Dr. Meryl Nass talks anthrax (continued)

Q: So this is a gold mine for somebody.

A: Admiral [William] Crowe, the former head of the Joint Chiefs of Staff, was given a free percentage of BioPort, the anthrax vaccine manufacturer, to join the board and be a spokesperson.

Q: Are there other situations like that, people moving out of the military into these kinds of positions?

A: Now that we’ve had those letter attacks, there are a lot more companies that stand to make money on a variety of medical measures for bioterrorism. There are a number of people, usually at the level of colonel, who have left to take, say, a vice-presidency at a biotech company that’s working on biodefense. Some of the people, including a couple of generals, who were in favor of the anthrax program while they were still active duty, have subsequently retired and gotten contracts — for instance — to write a report that was sponsored by BioPort on the need for bioterrorism protection with vaccines.

There’s a fellow named Colonel John Grabenstein, who is the deputy director of the Military Vaccine Agency. It used to be called the Anthrax Vaccine Program, but he got an expanded portfolio. This guy has consulted for a number of major drug manufacturers, has compiled information on all existing vaccines, he’s the chairman of a committee of the American Pharmacists Association to allow pharmacists to prescribe vaccines, so that you could actually get a vaccination when you go into a drugstore. His organization has pushed through legislation in over 30 states to allow this [ed. — this is common practice, though not technically legal in Maine].

Q: And he’s currently working as the head of the vaccine office for the Army?

A: He’s a career Army guy. He’s done all this consulting on the side, yet he’s been active duty from the beginning and he’s gotten all his degrees through the military. This one guy is very prolific, very sneaky, very smart, and he stands to make a killing personally when he leaves the military. He has practically single-handedly created a whole body of documents and studies that purport to show that the vaccine is safe and effective. It’s crap, and the FDA even on the package insert that accompanies every anthrax vaccine does mentions that the Army has these studies but they have a variety of methodological errors.

Q: This insert comes with every dose of the vaccine?

A: Yes. But if you’re in the military you never get to see it.

Q: What happens now? On October 27, Judge Sullivan said the vaccinations have to stop. Obviously the issue isn’t dead.

A: Well, as you know, [Secretary of Defense Donald] Rumsfeld said we’re going to figure a way around this, but I think they’re going to have a hard time because the judge was extremely clever and ruled very narrowly. I don’t think they’re going to be able to win an appeal. What I think will happen is that they already knew they had a lousy vaccine.

Q: They’ve got contracts out for new vaccines.

A: Fort Dietrich developed a number of alternative anthrax vaccines. One of them they picked up and decided it would be the next-generation vaccine. I don’t know why they picked that one because it really didn’t have anything in particular to recommend it. They picked this company to manufacture it that they had no business picking.

Q: Why’s that?

A: They had never manufactured a vaccine before. They had failed on their previous vaccines they’d developed. The company had been filing false financials, there were several lawsuits against it, and it had been thrown off the NASDAQ.

Q: What was the name?

A: VaxGen. Why would you pick this little company that is under a lot of intense scrutiny — the CEO and some other people had to resign a few months ago — and the government gave them close to a billion dollars to manufacture 75 million more doses of this vaccine. Who picked 75 million? Who decided that you only need three doses? There’s no data to suggest that three is the appropriate number. It was a political decision.

Q: Are there any connections between VaxGen and the military?

A: There’s got to be connections between VaxGen and somebody. There’s no good explanation for why anyone would pick this company to make anything.

Q: Judge Sullivan’s ruling wouldn’t have any effect on a new vaccine, right?

A: That’s correct.

Q: Okay. What are the projections on when this new vaccine will be ready to roll?

A: There’s two ways you can be ready to roll now, which again is a new way the government has come up with to deal with the fact that they have these garbage vaccines. Now they’ve come up with this new category — and I have a query in to the FDA asking what this means — called "licensable," and they’re using this as a justification to purchase huge quantities of unlicensed drugs and vaccines for the national stockpile, and that’s how they’re justifying the VaxGen purchase.

Q: How do they know whether something is licensable?

A: Well, who knows? That’s what I asked the FDA. I said, "Now that you’re using this as a regulatory term, I’d like the definition." There’s nothing in the Food, Drug, and Cosmetic Act that allows them to do this. It’s just some bullshit they concocted. That vaccine is probably not licensable, because in the Phase I study, compared head-to-head with the BioPort vaccine, there were more than twice as many bad systemic adverse reactions.

Q: From bad to worse.

A: Yeah. They published that data on the Phase I trial, but they’re into Phase III now. See, they don’t have to give you any information.

Q: It’s all proprietary.

A: All proprietary until it’s licensed, and then if it stays "licensable," it’s all proprietary until you vaccinate the whole country with it.

Q: Did you have anything specifically to do with the suit Judge Sullivan just decided?

A: I didn’t have to testify. I did review a lot of the filings, and I consulted. My colleague John Richardson was the brains behind the lawsuit. He’s a retired fighter pilot who flies for American Airlines. My colleague Russ Dingell is one of the guys who left the Connecticut Air National Guard. He’s only 48 or 49 and he’s dying of cancer now. He’s spent the last six years researching this issue, and he became an expert on FDA law and all the documents that have been filed regarding this vaccine, so he was a tremendous resource on this. The two lawyers who did this worked pro bono — one, again, is a retired fighter pilot who became a lawyer, and the other got involved early on, defending some of the original refusers back in 1998.

Q: Is there a single umbrella organization that filed the suit?

A: We have a loose affiliation, we don’t have an organization.

Q: Whose name was on the suit as plaintiff?

A: We had filed similar lawsuits previously and they had been knocked out of court because by the time they were heard, the people had been either court-martialed and thrown out or retired . . . they were no longer subject to having to get the vaccine. We had six plaintiffs, some civilian DoD employees and some military. The names of those plaintiffs were given to the judge but they were not made public.

Q: Do we need to be vaccinated for 50 diseases?

A: And what happens to us if we are? The deputy director of the biowarfare program in the Soviet Union did get about 50 bioterrorism vaccinations, and he says he’s allergic to tons of things now. There’s only a few foods he can eat because of this. He’s quite concerned. Unfortunately, one thing the military has a dearth of is people who will speak out against the current policy. You’ve got a bunch of yes-men. That’s the only way you get promoted in a peacetime military. Until the military actually cares about getting things right, you can’t make any inroads. They’re more powerful than Congress. They basically control the FDA and CDC. They gave $2 billion in contracts to CDC a couple of years ago. They give a free military aide to almost every member of Congress, and the job of that person is to control what happens in the office.

We had about 13 congressional hearings that dealt with the anthrax vaccine, and we had a lot of people in the House and Senate very concerned. Whenever one of them became concerned, a parade of generals would come in to convince them that we were nuts. And it works. We can never get the majority of Congress on our side on a military issue.

Q: The odds are stacked against you, it seems.

A: I know, but we had one honest judge. The suit was filed the day we went into Iraq, and somehow it got under the radar.

Q: Are there other lawsuits pending about the vaccine?

A: Yeah, there are a variety. There’s one with about a hundred plaintiffs regarding the illnesses. There’s one about a woman who was thrown out because she was concerned about pregnancy risk, and when the vaccine was relabeled, it was relabeled with a higher pregnancy risk. And there are a few others percolating through.

Q: What’s next for you?

A: I continue to be a resource for all these different people. I was called on behalf of a Merchant Marine who’s ill from the vaccine now. The judge decided that the government could be made a defendant in the lawsuit, so now for the first time we have the possibility of getting discovery against the Defense Department. But what will probably happen is they’re so afraid of discovery that they’ll settle.

Alex Irvine can be reached at airvine@phx.com