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Assistant Secretary of Defense Health Affairs William Winkenwerder Briefing

Presenter: Assistant Secretary of Defense Health Affairs William Winkenwerder
December 23, 2003 2:05 PM EDT
Dr. Winkenwerder:  Good afternoon.  Yesterday, a U.S. district court judge ordered a suspension of the department's anthrax immunization program against the deadly biological agent anthrax. This decision was in response to a suit brought by six anonymous individuals in March of this year.  The department is reviewing the judge's order.  As a matter of pending litigation, I'll have no further comment on that litigation at this time.


            I am here with this message for our troops throughout the world: Your safety and your protection is my top concern.  This vaccination program is important because it protects our troops against a deadly biological agent.  We stand behind this program.  Everything we do is guided solely by the best scientific information available, by independent review by outside experts, and by regulation by the FDA and other legal authorities.


            The anthrax vaccine is safe and effective, and the FDA has licensed it since 1970.  The Department of Defense has always complied with, and will continue to comply with all FDA requirements in its use of the anthrax vaccine.  The vaccine-manufacturing process was carefully reviewed just two years ago by the FDA.


            Our paramount concern is for the safety of our service members and the successful accomplishment of their military missions.  We will continue to act upon this fundamental principle and obligation.  As we learned from the deaths of innocent Americans in the fall of 2001, it doesn't take a Scud missile to kill with anthrax.  All it takes is an envelope.


            The safety and effectiveness of the anthrax immunization program is based upon the best science in the world.  In March 2002, the National Academy of Science's Institute of Medicine concluded in an exhaustive 250-page report -- right here -- that the anthrax vaccine is, and I quote from this report, "an effective vaccine for the protection of humans against anthrax, including inhalational anthrax, caused by all known or plausible engineered strains of bacillus anthracis," -- that's the medical term for anthrax -- end quote.  The Department fully supports this scientific finding and those of the FDA that the anthrax vaccine is safe and effective against all forms of anthrax.


            In summary, this court ruling is not supported by medical science or by medical facts.  It challenges the conclusions of America's best medical experts.


            Let me now say that I am accompanied here by Lt. Gen. Jim Peake -- and I ask Jim to come on up -- surgeon general of the United States Army, and Jim is responsible for the day-to-day operation of the anthrax immunization program, and also by Col. John Grabenstein, who manages the program as the person responsible for the military vaccine program and is quite involved in ongoing looks at vaccine safety and effectiveness and the like.  We'll be prepared to answer your questions at this time.


            Yes, sir?


            Q:  While this court -- legal proceeding moves forward, is the Department of Defense or the Army in any way changing the inoculation program:  are you calling a moratorium, are you slowing it down, will it only be given to those who want it -- any changes of any kind whatsoever?


            Dr. Winkenwerder:  We're not prepared to make any comment about our current plans for continuance of the program, and we'll have more to say about that in the near future.


            Q:  But you're looking at the question of --


            Dr. Winkenwerder:  We're looking at the question, we're looking at the options that we have available to us, given the judge's ruling.


            Yes, sir?


            Q:  Let me just ask you about two factual findings of the judge.  He seemed to conclude that the FDA has not licensed the vaccine for inhaled anthrax, number one.  And he noted that the adverse reaction indication of the vaccine was recently changed from .2 percent to 5-to-35 percent.  Could you address both those findings of the judge?


            Dr. Winkenwerder:  And the first, again, being that --


            Q:  The first again being that the judge concluded that the vaccine has not been licensed by the FDA as an effective safeguard against inhaled anthrax.


            Dr. Winkenwerder:  Right.


            Q:  I think he concluded it was licensed for subcutaneous anthrax, but not inhaled anthrax.


            Dr. Winkenwerder:  Right.  The FDA has provided guidance to us directly on that question.  That easily allows for the conclusion that this, in their judgment, is effective against inhaled anthrax.


            Now, being challenged in the way that they have been by this court decision -- and I'm not going to comment further, but -- except to say that clarification on that, on their part, is something that we'll need.


            Q:  But is the guidance short of an actual license?


            Dr. Winkenwerder:  No, it's a licensed product against all forms of anthrax.


            Your second question related to the side effects and the percentages, and let me just make one statement.  This vaccine is safe.  It has a side effect profile that's very much consistent with other commonly used vaccines.  We monitor the safety of the vaccine carefully, and actually relative to the vaccines that are used in the civilian sector, I would say that we have more aggressive collection of information and side effects because we're able to monitor that.


            But all of that said, let me turn to Dr. Grabenstein just to make a comment on that.


            Col. (Dr.) Grabenstein:  Yes, sir.  The change from 0.2 to 5 to 35 principally reflected a change to more modern data collection methods. DOD was the source of the information for the 5 to 35 percent.  The 5 to 35 percent is principally headaches, muscle ache, myalgas, swelling at the injection site.  If you asked -- if you went looking for the side effect data on flu shots, you'd get something in the range of 5 to 35 percent.  These are not scary numbers.  These are -- when you understand what's being counted, this is what's expected of every vaccine, and it's consistent with information fully available to the National Academy of Sciences when it said that the vaccine is as safe as other vaccines.


            Dr. Winkenwerder:  Yes?


            Q:  Could you explain why the Pentagon, given this body of, I guess, sort of fogginess about what the FDA -- whether it licensed it or just has guidelines -- why the Pentagon made inhalation -- made the anthrax vaccine not a voluntary vaccine the same way it did for smallpox?  That would have actually avoided this entire fight, because that gives you the option for a presidential waiver as well.


            Dr. Winkenwerder:  Actually, we have a variety of vaccines that are mandatory.  It does not just apply to the anthrax vaccine.  It also applies to the smallpox vaccine.


            Now we --


            Q:  (Off mike) – the smallpox is not mandatory, but it's --


            Dr. Winkenwerder:  We have medical exemptions, which gives an appropriate exemption for vaccination to any soldier for any medical intervention, be it a vaccine or a treatment or whatever.  In the final analysis, if somebody has a -- some sort of medical problem or condition that would warrant their not receiving a vaccine, then it won't be provided.


            Q:  I'm sorry.  I was under the impression that the smallpox vaccine, because it's an investigational new drug, was a voluntary --


            Dr. Winkenwerder:  Smallpox vaccination is an FDA licensed vaccine.


            We -- let me clarify one thing.  We do not do experiments on soldiers and service members.  We only use licensed FDA products.  And if there are, for rarely used types of products, an investigational-type of use, we follow assiduously the guidelines of the FDA in performing those studies.


            Yes, sir.


            Q:  Why do you think so many service members as the number that have refused to take the anthrax vaccine?  And was your comment you just made --


            Dr. Winkenwerder:  Let -- let -- let me answer that first question, and then I'll let you ask another one.


            In fact, that is an inaccurate statement that has been made that I want to clarify.  We have vaccinated approximately a million service members since the beginning of the program in 1998.  Since June of 2002, when the program was re-initiated after it had been slowed down because of a period of constrained vaccine supply, we have vaccinated about six -- somewhere between six and seven hundred thousand service members.  We have had approximately 10 -- out of that number, 10 refusals out of six to seven hundred thousand.


            So, contrary to what I think has already appeared in the press about several hundred of service members refusing, that was in the period prior to 9/11, that was in the period of 1998 and '99.  Our more recent experience the last two years is that our service members support the vaccine program and accept it.  And our refusal rate is very, very, very small.




            Q:  So you think that hundreds refused before 9/11, and --


            Dr. Winkenwerder:  That's correct.


            Q:  -- since 9/11 10 -- approximately 10 have refused?


            Dr. Winkenwerder:  Approximately 10.


            Q:  And could I just -- the comment you made about "We don't perform experiments on soldiers and service members," is that in response to the judge's remarks that -- suggesting that the Pentagon has used troops as human guinea pigs?


            Dr. Winkenwerder:  Absolutely.  I categorically reject the use of that term with respect to our treatments or any health programs for our service members.  We do not use service members as guinea pigs. It was an unfortunate use of terms, in my judgment.


            Again, I'll just reiterate that we're only guided by the best medical science.  We follow FDA regulations and other regulations very carefully, we seek outside experts and independent panels and reviews.  And that's the way we conduct our health care programs.


            Q:  Sir, on smallpox don’t you require informed consent?


            Dr. Winkenwerder:  No.


            Q:  No?


            Dr. Winkenwerder:  We don't.  We inform people.  We educate people.  I want to make sure you understand the distinction between informed consent and informing people and educating people.  Informed consent is a procedure that's generally applied to an experimental process or a trial, a clinical trial when either the safety or the effectiveness of a drug or treatment is being evaluated or tested. Informing people and educating people is what we do as a general matter of practice.  And so we spend a lot of time educating our service members about anthrax, about anthrax vaccine, about smallpox, smallpox vaccine; why we do what we do.  So there is not an informed consent process, but there is information and informing of the service member.


            Q:  And --


            Dr. Winkenwerder:   Let me go to somebody else.


            Q:  So you're saying that Judge Sullivan was factually wrong when he said that the vaccine is still in investigational drug.


            Dr. Winkenwerder:  Absolutely.




            Q:  Has there been -- do you have any data on the numbers of people who have had adverse reactions to the vaccine that would have required hospitalization or even a fatal reaction?


            Dr. Winkenwerder:  Let me ask Dr. Grabenstein to answer that.


            Col. (Dr.) Grabenstein:  The numbers I know best date from the period between 1998 and 2000.  In that period of time, roughly 1,700 adverse event reports were submitted to the CDC, the FDA or the DoD, and then shared among all three agencies.  Of that 1,700, I believe it was 69 involved hospitalization.  Of the 69, 11 -- well, all 1,700 were reviewed by an independent panel of civilian physicians.  The panel of civilian physicians concluded that of the 69, 11 were due to the anthrax vaccine, certainly or probably.  And of the -- and those 11 all involved injection-site reactions.


            There's been mention in the press that the 2002 package insert approved by the FDA mentioned six deaths, which is true.  It's in a paragraph next to the comment that the report of any given adverse event does not relate to a cause and effect -- does not -- one cannot assume a cause-and-effect relationship.  And again, all of those six deaths were reviewed by the independent panel of civilian physicians, and in each of the six cases, the conclusion was that the death was unrelated to the anthrax vaccination.


            Q:  Then why was it in the literature?


            Col. (Dr.) Grabenstein:  Because they were reported, and the description in the literature was a complete, exhaustive list of what was reported.


            Dr. Winkenwerder:  I might also add that it's typical practice, if you'll look in your Physician Desk Reference -- not yours, but the kind that's available certainly, or any review of package inserts, they'll generally have a very long, exhaustive list of all known facts and data, but they're very careful to note as to whether there's any cause-and-effect relationship.  In this case, there's not.




            Q:  Can I go back to your statement -- correct me if I'm wrong, but wasn't there a GAO report that said that the number of incident reports, event reports, were way, way below what the true number of reactions, adverse reactions, were?


            Dr. Winkenwerder:  Let me just start and I'll ask John to finish the answer if I don't answer it completely, and that is that generally, people are going to have reactions like the ones that are described here, and they're not going to report them because they don't think it's significant, and they're right.  On the other hand, if someone believes that it's something significant and it's of enough concern to them, then they will report it.  So the mere presence of local reactions or expected reactions are not -- often are generally not the reason to report and adverse event.


            John, is that --


            Col. (Dr.) Grabenstein:  The only other thing I would add, sir, is the -- one of the GAO reports added up all of the adverse events -- if you had any kind of adverse event at all after vaccination -- and they got a number something like 84 percent.  The troops already understand that -- shots hurt.  That's what -- I mean, it's counting pain or swelling or discomfort at the injection site; we already know that. You're welcome to submit that to VAERS or anything else that happens after vaccination.


            Dr. Winkenwerder:  Let me also add here that what is in question is not safety in this court ruling.  It has to do with effectiveness   -- it's very targeted -- concern with respect to inhalational anthrax exposure.


            Let me, before I answer -- I want give Gen. Peake just an opportunity to make some comments.  Gen. Peake, I think, represents the perspectives of our line and medical leadership in terms of the importance of this program.


            Gen. Peake:  First of all, what we haven't really talked about is the fact that this is in fact an agent that has been weaponized.  We know that:  that the inhalation form is what is a threat to our troops; that the inhalation form of anthrax will kill you, which you all know from the post-9/11 letters; that we put our soldiers in harm's way where they may be exposed and not know it for a while and so you can't necessarily get treatment started as you could, perhaps, down at the Capitol, even though it didn't necessarily protect the postal workers that were involved.


            And so, we have, in fact, I think, done a lot better job of informing our soldiers about this vaccine and about the potential side affects that John has laid out for you.  And, you know, during Desert Shield/Desert Storm we didn't do as well with that, but we have made a concerted effort to do it better.  And I can provide you some of the literature we provide to every soldier, [http://www.anthrax.osd.mil/] that talks about this vaccine. We give them a card also that tells them how to report if, in fact, they think they've had a reaction, because we want to know.  No one wants to know more than we do about what we give our soldiers.


            We do NOT experiment on our soldiers.  We are trying to protect them, because we are putting them in harm's way.  And you've heard the statistics already, that in the -- post-9/11 we've had very few people say that this isn't a good idea, or questioning it enough to want to refuse it.


            Yes, ma'am?


            Q:  Oh, I'm sorry.  (Laughs.)  I'm just --


            Gen. Peake:  I'm here to answer your question.


            Q:  Okay.  Actually, with -- sort of some housekeeping questions.  Could you give us an update on the program:  how many doses you have on hand, where things stand with maybe the second vaccination source, and also, could you tell us -- I'm recalling, I think it was October 2002, that the Pentagon voluntarily stopped administration the vaccine.  Could you catch us up on the history there?


            Dr. Winkenwerder:  We're not going to relate how many doses we have on hand.  Just suffice it to say that we have more than sufficient supplies to vaccinate all the people that we need to vaccinate at this time.  And our supplies as a result of the efforts of the manufacturer continue to grow.


            Q:  And that's because of BioPort, or is there a second source?


            Dr. Winkenwerder:  There is only a single source of the vaccine at this point in time, and that is BioPort.  There is other work that's going on on what's called a second generation, or a newer anthrax vaccine.  Some of that research and work is going on here at the Department of Defense.  It's also going on as a result of efforts by the Department of Health and Human Services.


            Q:  And then, the last time that this -- that the vaccine was suspended, I think voluntarily, there were some safety concerns, maybe the age of the -- what was it?  Could you remind us?


            Dr. Winkenwerder:  The vaccine has never been suspended.


            Q:  You've never stopped giving the vaccine --


            Dr. Winkenwerder:  There was a slowdown because of some supply constraints in the period of 2000 --


            Col. (Dr.) Grabenstein:  We -- we first slowed down in fall of 2000, further slowed down in spring and then summer of 2001.  And then when the renovated facility was approved by the FDA in January of 2002, we were able to resume the program to its current size.


            Q:  Could you -- who gets vaccinated now?  It used to be that the goal was every service member, but that's different now, correct?


            Dr. Winkenwerder:  That's right.  Our policy currently targets those service members that are deemed to be operating in higher-threat areas of the world or that have jobs or functions that might place them at higher threat.  That's a determination that's made by our combatant commanders, reviewed by my office, and ultimately approved by the Secretary of Defense.


            Q:  And those areas are currently the Persian Gulf and Korea?


            Dr. Winkenwerder:  There's certain other areas of the world. Obviously Southwest Asia is one of them.  Our efforts in the global war on terrorism involves placements of troops in many parts of the world, and so I'm not going to go into that specific location information.


            Q:  So you're still vaccinating people right now?


            Dr. Winkenwerder:  We are.  We were as of yesterday.  Yes.


            Q:  And if somebody announces, "No, thanks, I don't want this right now," will they not be disciplined, I take it, until --


            Dr. Winkenwerder:  Since you're asking a question that I tried to answer already, which is what is our plan at this point in terms of the continuation of the program, we will be announcing something further in the near term.  That's -- that entire issue is under active discussion as we speak.


            Q:  You're not bound by the court order?  You're not bound by the court order?


            Dr. Winkenwerder:  I -- best not to get into the litigation.  I'm going to leave the issues that I've talked about with our attorneys and our lawyers and others that are involved.  And we'll have more to say on that in the near future.




            Q:  (Off mike) -- for planning purposes?


            Dr. Winkenwerder:  I'm sorry?


            Q:  This week, do you think, just -- we're trying to --


            Dr. Winkenwerder:  I'm not going to speculate.


            Q:  But you are complying with the order, are you not? (Scattered laughter.)


            Dr. Winkenwerder:  We are -- your question is?


            Q:  Are you complying with the court order, the preliminary injunction issued by Judge Sullivan?


            Dr. Winkenwerder:  We -- I'm not going to comment on what --


            Q:  That's a pretty big story if you're not.


            Q:  Exactly.


            Dr. Winkenwerder:  No, I'm not going to -- well, I'm not going to comment on your question.  Okay.


            Q:  Why don't you know?  I mean, the lawsuit was filed --


            Dr. Winkenwerder:  Because -- let me --


            Q:  Well, let me ask the question --


            Dr. Winkenwerder:  Let me answer you very simply.  I said this issue is under review by our attorneys, and we are studying the options.  And we'll be able to provide an answer very soon for you.


            Q:  Well, my question -- I mean, the lawsuit was filed back in March, correct?  So up --


            Dr. Winkenwerder:  That's right.


            Q:  What have you been doing since March?  Shouldn't you have known --


            Dr. Winkenwerder:  The decision was not issued until today [Dec. 22]. Obviously, I think there is --


            Q:  Well, you had to foresee a decision.


            Dr. Winkenwerder:  No, we frankly didn't.  I think this was a -- came as quite a surprise.


            Q:  So it would be accurate for us to write that you are reviewing whether or not you are going to comply with the judge's order?


            Dr. Winkenwerder:  We're reviewing our best options, or we're -- let me restate that.  We're reviewing our options at this time, and we'll speak -- I would not have you speculate as to --


            Q:  That's not speculation.  This is -- I'm trying to be accurate in my reporting.


            Dr. Winkenwerder:  Well, you're speculating, and I'm not going to say any more than I've just said.


            Q:  Were shots given to people today?


            Dr. Winkenwerder:  I don't know that.  We just learned --


            Q:  (Can we get ?) an answer --


            Dr. Winkenwerder:  -- we just learned -- we just learned this last night.  So we're speaking in terms of hours.


            Q:  This is very reasonable.  We're not trying to be rude. This is a question you should answer.  I mean, that's --


            Dr. Winkenwerder:  I've given you an answer.


            Q:  No, you're not.


            Q:  No, you're not.


            Q:  No.


            Dr. Winkenwerder:  What I --


            Q:  So if a service member today refuses to take the vaccine, he can be court martialed for that, the judge's order notwithstanding?


            Dr. Winkenwerder:  Look, I've given you an answer, and that's as much as I'm going to say.  Okay?


            Q:  Your answer is that you're reviewing your options.


            Dr. Winkenwerder:  That's right, and that we'll have an answer for you --


            Q:  And one of your options is not to comply?


            Dr. Winkenwerder:  -- and we'll have an answer for you very soon. Okay?


            Q:  So in other words, you can say right now -- you won't say right now whether or not the Department of Defense is complying with a federal court order?  That's your answer to us.


            Dr. Winkenwerder:  That's correct.  There is interpretation of what that order means.  That's a process that we need to review, that we are reviewing, that our attorneys are reviewing.  And we'll have an answer as soon as practicable.


            Thank you.


            Dr. Winkenwerder:  Thank you.




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