. Thomas
Monath, vice president of OraVax and former U.S. Army biowarfare research
scientist.
But ìitî could also have been the WNV itself!
The virus itself will also ìcause a very mild infection with
no symptoms.î It will also ìleave the person
immunized against West Nile.î And if youíre lucky enough
to get bitten by a mosquito carrying it, the
alternative ìitî is free!
By the way, how is it that Col. Monath can tell us about the safety
and effectiveness of a vaccine that
his company hasnít yet developed? Ooops!
And how is it that no journalist challenged him? After all, the company
has yet to demonstrate that it
has ever produced an effective vaccine against anything. Of course,
thereís always a first time! But isnít
the announcement a bit overly optimistic, not to mention unsupportable?
Another quote:
ìPeople show no noticeable ill effects, or only mild symptoms
that can be mistaken for a flu.î ñas
reported in The New York Times 8-5-00, this time referring to Ö
West Nile Virus.
Thus, there are no symptoms from the vaccine, and no symptoms from the
virus. Which is better?
Which is worse?
The virus is almost certainly going to provide superior immunization
to itself, compared to a live
attenuated genetically engineered virus, which is what the vaccine
is. And the virus has already been
tested, whereas the vaccine has not.
Indeed, the vaccine may prove to be more dangerous than the virus, due
to other components and
impurities not found in WNV. It will be exceedingly difficult to produce
a vaccine that is safer and
more effective than WNV. The virus is the likely winner, as far as
being safer and more effective than
the vaccine.
But what about those few vulnerable elderly people who developed symptoms
after exposure to
WNV? Donít they deserve protection?
Absolutely. But unfortunately, if, as has been alleged, they did develop
these symptoms as a result of
WNV, then they will probably get sicker and die just as easily after
being vaccinated.
If the vaccine proves to be not safe enough to use to protect those
debilitated individuals who
supposedly need it the most, what good is it? Healthy people who donít
develop symptoms from
WNV certainly donít need to be protected (although weíll
be told otherwise).
Of course, it goes without saying that if the alleged ìvictimsî
of West Nile Virus were actually made ill
or killed by something other than West Nile Virus, the vaccine is also
totally useless. Either way, the
vaccine intended to protect our most vulnerable may function to hasten
their demise.
No vaccine is 100 percent safe, and a number of them have been shown
to be more dangerous than
has been alleged for the West Nile Virus itself. And itís not
too difficult to predict who is at greatest
risk of suffering adverse effects from the vaccine.
ìThe greatest risk is to the elderly, to very young children
and to people whose immune systems are
already suppressed, who can develop high fevers and encephalitis, a
potentially fatal brain
inflammation.îóThe New York Times 8-5-00,
referring to WNV. But itís almost certain that the same
groups will be at greatest risk from the vaccine, although, thanks
to genetic engineering, the symptoms
may be different, perhaps as frightening, or maybe even worse.
It is important that all of us get this vaccine for two reasons, and
protection against the WNV is not
one of them. Thatís just the pretext. The real reasons why all
of us should be vaccinated against WNV
are: 1) to generate profits for OraVax, which is financially distressed,
and 2) if large numbers of healthy
people who are not at risk for WNV encephalitis donít get vaccinated,
the vaccineís incidence of
adverse effects will be too high. In other words, theyíll need
to vaccinate a lot of healthy people who
will survive the vaccine in order to make it look good.
OraVax is so financially distressed that it was ìdelistedî
by Nasdaq in October of 1998, when its stock
plunged and lingered well under a dollar. Investors lost confidence
in the companyówith good reason.
OraVax has failed time and again to produce a vaccine that works. Despite
deals granting them
exclusive licenses over genetic sequences, the company has produced
no marketable product. OraVax
tried to produce a vaccine to prevent stomach ulcers, but the results
of clinical trials were unimpressive.
They may have even broken the law, according to The New York Times (see
below). Apparently,
none of that dissuaded the Army from granting OraVax an exclusive right
to market a vaccine
developed at taxpayerís expense, nor did it stop the U.S. government
from entrusting this embattled
company to protect the public health and save us from this ìfrighteningî
virus.
The firmís track record should have disqualified them from the
get go. But with a vice president such as
Col. Monath, whose resume includes impressive stints with both the
Army and federal Centers for
Disease Control, the pipeline to the federal trough seems well secured.
Col. Monath, who wears the
hat of an unbiased advisor to Giuliani on the WNV epidemic, was also
one of seven scientists who met
with President Bill Clinton on April 10, 1998 to urge the stockpiling
of vaccines against
bioweaponsóanother policy from which Monathís company
had hoped to profit handsomely.
According to The New York Times, Aug. 7, 1998:
ìOraVax at this time was increasingly desperate. In filings to
the Securities and Exchange Commission,
the company said it had won part of the Pentagon vaccine work. Its
stock price continued to slide. On
May 4, the company put out a news release boasting of the contract,
and the stock rose that day in
heavy trading to $1.31, up from $1.00.
ìBut in fact, OraVax had only a preliminary promise of possible
work as a subcontractor to the
Brtish-U.S. venture that had won the Pentagon contract, executives
from both companies now agree.
ìSecurities lawyers say such misrepresentations in SEC filings
are potential violations of federal
securities laws. Later that same month, as rumors and news reports
suggested the president was about
to announce a civilian stockpiling effort, OraVax president Lance Gordon
issued a press release saying
the company was prepared to take on the challenge.
ì ëAlthough there is no guarantee that OraVax will be involved,í
Gordon said in the May 21 statement,
ëthe company believes it has the capacity to produce both smallpox
and tularemia vaccines for civilian
use.í
ìThe next day, a Friday, Clinton announced the new push to create
stockpiles of "medicines
and vaccines to protect our civilian population." He also praised gene
research as ìvery, very importantî
to developing new ways of countering germ terror.
ìThe same day, 2,413,100 shares of OraVax changed hands on the Nasdaq
exchange,
closing at $1.41, up 28 cents, or 25 percent. It was the stock's heaviest
trading day ever. Later, the
company issued a statement explaining the sudden activity, which it
attributed to the president's action.
ìFor Monath, who owns or has options on 150,574 shares, the stock's
price increase
amounted to a profit on paper of $42,160.î
Then, according to The Times, ìTwo weeks after the president's
announcement, on June 8, the
government quietly began to back pedal.î
In the end, OraVax was left high and dry, and, with no other prospects
with which to entice investors,
its stock plunged to well under a dollar and was delisted by Nasdaq
on Nov. 17, 1998.
In parallel fashion, Col. Monath became part of Mayor Rudy Giulianiís
advisory team on the West Nile
Virus. Like an ambulance-chasing lawyer, Monath always seems to be
in the right place at the right
time in ongoing desperate attempts to revive his company. The occasion
provided an opportunity for
Monathís reunion with the then New York City head of emergency
management Jerry Hauer, a
Giuliani appointee and another one of the seven who, along with Monath,
had met with Clinton to push
for stockpiling biowarfare vaccines.
It should be noted that OraVaxís attempts to attract investors
have relied on deception since the
inception of its IPO five years ago. Hereís how Oravaxís
public-relations company, Lehman Millet,
Inc., brags about their ìaccomplishmentî in duping investors:
The Objectives
The Challenges
When OraVax, Inc., needed to raise investor and industry interest in
their pioneering research, LMI developed their
corporate identity and communications.
Biotechnology companies have not consistently met investor expectations.
And, while OraVax had three products
in preclinical and clinical trials, none had actually come to market.
Therefore, LMI needed to create a stable
corporate image, without any actual products.
The Solution, The Result
OraVax had a compelling story: Their research-and-development strategy
was unique, targeting specific diseases ñ
with broad economic impact ñ that can be treated or prevented
by bolstering the mucosal immune system. They had
a strong product pipeline and secure global partnerships. But, few
people knew the company. So, LMI made sure
that changed. For investors, we planned the initial public offering,
orchestrated a road show, developed analyst and
investor presentations, and produced annual and quarterly reports.
And, we used press kits and media relations
efforts to generate strong broadcast and print coverage, ensuring OraVax's
media presence.
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Positioned company for a successful initial public offering.
Developed strong stock valuation.
Increased analyst coverage.
Increased awareness of scientific approach among the medical profession and the public.
Fast forward back to the present. OraVax has announced plans for clinical
trials of WNV vaccine
lasting 18 months. They should be required to show that the vaccine
is both safer and more effective
(in providing immunity) than the virus. They should also be required
to show that it is safe for use by
those who most need protection against WNVóelderly people with
cancer who are undergoing
chemotherapy. Will these people even be included in the trials?
It won't happen, because the results using such a protocol will most likely not bode well for OraVax.
Here's what probably will happen: An ìoutbreakî will be
announced, andóforget the clinical trials, this is
an emergencyótheyíll coming running to the ìrescue,î
syringes in hand. People will be begging for the
limited supply of vaccine until production goes into full swing.
OraVaxís profits will skyrocket. And the ìskeetersî
will have been replaced by hypodermic needles.
The clinical trials, if they begin, will not be completed. And once
the vaccine has been used ìsafelyî on
millions of people with ìno significant adverse effects detected,î
clinical trials will no longer be needed.
Success in fighting the ìepidemicî will be claimed. Of
course, not a single life will have been saved, and
more than a few may be lost. Thatís when the public relations
folks get busy again, fabricating their
ìspins.î
Now thatís beating the system.
But thereís more. This is a much bigger issue than just the survival
of liíl olí OraVax. Letís not leave out
the other major playersóthe U.S. Army and Clarke Industries,
the pesticide industry beneficiary. Of
course, we can only scratch the surface, but let's.
Why did the Army spend its resources to develop a vaccine for WNV in
the first place? Surely it is not
the Armyís mission to protect us from disease. If the Army is
involved in something, and especially if
they are spearheading it, usually there is a military purpose. The
West Nile Virus is just one of many
viruses being studied as part of the Armyís Biowarfare research
effort, which is headquartered at Fort
Detrick, Maryland.
The link between the Army and OraVax has already been established as
the companyís vice president,
Col. Thomas Monath, formerly of Fort Detrick. If you think that Monath
was a factor in OraVax being
licensed to market and profit from the Army-developed vaccine, you
might be on to something.
Clearly, OraVax could boast no other credentials to recommend it for
the task.
West Nile Virus may be an insignificant public health threat, but it
seems to have much military and
economic significance. Thatís why the Army and Orafax (and Clarke,
the chosen pesticide beneficiary)
are so interested in sharing their ìexpertiseî to make
sure we do the right thing. The right thing for them,
of course. For support and help in fooling the public, they can and
do count on key public officials, like
Mayor Giuliani.
The West Nile Virus ìepidemicî does not derive its importance
from its public health consequences,
which are minimal to nonexistent. The public health crisis is merely
the pretext, so much smoke and
mirrors.
The epidemicís true significance appears to be economic and military.
By the most amazing of
coincidences, the ìappearanceî of this virus dovetails
all too perfectly with the Armyís biowarfare
research agenda and OraVaxís newly acquired vaccine in search
of a market. The Army needs to test
its products; OraVax needs to tap its markets.
Of course, pesticide companies are always looking for new opportunities
to unload their poisons,
especially at a time when demand for organic food is growing, pesticides
in danger of being banned are
stockpiled, and the failure of pesticides to control pests is becoming
more apparent than ever.
Another coincidence is the timely ìarrivalî of Aedes japonicus,
a species of mosquito new to our area.
These "skeeters" bite in broad daylight and the Army deems them to
be a particularly efficient vector
for WNV. Think the Army might also know how it got here?
As a relatively innocuous virus, WNV needs all the help it can get.
Richard Jannaccio is a New York City activist and researcher.