Vaccine link raised in U.S troops' deaths

WASHINGTON, Aug. 5 (UPI) -- The U.S. Army should look at whether the anthrax vaccine is behind the unexplained cluster of pneumonia cases among soldiers in Iraq, according to the co-author of a government-sponsored study that last year found the vaccine was the "possible or probable" cause of pneumonia in two soldiers.

Dr. John L. Sever of George Washington University Medical School told United Press International Tuesday that he expects the military to consider the anthrax vaccine, among other possibilities, as it investigates pneumonia among soldiers in and around Iraq, where troops have been widely vaccinated against anthrax.

The Pentagon announced Tuesday it is investigating 100 cases of pneumonia among soldiers in Iraq and southwestern Asia. Two have died. Fifteen have had to be placed on respirators.

"As physicians, I would think they would be looking at all possible causes. I would think vaccines would be part of that," said Sever, a medical professor at George Washington who was one of six authors of the study. Col. Robert DeFraites from the Army Surgeon General's office told reporters at the Pentagon briefing Tuesday that biological warfare -- including smallpox or anthrax -- was unlikely to be the cause of the pneumonia. He did not mention vaccines as a possible cause, and the issue was not raised by reporters.

DeFraites and spokeswoman Virginia Stephanakis of the Army Surgeon General's office did not return calls Tuesday asking whether the Pentagon was looking into a possible vaccine connection.

Sever said the anthrax vaccine study, printed in the May 2002 issue of Pharmacoepidemiology and Drug Safety, found that the vaccine was the "possible or probable" cause of pneumonia among two soldiers. The Department of Health and Human Services convened the group, called the Anthrax Vaccine Expert Committee, which studied 602 reports of possible reactions to the vaccine among nearly 400,000 troops who received it, Sever said.

In addition to identifying pneumonia and flu-like symptoms among troops who received the vaccine, the group also looked at four other cases of potentially serious reactions, including severe back pain and two soldiers who had sudden difficulty breathing in a possible allergic reaction to the vaccine.

Sever described the two cases of pneumonia as "wheezing and difficulty breathing going into a pneumonia-like picture."

To conduct the study, the Anthrax Vaccine Expert Committee examined reports from the U.S. military to the Centers for Disease Control and Prevention; they are anecdotal reports and do not necessarily show a cause-and-effect relationship.

DeFraites said the two deaths under investigation by the Army Surgeon General occurred in June and July and that both soldiers had been in Iraq. He said the investigation began as soon as the first death occurred. In a case apparently not included in that total, 22-year-old Army specialist Rachael Lacy of Lynwood, Ill., died at the Mayo Clinic in Rochester, Minn., on April 4 of what one doctor diagnosed as pneumonia, after receiving anthrax and smallpox vaccinations but without ever having been deployed.

Dr. Eric Pfeifer, the Minnesota coroner who performed the autopsy, told the Army Times that the smallpox and anthrax vaccines "may have" contributed to her death. "It's just very suspicious in my mind...that she's healthy, gets the vaccinations and then dies a couple weeks later." He listed "post-vaccine" problems on the death certificate.

Moses Lacy, Rachael Lacy's father, told the Army Times that she called in March and said she had chest pains and breathing problems and had been diagnosed with pneumonia.

One service member who was deployed to Kuwait and received the four-shot anthrax series told United Press International Tuesday he developed bronchitis and a severe cough after receiving his shots, and that about a fifth of the troops he was deployed with had similar symptoms and were prescribed medicine to treat them. His symptoms continued after he returned to the U.S., and he sought further treatment at a base clinic. He got better, but believes he nearly came down with pneumonia.

The Pentagon dispatched two teams to look into the pneumonia: one to Iraq and another to a U.S. military base in Landstuhl, Germany, where some sick soldiers are treated.

Tom, with all due respect you are wrong. It has not been given for decades at all. Before the Gulf War less than 2200 people ever got the old vaccine under the Brachtman study and none of those people were followed up on and they only got a three shot series. There is NO DOD data supporting any such instance of mass innoculation at all. Even during Gulf War I there was horrible tracking and the VAERS reports were underestimated and not encouraged as many soldiers did not know of it.

These facts can not be denied. DOD had to stop telling its people that it was widely used by Vetrinarians and Livestock handlers too. It was never the case. Follow up by GAO and others to the largest Vet schools like Iowa State U. and Texas A&M and others revealed that even the schools which are on the leading edge of the technology in vet medicine NEVER took the vaccine, never reccommended it and none of the instructors who were program heads ever even saw it. Livestock associations in states like Colorado, Montana, Utah, and Texas confirmed the same thing.

Its not that people did not get sick either. The Vaccine Adverse Event Reporting System, (VAERS) is a passive system. It requires the sick to make the report. During Gulf War I, the clinics in the military made the reports and washed them of the ones they deemed not needing forwarding. GAO in testimony to Congress proved an under-reporting of the VAERS forms by a factor of over 100. As a result of the blatent misunderstanding or falsehoods people were told, hundreds of folks never reported missing work for over 24 hours which constitutes a "SYSTEMIC" reaction.

Women react upwards of 70% of the time and men over 40%. This is one of the worst records in vaccines.

Its not some drum-beat against the institution of the Military, heck, I am in it and am proud to be so, but it is a program with highly problematic issues, a lot of sick people.

Isnt the vaccine a bit of a stretch if they had it months before getting sick?

Not necessarily. Most people who have had systemic reaction to this vaccine did so after shots 4 and 4 in the 6 shot series. Since the DOD claims, without any medical proof, that you are considered vaccinated afterjust 2 shots they do the following. You don't get this shot unless you are going into the theater of operations. It was nearly eneded until the mailings in DC. Even President Bush said "We need a new Vaccine" about Anthrax Vaccine. Anyway, the troop may get 1-3 shots prior to going to theater.

Shot one happens day one.
2 weeks later shot 2,
Two weeks later shot 3,
5 MONTHs later, shot 4,
6 MONTHS later shot 5,
6 MOMTHS later shot 6,
Then once a year after that continually.

You can see that there is a big lag time from when people go to when people typically reach the point where if they are going to react they do so. No, not all will react, but way to many do to call this a good vaccine. Besides, the vaccine has no proven ability against aerosolized anthrax challenge. It was made in a much less potent form for cutaneous anthrax which is the kind developed by skin contact.

How the heck should I know? I'm just saying there's a good possibility of an existing virus, endemic to the area, that we aren't used to.

Whenever a disease first hits a new population, the effects are very severe. Think of the Indians and smallpox. They had no natural resistance to the virus because they'd never been exposed to it before. The effects on the Indians who caught the virus were much more severe and fatal than it would have been for a European catching the virus. It didn't affect the Indians in the same way it affected the Europeans.

It's also the reason why people who travel to different countries often get diarrhea from eating the food and drinking the water, no matter how "clean" it is. There are bacteria that are natural to an area that exists in the food and water supply, and the natives, of course, are used to it. Even someone coming to the States from a third-world hellhole is likely to get the runs for a few days, because he's not used to the bacteria that our bodies are used to.

The same thing may be happening with our soldiers and this pneumonia. I would rule out a strain or mutation of a virus that is unique to Iraq before I started looking at anything else.

There is only one anthrax vaccine. It has been liscensed in this country since 1970, and it has been used by the military almost as long. I'm not sure how you can say it isn't safe and effective when there is no evidence to the contrary.

Then I guess the DOD is lying?? They have NEVER used it prior to Gulf I, Tom. Not once. It was developed by Merk in the late 50's at Ft. Detrick, MD. From that the bractman studies were commensed. It was a test for cutaneous Anthrax, and never considered for any kind of reaction to a bio-warfare agent. The facts do not support any kind of "Used safely and effectively since 1970" at all. If it were the case the FDA would have record you could get from them by FOIA request.

The DOD took an existing formula, gave it to Michigan Biologics Health Products Inc. and told them to make it for them in a great more potent form. The GAO proved without shadow of doubt that the formula was changed, the fermentation process alone dictated that a new license be issued and heres the part you may have difficulty with, the FDA has NEVER licensed this one because they NEVER completed the licensing process on the vaccine. They have admitted so as well. Hundreds of thousands of troops have received the vaccine and yet you want to blame a cluster of illness in Iraq on it. If the vaccine is responsible, why aren't we seeing it prevalent elsewhere. This strains credulity.

Yes, they have and the reactions alone drove the FDA to renew the package insert, Tom. It used to be the mantra you heard all day long from the DOD. They used to have briefings where they told people over and over and over thet the vaccine had a .07 reactagenic rate.....So, Tom, tell me why the FDA raised that from .07 to 35.0? This represents a 17,500% INCREASE in reactagenesis. This rate would have the product pulled from shelves and lawsuits a pleanty. Under Then Secretary of the Army Louis Caldera the company, Now called Bio-Port, was Indemnified. Only the 2nd company to be so ever for a health product by the DOD. the first one was the company that gave the swine flu vaccine in the 1970's. That was pulled after 3 linked deaths. We have 6 deaths attributed RIGHT ON THE PRODUCT LABLE and now more being considered. Let me guess, its all an Overreaction? Yes, it just happens to be a health one. Out of those thousands of people who have taken it we have well over 2000 VAERS reports. Take the underreporting factor of 100% plus the ones never sent in and you have a serious risk pool.

A very serious paper about Operational Risk Management was applied to this program and showed the DOD what a serious flaw it was to even institute it. It has more proof than I show here and all the places where it is documented. Below is the first page followed by the link to the whole document.

---------------------------------

Several events have occurred since our previous Process Analysis of the Department of Defense (DoD) Anthrax Vaccine Immunization Program (AVIP) that suggests a renewed scrutiny of the risks of both the vaccine and of weaponized anthrax. We will perform the review utilizing the US Air Force’s Operational Risk Management (ORM) Program. Air Force regulations define ORM as the systematic process of identifying hazards, assessing risk, analyzing risk control options and measures, making control decisions, implementing control decisions, accepting residual risks, and supervising / reviewing the activity for effectiveness. The facts presented in the following paper reveal five major areas of risk concern to the Department of Defense (DoD) and the Department of Veteran’s Affairs (DVA):

· A vaccine originally licensed with incomplete scientific data;
· A vaccine whose license the FDA has yet to be finalized;
· A vaccine produced with unapproved, adulterating manufacturing changes;
· A vaccine known by DoD officials to be experimental for inhalation anthrax;
· And a vaccine that could burden DoD and DVA with significant liability.

Based on these documented risks and this review, the DoD should implement the following recommendations:

· Conduct their own legal, medical and ORM analysis of the AVIP;
· Procure antibiotics, external protective garments, and biodetectors;
· Comply with the law and obtain a Presidential waiver or an “animal efficacy rule” approval for inhalation anthrax if continued use of the anthrax vaccine is desired;
· Expunge the records of any servicemember punished for refusing the anthrax vaccine;
· Minimize use of the anthrax vaccine, pending the deployment of the new anthrax vaccine as directed by the President of the United States in 2002;
· And develop a doctrinally sound, institutionally coherent, legal and ethical process for dealing with biological, chemical and other asymmetric threats in the future.

Click here and click cancel when prompted

Here are the results and conclusions from the study that was done by Dr. Sever and referenced in the main article you posted:

Results

Nearly half the reports noted a local injection-site AE, with more than one-third of these involving a moderate to large degree of inflammation. Six events qualified as serious AEs (SAEs), and all were judged to be certain consequences of vaccination. Three-quarters of the reports cited a systemic AE (most common: flu-like symptoms, malaise, rash, arthralgia, headache), but only six individual medically important events were judged possibly or probably due to vaccine (aggravation of spondyloarthropathy (2), anaphylactoid reaction, arthritis (2), bronchiolitis obliterans organizing pneumonia)

Conclusions

Since some cases of local inflammation involved distal paresthesia, AVEC recommends giving subcutaneous injections of AVA over the inferior deltoid instead of the triceps to avoid compression injury to the ulnar nerve. At this time, ongoing evaluation of VAERS reports does not suggest a high frequency or unusual pattern of serious or other medically important AEs.

Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.