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This statement is submitted in response to your letter of October 5. I believe the subject of force protection and the role vaccine play are important concerns for all Americans.
Your letter specifically requested that I review the background on the development of policy for biological warfare during my tenure as Chairman of the Joint Chiefs of Staff. You no doubt will recall that the President announced in 1969 that we were dismantling our inventory of biological weapons. In 1972, the Biological Weapons Convention (BWC) was completed and in 1975 was ratified by the U.S. Government. The three-year lag period can be attributed to the time it took to destroy the US stock of biological weapons. Throughout, Washington led the international effort to convince nations to forswear biological offensive weapons. The Convention to date has been ratified by 142 signatories. At a special conference held in Geneva in September 1994, the US promoted the development of a legally binding instrument that involved transparency of activities and facilities that could have biological weapons applications. The aim, of course, was to deter violations and enhance compliance with the BWC regime. This issue is still pending.
I served as Chairman, JCS, from 1985 to 1989. In the case of poison gas, our own inventory of these agents served as a deterrent in two world wars. Clearly, by 1985 we no longer had that option in the case of biological weapons. The JCS, however, were not especially uncomfortable with that situation. It was the unanimous view that, from a military perspective, our conventional and nuclear weapons were of sufficient number and quality to assure a reasonable degree of deterrence if foreign governments contemplated the use of such agents against US forces. That judgment was borne out in Desert
Storm. Saddam Hussein had impressive stockpiles of chemical weapons and biological agents. He chose, although faced with defeat in the field, not to employ those weapons. We know for a fact that he had not been that timid when repressing his Kurdish minority and engaging Iranian units in the 1980's. I am persuaded that Saddam knew that, if he resorted to chemical weapons, it would infuriate all Americans and invite our leaders to retaliate in a devastating fashion.
The JCS during my tenure understood that the Biological Warfare Convention would not necessarily protect us from all biological threats. There was always the possibility of regimes violating the agreement or countries that had not subscribed to the convention producing biological agents. In fact, we had hard evidence that several signatories continued to experiment with and to produce biological agents. Consequently, our security policy embraced a great deal more than merely depending on overt military strength. A vigorous intelligence effort was mounted to improve our ability to locate foreign production facilities, to assess the character of potential agents, and to estimate which foreign militaries might be planning to use such agents in the field.
From this information, a comprehensive threat analysis was compiled incorporating inputs from military commanders, relevant diplomats, and the scientific community. While the appraisal did not anticipate frequent employment of such weapons, it concluded that any possible use could wreak appalling casualties. This conclusion led to a review of our vaccine defenses. Bear in mind every step of this process was widely vetted internally in the US Government and relevant inputs sought.
These conclusions ultimately led to several programs to better prepare our fighting units for dealing with this threat. Protective gear for individual troops was upgraded; BW training was further stressed; the requirements for all equipment, such as tanks, aircraft and ships, to operate in a biological environment were tightened up. In turn, it was recommended that vaccines be developed to counter the effects of specific agents. When dealing with a question such as vaccines that require extensive expertise outside of the Defense Department, a steering group is formed with wide representation from both DOD and relevant outside departments. Their findings are then submitted for consideration at higher levels. It is normal with important initiatives, such as this, for the policy ultimately to be decided by the Secretary of Defense, the National Security Council, and the White House. As I recall, there was little disagreement throughout the process.
We should bear in mind, however, that the subject of biological agents had not reached the urgency that it enjoys today. Anti-toxins had not been used by the military as a matter of course and were not part of the normal routine. We, however, did initiate exploratory probes to determine the feasibility of incorporating such vaccines in the anti-terrorist effort. It was a deliberate and gradual process that received normal funding and not an especially high priority.
There were two fundamental reasons for pursuing this course: (1) if such reasons vaccines were successful in countering biological agents, their use would reduce the nation's vulnerability to biological weapons, and (2) it would save the lives of those exposed to such attacks.
We were primarily seized with the problem of deterring or countering direct attacks on US forces by the military units of hostile governments, i.e., governments we could identify and retaliate against directly in a manner we chose. We had some confidence that we could suitably respond, if any nation elected to employ biological warfare against US personnel. I stress this because the problem of terrorism had not reached the crescendo it has today and that is a problem of another order. By the time I retired ten years ago, we had not fully grappled with the possibility of covert terrorists mounting serious biological challenges.
For example, when I served as the Ambassador to Great Britain (1994-1997), we were increasingly worried about terrorist attacks on overseas installations, but we were almost solely concerned with the threat of small bombs, car bombs, mortars and assassination, not the possibility of terrorists mounting a full fledged biological event.
In late 1998 and early 1999, I headed two Accountability Review Boards to examine the August 1998 embassy bombings in Nairobi and Dar es Salaam. We found a number of discrepancies in the preparedness to survive such catastrophes. In fact, the State Department directives did not address the possibility of biological attacks.
While no biological agents were employed in those two incidents, it was the unanimous opinion of both boards at the conclusion of their deliberations that, sooner rather than later, terrorist groups will turn to biological or chemical agents. In East Africa, the attacks were sponsored by Osama bin Laden, who has impressive resources and who has declared an Islamic Jihad against Americans wherever they can be found. Such organizations are no longer restricted by national boundaries.
I believe that our rather remarkable "Desert Storm" victory demonstrated to Third World countries that Americans are vastly superior in waging conventional actions. Governments or others who wish to harm our interests will have to look for other ways to confront us. This will, of course, encourage non-government terrorists. It may also lead governments who oppose us to sponsor and employ clandestine terrorists to harm our interests. At this juncture, we are superbly postured to retaliate heavily against governments that provoke us -- and our opponents know that. But sophisticated terrorist groups and covert operations are another matter.
Terrorist groups are configured to strike and then to disperse or disappear. It is difficult to identify them, to locate them, to know where they reside or train. Often they meld back into the larger population of a host country. The "invisibility of the archer" severely complicates defensive or retaliatory efforts. Ease of concealment and delivery, when coupled with difficulties in detection of agents and delays in the appearance of symptoms, makes an assailant extremely difficult to detect and even identify after the fact. There is every likelihood that such tactics will be used more and more in the future. In turn, the military will undoubtedly be called upon to participate heavily in counter-terrorism efforts.
Unquestionably, the overall threat level has increased because of these developments; the Department of Defense rates anthrax as the number one biological threat in the world today. Clearly, this appraisal dramatically reinforces the importance of passive defense measures. I am not privy to the discussions and decisions that are taking place within our government today, but I suspect all the steps I discussed are receiving increased attention. Vaccines are a vital part of this effort. There are a host of new biological agents being developed in laboratories around the world. The problem is amplified by the researchers' ability to alter some agents so that they are more sophisticated, difficult to detect and to counter with anti toxins. The Defense Department has already let contracts to develop counters to the emerging threats. It has also mounted a robust program to build better detection devices for the spectrum of old and new agents.
This does not mean, however, that all agents represent an immediate threat. Each agent must be examined as to availability, difficulty of production, its lethality and the ease of delivery. Many of the new agents, while exotic, will represent too much of a challenge for terrorists and must be discarded as a likely threat. A few, however, may require genuine attention. Only in those cases will it be necessary to administer an inoculation program. Any decision to administer a particular vaccine would be thoroughly vetted with relevant departments and in particular the health authorities. The threat appraisal will ultimately prioritize the whole list. I believe all of these efforts are worthwhile and must be pursued if we are to keep abreast of emerging developments.
Such a process was employed in the US Government preceding the announcement to inoculate all military personnel with an anthrax vaccine. Since the issues were new, thorny, complicated and politically sensitive, a steering group was formed with representatives from every governmental organization that had an interest. Naturally, the government health agencies were involved and an extensive educational agenda was followed. They were briefed on the experience of other vaccines, on the state of development in the biological sector and on the findings of our intelligence community. The relevant issues were discussed -- more appropriately debated -- before any conclusions were reached. The end product was a recommendation to the Secretary of Defense that all military personnel be inoculated with anthrax vaccine. In every respect it was a deliberate and comprehensive effort.
The US Government considers the anthrax spore to be an ideal terrorist biological agent. It is easy and cheap to produce. It can be deployed widely and easily by the attacker, without disclosing his purpose. More important, it is almost certainly lethal for unprotected humans. The Defense Department reports that at least 10 nations are suspected of having weaponized anthrax.
As you know, I am a director of BioPort Corporation, the firm that supplies the US Government with anti-Anthrax vaccines, and I have a strong interest in its quality. I am well aware that the issue of safety has provoked some dispute.
The vaccine was developed in the United States during the 1950's and 1960's for humans. The FDA approved it in 1970. It is a cell free filtrate produced by a strain of anthrax that does not cause disease. The vaccine contains no whole bacterium, dead or alive. In essence, it is nonpathogenic. There is no possibility of contracting anthrax disease from this vaccine. Since 1970, it has been safely and routinely administered to at-risk wool mill workers, veterinarians, laboratory workers and livestock handlers in the United States.
The popular press often confuses this issue by mixing up the question of effectiveness and safety. They are distinct issues and should be treated as such. As to safety, the vaccine has been around for a number of years and has compiled an impressive safety record. Time prohibits me from reviewing the plethora of authorities that agree with that conclusion, but I will cite some evidence that I find especially convincing.
At Fort Detrick, Maryland, laboratory workers at the Medical Research Institute of Infectious Diseases have received shots for nearly 30 years without discernible problems. Of 1,700 workers followed for 10 to 25 or more years after anthrax vaccination, none developed any unexplained serious symptoms due to reported doses of anthrax or any other vaccine.
As a requirement for licensure, the safety of the anthrax vaccine was studied between 1965 and 1970 under an approved IND, sponsored by the CDC. During that period, some 16,500 doses of anthrax vaccine were administered. This included the initiation of vaccination of at least 4000 individuals and the administration of approximately 6,500 booster doses. In not one incident was there a safety problem.
Between licensure in 1970 and May 1994, adverse events reported to the Michigan Labs from the 65,000 doses distributed to Persian Gulf recipients were few in number. The adverse events reported were similar in nature to those found during clinical trials of the vaccine and none were associated with chronic or permanent local or systemic effects. In addition, through May 1994, no reports of adverse events were received directly by the Michigan Labs from the approximately 150,000 recipients who received the vaccine during the Persian Gulf conflict. Since then reports have been few in number from the over 1,000,000 does given.
Dr. Susan Ellenberg of the Food and Drug Administration summarized the most recent data from the VAERS adverse vaccine events reporting system of the the FDA and CDC in her July 21, 1999, written testimony before the Subcommittee on National Security, Veterans Affairs and International Relations as follows:
"Since the beginning of VAERS operations in 1990 through July 1, 1999, 215 reports of adverse events associated with the use of anthrax vaccine have been reported to VAERS. Of those, 22 are considered serious events. These reports are for diverse conditions, with no clear patterns emerging at this time." She concluded: "None of these events, except for the injection site reactions, can be attributed to the vaccine with a high level of confidence, nor can contribution of the vaccine to the event reported be entirely ruled out. It should be emphasized once again that it is not always possible to attribute a cause and effect relationship between a reported event and a vaccination. With the exception of injection site reactions, all of the adverse events noted above do occur in the absence of immunization. While the data gathered from the VAERS system can serve as a useful tool in identifying potential problems, the reports on anthrax vaccine received thus far do not raise any specific concerns about the safety of the vaccine."
The program currently in effect has inoculated over 340,000 military men and women. Approximately 200 have refused to receive it according to DOD representatives. Those refusals represent only 1/17 of 1%. I have heard reports that vast numbers are leaving the service as a result. I queried all 4 services and found no evidence this was true.
Surgeon General Satcher has testified and has often said in public statements that the anthrax vaccine is extremely safe. He has been supported by a host of distinguished medical authorities. Incidentally, I have had 4 of the 6 shots myself and I will complete the course next year. Moreover, my understanding is that a military recipient who has a reaction that requires medical attention is taken off the program. There have, of course, been some reactions to the shots. The great bulk of these have been normal reactions to a needle injection, e.g. some swelling, local pain, and perhaps a headache. The DOD has reported 72 cases of serious side effects that required hospitalization or missed duty for greater than a day. Of those only 55 could be attributed to the vaccine and all 55 have returned to duty.
Nevertheless, it is noteworthy that DOD has taken the subject seriously and is in the process of commissioning another in-depth study of the vaccine. In all candor, I simply could not find any hard data that suggested the vaccine was systemically unsafe or that reactions exceeded those of other vaccines.
BioPort monitors all reports of any unusual reaction. The company is dedicated "first and foremost" to producing a safe vaccine. Since the takeover of the laboratory in 1998, BioPort has installed an enhanced quality system and made extraordinary efforts to ensure the continued safety and efficacy of the vaccines. I should note in this regard that not a single dose of this vaccine has ever been released without FDA approval.
Frankly, there is no question in my mind that we should bend every effort to protect our forces against anthrax attacks. Believe me, the descriptions of people dying from the anthrax spore are horrifying. It is an agonizing way to die. The effect is very similar to that of the Ebola virus. I suspect if we had had more experience with anthrax deaths, we would better appreciate what the Department of Defense is trying to do.
The argument as to whether the military program should be voluntary or mandatory is outside my purview. I have little desire to enter that argument but, again, I have chosen personally to protect myself by taking the vaccine.
Before closing let me discuss one peripheral issue. It would be na´ve of me not to mention some of the vague and rather misinformed criticisms of my association with BioPort. It has on occasion been rumored that the decision to inoculate all service personnel was made to benefit the BioPort Corporation and indirectly me, presumably because of my past associations with the military and the Administration. If this charge were not so ridiculous, it would be offensive. It outrageously exaggerates my influence. I didn't have that much influence when I was Chairman and I certainly don't have it now.
Let me be completely clear. I never, repeat never, solicited any official of this Administration to install or promote a mandatory inoculation program. Secretary Cohen's announcement of the mandatory vaccine requirement was made on May 18, 1998. The Steering Group's deliberations took place many months before this date. Actually, a Washington Post article reported in late 1996 that such a policy was being considered. At the time of the official announcement, the group I was associated with was engaged in a spirited competition with a number of other bidders to privatize the old Michigan Laboratory. The bid winner was not selected until June 1998 and the decision was made by the State of Michigan. The Department of Defense maintained a neutral position throughout this process. Frankly, the May 18 announcement made the final bidding phase of the competition more intense. The attempt to link me with the Secretary's decision is pure fantasy.
I understand that there are irresponsible web sites run by organizations that oppose the military and/or the vaccine. I would urge the Congress to detach itself from the emotionalism of this debate and not to be deceived or distracted by charges and counter charges that have nothing to do with the real issues. Do vaccines make a worthwhile contribution to the country's defense against biological attacks? Are they reasonably safe to administer to our citizens? My answer is "yes" to both questions.
U.S. Government Website