October 31, 2007

Interview with Steve DeGuire - Biothrax Vaccine Casualty


Government: Vaccines threaten up to 44,000 soldiers

'This really is like Russian roulette. Spin the chamber and take your shot'

A U.S. soldier who is serving in Iraq is being punished for refusing an anthrax vaccine that has a questionable safety record, and apparently will be drummed out of the service. But such punishments may be of no avail to the military; the word already is out in a government report that up to an estimated 44,000 servicemembers could end up with "severe adverse events (including) disability or death" from such mandatory medicines.

The recent case involves Pfc. Leif Hamre, 22, who reports he's been subjected to threats and intimidation after refusing to take the controversial anthrax vaccine, and was given a variety of punishments including 18-hour work days.

Hamre reports he was given an ultimatum in June to take the vaccine or be punished but couldn't accept the medication, especially after he discovered the military wasn't even handling the vaccines under the rules for storing it at the correct temperature.

In an "open letter" to friends and family members, he said, "The tactics they have used to coerce me into taking the shot are unregulated, unscrupulous and downright un-American."

He reported he then was given an Article 15 – a non-judicial punishment in the military – and his mother reported he was taken off missions, assigned extra duty and had his pay scale lowered.

The controversial shots first were 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 the vaccine has been linked by investigative journalist Gary Matsumoto in his book, "Vaccine-A," to the Gulf War Syndrome, and a recent report from the General Accounting Office even confirmed that tens of thousands of soldiers are expected to suffer significant health threats from the mandatory vaccinations.

The GAO report confirms that about 2.2 million members of the military service get at least one mandatory immunization annually, including those for anthrax.

"No immunization is completely safe," the reported explained. "Like all individuals, servicemembers may experience side-effects as a result of their immunizations, known as adverse events. Most adverse events consist of relatively mild reactions, such as swelling near the site of the immunizations."

The report noted that a "small number" of people may experience more severe reactions. "Some servicemembers who received these vaccines experienced severe reactions such as migraines, heart problems, and the onset of disease including diabetes and multiple sclerosis."

The military suspended the use of the anthrax vaccine in October 2004 in response to a court order revealing concerns over the process through which it was approved for use on the military, but that order expired in October 2006 and the mandatory shots were resumed within a few months, the report noted.

As part of discussing the military's documentation of its anthrax vaccine program and the Vaccine Healthcare Centers Network established by the Department of Defense to monitor such problems, and "meet the health care needs of servicemembers receiving mandatory immunizations," the GAO report said officials with the VHC Network and the Centers for Disease Control "estimate that between 1 and 2 percent of immunized individuals may experience severe adverse events, which could result in disability or death."

"Some of these events may occur coincidentally following immunization, while others may truly be caused by immunization," the GAO said.

Marguerite Armistead, of the organization Protecting Our Guardians, told WND the potential number of soldiers lost to the military from an inoculation is huge.
"In public medicine, if someone is allergic and shows a contraindication, they are never ever forced to take that medication – it's written in red on their medical file – unless it's a life or death situation and that medication is the only one that can save them," she said.

"In this military program, we have a product that has led to numerous fatalities, numerous adverse reactions, and yet soldiers are told you won't be deployable if you don't take this," she told WND.

"This really is like Russian roulette. Put three bullets in, spin the chamber and take your shot," she said.

She said various federal reports document 44 deaths from the inoculations, and thousands of adverse reactions already, many of them involving auto-immune diseases or lesions on the brain.

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.

Hamre's parents have told Protecting Our Guardians that their son has reported he is expected to be leaving Baghdad on Nov. 17, and apparently is returning to a base in Alaska.

"He told us that a captain from another base refused the vaccine but he doesn't know the details of that situation. He got word about that from his old roommate who was working at that base …. That roommate now is back where Leif is located and it sounded like there may have been others who refused as well. Leif's commander was angry that that person shared the information with Leif and claimed it was over and now he was causing problems to bring it up again," they wrote the organization.
"He continues to work longer hours than the rest of the guys and has brought it up with the commander and is told 'you don't have it that bad.' I guess by keeping busy the time may go by faster. Anyway, Leif is glad to have a date set to start the process of leaving the war. He isn't sure about the discharge, money he was told he would receive and the bonus for serving in Iraq…" they wrote.

The vaccine BioThrax, by BioPort – now called Emergent Biosolutions – is the only FDA-licensed vaccine for anthrax in the U.S. and the Pentagon repeatedly has affirmed its safety.

"The vaccine is safe and effective," confirmed former Assistant Secretary of Defense for Health Affairs William Winkenwerder.

Still, the DOD has a number of studies evaluating its performance, and even BioPart's insurance company, Evanston Insurance, is questioning the safety of the product.

According to a report on Raw Story, the insurance company sued BioPort alleging "material misrepresentations" by the pharmaceutical company about "incidents, conditions, circumstances, defects, or suspected defects" in the vaccine.

"I believe as an American soldier you are expected to follow orders and put yourself in harm's way but unnecessary safety risks should not be part of the accepted risks one is asked to face," Hamre said. "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; I am an American citizen too, with rights I thought we were fighting to protect. I have given two years of dedicated service to the Army, with a clean record and a willingness to sacrifice for my country and fellow soldiers.

"I am looking forward to much more punishment and probably a discharge from the Army. I just don't think any of this seems right…" he said.

Hamre's mother told Protecting Our Guardians appeals to various upper officials in the military and even Congress have been unavailing.

While the GAO report warns of the 1-2 percent rate for "disability or death" from vaccines, that figure includes all vaccines administered to servicemembers by the military. But the report also notes the 2.2 million who are inoculated every year, as well as the mandatory anthrax shots for servicemembers assigned to certain locations in the world.

Armistead noted that the vaccine's own product insert warns of potential complications with heart problems, Guillain Barre Syndrome, seizures and paralysis among the nearly four dozen potential adverse reactions.

WND earlier reported Dr. Meryl Nass, a diplomate of the American Board of Internal Medicine, is warning 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, an order requiring civilians to be inoculated also 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.

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 [already] 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.

There are responses developing, too.

Barbara Damon-Day, whose son, Maine Army National Guard Capt. Patrick Damon, died in 2006 in Afghanistan from "undetermined cases," investigated.

She now believes military vaccinations played a role, and the state Legislature has approved with unanimous support a bill putting in place various safety measures and reviews.

The plan creates a commission to review various health care practices including vaccinations for the Maine National Guard.

WND also has reported on the aggressive campaign by Merck & Co. and state lawmakers to require Gardasil, a vaccine that targets the sexually transmitted human papillomavirus, to be given to all schoolgirls.

At least 11 deaths and about 3,500 adverse reactions already have been tied to that vaccine.

October 30, 2007

Anthrax Vaccine Side Effects Disable Many Military Veterans, Yet Very Little Help Is Available


The Anthrax vaccine, a mandatory immunization for many people serving in the US military, has been linked to dozens of serious side effects and adverse reactions. But in spite of this, the Department of Defense still insists that the defective drug is perfectly safe. And even though thousands of veterans have been permanently disabled following reactions to Anthrax vaccine side effects, the US government refuses to classify these injuries as combat related. As a result, many disabled veterans face even greater economic hardship because their already-paltry disability benefits are still subject to income tax.

The US military began requiring many of its uniformed personnel and civilian contractors to receive an Anthrax vaccine in 1998, amid concerns that enemies might use the deadly virus in biological weapons. Since then, well over 1 million people have received the controversial Anthrax vaccine. In 2004, military personnel were given a reprieve from mandatory Anthrax vaccinations when a US court ruled that the Food & Drug Administration (FDA) had to approve its use. But the FDA did that in short order in 2005, and now the Anthrax vaccine is again a requirement for soldiers and contractors serving in the Middle East, Central Asia and Korea.

To date, the FDA has received more than 5,000 adverse event reports for the Anthrax vaccine on its Vaccine Adverse Reporting System. At least 670 reports were classified as “serious”, and 44 resulted in deaths. Some doctors have attributed 10-15 medical conditions to the Anthrax vaccine, and the side effects include everything from hearing loss, sleep disorders and neurological problems that mimic Multiple Sclerosis. In spite of this, the Anthrax vaccine is not part of the National Vaccine Injury Compensation Program that allows people injured by defective vaccines to collect money for their injuries.

Soldiers and their families have repeatedly asked the Defense Department to stop using the Anthrax vaccine, but so far it has refused. For soldiers disabled by the Anthrax vaccine, life becomes both a physical and financial struggle. Those suffering the most serious Anthrax vaccine side effects can no longer work, and are forced to rely on disability payments that can equal as little as a third of what they earned before they became sick. What’s worse, even though the Anthrax vaccine is purportedly meant to protect these soldiers in combat situations, the injuries resulting from them are not considered combat related. As a result, these already cash-strapped veterans must pay taxes on these small disability payments.

So far, the US military has resisted all efforts to recognize Anthrax vaccine side effects, let alone reclassify these debilitating injuries as combat related. But a new bill in Congress could provide help to some veterans disabled by Anthrax vaccine side effects. While not specifically related to the Anthrax vaccine, the Disabled Veterans Tax Termination Act would give all disabled soldiers the same benefits given to retired veterans with 20 years of service. While this won’t protect future soldiers from the ravages of Anthrax vaccine side effects, the act could lighten the financial burden faced by those disabled from exposure to this dangerous vaccine.

October 29, 2007

Caution flag raised on mandatory anthrax vaccines

The Milwaukee Journal Sentinel Online

Former pilot says neurological reaction has left him disabled

With his trim runner's build, tight flattop and thin, muscular arms, Stephen DeGuire does not seem like a man who is unable to empty the dishwasher, mow the lawn or throw baseballs to his young sons.

He forgets the names of neighbors he has known for years and grimaces as he pushes himself into a standing position. His torso tilts forward as he walks stiffly through his Mequon home. A wooden cane hangs on a chair in the living room. It is one of a collection that DeGuire keeps around. He frequently forgets where he puts them.

DeGuire is one of possibly thousands of veterans suffering from what some military and civilian doctors believe is a neurological reaction to the anthrax vaccine. The vaccine is controversial, yet now mandatory for many American troops and civilian contractors. About 1.6 million people have received the vaccine since 1998.

Nearly four years ago, DeGuire was stationed in Kuwait as a pilot for the U.S Air Force. Today, the 43-year-old struggles with migraines, memory problems, chronic pain and fatigue as his body slips further from his control.

DeGuire's Air Force physical evaluation in 2006 listed his ailments and noted that they began to occur after he received the vaccine.

While DeGuire's main concern is to keep his body from further deteriorating, he worries about his family's financial future. He said he makes one-third of what he made as a civilian and will likely never work full-time again because of his condition.

Disability linked to reaction from the anthrax vaccine is deemed non-combat-related, meaning veterans like DeGuire are taxed on their disability payments. The anthrax vaccine is also not part of the National Vaccine Injury Compensation Program, which allows people who suffered vaccine reactions to collect money for their disability.
DeGuire worries about soldiers who will be required to receive the anthrax vaccine in the future. He says the program was "well-intentioned, " but that officials in the government did not stop the vaccine when problems arose.

"They've had enough data to know there is something wrong with the vaccine," DeGuire said.

The Department of Defense made the anthrax vaccine mandatory in 1998 out of concern that enemies would use anthrax as biological warfare. If inhaled, the substance is usually fatal. Mandatory vaccines were halted in October 2004, when a judge questioned the Food and Drug Administration' s approval procedures. In December 2005, the FDA gave final approval for the vaccine, and the Department of Defense made it mandatory again for soldiers and contractors serving in the Middle
East, Central Asia and parts of Korea.

The Department of Defense maintains that the vaccine is "safe and effective." In a media conference call last fall, assistant defense secretary William Winkenwerder said that the vaccine had not led to increased deaths or hospitalizations.

Critics of the vaccine disagree. Physician Meryl Nass said her patients usually have 10 or 15 different diagnosis that she attributes to the anthrax vaccine - sleep disorders, fatigue, cognitive disability and higher rates of neurological disorders such as multiple sclerosis. A doctor in Maine, Nass testified about the vaccine in July before the House Veterans Affairs Health Subcommittee.

Nass also points to records collected by the Vaccine Adverse Reporting System, which catalogs vaccine complications. The system has received about 5,359 adverse event reports for anthrax vaccine. About 670 of the reports were considered "serious" and about 44 of the reports recorded deaths. In the reports, some soldiers or their
families pleaded with the military to stop the vaccines.

Most vaccines are linked with side effects, ranging from simple soreness to death. But that's not much comfort to people like DeGuire, or other veterans he met while at Walter Reed Army Medical Center who also think they were affected by the anthrax vaccine.

Unlike many of those other veterans, DeGuire's case was recently accepted by the Mayo Clinic, so in early August, he lugged his three-inch-thick medical file to Rochester, Minn. While doctors are working on his physical problems, DeGuire and his family are pushing legislators to do something about veteran benefits and mandatory

DeGuire said he has tried to no avail to have legislators introduce an amendment to the defense appropriations bill that would stop mandatory anthrax vaccines until more research is done.

Congress is considering changes on the benefits issue. The Disabled Veterans Tax Termination Act would give disabled veterans the same benefits as retired veterans with 20 years of service. The act is pending in the House subcommittee on disability assistance and memorial affairs. But no efforts are under way to reclassify ailments
associated with the anthrax vaccine as combat related.

October 26, 2007

Defense contract award protested - Winkenwerder Ties

From the Los Angeles Times

The winning firm had an unfair advantage due to Bush administration links, say companies in complaints to GAO.
By Walter F. Roche Jr.
Los Angeles Times Staff Writer

WASHINGTON — A Defense Department medical services contract worth up to $790 million was awarded last month to a Wisconsin-based company three months after it hired a former Bush administration appointee who had supervised military health programs at the Pentagon for the last six years.

William Winkenwerder Jr., assistant secretary of Defense for health affairs from 2001 until April, joined Logistics Health Inc. as a director and consultant in June. The firm beat out two other bidders with proposals that ranged from $80 million to $100 million less, records show. Under the new contract, Logistics Health will provide immunizations and physical and dental exams for reservists and National Guard members.

Logistics Health of LaCrosse, Wis., is headed by another ex-official of the Bush administration -- former Secretary of Health and Human Services Tommy Thompson.

"They stacked the deck," said Fran Lessans, president of Passport Health, one of the losing bidders. Her Baltimore-based firm lost despite a bid projected over five years to cost nearly $100 million less than Logistics Health's winning proposal.

"It was wired. There is no doubt in my mind," Lessans said of the Defense procurement process.

Two other firms involved in the bidding have filed formal protests with the Government Accountability Office. A draft copy of one protest letter, reviewed by The Times, cited Winkenwerder's role and complained that the winning bidder may have "gained unequal access to information not available to other competitors" by hiring the former Pentagon official.

"This creates an organizational conflict of interest and potentially constitutes prohibited contact," the draft letter said.

Winkenwerder called such allegations inaccurate and untruthful. In e-mail responses to The Times, he said he had nothing to do with the procurement process or the selection of Logistics Health. He also said he had not begun contacts with Logistics officials about the directorship and consulting job until after he had resigned his Defense Department post.

His role at Logistics Health is to provide advice, he said, "on a variety of issues that are of concern and priority to the company. Government rules do not prohibit such advice in any way."

The rules bar him from contacting his former Pentagon colleagues on Logistics' behalf, "and I have followed those rules scrupulously. Further I support such rules and place a high importance on strict ethical behavior in all of my conduct."

Diana Henry, a spokeswoman for Logistics Health, said in a written statement that the company "conducts all of its business activities in a highly ethical and professional manner."

The contract, awarded in September, supports the Defense Department's Reserve Health Readiness Program. In prepared remarks for a subcommittee of the House Armed Services Committee two years ago, Winkenwerder said the program's goal was "to identify and proactively assist service members in getting needed support for deployment-related concerns." Besides routine exams, the program will provide full medical assessments to reservists and Guard members returning from Iraq and Afghanistan.

Logistics Health will be paid an estimated $151 million for the first year of a contract that can be renewed annually and extended up to five years at a total cost of about $790 million.

In other letters of protest filed with the GAO, officials of rival firms also charged that Logistics won the pact despite questions raised about its performance under a previous agreement with the Department of Health and Human Services. That pact, originally awarded in 2001, only applied to the Army, while the new one includes the Navy, Air Force and Marines.

Kenneth Moskowitz, an attorney for the Pennsylvania-based United States Military Dental Corp., said in an Oct. 12 letter that Logistics' prior performance and practices under the Health and Human Services contract "put reservists and National Guardsmen at possible undue risk."

He told the GAO that "no one was assigned to specifically monitor the level of care" received by military personnel and that the company operated with "a built-in incentive to lower provider cost for added profit." The Pennsylvania company was a subcontractor for Comprehensive Health Services of Florida, one of the failed bidders.

A spokesman for the Defense Department, citing the pending protests, declined to respond to a series of detailed questions about the contract and the selection process.

Records reviewed by The Times show that the Logistics Health bid also survived a major last-minute change when partner QTC Management abruptly withdrew days before the contract was awarded.

QTC Chairman Anthony J. Principi, another former Bush appointee, was secretary of Veterans Affairs.

The GAO has until early January to act on the protests.

The Defense Department gave initial notice of its intent to put the newly expanded program out to bid in October 2006.

Winkenwerder resigned from his Pentagon post April 16, and his appointment to the Logistics board was announced May 31. It became effective the next day. In announcing Winkenwerder's appointment, Thompson said: "He brings with him a wealth of knowledge and also shares LHI's commitment of helping military members receive the healthcare and support they deserve. He is a tremendous addition to our board of directors."

The formal notice of the bidding process was issued June 12. Bids were due July 26. On Sept. 10, QTC formally withdrew from the Logistics proposal. And on Sept. 25, the contract was awarded to Logistics.


October 25, 2007

Experimental AIDS Vaccine May Increase Risk of HIV

By Brandon Keim

The frustrating saga of AIDS vaccines -- 22 years of research, and not a single one yet works -- has taken a sad turn: an experimental vaccine developed by Merck may leave people more vulnerable to HIV infection.

The Washington Post reports that 19 South Africans who received the vaccine during a clinical trial have contracted the virus, compared to 11 people who received a placebo. Investigators are contacting participants to let them know whether or not they received the vaccine.

The trials, which began in December 2004, were not limited to South Africa, but included 15 U.S. cities, along with sites in Peru, Brazil, Australia, Haiti, the Dominican Republic and Jamaica. Those participants have not yet been told whether they received the vaccine; researchers will meet in November to decide whether the South African results are an aberration or indicative of a fundamental flaw in the vaccine.

It's possible that the infections were purely coincidental. It's also possible that the vaccine "could have caused immunological changes that made it easier for the virus to take hold during a later exposure."

This is a major setback for not only for Merck's vaccine, which was developed in conjunction with the NIH, but for the entire AIDS vaccine field. The Post notes that "researchers worldwide considered it the most promising candidate yet in a multibillion- dollar quest for an AIDS vaccine dating to the 1980s."

Why have AIDS vaccines proved so difficult to develop? An article published several years ago in PLoS Medicine discusses the many reasons -- the virus's hardiness, its uncanny ability to adapt to not only drugs but immune responses, and our own incomplete understanding of it. But some people are able to resist infection despite repeated exposures; and some are able to control the virus spontaneously. A vaccine is possible. And someday we'll find it.

October 24, 2007

Throw out old anthrax vaccine, expert tells U.S.

By Maggie Fox, Health and Science Editor Tue Oct 23, 7:05 PM ET

WASHINGTON (Reuters) - The U.S. government needs to throw away more than $12 million worth of expired anthrax vaccine and quickly use up the rest of a rapidly aging supply worth hundreds of millions of dollars, a Government Accountability Office expert said on Tuesday.

A report from the GAO, the investigative arm of Congress, shows that the Health and Human Services Department signed an overly optimistic contract with a struggling biotech company to make anthrax vaccine -- a contract that VaxGen Inc could never realistically have been expected to fill.

That deal was scuttled in January after it became clear that VaxGen would not be able to fill the order.

HHS must now find a way to use up rapidly aging stockpiles of anthrax vaccine and come up with better ways to contract for new and improved vaccines, the GAO said.

"Three lots of BioThrax vaccine in the stockpile have already expired, resulting in losses of over $12 million," the GAO's Keith Rhodes told a hearing of the Senate's Homeland Security and Governmental Affairs Committee.

"According to the data provided by U.S. Centers for Disease Control and Prevention, 28 lots of BioThrax vaccine will expire in calendar year 2008. (HHS) paid approximately $123 million for these lots."

More than $100 million a year worth of this vaccine could be lost as it expires, the GAO said.

The U.S. military routinely vaccinates troops against anthrax, a naturally occurring bacteria that can kill humans and cattle and can also be developed into a biological weapon.

This need became acute after October 2001, when 22 people were infected and five died after someone mailed letters containing finely milled anthrax spores to politicians and media outlets in New York, Washington and Florida in a crime that has never been solved.

The current vaccine, BioThrax, is based on old technology. It is irritating, causes side effects and requires six doses and annual boosters.

HHS contracted with VaxGen in 2002 to make a new and better vaccine but the contracts were too ambitious, the GAO said, because VaxGen was a small biotechnology firm still in the early stages of developing a vaccine and had not addressed many critical manufacturing issues.

"The contract required VaxGen to deliver 25 million doses of the vaccine in two years, which would have been unrealistic even for a larger manufacturer," the report added.

Sen. Susan Collins, a Maine Republican said: "This GAO report makes clear that the federal attempt to procure an improved anthrax vaccine has yielded not a new vaccine, but instead a textbook example of prodigious waste."

"HHS must learn the lessons from past failures so that we can improve our preparedness for a possible terrorist attack using biological weapons," said Collins, the ranking Republican on the committee.

A simple single inventory system for BioThrax with rotation based on a first-in, first-out principle, could help address the problem, Rhodes advised.

VaxGen, based in South San Francisco, California, has slashed its work force after the scuttled HHS deal.

Soldier's Violations Leads to Victory


With a Shot Part II

Matt and Robyn Burgess are battle-hardened. For more than four years, they have gone toe-to-to with the U.S. government fighting for the benefits Matt earned as a Reservist who was permanently disabled in service to his country. Unlike so many other soldiers with life-altering injuries, Matt’s wounds are invisible. After his third anthrax vaccination, Matt went from a healthy 31-year-old to a man plagued with a range of symptoms that destroyed his physical health.

By spring 2007, they’d gotten the diagnosis they needed from Army medical staff to validate their claims. They were finally getting medical treatment from several doctors from multiple health care systems to meet the Army’s demand for proper documentation. But they still hadn’t gotten what they both knew Matt deserved: permanent medical retirement with full benefits to ensure they’d always be able to meet Matt’s medical needs.

They continued to struggle financially and try to break through the red tape that continually blocked them. They started writing their local representatives, as well as lawmakers with reputations for defending veterans.

“We got responses saying you’re not our constituent, call your local congressman or senator,” Robyn said. “We’d sent stuff to John McCain and some of the other people we thought would be interested in hearing his story. We couldn’t get our letters read.”

So the couple decided it was time for their story to be read. The Washington Post had recently run an expose of a series of problems at Walter Reed. Because Matt was mostly isolated from other soldiers and didn’t stay in the moldy barracks that were part of the subject of the expose, he didn’t realize that his troubles at Walter Reed were not unique. He and Robin also took issue with the proffered solution of contracting out more work at the hospital to improve patient care; Matt had been victimized by a contract worker, not a fellow soldier.

They were also desperate.

“We were selling everything we could sell. We needed help. We needed attention. We needed somebody to care,” Robyn said. “One case is not newsworthy. A bunch of cases is newsworthy ... When we found out how others have been treated, we realized they needed to know about this, too.”

They started calling reporters in hopes that publicity of their plight would finally bring action in the wake of other scandals at Walter Reed.

The story of Matt’s sexual assault hit the front page of the Washington Post on April 7. One month later, Matt’s benefit checks finally started coming in. Two months later, he learned he would be retired permanently with full medical benefits.

Silver Linings

The Burgesses are convinced that the publicity of Matt’s assault is the reason they finally triumphed.

“After it got published, all of a sudden, we’re getting phone calls saying, ‘What can we do, what can we do? We’ll do whatever we need to do for you,’ ” Robyn said. “It sure was a coincidence, to say the least.”

Matt agreed.

“Until that point, it was just kinda like, you’re just another story. It’s sad that you have to have a scandal and that we had to use a scandal to get results,” Matt said. “That’s just disheartening. I feel bad for the soldiers that don’t have the scandals when all other resources have been used, how do they get help?”

Matt and Robyn now find themselves in the role of helper. They’re working with about six soldiers to help them navigate the system and pursue their claims.

“I also try to find the balance of helping someone win their case and being the listening ear,” he said. “It feels good that now I have this success behind it. We try to help anybody we can, and that’s a balance of your own personal life also. Robyn is a huge part of that.”

This in addition to Matt’s week of college classes at a community college in Dalton more than an hour from their Dallas, Ga., home. Their long term goal is to start a veterans’ retreat and marina to help other families heal. They recently attended a program at Syracuse University designed to teach disabled veterans how to launch businesses. It’s part of the stages of developing their vision of offering other veterans a place to relax, recharge and reconnect.

“If we do get this campground retreat off the ground, we can really make a difference. If we sit here and stay angry, it’s just not gonna get us anywhere,” Matt said.

Moving Forward

Their marriage also has suffered severe strain, but they managed to grow together rather than apart as debts, frustrations and side effects continued to pile up.

“It’s been through the grace of God, I guess,” Robyn said. “We have gone to a lot of counseling individually, and we’ve gone to some marriage retreats.”

Matt received some counseling from Walter Reed following his sexual assault, but he also credits Robyn’s devotion and determination for their relationship’s survival.

“We’re pretty proud of that. It’s been a lot of hard work. It hasn’t been easy,” he said. “Today, we’re glad that we’re still here. We’re not just another statistic. There’s tons of them out there.”

That’s why they’re determined to focus on the positives that have emerged from their struggle.

“A lot of good things have happened out of it,” Robyn said. “It’s difficult to be married to somebody who’s chronically ill. I think he’s a better person in the long run. Not physically, but mentally he’s definitely a better person. That’s how we choose to look at it.”

October 23, 2007

Vaccine problems, plans scrutinized during Senate hearing

By Dan Friedman Congress Daily

Facing criticism for wasting hundreds of millions of dollars on anthrax vaccines, a top Health and Human Services official said Tuesday that the agency needs more money to prevent similar problems.

A Government Accountability Office report released Tuesday detailed HHS missteps, including losing tens of millions of dollars on expiring vaccines and awarding a $877 million contract that the agency canceled after an unproven pharmaceutical company called VaxGen failed to meet what HHS acknowledges were unrealistic expectations for a new vaccine.

The report drew rebukes at a Senate Homeland Security and Governmental Affairs hearing on bioterrorism preparation, held to coincide with the sixth anniversary of anthrax attacks that killed six people in 2001.

"The Department of Health and Human Services' efforts to develop a second generation anthrax vaccine -- to improve upon the 30-year-old-technology we have in the stockpile -- has, in a word, failed," Senate Homeland Security and Governmental Affairs Chairman Joseph Lieberman, I-Conn., said in an opening statement. "This is a disappointing failure that has put us back at square one after years of work."

Gerald Parker, principal deputy assistant secretary in HHS' office of the assistant secretary for preparedness and response, observed that anthrax vaccines are only one piece of efforts by HHS and the Homeland Security Department to prepare for biological threats through their $5.6 billion BioShield project.

Recognizing that it had been contracting too early in the risky drug development process, the agency is working to buy vaccines that are "further down the pipeline," Parker said.
For commercial markets, drug makers often raise capital to pay for development costs. But with no private market for biodefense products, big pharmaceutical companies have not competed for contracts to sell vaccines to the government, causing agencies to rely on smaller, less risk-averse companies.

According to GAO, established drug-makers have also stayed away because a lack of clear requirements from government departments places additional risks on contractors. Lieberman agreed with those sentiments. "We have to find a way to entice the big pharmaceutical companies to get into this," he said.

Parker said $189 million in the president's fiscal 2008 budget request for advanced drug development will spur needed research. The Biodefense and Pandemic Vaccine and Drug Development Act of 2006 calls for advanced biodefense research, but Congress thus far has not funded the so-called BARDA Act.

Tara O'Toole, director of the Center for Biosecurity at the University of Pittsburgh Medical Center, said the gap between the government's goals for guarding against biological terrorism and its spending is much larger than most involved realize. "Five billion [dollars] is much less than we're going to need," O'Toole said.

GAO Report Cites Waste In Anthrax Vaccine Cache


By Renae Merle
Washington Post Staff Writer

Federal health officials are potentially wasting a stockpile of anthrax vaccine worth more than $100 million, according to a government report to be released today.

Six years after anthrax attacks killed five people in Washington and elsewhere, officials are struggling to prepare for another strike, the Government Accountability Office report said.

About $12 million of anthrax vaccine in the Strategic National Stockpile has expired. The vaccine had been kept for use in an emergency, even though federal standards prohibit expired vaccines from being administered.

Starting in 2008, about $100 million of the stockpiled vaccine would go bad each year, the report said. The GAO also said that because the Defense Department buys its vaccine separately, having two programs was wasteful.

The Department of Health and Human Services' effort to replace that vaccine with one easier to use and with fewer side effects has been hobbled by unrealistic expectations, the report said.

The report, to be discussed at a Senate hearing today, is the latest hit against the Bush administration's $5.6 billion BioShield program, established in 2004 to counter bioterrorism threats.

Last year, HHS scuttled the largest piece of the program, an $877.5 million contract with VaxGen of California to develop a new vaccine. The vaccine was to replace the stockpiled version made by Emergent BioSolutions of Gaithersburg, which must be administered over 18 months in six shots.

"We have an awful lot to do in the area of medical readiness and, to me, the results of the government's efforts to protect Americans through countermeasures and new technologies are mixed," Sen. Joseph I. Lieberman (I-Conn.), chairman of the Homeland Security and Governmental Affairs Committee, said in a statement.

The government rushed into the contract with VaxGen, setting unrealistic standards and timelines that would have been difficult for even a large firm to meet, the GAO said.

HHS is expected to issue a new contract for a vaccine this year, but has not completed a report on why the VaxGen effort failed, raising complaints from Congress.

"This GAO report makes clear that the federal attempt to procure an improved anthrax vaccine has yielded not a new vaccine, but instead a textbook example of prodigious waste," Sen. Susan Collins (R-Maine), ranking member of the homeland security committee, said in a statement. "HHS must learn the lessons from past failures so that we can improve our preparedness for a possible terrorist attack using biological weapons."

The report also examined the latest version of the vaccine, BioThrax, which has been around since the 1970s. By 2006, the HHS had acquired 10 million doses of BioThrax; it recently put in an order for an additional 10 million. But the agency does not have an effective strategy for stopping the waste of the vaccine, the report found.

Keeping the old vaccine past its expiration date violates Food and Drug Administration rules, but was considered necessary in an emergency, the report said.

In a response to the report, the HHS said it never planned to use the expired doses and considers developing a new vaccine a top priority. "The expired vaccine in question is being quarantined until a decision on disposition is made," the HHS said in its response.

The agency is in discussions with the Pentagon, which has its own stock of anthrax vaccine, about better management, the HHS response said. The agency said that transferring its vaccines to the Defense Department when necessary could save the government up to $25 million a year.

October 22, 2007

Scarce pandemic vaccine to be given in order


By Anita Manning, USA TODAY

In the early weeks of a flu pandemic, the first to receive scarce supplies of vaccine will include the military, medical and emergency workers, pregnant women and babies — nearly 23 million people — under a draft federal plan to be outlined Tuesday in Washington.

At the back of the pack, in a pandemic of the sort that killed 500,000 Americans in 1918, would be 74 million sick and elderly adults and 122 million healthy people ages 19-64.

The plan was developed by a government working group that met with scientists and business and community representatives over several months. It provides guidelines for pandemic planners and offers a glimpse into some agonizing decisions that could be necessary in the context of a swift-moving infectious disease and a shortage of protective vaccine.

"Once a pandemic starts, vaccine will come rolling off the line in lots, so there has to be a priority scheme on who would receive it first," says William Raub, science adviser to Health and Human Services Secretary Michael Leavitt.

"The committee tried to identify those who would be critical to national and homeland security, critical to fighting the flu itself, and critical to maintaining a functioning society."

In meetings, the working group and other participants highlighted pregnant women and children as a priority, the report says. This also is an efficient use of vaccine, it says, because immunizing pregnant women protects their newborns, too, and children need lower doses, stretching limited supplies.

Jeffrey Levi of Trust for America's Health, an advocacy group, says the report, being presented at a meeting of the National Vaccine Advisory Committee, is "logical," but more discussion is needed to refine how vaccine will be distributed and used in different populations.

The plan provides for changes based on local needs and severity. In mild pandemics, which cause fewer deaths among the young and healthy, it makes sense to move those at risk of serious illness, such as the elderly and people with chronic illnesses, higher on the list, Raub says.

For instance, the plan doesn't target such groups as banking, food and agriculture, postal or chemical workers in a mild or moderate pandemic. But in a severe pandemic, those groups are in the third tier for vaccination, just behind electricity, natural gas, communications and water personnel and essential government workers.

"The more severe the pandemic, the more aggressive people would be in trying to protect critical workers," Raub says. "But if it's at the milder end, critical workers would be a smaller group, so there would be more emphasis on getting everyone vaccinated. The disruption of society wouldn't be the same."

A pandemic occurs when a new flu virus emerges that can spread as easily as the seasonal flu, which causes 200,000 hospitalizations and 36,000 deaths each year. Because it's different from known flu viruses, people have no built-in immunity, so everyone is at risk.
Planning for the next possible pandemic moved into high gear when a new flu strain, H5N1, also known as bird flu, emerged 10 years ago and began causing illness and death in humans. The World Health Organization warned then that the world could be "on the brink" of the next pandemic. Since 2003, WHO has documented 331 human cases, including 203 deaths from the virus, most of them in Southeast Asia.

October 21, 2007

Insects: tougher than anthrax

By Jeffrey A. Lockwood

MICROSCOPIC AGENTS SUCH AS smallpox, ebola, and anthrax have become synonymous with bioterrorism. But insects can be more practical and effective.

Producing sufficient quantities of viruses or bacteria can be technically challenging, the process is extremely hazardous, and it is difficult to find a way to disperse the product effectively. Getting particles of the right size to stay aloft as an aerosol is not simple, and if the winds shift an otherwise effective attack is neutralized.

Anthrax, for example, is easy to isolate and can be milled into a light powder, but it doesn't replicate quickly and it doesn't pass readily between people. In the anthrax attacks via the US mail system in 2001, seven letters with up to a gram of highly refined, nearly pure spores yielded five deaths, and none of the infected people passed the disease on to others. The attack caused enormous disruption, but the mail bombs sent by Ted Kaczynski were nearly as lethal.

Insects, on the other hand, often can be gathered in sufficient numbers to seed an outbreak. Their eggs are environmentally robust and small enough to carry by the thousands without risk of detection. A single Medfly female in a survey trap is enough to immediately shut down an agricultural exporter, and finding two flies within a 1-mile radius triggers an eradication program.

Microscopic agents are typically highly vulnerable to ultraviolet radiation, desiccation, and heat, and lack the ability to seek out hosts. But insects can withstand adverse conditions and have evolved elegant sensory systems and incredible flight mechanisms that allow them to locate their hosts.

A decent representative of the technological level of today's terrorist is the Japanese biological warfare program in World War II. After seven years of work with microbes, the only people killed in the first attack with bacterial weapons were 40 Japanese who launched the assault and became accidentally infected with typhoid. So the Japanese turned to insect-borne diseases. A year later they killed 50,000 of their enemy in the first attack with plague-infected fleas.

October 18, 2007



Subject: Public Health and Medical Preparedness


(1) This directive establishes a National Strategy for Public Health and Medical Preparedness (Strategy), which builds upon principles set forth in Biodefense for the 21st Century (April 2004) and will transform our national approach to protecting the health of the American people against all disasters.


(2) In this directive:

(a) The term “biosurveillance” means the process of active data-gathering with appropriate analysis and interpretation of biosphere data that might relate to disease activity and threats to human or animal health – whether infectious, toxic, metabolic, or otherwise, and regardless of intentional or natural origin – in order to achieve early warning of health threats, early detection of health events, and overall situational awareness of disease activity;

(b) The term “catastrophic health event” means any natural or manmade incident, including terrorism, that results in a number of ill or injured persons sufficient to overwhelm the capabilities of immediate local and regional emergency response and health care systems;

(c) The term “epidemiologic surveillance” means the process of actively gathering and analyzing data related to human health and disease in a population in order to obtain early warning of human health events, rapid characterization of human disease events, and overall situational awareness of disease activity in the human population;

(d) The term “medical” means the science and practice of maintenance of health and prevention, diagnosis, treatment, and alleviation of disease or injury and the provision of those services to individuals;

(e) The term “public health” means the science and practice of protecting and improving the overall health of the community through disease prevention and early diagnosis, control of communicable diseases, health education, injury prevention, sanitation, and protection from environmental hazards;

(f) The term “public health and medical preparedness” means the existence of plans, procedures, policies, training, and equipment necessary to maximize the ability to prevent, respond to, and recover from major events, including efforts that result in the capability to render an appropriate public health and medical response that will mitigate the effects of illness and injury, limit morbidity and mortality to the maximum extent possible, and sustain societal, economic, and political infrastructure; and

(g) The terms “State” and “local government,” when used in a geographical sense, have the meanings ascribed to such terms respectively in section 2 of the Homeland Security Act of 2002 (6 U.S.C. 101).


(3) A catastrophic health event, such as a terrorist attack with a weapon of mass destruction (WMD), a naturally-occurring pandemic, or a calamitous meteorological or geological event, could cause tens or hundreds of thousands of casualties or more, weaken our economy, damage public morale and confidence, and threaten our national security. It is therefore critical that we establish a strategic vision that will enable a level of public health and medical preparedness sufficient to address a range of possible disasters.

(4) The United States has made significant progress in public health and medical preparedness since 2001, but we remain vulnerable to events that threaten the health of large populations. The attacks of September 11 and Hurricane Katrina were the most significant recent disasters faced by the United States, yet casualty numbers were small in comparison to the 1995 Kobe earthquake; the 2003 Bam, Iran, earthquake; the 2004 Sumatra tsunami; and what we would expect from a 1918-like influenza pandemic or large-scale WMD attack. Such events could immediately overwhelm our public health and medical systems.

(5) This Strategy draws key principles from the National Strategy for Homeland Security (October 2007), the National Strategy to Combat Weapons of Mass Destruction (December 2002), and Biodefense for the 21st Century (April 2004) that can be generally applied to public health and medical preparedness. Those key principles are the following: (1) preparedness for all potential catastrophic health events; (2) vertical and horizontal coordination across levels of government, jurisdictions, and disciplines; (3) a regional approach to health preparedness; (4) engagement of the private sector, academia, and other nongovernmental entities in preparedness and response efforts; and (5) the important roles of individuals, families, and communities.

(6) Present public health and medical preparedness plans incorporate the concept of “surging” existing medical and public health capabilities in response to an event that threatens a large number of lives. The assumption that conventional public health and medical systems can function effectively in catastrophic health events has, however, proved to be incorrect in real-world situations. Therefore, it is necessary to transform the national approach to health care in the context of a catastrophic health event in order to enable U.S. public health and medical systems to respond effectively to a broad range of incidents.

(7) The most effective complex service delivery systems result from rigorous end-to-end system design. A critical and formal process by which the functions of public health and medical preparedness and response are designed to integrate all vertical (through all levels of government) and horizontal (across all sectors in communities) components can achieve a much greater capability than we currently have.

(8) The United States has tremendous resources in both public and private sectors that could be used to prepare for and respond to a catastrophic health event. To exploit those resources fully, they must be organized in a rationally designed system that is incorporated into pre-event planning, deployed in a coordinated manner in response to an event, and guided by a constant and timely flow of relevant information during an event. This Strategy establishes principles and objectives to improve our ability to respond comprehensively to catastrophic health events. It also identifies critical antecedent components of this capability and directs the development of an implementation plan that will delineate further specific actions and guide the process to fruition.

(9) This Strategy focuses on human public health and medical systems; it does not address other areas critical to overall public health and medical preparedness, such as animal health systems, food and agriculture defense, global partnerships in public health, health threat intelligence activities, domestic and international biosecurity, and basic and applied research in threat diseases and countermeasures. Efforts in those areas are addressed in other policy documents.

(10) It is not possible to prevent all casualties in catastrophic events, but strategic improvements in our Federal, State, and local planning can prepare our Nation to deliver appropriate care to the largest possible number of people, lessen the impact on limited health care resources, and support the continuity of society and government.


(11) It is the policy of the United States to plan and enable provision for the public health and medical needs of the American people in the case of a catastrophic health event through continual and timely flow of information during such an event and rapid public health and medical response that marshals all available national capabilities and capacities in a rapid and coordinated manner.

Implementation Actions

(12) Biodefense for the 21st Century provides a foundation for the transformation of our catastrophic health event response and preparedness efforts. Although the four pillars of that framework – Threat Awareness, Prevention and Protection, Surveillance and Detection, and Response and Recovery – were developed to guide our efforts to defend against a bioterrorist attack, they are applicable to a broad array of natural and manmade public health and medical challenges and are appropriate to serve as the core functions of the Strategy for Public Health and Medical Preparedness.

(13) To accomplish our objectives, we must create a firm foundation for community medical preparedness. We will increase our efforts to inform citizens and empower communities, buttress our public health infrastructure, and explore options to relieve current pressures on our emergency departments and emergency medical systems so that they retain the flexibility to prepare for and respond to events.

(14) Ultimately, the Nation must collectively support and facilitate the establishment of a discipline of disaster health. The specialty of emergency medicine evolved as a result of the recognition of the special considerations in emergency patient care, and similarly the recognition of the unique principles in disaster-related public health and medicine merit the establishment of their own formal discipline. Such a discipline will provide a foundation for doctrine, education, training, and research and will integrate preparedness into the public health and medical communities.

Critical Components of Public Health and Medical Preparedness

(15) Currently, the four most critical components of public health and medical preparedness are biosurveillance, countermeasure distribution, mass casualty care, and community resilience. Although those capabilities do not address all public health and medical preparedness requirements, they currently hold the greatest potential for mitigating illness and death and therefore will receive the highest priority in our public health and medical preparedness efforts. Those capabilities constitute the focus and major objectives of this Strategy.

(16) Biosurveillance: The United States must develop a nationwide, robust, and integrated biosurveillance capability, with connections to international disease surveillance systems, in order to provide early warning and ongoing characterization of disease outbreaks in near real-time. Surveillance must use multiple modalities and an in-depth architecture. We must enhance clinician awareness and participation and strengthen laboratory diagnostic capabilities and capacity in order to recognize potential threats as early as possible. Integration of biosurveillance elements and other data (including human health, animal health, agricultural, meteorological, environmental, intelligence, and other data) will provide a comprehensive picture of the health of communities and the associated threat environment for incorporation into the national “common operating picture.” A central element of biosurveillance must be an epidemiologic surveillance system to monitor human disease activity across populations. That system must be sufficiently enabled to identify specific disease incidence and prevalence in heterogeneous populations and environments and must possess sufficient flexibility to tailor analyses to new syndromes and emerging diseases. State and local government health officials, public and private sector health care institutions, and practicing clinicians must be involved in system design, and the overall system must be constructed with the principal objective of establishing or enhancing the capabilities of State and local government entities.

(17) Countermeasure Stockpiling and Distribution: In the context of a catastrophic health event, rapid distribution of medical countermeasures (vaccines, drugs, and therapeutics) to a large population requires significant resources within individual communities. Few if any cities are presently able to meet the objective of dispensing countermeasures to their entire population within 48 hours after the decision to do so. Recognizing that State and local government authorities have the primary responsibility to protect their citizens, the Federal Government will create the appropriate framework and policies for sharing information on best practices and mechanisms to address the logistical challenges associated with this requirement. The Federal Government must work with nonfederal stakeholders to create effective templates for countermeasure distribution and dispensing that State and local government authorities can use to build their own capabilities.

(18) Mass Casualty Care: The structure and operating principles of our day-to-day public health and medical systems cannot meet the needs created by a catastrophic health event. Collectively, our Nation must develop a disaster medical capability that can immediately re-orient and coordinate existing resources within all sectors to satisfy the needs of the population during a catastrophic health event. Mass casualty care response must be (1) rapid, (2) flexible, (3) scalable, (4) sustainable, (5) exhaustive (drawing upon all national resources), (6) comprehensive (addressing needs from acute to chronic care and including mental health and special needs populations), (7) integrated and coordinated, and (8) appropriate (delivering the correct treatment in the most ethical manner with available capabilities). We must enhance our capability to protect the physical and mental health of survivors; protect responders and health care providers; properly and respectfully dispose of the deceased; ensure continuity of society, economy, and government; and facilitate long-term recovery of affected citizens.

(19) The establishment of a robust disaster health capability requires us to develop an operational concept for the medical response to catastrophic health events that is substantively distinct from and broader than that which guides day-to-day operations. In order to achieve that transformation, the Federal Government will facilitate and provide leadership for key stakeholders to establish the following four foundational elements: Doctrine, System Design, Capacity, and Education and Training. The establishment of those foundational elements must result from efforts within the relevant professional communities and will require many years, but the Federal Government can serve as an important catalyst for this process.

(20) Community Resilience: The above components address the supply side of the preparedness function, ultimately providing enhanced services to our citizens. The demand side is of equal importance. Where local civic leaders, citizens, and families are educated regarding threats and are empowered to mitigate their own risk, where they are practiced in responding to events, where they have social networks to fall back upon, and where they have familiarity with local public health and medical systems, there will be community resilience that will significantly attenuate the requirement for additional assistance. The Federal Government must formulate a comprehensive plan for promoting community public health and medical preparedness to assist State and local authorities in building resilient communities in the face of potential catastrophic health events.


(21) The Secretary of Health and Human Services shall establish an operational national epidemiologic surveillance system for human health, with international connectivity where appropriate, that is predicated on State, regional, and community-level capabilities and creates a networked system to allow for two-way information flow between and among Federal, State, and local government public health authorities and clinical health care providers. The system shall build upon existing Federal, State, and local surveillance systems where they exist and shall enable and provide incentive for public health agencies to implement local surveillance systems where they do not exist. To the extent feasible, the system shall be built using electronic health information systems. It shall incorporate flexibility and depth of data necessary to respond to previously unknown or emerging threats to public health and integrate its data into the national biosurveillance common operating picture as appropriate. The system shall protect patient privacy by restricting access to identifying information to the greatest extent possible and only to public health officials with a need to know. The Implementation Plan to be developed pursuant to section 43 of this directive shall specify milestones for this system.

(22) Within 180 days after the date of this directive, the Secretary of Health and Human Services, in coordination with the Secretaries of Defense, Veterans Affairs, and Homeland Security, shall establish an Epidemiologic Surveillance Federal Advisory Committee, including representatives from State and local government public health authorities and appropriate private sector health care entities, in order to ensure that the Federal Government is meeting the goal of enabling State and local government public health surveillance capabilities.

Countermeasure Stockpiling and Distribution

(23) In accordance with the schedule set forth below, the Secretary of Health and Human Services, in coordination with the Secretary of Homeland Security, shall develop templates, using a variety of tools and including private sector resources when necessary, that provide minimum operational plans to enable communities to distribute and dispense countermeasures to their populations within 48 hours after a decision to do so. The Secretary of Health and Human Services shall ensure that this process utilizes current cooperative programs and engages Federal, State, local government, and private sector entities in template development, modeling, testing, and evaluation. The Secretary shall also assist State, local government, and regional entities in tailoring templates to fit differing geographic sizes, population densities, and demographics, and other unique or specific local needs. In carrying out such actions, the Secretary shall:

(a) within 270 days after the date of this directive, (i) publish an initial template or templates meeting the requirements above, including basic testing of component distribution mechanisms and modeling of template systems to predict performance in large-scale implementation, (ii) establish standards and performance measures for State and local government countermeasure distribution systems, including demonstration of specific capabilities in tactical exercises in accordance with the National Exercise Program, and (iii) establish a process to gather performance data from State and local participants on a regular basis to assess readiness; and

(b) within 180 days after the completion of the tasks set forth in (a), and with appropriate notice, commence collecting and using performance data and metrics as conditions for future public health preparedness grant funding.

(24) Within 270 days after the date of this directive, the Secretary of Health and Human Services, in coordination with the Secretaries of Defense, Veterans Affairs, and Homeland Security and the Attorney General, shall develop Federal Government capabilities and plans to complement or supplement State and local government distribution capacity, as appropriate and feasible, if such entities’ resources are deemed insufficient to provide access to countermeasures in a timely manner in the event of a catastrophic health event.

(25) The Secretary of Health and Human Services shall ensure that the priority-setting process for the acquisition of medical countermeasures and other critical medical materiel for the Strategic National Stockpile (SNS) is transparent and risk-informed with respect to the scope, quantities, and forms of the various products. Within 180 days after the date of this directive, the Secretary, in coordination with the Secretaries of Defense, Homeland Security, and Veterans Affairs, shall establish a formal mechanism for the annual review of SNS composition and development of recommendations that utilizes input from accepted national risk assessments and threat assessments, national planning scenarios, national modeling resources, and subject matter experts. The results of each such annual review shall be provided to the Director of the Office of Management and Budget and the Assistant to the President for Homeland Security and Counterterrorism at the time of the Department of Health and Human Services’ next budget submission.

(26) Within 90 days after the date of this directive, the Secretary of Health and Human Services shall establish a process to share relevant information regarding the contents of the SNS with Federal, State, and local government health officers with appropriate clearances and a need to know.

(27) Within 180 days after the date of this directive, the Secretary of Health and Human Services, in coordination with the Secretaries of State, Defense, Agriculture, Veterans Affairs, and Homeland Security, shall develop protocols for sharing countermeasures and medical goods between the SNS and other Federal stockpiles and shall explore appropriate reciprocal arrangements with foreign and international stockpiles of medical countermeasures to ensure the availability of necessary supplies for use in the United States.

Mass Casualty Care

(28) The Secretary of Health and Human Services, in coordination with the Secretaries of Defense, Veterans Affairs, and Homeland Security, shall directly engage relevant State and local government, academic, professional, and private sector entities and experts to provide feedback on the review of the National Disaster Medical System and national medical surge capacity required by the Pandemic and All-Hazards Preparedness Act (PAHPA) (Public Law 109-417) . Within 270 days after the completion of such review, the Secretary shall identify, through a systems-based approach involving expertise from such entities and experts, high-priority gaps in mass casualty care capabilities, and shall submit to the Assistant to the President for Homeland Security and Counterterrorism a concept plan that identifies and coordinates all Federal, State, and local government and private sector public health and medical disaster response resources, and identifies options for addressing critical deficits, in order to achieve the system attributes described in this Strategy.

(29) Within 180 days after the date of this directive, the Secretary of Health and Human Services, in coordination with the Secretaries of Defense, Veterans Affairs, and Homeland Security, shall:

(a) build upon the analysis of Federal facility use to provide enhanced medical surge capacity in disasters required by section 302 of PAHPA to analyze the use of Federal medical facilities as a foundational element of public health and medical preparedness; and

(b) develop and implement plans and enter into agreements to integrate such facilities more effectively into national and regional education, training, and exercise preparedness activities.

(30) The Secretary of Health and Human Services shall lead an interagency process, in coordination with the Secretaries of Defense, Veterans Affairs, and Homeland Security and the Attorney General, to identify any legal, regulatory, or other barriers to public health and medical preparedness and response from Federal, State, or local government or private sector sources that can be eliminated by appropriate regulatory or legislative action and shall, within 120 days after the date of this directive, submit a report on such barriers to the Assistant to the President for Homeland Security and Counterterrorism.

(31) The impact of the “worried well” in past disasters is well documented, and it is evident that mitigating the mental health consequences of disasters can facilitate effective response. Recognizing that maintaining and restoring mental health in disasters has not received sufficient attention to date, within 180 days after the date of this directive, the Secretary of Health and Human Services, in coordination with the Secretaries of Defense, Veterans Affairs, and Homeland Security, shall establish a Federal Advisory Committee for Disaster Mental Health. The committee shall consist of appropriate subject matter experts and, within 180 days after its establishment, shall submit to the Secretary of Health and Human Services recommendations for protecting, preserving, and restoring individual and community mental health in catastrophic health event settings, including pre-event, intra-event, and post-event education, messaging, and interventions.

Community Resilience

(32) The Secretary of Health and Human Services, in coordination with the Secretaries of Defense, Veterans Affairs, and Homeland Security, shall ensure that core public health and medical curricula and training developed pursuant to PAHPA address the needs to improve individual, family, and institutional public health and medical preparedness, enhance private citizen opportunities for contributions to local, regional, and national preparedness and response, and build resilient communities.

(33) Within 270 days after the date of this directive, the Secretary of Health and Human Services, in coordination with the Secretaries of Defense, Commerce, Labor, Education, Veterans Affairs, and Homeland Security and the Attorney General, shall submit to the President for approval, through the Assistant to the President for Homeland Security and Counterterrorism, a plan to promote comprehensive community medical preparedness.

Risk Awareness

(34) The Secretary of Homeland Security, in coordination with the Secretary of Health and Human Services, shall prepare an unclassified briefing for non-health professionals that clearly outlines the scope of the risks to public health posed by relevant threats and catastrophic health events (including attacks involving weapons of mass destruction), shall coordinate such briefing with the heads of other relevant executive departments and agencies, shall ensure that full use is made of Department of Defense expertise and resources, and shall ensure that all State governors and the mayors and senior county officials from the 50 largest metropolitan statistical areas in the United States receive such briefing, unless specifically declined, within 150 days after the date of this directive.

(35) Within 180 days after the date of this directive, the Secretary of Homeland Security, in coordination with the Attorney General, the Secretary of Health and Human Services, and the Director of National Intelligence, shall establish a mechanism by which up-to-date and specific public health threat information shall be relayed, to the greatest extent possible and not inconsistent with the established guidance relating to the Information Sharing Environment, to relevant public health officials at the State and local government levels and shall initiate a process to ensure that qualified heads of State and local government entities have the opportunity to obtain appropriate security clearances so that they may receive classified threat information when applicable.

Education and Training

(36) Within 180 days after the date of this directive, the Secretary of Health and Human Services, in coordination with the Secretary of Homeland Security, shall develop and thereafter maintain processes for coordinating Federal grant programs for public health and medical preparedness using grant application guidance, investment justifications, reporting, program performance measures, and accountability for future funding in order to promote cross-sector, regional, and capability-based coordination, consistent with section 201 of PAHPA and the National Preparedness Guidelines developed pursuant to Homeland Security Presidential Directive-8 of December 17, 2003 (“National Preparedness”).

(37) Within 1 year after the date of this directive, the Secretary of Health and Human Services, in coordination with the Secretaries of Defense, Transportation, Veterans Affairs, and Homeland Security, and consistent with section 304 of PAHPA, shall develop a mechanism to coordinate public health and medical disaster preparedness and response core curricula and training across executive departments and agencies, to ensure standardization and commonality of knowledge, procedures, and terms of reference within the Federal Government that also can be communicated to State and local government entities, as well as academia and the private sector.

(38) Within 1 year after the date of this directive, the Secretaries of Health and Human Services and Defense, in coordination with the Secretaries of Veterans Affairs and Homeland Security, shall establish an academic Joint Program for Disaster Medicine and Public Health housed at a National Center for Disaster Medicine and Public Health at the Uniformed Services University of the Health Sciences. The Program shall lead Federal efforts to develop and propagate core curricula, training, and research related to medicine and public health in disasters. The Center will be an academic center of excellence in disaster medicine and public health, co-locating education and research in the related specialties of domestic medical preparedness and response, international health, international disaster and humanitarian medical assistance, and military medicine. Department of Health and Human Services and Department of Defense authorities will be used to carry out respective civilian and military missions within this joint program.

Disaster Health System

(39) Within 180 days after the date of this directive, the Secretary of Health and Human Services shall commission the Institute of Medicine to lead a forum engaging Federal, State, and local governments, the private sector, academia, and appropriate professional societies in a process to facilitate the development of national disaster public health and medicine doctrine and system design and to develop a strategy for long-term enhancement of disaster public health and medical capacity and the propagation of disaster public health and medicine education and training.

(40) Within 120 days after the date of this directive, the Secretary of Health and Human Services shall submit to the President through the Assistant to the President for Homeland Security and Counterterrorism, and shall commence the implementation of, a plan to use current grant funding programs, private payer incentives, market forces, Center for Medicare and Medicaid Services requirements, and other means to create financial incentives to enhance private sector health care facility preparedness in such a manner as to not increase health care costs.

(41) Within 180 days after the date of this directive, the Secretary of Health and Human Services, in coordination with the Secretaries of Transportation and Homeland Security, shall establish within the Department of Health and Human Services an Office for Emergency Medical Care. Under the direction of the Secretary, such Office shall lead an enterprise to promote and fund research in emergency medicine and trauma health care; promote regional partnerships and more effective emergency medical systems in order to enhance appropriate triage, distribution, and care of routine community patients; promote local, regional, and State emergency medical systems’ preparedness for and response to public health events. The Office shall address the full spectrum of issues that have an impact on care in hospital emergency departments, including the entire continuum of patient care from pre-hospital to disposition from emergency or trauma care. The Office shall coordinate with existing executive departments and agencies that perform functions relating to emergency medical systems in order to ensure unified strategy, policy, and implementation.

National Health Security Strategy

(42) The PAHPA requires that the Secretary of Health and Human Services submit in 2009, and quadrennially afterward, a National Health Security Strategy (NHSS) to the Congress. The principles and actions in this directive, and in the Implementation Plan required by section 43, shall be incorporated into the initial NHSS, as appropriate, and shall serve as a foundation for the preparedness goals contained therein.

Task Force and Implementation Plan

(43) In order to facilitate the implementation of the policy outlined in this Strategy, there is established the Public Health and Medical Preparedness Task Force (Task Force). Within 120 days after the date of this directive, the Task Force shall submit to the President for approval, through the Assistant to the President for Homeland Security and Counterterrorism, an Implementation Plan (Plan) for this Strategy, and annually thereafter shall submit to the Assistant to the President for Homeland Security and Counterterrorism a status report on the implementation of the Plan and any recommendations for changes to this Strategy.

(a) The Task Force shall consist exclusively of the following members (or their designees who shall be full-time officers or employees of the members’ respective agencies):

(i) The Secretary of Health and Human Services, who shall serve as Chair;

(ii) The Secretary of State;

(ii) The Secretary of Defense;

(iii) The Attorney General;

(iv) The Secretary of Agriculture;

(v) The Secretary of Commerce;

(vi) The Secretary of Labor;

(vii) The Secretary of Transportation;

(viii) The Secretary of Veterans Affairs

(ix) The Secretary of Homeland Security;

(x) The Director of the Office of Management and Budget;

(xi) The Director of National Intelligence; and

(xii) such other officers of the United States as the Chair of the Task Force may designate from time to time.

(b) The Chair of the Task Force shall, as appropriate to deal with particular subject matters, establish subcommittees of the Task Force that shall consist exclusively of members of the Task Force (or their designees under subsection (a) of this section), and such other full-time or permanent part-time officers or employees of the Federal Government as the Chair may designate.

(c) The Plan shall:

(i) provide additional detailed roles and responsibilities of heads of executive departments and agencies relating to and consistent with the Strategy and actions set forth in this directive;

(ii) provide additional guidance on public health and medical directives in Biodefense for the 21st Century; and

(iii) direct the full examination of resource requirements.

(d) The Plan and all Task Force reports shall be developed in coordination with the Biodefense Policy Coordination Committee of the Homeland Security Council and shall then be prepared for consideration by and submitted to the more senior committees of the Homeland Security Council, as deemed appropriate by the Assistant to the President for Homeland Security and Counterterrorism.

General Provisions

(44) This directive:

(a) shall be implemented consistent with applicable law and the authorities of executive departments and agencies, or heads of such departments and agencies, vested by law, and subject to the availability of appropriations and within the current projected spending levels for Federal health entitlement programs;

(b) shall not be construed to impair or otherwise affect the functions of the Director of the Office of Management and Budget relating to budget, administrative, and legislative proposals; and

(c) is not intended, and does not, create any rights or benefits, substantive or procedural, enforceable at law or in equity by a party against the United States, its departments, agencies, instrumentalities, or entities, its officers, employees, or agents, or any other person.

# # #

October 11, 2007

U.S. Issues $55M in Biodefense Contracts

“The ‘pipeline’ of candidate bioterror countermeasures is fuller than ever, which bodes well for our ongoing efforts to protect Americans from those who would do us harm with biological weapons.”

U.S. Issues $55M in Biodefense Contracts

Four U.S. firms have received a total of $55.3 million from the Health and Human Services Department to prepare countermeasures against anthrax, plague and tularemia, the agency announced last week (see GSN, Oct. 4).

The funding is coming through the National Institute for Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority, a new office intended to coordinate research and development of emergency medical countermeasures (see GSN, April 27).

“These contracts will help speed the development of new interventions against anthrax, plague and tularemia, three diseases considered to be important bioterror threats,” said NIAID chief Anthony Fauci in a press release. “The ‘pipeline’ of candidate bioterror countermeasures is fuller than ever, which bodes well for our ongoing efforts to protect Americans from those who would do us harm with biological weapons.”

Nanotherapeutics Inc. of Alachua, Fla., received $20 million to develop antibiotics for plague and tularemia, while PharmAthene Inc. of Annapolis, Md., received $13.9 to develop an anthrax antitoxin. Two previously reported contracts provided Emergent BioSolutions Inc. of Rockville, Md., with $9.5 million for development of an anthrax immune globulin and Elusys Therapeutics Inc. of Pine Brook, N.J., with $11.9 million for anthrax antitoxin development (U.S. Health and Human Services Department release, Oct. 5).

October 5, 2007

Experts detail risks of bioagent program


The growth in research meant to protect the U.S. from bioterrorism is overwhelming the oversight system, a House panel is told.

By Jia-Rui Chong
Los Angeles Times Staff Writer

WASHINGTON Rapid growth in the number of biodefense laboratories researching deadly pathogens has overwhelmed the government's ability to adequately monitor the program, federal investigators told Congress on Thursday.

Officials said the expansion of the program over the last few years, coupled with a lack of training of lab workers and poor reporting of lab accidents, posed a potential threat to national security and public health.

"There are too many [labs] at the moment for the level of oversight that's being provided," said Keith Rhodes, chief author of a preliminary report from the Government Accountability Office on biodefense and emerging diseases research. "It's stretched beyond the ability of the fragmented, decentralized oversight that there is now."

Rhodes also expressed concern that, in a survey of 12 federal agencies, none of them could tabulate a total number of the high-security labs -- known as Bio-Safety Level 3 and 4 labs.

Dr. Richard E. Besser, director of the Centers for Disease Control and Prevention's Coordinating Office for Terrorism Preparedness and Emergency Response, acknowledged that lab oversight could be improved.

"As a young program, there is a lot we can learn," he said.

Besser said it was "critically important" for the government to begin convening a task force to suggest better ways to watch over the now-sprawling biodefense program.

The testimony came during a subcommittee hearing of the House Energy and Commerce Committee that was prompted by several recent laboratory accidents, some of which resulted in human exposure.

It was the first time Congress had held a hearing on the safety and security of biodefense research laboratories.

Since 2003, more than 100 accidents have been reported to the CDC or the U.S. Department of Agriculture, both of which monitor parts of the biodefense research program.

Among the accidents was a release of anthrax during shipping because of improper packing by workers at Lawrence Livermore National Laboratory. The Department of Health and Human Services announced a $450,000 fine Thursday against the University of California, which manages the lab. It was the largest of the 11 fines issued by the inspector general since 2003.

Experts say the accidents are an outgrowth of the increase in biodefense work since the Sept. 11, 2001, terrorist attacks and the still-unsolved anthrax mailings that took place a week later. Five people died and 17 were infected by anthrax spores sent in ordinary-looking letters.

Funding for biodefense research from the National Institute of Allergy and Infectious Diseases has grown dramatically, from $187 million in 2002 to $1.6 billion in 2006.

Rhodes said the FBI was particularly concerned about its burgeoning workload in conducting background checks on scientists applying to work on a group of 72 dangerous pathogens. These "select agents" include the Ebola virus and the plague bacterium Yersinia pestis.

"As the number of laboratories balloons, [the FBI's] workload balloons," he said.

Subcommittee Chairman Bart Stupak (D-Mich.) expressed concern that the list of 72 pathogens was too restricted.

"Federal regulations require reports only for incidents involving so-called select agents," he said. "But other dangerous biological pathogens are not on the select agent list, such as hantavirus, SARS and dengue fever."


October 4, 2007

Mishandling of Germs on Rise at US Labs

Mishandling of Germs on Rise at US Labs

WASHINGTON (AP) — American laboratories handling the world's deadliest germs and toxins have experienced more than 100 accidents and missing shipments since 2003, and the number is increasing as more labs do the work.

No one died, and regulators said the public was never at risk during these incidents. But the documented cases reflect poorly on procedures and oversight at high-security labs, some of which work with organisms and poisons that can cause illnesses with no cure. In some cases, labs have failed to report accidents as required by law.

The mishaps include workers bitten or scratched by infected animals, skin cuts, needle sticks and more, according to a review by The Associated Press of confidential reports submitted to federal regulators. They describe accidents involving anthrax, bird flu virus, monkeypox and plague-causing bacteria at 44 labs in 24 states. More than two-dozen incidents were still under investigation.

The number of accidents has risen steadily. Through August, the most recent period covered in the reports obtained by the AP, labs reported 36 accidents and lost shipments during 2007 — nearly double the number reported during all of 2004.

Likewise, the number of labs approved by the government to handle the deadliest substances has nearly doubled to 409 since 2004, and there are now 15 of the highest-security labs. Labs are routinely inspected by federal regulators just once every three years, but accidents trigger interim inspections.

In a new report by congressional investigators, the Government Accountability Office said little is known about labs that aren't federally funded or don't work with any of 72 dangerous substances the government monitors most closely.

"No single federal agency ... has the mission to track the overall number of these labs in the United States," said the GAO's report, expected to be released later this week. "Consequently, no agency is responsible for determining the risks associated with the proliferation of these labs."

The House Energy and Commerce investigations subcommittee plans hearings Thursday on the issue. The lab incidents have sparked bipartisan concern.

"It may be only a matter of time before our nation has a public health incident with potentially catastrophic results," said Rep. Bart Stupak, D-Mich., the panel's chairman.

The subcommittee's senior Republican, Ed Whitfield of Kentucky, added: "Currently, there is a hodgepodge system of federal oversight regulating the ... laboratories responsible for researching the deadliest germs and diseases. At Thursdays hearing, I expect to probe witnesses about how to improve oversight of these laboratories in a post 9-11 world."

Lab accidents have affected the outside world: Britain's health and safety agency concluded there was a "strong probability" a leaking pipe at a British lab manufacturing vaccines for foot-and-mouth disease was the source of an outbreak of the illness in livestock earlier this year. Britain was forced to suspend exports of livestock, meat and milk products and destroy livestock. The disease does not infect humans.

Accidents aren't the only concern. While medical experts consider it unlikely that a lab employee will become sick and infect others, these labs have strict rules to prevent anyone from stealing organisms or toxins and using them for bioterrorism.

The reports were so sensitive the Bush administration refused to release them under the Freedom of Information Act, citing an anti-bioterrorism law aimed at preventing terrorists from locating stockpiles of poisons and learning who handles them.

Among the previously undisclosed accidents:

_In Rockville, Md., ferret No. 992, inoculated with bird flu virus, bit a technician at Bioqual Inc. on the right thumb in July. The worker was placed on home quarantine for five days and directed to wear a mask to protect others.

_An Oklahoma State University lab in Stillwater in December could not account for a dead mouse inoculated with bacteria that causes joint pain, weakness, lymph node swelling and pneumonia. The rodent — one of 30 to be incinerated — was never found, but the lab said an employee "must have forgotten to remove the dead mouse from the cage" before the cage was sterilized.

_In Albuquerque, N.M., an employee at the Lovelace Respiratory Research Institute was bitten on the left hand by an infected monkey in September 2006. The animal was ill from an infection of bacteria that causes plague. "When the gloves were removed, the skin appeared to be broken in 2 or 3 places," the report said. The worker was referred to a doctor, but nothing more was disclosed.

_In Fort Collins, Colo., a worker at a federal Centers for Disease Control and Prevention facility found, in January 2004, three broken vials of Russian spring-summer encephalitis virus. Wearing only a laboratory coat and gloves, he used tweezers to remove broken glass and moved the materials to a special container. The virus, a potential bio-warfare agent, could cause brain inflammation and is supposed to be handled in a lab requiring pressure suits that resemble space suits. The report did not say whether the worker became ill.

Other reports describe leaks of contaminated waste, dropped containers with cultures of bacteria and viruses, and defective seals on airtight containers. Some recount missing or lost shipments, including plague bacteria that was supposed to be delivered to the Armed Forces Institute of Pathology in 2003. The wayward plague shipment was discovered eventually in Belgium and incinerated safely.

The reports must be submitted to regulators whenever a lab suffers a theft, loss or release of any of 72 substances known as "select agents" — a government list of germs and toxins that represent the horror stories of the world's worst medical tragedies for humans and animals.

A senior CDC official, Dr. Richard Besser, said his agency is committed to ensuring that U.S. labs are safe and that all such incidents are disclosed to the government. He said he was unaware of any risk to the public resulting from infections among workers at the high-security labs, but he acknowledged that regulators are worried about accidents that could go unreported.

"If you're asking if it's possible for someone to not report an infection, and have it missed, that clearly is a concern that we have," Besser said.

Texas A&M's laboratory failed to report, until this year, one case of a lab worker's infection from Brucella bacteria last year and three others' previous infection with Q fever — missteps documented in news reports earlier this year. The illnesses are characterized by high fevers and flu-like symptoms that sometimes cause more serious complications.

"The major problems at Texas A&M went undetected and unreported, and we don't think that it was an isolated event," critic Edward Hammond said. He runs the Sunshine Project, which has tracked incidents at other labs for years and first revealed the Texas A&M illnesses that the school failed to report.

Rules for working in the labs are tough and are getting more restrictive as the bio-safety levels rise. The highest is Level 4, where labs study substances that pose a "high risk of life-threatening disease for which no vaccine or therapy is available." Besides wearing wear full-body, air-supplied suits, workers undergo extensive background checks and carry special identification cards.

"The risk that a killer agent could be set loose in the general population is real," Hammond said.

In other lab accidents recounted in the reports, the Public Health Research Institute in Newark, N.J., was investigated by the FBI in 2005 when it couldn't account for three of 24 mice infected with plague bacteria. The lab and the CDC concluded the mice were cannibalized by other plague-infested mice or buried under bedding when the cage was sterilized with high temperatures.

The lab's director, Dr. David Perlin, told the AP it would be impossible for mice to escape from the building and said a worker failed to record their deaths.

"I feel 99 percent comfortable that was the case," Perlin said. "The animals become badly cannibalized. You only see bits and pieces. They're in cages with shredded newspaper. You really have to search hard with gloves and masks."

A worker at the Army's biological facility in Fort Detrick, Md., was grazed by a needle in February 2004 and exposed to the deadly Ebola virus after a mouse kicked a syringe. She was placed in an isolation ward called "The Slammer," but the Army said she did not become ill.

In other previously undisclosed accidents:

In Decatur, Ga., a worker at the Georgia Public Health Laboratory handled a Brucella culture in April 2004 without high-level precautions. She became feverish months later and tested positive for exposure at a hospital emergency room in July. She eventually returned to work. The lab's confidential report defended her: "The technologist is a good laboratorian and has good technique."

In April this year at the Lovelace facility in Albuquerque, an African green monkey infected intentionally with plague-causing bacteria reached with its free hand and scratched at a Velcro restraining strap, cutting into the gloved hand of a lab worker. The injured worker at the Lovelace Respiratory Research Institute received medical treatment, including an antibiotic.

The National Animal Disease Center in Ames, Iowa, reported leaks of contaminated waste three times in November and December 2006. While one worker was preparing a pipe for repairs, he cut his middle finger, possibly exposing him to Brucella, according to the confidential reports.

A researcher at the CDC's lab in Fort Collins, Colo., dropped two containers on the floor last November, including one with plague bacteria.

A worker at Walter Reed Army Institute of Research-Naval Medical Research Center in Silver Spring, Md., sliced through two pair of gloves while handling a rat carcass infected with plague bacteria. The May 2005 report said she was sent to an emergency room, which released her and asked her to return for a follow-up visit.