January 29, 2006

Over half of troops have taken anthrax vaccine since April '05

By Jeff Schogol, Stars and Stripes
Voluntarily inoculations given to 81,000 DOD personnel

ARLINGTON, Va. - Since the anthrax shot became optional in April 2005, slightly more than half of servicemembers have agreed to take it, Army Col. John D. Grabenstein, director of the Military Vaccine Agency said Friday.

In 2004, a federal judge temporarily barred the Defense Department from administering the inoculation after finding the Food and Drug Administration had made mistakes in determining the drug was safe.

In April 2005, the judge allowed the military to administer the anthrax vaccinations on an "emergency use" basis, but also gave servicemembers the right to refuse the shots.

"We noticed a pattern that people who had received anthrax vaccine before the EUA [Emergency Use Authorization] were more likely to accept and those who had no experience with the vaccine were more likely to decline," Grabenstein said. "That's a 'familiarity effect.' The relative experience and knowledge base of the briefers also affected acceptance rates."

He said 81,000 Defense Department personnel received more than 106,000 doses of anthrax vaccine from April 2005 until Jan. 14, when the Emergency Use Authorization expired.

In December 2005, the FDA deemed the anthrax vaccinations safe and effective, prompting the Defense Department to announce that each service would continue to administer the vaccinations while continuing to allow servicemembers to refuse the vaccination.

A month later, the Military Vaccine Agency was to announce guidelines on the matter, Bethel said. The Marine Corps issued an announcement on Jan. 23 that anthrax vaccinations would continue after receiving the guidelines.

Marines affected are deployed, deploying or stationed in the U.S. Central Command area of responsibility, the Korean peninsula, III Marine Expeditionary Force on Okinawa and mainland Japan and additional units with bio-defense or other special missions, said Lt. Col. Dave Bethel, Marine Corps vaccine coordinator.

Bethel said Marines who decide against getting vaccinated are putting themselves at greater risk.

"If you're going to go into the fight, you should have all your defenses in place," he said. "By not having a defense against anthrax, you're doing yourself - and more importantly the Marine on your left and right - harm."

January 27, 2006

Tax break may buoy BioPort - House passes bill to allow company to get state credit

By Amy F. Bailey
Associated Press

Lansing-based BioPort Corp. would be eligible for a state tax credit that might keep the company in Michigan under a measure the state House approved Thursday. About 275 mid-Michigan jobs are at stake.

The bill, approved 105-0, is aimed at encouraging BioPort to proceed with an estimated $75 million construction project at its plant at 3500 N. Martin Luther King Jr. Blvd.

The legislation now goes to the Senate.

The company is considering adding a three-story fermentation and processing plant to that vaccine manufacturing facility. BioPort is the nation's only licensed manufacturer of the anthrax vaccine. The company was selected last spring to manufacture 5 million doses of anthrax vaccine as part of a federal program to stockpile antidotes to biological and chemical weapons.

Current law prohibits BioPort from being considered for a Michigan Economic Growth Authority grant because it had been located in a state-owned facility before the company purchased it, said state Rep. Scott Hummel, R-DeWitt, who introduced the legislation.

"Hopefully they can keep their facility here," Hummel said.

BioPort is considering two states for the expansion project: Michigan and Maryland, the headquarters of its parent company, Emergent BioSolutions Inc.

About 275 jobs would be lost in mid-Michigan if BioPort goes ahead with the expansion in Maryland, the company said.

"States are very competitive in terms of attracting life science jobs," BioPort spokeswoman Kim Brennen Root said.

"Because of that, they assemble attractive packages that make it possible to make this kind of investment over the long term."

MEGA was created to help keep Michigan businesses in the state. Companies approved for a grant by the MEGA board receive breaks in the amount they contribute to state taxes on the income of their employees.

Three representatives missed the vote: Republican Chris Ward of Brighton and Democrats Bill McConico and George Cushingberry, both of Detroit.

January 20, 2006

U.S. Defense Department Employees Discount Bush Administration Claims of Safety of Anthrax Vaccine

Global Security Newswire

Six anonymous U.S. Defense Department employees have claimed the Bush administration is trying to "manipulate" a U.S. Appeals Court in the ongoing legal case over the safety of the anthrax vaccine, Inside the Pentagon reported yesterday (see GSN, Dec. 2, 2005).

A U.S. District Court in October 2004 ruled that the mandatory anthrax vaccination program for military personnel was illegal. Justice Department lawyers have appealed that decision, while the Pentagon has gone ahead with a voluntary anthrax vaccination effort.

The Food and Drug Administration last month said the vaccine worked against anthrax contracted through the air and through the skin. After this determination was made, lawyers for the government filed a brief with the appeals court arguing the FDA decision justifies reinstating the mandatory program.

However, lawyers for the Defense Department employees have argued that the Bush administration is "attempting to orchestrate the course of litigation through their ability to act as government regulators," according to a brief filed last week in response to the government's December motion. As the recent FDA decision is not a part of the government's original appeal, "the court should reject this attempt by the government to put inadmissible material before the court in an effort to bolster its unsustainable case."

The Defense Department employees filed the lawsuit in March 2003 that later stopped the mandatory vaccination program. They argued that the vaccine was "investigational" and had not received FDA certification. Military law does not allow investigational vaccines to be administered to personnel without their informed consent or a presidential waiver.

Service members who refused to take the vaccine have faced administrative discipline and court-martials, Inside the Pentagon reported. Experts said that if the district court's ruling is upheld, the cases of the service members will be strengthened, as they would have been disobeying an illegal order.

"FDA's actions, which were specifically directed by the district court's order and judgment, cannot retroactively alter the status of the vaccine as determined by the district court in December 2003 and October 2004," lawyers for the employees argued.

However, the government argues that the program was legal since its inception and that the recent FDA action on the vaccine was needed only to show the court that the agency approved the vaccine.

"If the Court of Appeals doesn't reach the merits of the case due to the injunction having become moot, vacatur of [District] Judge [Emmet] Sullivan's judgment and injunction would be highly appropriate, [or] else a fundamentally flawed ruling . would evade review and remain on the books," said Brian Boyle, a former Justice Department attorney who worked on the case. "Mere dismissal of the appeal would be improper, since there is still a live dispute as to whether DOD was lawfully using the vaccine prior to the most recent FDA approval" (Elaine Grossman, Inside the Pentagon, Jan. 19).

January 18, 2006

Agency's 'Federal Preemption' Policy Included in Labeling Guidelines for Medications

FDA Tries to Limit Drug Suits in State Courts
Washington Post
By Marc Kaufman

People who believe they were injured by drugs approved by the Food and Drug Administration should not be allowed to sue drug companies in state courts, the agency said yesterday in a formal policy statement.

The FDA's controversial assertion of "federal preemption" was included as a preamble to long-awaited guidelines designed to make drug labeling information more accessible and readable for doctors and consumers. Agency officials said that though the preemption policy does not have the weight of law or formal regulation, they hope state judges will accept their position.

"We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge," said Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs.

The new labeling rules require drug makers to highlight the most important advisory information in the "package insert" issued with every prescription and to cut back on the often-technical legal language that officials said is included more to protect drug makers from lawsuits than to inform doctors and patients. Gottlieb said drug industry officials convinced the agency that they deserved more broadly stated FDA support because the new, more streamlined labeling would make them more vulnerable to lawsuits.

While the new labeling guidelines were widely applauded yesterday, the claim of federal preemption was quickly attacked by trial lawyers and members of Congress as another effort by the Bush administration to limit the public's ability to bring and win lawsuits.

Without state product liability laws, the critics said, drug companies could escape responsibility for injuries and deaths caused by drugs such as Merck & Co.'s Vioxx, which an FDA medical officer estimated had killed as many as 55,000 Americans.

"Eliminating the rights of individuals to hold negligent drug companies accountable puts patients in even more danger than they already are in from drug company executives that put profits before safety," said Ken Suggs, president of the Association of Trial Lawyers of America.

"The fact that the drug industry can get the FDA to rewrite the rules so that CEOs can escape accountability for putting dangerous and deadly drugs on the market is the scariest example yet of how much control these big corporations have over our political process," he said.

Anticipating that the FDA would make the preemption claim, the National Conference of State Legislatures, a bipartisan group that represents state legislators, said last week that the agency was seizing authority that it did not have. Yesterday, Sen. Edward M. Kennedy (D-Mass.) expanded on that criticism.

"It's a typical abuse by the Bush Administration -- take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into a protection against liability for the drug industry," he said in a statement.

The Bush administration has intervened in a number of state liability cases against drug and medical device manufacturers with friend-of-the-court briefs supporting the companies. Yesterday's policy statement was just a way to make the same points on a broad and general basis, Gottlieb said.

The drug labeling guidelines were first proposed as a new regulation in December 2000 and have been subject to years of debate and public hearings. The new guidelines -- which will go into effect on June 30 -- were announced yesterday by Surgeon General Richard H. Carmona and top FDA officials, who called them a major public health advance.

"Americans are overwhelmed with the complexity of health information. We have hit a point of information overload, and the public health message is being diluted," Carmona said. "This is of great concern when it comes to making sure a patient knows how to use prescription drugs safely and effectively. This problem is compounded by prescription medication information that reads more like legal disclaimers than useful or actionable health information."

The new labeling -- the first revision of its kind in 25 years -- is required for all new drugs that come on the market and those approved in the past five years. Officials said the new "highlights" section and a table of contents that organizes the information will help avoid some of the estimated 300,000 preventable drug-related complications reported in hospitals, many of which are the results of confusing medical information.

Although the new labeling will make it easier for doctors to digest information about the drugs they prescribe, consumers may not find it much more accessible. The patient information leaflets written in laymen's language that patients receive with their prescriptions are commercially produced and not approved or scrutinized by the FDA.

Sidney Wolfe, director of Public Citizen's Health Research Group, said patients should get the new, FDA-approved labeling information as well.

"It is time to end the double standard where doctors and other health professionals are informed by FDA-approved labeling, but patients are treated like second-class citizens, receiving whatever the out-of-control purveyors of patient information leaflets choose to dispense," he said.

DoD Asks Court To Reinstate Mandatory Anthrax Vaccine Program

By Sandra Basu

Posted: 18-Jan-2006
WASHINGTON-U.S. government officials asked a federal appeals court last month to reinstate mandatory anthrax inoculations for military personnel, while a lawyer for soldiers who refused the vaccinations argued that the vaccine was not intended for the broad use of it for military personnel that the Department of Defense (DoD) is advocating.

At issue during the federal appeals court hearing last month was whether the anthrax vaccine was intended and limited for use against anthrax contracted through spores transmitted by touch, or whether the vaccine was also intended for inhalation anthrax.

U.S. District Judge Emmet Sullivan had suspended anthrax vaccinations in October 2004 after he found fault in the Food and Drug Administration's process for approving the drug. He gave the DoD permission to resume vaccinating servicemembers against anthrax earlier this year, but he said that the vaccine must be given on a voluntary basis. In granting DoD's request to modify the injunction, which allows the resumption of vaccinations as long as they are voluntary, Sullivan said that he was requiring the government to provide weekly reports to the court that show that the vaccine is given voluntarily.

The U.S. government would like the federal appeals court to reverse Sullivan's decision, allowing for the vaccinations to be mandatory. At the hearing in Washington, D.C., Appeals Judge David Tatel asked John J. Michels, an attorney who represented the six plaintiffs in the case, why the language on the label of the vaccine was not broad enough to cover inhalation anthrax.

Michels told the judges that the vaccine was never intended to be used for inhalation anthrax and does not specify inhalation anthrax on its label. Rather, he said it was intended to protect veterinarians and certain types of industrial workers who have a high-risk exposure to anthrax.

"Nobody ever thought that this stuff was licensed for inhalation anthrax," said Michels.

Michael S. Raab, a Department of Justice attorney who represented the U.S. government, argued that while the labeling does not specifically say that it protects against inhalation anthrax, the labeling does not include any limitations on the routes of exposure that it protects against.

"The labeling does not include any limitations to the route of exposure," Raab told the judges.

The court could take months to arrive at a decision to either affirm or reverse Sullivan's decision, according to lawyers of the plaintiffs. The court's decision can also be appealed.

Anthrax Controversy
On Oct. 27, 2004, U.S. District Court Judge Emmet Sullivan said that the anthrax vaccine had not gone through the appropriate Food and Drug Administration (FDA) approval process and was therefore an experimental drug that could not be given to troops without their consent. The court imposed a permanent injunction prohibiting the government from vaccinating any individual without informed consent or a presidential waiver.

DoD asked the court at a hearing in March of 2005 to modify its injunction so as to allow the vaccines to resume under an emergency waiver, known as an Emergency Use Authorization (EUA). The EUA was issued in January by the Department of Health and Human Services and the FDA under authority granted by Project BioShield. Project BioShield was signed into law July 21, 2004 with the aim of facilitating a faster process to research, develop, purchase, and make available medications to combat bioterrorist threats that could cause public health emergencies.

In his April 6 subsequent court order, Judge Sullivan said that he was not ruling on the merits of any EUA, but would modify the injunction, allowing for the voluntary administration of the anthrax vaccine.

With that ruling, military personnel have been given an option of whether they would like to accept or decline the vaccine. Deputy Director for Clinical Operations for the Military Vaccine Agency, in Virginia, Lt. Col. Stephen Ford said during a presentation at the Combined Forces Pharmacy Seminar in October that about 50 per cent of military personnel were accepting the vaccine. He said that in the event of a biological attack where anthrax is deployed, 50 per cent of the troops that have not taken the vaccine could be rendered ineffective.

"We believe that it [the vaccine] is effective and safe," he said.

Since 2001, the Pentagon has inoculated more than one million soldiers with the vaccine. The vaccine program has been controversial since its creation in 1998 when mandatory vaccinations against anthrax were required of all active duty military personnel. Some military personnel who took the vaccine said it made them sick and questioned whether the vaccine was safe.

FDA’s Drug Label Rule Fails to Guarantee Access to Vital Information and Includes ‘Sneak Attack’ on Patients’ Legal Rights

Public Citizen
Press Release

Bush Administration Abuses Executive Powers in Attempt to Override State Liability Laws

WASHINGTON, D.C. – The U.S. Food and Drug Administration, though it has improved a drug labeling regulation through revisions announced today, continues to ignore the fact that its rule will not guarantee patients the most accurate, up-to-date information about their medications, Public Citizen said today.

Further, in an end-run around Congress, the FDA has added to the rule a preamble designed to preempt lawsuits filed by patients under state law, potentially leaving victims of FDA-approved drugs with no remedy for any harm caused by the approved drug.

Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said revisions in the final version of the rule released today will simplify and prioritize the labeling information that doctors receive. But the vast majority of patients will not get that information unless they specifically request it. Instead, they commonly receive patient information leaflets (PILs) that are commercially produced but whose content is not scrutinized by the FDA.

The FDA’s own study has shown that the content of unregulated leaflets gets a failing grade (average 50 out of 100) in conveying the most important information to patients, Wolfe said. The agency has the authority to require agency-approved “medication guides” for each new prescription and refill but has done so for only about 75 drugs.

“It is time to end the double standard where doctors and other health professionals are informed by FDA-approved labeling, but patients are treated like second-class citizens, receiving whatever the out-of-control purveyors of patient information leaflets choose to dispense,” Wolfe said. “This is a dangerous situation, made worse by the FDA’s poor record of approving harmful drugs based on limited, and even fraudulent, clinical trials performed by the drug companies.”

In a further blow to consumers, the final rule now contains a preamble aimed at preempting the rights of patients to sue drug manufacturers if a drug is approved by the FDA. The Bush administration has previously failed to persuade Congress and, with a few exceptions, the courts (where it has filed amicus briefs) to shield drug makers from liability. The new tactic of writing preemption language into federal regulation notices is an attempt to bypass Congress and override consumer protection liability laws, said Public Citizen President Joan Claybrook. The administration has also used such language in recently proposed automobile safety rules.

“This is a sneak attack on consumer rights,” Claybrook said. “President Bush is once again abusing his executive powers, this time in his attempt to protect the big pharmaceutical companies from the consequences of their actions. Thousands of people in this country have died or been seriously injured by drugs approved by the FDA, and this administration is saying it doesn’t think people should have any recourse.”

It remains unclear what impact the language will have on liability cases.

“Ultimately, we are confident that the courts will not defer to the FDA’s opinion on preemption, which is not based on any authority given to the FDA by Congress,” said Brian Wolfman, director of the Public Citizen Litigation Group and an expert on preemption law. “In the meantime, however, the drug companies will be emboldened by this preemption statement, and use it to complicate injury cases and deter victims from seeking justice in the courts.”

Drug labeling has been a problem for decades.

In 1981, the Reagan administration cancelled a proposed regulation requiring FDA-approved leaflets to be dispensed with prescriptions just before the rule was to go into effect. The abrupt reversal came at the behest of drug companies, pharmacy organizations and some physician groups. Private sector-designed leaflets, not approved by the FDA, thereby continued to be the norm.

Several years ago, shortly after Dr. Mark B. McClellan became FDA commissioner, he listed as one of his top five priorities helping consumers obtain truthful information about products they use so they can make informed decisions. The FDA could go a long way toward achieving this priority by immediately moving forward with a long-overdue initiative to require the mandatory distribution of FDA-approved written drug information with each new and refill prescription, Wolfe said.

In a study conducted several years ago by the University of Wisconsin for the FDA, although 89 percent of consumers were receiving some sort of information(unregulated PILs) when a prescription was filled, none of the approximately 1,300 leaflets studied for four common drugs achieved minimum goals for useful, scientifically accurate drug information. As measured by eight objective criteria, the overall usefulness of information was about 50 percent. According to the authors, “a majority of leaflets did not include adequate information about contraindications, precautions, and how to avoid harm.”

“The notion that consumer drug information can be 50 percent useful is unfathomable,” Wolfe said. “Drug information that communicates only half of what it should is misleading, and misleading drug information is potentially dangerous.”

January 17, 2006

Expect more surprises - U.S. Official Says Terror Strike with WMD Likely

U.S. State Department Counterterrorism Coordinator Henry Crumpton warned today that al-Qaeda is likely to use weapons of mass destruction against the West, Agence France-Presse reported (see GSN, Nov. 23, 2005).

“We are talking about micro targets such as al-Qaeda which, when combined with WMD, have a macro impact. I rate the probability of terror groups using WMD (to attack Western targets) as very high,” he told the London Daily Telegraph.

“It's simply a question of time. And it is not just the nuclear threat that bothers me. I think, if anything, the biological threat is going to grow. As catastrophic as a nuclear attack would be, it would be self-contained,” Crumpton said. “But if you look at a worst-case scenario for a biological attack, it would be difficult to determine whether or not it was a terrorist attack, and it would be far more difficult to contain.”

Crumpton said fears that countries like Iran or Syria would supply al-Qaeda with weapons of mass destruction are behind Washington’s resolve to stop Tehran’s nuclear program.

“If we look at the threat posed by Iran, they have links with Hezbollah (the Lebanese Shiite Muslim militia), which is a terrorist organization with a global reach, and they are actively pursuing WMD. And the [Iranian] leadership has made a conscious decision to defy international treaties. I am deeply troubled by this,” he said (Agence France-Presse/Yahoo!News, Jan. 17).

January 13, 2006

Unequipped to Cure

The Nation
Dr. Marc Siegel

Vaccine-making resources in the United States are stretched alarmingly thin. There are only three manufacturers responsible for making more than 80 million doses of the human flu vaccine each year, with no guarantee that the entire supply will be sold or adequately distributed. In 2004 the entire 50 million-dose batch made by Chiron (a US company whose manufacturing plant is in Britain) had to be discarded because it was found to be contaminated with a common bacteria known as serratia.

As recently as the 1970s, there were thirty-seven vaccine makers in the United States. But because of the narrow profit margin and fear of litigation, many manufacturers left the game. Tommy Thompson, when he was Secretary of the US Department of Health and Human Services, attempted to corral funding to upgrade the country's capability of making flu vaccine. Concerned about the possibility of a pandemic, Thompson requested $100 million in 2002 for the purpose of helping the vaccine industry switch over from using chicken eggs to make vaccine to the latest cell-based method that relies on genetic technology. In 2002, his request was denied. In 2003, $50 million was approved. Finally, in 2004, it took the public panic over a flu vaccine shortage to put enough pressure on Congress to approve the entire $100 million allocation.

But even at a time of such great difficulty with the flu vaccine supply, in the post-9/11 era, lawmakers have focused their attention elsewhere. In early 2005, a powerful group of Republican lawmakers began pushing Project BioShield 2 through Congress. The original Project BioShield, signed into law in July 2004, allocated $5.6 billion over ten years to the Department of Homeland Security for the purchase of countermeasures against anthrax, smallpox and other terrorist threats. This expenditure includes allocation for 75 million doses of a second-generation anthrax vaccine to be made available for stockpiling.

BioShield 2 also proposes to shield the drug companies against lawsuits, one of the major disincentives against making vaccines, while expanding by several billion the money allocated for an ultra-expensive anthrax vaccine against a theoretical threat that remains remote.

Last fall, the federal government's vaccine focus switched dramatically to bird flu, when articles in Nature and Science disclosed the final sequencing of the 1918 Spanish Flu H1N1 molecules. The fact that the Spanish flu originated in birds had been known for at least thirty years, and the exact way it made its jump to humans was known for at least a year. Nevertheless, these studies, combined with the continued spread of the H5N1 virus among birds migrating from Asia to Europe, fueled a concern that was useful to public health officials who wanted more attention put on avian flu in general and on the bird flu vaccine in particular.

A vaccine against H5N1 had already been developed using a virus isolated from a Vietnamese patient in 2004. In 2005 the National Institutes of Health began testing this vaccine against humans; preliminary results showed that it was effective at causing an immune response.

But with the odds of a bird flu pandemic looking very slim this year, it would appear to be far more cost effective to improve the ability to respond to a future pandemic. One of the weakest links in our preparation chain is vaccine production. When we vaccinate, a dead or weakened virus is injected into a person, where it generates an immune response, but without causing any symptoms of the disease. The body then carries, for some extended period of time, the specific antibodies for that virus or bacteria and has the capacity to make more if actually challenged by the actual virus or bacteria.

Genetic recombinant techniques have routinely been used since the 1980s to develop vaccines for hepatitis, in which E. coli bacteria is "programmed" to make a viral antibody. But the United States still currently produces all influenza vaccines, including potential bird flu vaccines being tested in humans, using a method created almost fifty years ago. First, scientists identify the live virus from the blood of a victim. Next, it must be injected into a fertilized chicken egg. Once it's been grown in chicken eggs, it has to be injected into more chicken eggs, until millions of eggs have been injected with the virus. Then the virus is harvested, purified and neutralized. It may take half a year--or more--to identify the strain, develop and release the first set of vaccine doses to the public. Ironically, the H5N1 bird flu virus is so deadly to chicken embryos that it interferes with the process to make a vaccine against itself. The eggs have to be specially treated so they can be used.

More advanced technology is available, but it is expensive to change over to state-of-the-art methods. The most commonly used methods involve reverse genetics and cell cultures. In reverse genetics, using the structure of the bird flu virus, scientists can genetically engineer an existing influenza virus by inserting strips of genetic material and turning one viral strain into another. Then, instead of injecting that genetically manipulated strain into a million eggs, they grow it with cell cultures.

Using this cell culture technique, scientists grow animal cells or human cells in big vats of nutrient solution. Then they inject the newly created virus strain into the cells. As the cells reproduce, so does the virus. Eventually, the outer wall of cell is removed, and the viruses are harvested, purified and then neutralized or killed. Once dead, they can safely be injected into subjects as a vaccine, inducing an animal or person to make antibodies against this "manufactured" virus. Using this method, the interval between the identifying a strain and producing the first batch of vaccines can be measured in days instead of months.

So why do we still rely on the chicken eggs? Vaccine manufacturers, though they use these techniques routinely for other viruses, have been reluctant to switch with flu vaccines because of expense as well as potential liability. Simply put, they don't know what side effects will occur until they start to test people. So they would rather stick to obsolete techniques that have been proven safe rather than use existing technology to venture into unknown legal territory.

On the horizon are other exciting advanced techniques, including one that targets the M2 protein of the influenza molecule. Since that molecule doesn't change, this kind of a vaccine might provide immunity to all flus (including bird flu) for a decade, rather than one flu for a year only. Urgent pandemic preparation or stockpiling would be rendered obsolete, since a vaccinated individual would carry an immunity to all flus.

And then there's Jose Galarza. In a tiny lab perched above the Hudson River, Galarza, a lone researcher who has the reputation in the vaccine world as a maverick, has been experimenting with tiny specks of genetic matter for nearly ten years. He works with microscopic blobs of genes (called viral-like particles known as VLPs) from which he fashions painless, oral vaccines more rapidly than traditional methods. In fact, Galarza believes he can command his VLPs to knock out bird flu in lab animals-- and potentially in humans--more quickly and safely than conventional vaccines.

Work such as Galarza's is evidence that the human flu shot can be modernized, both for the yearly flu as well as for the more remote H5N1 bird flu, given the rare chance that it could mutate into a form that could routinely affect humans. Stockpiling vaccine now using the old methods has limited value since this virus may well not mutate, and even if it does, it may change to a form that renders the current bird flu vaccine ineffective. If a worst-case scenario were to occur, we would need a modern vaccine to be able to combat it.

One of the major problems in the United States is that we rely on the motivation of vaccine manufacturers who are neither motivated nor altruistic. Our country could learn a great deal about vaccine production from the countries of Western Europe, where the government controls the production and distribution of vaccines. Relying on corporate good will and a large supply of vaccine with a small profit margin is a dangerous strategy where public health and safety are involved.

January 10, 2006

U.S. Vaccine Healthcare Centers Partially Funded

By David Ruppe
Global Security Newswire

WASHINGTON - The U.S. Vaccine Healthcare Centers, which assess and help treat military personnel potentially sickened by biodefense vaccines, received specific congressional funding for the first time in this fiscal year (see GSN, July 7, 2005).

While helping to ensure their continuity, the authorized funding is only $3 million of the $6 million sought, leaving the centers to appeal to the Army or other military services to make up the difference.

Key senators and congressmen finalizing the $453 billion fiscal 2006 defense appropriations bill approved the money last month. President George W. Bush signed the bill into law Dec. 30.

Congress in 2000 created the Vaccine Healthcare Centers' headquarters, located at the Walter Reed Army Medical Center in Washington, D.C., as a place for personnel who might have been made ill by anthrax vaccinations to receive specialized assessment, treatment and study.

Three other locations opened in 2004, at the Naval Medical Center in Portsmouth, Va., the Womack Army Medical Center at Fort Bragg, N.C., and the Air Force's Wilford Hall Medical Center in San Antonio, Texas.

None of the armed services, however, has specifically budgeted for the centers. Despite the efforts of Senators Joseph Biden (D-Del.) and Jeff Bingaman (D-N.M.), congressional authorizers until now have also refused to fund them directly, leaving Walter Reed to transfer some of its resources.

Meanwhile, the military since 2002 has been conducting mass vaccinations for anthrax and smallpox. The centers in fiscal 2003 and fiscal 2004 combined treated approximately 1,200 recipients of the anthrax and other vaccines presenting a range of side-effects, from muscle pain and chronic fatigue to multiple sclerosis (see GSN, May 6, 2005).

Many personnel are believed eligible for treatment but unaware that the centers exist.

January 6, 2006

PENTAGON HID TRUTH ON ANTHRAX VACCINE - Over 20,000 Hospitalizations Unreported

Free Market News

Over the last seven years, the Pentagon only revealed information about a small fraction of the cases in which serious complications caused by giving soldiers the anthrax vaccine, according to the Daily Press. The Pentagon had repeatedly promised to send Congress reports anytime a soldier was hospitalized after taking the vaccine from 1998 to 2000.

In the last seven years, 1.2 million soldiers have been forced to take the anthrax vaccine. Less than 100 cases of complications from the vaccine were reported to Congress, leading experts to project that about one in 100,000 would suffer from severe complications after taking the vaccine. However documents recently obtained by the Daily Press show that over 20,000 soldiers were hospitalized after being subjected to the shot. Among the severe complications that weren’t reported were three cases of Lou Gehrig's disease, a disease that kills the muscles and nerves in the body and always leads to death.

As reported earlier by FMNN, President Bush has requested that every service member in the Armed Forces is given the Anthrax vaccine. A group of soldiers are currently suing the government to prevent themselves from being forced to take the vaccine.

Group challenges FDA’s anthrax vaccine statement

Roman Bystrianyk,
"Group challenges FDA’s anthrax vaccine statement"
Health Sentinel, January 6, 2006,

This is Agent Orange all over again

On December 15, 2005, the Food and Drug Administration (FDA) issued a statement that the anthrax vaccine being given to members of the United States Military is safe and effective. Published in the Federal Register on Thursday, the FDA review on the Anthrax Vaccine Absorbed, or AVA, stated that they determined, “AVA to be safe and effective.”

According to Fox News, FDA spokeswoman Julie Zawisza said the agency found no evidence to alter its previous determination that the vaccine was safe. Zawisza stated that, “we believe the vaccine is safe and effective for intended use, which would include the prevention of inhalation anthrax.”

Since 1998, over 1 million troops have been vaccinated with the anthrax vaccine. Large numbers of service personnel have refused to be vaccinated and have been punished for refusing, including fines of tens of thousands of dollars, and/or jail time, ultimately being discharged from service with a felony conviction.

A group of former and current military members and concerned citizens are appalled by the FDA's statement. The group at this time remains anonymous. According to a spokesperson for the group, “the FDA's decision is without scientific merit and stands in contrast to the anthrax vaccine’s product labels’ own warnings regarding adverse events. This is Agent Orange all over again.”

The group states that it has documented hundreds of cases of adverse reactions from the anthrax vaccine. The reactions range from mild, such as swollen arms and fever, to major problems which include, auto-immune dysfunctions, seizures, chronic fatigue, numbness in extremities, migraines, multiple sclerosis, Lupus, and even death.

“The FDA has completely disregarded all these people that have been harmed or killed by the anthrax vaccine”, said the spokesperson for the group. “Their statement that it is safe is completely ridiculous and borderline criminal. In recent data submitted to the daily press by the Pentagon, in two years (1998-2000) 20,000 hospitalizations following the administering of the anthrax vaccine were not reported.”


A few examples of what the FDA claims to be safe follow:

· A young healthy male, one day after receiving the anthrax vaccine, collapsed. While fluid formed around his lungs, and his lungs collapsed, later that week he died.

· A once healthy male now is bed-ridden on a breathing apparatus, he has ALS. He needs a feeding tube and his wife had to quit work to care for him.

· A young healthy male, 24 hours after receiving the anthrax vaccine, 2 ½ liters of blood filled the sac around his heart. His lungs then collapsed. He passed away.

· A healthy young female, after receiving the anthrax vaccine, developed poly-cystic ovarian disease.

· A healthy female developed blood clots, a lung disease and began coughing up blood after receiving the anthrax vaccine. She soon afterwards developed Multiple Sclerosis.

· A healthy female had dysfunctional uterine bleeding, hair loss, numbness in her extremities and a rash that covered her body.

· A female had blood in her stool, chronic fatigue, chronic pain, concentration problems, Fibromyalgia, GERD, joint pain, lesions on her legs, migraines, bleeding gastric ulcers, rapid heart palpations and mood disturbances.

· A male developed blisters in his mouth, concentration problems, heart problems, joint pain, memory loss, a stutter, migraines and numbness in his extremities.

“Twenty-One (21) deaths have so far been attributed to this vaccine, and yet the FDA claims this to be a safe vaccine?”

The group issued a challenge to the people at FDA that have declared the vaccine to be safe.

“We'd like to see those people within the FDA who think the anthrax vaccine is safe to go on national television and have themselves and/or their sons/daughters injected with all six doses of the anthrax vaccine followed by yearly boosters. Of course we don't expect the FDA will take the challenge because most of them are yes-men and women that don't have to suffer any consequences of being wrong. The intent of the FDA protecting Americans’ health went out the window a long time ago.”

January 5, 2006

Given FDA Order, Bush Lawyers Ask Court To Reverse Anthrax Ruling

Inside The Pentagon
Elaine M. Grossman

With a new order in hand from the Food and Drug Administration that supports the use of anthrax vaccine to prevent an inhaled form of the disease, Justice Department attorneys late last month asked a federal appeals court in Washington to reverse "on the merits" a lower court decision banning mandatory shots for military personnel.

Defense Department leaders argue the vaccine is necessary to protect personnel in high-risk areas from becoming infected if an adversary releases anthrax spores into the air.

In October 2004, U.S. District Court Judge Emmet Sullivan issued an injunction against involuntary anthrax inoculations, saying the FDA had not yet completed a longstanding review to formally approve the drug. The court considered the vaccine "investigational" -- in other words, uncertified as safe and effective for protection against inhaled anthrax, according to Sullivan's opinion.

Title 10 of the U.S. Code requires the "informed consent" of military personnel in taking unapproved or investigational drugs. To override that requirement and mandate inoculations, the president could issue a waiver based on national security concerns. But both the Clinton and Bush administrations have insisted the anthrax vaccine is not investigational for such a use, and no presidential waiver has been issued.

Sullivan's finding constituted a win for six anonymous military plaintiffs who filed a lawsuit in March 2003 to stop the mandatory shots.

In December 2004, following Sullivan's summary judgment on the case, the FDA opened a 90-day public comment period on its proposal that the anthrax vaccine is "safe and effective and not misbranded." After reviewing the public comments, FDA last month issued a final rule and order certifying the vaccine.

In the document, the agency said it "agrees" with a March 2002 finding by the National Academy of Sciences' Institute of Medicine "that certain studies in humans and animal models support the conclusion that [anthrax vaccine] is effective" against the disease, "regardless of the route of exposure."

"The FDA's analysis continues to be fundamentally flawed because they have failed to acknowledge that although the mechanism for anthrax [infection] appears to be universal, the widely differing mortality rates based on route of exposure have significant implications for vaccine efficacy," responds one source who is critical of the government position.

The U.S. government has said that more than 90 percent of individuals who contract inhaled anthrax may die of the disease, but fatality rates are less than 20 percent for those who become infected through the skin. Use of antibiotics promptly after exposure to anthrax can significantly lower fatality rates, according to the Centers for Disease Control and Prevention.

The existing FDA-approved label is not specific about the protection the vaccine offers against various types of exposure.

"A vaccine that can protect against low levels of infection may not be sufficient at high levels," asserts the government critic. Advanced efficacy testing that might have gone beyond the contested 1950s-era "Brachman study" in proving the vaccine's ability to prevent inhaled disease was never demanded by FDA and never carried out, this source contends.

"They can't do anything about it now -- it's too late," according to this source, who demanded anonymity while the case remains pending before the court. "The vaccine was improperly licensed from the beginning." For its part, the FDA disputes a 1985 government advisory panel's finding that the vaccine is 93 percent effective against cutaneous anthrax only, saying instead in its new order that the calculation "pertains to both cutaneous and inhalation anthrax."

The contentious debate over vaccine efficacy, however, is not central to the current case, which was decided by the lower court principally on a question of procedure.

Last summer, the Bush administration took Sullivan's decision to the DC Circuit of the U.S. Court of Appeals. Now, following the latest FDA action, government attorneys are asking the three-judge appeals panel to review the status of the case.

"In light of the FDA's Dec. 19 order, the district court's permanent injunction has by its terms expired," the administration lawyers argued two days later in a written motion on behalf of the Defense Department.

The Justice attorneys say the appeals court could now declare the issue moot, vacate Sullivan's decision and lift the ban on involuntary inoculations. But the administration would prefer that the judges go a significant step further -- to decide the case in their favor and explicitly reject the lower court's basis for prohibiting the mandatory shots in the first place.

"We do not believe . . . that the appeal of the [lower court's] final judgment has become moot" because of the FDA action, the Dec. 21 document states. "The final judgment reflects the district court's erroneous conclusion that the 1970 licensure does not encompass use against inhalation anthrax, and there remains a live dispute between the parties regarding the scope of that license."

Rather than replace or supersede the vaccine's original 1970 license, the new agency order instead "completes the FDA's review of the 1970 license[;] confirms the FDA's interpretation of the 1970 license to include inhalation anthrax; and sets forth the FDA's current expert judgment, based on the presently available scientific evidence, that the vaccine is safe and effective for that use," according to last month's brief.

The government attorneys appear concerned that, if left as the decision of record, Sullivan's declaration that the Pentagon's shots program was "illegal absent informed consent or a presidential waiver" implies "that DOD's mandatory program became legal not in 1970, but on Dec. 19, 2005," in the words of the brief.

Beginning in May 1998, more than 1 million military personnel and defense employees were inoculated involuntarily (Inside the Pentagon, Oct. 24, 2004, p1). The Pentagon restarted shots last spring, but only on a voluntary basis (ITP, May 5, 2005, p5).

Since the mandatory shots effort was launched, hundreds of service personnel have faced court-martial or administrative discipline for refusing the order to take the vaccine, which is to be given in six doses over an 18-month period. Some of those cases are currently pending before the U.S. Court of Appeals for the Armed Forces, where oral arguments were heard last month.

If the DC Circuit Court does not reverse on the merits Sullivan's finding that the Pentagon's inoculation program was illegal, that could significantly strengthen the case of military defendants who assert they were resisting an illegal order to take the shots, according to some observers.

One reason the federal appeals court may not simply declare the case moot at this juncture is a pending question the judicial panel raised last month. The judges asked both sides whether the anthrax vaccine must be considered a "drug unapproved for its applied use" under Title 10 because it was originally licensed in a manner that law does not recognize (ITP, Dec. 8, 2005, p2).

In a written argument submitted to the court, the military plaintiffs who brought the suit supported the view that, under Title 10, the vaccine must be considered unapproved.

The Public Health Service Act (PHSA), under which use of anthrax vaccine was initially approved, "holds vaccines to a different and lower standard for licensing," attorneys for the service members argued. Given the Pentagon desire to mandate inoculations using this particular vaccine, "Congress' concern about a lack-of-effectiveness standard was not misplaced," they stated in a Dec. 19 brief to the federal appeals court.

But the government asserted in its own supplemental briefs that all vaccines are approved in the same manner, and "there is no basis for concluding that Congress intended" to prohibit the Pentagon from administering any mandatory inoculations at all, to include not only anthrax but also yellow fever and polio.

In a friend-of-the-court brief filed this week, Connecticut Attorney General Richard Blumenthal disputes that notion as one among "a parade of horribles" the government has alleged would ensue if the appeals panel finds the anthrax vaccine invalid under Title 10.

Administration lawyers "seem to assert that invalidating [anthrax vaccine] would invalidate all other PHSA licenses, and prevent mandatory use of such drugs by the military . . . This is not true," Blumenthal writes. "Though old, PHSA-licensed drugs do not need new licenses, such drugs still must comply" with up-to-date requirements for "safety, efficacy and labeling," he asserts.

The Justice attorneys concede in their latest motion that the supplemental briefing "issue remains live even after the FDA's Dec. 19 order."

They also seek an appeals reversal of the "false premise that worldwide injunctions against the military should be freely available in non-class actions."

In his summary judgment, Sullivan accepted the plaintiffs' argument that the ban on shots should be implemented across the military because the program is not illegal simply for the six individuals who filed the suit.

A principal basis for finding the vaccine was not labeled for inhalation anthrax was that the vaccine manufacturer applied to the FDA for an "investigational new drug" study on that proposed use in September 1996, as the Defense Department was preparing its massive inoculation program. The application remained active at FDA until the government withdrew it in January 2004, shortly after Sullivan issued a preliminary injunction.

Last July, the complainants said a discussion of the application for a license amendment was "inexplicably missing from the government's brief" to the D.C. Circuit Court of Appeals and argued the issue is "absolutely essential to understanding the ultimate success of plaintiffs' claims" (ITP, Aug. 4, 2005, p1).

"In fact," the plaintiffs said later in the same filing, "the district court's preliminary injunction was based on the undisputed investigational new drug status of the vaccine, as established by the defendants' own documents."

Government attorneys argued in August the submission of the application "was not triggered by any regulatory action on the part of the FDA, nor could its filing by the manufacturer purport to speak on behalf of the FDA as to the scope of [the anthrax vaccine] license" (ITP, Sept. 1, 2005, p3).

Ky. Air Guardsmen Say Anthrax Vaccine Caused Ongoing Health Problems

Wave 3 TV, Louisville, KY
Online Reporter: Eric Flack
Online Producer: Michael Dever

There are serious accusations against the military, and they're coming from within ranks. Two Kentucky Air National Guardsmen claim a required vaccine has caused them major health problems. As WAVE 3 Investigator Eric Flack reports, this is not the first time the anthrax vaccine has been the center of controversy.

Kentucky Air National Guardsman Lucas Coffey used to dream of becoming a pilot. Now he just dreams of being healthy again.

On April 24, 2003, Coffey was sitting in his room at Ramstein Air Force Base, Germany, when according to medical records obtained by WAVE 3, he suffered what is known as a "Grand Mal" seizure.

"I remember about three seconds of it," Coffey said, "and my roommate saying, 'We need help, call 911! Call 911!"

The kind of seizure Coffey was having is considered the most serious kind. His bunkmates watched as Coffey shook violently, fearing he was gagging on his own tongue.

"Your head pulls to the right," Coffey recalled. "Your eyes roll behind you're head. You're biting, you're gripping so hard you pop your thumbs."

The seizure came just 12 days after Coffey received the anthrax vaccine in preparation for a possible deployment to Iraq. The military says the vaccine is safe -- and mandatory.

Col. Mark Kruas with the 123rd Airlift Wing said he has suffered no ill effects from the vaccine. "I know I take vaccinations like everybody else -- have for about 30 years. And I haven't had any difficulties myself."

But Coffey's seizure was just beginning. Less than two weeks after the first one, Coffey says he had another. That time, he felt twitching in his leg, and blacked out.

In medical notes, a military doctor called the seizures "an allergic reaction" and wondered if they were "related to the immunizations."

Coffey was put on anti-seizure medication and sent back to Louisville.

Now more than two years later, he says the seizures continue. "It's horrible. It's tremendously hard."

Coffey is now convinced the anthrax vaccinations caused his seizure disorder. He is not the only one to make that claim.

Aaron Haycraft, who was also a member of the Kentucky Air National Guard, suffered vision loss and paralysis after he got the vaccine in 2002.

In response to questions about the safety of the anthrax vaccine, a military spokesman sent us two Army studies which show no increased health risks for service members who were vaccinated.

In fact, the Air Force initially refused to give Aaron Haycraft medical discharge, saying there was no evidence linking his problems to the anthrax vaccine. But after a prolonged, public fight, the Air Force did an about face.

Haycraft received a medical discharge and a disability pension.

But Coffey has been denied disability by the Air Force, which ruled that he "had not produced any medical evidence" of a "chronic seizure disorder."

The evaluation board recommend Coffey be discharged, with only severance pay, which comes to just 10 percent of his base salary -- "$700 after taxes," Coffey said. "That's almost laughable."

Coffey has appealed, and recently sent the medical evaluation board a letter from a private neurologist in Louisville, who confirmed Coffey's ongoing seizures, and believes there is only a slim chance they will ever end.

And that leaves Coffey at a dead end, not knowing what to do, now that he can't do what he loves most.

"I think about it every day," Coffey said. "Every time I pass an airport, I think about it. It's so devastating, no doubt about it."

While a military spokesman said he could not specifically comment Coffey's case, he says the anthrax vaccine has been safely given to military personnel since the 1950s, and is still being administered routinely.

As for Coffey's appeal to be granted a medical discharge with full benefits, he's been awaiting a decision for months. We'll let you know how it turns out.

January 4, 2006

U.S. Receives Experimental Smallpox Vaccine

Global Security Newswire

British drug maker Acambis early last month completed delivery of 500,000 doses of an experimental smallpox vaccine to the U.S. National Institute of Allergy and Infectious Diseases (see GSN, Nov. 14, 2005).

Delivery of the vaccine, known as MVA3000, fulfills Acambis' end of a 2004 contract with the agency, according to a company press statement.

The vaccine was developed by Acambis and Baxter Healthcare SA, which produced the vaccines at its facilities.

"With the delivery of 500,000 doses of MVA3000 to the U.S. government, we have cleared the major hurdle of the NIAID's second contract for MVA vaccine," said Acambis CEO Gordon Cameron in the press release. "By achieving this milestone, the Acambis/Baxter team has once again demonstrated its ability to manufacture and deliver large quantities of critical biodefense smallpox vaccines. Our proven manufacturing capability for MVA3000 can only strengthen the proposal we submitted to the U.S. government for the manufacture of up to 20 million doses of MVA" (see GSN, Oct. 4; Acambis press release, Dec. 2).

January 3, 2006

Bioshield Story - Inside the Spore Wars

Time Magazine

Controversial contracts, bureaucratic bungling -- the Fed's biodefense drug program is a mess. How did it go so wrong?

Had you listened to President Bush on Jan. 28, 2003, you might think the U.S. would have a bustling biodefense industry by now. In a State of the Union speech laced with references to terrorism, Bush asked Congress for nearly $6 billion to fund Project BioShield, a program he said would "quickly make available effective vaccines and treatments against agents like anthrax, botulinum toxin, Ebola and plague." That sounded like a good idea, considering the havoc wrought by the anthrax mailings of 2001, which killed five people and set off a near panic for treatment. So Congress anted up. Eighteen months later, Bush signed BioShield into law. The measure set aside $5.6 billion for drug companies, offered the promise of a guaranteed and speedy contract--even an opportunity to sell the government novel treatments before they are fully approved by the Food and Drug Administration (FDA). The law, Bush promised, "will transform our ability to defend the nation."

Yet BioShield hasn't transformed much of anything besides expanding the federal bureaucracy. Most of the big pharmaceutical and biotech firms want nothing to do with developing biodefense drugs. The little companies that are vying for deals say they are being stymied by an opaque and glacially slow contracting process. The one big contract that has been awarded--for 75 million doses of a next-generation anthrax vaccine--is tangled in controversy; it went to a California firm, VaxGen, which in its 10-year history has never brought a drug to market. In the scientific community, biodefense is viewed as yet another boondoggle that is sucking money and resources from critical public-health needs like new antibiotics and vaccines. Indeed, the consensus outside the Administration is that the program is broken before it even gets off the ground. "BioShield has failed miserably," says Jerome Hauer, a former senior official with the Department of Health and Human Services (HHS). "The intent of BioShield was to attract new companies to get involved in developing countermeasures. It has not only failed to do that; it has kept a lot of other companies away because they're so concerned about the program's lack of focus and direction."

Administration officials say the criticism misses the many steps being taken to shore up the country's biodefenses. They point out that the U.S. has been stockpiling countermeasures, such as 300 million doses of smallpox vaccine. Since 2001 HHS has doled out $5.5 billion to state and local governments for bioterrorism emergency-response programs, and including BioShield, the government has spent about $18 billion on biodefense. "No matter how hard we try, some steps in the process cannot be rushed," said Stewart Simonson, assistant secretary for Public Health Emergency Preparedness, defending BioShield's slow start before Congress in July.

Proposals to fix BioShield have gained a new sense of urgency, however, as fears of another biological threat--avian flu--have mounted. China and Indonesia recently reported human fatalities from the disease, bringing the total number of deaths as of late December to 73, and the U.S. is now scrambling to stockpile medicines--such as the antiviral Tamiflu--to thwart a possible pandemic. Bush has asked Congress, as part of his $7.1 billion response plan, for a "crash program" to speed the development of new vaccine technologies, and Congress last month passed a defense bill that included $3.8 billion, mainly for flu vaccines and medicines.

To entice more drugmakers into biodefense, North Carolina Senator Richard Burr is sponsoring a bill that would establish a Biomedical Advanced Research and Development Agency (BARDA) headed by a biosecurity czar. (Estimated cost: $1 billion annually.) His bill would require the government to make gradual payments to drug companies based on R&D milestones, similar to the way defense contracting works, and would grant companies a 10-year period of market exclusivity for drugs designated as countermeasures. (Drug-patent terms typically vary depending on the date the application was filed and when the product is actually marketed.) More controversial, the bill would make it virtually impossible for individuals to sue for damages caused by any drug deemed a bioterrorism countermeasure, and BARDA would be exempt from the Freedom of Information Act, keeping its work largely veiled from public scrutiny. HHS Secretary Michael Leavitt has said new liability protections should apply only to vaccines and medicines for pandemic flu, which is likely to delay action on Burr's "BioShield 2" bill until next year.

Yet the market forces that have given us flu-drug shortages are also working against biodefense. With the industry's profits under pressure, none of the big firms are keen on diverting research from potential blockbusters to drugs for exotic germs like Ebola and plague, which may be stockpiled and used only in an emergency. Biodefense is "not attractive to Big Pharma, which is making money off things we use a few times a day," says Michael Greenberger, director of the Center for Health and Homeland Security at the University of Maryland. Companies are also leery of huge liability risks if biodefense vaccines and treatments are administered to wide swaths of the population. As for that $5.6 billion that is supposed to be allocated over 10 years? It's a pittance, given that the average cost of bringing a new drug to market is estimated to be $800 million, according to a 2001 study by the Tufts University Center for the Study of Drug Development. "There has to be a big bucket of gold at the end of the rainbow to get the big companies," Greenberger says.

While Big Pharma largely steers clear, dozens of small companies are working on biodefense products, though most of the drugs they're developing are years from being ready for clinical trials. And the government isn't exactly encouraging those firms to plod on--judging by the testimonials from companies now dealing with BioShield. Take the experience of PharmAthene, a tiny, private biotech company in Annapolis, Md., working on an antibody to treat anthrax. PharmAthene has spent $15 million taking the compound to its first clinical trial, but company officials still don't know if the government will stockpile it. CEO Dave Wright has been shuffled from the FDA to the Department of Homeland Security and HHS and still isn't certain what the drug must do to receive FDA approval. In a meeting with HHS officials last August, he wanted to know if he'd lose points on a contract if he were to manufacture the drug abroad, where production would be cheaper. Sorry, he was told, that couldn't be discussed because a contracting officer wasn't in the room. What about whether the feds would like it in a tablet or syringe? Sorry, couldn't tell you that either. Meanwhile, Wright is weighing whether to invest $8 million to scale up manufacturing. "And they want to know why no one wants this business?" he asks.

VaxGen managed to win a huge deal for a next-generation anthrax vaccine, only to find itself at the center of the controversy over BioShield. In November 2004 HHS awarded the firm a contract worth $877.5 million to deliver 75 million doses of anthrax vaccine manufactured via a new recombinant-DNA technique. Since then, however, VaxGen has faced a barrage of questions about its qualifications to develop and deliver the drug. Founded a decade ago as a spin-off of Genentech, VaxGen spent the late '90s trying to develop an AIDS vaccine and seemed close to success, only to report during Phase 3 trials that the drug had flopped, causing its stock to crash and lawsuits to fly. Investors charged the company with issuing false statements about the drug's prospects. (One suit was dismissed and VaxGen settled another for $500,000 in plaintiff's legal fees.) VaxGen's accounting hasn't inspired confidence either. Its shares were delisted from the NASDAQ in 2004, after the firm failed to file two quarterly financial reports. VaxGen is now revising financial statements to properly account for government contracts.

While VaxGen convinced HHS that it was the best company to develop a new vaccine, some members of Congress are not so sure. Iowa Senator Charles Grassley wrote to Secretary Leavitt in January and said HHS's decision to award such a huge contract to a single firm, with an unproven product, was "highly suspect." Two months later, he asked why HHS had issued a press release declaring that VaxGen's vaccine was "stronger and more effective" than the old vaccine, manufactured by a competitor named BioPort--a claim that, Grassley said, "appears to have no basis in fact." (Bioport cites a 2004 National Institutes of Health study, which, it says, indicates the superiority of its vaccine.) Grassley still doesn't have answers. "So far, the assurances given about our readiness for an anthrax attack don't add up," he told TIME. Indeed, VaxGen is now behind schedule in delivering its first batch of vaccine, promising it by the fourth quarter of 2006 instead of the first half of the year.

VaxGen CEO Lance Gordon vigorously defends his product. He says lab tests on rabbits and primates, conducted by the government since 2003, have found VaxGen's vaccine "highly effective" against inhaled anthrax. In September the company released results from a study conducted with the Battelle Memorial Institute and the National Institute of Allergy and Infectious Diseases (NIAID)--the "first ever," VaxGen said, to show that an anthrax vaccine worked post exposure. (The results have not yet been peer reviewed.) As for the delivery delay, Dr. Noreen Hynes, who oversees BioShield at HHS, describes it as a "hiccup" that's "de rigueur in product development." She says HHS didn't want to split the contract with other companies to achieve economies of scale, and she points out that VaxGen won the contract "in a full and open competition." In the meantime, HHS is adding 5 million doses of BioPort's vaccine to the Strategic National Stockpile at a cost of $122.7 million.

Beyond the anthrax-vaccine controversy, some scientists question the government's "one bug, one drug" scientific approach to biodefense. Developing a new smallpox vaccine for a strain found in nature may sound reasonable, but what about bioengineered strains produced at old Soviet labs, say, which may be floating around on the black market? There's no guarantee that those germs will respond to drugs tailored to other strains. Dr. Steven Projan, vice president of biological technologies for the pharmaceutical firm Wyeth, argues that it would make more sense for the government to stockpile and invest in broad-spectrum antibiotics, antivirals and new vaccine technologies that could be applied to biodefense. He and other scientists are also concerned that the FDA's approval standard for biodefense drugs, which is lower than that for commercial medicines, could lead to unforeseen, perhaps dangerous side effects in humans. Companies aren't required to conduct human clinical trials to show that a biodefense drug is effective; they only have to demonstrate that the drug works in animals and is safe in humans (since infecting people with a disease like anthrax to test a medicine is obviously unethical).

Public-health experts are also worried that money is flowing into terrorism-related medicine at the expense of more basic needs like hospital beds and respirators, which may be just as critical to saving lives in a crisis. And they are concerned that the government's obsession with biodefense is distracting from research into infectious diseases. Last March, 758 microbiologists signed a petition to the NIAID, complaining about the "massive influx of funding" for bioterrorism agents like anthrax, tularemia and plague. The institute now spends nearly $1.7 billion on biodefense--up from just $42 million in 2001--out of a $4.3 billion budget (although the biodefense funding hasn't detracted from other research, according to the agency). Meanwhile, hardly any new antibiotics have been approved by the FDA in recent years, despite the fact that scientists have grown more concerned about antibiotic-resistant bacteria. "The big challenge is how we deal with epidemic infectious diseases, not anthrax," says Dr. David Ozonoff, a professor at Boston University's School of Public Health.

In fact, the government has so far spent very little on new biodefense drugs, thanks in part to the long and torturous contracting process. Under BioShield, HHS has paid $5.7 million to buy black raspberry--flavored liquid potassium iodide, a child's version of a pill intended to protect against radioactive iodide in a dirty bomb. The agency is also spending $2.2 million on experimental anthrax treatments (although that money is not coming from the BioShield fund), and a contract for a new smallpox vaccine is expected in 2006. But more than a year into the program, drug companies still complain that they don't have a clear sense of what to develop and how much the feds will buy. Although HHS has formally identified four threats--anthrax, smallpox, botulinum toxin, and radiological and nuclear devices--that's only the first step. Requests for treatments must then be issued, competing drug proposals have to be evaluated, and the White House's Office of Management and Budget has to sign off on each contract.

Overall, it's a cumbersome process that can leave companies with promising treatments in limbo for years. "You wouldn't expect a defense contractor to build an aircraft carrier without a contract, but they're expecting pharmaceutical companies to develop these drugs without contracts," says Richard Hollis, CEO of Hollis-Eden, a San Diego biotech hoping to sell the government a treatment for acute radiation syndrome (a blood sickness caused by a dirty bomb or nuclear explosion). Hollis says his company has spent $100 million on the drug, Neumeune, betting the feds would stockpile doses for 12 million to 24 million people. As it turns out, the government intends to buy only 100,000 treatments for now, including alternatives to Neumeune. "If two years ago HHS had said we're looking for 100,000 sources of treatment, I don't think we'd have developed the product," says Hollis. An HHS official says Hollis-Eden's projections were at odds with the nuclear-threat scenario envisioned by the Department of Homeland Security. He also acknowledges that government health officials aren't accustomed to dealing with national- security issues. "It's new to have the medical side of the house working with the intel side," he says. "We're kind of learning as we go." Biodefense companies are also learning that national security can be a messy business.