>So just to settle this, here's what This Tara O'Toole person at Johns
Hopkins >said, according to The Observer:
>- ----------------------------------
>Tsonas was also interviewed, and his notes examined, by experts at the
Johns
>Hopkins Centre for Civilian and Biodefence Strategies.
>There, Dr Tara O'Toole reached the same conclusion, saying 'I am more
>persuaded than ever' that the correct diagnosis is cutaneous anthrax."
And, among many omissions, what the reporter fails to point out is that worldwide there are as many as 2000 reported cases of cutaneous anthrax annually (and since most don't result in death, there might well be more where access to healthcare is non-existent). Given the presence of it in Florida's soils, one has to wonder why the doctor didn't even suspect it in the first place, if the lesion seemed to be so unusual (even if he was oblivious to the guy being a terrorist).
>However, the same story has the FBI saying:
- ----------------------------------
>Federal investigators, however, have said they are targeting someone with
>knowledge of science, possibly a scientist with military links, in their
>hunt for those behind the anthrax attacks.
>The New York Times quoted FBI spokesman John Collingwood as saying the
>possibility of a link between the alleged hijackers and the anthrax attacks
>had been fully investigated months ago. 'Exhaustive testing did not support
>that anthrax was present anywhere the hijackers had been. While we always
>welcome new information, nothing new has in fact developed.'
Like Collingwood of the FBI, I find the diagnosis now less than compelling. And it sure does seem to be the case that the activities at Ft. Detrick are related to the anthrax letters. Johns Hopkins, by the way, is the single largest receiver of US gov't R&D money, coming in at a whopping $300 million.
>So what about those military links (more - much more - at the end of this
>post)?
- ----------------------------------
>http://www.sunspot.net/news/custom/attack/bal-te.anthrax24mar24.story?coll=
bal-home-headlines
>"In recent weeks, FBI agents have repeatedly visited the Army's biodefense
>center at Fort Detrick in Frederick, one of more than 20 laboratories in
the
>United States and several foreign countries that have the Ames strain of
>anthrax used in the mail attacks.
The strains might have been exported to Saudi Arabia, which, apparently, was working on biowarfare programs to counter the great Iranian menace (and then the Iraqi menace as well).
If anyone can figure out what actually went on and is going on with Bioport, Inc. (apparently their old web site which used to list Carlucci's cronies from the DoD and the Lebanese guy in name is now down), they might get pretty close to a major scandal.
Bioport was allowed to acquire the only means of providing an anthrax vaccine to the US troops (and the US population). But it looks like:
1. the anthrax is alleged to be unsafe with pretty good evidence of that , and the NY Times pointed out it didn't get the usual FDA approval
2. that it was another insider deal that got Bioport the contract in the first place (Bioport is a company that is not really open to public scrutiny, but its ownership is being traced back to an Arab Lebanese who apparently worked with the Saudi biowarfare programs and who set up the company so Carlyle Group--you know Carlucci, Baker and the Bushes) could take a stake.
3. Bioport is basically using old techniques (for one thing the 6 dose requirement sounds a lot like very old anthrax vaccines) packaged as new and it turns out isn't very good at doing that even--it can't produce enough of the vaccine even for the military, let alone the population at large (for like an event where someone explodes a bomb that disperses anthrax in an urban area).
This is an excellent link for the lowdown:
http://www.pittsburghlive.com/x/tribune-review/opinion/datelinedc/s_9935.htm l
And the follow excerpts and articles are also very informative background info to what should be yet another scandal for the Bush-Cheney-Ashcroft regime (and yes, the O'Toole at Johns Hopkins pops up, saying it's regrettable the contract for the vaccine didn't go to a real pharmaceutical company while also criticizing someone for lack of funding, never mind the fact that Bioport got its exclusive deals because it was supposed to have the capability to produce the vaccine in the first place ).
----------------------------------- http://www.partnersforimmunization.org/anthrax.html
1.Cutaneous anthrax: Up to 2,000 cases of cutaneous anthrax occur worldwide in humans each year. Most of these infections (about 95%) occur when the bacterium enters a cut or abrasion on the skin. Infections begin as a raised itchy bump resembling an insect bite and progress to a fluid-filled blister with a black dying area in the center. Lymph glands may swell in the areas surrounding the blister. While approximately 20% of untreated cases will result in death, such deaths are rare (<1%) when the infection is treated with the appropriate antimicrobial therapy.
VACCINE: Anthrax vaccine was first licensed in the US in 1970 and is produced by Bioport Corporation, Lansing MI (formerly Michigan Biologic Products Institute). The vaccine is a cell-free filtrate that is produced from a form of anthrax that does not cause disease. Since its licensure, the anthrax vaccine has been safely administered to at-risk wool mill workers, veterinarians, laboratory workers, livestock handlers and the US military. The vaccine is currently given in a 6-dose series over an 18-month period. The duration of protection from disease following vaccination is unknown. Approximately 30% of men and 60% of women will experience temporary reactions such as soreness, redness, itching, swelling and lumps at the injection site. Muscle aches, joint aches, headaches, rash, chills, fever, nausea, loss of appetite, malaise or related symptoms will occur in 5% to 35% of persons vaccinated. Severe allergic reactions may occur in one out of 100,000 doses administered and rare serious events such as those requiring hospitalization occur once per 200,000 doses.
-----------------------------------
http://www.nti.org/d_newswire/issues/2001/11/13/9s.html
Anthrax Vaccine Protested
About 40 demonstrators protested against the U.S. military’s anthrax vaccination program over the weekend outside the Michigan headquarters of BioPort Corp (see GSN, Nov. 12), which is the only U.S. manufacturer of the vaccine. Protestors also demonstrated outside the state Capitol in Lansing, Michigan.
The Defense Department and BioPort are ignoring signs of illness in many of the 500,000 troops who have been inoculated, protestors said. The vaccine is linked to medical complaints such as chronic fatigue, memory loss and bone and joint pain, according to the protestors. They said that the Pentagon has not done enough to investigate the vaccine’s long-term effects.
“Something is wrong with the vaccine,” said Steve Robinson with the National Gulf War Resource Center. “You don’t have to be a scientist to figure it out.”
BioPort Medical Director Tom Waytes said 18 studies have shown that the anthrax vaccine is safe.
An independent panel of physicians has examined over 1,500 claims of adverse reactions to the vaccine, according to Waytes. The panel found no pattern suggesting that the anthrax vaccine caused more adverse reactions than any other vaccine, Waytes said (Associated Press/Washington Times, Nov. 13). -----------------------------------------------
http://www.newsmax.com/archives/articles/2001/10/6/01001.shtml
Sole Source of Anthrax Vaccine Isn't a Source at All
Phil Brennan, NewsMax.com Monday October 8, 2001
The only laboratory in the U.S. capable of making crucial anthrax vaccine hasn't been able to produce a single dose of the vitally needed immunilogical substance in the face of a potential bioterror attack using deadly anthrax agents.
Meant to be the source of the vaccine to be used to immunize the military from the deadly anthrax disease, Michigan's BioPort Corporation, the sole supplier of anthrax vaccine to the military has not produced a single dose since 1998, when it bought the plant from the state, according to Saturday's New York Times.
Writing in the Times, correspondent Stephen Kinzer reports that BioPort has been plagued with problems from the very beginning, including poor documentation and improper procedures in the room where the vaccine was packaged, according to FDA inspectors.
While the company says it hopes finally to begin producing anthrax this year it still must pass another FDA inspection, which has yet to be scheduled.
BopPort's problems are well known by the government. Last year, Arkansas GOP Senator Tim Hutchinson called the company's record "an unmitigated disaster," noting that its failures were "costing the American taxpayer millions and millions of dollars and jeopardizing the safety of our troops who we're not able to provide that anthrax vaccination."
The company is not without its sympathizers, however. "There's a lot of criticism of BioPort," Tara O'Toole, deputy director of the Center for Civilian Biodefense Studies at Johns Hopkins University told the Times. "But to be fair, there's also a lot of talk that the Defense Department significantly underfunded the whole effort and didn't give it the priority it deserved."
"In retrospect," O'Toole added "the whole notion of turning this over to a new contractor instead of an established pharmaceutical company looks questionable."
While BioPort is working frantically to get into production, the fact that there is at present no source in this country of a vaccine that could mean life or death to Americans in the event of an anthrax attack is a critical one, especially since many experts say that if terrorists launch a biological attack using biological agents, they would most likely use anthrax.
The Times reveals that even though anthrax is reportedly hard to produce and spread in large doses, any enemy that was able to do so could inflict horrendous damage on their targets.
"A 1993 government study found that spraying just 220 pounds of aerosol anthrax over Washington could kill up to three million people," the Times reported, noting that Osama bin Laden has also taken an interest in chemical and biological warfare.
"It's a good bio-terror weapon and even better for biological warfare, and it's lying on the ground in places like Afghanistan" William Dietrich, an assistant professor at Harvard Medical School told the Times.
Dietrich, who is researching the anthrax bacterium added. "If you have a collection of soldiers you want to kill without infecting your own population or soldiers anthrax has good properties with regard to that. If you can produce it and disperse it on a battlefield, you can kill a lot of people very quickly. It's a very terrible, high-fatality kind of illness that we don't have enough tools in our arsenal to stop."
The Times says that should the company finally pass its next FDA inspection and can resume production, the first several million doses will go solely to the military.
The Defense Department is BioPort's sole customer, spending $126 million in the plant over the last decade, according to the Times. The military plans to immunize all 2.4 million active and reserve troops against anthrax but have so far managed to begin immunizing only about 500,000, mostly those in the Persian Gulf.
Anybody else will simply have to wait, scarce comfort at a time when an anthrax attack by terrorists remains a real possibility.
------------------------------- http://www.naplesnews.com/01/10/florida/d677302a.htm
hurdles for vaccine
Thursday, October 11, 2001
By KATHY BARKS HOFFMAN, Associated Press
LANSING, Mich. ? With heightened concern about anthrax since a Florida man died from it, the only U.S. manufacturer of a vaccine to fend off the disease is facing growing criticism.
Bioport Corp., under contract to provide the vaccine for the military, has been unable to ship any of its product during its three years of operation. It has been stymied by its failure to meet federal drug agency standards for its renovated plant here.
And questions have arisen over Bioport's ability to produce the anthrax vaccine, and over whether the Pentagon's exclusive contract with the company has kept newer, better vaccines from being developed.
"It's very expensive to do this right," said Tara O'Toole, deputy director of the Center for Civilian Biodefense Studies at Johns Hopkins University. "Nobody wanted to pay what it was worth."
BioPort Corp. officials insist they have made the changes necessary to produce the vaccine and on Monday plan to submit new information to the U.S. Food and Drug Administration.
The FDA has up to six months to review the information, and Bioport is hopeful it could ship the vaccine for use by early next year.
"There is a formidable stockpile available," BioPort spokeswoman Kim Brennen Root said Tuesday. "This vaccine is the centerpiece of protection for the U.S. military."
Root declined to say how much of the vaccine is available, citing national security. The military refuses to say how much vaccine it has left, but it had only 60,000 doses last December. Root said BioPort has been manufacturing the vaccine even as it awaits FDA approval.
The vaccine has come to the forefront as the United States and its allies began military strikes to root out the terrorist organizations. At least 10 countries are believed to have the capacity to produce biological weapons using anthrax.
Citizens worried about a bioterrorist attack in this country have called BioPort and a company it's working with in Spokane, Wash., asking if they can get immunized. Most health officials see little need for a nationwide anthrax immunization program, even if any of the vaccine were available.
Root said that any decision by Bioport to set aside some vaccine for civilians will have to be made by the departments of Defense and Health and Human Services. Other companies are attempting to develop a vaccine, but those are years away.
Anthrax produces a toxin that can cause severe damage to the respiratory system and brain, killing untreated patients within days. Treatment with antibiotics is often successful if the infection is caught in time.
Production of the vaccine requires live anthrax bacteria which must be carefully stored. So manufacturing has been limited for decades to one building, a squat brick facility in a quasi-industrial section on Lansing's north side.
But the amount is too small and isn't in a form that would be of use to terrorists, company officials have said. Michigan National Guard troops have been stationed at the plant since last week, however.
Since buying the aging facility from the state in 1998, BioPort has spent $1.8 million to upgrade it and $15 million to expand, with much of the money coming from the federal government. It also got the Pentagon to triple the per-dose payment, increasing its government contract to more than $50 million.
But it hasn't been able to pass FDA requirements to ship the anthrax vaccine. The lab failed FDA inspections in 1999 and 2000, mostly for packaging problems.
The company still has some vaccine that was made when the state produced it before BioPort bought the plant. But some of that vaccine has expired or failed potency or purity tests while in storage, according to a government report.
Lingg Brewer, a former state representative who opposed the sale of the state laboratory to BioPort, said the money the Pentagon now is spending on its BioPort contract would be better spent on letting others come up with a different vaccine, or even on stockpiling more antibiotics to treat anthrax infections.
He wants to make sure the FDA, if it grants BioPort approval to ship vaccine, does so for the right reasons.
"The FDA is under tremendous pressure to cave on this," Brewer said. "It's really important to let the FDA do its job."
Root said BioPort has no desire to have the FDA cut corners.
O'Toole, of Johns Hopkins, criticizes Pentagon officials for underestimating the amount of money and time it would take to turn BioPort into a major manufacturer of the anthrax vaccine.
Calls to the Pentagon for comment were not returned.
This isn't the first time the relationship between BioPort and the Pentagon has been criticized.
Last year, the Committee on Government Reform issued a report that accused the Pentagon and BioPort of having a relationship that blocked the creation of newer and better forms of the anthrax vaccine, left the vaccine program vulnerable to supply shortages and price increases and left the Pentagon "captive ... to a single, untested company."
The report also raised doubts over whether the anthrax vaccine, which was created in what was then a state-owned laboratory in 1970, would work against airborne anthrax in biological warfare. The vaccine is given in a series of six shots over 18 months. The Pentagon has said it offers protection as soon as the third shot is given, one month after the first shot, but others have disputed that.
The report even questioned the vaccine's safety, noting that some military personnel and reservists said the military-required vaccines they took in the late 1990s made them ill.
BioPort officials have repeatedly said they have a viable program to produce the vaccine and that it is safe. Since the Sept. 11 attacks, the company's 220 employees are more eager than ever to do their part to protect U.S. troops, Root said.
About 500,000 of the 2.4 million troops and reservists the military wants to vaccinate have received the vaccine.
Other companies seeking anthrax vaccine; production years away
As BioPort Corp. of Lansing, Mich., awaits U.S. Food and Drug Administration approval to ship its anthrax vaccine, several labs are trying to make a better one:
n Vaxin, in Birmingham, Ala., is working on a genetically engineered anthrax vaccine that could be given with a skin patch.
n Scientists from biotech firm EluSys Therapeutics say they are developing an antidote to anthrax that soldiers would inject before entering combat.
n Goutam Gupta, a biologist at Los Alamos National Laboratory, is doing research on "decoy molecules" that would fool anthrax and HIV bacteria into latching onto the decoy, allowing the body's immune system time to destroy the invaders.
n Scientists from the University of Texas Health Science Center, Brooks Air Force Base and Southwest Foundation for Biomedical Research are studying salmonella to see if it could prove valuable in developing oral vaccines against anthrax, tularemia and other potential biological weapons.
n Seattle-based Corixa Corp. has been working with a $3.5 million grant from the Department of Defense to develop drugs administered by inhaler or nasal spray that would fight anthrax and other diseases.
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Posted by Charles Jannuzi