May 29, 2008

Even Fort Detrick Scientists Themselves Think the Killer Anthrax Came from their Facility

See below site for links:

Even Fort Detrick Scientists Themselves Think the Killer Anthrax Came from their Facility

Diary Entry by George Washington

Even experts at the U.S. bioweapons facility at Fort Detrick think that the anthrax which was used in the 2001 attacks came from their facility:

"In an e-mail obtained by FOX News, scientists at Fort Detrick openly discussed how the anthrax powder they were asked to analyze after the attacks was nearly identical to that made by one of their colleagues.

"Then he said he had to look at a lot of samples that the FBI had prepared ... to duplicate the letter material," the e-mail reads. "Then the bombshell. He said that the best duplication of the material was the stuff made by [name redacted]. He said that it was almost exactly the same … his knees got shaky and he sputtered, 'But I told the General we didn't make spore powder!'"

Indeed, 3 of the 4 suspects the FBI is investigating are employees of Fort Detrick, which is run by the Army.

This new information verifies that the anthrax came from the Fort Detrick military base
(confirmed here).

Some people are pretending that someone unconnected with the army bioweapons facility at Fort Detrick stole the anthrax. However, as the above-quoted article states:

"Fort Detrick is run by the United States Army. It's the most secure biological warfare research center in the United States," a bioterrorism expert told FOX News."
It is not very likely that someone could steal anthrax from the most secure facility in the U.S., run by the Army.

Indeed, the FBI apparently knew in 2002 who mailed the anthrax letters. See this, this, and this.

And yet government investigators and prosecutors have covered up and refused to disclose who did it for 6 years. Initially, the FBI tried to frame an innocent man for the attacks.

More importantly, "The FBI has completely shut Congress out of its now five-year investigation into anthrax attacks on Capitol Hill and around the nation". In other words, Congress -- which legally has every right to know what really happened, and which was the main victim of the attack -- is being kept in the dark. If the FBI really didn't know who did it, and was really conducting an honest investigation, why would it stonewall Congress?

There is strong evidence that the anthrax attacks were a false flag attack. Indeed, the bioweapons expert who actually drafted the current bioweapons law (the Biological Weapons Anti-Terrorism Act of 1989) while working for President George H.W. Bush has said that he is convinced the October 2001 anthrax attacks that killed five people were perpetrated and covered up by criminal elements of the U.S. government. The motive: to foment a police state by killing off and intimidating opposition to post-9/11 legislation such as the USA PATRIOT Act and the later Military Commissions Act. See also this.

At the very least, the FBI and the White House are actively covering up for the person who really did it.

May 27, 2008

Emergent BioSolutions To Buy Maker Of Flu Vaccine

By Kendra Marr
Washington Post Staff Writer
Tuesday, May 27, 2008; Page D01

Emergent BioSolutions, in a push to diversify beyond its biodefense business, plans to announce today that it is buying Protein Sciences, a maker of a next-generation flu vaccine that federal regulators have put on a fast track to approval.

Under the deal, which includes assumption of debt and future payments, Rockville-based Emergent could pay $75 million or more for Protein Sciences, which is based in Meriden, Conn.

At the start of the year, Emergent chief executive Fuad El-Hibri said the firm's key growth strategy would be to acquire products in late-stage testing. The company has felt pressure to move beyond biodefense, which mostly relies on government contracts. Protein Sciences' vaccine, which is in late-stage testing, fits into Emergent's plans.

"Looking at our vaccine pipeline, this is our most advanced one," El-Hibri said.

Each year, 5 to 20 percent of the U.S. population gets the flu, according to the Centers for Disease Control and Prevention. Vaccines are reformulated every year to combat the three most common strains of the circulating flu virus. To manufacture the flu vaccine, drug companies for decades have been injecting flu strains into chicken eggs. The eggs incubate the virus, which is later killed and bottled into the vaccine.

The system is too time-consuming and inflexible to respond to pandemics or flu-shot shortages, such as the one in 2004.

"One step relies on the previous step, which relies on a previous step," said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. "If something goes wrong, you're in trouble."

Also, a bird flu pandemic could wipe out the egg supply.

Protein Sciences' vaccine, called FluBlok, would not rely on eggs. Instead, the vaccine would be grown in insect cells. The result: a more easily manufactured vaccine that can quickly react to evolving flu strains and vaccine demand. Such vaccines are more controlled, flexible and predictable, Fauci said.

"It will allow us to manufacture the vaccine sooner and get it to the customer before the start of the flu season and faster than our competitors," said Jim Jackson, Emergent's chief scientific officer.

Approval from the Food and Drug Administration will take time. The next steps include an inspection of FluBlok's production facility in Meriden. Emergent plans on keeping Protein's 50 employees, as well as production, in Meriden.

"There are still risks getting it through the finish line," El-Hibri said.

Emergent's move into flu vaccine production may prove to be well-timed.

In February, a CDC panel voted to expand annual flu vaccination to nearly all children, excluding infants younger than 6 months and those with egg allergies. About 30 million more children could be vaccinated.

Emergent's primary business has been anthrax vaccines. Since 1998, Emergent has delivered 20 million doses, mostly to the Defense Department. Last year, it won a three-year, $448 million contract to provide 18.75 million doses for the national stockpile.

However, some soldiers have reported serious side effects, and Emergent's anthrax vaccine can take 18 months and six shots to produce immunity.

This month, the company paid its rival VaxGen $2 million for a new anthrax vaccine that promises to produce immunity faster.

In buying Protein Sciences, Emergent will also acquire the technology behind FluBlok, which the company has also been using for a SARS vaccine in early development.

Because FluBlok is in late stages of testing, Emergent hopes it won't be much of a gamble.

Emergent is not changing its revenue projection for 2008, keeping it at $180 million to $195 million.

"A lot of biopharmaceuticals have growth through acquisitions," said Eric Schmidt, a biotechnology analyst with Cowen in New York. "It's not an unproven strategy, but it's not risk-free, of course. You have to select the right candidates and products to acquire."

If the flu vaccine is approved, it would put Emergent on a short list of diversified biotechs.

"In biotech, for better or for worse, it's not too uncommon for companies to have their fortunes tied to a single product," Schmidt said. "It's rare for a biotech company to have more than one product on the market."

May 23, 2008

Anthrax Vaccine Loses to Lobbying

Politically Connected Firm Knocked Out Bay Area Start Up for Choice Contracts
By Arthur Allen 05/19/2008 -->| 3 Comments

Update: The Department of Health and Human Services sent a response after this story was originally posted. The department's comment has been inserted.

Six-and-a-half years after someone mailed finely milled anthrax spores to the U.S. Capitol, the industry created to respond to that attack has received billions in cash but produced little protection. A little-noticed news item last week reveals the most dramatic failure of the $5.6 billion Bioshield program, which was supposed to provide drugs and vaccines against terror agents--its cornerstone being the creation of a safe, effective vaccine against anthrax.

As demonstrated by the anthrax mailings—a case the FBI has yet to crack—deadly anthrax bacteria are a real potential threat. The most likely assailant in the October 2001 attack was an American scientist, perhaps someone who wanted not to kill, but to focus Congress' attention on the bioterror threat.

If that's the case, the attack was extremely successful. But in the so-far fruitless effort to get a better vaccine, the government has ruined one company that was developing an inventive solution while it has allowed another, politically well-connected firm to reap the benefits.

Last week, Emergent Biosolutions, which has been making a crude anthrax vaccine since the 1960s, under various names, quietly purchased recombinant anthrax vaccine technology for the bargain-basement price of $2 million. It bought the vaccine from Vaxgen, a sophisticated, San Francisco-area company that the government drove out of business through its bungled management of the Bioshield program. Vaxgen, which once had more than 300 employees, now has six, and is basically in the process of selling off its assets.

Emergent, which is based in Rockville, Md., but makes the old vaccine at a plant in Lansing, Mich., used an army of lobbyists to undercut Vaxgen’s relationship with the Dept. of Health and Human Services. In late 2006, HHS canceled a $878 million contract with Vaxgen, leaving the company holding the bag for more than $150 million it had spent to develop the vaccine. HHS said Vaxgen had failed to meet production deadlines; Vaxgen executives said they were delayed by minor technical problems that have since been clarified.

Vaxgen continued to improve its recombinant anthrax vaccine after HHS cut it loose, but it was unable to find a major drug company to buy it. After witnessing what HHS had done to Vaxgen, former company officials say, none of the major vaccine makers wanted to enter a contract with the government.

Emergent, on the other hand, was nothing if not politically connected. Its chief executive and his wife, for example, alone donated more than $220,000 to lobbying and political campaigns. Emergent had lobbied for years to paint Vaxgen as unreliable, and it ended up buying its vaccine for a song.

The story of the recombinant anthrax vaccine stands as the most poignant fiasco of the Bioshield program. President George W. Bush announced the program in 2003, during a visit to the National Institutes of Health. Bush said the program would “put NIH squarely in the midst of our war to defend America and to defeat international terrorism.”

The idea was to provide government stimulus to get drug companies to make products that had no market other than the government. Many scientists and public health officials believed it could have the secondary benefit of stimulating the development and manufacturing of much-needed civilian vaccines, at a time when the nation’s vaccine industry had been reduced, effectively, to five companies.

But five years later, companies that signed deals with HHS to produce anthrax vaccines, as well as drugs to fight radiation sickness, have dropped out of the program after acrimonious disagreements. One company, Acambis, has delivered a successful new vaccine against smallpox--a disease that was eradicated in 1980 and is believed to exist only in two secure laboratories. Except for a related effort to make pandemic flu vaccines, none of the big vaccine manufacturers have bought into the biodefense program.

Perhaps the most egregious fallout from Bioshield, however, was the destruction of Vaxgen, a company that included some of the country's most talented and experienced vaccine manufacturers. It was led by Lance Gordon, a scientist who helped create more than a dozen vaccines -- including a groundbreaking meningitis shot now given to all children in the United States, Europe and Latin America.

“It’s a horrible story,” said Donald Francis, the former president of Vaxgen. “We spent $150 million of our own money and $100 money in NIH to develop a vaccine. We miss a deadline and they jerk the contract and destroy the company. And there aren’t many vaccine companies. They took a high-tech company capable of making vaccines and killed it!

“This is a symptom of a government that doesn’t know what it’s doing when it comes to interacting with the private sector,” said Francis, who now leads a non-government organization that promotes vaccination in poor countries. “The Pentagon knows how to do things like this. Health and Human Services had never contracted out anything this big, and they didn’t know what they were doing.”

Under the terms of its contract with HHS, Vaxgen was obligated to use an aluminum-based adjuvant, or immune-stimulator, in the vaccine. But the adjuvant and the anthrax protein interacted in a way that caused the vaccine to lose potency. As a result, the company wasn’t able to meet its deadline for delivering the vaccine. “With trial and error we could have fixed the problem,” another former Vaxgen executive said. “It wasn’t a fundamental safety or efficacy problem.”

But Emergent, which was already producing an outdated anthrax vaccine, spent large sums of money on a lobbying campaign against Vaxgen, including hiring two former aides to Vice President Dick Cheney. Congressmen like Michael McCaul (R-Texas) and Mike Rodgers (R-Mich.), both recipients of Emergent executives’ campaign donations, attacked the Vaxgen contract in committee hearings, while Emergent’s lawyers wrote newspaper op-eds attacking the company.

What’s more, HHS frequently changed officials in charge of overseeing the contract, and none seemed to understand the complexities of making vaccines, the Vaxgen officials said. This impression was echoed by two other officials -- one at another company, the other at the Centers for Disease Control -- who asked not to be named.

While HHS has said it followed the letter of the law in canceling the contract, Vaxgen officials say it caved to political pressure. “We were under the illusion that if we did good science, we’d win out,” the official said. “That’s not how this works. Politics played a more important role than science." A government scientist familiar with the deal said that while Vaxgen was not blameless, its problems were typical of the trial-and-error nature of the vaccine-making process.

HHS spokesman Bill Hall denied that the agency had erred in withdrawing the Vaxgen contract. Vaxgen missed its deadlines and failed to fix its problems, he said, and HHS was still pursuing a recombinant anthrax vaccine.

The Vaxgen vaccine uses a refined anthrax protein and is designed to require three doses for long-term immunity. HHS signed the deal with Vaxgen to place the 1950s-vintage vaccine produced by Emergent, formerly called Bioport. The older vaccine, made from material extracted from living bacteria, requires six doses -- and yearly boosters.

In 1998, Bioport took over the Michigan state biologics laboratory, the nation’s sole manufacturer of anthrax vaccine. Starting with the Gulf War, all U.S. service members have received the vaccine. Many have blamed it for a variety of health problems, including autoimmune disorders. While expert panels have refuted claims that the vaccine causes seriously problems except in rare cases, resistance to the vaccine created a morale problem on some military bases. In 1998, for example, pilots at Dover Air Base in Delaware refused the vaccine, forcing their commander to suspend vaccination against anthrax.

After signing the 2004 contract with HHS, Vaxgen had two years to come up with 25 million doses of vaccine. In November 2006, the vaccine was not ready, and the contract was canceled.

But since the Vaxgen fiasco, the government has relaxed the rules, so that Emergent -- which, according to its Website, expects to seek an HHS contract for the vaccine soon -- will have several years to deliver it. The government will also provide milestone payments and cover development costs -- something it didn't do for Vaxgen.

“If we had had that system two years ago," said Gordon, "Vaxgen would probably already have provided millions of doses of a vaccine already to the national stockpile.”

But the Emergent company spokeswoman, Tracey Schmitt, said, "We believe that Emergent has both the experience and expertise to pursue development of this important medical countermeasure to meet the United States government's stated need." She declined to comment on the rest of this article.

Perhaps the worst fallout of the affair is the loss of Vaxgen. Over the past 30 years, most vaccine manufacturers have gradually gotten out of the business. The United States has to import all of its whooping cough vaccine, as well as more than half the 110 million doses of flu vaccine it uses every year. “If there were a bad flu year—not to speak of a pandemic—we would need hundreds of millions of doses,” says Gordon. “And during bad flu years, most countries prohibit export of their flu vaccine.”

Vaxgen had built a factory in South Korea, originally to make an HIV vaccine (which failed), and has another state-of-the-art factory in South San Francisco sitting idle. “We were becoming a company that could develop and manufacture a number of vaccines,” says Gordon, who recently started a new biotech company. “As a result of the cancellation of contract, that was thrown away.’’

Gordon tries to view the latest twist in a positive light. “I’m glad that someone picked up our recombinant vaccine,” he said. “From my perspective, it’s a good product. I’m hopeful that the huge investment and time and effort that went into it won’t go to waste.”

For $2 million, Emergent bought enough vaccine antigen to make millions of doses, along with the recipes it needs to make the vaccine. Including NIH and other funds, more than $250 million was spent to develop it.

“I hope we never find out whether it’s really effective in humans,” added Gordon. “God willing, another major anthrax attack will never happen.”

May 9, 2008

Airmen who refused anthrax vaccine could have their records cleared

False: "The vaccine has long been approved for use against anthrax contracted through the skin."

Truth: FDA never licensed the anthrax vaccine until December 2005, and this is why the AVIP was illegal prior per the summary judgement by the DC District federal court, which the DC Appeals Court declined to vacate or overrule. The federal court's affirmed since that the program was "not substantial justified", and that any attempt to imply the program was legal previously is "fiction."

By William H. McMichael -

A federal judge’s decision could lead to clearing the records of military personnel who refused to take mandatory anthrax shots between 1999 and 2004.

Judge James Robertson of the district court for the District of Columbia admonished the Air Force Board for the Correction of Military Records, which had rejected a petition by two former Connecticut Air National Guard officers for compensatory relief for back pay and lost promotions after they claim they were forced to resign for refusing the vaccine.

The plaintiffs, Thomas Rempfer and the estate of the late Russell Dingle, based their appeal on a separate anthrax vaccine lawsuit.

Robertson said the Air Force records board mistakenly characterized that lawsuit as a victory for the government, when it was not, and cited that conclusion in rejecting the petition.

The board is a civilian entity empowered to review Air Force records “when necessary to correct an error or remove an injustice.”

In early 1998, Rempfer and Dingle were appointed to look into concerns they and other unit members had about the vaccine’s efficacy against airborne anthrax, which the Pentagon considered the likeliest threat against troops. After their review, they felt the concerns were justified, refused an order to be vaccinated and were disciplined, as were what is believed to be hundreds of other service members.

Rempfer and Dingle’s estate want their personnel records corrected to reflect their work with that task force, to document that their discharge was an “illegal constructive termination” and to get back pay and allowances, plus rank and points lost as a result of that termination.

In his March 14 decision, Robertson wrote that the Air Force board must reconsider the cases “and explain its conclusions about the merits of plaintiffs’ constructive discharge claims and their accompanying demands for compensatory relief.”

In other words, said John J. “Lou” Michels, a pro bono attorney for the plaintiffs, the court told the board: “You’re wrong, and you’re going to have to reassess your opinion. And when you reconsider this matter, we’re going to look very closely at your basis. You’re disagreeing with a federal court ... it’s not your job to do that. It’s the federal court’s expertise. You’d better have a pretty good justification.”

Along with forcing review of the plaintiff’s claims, the decision could open the door for other service members who may have similar complaints, Michels said.

But some claims could be blunted by a six-year statute of limitations on civil cases. In fact, Robertson ruled that time had run out on two of the three claims made by Rempfer and Dingle.

“For a lot of these folks, time has run out, which is why I think we need some legal redress on this, or an executive decision,” Michels said in an April 24 interview.

“What this should do is send a very clear message to Congress that this whole program was wrong from the very beginning,” Michels said.

The Pentagon “illegally injected people with an uncertified vaccine,” he said. “It seems to me a legislative fix is in order so that these kids don’t have to go out and hire lawyers to get their records fixed.”

Michels said Congress also should order the Veterans Affairs Department “to do a much better job of going out and finding people who took the vaccine, were sickened, and get them care for their injuries — very similar to what they did for Agent Orange folks.”

The vaccine has long been approved for use against anthrax contracted through the skin. In a 2003 decision, U.S. District Court Judge Emmet Sullivan sided with six anonymous military litigants to rule that the Food and Drug Administration had never approved the anthrax vaccine for protection against inhaled spores and that it was being used for an “unapproved purpose.”

It was this ruling that the Air Force board misinterpreted, Robinson found.

Sullivan’s decision, Robertson wrote, meant that up to that time, forcing service members to take anthrax shots violated federal law.

The Pentagon had to suspend its involuntary program for most of the time between December 2003 and February 2007, until after the FDA ruled that the vaccine was safe and efficient for all forms of anthrax and the Pentagon could obtain new supplies.

Inoculations are required for service members and emergency-essential and equivalent Defense Department civilians assigned for 15 or more consecutive days to the U.S. Central Command or U.S. Forces Korea areas.

May 7, 2008

Florida Court Mulls Liability for Anthrax Death

The Florida Supreme Court is considering whether the U.S. government and an Ohio research firm can be held liable for an anthrax mailing that killed a journalist in 2001, the Associated Press reported yesterday (see GSN, Aug. 3, 2007).

American Media Inc. photo editor Bob Stevens received an anthrax-tainted envelope on Sept. 19, 2001, and died just over two weeks later. Maureen Stevens claimed in a lawsuit that the material that killed her husband came from a U.S. Army biological defense laboratory in Maryland or the Battelle Memorial Institute.

U.S. Justice Department attorney Jeffrey Bucholtz and Battelle attorney Tami Lyn Azorsky in oral arguments yesterday contended it was not possible to anticipate the 2001 anthrax mailings because the material had never previously been used in acts of terrorism. They noted that their clients possessed the anthrax to develop treatments and protective measures.

Attorney Phillip Burlington, representing Stevens, said the entities should have foreseen the possibility of someone acquiring the anthrax for illicit use. It remains unknown who mailed the anthrax that killed five people or how that person obtained the disease agent.

“When you are dealing with biological warfare materials it is not unreasonable in this day and age to expect the government to reasonably anticipate that, or a private lab,” Burlington said.

The arguments were conducted at the request of a federal appeals court determining whether the lawsuit, which includes negligence claims for failing to secure the anthrax, has legal grounding. There was no word on the schedule for a decision by the Florida court (Bill Kaczor, Associated Press/Google News, May 5).

May 6, 2008

VaxGen sells anthrax vaccine candidate to Emergent BioSolutions

SOUTH SAN FRANCISCO, CA (Thomson Financial) - Biopharmaceutical company VaxGen Inc. said it has completed the sale of all assets and rights related to its recombinant protective antigen (rPA) anthrax vaccine product candidate and related technology to Emergent BioSolutions Inc. Under the terms of the transaction, Emergent BioSolutions paid VaxGen an initial $2 million and may be obligated to pay up to an additional $8 million in milestone payments, plus specified percentages of future net sales.