By Nicholas Regush

I note today that Dr. Timothy Johnson, my colleague at ABC News, also has problems with the anthrax vaccine. He wrote:

"I personally need to see more data on safety and effectiveness before I would consider getting the six shots currently recommended, even if they become available."

Good for you Tim! That makes at least two of us (I'm sure there may be more) in the mainstream media who have considered the science on the vaccine and have come away with serious questions about its use against the inhalation of anthrax. See Tim Johnson's "On Call" column at ABCNews.com. And also see my "Second Opinion" column on that site and the Red Flag Daily postings below for details, particularly on the issue of the vaccine's effectiveness.

Much of the anthrax vaccine focus these days in the media has been on whether BioPort, its manufacturer, will receive approval from the FDA to release the vaccine, and whether the company, which has a contract with the U.S. military, can eventually produce enough of the product for anyone who wants it.

That's NOT the right focus. Our attention is being diverted from seeking new ways to protect ourselves effectively and safely against anthrax. Foolish money that will go into the making and distribution of a suspect vaccine could be used to further other research on how an anthrax infection might be stopped.

Politics

Desperation by the military to have a vaccine for its service members is hardly a reason to take a flying leap off a cliff and hope for the best. This desperation smells too much of politics. Careers are hanging on the line.

If the Department of Defense really had a ton of faith in the anthrax vaccine and the manner in which it has been licensed, it would have asked the White House for a presidential waiver that would allow the vaccine to flow freely. The FDA has prevented its distribution because of serious quality-control problems in the manufacturing process, including contamination of the vaccine.

FDA Review

The FDA will soon conduct another review of the vaccine, supposedly to determine if BioPort has made the necessary changes to its manufacturing procedures. The company says it has done so. If the FDA agrees, this could result in allowing stockpiles of it to be released to the military and full-scale production.

There has been a slowdown, almost to a crawl, in providing the vaccine to service members because of FDA actions against the company. The military has been left with only a small stockpile. But poor quality manufacturing of the vaccine should NOT be the only issue that needs to be resolved.

One Legal Matter That Should Be the Focus of Media Reports on the Vaccine

One key question should be: Has this vaccine ever been approved for use against inhalation anthrax? The approval in 1970 centered on use by individuals who came in contact with animal products such as hides, hair or bones, which could have been contaminated with anthrax.

The concern was infection via the skin. The military has since claimed that the original licensing covers all forms of transmission of the disease. How very strange, considering the history of the anthrax vaccine.

For example, on September 20, 1996, the manufacturer submitted a request (an investigational new drug application - IND 6847) to the FDA for new labeling of the vaccine, which would indicate use for inhalation anthrax. (They also wanted a change in dosage and the manner of administering the vaccine).

On October 15, 1996, the Army placed an ad in the Washington Post, calling for experimental subjects for research related to the manufacturer's new IND. Very intriguing. Here we have the projected consumer of the product (the Army) acting as the principal investigator, rather than the manufacturer or its scientific associates. Is this a conflict of interest?

Well, the FDA wasn't amused by the come-on in the ad. The agency wrote to the chairman of the Army's Human Use Committee at Fort Detrick, objecting to the misleading statement that the vaccine had already been licensed and approved for use.

Yes, it was approved for use, but only for its initial labeling, and not for inhalation anthrax, the new indication being requested by the manufacturer. The ad was "misleading in that potential subjects could think the safety and efficacy of the product has been established for the purposes for which it is under investigation."

I might emphasize here that the manufacturer's updates to its 6847 IND have made it clear that the purpose of its application was to get approval for use of the vaccine against inhalation anthrax.

Reading through the various testimonies on the anthrax vaccine given at congressional hearings in the past several years, one wonders whether history means anything anymore to either the FDA and the Department of Defense. Or maybe you simply ignore what has transpired - even if there is a strong paper trail- and then yield to political considerations.

Since the FDA reprimanded the Army for its 1996 ad, there has been one attempt after another by the military to suggest that the initial licensing of the anthrax vaccine covers use against inhalation anthrax. This is nonsense.

Red Flag Daily October 10, 2001

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