2003 : WHAT ARE THE PRESSING SCIENTIFIC ISSUES FOR THE NATION AND THE WORLD, AND WHAT IS YOUR ADVICE ON HOW I CAN BEGIN TO DEAL WITH THEM? - GWB

Mr. President,

During the past several months, I've been frustrated by the smallpox puzzle and the accompanying national agony about vaccination. Dozens of people have cornered me asking "what should I do about vaccinating my family" or, more pointedly: "are you or your family getting vaccinated?"

I was vaccinated against smallpox hundreds of times in the smallpox program in India, and again by CDC last year during the "smallpox bio terrorism" sessions for first responders. In this regard, it is appropriate that as President, you were recently vaccinated. My children, wife, mother, brother and neighbors have not been recently vaccinated and I do not recommend it, at least not yet. Based on the risks and benefits of what we know today, I do not recommend anyone rush out to get vaccinated unless they will be a "first responder" or work in a hospital emergency room.

Why? My decision is based on trying to solve many simultaneous equations. The smallpox dilemma has no simple answers, and making the correct decision may, literally, be a matter of life and death.

The facts today: Smallpox as a disease does not exist. It has been eradicated. A very small amount of the virus which causes smallpox, Variola, has been held frozen in liquid nitrogen in two "legal and secure" facilities in Atlanta and Moscow, as agreed to by the 150+ member states of the World Health Organization. It is easy to "awaken" the demon of smallpox if it is removed from these freezers. Except for a very controversial and potentially destabilizing removal last year of some viral material by U.S. Army scientist Peter Jahrling who used those viruses to infect monkeys with smallpox with the thought of testing smallpox anti viral agents and improved vaccines all the other legal viral samples remain in place. The fear of smallpox as a weapon of mass destruction in the hands of terrorists is based either on the public information, which is speculative and anecdotal, or on military or secret intelligence sources which are unavailable. Vaccination of 280 million Americans could cause potentially fatal vaccine side-effects in tens of thousands and death in 500 to 1000. In order to justify so many vaccine side-effects, there must be real evidence of incremental risk of an epidemic caused by vaccine preventable smallpox. There are at least three gating items, all of which must be true before it is logical to begin vaccinations against a disease which does not exist:

• Gating item #1: Smallpox virus must exist outside of the two "legal and secure" repositories where, with the only known exception being the Jahrling experiments, it has resided securely for nearly three decades

• Gating item #2: That smallpox virus which is outside of the two "legal and secure" repositories must have reached the hands of terrorists or nation-states that would use smallpox in war

• Gating Item #3: That smallpox virus which is outside of the "legal and secure" repositories, in the hands of terrorists with an intent to use it, must not have been genetically altered so as to be impervious to the vaccine we currently have.

As is quite clear from credible journalistic sources, Gating Item #1 appears to have occurred-Russian scientists operating under a Gorbachev approved billion dollar 5-year plan manufactured as much as 100 tons of Variola virus annually at a then secret facility called, ironically, Vector, near Novosibirsk, Siberia in the Soviet Union during the 1980's. There may have been other programs that have remained secret, just as the CIA program "Bacchus" to build a miniature anthrax production lab stayed secret virtually until the anthrax attacks of 2001.

There is no public knowledge, and I stress "public" for obvious reasons, that Gating Item #2 is true. The major known sources of concern are:

• a) Saddam Hussein used saran gas and anthrax in missiles and shells and attempted to use Camelpox in horrid experiments against the Kurds. Logic dictates that if he does have smallpox, he is a serious threat to use it as a "doomsday" weapon.

• b) Weapons inspectors found a refrigerator in Iraq, "ominously" labeled "smallpox" during the last round of inspections-we do not know if the "smallpox" referred to the disease of smallpox or the vaccine against it, but there were active cases of smallpox in Iraq as late as 1972 and there is no reason to believe harvesting viral specimens from those cases was not done. Iran, Iraq's neighbor and sometime enemy, certainly hid cases of smallpox from WHO inspectors (I was one of these) as late as the Shah's ceremonial coronation in 1972-73. When Iran and Iraq went to war a few years later, Saddam Hussein had reciprocal regional reasons for hoarding the Variola virus.

• c) Al Qaeda documents, including some found on a personal computer purchased by a Wall Street Journal reporter, contained references to smallpox as a weapon to be used by terrorists. Taliban fighters and Al Qaeda terrorists frequented a Soviet era "weapons dump" just North of the Afghanistan border; it is not known if any biological weapons were included amongst the other weapons acquired there.

• d) Soviet smallpox epidemiologists, who had betrayed many of us in the World Health Organization by lifting smallpox scabs from patients in India and elsewhere, and then smuggling these infectious specimens back to Russia to become part of Vector's "collection" used to create the infamous India-1 "weaponized smallpox", fell on hard times after the breakup of the Soviet Union. So did some of the virologists at Vector who worked on weaponizing smallpox and other biologicals; there is evidence some of these scientists visited Iraq, and were paid to consult with colleagues in Saddam Hussein's government on biologicals. There has recently been an active US program to find other work for these scientists to rid them of the financial necessity of such activities. There is even the suggestion, strongly denied by her Russian colleagues, that the eminent smallpox virologist Dr. Nelja N. Maltseva, might have visited or even collaborated with the Iraqis.

As for Gating Item #3, no one knows. The well known Australian experiments altering a gene in mousepox suggests it would be easy for terrorists-or even college microbiology students who had access to pox to create a "superpox" impervious to today's vaccines. I won't go into the details but the bottom line is that if anyone had enough hatred and enough money, the creation of a vaccine-proof smallpox variant is well within the realm of the possible. Obviously, if the terrorists have vaccine-proof smallpox, it is silly to vaccinate anyone with a high risk vaccine that is impotent against genetically altered smallpox.

How great is the risk of adverse reactions? Again, no one can really quantify it because much has changed, for better and for worse, since the 1970's from which the last large datasets are available. At that time the death rate from vaccine was about 2 or 3 per million vaccinated, and the risk of serious side effects about ten times higher. There are factors today which might raise or lower the rate of complications. Thirty years ago far fewer Americans had immune systems compromised by chemo therapy or AIDs, and the prevalence rates of eczema, a serious contra indication to smallpox vaccine, were lower as well. On the other hand, recent data from Israel and from vaccination in the US military suggests that vaccinating young healthy pre-screened men and women carries very few risks of side effects and today's ICU medical care for vaccine complications is likely to markedly reduce fatalities. All in all, it is likely that ten to one hundred people per million vaccinated from the general public would have a very serious reaction or even death from the vaccine-somewhere between 3000 and 30,000.

And so, here we are, faced with the need to decide whether to vaccinate our families. We will each need to make personal decisions under conditions of uncertainty.

Here is why I chose not to vaccinate my family:

• 1) To the best of my knowledge, there is no proof of any link between the experiments at Vector and either Al Qaeda or Saddam Hussein, but concern is understandable. If any proof of linkage arises, I might change my mind.

• 2) If Saddam Hussein has smallpox, I believe he might well be crazy or desperate enough to use it as a "doomsday weapon" if he were about to be destroyed; but it is also likely that Iraqi scientists have the ability to genetically alter the virus to make it vaccine-proof. If it is an end game, why would he use a virus that we have a vaccine against? It makes no sense.

• 3) If Al-Qaeda has the smallpox virus, I do not believe they would be willing to use it. Unlike Saddam Hussein, Al-Qaeda seeks the victory of an entire people, a culture, a religion-not the hegemony of any individual. Smallpox is the ultimate boomerang weapon. If it is released from its captivity at Chicago O'Hare airport, it is only a matter of days before it infects Mecca and Medina. It is not a likely weapon for a war that is a "Clash of Civilizations" unless a combatant sought the destruction of both civilizations.

• 4) Smallpox can be prevented if an exposed person is vaccinated as late as four or five days after exposure. While there is some risk that smallpox could be spread unseen for the first attack, within two weeks cases would start to appear and for nearly all Americans, there would be ample time and ample vaccine to be vaccinated after the first attack and still be safe.

• 5) I do not want to go into the fear that a small minority of Americans have that the your administration is prone to exaggerate the risks of terrorism in general and smallpox in particular as part of an attempt to frighten the public into accepting the erosion of civil liberties. As horrible as that allegation is, I simply have no information on which to make any comment other than to note the fear exists. And for my purposes here, it really does not matter. Based on the evidence I have seen to date, the risk of getting a case of vaccine-preventable smallpox today is just not as high as the risk of an adverse reaction to the smallpox vaccine.

That is the conclusion that I have reached as of today. And unless or until that changes, I will not vaccinate my family and the ones that I love.

Lawrence B. Brilliant, M.D.
Interim CEO of Cometa Networks, Inc.
Medical officer for the United Nations World Health Organization(1970s) helping lead the successful effort to eradicate smallpox.
Author of nearly 100 scientific articles and two books and is an expert on smallpox.