April 30, 2007

Rudy Giuliani's Wife - Biological Expert... to Pharma

Germ-warfare adviser.


April 29, 2007 -- Rudy Giuliani consulted his wife Judith on bioterrorism after 9/11, and considered her "an expert we rely on" at his high-powered consulting firm, he has revealed.
Referring to his Manhattan-based business, Giuliani Partners, the ex-mayor spoke about her role in a 2003 interview, with his bride at his side:

"She gives us a lot of advice and a lot of help in areas where she's got a lot of expertise - biological and chemical," the ex-mayor said in a taping never aired in the United States. "And since we do security work, that's an area of great concern - you know, another anthrax attack, a smallpox attack, chemical agents. She knows all of that."

Giuliani made the comments to worldwide syndicated interviewer Daphne Barak in footage seen by The Post.

Last week, Giuliani, the GOP presidential front-runner, touted himself as the candidate most likely to protect the country against terrorism. The Democrats, he argued, would make the nation more vulnerable to attack.

Giuliani said his wife "worked in the pharmaceutical industry for years. So, she's an expert that we rely on," he said.


April 27, 2007

U.S. Opens Bioshield Office

U.S. Opens Bioshield Office

The U.S. Health and Human Services Department has established an office to manage Project Bioshield, the troubled multibillion-dollar program intended to spur development of WMD countermeasures, according to a press release issued yesterday (see GSN, Dec. 20, 2006).

The Biomedical Advanced Research and Development Authority office operates under the agency’s assistant secretary for preparedness and response.

“The creation of BARDA enhances the opportunity for innovation in our efforts to develop effective medical countermeasures against a host of public health threats, either natural or man-made,” HHS Secretary Michael Leavitt said in the release.

The White House requested $189 million in its fiscal 2008 budget “to help further the department’s efforts to bridge the gap between the National Institutes of Health’s research and development programs and Project Bioshield,” Leavitt said.

The department is presently looking for a BARDA director (U.S. Health and Human Services Department release, April 26).

April 25, 2007

HHS Offers Plan for Defense against Biological Threats

HHS offers plan for defense against biological threats

Apr 25, 2007 (CIDRAP News) – The US Department of Health and Human Services (HHS) recently unveiled its plan for developing and buying medical countermeasures against a range of biological, chemical, and other threats, with new anthrax and smallpox vaccines among the near-term priorities.

The 21-page implementation plan, released Apr 20 on the HHS Web site and in the Federal Register, details how the agency will acquire countermeasures against 14 threats on its priority list, which include nine category A biological agents, two category B biological agents, typhus, certain volatile nerve agents, and radiological and nuclear agents.

HHS Secretary Mike Leavitt said in an Apr 18 press release that since the Sep 11 terrorist attacks the United States has made significant progress in securing medical countermeasures against a number of threats, but much more work remains.

"This plan lays out our path forward in the coming years and will take advantage of our new authorities under the Pandemic and All-Hazards Preparedness Act to move forward with Project BioShield," he said.

Project BioShield, a $5.6 billion program, was established in 2004 to speed the development of medical treatments for the effects of biological and other unconventional weapons. But major drug companies showed little interest in the program. In passing the All-Hazards Preparedness Act last December, Congress tried to revitalize the program by authorizing partial payments to companies working under BioShield contracts before final delivery of their products.

The HHS plan identifies acquisitions the agency will make under the remaining 5 years of Project BioShield, a 10-year program, as well as those the agency will pursue through fiscal year 2023.

The report says the maturity of the product development pipeline and estimated costs guided HHS decisions and placement of items on near-term, mid-term, and long-term development lists. The agency focused on the countermeasures that offer the greatest opportunity to improve emergency preparedness across a range of threats.

Priority is placed on countermeasures that involve "post-event prophylaxis" or postexposure treatment, the HHS report said. Though single treatments are appropriate for some of the biological threats—a "one bug, one drug" approach—HHS aid it wants to focus its efforts to more efficiently address groups of threats, using tools such as broad-spectrum antibiotics and broad-spectrum antivirals.

The centerpiece of the HHS report is two tables: one that plots the priority countermeasures for each threat and another that lists the proposed funding sources for each countermeasure.
Diseases listed among the priority threats include anthrax, botulism, glanders, meliodosis, Ebola and Marburg hemorrhagic fevers, tularemia, Argentine hemorrhagic fever, typhus, smallpox, and plague.

Countermeasures that HHS would like to acquire in the near term, meaning in fiscal years 2007 and 2008, include broad-spectrum antibiotics and anthrax and smallpox vaccines. The report notes that HHS recently canceled a contract for a recombinant anthrax vaccine (a reference to a vaccine that was under development by VaxGen Inc.), but the agency "remains committed to acquiring next-generation anthrax vaccines."

HHS is also working to acquire a smallpox vaccine that would be safe for immunocompromised people, the report notes. The agency "is well advanced in the pre-award stage" of a program to buy one such vaccine, called modified vaccinia Ankara, it says.

The list of products for mid-term acquisition—in fiscal years 2009 through 2013—includes broad-spectrum antibiotics, diagnostic tests for all biological agents, an anthrax antitoxin, filovirus countermeasures, and smallpox antivirals, as well as measures for diagnosing and treating radiological and nuclear agents and improving the distribution of nerve agent antidotes.
Longer-term projects, beyond fiscal year 2013, would include broad-spectrum antivirals and a single, easy-to-use antidote effective against several volatile nerve agents.

In its press release, HHS said it was seeking public comments on the implementation plan, which can be made through the Federal Register. The agency will also hold a stakeholders meeting for those involved in developing medical countermeasures, scheduled July 31 through Aug 2 in Washington, DC.

See also:
Apr 18 HHS press releasehttp://www.hhs.gov/news/press/2007pres/04/pr20070418a.html
HHS countermeasure implementation planhttp://www.hhs.gov/aspr/ophemc/enterprise/strategy/strategy.html
Apr 18 CIDRAP News story "Danish firms expects to sell smallpox vaccine to US"

April 20, 2007

Vical Expands Testing Of Vaxfectin(TM) Adjuvant To U.S. Navy Malaria Vaccine Program

Vical Expands Testing Of Vaxfectin(TM) Adjuvant To U.S. Navy Malaria Vaccine Program

Vical Incorporated (Nasdaq: VICL) announced today that the company has signed a Cooperative Research and Development Agreement (CRADA) with the Naval Medical Research Center (NMRC), a biomedical research organization within the U.S. Navy, to explore the use of Vical's novel Vaxfectin(TM) adjuvant with experimental DNA vaccines against malaria. Vaxfectin(TM) is a cationic lipid/co-lipid formulation designed to increase the immune response to vaccines.

The company holds patents in the United States and Europe covering a new class of adjuvants including Vaxfectin(TM) and their use with DNA vaccines, as well as patents in the United States covering the use of Vaxfectin(TM) with conventional vaccines based on proteins, polypeptides, and polysaccharides, including those containing all or part of a bacterial or viral pathogen. Vical has provided Vaxfectin(TM) to academic researchers for several years, and data have been published showing evidence of increased immunogenicity and/or protective efficacy of DNA vaccines against diseases including anthrax (Vical), tuberculosis (Pasteur Institute of Brussels), HIV (UC-San Francisco), Japanese Encephalitis Virus (Kobe U. School of Medicine), influenza (Vical), and malaria (NMRC) in animal models ranging from mice to non-human primates.

"We expect initial human testing of a Vaxfectin(TM)-formulated DNA vaccine to begin in the second half of 2007 in our pandemic influenza program," said Vijay B. Samant, Vical's President and Chief Executive Officer, "potentially paving the way for other applications to advance into clinical-stage development. We believe the potential of this new class of adjuvants is quite broad, including DNA vaccines and conventional vaccines against infectious diseases or cancer. We are especially pleased to expand our collaboration with the U.S. Navy on the malaria vaccine development program with the Vaxfectin(TM) adjuvant.

"Vaxfectin(TM) was developed to boost the immune response to DNA vaccines, but also has been shown to boost the immune response to a conventional seasonal influenza vaccine. In mouse studies, conventional influenza vaccines (Sanofi-Pasteur Fluzone(R) 2005-2006 Formula commercial product) formulated with Vaxfectin(TM) yielded significantly higher hemagglutination inhibition titers, the accepted standard correlate of protection, than unformulated vaccines at even an approximately 10-fold higher dose. Results from the study suggest that Vaxfectin(TM) has the potential to be used as a dose-sparing agent with conventional influenza vaccines against seasonal or possibly pandemic influenza strains.

The NMRC plans to conduct a series of antigen screening tests and further development in several animal models of malaria to optimize the design of a vaccine potentially leading to initial testing in humans. The Vaxfectin(TM)-formulated vaccine will be designed to elicit both T-cell and antibody immune responses.

About Vical

Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company is developing certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and address significant unmet medical needs. Additional information on Vical is available at http://www.vical.com.

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about Vical's technology and its current and potential applications, the scope of coverage of and potential applications for the company's issued and future patents and the potential uses and benefits of Vaxfectin(TM), as well as the company's focus, collaborative partners, and product candidates. Risks and uncertainties include whether the company's technology will be successfully applied by the NMRC or others; whether the company's issued patents will be challenged and whether such challenges will have an adverse effect on the scope of the patents; whether the company will enforce its issued patents or will be successful in any enforcement efforts; whether the company will successfully prosecute additional patent applications and whether such applications will lead to the issuance of additional patents; whether we will begin human testing of a Vaxfectin-formulated vaccine as anticipated in the second half of 2007, or at all; whether Vaxfectin(TM), if used as an adjuvant in any vaccine in human clinical trials, will be safe and effective at enhancing the immune response; whether the company or any of its collaborative partners will incorporate Vaxfectin(TM) into any of their products; whether Vical or others will continue evaluation of Vaxfectin(TM) as an adjuvant for conventional vaccines against seasonal or pandemic influenza; whether Vaxfectin(TM) will be used as a dose-sparing agent with conventional influenza vaccines against seasonal or pandemic influenza strains; whether Vical or others will continue development of the pandemic influenza DNA vaccine candidate; whether any strains of influenza will emerge as pandemic threats; whether the company's DNA vaccine candidate will be effective in protecting humans against emerging strains of influenza; whether the influenza vaccine or any other product candidates will be shown to be safe and effective; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; whether Vical or its collaborative partners will succeed in marketing any product candidates; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
Vical Incorporated

April 19, 2007

Emergent BioSolutions Announces That DHHS and DoD Issued Notices of Intent to Procure up to a ComCombined 22.75 M Doses of BioThrax (Anthrax Vaccine)


ROCKVILLE, Md.--(BUSINESS WIRE)--Apr 19, 2007 - Emergent BioSolutions Inc. today announced that the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Defense (DoD) issued two separate notices of intent to procure up to a combined total of 22.75 million doses of BioThrax(R) (Anthrax Vaccine Adsorbed).

In a Presolicitation Notice issued today, HHS stated its intent to procure 10.4 million doses of BioThrax for the Strategic National Stockpile (SNS) with options for up to an additional 8.35 million doses. HHS announced that it intends to enter sole source negotiations with the company to finalize the procurement and to make an award on or about July 24, 2007.

Separately, DoD issued a Special Notice signaling an anticipated sole source contract award to procure a minimum of 4 million doses of BioThrax, over a base period and 3 optional ordering periods.

"We were very pleased to learn of HHS and DoD's intent to procure additional doses of BioThrax," stated Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions Inc. "These notices indicate a continued commitment by the U.S. Government to Emergent BioSolutions' FDA-licensed anthrax vaccine for the protection of military personnel and civilians. We are committed to working with both HHS and DoD to promptly complete these intended procurements to ensure both federal agencies have continued access to and supply of this critical biodefense countermeasure."

"We compliment the Government's leadership in following a strategy of acquiring licensed available countermeasures for the highest threat agents, while pursuing next generation development utilizing new and emerging technologies," continued Mr. El-Hibri. In support of this strategy the company has a next generation anthrax countermeasure development program which includes both BioThrax and rPA-based candidates. This program is designed to meet the next generation requirements of the Government, including: room temperature storage, extended shelf life, novel adjuvants and novel delivery systems.

Since 1998, the company has delivered 19 million doses of BioThrax under contracts with HHS and DoD.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics, consisting of vaccines and therapeutics that induce or assist the body's immune system to prevent or treat disease. The company's biodefense business is focused on immunobiotics for use against biological agents that are potential weapons of bioterrorism. The company's commercial business is focused on development, manufacture and commercialization of immunobiotics for use against infectious diseases. These immunobiotics are designed to address significant unmet or underserved public health needs. More information on the company is available at www.emergentbiosolutions.com.

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management and any other statements containing the words "believes", "expects", "anticipates", "plans", "estimates" and similar expressions are forward-looking statements. There are a number of important factors that could cause the company's actual results to differ materially from those indicated by such forward-looking statements, including our performance under existing BioThrax(R) sales contracts with the U.S. government, including the timing of deliveries under these contracts; our ability to obtain new BioThrax sales contracts with the U.S. government; our plans for future sales of BioThrax; our plans to pursue label expansions and improvements for BioThrax; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs, preclinical studies and clinical trials; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company's Registration Statement on Form S-1 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

Contact Emergent BioSolutions Inc.Robert G. Burrows, 301-795-1877Vice President, Corporate Communicationsburrowsr@ebsi.com

April 18, 2007

Fort Lewis Soldiers Vaccinated

Christian Hill The Olympian

Nearly 4,000 soldiers assigned to a Stryker combat brigade in transit to Iraq are the first from Fort Lewis to receive a controversial anthrax vaccine since the shots again became mandatory for select U.S. service members.

On Feb. 8, the Army and the other service branches resumed mandatory inoculations for U.S. service members deploying to the Middle East and South Korea for more than 15 days, as well as those responsible for homeland bioterrorism defense.

Since than, Madigan Army Medical Center has administered 6,225 doses to soldiers, hospital spokeswoman Sharon Ayala said. The vaccine is delivered through six shots over an 18-month period, followed by an annual booster shot. Subsequent shots will be given to the soldiers where they’re stationed overseas.

No soldier has refused the vaccine, Ayala said.

Airmen from McChord Air Force Base also are receiving the vaccine.

The 4th Brigade, 2nd Infantry Division (Stryker Brigade Combat Team) recently departed Fort Lewis to serve for a year in Iraq.

The government has insisted that studies prove the vaccine is safe and effective. However, the vaccine has been a source of controversy for years.

It contains harmless parts of the bacteria. Some U.S. service members have been reluctant to be inoculated with the vaccine because of concerns about safety and possible side effects, which can include pain in the injected arm, swelling of lower arm, redness, chills and fever.

A federal judge stopped the Department of Defense’s six-year-old mandatory vaccination program in October 2004, responding to a lawsuit filed by several U.S. service members and civilian employees at the Pentagon.

The program became voluntary in 2005, and about 50 percent of troops participated.
Dr. William Winkenwerder Jr., assistant secretary of defense for health affairs, said that participation rate put troops at risk when he announced in October that mandatory vaccinations would resume.

“The anthrax vaccine will protect our troops from another threat — a disease that will kill, caused by a bacteria that already has been used as a weapon in America, and that terrorists openly discuss,” he said in a news release.

Anthrax-laced letters sent to media outlets and government offices in fall 2001 killed five people. No suspect has been charged.

The Pentagon was authorized to resume mandatory inoculations because of a December 2005 order by the Food and Drug Administration that the vaccine — known as Anthrax Vaccine Adsorbed (AVA), or Biothrax — was safe and effective against all forms of anthrax.
The federal government licensed the vaccine in 1970 as being safe and effective for people who come in contact with animal hides and fur where anthrax spores might reside.
Six U.S. service members and civilian employees filed a federal lawsuit in December to again stop the mandatory vaccination program. The service branches had to draft instructions for the program before mandatory vaccinations could resume.

The federal government has asked the court to dismiss the lawsuit, and the plaintiffs submitted their response this week.

“Our primary argument is that the FDA’s decision was arbitrary and capricious in that efficacy of the vaccine cannot be proven, and that the agency intentionally and disingenuously manipulated statistical data to support their erroneous conclusion,” Mark Zaid, an attorney representing the unnamed plaintiffs, wrote in an e-mail.

AVA is the only anthrax vaccine licensed in the United States, although new vaccines using modern technology are being researched.

April 17, 2007

Anthrax Vaccine the Killer?

CBS News
Video Clip


April 16, 2007

Montel Williams Show

Kelli Donley was to appear on the Montel Williams' show on April 20th. Kelli suffered severe side effects from the anthrax vaccine, and is rated 100% both from the military and the VA.

The show has been postponed and will re-air at a later date. When the date is known, it will be posted on the site.

April 12, 2007

Waiting for a Heart (Smallpox Vaccine)

http://www.bradento n.com/mld/ bradenton/ news/local/ 17058234. htm
By DONNA WRIGHT dwright@bradenton. com

BRADENTON - After weeks of fighting red tape and insurance problems, Navy veteran Andrew Spehr is now on the transplant list for a new heart.

Spehr, 26, was released from Tampa General Hospital early Monday evening after successfully undergoing evaluation for a new heart.

"We drove home in a rain storm," Spehr said Tuesday. "It's so good to be home. I feel great, a lot better than when I went into the hospital."

Spehr spent 12 days at Tampa General. Before that, he had been hospitalized at Blake Medical Center twice for a total of two weeks. All told, the Navy vet has spent all but one day of the last four weeks in a hospital bed.

Unless he gets a new heart, doctors warn he could die.

Now, Spehr and his family must wait for the call that a new, suitable heart has been found. "It could come at any time," Spehr said. "When we get the call, we go. They told us not to worry about clothes or anything, just get up to Tampa."

On Tuesday, Andrew's parents, Sally and Kurt Spehr, learned how to maintain a portable medicine pump to keep life-giving drugs flowing into Andrew's heart through an IV line until a transplant becomes available.

His mother is relieved Andrew finally made the list. "This is what we have been working for," she said. "You have to qualify to get the heart. Your heart has to be damaged to the point where nothing else can be done."

During his stay at Tampa General, Andrew was in intensive care for five days, his mother said. "It's wonderful to have him home," she said. "We just hope we don't have too long of a wait, but that depends on things outside of our control. But we are ready."

Dr. John K. Lourie, a Bradenton cardiologist, diagnosed Spehr as having myocarditis. The Navy veteran and Lourie believe it is possible his heart condition may have been caused by an adverse reaction to a smallpox vaccine three years ago.

Spehr was set to come home in the spring of 2004 when his destroyer, the USS Spruance, was ordered to the Middle East. Spehr volunteered to extend his duty. His medical record clearly shows that he had an exemption from getting the smallpox vaccine because he was due to be discharged.

But his commanding officers told him he had no choice - get the shot or be court-martialed.

Shortly after he came home Sept. 5, 2004, Spehr began experiencing symptoms that were later determined to be signs of congestive heart failure.

Nonetheless, in an interview Tuesday, Spehr was upbeat about his chances for a new heart. "When I get the call, doctors say surgery will happen that day, if the heart is good," he said.

Meanwhile, Spehr is following doctors' orders and watching his fluid and salt intake. "I am learning to live with this," he said. "It's going to happen. By the end of the year, it's going to happen."

Donna Wright, health and social services reporter, can be reached at 745-7049.

April 10, 2007

Responding to a Small-Scale Bioterrorist Anthrax Attack

Responding to a Small-scale Bioterrorist Anthrax Attack

Cost-effectiveness Analysis Comparing Preattack Vaccination With Postattack Antibiotic Treatment and Vaccination

Brian Schmitt, MD, MPH; Deborah Dobrez, PhD; Jorge P. Parada, MD, MPH; Demetrios N. Kyriacou, MD, PhD; Robert M. Golub, MD; Rishi Sharma, MD; Charles Bennett, MD, PhD
Arch Intern Med. 2007;167:655-662.

Background In 2001, a small-scale bioterrorism-related anthrax attack was perpetrated via the US mail. The optimal future response may require strategies different from those required in a large-scale attack.

Methods We conducted a cost-effectiveness analysis using Monte Carlo simulation during a 10-year time frame from a societal perspective to determine the optimal response strategy for a small-scale anthrax attack perpetrated against US Postal Service distribution centers in a large metropolitan area. Three strategies were compared: preattack vaccination of all US distribution center postal workers, postattack antibiotic therapy followed by vaccination of exposed personnel, and postattack antibiotic therapy without vaccination of exposed personnel. Outcome measures were costs, quality-adjusted life-years, and incremental cost-effectiveness. The probabilities for anthrax exposure and infection; vaccine and antibiotic benefits, risks, and costs; and associated clinical outcomes were derived from the medical literature and from bioterrorism experts.

Results Postattack antibiotic therapy and vaccination of exposed postal workers is the most cost-effective response compared with other strategies. The incremental cost-effectiveness is $59 558 per quality-adjusted life-year compared with postattack antibiotic therapy alone.

Preattack vaccination of all distribution center workers is less effective and more costly than the other 2 strategies. Assuming complete adherence to preattack vaccination, the incremental cost-effectiveness compared with postattack antibiotic therapy alone is almost $2.6 million per quality-adjusted life-year.

Conclusion Despite uncertainties about a future anthrax attack and exposure risk, postattack antibiotic therapy and vaccination of exposed personnel seems to be the optimal response to an attack perpetrated through the US Postal Service.

Author Affiliations: Medicine and Neurology Service Line (Dr Schmitt) and Department of Medicine, Hines VA Medical Center, Hines, Ill, and Stritch School of Medicine, Loyola University Chicago, Maywood, Ill (Drs Schmitt and Parada); Division of Health Policy and Administration, School of Public Health, University of Illinois at Chicago (Dr Dobrez); Departments of Emergency Medicine and Preventive Medicine (Dr Kyriacou) and Medicine (Dr Golub), and Division of Hematology/Oncology of the Department of Medicine, Center for Healthcare Studies, and Robert H. Lurie Comprehensive Cancer Center (Dr Bennett), Feinberg School of Medicine, Northwestern University, Chicago, Ill; and Midwest Center for Health Services and Policy Research, VA Chicago Health Care System, Lakeside Division (Drs Sharma and Bennett).

Dad's Vaccination Hospitalizes Boy, 2 (smallpox)


Associated Press

CHICAGO -- A 2-year-old Indiana boy who contracted a rare and life-threatening infection from his soldier father's smallpox vaccination is recovering and should be upgraded from critical condition soon, according to a published report.

Doctors have relied on some untested measures to save the boy's life, including skin grafts and an experimental drug that has never been used to treat a human patient, the Chicago Tribune reported in its Sunday editions. The boy's pox lesions left him with the equivalent of second-degree burns, requiring grafts to let the underlying skin heal.

"He's really on the road to recovery," said Dr. John Marcinak, an associate professor in the University of Chicago's section of pediatric infectious diseases.

The boy has been in pediatric intensive care at the University of Chicago's Comer Children's Hospital for the past month with a virulent rash over 80 percent of his body. He developed the rash after coming in contact with his father, who had recently been vaccinated for smallpox before he was to be deployed overseas by the Army.

The boy is not suffering from smallpox, but from the related vaccinia virus which is used to convey immunity to the much deadlier disease. The infection is a rare condition called eczema vaccinatum, which has not been reported since at least 1990, when the military ended a previous program of smallpox vaccination. Smallpox was declared eradicated in 1980.
The boy, whose name and hometown have not been released at his family's request, will remain isolated as long as he has infectious pox lesions, which doctors predicted would be gone within two weeks. The boy's mother, who developed milder lesions, has recovered completely, Marcinak said.

The federal Centers for Disease Control and Prevention and the U.S. Defense Department still consult with doctors but are no longer in daily contact with the hospital about the case, officials said. Health officials say there is no infection risk for the general population because the vaccinia virus can be spread only through close physical contact.

The child suffered from eczema, which is a known risk factor for vaccinia infection, doctors said. People with eczema are warned not to have close physical contact with the recently vaccinated because the condition allows the virus to enter the skin.

The military began smallpox vaccinations again in 2002 because of bioterrorism fears.

April 8, 2007

Emergent Vaccine Boosts Big Profits

[From Ingham County Community News ]
Emergent vaccine boosts big profits

LANSING — Delivery of more than 6 million doses of its Lansing-made anthrax vaccine helped boost Emergent BioSolutions Inc.'s bottom line.

In its first earnings report as a publicly traded company, Rockville, Md.-based Emergent reported it earned $22.8 million, or 99 cents a share, in 2006. That was a 44 percent increase from a profit of $15.8 million, or 77 cents a share, in 2005. Emergent, which went public last year, said revenue grew 17 percent to $152.7 million, up from $130.7 million in 2005.

The BioThrax anthrax vaccine doses were delivered to the U.S. Department of Health and Human Services and Defense Department.
Fuad El-Hibri, Emergent's chairman and chief executive officer, said the company has begun marketing to first responders, including police officers and firefighters, as well as foreign markets to grow its BioThrax sales.

"These additional markets represent important potential areas of operation for diversifying our BioThrax customer base," he said.

The vaccine is the main source of Emergent's revenue, accounting for $148 million in sales, Chief Financial Officer Don Elsey said.

El-Hibri said work on Emergent's new $75 million vaccine manufacturing facility in Lansing is complete, though the building still needs Food and Drug Administration approval before it becomes operational.

The facility will be capable of producing 40 million doses of vaccine a year, El-Hibri said.

Emergent also said that Robert Kramer Sr., president of the local operation, Emergent Biodefense Operations Lansing, is being promoted to executive vice president manufacturing operations.
— Jeremy W. Steele is a reporter for the Lansing State Journal.

April 7, 2007

Sex Assault at Walter Reed Georgia Guardsman was One of at Least Three Victims at Troubled Hospital (mentions effects from AVA)

Sex assault at Walter Reed: Georgia Guardsman was one of at least three victims at troubled army hospital.
By Ron Martz
The Atlanta Journal-Constitution

In the spring of 2004, Cpl. Matt Burgess of Dallas was sent to Walter Reed Army Medical Center in Washington for a series of tests to determine what was causing him to vomit nearly a dozen times a day, stop breathing while he slept and suffer excruciating pain in his joints.

The Georgia Army National Guard soldier already felt victimized. He said the Army medical system questioned his honesty and integrity, telling him his problems were of his own making after he became ill in Iraq. Then after 2 1/2 years on medical hold, doctors diagnosed his numerous health problems that now require him to take 21 pills a day and sleep with a special breathing machine, all the result of a series of mandatory anthrax shots he was given in 2003.
While at Walter Reed, Burgess was victimized again.

According to federal court documents, Burgess was one of at least three Walter Reed patients who were sexually abused that spring by a civilian medical technician who had a history of sexual molestations.

The incidents are the latest in a series of revelations of substandard conditions at the Army's premier medical center that have prompted congressional investigations, promises from President Bush to rectify the problems and resulted in the firing or resignation of several high-level generals and the Secretary of the Army.

Walter Reed officials did not respond to telephone messages and repeated calls for comment.
Although The Atlanta Journal-Constitution generally does not identify the victims of sexual abuse, Burgess and his wife, Robyn, agreed to talk about the Walter Reed incident "so future soldiers won't have to go through what I have. It's disheartening," Matt Burgess, 34, said in a lengthy interview this week.

"By speaking out," he added, "I hope to be able to turn this into a positive experience."
Burgess was sent to Walter Reed for a two-day sleep test in April 2004 to help doctors determine the cause of his breathing problems.

On April 21, while Burgess was under the influence of Ambien, used to treat insomnia, he was sexually abused by Mario Echeverri, a civilian technician, according to federal court documents.
"When the incident happened, I was mentally there but I felt powerless to stop it physically," Burgess said.

He said he was traumatized about what happened, and he filed a complaint with Walter Reed officials that day. He stayed at the hospital for the second night of tests, but was given a different technician.

When investigators were called in by Walter Reed officials, it was discovered that the incident involving Burgess and two others had been captured on videotape.

Echeverri "was evidently dismissed from a prior job as a sleep technician for touching a patient in a sexual manner" and had previously pleaded guilty to disorderly conduct "as a result of him fondling the genitalia of a law enforcement officer," federal prosecutors wrote in court documents.

Echeverri pleaded guilty in February 2005 to one count of sexual abuse.

He was sentenced to 18 months in jail and two years of supervised probation, but served only 75 days, said Channing Phillips, spokesman for the U.S. Attorney in Washington, D.C. Echeverri is now a registered sex offender in the District of Columbia.

"We agreed not to prosecute him on the other two cases for the plea on the [Burgess] charge," Phillips said.

When Burgess left Walter Reed, he had to deal not only with his physical problems, but with the emotional trauma of what had happened at the hospital, his wife said.

"He has anxiety attacks when he even thinks about going back to the Army to be seen" by a doctor, she said. "Medical professionals bother him now. He's had too many of them break their confidence with him."

Robyn said their marriage suffered after her husband came home.

"It was a year after the incident before we could get back on track," she said.

The two sought counseling individually at Fort Benning, where Matt was on medical hold, to save their marriage.

Among the confirmed medical diagnoses, according to Burgess' medical records, are sleep apnea, diabetes, fibromyalgia, migraine headaches, irritable bowel syndrome and post-traumatic stress disorder, the latter as a result of the sexual abuse.

"All conditions he is being treated for stem from the anthrax vaccination," an Army doctor wrote in a medical evaluation report on Burgess in 2004.

He has been placed on a temporary medical disability retired list and must return for checkups, even though the Department of Veteran Affairs has rated him 100 percent disabled.

Burgess is now completing a course in recreational vehicle repairs at East Central Technical College in Fitzgerald, and he and Robyn hope eventually to open an RV park and marina that would cater to ill and wounded veterans.

"Our lives were in limbo for three years for a deployment that was supposed to last one year," Robyn said. But now, she added, "We feel we have a direction for our lives."

Court tapes reveal Walter Reed abuse


Court tapes reveal Walter Reed abuseGI says it shows the Army's failure to take good care of its war veterans
Washington Post

WASHINGTON — Two months before Mario Alberto Echeverri administered a sleep disorder test to an Army corporal at Walter Reed Army Medical Center, the medical technician had been arrested on charges of fondling the groin of a U.S. Park Police officer.

Seventeen months before, Echeverri had been observed touching a Walter Reed patient inappropriately and was warned against such behavior. Two years before, he had been accused of improperly touching a patient at a private sleep center in Gaithersburg, Md.

Cpl. Matthew Burgess knew none of this when he went to the Army hospital the evening of April 21, 2004. Echeverri gave the soldier sleep medication, asked him to strip to his shorts, connected him by wire to monitoring equipment and had him lie down. The test was part of a study of whether Burgess' headaches, fatigue and diarrhea were connected to the anthrax vaccine he received when he was deployed to Iraq in 2003.

As the machine monitored Burgess, a surveillance camera captured Echeverri fondling the drugged soldier while he was helpless to respond, court records reflect. Tapes show the technician engaging in similar conduct with two other male patients, one an active-duty soldier and the other a 16-year-old boy, according to records and interviews.

Echeverri, who worked for a private contractor hired by Walter Reed, pleaded guilty in 2005 to second-degree sexual abuse of Burgess, court records indicate. He was not charged in the other two cases as part of his plea agreement, said a spokesman for the U.S. attorney's office in Washington.

For Burgess, 34, his experience at Walter Reed is an unforgivable betrayal that points to a failure by the Army to take care of soldiers returning from Iraq.

"I had already lost my health because of the anthrax vaccine, and this on top of it," said Burgess, whose illness was ultimately determined by the Army to have been caused by the vaccine, medical records show.

"The Army always tells you all the way from basic training that we're a family, and if you do the right thing, we'll take care of you," Burgess said.

Walter Reed officials said they were unaware of Echeverri's arrest by U.S. Park Police or the Maryland allegations. Once they discovered he had abused patients, Walter Reed removed him from his job and reported him to authorities. "We reported everything very honestly as we knew it at the time," said Col. David Kristo, then-commander of the sleep center.

The Washington Post does not typically name victims of sexual abuse, but Burgess said he wanted his story told publicly because he thinks it demonstrates the Army's neglect of Iraq war veterans and raises questions about Walter Reed's oversight of contractors.

Burgess and his wife said his experience should be considered as Congress and the Army explore how to fix the system.

"We want to expose the way our heroes are treated and help our future veterans," Robyn Burgess said.

April 4, 2007

Civilians Could be Facing Mandatory Anthrax Shots - Expert Warns

Civilians could be facing mandatory anthrax shots
Expert warns government has 10 million doses for 'emergency'
By Bob Unruh

Not only has the highly controversial anthrax vaccine returned as mandatory for members of the U.S. military, but now a medical expert who testified before Congress on the dangers of those shots is warning that under some circumstances civilians could be facing government-ordered anthrax vaccinations.

Dr. Meryl Nass, a diplomate of the American Board of Internal Medicine, told WND that should there be another anthrax attack, such as the powder-laden envelopes that arrived at a U.S. Senate office building and other offices in 2001, such an order is legally and technically possible. If a handful of people were to be exposed in an office building in Los Angeles, for example, the government could issue an order for vaccination for "everybody in the building, maybe everybody in Los Angeles. That's what people now are facing," she said.

The highly controversial shots were first mandated for U.S. military troops heading to the Middle East for the Gulf War in 1991, and again for the Iraq War in 2003. But according to investigative journalist Gary Matsumoto's book, "Vacccine-A," many of the military service members were given an experimental anthrax vaccine without their knowledge or consent.
There have even been questions raised by medical experts about what was approved by the Food and Drug Administration – and how it was approved – as well as the side effects that went undocumented, and the thousands of cases of sometimes-horrific reactions that allegedly have resulted.

Matsumoto, a New York-based war correspondent who won 10 journalism awards during his years working for NBC and Fox News Channel, in 1998 drew a connection between the vaccine and the Gulf War Syndrome. His book describes several cases, including an Army sergeant whose skin became so diseased that doctors, in a desperate attempt to cure him, removed every square inch of skin from his body. Then there was the Green Beret colonel who suffered walking blackouts that left him unable to find his way home, and the man whose brain literally shrank until he could no longer write his name or walk straight.

Matsumoto's book goes further than the simple administration of medicine that somehow went wrong; he alleges that members of government at the highest levels knew the drugs were experimental and had not been tested adequately, but decided anyway to go ahead and use the vaccine on 1.4 million members of the military.

The reason? Matsumoto claims the existing anthrax vaccine was too weak to confer immunity in a timely way – on U.S. troops about to be deployed to Iraq a week or two later, facing a possible threat of biological weapons in the hands of Saddam Hussein. So a more potent, fast-acting vaccine was deemed necessary, even if it meant using an untried formulation on America's fighting forces, he says.

Anthrax loomed large on the public's consciousness when anthrax-laced letters were received by U.S. Sen. Tom Daschle's government office, and several media offices, resulting in several human cases of anthrax.

"Death to America. Death to Israel. Allah is Great," was the theme in the letters, which were investigated by the FBI, although no one ever was charged.

Now Dr. Nass is suggesting that not only should members of the military be raising objections, but civilians at large should be clamoring for a government that protects them, not subjects them to questionable medical processes.

The doctor, who for years has specialized in the care of military personnel suffering from brain and immune system dysfunctions subsequent to anthrax vaccinations, has provided expert testimony to Congress, the National Institutes of Health and the FDA on the issue.
She also vigorously opposes the anthrax vaccine, and her website actively is recruiting volunteers to participate as plaintiffs in a new lawsuit against the government over the restart of the vaccine program.

"I think what's important for the average person to know is that the military has vaccinated 1.4 million people, and there have been thousands of people … with adverse reactions," she told WND.

And she said there undoubtedly are many more cases that have gone unreported or misdiagnosed as another disease.

Worse yet, the urgent need for the vaccine never has been documented by the government, meaning that military service members – and possibly civilians – could be getting a dangerous and life-threatening vaccine for no reason.

"The threat [of anthrax] is nebulous. It's a good terror weapon, but a poor strategic weapon. It's very unlikely to be used," she said. That's because the anthrax, if released on a large scale, would follow the line of the air currents, and be confined to that very narrow area.

An accidental release in Russia in 1979 did kill several dozen people, primarily because little or no treatment was available, but all in a very narrow pathway directly downwind from the release point. For a large-scale disaster to develop, someone would have to be flying an airplane back-and-forth over a target area, with a continuous release of the anthrax, she said.
And with the medicines that are available for treatment after the fact, the impact of such an unlikely attack probably could be kept to a minimum with the common-sense application of those treatments, she said.

"If somebody sees that airplane [flying back and forth], then take the treatments," she said.
She said her concern was that the government, instead of taking all reasonable precautions to treat people, now has stockpiled 10 million doses of anthrax vaccine for civilians.

"This has stopped just being a military issue. If there were a threat or the potential for that threat, civilians could be subjected to mandatory vaccinations," she told WND.

The history of using biological agents in war primarily include instances during World War II where the Japanese used such attacks in China – on a small scale, she said. There never was developed an ability to release them over large areas.

"If they are viruses, they may or may not be sensitive to a number of anti-virals that are available. If it is bacteria, there are antibiotics that can be used for most biological threats, and in fact many are responsive to doxycyclin," she said.

"It's old and cheap, doxycyclin. You should go out and buy a month's worth. It attacks tularemia … plague and the like," she said.

She said "mass treatments" should only be done when there is a risk-benefit analysis that has been defined, and the Advisory Committee on Immunization Practices for the National Centers for Disease Control has found that's never been done for anthrax.

She said she found it interesting that the military chose not to make its anthrax efforts a medical campaign, but instead made it a command program.

"The guy who teaches the soldiers how to shoot now is the one who has to force everyone to get [the anthrax vaccine] and punish them if they don't."

Nass said the attraction to terrorists is that in some ways anthrax could be used clandestinely, but "you can do that with other bombs too," she said.

Her only explanation for the continuing pursuit of the vaccination program by the military was financial. "There's a lot of money involved, the price of the vaccine has increased tenfold since they started," she said. Several other websites noted the same explanation, specifically citing retired Navy Adm. William Crowe, who owned part of Bioport, in Lansing, Mich., which produced the vaccine.

"The whole program has never made sense," she told WND. "We've got a lawsuit pending again to fight them on the science. I feel – actually I don't know why, I've been involved with this for nine years – but I feel optimistic this year we're going to end it."

"Almost everybody has a big problem with this vaccine," she said.

Matsumoto's book documents the development of the anthrax vaccine by the Pentagon starting in 1978, to which eventually was added an oil called squalene, which has been linked to autoimmune diseases such as lupus, multiple sclerosis and arthritis.

His book also warned then of just what is developing now: the mandatory program for military members as the inclusion of the civilian population in plans for the vaccination. He warns that will result in a "man-made epidemic of unprecedented size."

A website called Military Corruption described the court ruling that ended the first wave of mandatory inoculations for the military.

"Judge Emmet Sullivan of the U.S. District Court for the District of Columbia fired a torpedo into the highly controversial program when he declared that the Food and Drug Administration failed to follow its own regulations when it approved the 'vaccine' to specifically protect against 'aerosolized anthrax' that could be used in a biological attack," the site said.

"The FDA failed to properly classify the vaccine as 'safe and effective' for us against the inhalation type anthrax, Judge Sullivan wrote. 'Unless and until' the federal agency does that, the judge ruled, 'the involuntary anthrax vaccination program, as applied to all persons, is rendered illegal.' The judge said service members must have their 'informed consent rights' protected in view of what he called forced submission to 'an investigational drug,'" the website concluded.

Nass confirmed that the military had made a very quiet announcement late in 2006 that the mandatory military program would be resumed soon, and in fact it has been relaunched.
That was more fully described by the Raw Story website.

"While the Defense Department maintains that the anthrax vaccine is safe and poses no long-term risks to recipients, a little-known program at Walter Reed – the National Vaccine Healthcare Center – seems to contradict the military's assertions," the report said.
"Documents … show that military medical personnel have known since at least 1998 that there are genetic triggers between illnesses and some required immunizations, including the anthrax vaccine. They also reveal the military knew and did not implement routine pre-screening which could help reduce vaccine-related illnesses," the report said.

Nass said whatever results such research has generated should be made public. "This could save more people from becoming ill," she said.

During the earlier mandatory injections, a number of service members simply refused, choosing to take the punishment rather than the inoculation.

Airman Jessica Horjus was one. In 2004 she told the Washington Post that if there's no documentation of a threat, or confirmation that the vaccine is safe and effective, what's the point?

"I have a kid to take care of," she told the newspaper. "The Air Force can always fill my slot with someone else, but who's going to fill the mommy slot?" She was demoted.

Nass now warns that the government stockpile exists, and the laws allow mandatory orders, not only for service members, but civilians.

"There's no more emergency than there has been for the last seven years, but the laws … require only the potential for an emergency," she told WND. "You can make that decision as head of HSS [the Department of Health and Human Services], or governors can give a vaccine on that basis."

"Under a standing emergency, officials can say, 'We don't have to tell you. We get to make the determination… ' There's a lot of scary things that have happened since 9/11," she said.
She said she still is contacted regularly – at least several times a week – by soldiers who were sickened by the vaccines. And she noted that with the process for producing the anthrax vaccine, each lot has different characteristics, and can produce different results.

"Many studies of Gulf War veterans suggest anthrax vaccine caused or contributed to chronic illness in those veterans. The only studies that claim the vaccine is safe were performed by the Defense Department. Most of those students were supervised by the same individual, Col. John Grabenstein, who was the director of the military's vaccine program.

"Col. Grabenstein claimed that no chronic illnesses resulted from anthrax vaccine. Yet on the anthrax vaccine package insert, FDA explains why those military studies had serious problems and cannot be relied upon," she wrote.

In her estimate, up to one-third of the soldiers vaccinated developed problems ranging from muscle and joint pain and short-term memory loss to lupus and thyroid disorders.

"What can soldiers do when faced with the anthrax vaccine? It seems we are in a legal gray area now. Personally, I would ask to be given informed consent. I would ask for a copy of the vaccine label to review, which can be found at: [this web link]," Nass wrote.

Bob Unruh is a news editor for WorldNetDaily.com.

April 2, 2007

Anthrax Shot Returns to Base (Dover AFB)

Anthrax shot returns to base
By Kate House-Layton, Delaware State News

DOVER — Dover Air Force Base is again vaccinating its members for anthrax.

The military-wide mandatory immunization program started March 19 at Dover after a three-year hiatus due to federal questions about the vaccine’s effectiveness.

All “uniformed personnel, emergency-essential and equivalent civilian employees” who are assigned for at least 15 consecutive days to the Middle East, East Africa and Central Asia or U.S. Forces in Korea are required to take the shot, U.S. Department of Defense spokeswoman Cynthia Smith said.

Those assigned to “special units with biowarfare- or bioterrorism-related missions and other specially designated units,” also are required to take the shots, Ms. Smith said.

The latest round of shots troubles retired Dover Air Force Base Lt. Col. Jay Lacklen. The Dover resident, who was in charge of the 326th Airlift Squadron in 1999, hasn’t forgotten the health problems he and fellow airmen at the Dover base suffered when the shots were given in the late 1990s or how 55 out of the 120 reserve pilots he supervised left his unit at the Dover base to avoid the shots. “I don’t know how many will leave to avoid the shot this time,” he said.

The U.S. Department of Defense announced its plan in October to bring back the shot program military-wide. In February, the assistant secretary of defense for health affairs approved service implementation plans, the military’s Anthrax Vaccination Information Program Web site said. The vaccine is given in a six-shot series over an 18-month period. The first three shots are administered within two weeks of each other, then two more after a couple of months and a yearly booster.

Dover Air Force Base spokeswoman Lt. Christine Sukach said the base could not say how many vaccines have been given locally since the program returned because it is a readiness indicator for airmen deployed in high threat areas.

The DOD, however, has vaccinated more than 1.5 million people worldwide with more than 5.7 million vaccine doses since 1998, she said. DOD’s vaccination program started in 1998. The shots stopped in 2004 after several service members filed a suit in the U.S. District Court of Washington and a federal judge placed an injunction against the anthrax vaccination program. The judge ruled that the Food and Drug Administration made mistakes in its decision about the vaccine’s effectiveness against anthrax inhalation. The FDA then declared it safe for inhalation anthrax in 2005.

The Pentagon has repeatedly said the vaccine was approved by the Food and Drug Administration and it was proven safe and effective.

The vaccine itself doesn’t concern Lt. Col. Lacklen. His biggest concern is whether the latest round of shots contain squalene, an agent that he said was added to the vaccine to boost its effectiveness in the ’90s. Studies, he said, point to squalene as the source of various autoimmune disorders, which includes muscle and joint pain, heart and breathing problems among other things. The squalene, he said, was in five of the first 50 lot numbers in 1999. The military, he said, refuses to test for it. He also said the product insert that accompanies every vaccine package lists a string of autoimmune disorders that occur coincidentally with the shots. The military does not talk about the product insert, he said.

Ms. Smith said it is a myth that the military added squalene to the anthrax vaccine. “Food and Drug Administration scientists found trace quantities of squalene in anthrax, diphtheria and tetanus vaccines — less than the natural level of squalene in the human bloodstream. The FDA notes that these minute quantities could have come from processing during FDA tests. Squalene is present in the oil in fingerprints.

Lt. Col. Lacklen disagrees with this explanation. “Is it still contaminated?” he asked. “Are they testing to see if its still contaminated?”

The AVIP Web site also said the squalene present in anthrax vaccine probably comes from the bacteria used to make the vaccine. Lt. Col. Lacklen said according to a Tulane University study, there is no squalene in anthrax bacteria. DOD also has said anthrax is still used as a bioweapon against U.S. soldiers which makes the vaccine necessary. Lt. Col. Lacklen disagrees. “There’s been no anthrax threat evident overseas,” Lt. Col. Lacklen said. “The issue is (the military is) conducting a surreptitious experiment on the troops by using the illegal additive that boosts the effect of the vaccine. “They can’t explain how the booster got in there in 1999 and they can’t explain if it is still in there now. And that is the cause for concern. “They can’t answer the questions. Yet even though they can’t answer the questions they’re still going to order their people to take the shot and I find that unconscionable.”

Lt. Sukach said per DOD’s instruction that all the Dover base’s airmen have received briefings from their commanders regarding the resumption of the AVIP and informational brochures regarding the vaccine have been made available to them.

“While any specific concerns regarding the vaccine would be covered under Privacy Act restrictions, I can tell you that our airmen are educated about the vaccine and if they have concerns, we have subject matter experts at the base and within the Air Force who can address those with them,” she said.

Post your opinions in the Public Issues Forum at newszap.com
Staff writer Kate House-Laytoncan be reached at 741-8242 or khouse@newszap.com

Vet Transferred to begin Heart Transplant (Smallpox Vaccine)


Vet transferred to begin transplant tests
dwright@bradenton. com

TAMPA- Andrew Spehr, of Bradenton, is one step closer to a new heart.

The 26-year-old Navy veteran was transferred from Blake Medical Center to Tampa General Hospital on Thursday to begin preliminary tests for a heart transplant.

He underwent a heart catheterization to determine his heart's strength, according to his mother, Sally Spehr. "He's doing OK and things are really moving along," his mother said.

The news of Spehr's transfer thrilled Eddie Mulock, a Bradenton attorney who has successfully had four transplants, including a new heart. Mulock is advising Andrew and his parents. "I'm relieved and real happy for the family," said Mulock, who helped Sally and Kurt Spehr get their son transferred to Tampa General. "He's where he should be, but now we'll see the importance of organ donors. "Being on the list for a new heart is not enough, said Mulock. "Even if a heart becomes available, it has to be the right match," the attorney said. "We have to pray he gets the right heart. That's the stress on the family right now."

Spehr's case illustrates how important it is for people to sign up to be organ donors, Mulock said. "Don't take those organs to heaven," he said. "Heaven knows we need those organs here."

Tests will continue for several days and Tampa General's cardiac team is scheduled to review the results Thursday to determine if the former Navy navigator is eligible for a heart transplant, his mother said.

Andrew Spehr and Bradenton cardiologist Dr. John K. Lourie believe his congestive heart failure may have been caused by an adverse reaction to a smallpox vaccine he had just weeks before his discharge Sept. 5, 2004.

Spehr's medical records show he was supposed to have an exemption from the smallpox vaccine because he was close to discharge. But when his ship was ordered to Middle East in early summer of 2004, Spehr volunteered to extend his duty. His commanding officers told him he had to have the shot or face court-martial.

"I had no choice," Spehr said in an interview this week before going to Tampa General. "I had to get the shot."

The Centers for Disease Control and Prevention have documented adverse reaction to the smallpox vaccine that have resulted in cardiomyopathy, which is Spehr's diagnosis.

Spehr served on the destroyer USS Spruance in the Mediterranean Sea and Persian Gulf from 2000 to 2004. He also was part of Operation Northern Lights off the coasts of Scotland, England and Norway.

Donna Wright, health and social services reporter, can be reached at 745-7049.