June 30, 2008

Emergent Biosolutions spent $550K lobbying in 1Q


WASHINGTON - Biopharmaceutical company Emergent BioSolutions Inc. spent $550,000 lobbying in the first quarter, according to a recent disclosure form.

Emergent BioSolutions (nyse: EBS - news - people ) lobbied on the government stockpiling of biodefense vaccines. The company holds a three-year, $448 million contract with the Department of Health and Human Services for the anthrax vaccine BioThrax.

Besides Congress, the Rockville, Md.-based company lobbied the departments of Defense and Health and Human Services, according to the form posted online April 17 by the House clerk's office.

Ex-Army scientist to get $5.8M in anthrax lawsuit


WASHINGTON - A former Army scientist who was named as a person of interest in the 2001 anthrax attacks will receive $5.8 million to settle his lawsuit against the Justice Department. Steven Hatfill claimed the Justice Department violated his privacy rights by speaking with reporters about the case.

The deal requires the Justice Department to pay $2.825 million up front and buy Hatfill a $3 million annuity that will pay him $150,000 each year for 20 years.

"Our government failed us, not only by failing to catch the anthrax mailers but by seeking to conceal that failure," Hatfill's lawyers said in a statement. "Our government did this by leaking gossip, speculation, and misinformation to a handful of credulous reporters."

The statement also blamed journalists for not questioning the motives of the government's statements or its tactics.

"As an innocent man, and as our fellow citizen, Steven Hatfill deserved far better," they said.

The Justice Department said the settlement was in the best interest of the nation.

"The United States does not admit to any violation of the Privacy Act and continues to deny all liability in connection with Dr. Hatfill's claims," Justice Department spokesman Brian Roehrkasse said in response to the settlement.

Five people were killed and 17 sickened by anthrax that was mailed to lawmakers on Capitol Hill and members of the news media in New York and Florida just weeks after the Sept. 11, 2001, terrorist attacks.

After the attacks, Attorney General John Ashcroft called Hatfill "a person of interest" in the investigation and stories by various reporters followed. Hatfill had worked at the Army's infectious diseases laboratory from 1997 to 1999. The anthrax attacks remain unsolved.

The settlement likely also means that former USA Today reporter Toni Locy will no longer face up to $5,000-a-day in fines in the case. A federal judge ordered her to identify the officials who discussed Hatfill. When she said she couldn't remember, the judge ordered her to identify all her sources on the anthrax case.

She challenged that order, but a federal appeals court has yet to rule in the case. Because Hatfill's lawsuit is being settled, Locy's case will probably be dismissed as moot, though that will be up to the appeals court. Hatfill's lawyers told the court Friday that they no longer need her testimony.

"I hope this means that this ordeal is over and that I can get on with my life," Locy said. "I am pleased that Dr. Hatfill's lawyers are now saying they no longer need my testimony, but I don't know if my appeal is moot or if the contempt order against me will be lifted because I don't have anything at this point from the Court of Appeals or Judge Walton that says I'm in the clear."

Attorneys for Locy said she had no money to pay the fines imposed by U.S. District Judge Reggie Walton. Locy, a former reporter with The Associated Press and other news organizations, now teaches journalism at West Virginia University.

June 25, 2008

The Weapon of Mass Destruction is Cancer

R.B. Stuart

In March, 2003 my sister, Army Captain Chaplain Fran E. Stuart was deployed to Iraq with the rest of her battalion, from Ft. Campbell, Kentucky, the 101st Airborne. The uncharted desert would not only hold uncertainty for Operation Iraqi Freedom and Operation Enduring Freedom, but if she survived during her one-year deployment, she would return to the U. S. forever changed.

Although the changes that would occur two years to the day from her return home were changes she never could have fathomed. Not only had the desert sand, gun blasts and heat penetrated the armor of her psyche, but a carcinogen did too. It made a home in her body, mixed between the Anthrax Vaccine, depleted uranium, crude oil smog, and contaminated water dished up with every meal. It would, in two years, become part of the wrapping around her inner organs like an Octopus, gathering its fuel from her central abdomen. The volleyball size tumor would become the pregnancy she never had -- and the birth of cancer she'd never forget.

In March 2006, the 41-year-old captain was diagnosed with a rare, aggressive, stage IV Dysgerminoma cancer, the "germ cell" cancer usually only seen in pregnant women, or teenage girls. Captain Stuart was medevaced from her new tour in Germany to Walter Reed Army Medical Center (WRAMC) in D.C. to undergo further testing and immediate surgery to remove the massive tumor, only to discover three more. It would take ten months of treatments to corral the cancer. After 35 rounds of chemotherapy and two more surgeries was she deemed in clinical remission.

While her family was supporting Captain Stuart at WRAMC, my exclusive access to WRAMC exposed cancer as a affliction suffered by many soldiers are returning from Iraq/Afghanistan, unknown to the public and unacknowledged by the military.

Although WRAMC Forrest Glen Fisher House provides housing exclusively for soldiers with cancer, undergoing surgeries, chemotherapy or radiation treatments at Walter Reed -- the DoD hasn't gone public with their findings. WRAMC has dedicated floors six and seven to the stricken soldiers arriving daily -- their life may have been spared on the battlefield, but the savage beast within -- cancer -- had created its own war.

Soldiers face a more deadly and rapidly moving carcinogen that covertly infiltrates all ranks, ethnicities, gender and ages from 21-57. Developing different stages and forms of rare cancers within 4-24 months, a portion are medevaced to WRAMC from Iraq already ill. Others, like my sister, are diagnosed two years post-deployment. Since soldiers are uninformed about depleted uranium (DU), they are not wearing protective gear and are unknowingly inhaling and ingesting the toxic dust.

Through the world of military red tape and their language: acronyms, I've witnessed and reported firsthand the challenges and struggles OIF and OEF soldiers undergo as they battle cancer while in the military. While the DoD denies that cancer is a "War Wound," many are left inflicted with the life-threatening illness, uncertain and fearful of their own mortality and military career.

The new veterans of the Iraq War are left afraid of the future. They wrestle with hopelessness and helplessness while they're tucked away alone in VA hospitals across the county, thinking they are the only ones. The response is, no, they're not alone. But, their story on a national and International/ level, remains untold....

Captain Stuart, soldiers fighting daily for their life, and those brave military loved ones who have succomed to the carcinogen -- put a face on Cancer in the military post Operation Iraqi Freedom & Operation Enduring Freedom, as Vietnam Veteran's did twenty years later with Agent Orange, and Desert Storm Veteran's did ten years after with The Gulf War Syndrome. Only let's not wait that long... let the faces be seen, let the names be read, let the stories unfold and let the voices be heard now. And it begins with Army Captain Chaplain Fran E. Stuart.

August 2002, seven months before the Iraq war commenced, U. S. Army Colonel J. Edgar Wakayama wrote a report for the military on DU Munitions, and the risks to health and the environment. He noted DU is produced as a by-product of the enrichment process for nuclear reactor-grade or nuclear weapon-grade uranium. Due to its extreme density (1.7 times the density of lead), it is used as the armor plating [DU penetrators] in 16 different model/size cartridges of U. S. ammunition. DU is radioactive and produces Alpha particle, Beta particle, Gamma ray.

Col. Wakayama addressed the Epidemiological Studies after Wars in Gulf and Balkans where 340 tons of DU munitions were fired during the 1991 Gulf War; 11 tons fired in the Balkans 1990 (about 70-80% of all DU munitions penetrators remain buried in the soil). The estimated DU intake for most soldiers on the battlefield: 0.1 mg uranium/g kidney, but long-term effect is unknown.

The emerging environmental concerns include a significant exposure to DU among children playing in the impact sites by ingesting heavily-contaminated soil, slow leaching of DU in local water supplies over years, consuming DU contaminated food sources (animals and plants). He outlined the three major routes of human exposure to DU is wounding by shrapnel, inhalation (lungs and thoracic lymph nodes), ingestion (contaminated soil, contaminated drinking water and food in the community).

Once the alpha particle is taken inside the body in large doses there's a hazardous producing cell damage and cancer (he reports lung Cancer is well documented), clothing and skin protects from external alpha exposure. The beta particle is hazardous to the skin and the lens of the eyes. The gamma radiation is an electromagnetic radiation of high energy that penetrates through the body. DU is chemically toxic due to heavy metal like lead, the target organ is the kidney and bone. The cultured human stem bone cell line with DU also transformed the cells to become carcinogenic. Urine samples containing uranium are mutagenic as determined by the Ames test.

Lastly, Col. Wakayama noted in the brief, the radiation effects of inhalation exposure is to the lungs and thoracic lymph nodes. A large inhalation of dust (without radiations) equate long-term respiratory effects (lung fibrosis, in addition to risk of lung Cancer). DU can be deposited in bone causing DNA damage by the effects of the alpha particles. Immune deficiency is a negligible effect, with an extra risk of death from leukemia and other Cancers.

After this study was completed for the DoD, seven months later the U.S. Military began the Shock & Awe Campaign on Iraq. In the early months of the war the U.S. dropped 320 metric tons of DU munitions on Iraq. The radioactive drenched soil in Iraq was reported in 2003 by journalist Scott Peterson, The Christian Science Monitor, with a Geiger counter registering radiation in Baghdad 1,900 times higher than normal. DU has a half-life of 4.5 billion years, and total disintegration estimated after 25 billion years.

November 2006, the BBC reported "Depleted Uranium Risk 'Ignored." The investigation found that UK and US forces have continued to use depleted uranium weapons despite warnings they pose a cancer risk. Noting, scientists have pointed to health statistics in Iraq, where the weapons were used in the 1991 and 2003 wars.

February 2007, CNN's American Morning aired a two part special with Greg Hunter, "Is DU Effecting our Troops?"

July 2007, Iraq's environment minister blamed "at least 350 sites in Iraq being contaminated during bombing" with depleted uranium weapons for about 140,000 cases of cancer there and for between 7,000 and 8,000 new cases each year.

May 22, 2008, Representative Jim McDermott a Democrat of Washington, in the most recent Institute of Medicine report, "Review of the Toxicologic and Radiologic Risks to Military Personnel from Exposure to Depleted Uranium During and After Combat," secures DU Amendment in Department of Defense Authorization Bill. The amendment requires the Secretary of Defense to report to Congress within 120 days of the legislation becoming law.

McDermott, a medical doctor who has long expressed concerns over potential health risks to U.S. soldiers and Iraqi civilians from exposure to DU. McDermott said there are anecdotal and seemingly unexplained stories of cancers striking previously healthy young American soldiers who have served in Iraq, and as a scientist he wants independent and in-depth scientific research conducted to determine if there is any link between exposure to DU and their illnesses.

He reiterates, depleted uranium, is a dense and toxic, low level radioactive material used by the U.S. military to super-harden munitions to penetrate armor. Upon impact the munitions pulverize into a fine dust that can be inhaled into the lungs when breathing, or fall to the ground as a microscopic dust where it can remain in the soil and leach into the groundwater over time. Hundreds of tons of DU were used during the First Gulf War and at the beginning of the Iraq war.

June 5, 2008

India to test vaccine against anthrax


NEW DELHI: India may soon be able to stockpile a vaccine to protect both its military and civilians against a possible attack with one of the world's most feared biological weapon — anthrax.

The drug controller general has allowed a pharmaceutical company to import the only US FDA licensed human anthrax vaccine into the country for testing before it can be available in the country.

Around 20 vials of the vaccine Biothrax has just reached Central Drug Laboratory (Kasauli) which will test the vaccine's potency and sterility. Each vile contains 10 doses of the vaccine.

Joseph Chettiar of the Hyderabad-based distribution partner for the original makers of Biothrax, says only after CDL gives its final report on the vaccine will the DCGI decide whether to allow the company to import the vaccine for potential buyers like the defence ministry.

A Union health ministry official told TOI, "India needs to be prepared against a bioterrorist attack. That's why we are looking at allowing the company to import Biothrax only for limited use, like for the military and not for general civilians. CDL will first look at the protocol, its manufacturing quality control and test the vaccine's potency and sterility on animals before DCGI gives final marketing authorization."

Chettiar said, "Several countries in South-East Asia, US and Europe have started stockpiling Biothrax. It is essential for their bioterrorism preparedness, especially for its first responders like the military. The vaccine won't be used on humans at CDL which will only look at the quality control parameters and its pharmaceutical components."

Anthrax was used as a biological weapon in the United States in 2001. It was deliberately spread through the postal system by sending letters with powder containing anthrax. This caused 22 positive cases of inhalation anthrax infection, half of whom died.
The Centers for Disease Control and Prevention (CDC), Atlanta, classifies agents with recognized bioterrorism potential into three priority areas — 'A', 'B' and 'C'. Anthrax is classified in category 'A' — agents that pose the greatest possible threat for a bad effect on public health having the capability to spread across a large area.

Even though Biothrax is known to be highly protective against anthrax, its vaccine schedule involves a cumbersome six-dose injection regimen over a period of 18 months to induce a protective immune system response. This has to be then followed by annual booster doses.

"The vaccine can't be injected to all civilians but only to the first responders to reach the spot of attack, like the military and laboratory workers who may enter or re-enter contaminated areas. Countries are now preparing such battalions and vaccinating them in advance so that they develop complete immunity against anthrax before such an attack occurs. Inhalation anthrax is the most lethal form with fatality rates reaching up to 90%," Chettiar added.

June 1, 2008

Researchers' complaints ignored over anthrax vaccine problems


By Yossi Melman

Despite the enormous investments in developing an anthrax vaccine, senior employees at the Israel Institute for Biological Research have warned that there are problems with the product. However, institute director Dr. Avigdor Shafferman ignored their claims, and demoted one of the complainants, a senior manager.

The Biological Research Institute, one of the most secret institutions in Israel, employs 350 persons and operates with nearly no external supervision. In terms of administration, the institute answers to the Prime Minister's Office, while physical and field security are handled by Malmab - the body responsible for security in the defense establishment at large.

According to foreign publications, the institute conducts research and development on biological and chemical weapons, and also develops antidotes - including medicines, vaccines and antibodies - against poison gas, microbes and viruses like anthrax, the plague, chicken pox and cholera.

Targeting the respiratory system

Anthrax is a virus that generally affects animals, but can also harm humans. During the Gulf War in 1991, the United States feared Saddam Hussein might use biological weapons against its troops, and some 40,000 members of its armed forces were vaccinated against the disease, which targets the respiratory system.

Biological science researchers at the Nes Tziona institute, then headed by Dr. Shafferman, conducted intensive research on the virus, and as a result of their work, the institute decided to try to develop a vaccine.

In 2001, scientific and defense sources said the institute had developed a vaccine for anthrax, and that large-scale production would commence within a few months, enough for the entire population of Israel.

Intelligence assessments hold that countries in the Middle East, including Syria, Egypt and Iran, have developed anthrax as a biological weapon.

However, a senior manager at the institute, Dr. Yaakov Hadar, recently complained that the institute's management of the anthrax vaccine was problematic. Dr. Hadar presented the issues in writing to Dr. Shafferman, who reprimanded Dr. Hadar, and convinced him to withdraw his letter of complaint.

Hadar was later demoted. Dr. Hadar refused to comment on the case, and directed Haaretz to Dr. Shafferman.

In its response to Haaretz's inquiry, the Defense Ministry did not acknowledge the claims that there are problems with the vaccination.

"During the development of the anthrax vaccination that was carried out on behalf of the defense establishment, there were no problems in the conduct of any party," the ministry spokesman told Haaretz.

Dr. Shafferman was appointed to head the institute in 1995, and employees have complained of his "dictatorial rule" several times.

The State Comptroller began an investigation last year into allegations that Shafferman allegedly had advised a pharmaceutical firm in developing anti-anthrax and nerve agent medicines, which would have been a conflict of interest.