June 30, 2005

Pediatricians ponder anthrax vaccine tests

Knight Ridder Newspapers

WASHINGTON - The government’s effort to develop a new vaccine against anthrax has raised red flags among critics over plans to eventually test an experimental version on children.

Robert Bock, a spokesman for the National Institute of Child Health and Human Development, said the new anthrax vaccine would not be tested on 100 first- and second-graders until it is first tested safely on adults. That is under way now, he said.

"If that study is successful, there will probably be a protocol to test the anthrax vaccine in children," Bock said.

While federal rules govern how children can be used in medical research, Barbara Loe Fisher, president of the National Vaccine Information Center, said the threat of anthrax exposure was too remote to subject children to a possibly dangerous substance.

"There is almost no risk to these children of being exposed to a form of ... anthrax that has been weaponized" so it can be inhaled, said Fisher, whose not-for-profit group has been pushing for vaccine safety since the 1980s.

"The benefits are zero, and risk is quite high," she said.

Several pediatricians involved in bioterrorism issues, however, said that given the potential threat, it would be irresponsible not to include children in the test.

"Considering that in a worst-case scenario, this vaccine would have to be used in an emergency over a very short period of time, we would be in a bad position medically and ethically if it were not tested beforehand," said Stanley Plotkin, emeritus professor of pediatrics at the University of Pennsylvania.

Plotkin was a consultant on a 2002 study that declared the current anthrax vaccine to be "effective" and "acceptably safe."

But government researchers at the National Institutes of Health now are trying to find a better vaccine.

There are concerns the current vaccine, which has been in use for several decades, causes too many side effects. They range from simple headaches and muscle pains to more serious and complex ailments such as heart problems, arthritis, multiple sclerosis, hypertension, diabetes and blood clots.

The current vaccine is given in a series of six doses over 18 months, with annual boosters. More than 1.3 million military and civilian personnel have taken it.

Made by the BioPort Corp. of Lansing, Mich., the vaccine has been approved only for anthrax exposure through the skin, not through inhalation, the way it would be disseminated on a battlefield or in a public place.

June 27, 2005

Troops who refused to take anthrax shots in legal limbo

Military court may look to decision in civilian case
By Deborah Funk, Times staff writer

Ocean T. Rose worked as a firefighter in the Marine Corps until he was court-martialed in 2001 and sentenced to a bad conduct discharge for refusing anthrax vaccination. But he’s technically still in the Marines while he appeals his conviction — and thus can’t get a civilian firefighting job.

“Since I’m still an active-duty member, I can’t be hired by any city, state or federal fire departments,” Rose, 25, said in an interview, adding that one local fire department told him: “We can’t touch you.”

As U.S. troops prepare to decide whether they will voluntarily accept an anthrax shot, Rose is one of a number of service members who were court-martialed for refusing the shots under the old mandatory program and whose cases are still in limbo.

The total number is unclear, but the cases of about a half-dozen Marines and sailors are at the Navy-Marine Corps Court of Criminal Appeals awaiting a final ruling. And at least six more cases, including one Army case, are on appeal to the military’s highest court, the Court of Appeals for the Armed Forces.

These service members are on appellate leave while their cases wind their way through the appeals process. They technically are on active duty but are not paid and do not perform military duties, and their final discharges are pending.

Officially, the troops were court-martialed for disobeying a lawful order. Ultimately, the final disposition of their cases may rest on whether that order was, in fact, lawful — the very issue at the heart of the case now in federal court that led to the shutdown of the mandatory anthrax vaccine program last fall.

Six service members and civilian defense employees successfully sued the government to stop the mandatory anthrax shots when the judge ruled that the vaccine was not licensed to protect against inhalation anthrax, the type the Defense Department said is a germ warfare threat.

The Defense Department has appealed that civil case to the U.S. Court of Appeals for the District of Columbia in an effort to reinstate the mandatory vaccination program.

The Court of Appeals for the Armed Forces is considering whether to wait for the outcome of that civilian case before hearing an appeal by a soldier who was convicted of disobeying an order to submit to anthrax shots.

“It does seem to me that the dust has got to settle in the civilian litigation before the military courts can know what to do,” said military law expert Eugene Fidell, president of the National Institute of Military Justice. “It doesn’t make a lot of sense to have the same underlying issue litigated in two different court systems.”

The Navy-Marine Corps Court of Criminal Appeals recently upheld that the order to take anthrax shots was legal because the 1998 instruction from the secretary of the Navy that was in effect at the time said the vaccine was approved by the Food and Drug Administration and did not require consent to be administered.

Rose’s case is among those that have recently been appealed to the Court of Appeals for the Armed Forces in hopes of overturning his conviction.

Although Rose, who lives near Atlanta, receives health care benefits under Tricare, his appellate leave status makes him unattractive to some employers because companies don’t want to invest the resources in someone who may be recalled to put on a uniform, he said.

“As far as getting a job, a lot of people look at it in a negative light,” Rose said.

He works for a private company selling office supplies, but the training for that job is not as costly to an employer as training for a fire department job would be.

“I’m not making a whole lot of money — enough to get by,” he said.

Rose’s saga has dragged on for more than four years.

He joined the Marine Corps in January 1999. While based at Marine Corps Air Station Miramar, Calif., he received two anthrax shots in 2000, which he said were given to him nearly a month apart instead of two weeks as required by the vaccine label.

He experienced large lumps on his arm after the first two shots, along with flu-like symptoms and an irregular electrocardiogram. Moreover, research he did on his own convinced him the military was not following the shot course required by the vaccine’s label and that the vaccine was not licensed to protect against inhalation anthrax.

He refused to take his third shot and, after declining non-judicial punishment, was convicted at court-martial in January 2001 for disobeying a direct order. A lance corporal at the time, he was reduced to the paygrade of E-1, fined all pay at lance corporal rank and was to receive a bad-conduct discharge, which is still pending.

Rose said his refusal of anthrax vaccination was the only thing he’d ever done to land him in trouble in the Marine Corps.

“I want this to be dismissed,” he said. “I want my honorable discharge.”

Plans to test anthrax shot on children questioned - Safety of vaccine first must be proven on adults

KC Star
By DAVID GOLDSTEIN, The Star's Washington Correspondent

WASHINGTON — The government’s effort to develop a new vaccine against anthrax has raised red flags among critics over plans to eventually test an experimental version on children.

Robert Bock, a spokesman for the National Institute of Child Health and Human Development, said the new anthrax vaccine would not be tested on 100 first- and second-graders until it is first tested safely on adults. That is under way now, he said.

“If that study is successful, there will probably be a protocol to test the anthrax vaccine in children,” Bock said.

While federal rules govern how children can be used in medical research, Barbara Loe Fisher, president of the National Vaccine Information Center, said the threat of anthrax exposure was too remote to subject children to a possibly dangerous substance.

“There is almost no risk to these children of being exposed to a form of … anthrax that has been weaponized” so it can be inhaled, said Fisher, whose nonprofit group has been pushing for vaccine safety since the 1980s. “The benefits are zero and risk is quite high.”

Several pediatricians involved in bioterrorism issues, however, said that given the potential threat, it would be irresponsible not to include children in the test.

“Considering that in a worst-case scenario, this vaccine would have to be used in an emergency over a very short period of time, we would be in a bad position medically and ethically if it were not tested beforehand,” said Stanley Plotkin, emeritus professor of pediatrics at the University of Pennsylvania.

Plotkin was a consultant on a 2002 study that declared the current anthrax vaccine to be “effective” and “acceptably safe.”

But government researchers at the National Institutes of Health now are trying to find a better vaccine. There are ideas the current vaccine, which has been in use for several decades, causes too many side effects.

They range from simple headaches and muscle pains, to more serious and complex ailments, such as heart problems, arthritis, multiple sclerosis, hypertension, diabetes and blood clots.

For decades, the current vaccine was largely given only to people who worked in the livestock industry, where most exposures occur. But in 1991, it was issued to some troops during the first Gulf War because of fears Saddam Hussein had biological weapons.

By 1997, the military was concerned enough about the spread of such weapons that it made anthrax inoculations mandatory for all troops. Developing a national vaccine program to protect the public became a priority after the Sept. 11, 2001, terrorist attacks when five persons died from anthrax-tainted letters and 13 others were infected. The sender has never been identified.

The current vaccine is given in a series of six doses over 18 months, with annual boosters. More than 1.3 million military and civilian personnel have taken it.

Made by the BioPort Corp. of Lansing, Mich., the vaccine has been approved only for anthrax exposure through the skin, not through inhalation, the way it would be disseminated on a battlefield or in a public place.

But numerous soldiers who have taken it under military orders have reported severe side effects.

In response to a lawsuit by six anonymous service members challenging the mandatory vaccinations, a federal judge stopped the program last fall because he said federal regulators had not properly followed rules to declare it safe.

Secretary of Defense Donald Rumsfeld called the vaccine “safe and effective” following the ruling. The program has been reauthorized, however, on a voluntary basis, under provisions of the Project Bioshield Act, which permits emergency use of unapproved vaccines.

In the new vaccine tests, 350 adults are randomly being given either the experimental vaccine or the BioPort vaccine to compare their effects.

“No children have been given a licensed or experimental vaccine in the trial,” according to a statement from the National Institute of Child Health and Human Development, the division of NIH that is conducting the trial. “Studies in children will not begin until the safety of the new vaccine has been demonstrated in adults.”

Meryl Nass, a Maine internist who has treated numerous soldiers who’ve experienced medical problems after taking the BioPort vaccine, said one of the primary ingredients in the experimental vaccine — the protective antigen — is a known toxin.

“There is no good reason to expect that (the experimental) vaccine will be any safer than the older one,” she said.

BioPort spokeswoman Kim Brennen Root said the company was unaware that its vaccine was being used in a new NIH trial and could not comment.

Steve Robinson, executive director of the National Gulf War Resource Center, which helps former soldiers with service-related health problems, said, “Anybody who gets involved is taking a huge gamble that maybe their children might become harmed.”

When the NIH conducts a clinical trial, it generally advertises for participants and asks for referrals from physicians.

Under federal rules governing medical research and children, the research must not present more than a “minimal risk.”

If the risk is greater, the rules generally require that the research either directly benefit the children involved, or that it “further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children.”

The rules also require that parents or guardians must be fully informed of the risks and benefits, and must give their informed consent before their children can participate.

“As long as effective safeguards are in place and families and the children understand the risk, I think that this is the right thing to do,” said Julia McMillan, a member of the American Academy of Pediatrics Committee on Infectious Diseases and professor of pediatrics at Johns Hopkins University.

Reactions to testing on children

■ From a critic: “There is almost no risk to these children of being exposed to a form of … anthrax that has been weaponized.… The benefits are zero and risk is quite high.”

■ From a proponent: “Considering that in a worst-case scenario, this vaccine would have to be used in an emergency over a very short period of time, we would be in a bad position medically and ethically if it were not tested beforehand.”

June 23, 2005

Critics Blast Anthrax Vaccine Test - National Institutes Of Health Officials Plan Trial On 100 Children

By THOMAS D. WILLIAMS, Courant Staff Writer

The National Institutes of Health is under fire from critics over a plan to test two anthrax vaccines on children.

The trial will test and compare the reactions in humans to the vaccine manufactured by BioPort Corp. of Lansing, Mich., and another being developed by NIH. Bob Bock, an NIH spokesman, said the trial planned for 100 children in first and second grade will not occur until the vaccines are fully tested on 350 adults and shown to be safe for them.

"The results in this study," says an NIH announcement, "will help in the development of improved vaccines for anthrax." The NIH and U.S. Health and Human Services Department are calling for development of the vaccine to protect civilians from terrorist or other attacks.

Critics, however, are appalled.

"This vaccine is totally inappropriate for children, because the [exposure] threat is so remote," said Barbara Loe Fisher, president of the National Vaccine Information Center. "They will likely never be exposed to anthrax either through contamination by animal products or inhalation of weaponized anthrax."

"Children are involved in trials of vaccines that benefit children," she said, "but this vaccine will not do so." Fisher said based on the NIH announcement of "rare severe reactions" to BioPort's vaccine, she fears the parents of children used in the experiments will not be given proper warnings of the vaccine's potential for adverse reactions.

However, Bock said adults and parents or guardians of the children will be given complete information on the two vaccines and their benefits and risks.

"I don't understand how they can do efficacy tests with children at the same time that we are discovering more and more U.S. soldiers who have been harmed by the vaccine," said Steve Robinson, executive director of the National Gulf War Resource Center for service members and veterans. "[NIH officials] want parents to want their children to be vaccinated against the anthrax terrorist attacks that have not happened."

But Bock said that if terrorist attacks occur, both children and adults would be at risk.

BioPort's vaccine, used almost exclusively on soldiers, has already demonstrated an adverse reaction rate 100 times the figure initially stated on the label. Adverse reactions include immune disorders, muscle and joint pain, headaches, rashes, fatigue, nausea, diarrhea, chills and fever. At least half a dozen deaths and a number of birth defects have been attributed to its use.

BioPort officials did not respond to repeated messages seeking comment Wednesday.

Retired Air Force Col. John Richardson, who has independently researched the vaccine extensively, said that in 2003, there were 16,869 federal adverse reaction reports for all vaccines and of those, 1,068 were for the anthrax vaccine. The anthrax vaccine drew more than 6 percent of all vaccine complaints, said Richardson, even though anthrax vaccinations represented less than 1 percent of an estimated 100 million immunizations of all types administered that year.

For last year, he said, there were 15,488 federal adverse reaction reports for all vaccines, and 806 for anthrax, or 5.2 percent of the total.

Complaints to the reporting system - which even federal officials acknowledge typically represent as few as 10 percent of all adverse reactions to vaccines - can be filed by vaccine users, doctors and medical personnel.

The vaccine, aimed at protecting soldiers against anthrax spores fired into the air in combat, has been under attack by service members and their advocates ever since the Pentagon mandated its use in 1998. Aside from the anthrax spore attacks aimed at government officials 3½ years ago, no such attacks are known to have been used during modern warfare or by terrorists.

June 17, 2005

U.S. Health and Human Services Retracts Statement on New Anthrax Vaccine after Inquiry by Senator

By David Francis
Global Security Newswire

WASHINGTON — An inquiry from a U.S. senator prompted the Health and Human Services Department last month to retract a statement about the advantages of a new anthrax vaccine being developed to replace the existing licensed vaccine (see GSN, May 6).

Senate Finance Committee Chairman Charles Grassley (R-Iowa), in a series of letters obtained by Global Security Newswire, questioned whether a statement in a March 2004 press release about VaxGen’s recombinant anthrax vaccine was true. The HHS press release said the treatment, being developed under a Project Bioshield contract, “has already been shown to be stronger and more effective than the vaccine being used today.”

Assistant Secretary for Public Health Preparedness Stewart Simonson wrote in a May 4 response to Grassley that the department’s claim that the new vaccine is more effective than BioPort’s licensed treatment had been removed from the agency’s Web site.

“The statement in question was based on preliminary test data,” said department spokesman Marc Wolfson. “It was decided that the statement was premature and could be misleading. So in response to Senator Grassley’s request [the Health and Human Services Department] decided to remove the release from its Web site.”

Grassley sent a letter to Secretary Michael Leavitt in January, expressing concerns that the country was inadequately prepared for an anthrax attack.

After meeting with agency officials, Grassley followed up with a second letter in April asking why additional doses of the licensed anthrax vaccine had not been added to the Strategic National Stockpile and whether the statement in the press release was misleading.

Simonson admitted in the May 4 letter to Grassley that the press release touting VaxGen’s vaccine as more effective than the licensed vaccine was unsupported by current science.

Department officials believe the new vaccine will prove superior to BioPort’s vaccine because the recombinant DNA technology used to produce the drug is expected to result in more consistent immunity from batch to batch. It would be administered in a three-shot cycle, as opposed to BioPort’s vaccine, which requires six shots. In addition, BioPort’s vaccine is manufactured using a decades-old process, and questions have been raised by Defense Department personnel about the vaccine’s safety and effectiveness (see GSN, May 6).

In his letter, Simonson also noted that the department was adding 1.5 million doses of the licensed vaccine to the stockpile by the end of this month, with an additional 6 million doses to be added in fall 2006.

Unsatisfied with the agency’s response, Grassley sent a letter May 5 asking why it has taken so long after the 2001 anthrax attacks to procure licensed vaccine for the stockpile.

In a May 13 response, Simonson attributed contractual difficulties between the Health and Human Services Department, the Defense Department and vaccine manufacturer BioPort, for the delay.

“The transfer of 5 million doses of AVA from DoD to HHS was delayed and eventually abandoned because of issues connected with the passage of the Homeland Security Act and the Project Bioshield Act as well as the usual problem inherent in negotiating a complex interagency agreement (e.g. pricing, indemnification, etc),” Simonson wrote. “In the end, it was clear that a direct contractual relationship between HHS and BioPort was preferable to the interagency process.”

Grassley does not plan to send additional letters or schedule hearing on the vaccine issues, said spokeswoman Jill Kozeny.

“Senator Grassley will continue to monitor the situation but no hearings or additional letters of inquiry are planned right now,” Kozeny wrote in an e-mail.

VaxGen is scheduled to deliver the first 25 million doses of the new vaccine in 2006. The remaining 50 million doses would be delivered by 2009. The product is not scheduled for Food and Drug Administration licensure review until 2007 (see GSN, Nov. 5, 2004).

Lance Ignon, VaxGen’s vice president of corporate affairs, said during a June 6 webcast that congressional questions about the vaccine are to be expected and would not delay licensure.

“We’re happy and have been happy to speak with any number of legislatures to bring them up-to-speed on this because while we’ve been intimately familiar with the workings of this program now for quite a few years, many in Washington have not. The award of the contract in November was sort of the first [time] they really started thinking about how Project Bioshield works,” Ignon said.

Meanwhile, two key House panels are planning hearings this summer on the country’s preparedness for a biological attack.

House Democratic sources said the House Homeland Security Subcommittee on Emergency Preparedness, Science and Technology is planning a hearing on Bioshield tentatively scheduled for the end of June.

A majority spokeswoman refused to confirm whether the hearing would occur, saying nothing has been officially placed on the calendar.

However, Democratic sources said ranking Homeland Security Committee Democrat Bennie Thompson (Miss.) is concerned that the contract with VaxGen for an unapproved vaccine detracts from preparedness. Thompson sent nearly identical letters to Homeland Security Secretary Michael Chertoff and Leavitt in May outlining his concerns.

“The new type of anthrax vaccine under development in Project Bioshield has some unique benefits, but is offered by only one manufacturer and is not yet approved by the Food and Drug Administration,” Thompson wrote. “I know Project Bioshield’s purpose is to develop vaccines from an experimental stage, and I support effort to develop new anthrax vaccines such as those offered buy this unique technology. However, I am concerned about the possibility that if this new technology is not ultimately successful, or does not receive FDA approval, the [Strategic National Stockpile] may be left without an adequate supply of anthrax vaccine in the case of an emergency.”

Thompson asks for details on efforts to secure additional vaccines and for progress on the development of the new anthrax vaccine. He has not received a response yet, and plans to address these issues at the upcoming hearing, according to the Democratic sources.

The House Government Reform Committee is also planning a Bioshield hearing in July, according to a Republican committee source. The committee plans to invite industry representatives and government officials to testify, the source said.

According to the source, Representative Chris Shays (R-Conn.) plans to ask questions about the use of Bioshield’s emergency use authorization authority. This power allows the Health and Human Services Department at the request of the Pentagon to approve the use of unlicensed countermeasures.

The authority has been granted once, when the Food and Drug Administration last year approved BioPort’s anthrax vaccine to combat inhalation anthrax, an approved indication. The move prompted a series of letters from Shays to Leavitt and Central Intelligence Agency chief Porter Goss, questioning the legality of the request and whether the application of this power was intended under Bioshield (see GSN, Dec. 17, 2004).

“Congressman Shays is going to make a point to talk about that,” the source said.

The Senate Health, Education, Labor and Pensions Committee’s bioterrorism preparedness subcommittee is in the middle of a series of hearings to review a bill introduced by Republican leadership and another by Senators Joe Lieberman (D-Conn.), Orrin Hatch (R-Utah) and Sam Brownback (R-Kan.). Both pieces of legislation would provide incentives, such as liability shields and patent exclusivity, to encourage big drug makers to enter the vaccine market.

Senator Richard Burr (R-N.C.), subcommittee chairman, plans to review the bills and has pledged to consider both before combining them into a single piece of legislation.

June 16, 2005

More than 1,200 who had anthrax vaccine now sick

By Jeff Donaldson

More than 1,200 military personnel who received the anthrax vaccine before going to Iraq have developed serious illnesses, according to an Army report released last month, though local military officials contend the shots still are safe and necessary.

Since 1991 and the first Gulf War, the Defense Department has required service members to be immunized against such childhood diseases as Typhoid and Hepatitis A as well as against biological agents such as anthrax, when deploying to Korea or the Middle East.

But with Army officials reporting 1,200 illnesses and several thousand more queries about potential side effects, the Defense Department has started allowing troops deploying overseas to opt out of receiving the anthrax vaccine without penalty, according to the Army and Air Force.

Maj. Brian Blalock, public health flight commander at Nellis Air Force Base, said the anthrax shot is no longer mandatory for service members who are willing to sign a waiver releasing the military from liability. Still, the majority of service members elect to have the shot, he said.

"We've really not seen a big problem with anthrax -- nothing outside of the normal range of side effects," Blalock said.

Roughly 30 percent of men, and 60 percent of women, who receive the anthrax vaccine have some sort of minor reaction, such as swelling or a small lump at the injection spot, Blalock said.

But the illnesses reported by the Army have been more severe. Initial symptoms of the reported cases included minor diarrhea, cramping and fever to more intense problems like sleep and memory loss, chronic fatigue, headaches and chest pains.

Local numbers for service members affected are not available.

The national cases have been handled by the Vaccine Healthcare Centers, which are located at several U.S. military bases, but are overseen by the vaccination program at Walter Reed Army Medical Center in Washington D.C.

Despite the illnesses, Walter Reed officials contend that more than 1.3 million military and civilian personnel have received the vaccine since 1998 when the military began requiring members to receive a series of six shots to guard them against the anthrax virus.

The hospital contends anthrax vaccinations are safe and more necessary than ever, especially considering the threat of anthrax contamination that hit several post offices and office buildings following Sept. 11.

"We're living in a completely different era. There are terrorists who are intent on using biological agents and there are countries that certainly have the capability," Blalock said.

The military shut down the anthrax vaccination program temporarily prior to 1998 citing concerns about outdated versions of the shot. The necessity of the shot has been a hot point of debate in Washington and among soldiers' advocacy groups that contend illnesses from the vaccine have put some members out of the service.

Medical officials hope that educating service members about the benefits of getting the shots will encourage "across the board" compliance. They contend there is insufficient information to quantify the seriousness of illnesses resulting from the anthrax vaccine.

The Nevada National Guard, which routinely deploys members to Iraq and Afghanistan to fight the global war on terror, still requires the anthrax shot for soldiers and airmen going there or to Korea.

Spokeswoman Lt. April Conway said there have been no reported cases of adverse reactions to the shots among Guard members, but there have been some members who refused to have the vaccine.

"A couple years ago we had a few people who asked not to do it," Conway said. "Their positions were filled by volunteers who were willing."

Though military budget concerns may force the closure of the Vaccine Healthcare Centers which oversees assessment and treatment of anthrax-based problems, Congress and the Food and Drug Administration have approved an emergency use authorization to fund more of the anthrax vaccine.

Citing a renewed threat of anthrax poisoning to U.S. forces overseas, the Pentagon announced last month it would resume providing mass anthrax vaccinations for service members deploying to Korea or Southwest Asia.

While the debate about the seriousness of anthrax-related illnesses is likely to get bogged down in the same discussion over such war-related illnesses as Gulf War Syndrome, Blalock is among those who believe the benefits far outweigh the cost.

"There are a lot of diseases out there -- very lethal, very deadly," Blalock said. "It really comes down to people making the best choice."

June 13, 2005

Fleishman-Hillard exec joins Emergent's board

Neil Adler, Staff Reporter

Emergent BioSolutions has named a former assistant secretary at the U.S. Department of Health and Human Services to its board of directors. The new board member, Jerry Hauer, is a senior vice president with D.C.-based Fleishman-Hillard Government Relations. He previously served as acting assistant secretary for HHS' Office of Public and Emergency Preparedness.

Hauer joins six other directors on the board of Gaithersburg-based Emergent BioSolutions, the parent company to vaccine maker BioPort of Lansing, Mich., and the former Antex Biologics of Gaithersburg.

Emergent BioSolutions was created in 2004 as the parent company to BioPort, which decided to take a 200,000-square-foot manufacturing facility in Frederick last year after scouting spaces in Maryland, Virginia and Michigan for more than a year. BioPort makes anthrax vaccine and recently received a $122.7 million contract from the government to deliver 5 million doses.

"Emergent BioSolutions is poised to become a leader in the vaccine industry, in both the biodefense and commercial sectors," Hauer says. He has also served as director of the Response to Emergencies and Disasters Institute at George Washington University's School of Public Health, and as director of the New York City Mayor's Office of Emergency Management under former Mayor Rudy Giuliani.

"Jerry's distinguished career in the field of emergency preparedness at all levels of government makes him an invaluable addition to our board," says Fuad El-Hibri, chairman and CEO of Emergent BioSolutions.

June 9, 2005

U.S. Armed Services Outline Implementation of Voluntary Anthrax Vaccinations Programs

By David Francis
Global Security Newswire

WASHINGTON — The attorney representing six anonymous Defense Department employees in a suit that stopped a U.S. Defense Department’s mandatory anthrax vaccination program is praising implementation plans outlined by the Armed Services last month for a voluntary inoculation program (see GSN, May 23).

However, John Michels, counsel for the Pentagon employees who requested and received an injunction against the mandatory program last October, questioned why the guidance does not require soldiers to give consent to receive the actual vaccination. Instead, under the new practice, vaccine candidates are asked to acknowledge that they have received a brochure outlining the risks associated with the vaccine.

“They don’t actually have the guys signing for consent,” Michels said. “They have to sign, ‘Yes, I’ve gotten the brochure,’ but they don’t give consent to be vaccinated. I don’t understand why.”

“Why not say I certified that I received the brochure and I consent to be vaccinated?” Michels asked.

Calls to the Pentagon for clarification on consent were referred to the individual branches of the Armed Services. Calls to the branches were not returned at press time.

Despite his confusion over consent, Michels is pleased with the implementation plans. He said many of the requirements for vaccinations, allowed under emergency use authority granted to the Pentagon by the Food and Drug Administration, mirror what he has been asking the Pentagon for since the original suit was filed.

“This looks an awful lot like what we asked for,” Michels said. “We’re surprised they’re going through all this trouble.” Michels believes the Pentagon is taking special care to ensure no legal challenges to the emergency use authority.

The EUA, which allows for voluntary inoculations, took effect at the beginning of May and expires at the end of June. It can be extended by the Food and Drug Administration. Throughout May, military branches gave instructions to commanders on how to implement the voluntary program.

The Pentagon has appealed the original ruling that stopped the program in hopes of resuming mandatory vaccinations.

Program Implementation

The requirements outlined in actions plans for the Army, Navy, Air Force and Marines are generally similar. Vaccinations are limited to troops deployed in Central Command theaters, such as Iraq and Afghanistan, and in Korea. Soldiers must be informed that a federal court stopped the mandatory program and that all vaccinations are voluntary, and superior officers cannot pressure anyone to take the vaccine.

All wishing to receive the vaccine must be briefed on the risks and benefits of the vaccines by their commanders, and must acknowledge receipt of the brochure explaining these risks. The Air Force requires a soldier sign the brochure, while the Army, Marines and Navy only require a roster be kept of who received the information.

All data on immunization will be entered into the soldier’s medical file and tracked electronically using the system of each respective branch. Refusals will also be tracked. Reports of adverse events associated with the vaccine will be tracked in the Vaccine Adverse Events Reporting System.

If a soldier is transferred outside of Central Command or Korea, the regimen of vaccination shots does not have to continue.

The Coast Guard’s plan is much more limited, only allowing vaccinations of personnel in specific areas determined by the Pentagon.

Vaccinations cannot begin until the Military Vaccine Agency certifies that the brochures explaining risks are received by the individual branches.

Michels said these requirements ensure soldiers are well-informed before taking the vaccine, and know they have the option to refuse.

“This is starting to look more and more like the practice of medicine,” he said.

June 6, 2005

Spore Wars

Elizabeth MacDonald Robert Langreth

The anthrax attacks of 2001 were brutal and deadly. The next attack could be even worse. Are we prepared? The short-lived anthrax attacks that started a week after Sept. 11 are still shrouded in mystery. Innocuous white envelopes arrived by mail at big media companies and Capitol Hill. Twenty-two people were sickened and five died. "This is next," the letter-writer warned. To date no one has been charged.

The next attack could be far more horrific. Two hundred and twenty pounds of aerosolized anthrax spores sprayed from a nondescript truck in any U.S. city would wipe out anywhere from 130,000 to 3 million people, the equivalent of a hydrogen bomb. The scenario is considered one of the gravest bioterror threats to the U.S. Victims would be utterly clueless. Anthrax is odorless and tasteless and produces early symptoms that can dupe people into thinking they have the common flu. The inhaled version is usually fatal. But a vaccine, given postexposure in combination with antibiotics, could arrest it.

In 2004 the federal government allocated $5.6 billion to Project BioShield, an effort to boost the country's defenses against biological, chemical and nuclear threats. Nearly $1 billion was committed to stockpiling 75 million shots of anthrax vaccine, enough to inoculate 25 million and, hopefully, deter a terrorist biostrike.

Yet a year after BioShield and four years after the envelope attacks, the civilian stockpile is negligible. Instead we have a national security effort pinned mainly on a biotech firm with a checkered past pursuing an unproven vaccine technology on an extraordinarily tight deadline. Now that firm's rival, the sole current supplier of anthrax vaccine, a product that itself has been tarred as a serious health risk, has launched an intense lobbying effort to undermine its competitor's contract, accusing it of cozy ties with federal agencies.

Congress is threatening to hold hearings on the award. "It is unclear how quickly this new vaccine could be manufactured. I am especially concerned about potential delays," wrote Representative Bennie G. Thompson (D-Miss.) in a May letter to the Department of Homeland Security. Senate Finance Chairman Charles Grassley (R-Iowa) has fired off two letters to Health & Human Services demanding answers, noting he's "greatly concerned" that the government is "not prepared to protect the American people from an anthrax attack." Stewart Simonson, an assistant secretary at HHS, recently admitted to Congress that he remains unsure about the BioShield award process. "We're learning as we go," he said.

VaxGen, a little-known biotech firm in Brisbane, Calif., won the $878 million award, one of the largest government vaccine contracts ever, to make the 75 million anthrax vaccine doses. In October 2003 VaxGen was granted a license to use a bioengineered anthrax vaccine technology developed by the U.S. Army Medical Research Institute for Infectious Diseases at Fort Detrick, Md. The vaccine produced by this technology,
using genetically manipulated anthrax cells, is thought to be purer than traditional vaccines cultured in vats of souplike brews and laboriously filtered.

By the Numbers

Supplying the Stockpile

The U.S. is counting on two biotechs for a vaccine.


VaxGen, rpa102; Cost per dose: $11.70; Regimen: 3 doses; How it's made: Genetically; Doses Available: None yet.

BioPort, Biothrax, Cost per dose: $25.00 on average; Regimen: 6 doses over 18 months; How it's made: Cultured in Organic Soup; Doses Availabe: 5 Million.

BioPort is working to reduce that regimen. ²To be delivered to the government over the next 18 months. Source: Companies.

"BioShield was always designed to bring in new products," says Dr. Philip Russell, a former chief of U.S. Army medical research who advised HHS on its biodefense plans. "It was not a piggy bank to buy licensed products."

But VaxGen won't see a nickel of that money until it delivers a working vaccine. VaxGen has never made a licensed vaccine and is known mainly for a failed AIDS vaccine. Its accounting has been such a mess that Nasdaq delisted it in 2004 for not filing timely financial reports. VaxGen needs more cash to deliver its first batch of 25 million doses by 2006, as required by contract. "We're not going to let anyone down," says Lance Gordon, its chief executive.

Watching anxiously from the sidelines is VaxGen's rival, BioPort, a Lansing, Mich. company that has up to now been the government's sole anthrax vaccine supplier. The company has run into serious criticism over the quality of its vaccine, BioThrax, made using a 40-year-old process. Some 450 military personnel have refused to take it, to the point of being court-martialed or jailed. Soldiers have sued BioPort and the government to stop a mandatory anthrax vaccination program for the military, alleging BioPort's vaccine made them sick, caused birth defects, even killed some of them. Nevertheless, in May the government ordered 5 million emergency doses of BioThrax for civilians. The company and the Pentagon insist it's safe.

BioPort was stunned that VaxGen won the big award. If VaxGen delivers, it could seriously threaten BioPort's rich defense contracts. Since 1998 BioPort has grossed $223 million on contracts worth $500 million. In an effort to derail VaxGen, BioPort is lobbying Congress with a PowerPoint presentation entitled "A Nation Unprotected," attacking VaxGen's science and credentials.

BioPort says that VaxGen could miss its 2006 deadline. That's plausible, given the government's urgent demands. Vaccine stalwart Sanofi-Aventis dropped out of the bidding for an earlier government anthrax contract. "The time frame outlined by the government for us was not feasible," a company spokesman says. One government report says Sanofi believed that earlier deadline could not be met by anyone.

The government, says BioPort, has "bet the health and protection of the American public on a company with a history of scientific failure and financial scandal."

All the squabbling on Capitol Hill is beginning to get in the way of VaxGen's efforts. Calling the congressional commotion "political theater," Lance Ignon, VaxGen's spokesman, says the Capitol Hill fights won't stop the company but that any hearing "certainly unnerves Wall Street, and it's Wall Street that's funding this work," adding that having to deal with Congress "does create a distraction."

The brouhaha underscores the glaring cracks in the U.S. biodefense. Most drug companies avoid the vaccine business like, well, the plague. The market is limited, and capital costs are high. Overdependence on a botched influenza vaccine from Chiron set off a panic last fall. The issue will only worsen as Congress gears up for BioShield II and a badly needed avian flu vaccine.

BioPort, which started out as a state-run vaccine lab in Lansing, Mich., began making an anthrax vaccine in the mid-1960s with a formulation tested in a late-1950s trial on 1,200 textile mill workers exposed to anthrax. Though that study was inconclusive about the vaccine's effectiveness against inhalation anthrax--only five people in the study got that disease--BioPort says that much research, including a report by the prestigious Institute of Medicine, has backed its safety and effectiveness against both inhalation and cutaneous, or skin, anthrax.

But the state lab ran a filthy operation. In the 1990s the Food & Drug Administration threatened to revoke its license, citing numerous "significant" violations, including rusting storage freezers, dirty equipment, dead insects littering the floor and a failure to keep work areas separate to prevent contamination from other vaccines. Though the lab continued distributing vaccine for the military, its operations were suspended by the FDA in 1998. It took four years of renovations and upgrades to get approval to resume licensed work.

While BioPort accuses VaxGen of getting lots of help from the government, it, too, has benefited from the kindness of bureaucrats. The state sold the lab for $25 million in September 1998 to a partnership led by Fuad El-Hibri, a former director of Porton Products, a British vaccinemaker. El-Hibri got family friend William Crowe, former chairman of the Joint Chiefs of Staff, to join the board. Crowe
got a 13% stake in the company. The buyers paid just $3.25 million in cash, borrowing the rest mostly with interest-free notes from the state of Michigan. When it got into fiscal trouble, BioPort got government bailouts, including multimillion-dollar contract increases, protection against product liability and the right to sell its vaccine on the private market. Since 1988 the government has spent $112 million on the lab.

The government has continued to buy BioThrax, even though in 2001 the FDA stuck a warning in the drug's packaging about potential side effects, including lymphoma, lupus, multiple sclerosis, seizures and even death. "Any other vaccine in the civilian market with such a comparably bad track record would have been yanked in minutes," says John Michels, Jr., a lead attorney for soldiers suing the military.

VaxGen has a rocky track record, too. It began in 1995 as a spinoff from Genentech. In 1999 it won an $8 million government contract to test its AIDS vaccine, but the official negotiating that contract for the Centers for Disease Control got in trouble for simultaneously talking to VaxGen about a job. VaxGen soon got in its own trouble for hyping its AIDS vaccine in press releases. It boasted that trial data
showed its AIDS vaccine "is safe and raises a powerful immune response against HIV."VaxGen also corrected a disappointing sales estimate that ran in Investor's Business Daily, instead noting that "sales for the first year alone could total between $500 million and $650 million." As its stock rose, insiders started selling.

But in February 2003 VaxGen announced that its AIDS vaccine failed its first big trial. A later trial confirmed it was a flop. Investors sued, alleging executives knew things were going badly and had tried to inflate VaxGen's stock price. One suit has been dismissed, and VaxGen has agreed to settle a derivative action for $500,000 to cover attorneys' fees.

As its AIDS work was blowing up, VaxGen was working to get access to Fort Detrick's anthrax vaccine technology. It had friends. VaxGen Chief Gordon is a long-time acquaintance of Philip Russell, the former chief of Army medical research. Both sit on the board of the Albert B. Sabin Vaccine Institute in New Canaan, Conn. Fort Detrick gave VaxGen the license to its anthrax technology in October 2003. Russell, then an adviser to HHS, stepped in to settle a fight between government bureaucrats over whether VaxGen would pay royalties to the government. "He said, 'Dammit, I don't care what you do, but settle it--don't leave this company in the lurch,'" recalls Gordon.

A year later HHS awarded VaxGen the BioShield award. Gordon and Russell adamantly deny their relationship had any influence on VaxGen's selection. "I scrupulously stayed away from talking to him, to the point where I felt terrible about it," says Gordon. The company now quotes Russell in its media kit: "We have a lot of faith in this vaccine, and we believe it's the right way to move forward to protect the country against anthrax."

VaxGen is now restating its financials for 2001 through 2003 but appears to have lost a cumulative $173 million from the end of 1997 through 2003. Because of the restatement, VaxGen hasn't filed 2004 reports. Since December 2003 it has raised $100 million in equity and convertible debt financing and brought in $101 million in earlier federal contracts to develop its anthrax vaccine. It says it has $55 million in cash.

Both BioPort's and VaxGen's vaccines aim to spur the body to generate antibodies against the lethal bacterium. Bacillus anthracis (anthrax comes from the Greek word for coal, an allusion to the black skin lesions of the cutaneous disease) is a naturally occurring, spore-forming bacterium that is at least 11,000 years old. On a
microscopic level, anthrax is elegant in its simplicity and terrifying in its power.

After spores enter the body, they germinate into spaghetti-like strings
of bacteria cells, which then multiply and secrete three proteins: protective antigen, lethal factor and edema factor. Rings of protective antigen latch on to the surface of human cells and bind to the other two proteins to form toxins that then bore inside the cell, causing hemorrhaging, necrosis (blackened flesh) and death.

BioPort's vaccine uses filtered elements of dead anthrax bacteria grown in a soup of sugars, salts, amino acids and vitamins. The company says the vaccine consists primarily of protective antigen, but that it also contains small amounts of edema factor and other proteins.

In contrast, VaxGen uses genetically engineered anthrax cells to create a vaccine containing only the protective antigen. The company believes that antibodies to this protein are all that's needed for immunity. The recombinant manufacturing process allows for high volumes of consistent medicine.

VaxGen is scrambling to complete its clinical trials by the end of 2006, but Gordon says that by the end of this year it will start pumping out doses that are 95% pure, as required by its contract. Though the FDA won't review for licensing the safety and effectiveness of VaxGen's vaccine until 2007, the government is scrutinizing it,
conferencing with executives every two weeks.

After all this, a preliminary trial of VaxGen's vaccine involving 100 human volunteers found that high doses had an immune response comparable to BioPort's vaccine, says a trial investigator, Dr. Harry L. Keyserling, professor of pediatrics at Emory University. (BioPort, of course, disputes this analysis.)

The sad truth is that we'll never know if these anthrax vaccines can defend us from a large-scale attack--until one occurs. Drugmakers are prohibited from infecting people with the deadly disease just to test a vaccine. If an attack ever comes, we could have big problems on our hands.

June 5, 2005

Why did he die?

The Globe Gazette (Mason City, Iowa)
Original link:

Did a former member of North Iowa's 1133rd Transportation Co. die as a result of an experimental anthrax vaccine?

"The only thing I ever wanted is to find out what happened to my son," says Scott Siefken's mother, Ardie Siefken of Waverly. "Why did he die? "Because of Gary Matsumoto's book, "Vaccine A," which alleges a new anthrax vaccine has harmful effects on service personnel, Ardie said she now believes she knows.

The book was published in 2004 by Basic Books of New York City. Scott Siefken, who was in the Gulf War during the winter of 1990-91, suffered from hot and cold spells when he came back from the Middle East in the spring of 1991. He developed sores in his mouth and a severe rash that would not respond to treatment. Scott died Oct. 5, 1994. He was 37. A maintenance worker for the Iowa Department of Transportation, Scott, who lived in Manly, worked until just before entering the hospital for the last time even though he had to put his boots on before getting out of bed or his feet would be too swollen, his mother said. "Vaccine A" is a book "the U.S. Department of Defense does not want you to read," Matsumoto says in its introduction. A portion of the book tells Scott Siefken's story. "He was very truthful," said Ardie of Matsumoto. The author talked with Ardie and with her daughter, Cristie Sanford, who lives in New Mexico, about a year ago.

Scott's widow, Lydia, who now lives in Nashua, did not return phone calls when contacted for this story. "I have heard from so many people who read the book. I really truly feel that he's onto something," Ardie said. The government has involved people in experiments that impacted their health without their knowledge before, she said. Scott had many inoculations at Fort McCoy, Wis., his mother said, adding that she now believes he was one of the soldiers who must have received an experimental anthrax vaccine. "We've never been able to get his records of his immunizations. They tell us that they're lost or can't be found or the wrong person is asking for them," she said. Siefken's mother said the family began trying to get those records within a year of Scott's death. "If only the government would just be honest with us, tell me what happened. I can accept that," Ardie said. "I would like to be told the truth. They owe us that.

"The constant news of the current war in Iraq keeps her son's suffering fresh in Ardie's mind and reminds her and Scott's widow, Lydia, of the sacrifices being made daily by other families. "When you hear that 20 or so have been killed over there it's just like somebody stabbed you in the heart because you know exactly what those families are going through, today, tomorrow and forever," Ardie said.

Ardie makes a point of collecting information to share with her grandchildren whenever she can. She bought copies of "Vaccine A" for each of Scott's children. The oldest one has his copy and the younger two will be able to have their copies when they're older, she said. "I think anger and betrayal were my reactions, but I just couldn't go on," said Cristie Sanford, Scott's sister, who said she read several chapters of the book but couldn't finish it. Scott's youngest son, Ryan, was born two weeks after Scott died. He "looks like Scott and acts like Scott in every way," his grandmother said, and has asked repeatedly, "What happened to Daddy?

"When she has bad days, Ardie sometimes goes to the cemetery and talks to Scott. His grave is under a maple tree where wren houses hang in the summer. An image of a sailing clipper ship that he loved and the daisies and roses that were his bride's wedding flowers are etched on the marker. "There are no words to tell you what an impact" his illness and death had, said his mother. Scott's sister, Josie Siefken of Boone, said she found the book credible and even-handed. The author seemed to have "appropriate background credentials" and "to have done his homework," she said.

After serving four years in the Navy after high school, Scott joined the National Guard because he was "a compassionate person," his mother said. At that time, the National Guard helped in times of tornados and floods. He willingly went to the Gulf. "He believed he had a job to do and was willing to do it, his mother said. She has doubts, however, about the war in Iraq. "I feel this war is based on untruth and I don't like that," Ardie said. "We're losing too many precious young people."

At one time, Ardie had an Internet newsletter for families of Gulf War veterans. She has heard a lot of family stories with common threads. That newsletter arose from the pain she felt as the mother of a serviceman who suffered from Gulf War illness. "His father (Rollie) died on the fifth anniversary of Scott's death," Ardie said. He had remarked the day before that he didn't know why the year had been so tough, that some of the grief should have been behind them, but it wasn't.

When Scott died, he left behind his wife, Lydia; his children, Trent, now 21, Wellsburg; Justin, now 14, and Ryan, now 10, both of Nashua; his parents and five sisters.