Anthrax Vaccine Ruling

RAY SUAREZ:

Ever since the Pentagon ordered all U.S. military personnel to get the anthrax vaccine in 1998, there's been resistance from some U.S. troops. Some complained of side effects, others quit the armed forces, and still others sued.

Yesterday, six unidentified plaintiffs won a key victory in federal court. In his ruling, Judge Emmett Sullivan noted that the vaccine is used, in part, to prevent the inhaled airborne form of anthrax, and that, said Judge Sullivan, makes the drug an "investigational one" not approved by the FDA for such use. The judge ordered the forced vaccinations to stop. And he concluded: "The United States cannot demand members of the armed forces also serve as guinea pigs for experimental drugs." Pentagon officials, including Defense Secretary Donald Rumsfeld, have not said whether the department will follow the judge's preliminary injunction.

REPORTER:

What's your response to the judge's suggestion that the Pentagon has used troops as guinea pigs for an experimental drug?

DONALD RUMSFELD:

The decision is recent. The lawyers are examining it. And at the appropriate time, they will be making a recommendation as to the way forward. The only kind of thing I would say in addition is, obviously the comment that you quoted, if in fact the judge said it, is inaccurate.

RAY SUAREZ:

General Richard Myers chairman of the Joint Chiefs defended the vaccine.

GEN. RICHARD MYERS:

From a military standpoint, I think it's extremely important. As you know, when we went into Iraq, we had all the troops in their chemical protective gear because we thought there was a very real threat of either chemical or biological weapons, and in particular, anthrax was a big worry.

RAY SUAREZ:

In all, some 800,000 members of the military have received an anthrax injection — many just before the Iraq war. Since the program began in the late 1990s, plaintiffs say as many as 1,000 people have refused the vaccine. The Pentagon says its numbers are much smaller.

RAY SUAREZ:

For more on the future of the Pentagon's anthrax inoculation program, we get two views. Dr. William Winkenwerder is assistant secretary of defense for health affairs; and Republican Congressman Christopher Shays of Connecticut is chairman of the Government Reform's Subcommittee on National Security. His committee has conducted an extensive investigation of the Pentagon's anthrax program.

Dr. Winkenwerder, the Department of Defense has had a couple of more hours to absorb the ruling, digest it. You've just come from a top-level meeting on it. What's your response to Judge Sullivan's ruling?

DR. WILLIAM WINKENWERDER:

Well, we're still working through the issue and through the legal options, and I would just say that we fully intend to comply with all of our legal obligations in this instance.

RAY SUAREZ:

What are your obligations as you understand them?

DR. WILLIAM WINKENWERDER:

Well, that's just the issue. We're seeking to understand, will be seeking to understand from the judge to have him clarify his decision further for us so that we're clearer with respect to whom it applies, the scope and the breadth of this decision and that and other questions that we want to ask will help, I think, clear the path forward.

RAY SUAREZ:

As troops turn over in Iraq, for instance, there are units all over the country preparing to ship out. If someone refuses their injection tomorrow, what happens to them?

DR. WILLIAM WINKENWERDER:

Well, first of all, it would be practically impossible for us to get out on such short notice any what we call issuing guidelines or regulations as to how to handle the situation. So under any circumstance, we're going to need at least a few days to turn the ship, so to speak. We're talking tens if not hundreds of thousands of people. And we want to be very clear and very specific about the guidance that we need to operate under. So, that would just in terms of practical terms take at least a couple of days to sort out.

RAY SUAREZ:

Representative Shays, what was your reaction to Judge Sullivan's ruling?

REP. CHRISTOPHER SHAYS:

Well, it's basically what we've been saying for a number of years. I'm getting an echo, by the way. This is a program that is basically illegal. That's what the judge said, and he put an injunction and said stop the program. He said stop the program because they are using our troops in an experimental program. This vaccine is a 1950s vaccine. The only thing it has going for it, that it's old, not that it's good. It's six shots, not one shot. And because of that, there are side effects because of its not being as pure a vaccine as a newer one and we have troops that simply don't want to be guinea pigs.

RAY SUAREZ:

Do you feel you have the science to back you up on this, doctor?

DR. WILLIAM WINKENWERDER:

Well, I think the congressman's characterization of the program is not accurate. I certainly respect Congressman Shays. He and I have worked together on this issue. This is an FDA-licensed product.

We've been using it, fully aware by the FDA, under the licensing terms for six years. There is a study, the Institute of Medicine of the National Academy of Sciences, produced an exhaustive 250- page study totally independent of the Department of Defense that said the vaccine is safe and it's effective against all forms of anthrax, including inhalational anthrax. And so we obviously were quite perplexed and surprised by this decision by the judge, but we're going to comply with our legal obligations. We're going to do the right thing. I would just say that speaking as a physician, speaking as someone who has to be responsible for the health and safety of our service members, I believe that the vaccine is safe and effective, and I believe it's an important layer of protection that we're able to offer them when we know that the threat is still there. It's still real in certain parts of the world and we know that terrorist groups have expressed a keen interest in bioweapons. And anthrax is right at the top of the list.

RAY SUAREZ:

Congressman, you said it's an old drug. Does that necessarily mean it's a bad drug?

REP. CHRISTOPHER SHAYS:

No, it doesn't mean it's a bad drug for what it was intended. It was intended for not thousands, not hundreds of thousands, not millions. It was intended for hundreds of veterinarians basically. That's what its intention was for. And it was proved and approved by the FDA for that purpose not for weaponized defense. It wasn't approved for the use it's being used for right now.

That's why the judge ruled that this program is illegal. It's illegal because it is not FDA approved for the purpose for which it is being used. It is not voluntary and when you do an investigative process like they're doing, it has to be voluntary. It's crazy that this was universal. They were having people at the Pentagon having to take this, not just the folks that were going into the Middle East. It was a program done by the past administration for the life of me I don't know why this administration is insisting on doing this program. Let me say, we said in our report in 2000, get a new drug — not six shots — one shot. They simply have been slow to do that. It's just really a pathetic program that is so regretful that they consider to keep going on. It just boggles my mind.

DR. WILLIAM WINKENWERDER:

— Not respond to that — again with all due respect to the congressman, if I recall correctly, Congressman Shays, you were commending the program when we reinitiated it and commending our efforts in June of 2002 when we restarted the program indicating that it was thoughtful and appropriate. And so that along with … I'm not going to substitute anyone's opinion for the best experts who have looked at this and who have come to the conclusion that the vaccine is safe and effective. That does not address the…

REP. CHRISTOPHER SHAYS:

Is it FDA-approved for the purpose it's being used? The answer is no. That's why the judge threw it out. You can't invent something….

DR. WILLIAM WINKENWERDER:

Congressman, we have sought the judgment of the FDA on this issue. This was sought in 1997 and the statement….

REP. CHRISTOPHER SHAYS:

They did not approve it.

RAY SUAREZ:

Let me jump in here.

DR. WILLIAM WINKENWERDER:

Let me just say that the statement that was provided was the use that we had put forward in front of them for the protection against inhalational anthrax and raised that question, their response was not inconsistent with the current labeling. That is for other forms of anthrax. That's very common. In medicine that a different indication or different use for the very same … it would be as if we were saying that for influenza that whether you got the influenza by ingesting it in your mouth or on your skin or as opposed to inhaling it in your lungs that there was somehow a difference in terms of how flu vaccine works. The science doesn't support that. The science says that if it works against the bug, it works against the bug. So that's what the experts have said. That's been our interpretation. That's been the FDA's interpretation. Obviously the judge here has substituted his judgment but this needs to be clarified.

RAY SUAREZ:

A quick response, congressman. Do you want more study to check that this is right against inhaled rather than the skin form of anthrax?

REP. CHRISTOPHER SHAYS:

In 1996 they applied this drug to be an investigative new drug. The FDA has not approved it. There have been no protocols to establish this program. They just basically invented this program. You're supposed to have six shots. They don't do six shots. That's what the protocol says.

Now when they didn't have enough vaccines and they made it voluntary I said that's a good step. That's a wise thing to do. Make it voluntary and in certain very specific instances make it mandatory if the president signs off. I think that makes sense. I can't tell you how strongly the veterans and others and the people in the military resent that they're being used as guinea pigs.

RAY SUAREZ:

I'm going to have to jump in and stop this now. We'll revisit this issue when the Department of Defense comes up with a response.

DR. WILLIAM WINKENWERDER:

Can I make one last point.

RAY SUAREZ:

Sorry, we're out of time. Thanks a lot, doctor.

DR. WILLIAM WINKENWERDER:

Thank you.