September 27, 2007

Rockville biotech wins $448M contract for anthrax vaccine

A quick view of anthrax/biothrax's safety profile:

Pregnancy - Category D (evidence exists of harm caused to fetus, including spontaneous abortions/miscarriages)
Deaths from vaccine: A potential 44 that's admitted
Serious Adverse Events: 12.5% (meaning life-long disability)
Systemic reactions: 5-35%

http://www.bizjourn e/stories/ 2007/09/24/ daily18.html

Emergent BioSolutions Inc. won a three-year contract worth up to $448 million from the U.S. Department of Health and Human Services to beef up the national stockpile of a vaccine for anthrax.

The Rockville-based biopharmaceutical company is delivering 18.75 million doses of BioThrax through 2010 to the government agency for $400 million.

The company said it anticipates delivering a third of the doses, or 6 million, by the end of the year.

If Emergent (NYSE: EBS) gets regulatory approval from the Food and Drug Administration to extend the drug's shelf life from three to four years during the three-year contract, the company will get an additional $34 million from the agency. The company submitted the application in 2006.

Under the contract, Emergent also will receive $11.5 million if the company gets a new pre-exposure prophylaxis indication that would allow the health agency to combine antibiotics with BioThrax in the event someone is exposed to anthrax.

The Department of Health and Human Services awarded the money through the Project BioShield Special Reserve Fund created by Congress in May 2004 following the anthrax scares in the fall of 2001.

Since 2005, Emergent has already provided the health agency with 10 million doses of BioThrax valued at $243 million.

Emergent lost $4.9 million in the second quarter ended June 30, compared with a $3 million loss a year ago. Second quarter revenue was $23 million, more than double the $11 million in the year ago quarter. The company's 2006 sales of BioThrax was $148 million.

September 26, 2007

Illnesses still dogging 25% of Gulf War veterans

By Les Blumenthal
McClatchy-Tribune News Service

WASHINGTON — Sixteen years after the Persian Gulf War ended, more than 1 in 4 of those who fought remain seriously ill with medical problems ranging from severe fatigue and joint pain to Lou Gehrig's disease, multiple sclerosis and brain cancer, the chairman of a congressional advisory committee testified yesterday.

But even as more is learned about what's now called Gulf War Veterans Illness, the Defense Department and the Department of Veterans Affairs remain in virtual denial about its causes and have been slow to offer treatment, said James Binns, head of the research advisory committee on the disease.

"This is a tragic record of failure, and the time lost can never be regained," Binns told the Senate Veterans' Affairs Committee. "This government manipulation of science and violation of law to devalue the health problems of ill veterans is something I would not have believed possible in this country until I took this job."

The hearing was called by Sen. Daniel Akaka, D-Hawai'i, chairman of the Senate committee.


Pentagon and VA officials defended their approach to studying and treating Gulf War Veterans Illness, saying they're taking it seriously, funding clinical and other research, and are committed to ensuring that Gulf War veterans receive needed care.

"Veterans who report health problems are definitely ill," said Michael Kilpatrick, the Defense Department's deputy director for force health protection and readiness programs.

Though the focus was on the earlier Gulf War, concerns hovered over the hearing that those now fighting in Iraq might face similar medical problems.

*** Fifteen percent to 20 percent of those who've fought in Iraq recently are returning with "ill-defined" medical symptoms, Kilpatrick said. He didn't elaborate.


Among those testifying was Julie Mock, a 40-year-old mother of two from Seattle who served along the Iraq-Kuwait border with a medical unit. In early 1991, the alarms of chemical detectors went off repeatedly, she said.

"We ingested expired pyrostigmine bromide tablets; we wore gas masks with expired filters, inhaled dust and sand in the air that was thick with the black of burning oil," she said. "I experienced respiratory difficulties, my skin grew hot with red rashes and I began to suffer from debilitating headaches."

Four years ago, Mock was diagnosed with multiple sclerosis, a chronic disease that affects the central nervous system. Her voice choking with emotion, Mock told the committee that her oldest son has Tourette's syndrome and a handful of other neurological problems. Her youngest son has some of the same disorders.

Mock said she was convinced that the predeployment vaccines she received and chemical and other environmental exposures she underwent while serving in Iraq caused her health problems and those of her children. Her husband also served in the Gulf War but in a different area. He hasn't reported problems with his health.

"We know persons who deployed with us in theater who have not been healthy since their deployment, and we know that there are many who have deteriorated slowly over the years and who are now in crisis," she said.

Of the 700,000 or so U.S. troops who served in the Persian Gulf War, 175,000 to 200,000 are sick, Binns said.

Others who testified said that in addition to the predeployment vaccines, the health problems that Gulf War veterans experienced might have been caused by exposure to the depleted uranium used in munitions and armor, low-level nerve agents such as sarin that were released when a large weapons depot was destroyed, and smoke from
more than 600 burning oil wells in Kuwait.

Pentagon and VA officials long have linked Gulf War Veterans Illness to battlefield stress and other related psychological disorders.

"That's garbage," Binns said. He said the Pentagon had cut important research programs associated with the illness.

The VA has conducted more than 330 projects associated with the health problems of Gulf War veterans. Because of "persistent concerns," the agency will launch a study next year of possible links between the veterans and brain cancer and multiple sclerosis, said Joel Kuppersmith, the VA's chief research and development officer.

"VA's commitment to funding clinical trials to identify new therapies for ill Gulf War veterans continues to this day," he said.

"We must all work together to make this a reality so that what happened to our troops in the first Persian Gulf War is not repeated," Akaka said.

The Associated Press contributed the Akaka quote to this story.

The Biggest FDA Reform In A Decade

The Biggest FDA Reform In A Decade

You wouldn't know it from the lack of fanfare, but the Food and Drug Administration is getting its biggest overhaul in a decade in a dramatic coda to Merck's withdrawal of the blockbuster painkiller Vioxx three years ago.

A bill to give the FDA more power passed both houses of Congress with only a handful of no votes, and the president is expected to sign it into law. Because the bill is attached to the re-authorization of an important part of the FDA's funding, a veto is unlikely. If the law doesn't pass soon, FDA head Andrew Von Eschenbach is going to have to start informing staffers that their jobs are no longer funded.

The bill represents a victory for advocates of higher standards for making sure that drug side effects are known and promptly dealt with. Before Vioxx was yanked, some of the changes being made would be unimaginable. Until now the claims drug companies like Merck (nyse: MRK - news - people ) and Pfizer (nyse: PFE - news - people ) made about their medicines were, to a degree, negotiated. Labeling discussions between Merck and the FDA dragged on, and as a result, the agency will now be able to dictate what claims companies can make with much more force.

Another change: The FDA will be able to force drug makers to do clinical trials even after a medicine is approved and fine them if they don't follow through. Previously, many big clinical trials regulators asked for weren't finished. And there will be more money to study side effects of new medicines post-approval. Companies will pay more in fees when they submit drug applications, increasing the amount of money the FDA gets from industry by 25% to $400 million.

One of the farthest-reaching changes may be a new requirement demanding that the drug companies list all of their clinical trials in a registry maintained by the National Institutes of Health accessible to anyone with an Internet browser. After the studies finish, the results will also have to be posted. This will expose drug companies to new levels of scrutiny about the safety of their medicines. (See: Lynch 'Em)

Rough-and-ready analyses of existing data set off the Vioxx controversy and the recent kerfluffle over the diabetes drug Avandia. Such analyses, where researchers try to combine different studies to get a better idea of what kinds of side effects emerge in incredibly large groups, also linked antidepressants like GlaxoSmithKline' s (nyse: GSK - news - people ) Paxil to suicide risk and the Johnson & Johnson (nyse: JNJ - news - people ) heart failure medicine Natrecor to kidney problems. In both cases, there are still debates about how real the risks are, but they put a squeeze on sales.

Lots of stuff didn't go into the bill. The Union of Concerned Scientists, while lauding the bill, worried that it didn't do enough to deal with the financial conflicts of FDA advisers. It appears to only increase the FDA's power to regulate direct-to-consumer ads a little bit. Pharmaceutical companies had at one point hoped that the bill would contain language that helped protect products that had been vetted by the FDA from product liability suits.

At one point, it looked as if the bill might address how the FDA should go about approving cheaper copycat versions of biotech protein drugs like insulin and human growth hormone. Right now, there's no mechanism for approving true generics of these products, which can be extremely expensive. Part of the reason: Complex safety issues arise because proteins are far more difficult to manufacture than the simpler chemicals in pills like Vioxx and Lipitor.

But all of these issues were Johnny-come- latelies to the Congressional debate. The focus was creating a more transparent FDA with the power to better study and regulate drug safety. Legislators were probably smart, in the end, to stick with the issues they had debated the most and approve a bill that is uncontroversial now but would have seemed like a radical step three years ago.

Hopefully, the changes will strengthen the FDA, renewing the public's shaken faith in the safety of medicines. Drug makers could wish for nothing more.

Emergent BioSolutions signs $448 mln contract

Sept 26 (Reuters) - Emergent BioSolutions Inc (EBS.N: Quote, Profile, Research) said it has signed a three-year contract worth $448 million with the U.S. health department, that includes delivery of anthrax vaccine, certain milestone payments and services.

The biopharmaceutical company said in a statement that it continues to expect full-year revenue growth of 10 percent to 15 percent, with a bias toward the upper end of the range, and positive net earnings. (Reporting by Deepti Chaudhary in Bangalore)

September 17, 2007

Soldier faces threats from military after refusing anthrax vaccine
Filed by Julie Weisberg

A soldier serving in Iraq who is stationed in Baghdad says he has faced “threats” and “intimidation” from his Army superiors – including the possibility of forced inoculations – after he refused to take the military’s controversial anthrax vaccine.

Private First Class Leif Hamre, 22, is currently serving out a Field Grade Article 15, a non-judicial punishment for disciplinary offenses, for refusing to take the Pentagon’s anthrax vaccine, BioThrax, earlier this summer.

According to Hamre, 22, the military gave him an ultimatum in late June: Either take the mandated six-shot anthrax series or face military punishment. He was given 24 hours to decide.

After conducting several hours of research into the drug and its history of triggering serious adverse reactions, the Minnesota native concluded that the “vaccine was dangerous” and “should probably still be in a lab right now for further testing.”

He decided to refuse it.

In March, RAW STORY revealed that Walter Reed is investigating links between the vaccine and life-threatening autoimmune diseases. Hundreds of US servicemembers have refused the shots, fearing the side-effects experienced by some 80 percent of the soldiers who receive them, according to a 2002 General Accountability Office report.

But the Army has not taken Hamre’s “no” as its final answer.

“The tactics they have used to coerce me into taking the shot are unregulated, unscrupulous and downright un-American,” Hamre wrote in a recent open letter to family, friends and others who are campaigning against the military’s mandatory anthrax vaccine program. “They have tried to turn my platoon against me in various ways (which is not totally unsuccessful). Along with the more common tactics like intimidation and threats (including the possibility of a forceful inoculation). I can only imagine what will come as I continue with this.”

During a recent interview with RAW STORY, Hamre’s mother, Mary, said that after her son refused the anthrax shot series he was assigned extra duty, taken off missions, significantly dropped in rank and pay scale, and confined to a certain area on the base – all while working an 18-hour work day, seven days a week.

Making matters even worse, she said, is the difficulty the family has had in trying to communicate with Leif since he refused the shots. Baghdad remains a volatile and unstable city, and the electricity is still very unreliable, frequently cutting in and out, and is only on for certain portions of the day. Hamre is pictured with Iraqis at right.

This has made speaking over the telephone to Leif sporadic at best, leaving the family to interact with him through a MySpace page.

Facing the possibility that he could be permanently dismissed from the military because of his refusal to take the anthrax vaccine has been hard on her son, Mary said, especially since Leif has been proud to serve his country and follow in the footsteps of his father, who also was in the Army. Mary, 55, lives in Minnesota and works as a massage therapist.

“They try to break them down... but someone has got to take a stand,” she said.

The Army did not respond to repeated requests for comment, even after several extensions.

A troubled vaccine

BioThrax is the only FDA-licensed vaccine for anthrax in the United States. The Pentagon has used it for the military’s mandatory anthrax vaccination program for the last ten years. Although the military continues to publicly claim the vaccine is “safe and effective,” thousands of soldiers have suffered adverse reactions.

The vaccine’s troubled history has made many soldiers wary of the required inoculations.

“It is natural for people to be concerned with medicines they are not familiar with,” Col. Randall G. Anderson, director of the Military Vaccine Program, said in an email to RAW STORY last week. “The DoD continues to educate our forces with a variety of products, such as individual briefings and trifold pamphlets.”

“Additionally, there is a great variety of medical misinformation available on the Internet,” he continued. “That is why the DoD focuses on providing facts about the disease and vaccine, based on science from credible organizations like the Institutes of Medicine and the Centers for Disease Control and prevention.”

A federal judge ruled in 2004 that the military’s mandatory administration of the vaccine was illegal because the Food and Drug Administration had not approved its use for inhalation anthrax, only for anthrax contracted through the skin. After FDA approval, the judge allowed voluntary injections. The Defense Department resumed mandatory shots again in March. The Pentagon continues to defend its efficacy and safety.

“I'll say once again, the vaccine is safe and effective,” former Assistant Secretary of Defense for Health Affairs William Winkenwerder said last year.

The Pentagon, however, has at least four separate research studies investigating the vaccine’s often debilitating side effects.

And even BioPort’s insurance company, Evanston Insurance, has questioned the product’s safety. Last December, Evanston filed suit against BioPort in federal court for what it termed BioPort’s “material misrepresentations,” alleging that the pharmaceutical company knew about but failed to disclose “incidents, conditions, circumstances, defects, or suspected defects” related to the vaccine’s safety.

Evanston has assisted and reimbursed the company for legal costs associated with BioPort’s defending itself against numerous lawsuits filed by service members who claim they have been seriously injured by BioThrax.

BioPort initially filed a motion to dismiss the case, but that motion was denied earlier this year, and the case continues to move forward in the Michigan federal court system.

Cause of vaccine’s side effects unknown

It remains unclear what within the drug is triggering such severe autoimmune reactions in many of the soldiers who take it. The Army has yet to publish any information or findings related to its several research studies on the vaccine’s adverse reactions.

Although some have pointed to previous problems with the vaccine’s manufacturing process and stability, many feel the more likely culprit is the use of the experimental adjuvant -- or immune enhancer -- squalene. Traces of squalene were found in several batches of the anthrax vaccine several years ago.

Squalene, an oil-based adjuvant that is often used to boost the effectiveness of experimental vaccines at Army and NIH research centers, has not yet been approved by the FDA for use in public vaccines because of safety concerns. The adjuvant is frequently used by researchers to deliberately trigger severe autoimmune reactions in mice and other animals for research projects.

Hamre said when he began asking his own questions about the vaccine and how it is stored at his Baghdad base’s medical aid station, he not only found that the clinic was violating the Army’s own implementation standards regarding storage temperatures, but met stiff resistance to his queries from superiors.

“The result of asking questions today about a quality control issue with their storing equipment got me more than a few dirty looks and even an under-the-rug threat to my safety,” Hamre wrote.

Mother defends son’s decision

Although his mother said his future in the military is uncertain, Hamre said it is important for him to continue to refuse the vaccine and question its necessity, safety and efficacy, in hopes his struggle will make a difference in protecting the well-being and health of future Americans who choose to serve their country.

“I believe as an American soldier you are expected to follow orders and put yourself in harms way but unnecessary safety risks should not be part of the accepted risks one is asked to face,” Hamre wrote. “We are being forced to accept chemicals into our already weary bodies that have caused the suffering of thousands of individuals; of course those people are easily dismissed by the government because they took a ‘safe’ drug.”

“One thing bothers me, though,” he added. “I am an American citizen too, with rights I thought we were fighting to protect.”

Leif entered the Army when he was 20, which was two years this July. He is scheduled to conclude his service in the autumn of 2008. His unit, however, is slated to rotate out of Iraq and return home in December, where they will be stationed in Anchorage, Alaska.

Leif will serve in Alaska until his term is up next year.

September 12, 2007

South Texans donate plasma to defend against anthrax
Wendy Rigby, KENS 5 Eyewitness News

The threat of terrorism became clear in the fall of 2001. Just after the Sept. 11 attacks, five people were killed in anthrax attacks.
Now, South Texans are taking part in a donation process to save lives in the event of another anthrax scare.

At Nabi Pharmaceuticals in downtown San Antonio, donors roll up their sleeves to give plasma, the liquid component of blood.

As part of a federal program called Project Bioshield, San Antonians who have been vaccinated for anthrax can donate their plasma to a national stockpile.

Dr. Ronald Brown says it's an important part of America's plan to be prepared.

"September 11th was a real wake-up call, and it made us realize that we don't have sufficient stockpiles of certain types of medications," Brown said.

Volunteers for the project are given the anthrax vaccine before donating plasma twice a week for a month.

A machine is used as a centrifuge to separate the blood components. The red blood cells are returned to the donor.

The plasma is separated and sent off to make an anthrax immune globulin or a medication that would be given to people who inhale anthrax or who are at risk from the deadly toxins released in their bodies.

Robin Weyrich, a plasma donor, says it's an easy way to help.

"Somewhere down the line somebody's going to ... what I'm doing is going to help somebody else. And at my age, you know, there's not a whole lot I can do for a lot of people, but this I can do," Weyrich said.

The Department of Health and Human Services has contracted to collect 10,000 doses of the anthrax immune globulin, which can't be created in a lab and can only come from people.

"As a physician, personally, I can say that you know, probably the greatest thing we could do is do something to prevent somebody from dying. And this medication is truly is going to save their life," Brown said.

Plasma donors involved in the anthrax project are paid for their time and trouble. To find out more about Project Bioshield, go online and visit

If you would like to become a donor, call (210) 224-1749 or stop by Nabi Pharmaceuticals at 711 Broadway.

September 11, 2007

Lawmakers concerned over slow pace of anthrax vaccine acquisition
By Zack Phillips,

More than three months have passed since the Health and Human Services Department closed an early solicitation for anthrax vaccine, and a bipartisan group of lawmakers wants to know the results.

Rep. Bennie Thompson, D-Miss., chairman of the House Homeland Security Committee, and six other panel members wrote HHS Secretary Michael Leavitt on Monday to express concern that the department is not moving aggressively enough to acquire the anthrax vaccine.

In May, HHS released a notice seeking to identify potential manufacturers of a next-generation vaccine based on recombinant protective antigen (rPA) technology that does not use the anthrax germ itself. That solicitation closed in June. The notice said the department anticipated that a formal solicitation would be released in July, with proposals due in November, but HHS has yet to release such a request.
The lawmakers asked Leavitt how many responses the department received to the notice, and what the timeline is for issuing a formal request for information or proposals.

Spokesman Marc Wolfson said the department was expecting to release a request for proposals before the end of the year.

Delays have beset Project BioShield, a $5.6 billion program meant to lure pharmaceutical companies to the traditionally less lucrative biodefense market. The anthrax program has been a particular problem. Last December, the department terminated a contract with Brisbane, Calif.-based VaxGen Inc., the highest profile BioShield contractor, for 75 million doses of a next-generation anthrax vaccine based on the rPA technology.

VaxGen had pushed back its delivery date several times and was unable to begin its Phase 2 trial by the HHS-imposed deadline of Dec. 18. The department subsequently released the sources-sought notice for 25 million doses of a new rPA-based anthrax vaccine, but it has not said how many responses it received.

"We remained concerned that this cancellation impedes development work and sends the wrong signal to private sector companies who would seek contracts under BioShield," the letter said.

VaxGen and San Diego-based Hollis Eden Pharmaceuticals, which formerly was developing a countermeasure to radiation sickness, have said they will no longer pursue biodefense products out of frustration with HHS. And Thompson's letter said that British vaccine manufacturer Acambis, the government's main supplier of smallpox vaccine, also has decided to leave the biodefense market.

The letter also expressed concern about an implementation plan HHS released in April, because the plan scheduled the next round of acquisition of anthrax antitoxins -- which would counter multidrug-resistant anthrax -- until at least fiscal 2009, and possibly as late as fiscal 2013.

Acquisition delays are significant because many private sector firms say that for investors to fund the costly drug development process, they need unambiguous commitments on how much of a countermeasure the government plans to buy. Delays and uncertainties make investors less interested in funding such projects, they say.
As of September, the government's Strategic National Stockpile had 10 million doses of the current generation anthrax vaccine, made by Lansing, Mich.-based Emergent BioSolutions. That vaccine also has had problems, with concerns about side effects and safety leading some soldiers to sue to stop a mandatory vaccination program in the military. HHS posted a notice in April of its intent to buy another 10.4 million doses from Emergent, with an option for another 8.35 million doses, around July 24. The department and company are still in negotiations.

Emergent and the British firm Avecia Biotechnology are developing rPA vaccines, which would require fewer doses than the current generation vaccine. VaxGen is trying to sell its rPA vaccine program to another entity, although HHS' sources-sought notice precluded responses from companies with an Investigational New Drug application on hold with the Food and Drug Administration -- a condition that applies to VaxGen's vaccine.

September 7, 2007

DON'T MISS the Montel Williams Show, Friday, Sep 7

PLEASE WATCH veterans who believe our health problems were caused by the anthrax vaccine (2 are sick from exposure to depleted uranium) on Friday, September 7, 2007.

Episode Detail: Dying to Serve? - Montel Williams
"Military personnel and exposure to depleted uranium; the Defense Department's policy on anthrax vaccination for servicemembers. Guests include Kelli Donley, a former Air Force captain who says she became ill after receiving the anthrax vaccine [Diagnosis: Spinocerebellar Ataxia]; and Raymond Ramos, a former National Guard sergeant who believes he was sickened by depleted uranium."

For a detailed summary of "Dying to Serve," and to check local air times & channels, go to

OkCity KAUT- Ch. 16 - Noon (Ch. 16, OK-43 is part of limited basic cable - they also air repeat Montel shows at 2pm)
Tulsa KJRH-NBC Ch. 9 - 2pm

KS - Topeka Fox KTMJ - 3pm Ch. 6
Wichita Fox KSAS - 11am (Salina - Ch. 4)

DC - WUSA Ch. 9 - 10am local

* Recommend that you verify the show time at, or at least check the station's link from the Montel Show website.

Kelli's hometown is Beloit, KS. She graduated from Fort Hays State University with a BA in Political Science in 1993, Oklahoma State University with a MA in Political Science in 1995 and Washburn University School of Law with a Juris Doctorate in 1998. She is now a medically retired Air Force captain living in Oklahoma City. She can be reached at the email address:

Please forward this announcement to everyone you think interested, even uninterested, even your members of Congress, especially if they're on the Armed Services or Veterans Affairs Committees. Find them at: and

September 6, 2007

Emergent BioSolutions Paid Lobbyist

NOTE: See below for articles related to Senator Frist and his neglect for the health and safety of Americans. The articles relate specifically to "Avian Flu" - however, this also includes any and all countermeasures to be used in a national emergency/pandemic/epidemic/natural or bioterrorism - real, speculated or imagined.

Associated Press
Emergent BioSolutions Paid Lobbyist
Associated Press 09.05.07, 6:53 PM ET

WASHINGTON - Emergent BioSolutions Inc., which develops vaccines and other immunobiotics, paid OB-C Group LLC $120,000 to lobby the federal government in the first half of 2007, according to a recent disclosure form.

The firm lobbied on issues related to an anthrax vaccine, according to the form posted online Aug. 13 by the Senate's public records office.

Robert Stevenson, who was communications director for former Sen. Bill Frist, R-Tenn., is among those registered to lobby on behalf of Emergent BioSolutions (nyse: EBS - news - people ).

Under a federal law enacted in 1995, lobbyists are required to disclose activities that could influence members of the executive and legislative branches. They must register with Congress within 45 days of being hired or engaging in lobbying.
Emergent BioSolutions is based in Rockville, Md.


But Sen. Bill Frist, R-Tennessee, a physician who has taken an active role in the treatment for anthrax on Capitol Hill, is skeptical of the vaccine as a widespread treatment.
"The vaccine is a dated vaccine, it's an old vaccine. There are very real and potentially serious side effects from the vaccine and anyone who elects to receive the vaccine needs to be made aware of that," said Frist.
"I do not recommend widespread inoculation for people with the vaccine in the Hart Building," he said. "There are too many side effects and if there is limited chance of exposure the side effects would far outweigh any potential advantage."

[For complete details, please read "Frist's Backroom Coup Is a Shot in the Arm
for Drug Industry, a Slap in the Face of Consumers" Dec. 20, 2005
11th Hour Conference Report Rider Bars Compensation for the Injured and
Absolves Reckless, Negligent Drug Companies of Responsibility]

Republicans are exploiting anxieties about avian flu to quietly pass
legislation that shields the drug industry from being held legally accountable
when flu vaccines and other pharmaceuticals used to treat pandemic diseases
cause death, disability or serious sickness. (Majority Leader Frist has
attached it as a provision in a completely unrelated defense spending bill,
hoping no one will notice!)

Update: The vote has already taken place. Shamefully, Congress put corporate
interests above the public interest and passed this unsafe, unfair, and
unnecessary legislation. Thank you for your efforts in helping to stop the drug industry giveaway.

We plan to take action at the start of the new year, and will need your help
to convince members of Congress that they made the wrong decision.

Until then, please click on the link below to send a personal note to
your member of Congress expressing your disappointment in the passage of this
link to

If you have time, please also call or visit the district offices of your
Senators and Representative during the recess to express your opinion on this
legislation. It is also effective to call your Congresspersons' Washington, DC office.
Capitol switchboard: 1-866-340-9279 or 1-202-224-3121

Note: This legislation was originally S1873/HR3970, The Biodefense and
Pandemic Vaccine and Drug Development Act of 2005. The drug liability shield
rider that was passed has some changes from the original bill; the rider does
not create the secret agency BARDA.

Primary organizations opposing this legislation: Public Citizen National Vaccine Information Center Protect American Families Center for Justice and Democracy Association of Trial Lawyers of America Dr. Rath Health

**Contact the Dr. Rath Health Foundation for free "Protect Your Health Rights - Act" petition pads to take action
on this legislation and other anti-vitamin legislation.
Phone: +1-800-381-4185

Stay informed on this legislation by visiting and

Background articles:
Dec. 20, 2005
Frist's Backroom Coup Is a Shot in the Arm for Drug Industry, a Slap in the
Face of Consumers
11th Hour Conference Report Rider Bars Compensation for the Injured and
Absolves Reckless, Negligent Drug Companies of Responsibility

Consumer Group Letter Opposing Vaccine Legislation, (November 29, 2005)
Dr. Frist and the Night of the Deadly Vaccines
The Terrible Sequel
"Senator Bill Frist, who has a history of delivering special favors for his big donors in the drug industry, is exploiting fears over a potential bird-flu epidemic to give pharmaceutical companies a huge break that will put the public's health at risk by giving sweeping immunity if they make deadly drugs or vaccines - and he's doing it in the dead of night."

Association of Trial Lawyers of America
"U.S. Senate Passes Drug Company Giveaway"

December 15, 2005 edition
Bill to shield vaccinemakers raises alarms
By Gregory M. Lamb | The Christian Science Monitor
A measure to shield drug manufacturers from lawsuits in an effort to encourage
them to develop new vaccines is likely to be quietly attached to a "must pass"
defense appropriation bill within the next few days.

September 5, 2007

Judge Affirms Win for Plaintiffs in ‘Anthrax I’ Case

Judge Affirms Win for Plaintiffs in ‘Anthrax I’ Case
By Elaine M. Grossman
Global Security Newswire

WASHINGTON — For the first time, a federal judge last month declared six U.S. defense personnel the definitive winners in a four-year court battle over the anthrax vaccine (see GSN, Aug. 21).

The Aug. 21 decision, which revolves around payment of attorneys’ fees, is the latest chapter in a protracted struggle over whether the Defense Department can require service members to take the anthrax vaccine. U.S. District Court Judge Emmet Sullivan decided the government defendants must pay the plaintiffs’ expenses because the plaintiffs won the case.

The litigants — defense personnel who were required to take anthrax vaccine shots in a Defense Department effort that began in 1998 — won the first round of litigation in October 2004, when Sullivan issued a permanent injunction banning mandatory inoculations. Based on a finding that the vaccine was never certified to protect against “weaponized” airborne anthrax spores, the judge declared the Pentagon’s mandatory vaccinations “illegal” (see GSN, Oct. 28, 2004).

However, the Food and Drug Administration 14 months later certified the drug for preventing inhaled anthrax. Citing the FDA move, an appellate court in February 2006 officially “dissolved” the injunction (see GSN, Dec. 16, 2005).

The Pentagon restarted its mandatory shots program early this year.

In the latest matter under dispute, Justice Department attorneys argued the so-called “Anthrax I” plaintiffs were ineligible for government reimbursement of attorneys’ fees and expenses because they had not prevailed on appeal. The government defendants insisted they had won at the appellate court, where a three-judge panel allowed the Pentagon to restart its vaccine program.

Sullivan concluded otherwise, declaring: “There is no question that plaintiffs have prevailed overall as they achieved the permanent injunctive relief that they sought.”

The judge noted that the appellate court sent the case back to the lower court only after the Food and Drug Administration issued a final ruling that certified the anthrax vaccine for use in preventing inhaled anthrax. That was “the exact result” the plaintiffs sought, according to Sullivan.

In the end, then, the government appeal was unnecessary, Sullivan said. He thus termed it “reasonable” for the government to reimburse the plaintiffs for their expenses, “as they ultimately prevailed.”

The decision might well strengthen the hand of the two plaintiff attorneys, Mark Zaid and John Michels, who filed a second legal challenge to the Pentagon’s anthrax vaccination program last December.

Known as “Anthrax II,” the latest lawsuit alleges that the December 2005 FDA certification was invalid and that the Pentagon has resumed administering treatments inconsistent with the approved drug license. Zaid and Michels are asking the federal judge hearing that case, Rosemary Collyer, to impose another ban on the defense effort until the vaccine is properly tested and licensed for Pentagon use.

In last month’s decision, Sullivan bolstered from the bench the arguments the new set of eight plaintiffs make in their lawsuit. The judge clearly rejected the government’s long-standing contention that the original drug license allowed the vaccine to be used for the prevention of anthrax regardless of the route of exposure, including disease contracted through the lungs. The license cited a more narrow use for the vaccine: to prevent disease in mill workers, veterinarians or laboratory personnel, who might contract anthrax through the skin by handling animals or pelts.

When the Food and Drug Administration issued its court-mandated certification in 2005, the license was updated to reflect the agency’s contention that the vaccine could be used more broadly to prevent disease from airborne spores.

Sullivan’s new decision reaffirms the plaintiffs’ view that the vaccine was proven safe and effective only in “limited circumstances” and that a “lack of data permitted no meaningful analysis of the [vaccine’s] effectiveness against inhalation anthrax.”

September 4, 2007

Gulf War veteran believes illness related to anthrax vaccine

By Rick Wagner
Todd Sanders and his wife, Paula. Times-News photo.

KINGSPORT — Todd Sanders says he and thousands of other Gulf War veterans may be running out of time to live.

Sanders believes that’s because of the mandatory anthrax vaccine he and others received in the Army.

Late last year, at age 41, the Kingsport resident had a pacemaker installed to keep his heart rate and blood pressure up, but he still blacks out from low blood pressure from a condition called sinus bradycardia neurocardiogenic syncope.

His other medical problems include chronic fatigue, neurological symptoms, muscle deterioration, memory loss, ringing in the ears, double vision, confusion, depression, anxiety, incontinence, sleep apnea, respiratory distress, and extreme muscle and joint pain.

Sanders’ medical condition, however, has not been diagnosed as an illness related to his military service, so he does not receive any financial compensation for his illness. Sanders, a master auto mechanic who can no longer work, has not been able to obtain unemployment pay, military disability or Social Security disability,
and this has put a severe financial hardship on his family.

Sanders is now seeking letters of support from veterans who have similar symptoms and received the anthrax vaccine.

He’s asking that anyone with past military service with similar medical issues fill out a Veterans Affairs Form No. 21-4138 — Statement in Support of Claim. The form is available at

Enough of those letters, according to Sanders and spokesmen for the military and VA, might convince the VA hospital system that his condition is related to his military service and open the door to receiving free health care from the VA system, including the Mountain Home Medical Center in Johnson City.

Sanders is an ASA master technician, General Motors master technician and Chrysler master technician.

“Days that I can do a little bit, I will,” Sanders said.

He has worked as a mechanic, for nine years at the old Sherwood Chevrolet in Johnson City, about five years at Courtesy Chevrolet in Kingsport, and almost four years at Carl Gregory Chrysler-Plymouth in Johnson City.

“You very seldom find somebody who would work as hard as he would,”

said Keith Cutshall, who has known Sanders for 14 years.

“He’s just a good person,” Cutshall said. “It’s just a shame to see him going through this and can’t get any help.”

James Johnson, a serviceman at Carl Gregory who has known Sanders for 13 years said, “He’s very meticulous. He’s always done top-quality work.”

“He would be working on a car, kind of get a dizzy feeling and go over to his toolbox. The next thing you knew, he was sliding down his toolbox to the floor,” Johnson said.

Sanders’ doctors ordered him to stop working Jan. 26.

A neurologist is trying to find out what is causing this latest round of blackouts.

“The co-pays and deductibles we’ve been paying are overwhelming,”

Sanders’ wife, Paula, said.

Johnson said the physical toll, however, was even greater.

“You could watch him deteriorate over time. You could see it happen.”

High school sweethearts, Todd and Paula Sanders attended North High School. They have been married 23 years and have a daughter, Tasha, who is a full-time nursing student who works at Holston Valley Medical Center.

Paula Sanders has worked in the snack distribution business and now works for Unilever in retail sales.

While Sanders believes he may have or be getting amyotrophic lateral sclerosis, commonly called ALS or Lou Gehrig’s disease, at least he is still among the living. The Internet is full of stories about Gulf War veterans who have died well after the war.

“Everybody he tried to find in his brigade, either he can’t find them or they’re dead,” Paula Sanders said.

Parallel stories told

Bill Robertson, one of Todd Sanders’ best Army buddies from Georgia who also served in the 3rd Infantry Division during Desert Storm, is among those already dead from what Sanders and others believe is Gulf War Syndrome. Sanders contacted his friend about a year and a half ago.

“Every single symptom Bill Robertson had, my husband had — every single one,” Paula Sanders said.

Robertson, who died in late December and had ALS, told Sanders he believed his condition was caused by the anthrax vaccine.

“That’s what they figure with me — I’ve either got multiple sclerosis or ALS,” Sanders said.

Robertson was deployed to Iraq, while Sanders stayed in Germany.

However, Sanders said both received the vaccine. He said they also were exposed to depleted uranium the military used to strengthen armor, chemicals used by the military and whatever else was in the environment of Iraq.

A recent study that received worldwide attention said that Iraqi munitions American troops destroyed had sarin, a nerve gas that could be causing or aggravating Gulf War Syndrome.

Sanders said he and Robertson may have gotten that exposure from military vehicles — Robertson from serving in Iraq and Sanders in Germany from cleaning vehicles used in Iraq.

But Sanders said he believes — and that Robertson believed — their condition was caused by the anthrax vaccine, which made him sick and almost caused him to pass out when he first received it.

Sanders said he believes the squalene — used to make the immune system quickly develop immunity — in too large doses make the immune system attack itself. The approval of that anthrax vaccine, which is no longer used, was expedited by the Food and Drug Administration.

“I started getting insomnia, joint pain and soreness immediately,” Sanders said.

He continued his military service, started in 1987, until a discharge in 1992. And although he had some times with few symptoms, he said his energy and strength never went back to pre-vaccine levels.

Sanders was able to work for years, but he said things got quickly and progressively worse starting in 2001. And he began having blackouts.

Stories nationwide and worldwide abound of veterans with similar health ills, including British soldiers who report similar problems getting their government to recognize the connection between their condition and military service.

But Paula Sanders said she and her husband take some comfort in the outcome of a 21-year-old soldier’s recent success in getting his heart problem disability — and plans to install a pacemaker — recognized as service related by a military discharge board.

David Brace, the 21-year-old soldier, received a newer anthrax vaccine that is supposed to be safer.

The Brace and Sanders families, along with Dr. Meryle Nass of Bar Harbor, Maine, have been communicating over the Internet about common threads in various cases nationwide. Nass in late July testified at a hearing of the House Committee on Veterans Affairs, Subcommittee on Health.

Nass said Gulf War Syndrome symptoms overlap closely with chronic fatigue syndrome, fibromyalgia, multiple chemical sensitivity and irritable bowel syndrome.

Sanders said about 700,000 soldiers received the anthrax vaccine in the first Gulf War, with more than 1 million receiving a later version of the anthrax vaccine.

Nass said 200,000 “Gulf War I” veterans have chronic “Gulf War” illness related to their deployment and cited a Washington Post article that said 199,000 Gulf War veterans receive compensation for such illnesses. But Sanders is not among the 199,000.

Sanders on a new mission

Blackouts or not, with the help of his wife, Todd Sanders’ new full-time mission is trying to get the word out to other Gulf War veterans. And to get the support letters from veterans who have similar symptoms and received the anthrax vaccine.

But one problem that Sanders and others who served from 1987 to 1992 face is a lack of medical records. Working through the office of U.S. Rep. David Davis, R-1st District, Sanders was able to get copies of his military entry and exit physical exams.

Everything else, including the record of his anthrax and other vaccines received while in service, are gone. He said a VA official once told him they were “inadvertently destroyed.”

In a nutshell, Washington, D.C.-based Veterans Affairs spokesman Jim Benson and Northern Virginia-based Department of Defense spokesman Terry Jones said veterans seeking full VA health care must show their injury, illness or disability is connected to their military service.

They said the letters of support can help Sanders.

However, Benson and Jones also said they were not aware of a mass loss or destroying of records from the Gulf War era, although Sanders said they have been told by VA officials and others that medical records went missing for many who served in the Gulf War.

As for Todd Sanders’ claim, Jones said he would contact folks in the DOD in an attempt to help find Sanders’ medical records. And although he’s never met or talked with Sanders, he did have a friend who served in the Gulf War.

“He said there was something to it,” Jones said of after effects of the war. “He did eventually die.”

Cathy Brace, the mother of the 21-year-old veteran with heart problems, recently wrote that the problem with vaccine records that do exist is that they bear the date of when the vaccine was recorded, not when it was actually given, although Jones said he never heard of that happening.

One other option to get some VA medical care is based on income levels, but the Sanderses made too much last year. However, with Todd having almost no income this year, Paula said he may be eligible next year. They have been turned down twice this year and their appeal denied for income-based VA assistance.

Sanders plans for future

Sanders said if he can convince the federal government his condition is related to his military service and get some civilian and/or military disability, his goal is to work on behalf of other veterans with Gulf War Syndrome.

“Once we get ours done, I think we’ll be able to help people a whole lot,” Sanders said.

Lori Cutshall, wife of Keith Cutshall and a friend of the Sanderses who attends church with them at Christ Fellowship, has helped set up an account for donations to help pay for his medical care.

Donations, which are tax deductible, can be sent to Christ Fellowship Church, attention Melinda Williams, 260 Victory Lane, Kingsport, TN 37664. The memo line of checks should be filled out “Todd and Paula Sanders.” For more information call the church at 349-0600.

To contact Sanders call 247-1987 or e-mail or

September 2, 2007

PREMEDITATED MERGER - U.S. under U.N. law in health emergency

Bush's SPP power grab sets stage for military to manage flu threats
By Jerome R. Corsi

David Nabarro is new U.N. system influenza coordinator

The Security and Prosperity Partnership of North America summit in Canada released a plan that established U.N. law along with regulations by the World Trade Organization and World Health Organization as supreme over U.S. law and set the stage for militarizing the management of continental health emergencies.

The "North American Plan for Avian & Pandemic Influenza " was finalized at the SPP summit last week in Montebello, Quebec.

At the same time, the U.S. Northern Command, or NORTHCOM, has created a webpage dedicated to avian flu and has been running exercises in preparation for the possible use of U.S. military forces in a continental domestic emergency involving avian flu or pandemic influenza.

With virtually no media attention, in 2005 President Bush shifted U.S. policy on avian flu and pandemic influenza, placing the country under international guidelines not specifically determined by domestic agencies.

The policy shift was formalized Sept. 14, 2005, when Bush announced a new International Partnership on Avian and Pandemic Influenza to a High-Level Plenary Meeting of the U.N. General Assembly, in New York.

The new International Partnership on Avian and Pandemic Influenza was designed to supersede an earlier November 2005 Homeland Security report that called for a U.S. national strategy that would be coordinated by the Departments of Homeland Security, Health and Agriculture.

The 2005 plan, operative until Bush announced the International Partnership on Avian and Pandemic Influenza, directed the State Department to work with the WHO and U.N., but it does not mention that international health controls are to be considered controlling over relevant U.S. statutes or authorities.

Under the International Partnership on Avian and Pandemic Influenza, Bush agreed the U.S. would work through the U.N. system influenza coordinator to develop a continental emergency response plan operating through authorities under the WTO, North American Free Trade Agreement and the U.N. Food and Agriculture Organization.

WND could find no evidence the Bush administration presented the Influenza Partnership plan to Congress for oversight or approval.

The SPP plan for avian and pandemic influenza announced at the Canadian summit last week embraces the international control principles Bush first announced to the U.N. in his 2005 International Partnership on Avian and Pandemic Influenza declaration.

The SPP plan gives primacy for avian and pandemic influenza management to plans developed by the WHO, WTO, U.N. and NAFTA directives – not decisions made by U.S. agencies.

The U.N.-WHO-WTO-NAFTA plan advanced by SPP features a prominent role for the U.N. system influenza coordinator as a central international director in the case of a North American avian flu or pandemic influenza outbreak.

In Sept. 2005, Dr. David Nabarro was appointed the first U.N. system influenza coordinator, a position which also places him as a senior policy adviser to the U.N. director-general.

Nabarro joined the WHO in 1999 and was appointed WHO executive director of sustainable development and health environments in July 2002.

In a Sept. 29, 2005, press conference at the U.N. , Nabarro made clear that his job was to prepare for the H5N1 virus, known as the avian flu.

Nabarro fueled the global fear that an epidemic was virtually inevitable.

In response to a question about the 1918-1919 flu pandemic that killed approximately 40 million people worldwide, Nabarro commented, "I am certain there will be another pandemic sometime."

Nabarro stressed at the press conference that he saw as inevitable a worldwide pandemic influenza coming soon that would kill millions.

He quantified the deaths he expected as follows: "I'm not, at the moment at liberty to give you a prediction on numbers, but I just want to stress, that, let's say, the range of deaths could be anything from 5 to 150 million."

In a March 8, 2006, U.N. press conference that was reported on a State Department website, Nabarro predicted an outbreak of the H5N1 virus would "reach the Americas within the next six to 12 months."

On Feb. 1, 2006, NORTHCOM hosted representatives of more than 40 international, federal and state agencies for "an exercise designed to provoke discussion and determine what governmental actions, including military support, would be necessary in the event of an influenza pandemic in the United States."

NORTHCOM and other governmental websites document the growing role the Bush administration plans for the U.S. military to be involved in continental domestic emergencies involving health, including avian flu and pandemic influenza.

NORTHCOM participated in a nationwide Joint Chiefs of Staff-directed exercise – code-named Exercise Ardent Sentry 06 – to rehearse cooperation between Department of Defense and local, state and federal agencies, as well as the Canadian government.

A pandemic influenza crisis was one of the four scenarios gamed in Exercise Ardent Sentry 06, involving a scenario of a plague in Mexico reaching across the border into Arizona and New Mexico.

As has been customary in SPP documents and declarations, the Montebello, Canada, announcement of the North American Plan for Avian & Pandemic Influenza acknowledges in passing the sovereignty of the three nations.

The announcement says, "The Plan is not intended to replace existing arrangements or agreements. As such, each country's laws are to be respected and this Plan is to be subordinate and complementary to domestic response plans, existing arrangements and bilateral or multilateral agreements."

Still, the SPP plan argues the risk from avian and pandemic influenza was so great to North America that the leaders of the three nations were compelled "to work collectively and with all levels of government, the private sector and among-non-governmental organizations to combat avian and pandemic influenza."

Moreover, the SPP plan openly acknowledges, "The WHO's international guidance formed much of the basis for the three countries' planning for North American preparedness and response."

WND previously reported NORTHCOM has been established with a command center at Peterson Air Force Base, tasked with using the U.S. military in continental domestic emergency situations.

WND also has reported President Bush signed in May two documents, National Security Presidential Directive-51 and Homeland Security Presidential Directive-20, which give the office of the president extraordinary powers to declare national emergencies and to assume near-dictatorial powers.

Following the Montebello summit last week, the SPP North American Plan for Avian & Pandemic Influenza was published on a made-over SPP homepage redesigned to feature agreements newly reached by trilateral bureaucratic working groups.

FDA licenses new vaccine against smallpox

FDA licenses new vaccine against smallpox; can be produced quickly if needed

WASHINGTON (AP) — The approval of a new vaccine against smallpox was announced Saturday by the U.S. Food and Drug Administration, which says the shots could be made quickly if the virtually extinct virus reappears.
The vaccine, ACAM2000, is intended to inoculate people at high risk of exposure to smallpox, a highly contagious and deadly disease. The FDA said the vaccine also could be used to protect individuals and populations during a bioterrorist attack.
"The licensure of ACAM2000 supplements our current supply of smallpox vaccine, meaning we are more prepared to protect the population should the virus ever be used as a weapon," said Dr. Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research.
Goodman said the vaccine is made using modern cell culture technology that would allow for speedy manufacturing if large quantities were needed quickly.
ACAM2000 is made by Acambis Inc. of Cambridge, England, and Cambridge, Mass.. The U.S. Centers for Disease Control and Prevention already has stockpiled 192.5 million doses of the vaccine.
The United States ended routine vaccination against smallpox in 1971, and world health authorities declared the disease eradicated from the wild in 1980. The last known case was reported in Somalia in 1977.
But after the terrorist attacks of Sept. 11, 2001, concern arose that smallpox and other infections could be engineered as weapons. That led to the stockpiling of certain vaccines in case they ever are needed - and to vaccinate some military personnel and health care workers.
Only two approved U.S. and Russian labs keep known stockpiles of smallpox, which the CDC considers among the greatest potential threats to public health.
"Smallpox could be a particularly dangerous biological threat to us that would kill or debilitate a high percentage of the population," said Dr. W. Craig Vanderwagen, a rear admiral and assistant secretary for preparedness and response at the U.S. Department of Health and Human Services.
Smallpox is caused by the variola virus, which spreads through close contact with infected individuals or contaminated objects. There is no FDA-approved treatment for it.
The new vaccine is derived from the old smallpox vaccine, called Dryvax, which is no longer made, although there are leftover supplies. ACAM2000 is made using a pox virus called vaccinia, which is related to but different from the virus that causes smallpox.
It contains live vaccinia virus, the FDA said, and works by causing a mild infection that stimulates an immune response that effectively protects against smallpox without actually causing the disease.