Last August, a little company based in Cambridge, MA?OraVax?received a $3 million grant from the National Institutes of Health to begin work on a West Nile vaccine.
As was reported in the Daily News on Aug. 21, "Federal health officials say they will recommend that anyone in the high-risk group?children and the elderly?take the vaccine." The story went on to report that OraVax hoped to begin human testing of the vaccine in 18 months?though federal officials were expecting it sooner?perhaps even by next summer.
Dr. Thomas Monath, vice president of vaccine research and medical affairs at OraVax, who's perhaps the world's leading authority on arboviruses (insect-borne diseases)?and the man behind the development of the new vaccine?says things are coming along "outstandingly well."
"We really only began this initiative last fall, briefly," he told me via telephone. "Then, when we got funded by NIH, we started around August 1. And at this point, we have generated a vaccine candidate, so we're initiating pre-clinical studies."
This all sounds like very promising news. However, it scares the hell out of a small handful of researchers and conspiracists, who are convinced that something ominous is behind it all. Why? Most of their concerns lie with the figure of Monath himself and, to a lesser degree, with OraVax.
A bit of background. From 1974 to 1988, Dr. Monath was the medical director of the Division of Vector (i.e., mosquito)-Borne Infectious Diseases at the Centers for Disease Control. Then, from '89 to '92, he was the colonel-in-chief of the virology division at the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, in Maryland.
In other words, he worked in the U.S. Army's biowarfare division?and that's what worries people. What's more, together with Jerome Hauer, former director of the Mayor's Office of Emergency Management, he's been an adviser to both President Clinton (on biowar preparedness) and Mayor Giuliani (at the initial outbreak of WNV). And now he just happens to be with the company that landed the grant to develop the vaccine?a vaccine that could well mean billions for the small biotech firm in the coming years.
The conspiracy stories range from speculations that WNV was accidentally released from the biological research facility on Plum Island to the firm conviction on the part of some that OraVax intentionally unleashed the virus upon the city?first, to ensure that they would sell their vaccine, and, second, as part of a grand eugenics experiment being spearheaded by the Rockefeller Foundation.
I asked Dr. Monath if he was aware of some of the things people were saying about him.
"I've seen the e-mails," he admitted. "Of course I don't know whether I've seen them all?I don't go looking for them, because they're all tommyrot. My friends send them to me. We don't fight these things or dismiss them, because they're trying to mix truth with lies?the standard way of making things believable. But it's all preposterous, and I'm happy to tell you why."
Dr. Monath explained that most of these conspiracy tales have arisen as a direct result of his background in biodefense. "I've served on many committees on biodefense issues and so on. I'm connected in that way, and people can find that out. Also, there's the connection with my interest in arthropod-borne viruses. What I'm doing now is corporate, and it's easy to weave all sorts of conspiracy theories together. I mean, none of this has any basis in fact. For example, there was one saying that I had done work on Japanese encephalitis vaccines when I was in the Army, and that's not true at all."
When you look at OraVax and Monath over the past 10 years, however, it's easy to see why some questions could arise.
OraVax, Inc. was formed in 1990.
In December of 1990, with the Gulf War still a few weeks away, the Dept. of Defense released a memo to the Tri-Service Vaccine Task Force, recommending, among other things, that the task force "Establish as high priority the institution of a Manhattan-like project to evaluate the above vaccines in a real operational setting and to develop specific vaccines for shigella sonnei, STLT and ST enterotoxigenic E. coli, West Nile Fever, and post-wound infectious agents."
In short, military researchers were working on a WNV vaccine 10 years ago, in preparation for the possible use of biological agents by the Iraqis.
In 1992, Monath left the military, and joined OraVax.
In May of 1997, as reported in the Boston Business Journal, OraVax was given a $322 million contract with the Dept. of Defense to develop vaccines for several potential biowar agents. According to the Journal, "[OraVax] will manufacture vaccines for at least two of the diseases being targeted by the defense department's Joint Vaccination Acquisition Program."
Unfortunately, according to an OraVax memo dated Aug. 18 of the following year, the deal fell through: "OraVax, Inc...announced today that it has been unable to reach agreement with DynPort concerning the manufacture and development...of the first two vaccines proposed under the program."
As a result of that lost contract, OraVax stock value plummeted from $75 a share to 25 cents, leaving the company on the brink of being booted off of NASDAQ.
Soon thereafter, OraVax was bought out by Peptide, a British vaccine manufacturer.
On April 10, 1998, Monath and Jerry Hauer met with President Clinton, suggesting that Clinton stockpile vaccines across the country in preparation for the possibility of a bioterror attack. The President rejected the idea.
In the summer of 1999, as we all know, the first cases of WNV appeared in New York, and Monath and Hauer were called in to advise the Mayor on the crisis. A year later, OraVax received the NIH grant.
There's absolutely nothing ostensibly sinister in any of that. But it reveals that there was an initiative to develop a WNV vaccine 10 years ago?and that Monath was in such a position that he was quite possibly involved.
Some researchers on the subject have pointed out that it usually takes a full 10 years to develop a vaccine from the research stages to a point where human testing can begin. Yet OraVax is saying their vaccine will begin testing in 18 months, if not sooner.
It also seemed peculiar that there was an outbreak of WNV in New York just about 10 years after military research began?and that Monath was involved in the WNV hysteria from the very beginning?and that a struggling company that, just a year earlier, was in serious financial trouble, landed the contract. Was it all just very fortuitous?
I brought up the DoD memo to Monath, and asked about his involvement.
"I went to a number of those Tri-Service meetings," he said. "I don't recall anything specifically about West Nile. But at that time, I know that the folks at Walter Reed?where I was not, I was at Fort Detrick?were doing some initial work on West Nile. My recollection is it never really went anywhere. As far as I know, there was no STO, or Science and Technology Objective, or fund line for West Nile vaccine development. If there had been one, it would've been at Walter Reed, where the infectious disease threats were addressed. Fort Detrick only dealt with bioweaponry issues."
(It should be noted, however, that Dr. Monath's work at Fort Detrick took place at the Medical Research Institute of Infectious Diseases.)
And when I further asked him about the unusual speed with which the vaccine development seemed to be progressing, he explained, "It reflects this platform technology that we're using, which is very robust. We splice the genes for the co-protein of the virus into yellow fever [vaccine]. We've got a lot of experience with that, and it has proven itself to work again with West Nile."
There's much evidence of that, too. Monath has, in the past, developed several vaccines using his yellow fever vaccine as a base. You might say it gives him a good head start.
He also went on to explain that the NIH grant?which seemed paltry when compared with other grants and contracts OraVax has been involved with?was little more than seed money, used to kickstart the program?and that other investors would be needed as the work progressed. Three million dollars, it turns out, is also the maximum amount the NIH could grant them.
These are all responses that the conspiracists, of course, have their own scary answers for?with plenty of documentation to back them up. In and amongst all of the interweavings and speculations, though, they do raise a few very good questions.
"Why would you be working on a vaccine," asks Robert Lederman, president of A.R.T.I.S.T. (Artists' Response To Illegal State Tactics)?who's done perhaps more writing on "The West Nile Plot" than anyone else?"for a disease that's so difficult to get? And so unlikely to even make anybody sick, let alone cause fatalities? When there are so many diseases in the world, why would you be pursuing this?"
And he's got a point. West Nile just doesn't seem to be that bad?so why the hubbub about the vaccine?
The answer, I would guess, has less to do with government plots than it does with the nature of contemporary science. Like conspiracy theories, scientific work takes place in tight focus. Both study the tiniest of issues, the incidentals, in the hopes of adding something to the big picture.
For instance, it should be noted that the West Nile vaccine is not the only vaccine that OraVax is currently working on. A month after they received the $3 million NIH grant, they received a $343 million contract with the CDC to develop a new smallpox vaccine. They also have another dozen vaccines in the works. West Nile seems innocuous, yes?but it's also a strain of Japanese encephalitis, which does kill people?so the possibility certainly exists that it could turn into something worth worrying about. And if that's the case, why not have a vaccine for it?
Fact is, I would have been much more suspicious had they received $300 million for a WNV vaccine, as opposed to $3 million.
And what about Dr. Monath? How peculiar is it that he advised the President and the Mayor and then ended up at the company that received the contract? If you look at things backwards?his background in the military's biodefense program, etc.?it might seem more than a little suspicious. Questions of conflict of interest aside, however, Monath remains the world's leading authority on these diseases, as well as the most prominent researcher into the development of vaccines for these diseases. It seems likely that wherever he ended up?whether at a small company with a shaky past or the world's largest biotech firm?he would be the one who would be given the job.
Perhaps a more important question, though, concerns the spraying itself. There's no denying that the pesticides being dumped on the city are potentially much more harmful to humans than WNV. Lord knows they kill every form of aquatic life they touch. And we have no idea what sort of long-term effects they'll have on the health of New York's population. So why the quasi-military response to such a useless "epidemic"?
Lederman feels that it's a ploy, a patently offensive tactic used to make next year's vaccine a more pleasant alternative and ensure sales. But, again, I think there's a simpler answer?namely, that this is how we've always dealt with problems like this. Not only in New York, or in California with the medflies, but all over the world.
According to a 1998 article by the CDC's Duane Gubler, "Vector-borne infectious diseases are emerging or resurging as a result of changes in public health policy, insecticide and drug resistance, shift in emphasis from prevention to emergency response, demographic and societal changes, and genetic changes in pathogens."
Historical records going back to the early part of this century indicate that outbreaks of insect-borne diseases like malaria, yellow fever, sleeping sickness and the black plague have traditionally been met with kneejerk insecticide saturation, in order to contain the problem after the fact, by killing adult carriers. Thing is, this method always seemed to work for a while.
A few decades after the problem was taken care of, however, there have been resurgences of all these diseases?usually in more virulent strains?in Asia, Africa, Europe and North America. Everything came back.
"Although the reasons for the failure of [vector-borne disease control programs] are complex and not well understood," Gubler writes, "two factors played important roles: 1) the diversion of financial support and subsequent loss of public health infrastructure and 2) reliance on quick-fix solutions such as insecticides and drugs."
He goes on to argue for the development of vaccines and a greater emphasis on prevention as opposed to reaction.
Point being, I guess, that in response to WNV, the city is only doing what every country on Earth has done in the past?and because of it, we may need that damn vaccine down the road.
When I first started looking into this story late last summer, I was convinced something shady was going on with Monath and OraVax, even before I read any of Mr. Lederman's articles. I was so suspicious of the spraying that I desperately wanted to discover that something diabolical was behind it. Believe me, Lederman and the others writing on this subject tell good stories and make strong cases?until you take a step back. Or maybe two steps back, to a point where Occam taps you on the shoulder and whispers in your ear.
There are still plenty of questions that I have about the city's West Nile hysteria. But I've come to the conclusion that the answers are more likely to be found in human stupidity than in superhuman evil.