Following up on my (attorney Richard Stevens) previous anthrax vaccination blog post, it appears this issue continues to heat up as we draw closer to the return of mandatory anthrax vaccinations for military personnel. The Department of Health and Human Services has canceled its $877 million contract with VaxGen to produce a new "improved" anthrax vaccine. Meanwhile, a new lawsuit was filed against the government based on the claim that the current anthrax vaccine is unapproved for its applied/intended use. Nevertheless, the DoD plods ahead, unwilling to admit they may be wrong. Below are some recent news articles...
December 20, 2006
Government Yanks VaxGen’s Contract to Produce New Anthrax Vaccine
The Associated Press
The government has canceled an $877 million contract for a new anthrax vaccine, after the struggling manufacturer missed a key deadline to begin human tests of the shots.
VaxGen Inc.’s “failure to perform is not excusable,” said a terse letter the Department of Health and Human Services sent to the California-based company late Tuesday.
The agency concluded the failure put VaxGen in default of the company’s federal contract — meaning that for now, the government has no clear plan to find a next-generation anthrax vaccine.
The decision had been expected since November but still was bad news, both for VaxGen and the government.
The VaxGen contract was supposed to be the crown jewel of Project BioShield, a $5.6 billion government program to build national drug stockpiles in case of a bioterror attack — by guaranteeing sales if a company took the risk of developing such a drug.
VaxGen’s shots were intended to replace the current anthrax vaccine, which requires six shots administered over 18 months. VaxGen’s was to require no more than three shots.
But VaxGen, a company best known for the flop of an experimental AIDS vaccine, had trouble almost from the beginning.
First, it disclosed it would miss by a year the original November 2005 deadline for producing vaccine. Then last fall, the Food and Drug Administration halted plans for human testing, citing concern that the vaccine would lose its potency too quickly to be effective.
VaxGen, of Brisbane, Calif., has the right to appeal and said in a statement that it “is actively exploring its strategic and legal alternatives.”
Posted on Fri, Dec. 22, 2006
Mandatory Anthrax Vaccinations Raise Concerns
By Greg Gordon, McClatchy Newspapers
WASHINGTON - En route home from the Persian Gulf on a military supply ship in 2003, merchant seaman James Francis and his mates got an ultimatum: Take anthrax and smallpox vaccinations or lose your jobs.
Francis' Seattle attorney, Russell Williams, described the shipboard scene the next day off the isle of Crete as: "Wham, bam. 'Get in line. Take your shots.'"
Within days of taking the two shots, Francis' feet began to tingle and burn. When he later took the second in a series of six anthrax shots, his health slid downhill. Since then, the 45-year-old messmate from Las Vegas has fought a rare nervous system disease known as Guillain-Barre Syndrome, along with chronic pain, pneumonia and a life-threatening blood clot.
Vaccine makers are immune from lawsuits, so Francis sued the government, winning what his lawyer calls a "substantial" settlement in December 2005. Others say Uncle Sam shelled out about $2 million.
But Francis' success is unlikely to be duplicated by any soldier harmed in the massive anthrax inoculation program that's set to get under way in earnest early next year. Some 200,000 troops, who unlike private employees are barred from suing the U.S. government, will be required to take the vaccine.
The Pentagon is reviving its mandatory anthrax vaccinations despite allegations that the shots have contributed to as many as 23 deaths and sickened hundreds, and perhaps thousands, of soldiers.
On Tuesday, the Department of Health and Human Services canceled an $877.5 million contract with California-based VaxGen. Inc. for what would have been a substitute anthrax vaccine. HHS said the company missed deadlines for beginning tests on humans.
That puts even more focus on the controversial, decades-old vaccine, which has been used to inoculate 1.5 million military personnel. The Pentagon has been rocked by criticism that it has failed to adequately track whether the shots have caused diseases. Indeed, as occurred with Francis, many soldiers are injected with several vaccines on the same day, making it harder to identify the cause of illnesses.
In 2004, lawyers for sick soldiers won a court injunction blocking the mandatory shots until the Food and Drug Administration reviewed the license of Maryland-based vaccine manufacturer Emergent BioSolutions. In December 2005, the FDA declared the vaccine safe and restored the license.
But testimony from some military doctors undercuts that decision.
Dr. Limone Collins, the medical director of the Vaccine Healthcare Center at the Army's Walter Reed Army Medical Center, testified that Francis had "a rare, vaccine-associated, neuro-immunological disease," according to court papers.
Dr. William Campbell, a neurologist at the center, said the dual vaccinations afflicted Francis with a Guillain-Barre variant in which the body's immune system attacks the nervous system.
In another case, the medical director of a Vaccine Healthcare Center at Lackland Air Force Base testified last year on behalf of Nathan Torquato, a senior airman being court-martialed for using cocaine and methamphetamine to cope with muscle pain and chronic fatigue syndrome, which he blames on his anthrax shots. Helping Torquato win a lighter sentence, Dr. David Hrncir said it "appears that we are having higher numbers of people coming down with chronic fatigue syndrome as a result of this vaccine."
Despite such testimony, Pentagon health chief William Winkenwerder announced on Oct. 16 that safety questions had been resolved and that the shots would soon resume - the Pentagon now says in January - for troops deployed in the Middle East, Korea and other areas at high risk of a terrorist attack with germ weapons such as smallpox and anthrax.
Col. Randall Anderson, who runs the Military Vaccine Agency, said the Pentagon believes health risks from the anthrax vaccine "are equal to those of other vaccines" that cause illnesses in only a tiny percentage of those vaccinated.
Robert Burrows, Emergent's vice president of corporate communications, pronounced the vaccine - sold as BioThrax - to be "safe and effective" and vetted "more than any in history."
But on Dec. 13, lawyers who succeeded in stalling the mandatory program in 2004 filed suit seeking a new injunction, alleging that the FDA manipulated data from a 1950s clinical study and circumvented its rules in licensing a vaccine that was modified multiple times.
Numerous public health experts believe BioThrax causes a range of problems, particularly among women and people prone to autoimmune diseases. They list Guillain-Barre, which can kill or paralyze; other neurological disorders; diabetes; arthritis; chronic fatigue syndrome; chronic muscle and joint pain; respiratory ailments; vision problems; memory loss, and depression.
The afflicted soldiers blame their government.
Retired Army Capt. B. David Hodge, 54, of Carlsbad, N.M., said he was serving as a chaplain when he and his Tennessee-based Army reserve unit were injected with half a dozen shots of anthrax vaccine at Fort Bragg, N.C., in 1990 before being deployed to Saudi Arabia.
Hodge said Army health care personnel refused at the time to identify the anthrax vaccine, instead calling it "Vaccine A." He said he burned with fever for several days and permanently lost feeling in his fingers. Now he fights an autoimmune disorder that's destroying his lungs. "I love my country," Hodge said. "It's my government I don't trust."
Retired Air Force Sgt. David Lyles, 32, of Mentor, Ohio, said he was injected with the shot in October 2003 at Youngstown Air Force Base.
A few minutes later, Lyles said, he fell off a stool in the base's avionics shop from anaphylactic shock and hit his head on the cement floor. Lyles, who had always been athletic, said that he recovered from the concussion but that Guillain-Barre left him walking with a cane.
"If there is a problem with the vaccine, why subject people that are helping you defend what you believe in?" asked Lyles, who also said he's lost some of his short-term memory.
An FDA system that collects adverse reaction reports for all vaccines has recorded more than 4,700 reports related to anthrax shots over the last 16 years. The number of cases, the agency says, will "inevitably be underreported."
The FDA said it has received 23 reports of anthrax vaccine-related deaths, but has seen no proof that the shots were to blame. The FDA also couldn't readily estimate the number of serious illnesses associated with the vaccinations. In the past, it has estimated 500 cases.
Dr. Meryl Nass, an internist in Bar Harbor, Maine, who has specialized in anthrax vaccine-related illnesses, says the estimates of health problems are vastly understated.
Nass said she has treated more than 500 seriously ill patients and that at least 1,500 more have phoned or sent e-mails.
Defense Department officials say several studies, including analyses of soldiers' disability claims and of post-vaccination hospitalizations, debunk the health concerns. But as recently as May, the Government Accountability Office said that the vaccine's long-term safety "has not been studied."
The Pentagon also draws criticism for giving anthrax shots with other vaccines. John Richardson, a retired Air Force pilot who has crusaded against the vaccine, charges that this is done "so they can hide which vaccine is causing the problem."
He cites the case of Rachel Lacy, a 22-year-old Army reservist who was awaiting deployment to the Persian Gulf in early 2003 when she received an anthrax shot and four other vaccinations at Fort McCoy, Wis.
A month later, she died of a pneumonia-like affliction at the Mayo Clinic in Rochester, Minn. The Pentagon called her death "a rare, tragic event that may have been related to vaccination," but said two expert medical panels couldn't identify any of the five vaccines as the culprit.
Pentagon spokeswoman Ann Ham said each reported death is similarly investigated, but none has been "causally associated with anthrax immunization alone." Anderson said a government immunization panel found no reason not to give vaccines together.
Much Pentagon data remain out of the public's reach, even though a Defense Medical Surveillance System tracks all illnesses among troops. After the National Academy of Sciences' Institute of Medicine found no proof of causal links between the vaccine and illnesses in 2002, but urged more research, the Pentagon stopped issuing quarterly analyses of BioThrax's effects. "There isn't a need for that," Anderson said.
David Geier, vice president of the Maryland-based Institute for Chronic Illnesses, and his father, Dr. Mark Geier, have analyzed the FDA's vaccine adverse reaction reports and published numerous articles on vaccine safety. David Geier said the reactions to BioThrax among healthy soldiers have been "many orders of magnitudes higher" than they've been for nearly all other civilian vaccines.
The Defense Department has said it's given the vaccine to an estimated 175,000 troops involved in the 1991 Gulf War, but said it didn't keep accurate records of who was inoculated.
A Department of Veterans Affairs advisory committee that investigated possible causes of Gulf War Syndrome, clusters of illnesses that afflicted some 200,000 war veterans, didn't rule out the anthrax vaccine as a possible cause, said Steve Robinson, a panel member and official of Veterans for America.
While Anderson said that more BioThrax studies are under way, Nass dismissed the Pentagon research as "epidemiological garbage."
For example, she cited a military study of vaccine links to optic neuritis that excluded troops who developed vision problems in their first 18 weeks in the military, even though many soldiers get their shots in boot camp. The study also omitted other soldiers not diagnosed within 18 weeks of vaccinations - shots given just before they were sent overseas where there were no ophthalmologists, she said.
The mandatory anthrax vaccine program has been beset with problems almost since deputy FDA commissioner Michael Friedman granted a 1997 Pentagon request to expand its use from protecting people against anthrax infection in skin wounds to shielding those who breathe it.
In 1998, FDA inspectors halted production until the vaccine's manufacturer, Michigan-based BioPort Corp. (now an Emergent subsidiary), corrected deficiencies. Its plant didn't reopen until 2002.
From 1998 to 2000, hundreds of active troops, reservists and National Guardsmen risked courts-martial by refusing to take anthrax shots for fear of health problems. Then the 2004 court injunction forced the Pentagon to shift to a voluntary program. About 50 percent of troops have refused the shots.
Vaccine critics note that both the VA and the Pentagon have routinely paid disability benefits to soldiers who blame BioThrax for chronic illnesses, but they list the ailments as "service-connected" without mentioning the vaccine.
Virginia attorney Richard Stevens, who has handled a number of claims, said that way, "they always have plausible deniability."
December 25, 2006
New Plaintiffs File Suit Over Vaccine Program
By Gayle S. Putrich, firstname.lastname@example.org
Six unnamed plaintiffs filed a class-action lawsuit against the government Dec. 13, resuming a legal tug-of-war over the military’s mandatory anthrax immunization program.
According to court documents, the basic premise of the lawsuit is the plaintiffs’ claim that the vaccine is “unapproved for its applied/intended use.”
The lawsuit says the “plaintiffs will suffer substantial and irreparable injury if they are forced to take the vaccine,” which the suit says has not been properly approved by the government — despite the Food and Drug Administration issuing its “final rule” on the vaccine a year ago.
The suit also says the Defense Department has failed to follow presidential orders and federal laws that require the government to obtain informed consent before giving an unapproved and experimental vaccine to anyone.
“FDA’s certification of the vaccine, which is based on slipshod statistical analysis and improper use of testing data, as well as DoD’s alteration of the vaccine dosing schedule, render the vaccine a drug unapproved for its applied use under current federal law,” said Chicago lawyer John J. Michels Jr., co-counsel in the lawsuit. “Under these circumstances, the vaccine may not be administered to service members without their informed consent. It is patently illegal.”
In particular, the suit says:
• The original science and reasoning behind the FDA’s original 1970 approval of the vaccine was flawed.
• The vaccine now being used by the Defense Department has a different formula from the one that was originally approved.
• No new studies were conducted on the current vaccine to determine if it is effective against inhaled anthrax.
“The key in the lawsuit is efficacy,” said Mark Zaid, co-counsel for the plaintiffs.
The Pentagon and FDA “have no animal data and no human data to show that it’s actually effective,” he said. “They have to show that it’s safe, effective and not misbranded, and they have to show all three.”
Because, they claim, the FDA did not follow its own rules in approving the vaccine, Zaid and Michels also say the Defense Department is in violation of Executive Order 13139, which requires informed consent from anyone receiving an unapproved or investigational drug unless the president issues a waiver.
The new lawsuit is just the latest chapter in the long and turbulent history of the Pentagon’s anthrax vaccination program. Since December 2004, the six-shot anthrax vaccine has been optional for all troops following the decision of a federal judge for the U.S. District Court for the District of Columbia to halt the mandatory program with an injunction.
In December 2005, the FDA finalized its approval of the vaccine and a federal appeals court dissolved the injunction, clearing the way for the Pentagon to resume mandatory shots.
The Pentagon announced in October that mandatory inoculations would resume, but defense officials are still formulating some parts of the vaccination plan, which is now expected to begin early next year.
The policy unveiled in October directs mandatory anthrax shots for troops, emergency-essential civilians and Defense Department contractors carrying out mission-essential services in the Central Command area or South Korea for 15 consecutive days or more. Others assigned to special mission units, such as biodefense units, are also expected to be vaccinated as needed under the new policy.
As in the first anthrax vaccine lawsuit, the five male and one female plaintiffs are unnamed — out of “fear of retaliation by the government,” their lawyers say. Court documents claim they run the gamut of those who will be required to take the vaccine early next year: active-duty service members, reservists, National Guardsmen, civilian Defense Department employees and contractors.
Zaid said these are not the same plaintiffs from the first suit.
Robert Gates, who will be sworn in as defense secretary Dec. 18, replacing Donald Rumsfeld, is named in the lawsuit, along with Heath and Human Services Secretary Mike Leavitt and FDA Commissioner Andrew Von Eschnebach.
“When it comes down to it, this is really a lawsuit against the FDA,” Zaid said. “The injunction against DoD is just to keep them from using the vaccine. But the legal and factual attack is against the FDA.”
Federal agencies do not usually comment on pending litigation.
FDA spokesperson Julie Zawisza would say only that the agency will “evaluate and defend the complaint.”
Department of Health and Human Services aides said they could not comment.
Defense Department officials said that while they also could not comment on pending litigation, the department stands by the vaccine as an important force-protection measure. They said the FDA has repeatedly ruled it is a safe and effective vaccine, and plans for a new mandatory program will continue to move forward.
Only about half of the troops offered the vaccine during the voluntary phase of the program have taken the shots, and officials say it is a preventive medicine and military readiness concern for half the force to be vaccinated and half not to be.
Blog Content By: As Identified Above
By: Attorney Richard V. Stevens
Civilian criminal defense lawyer and military defense lawyer
Military Defense Law Offices of Richard V. Stevens, PC
Blog postscript: Attorney Frank Spinner and I (attorney Richard Stevens) are former active duty military lawyers (JAG). Our perspectives and advice, therefore, are based upon our experience as military defense lawyers and as civilian criminal defense lawyers practicing exclusively in the area of military law. This blog addresses issues in military law, military justice, military discipline, military defense, court-martial practice, the Uniform Code of Military Justice (UCMJ) and other military and/or legal topics. Nothing posted in this blog should be substituted for legal advice in any particular case. If you seek legal advice for a particular case, please contact The Law Offices of Richard V. Stevens & The Law Office of Frank J. Spinner for a free consultation.