December 28, 2005

A Building Boom for Labs


By JENNIFER S. FORSYTH and BETSY MCKAY
Staff Reporters of THE WALL STREET JOURNAL

U.S. Plans to Spend $1 Billion On New Facilities to Study Highly Infectious Diseases

In October of 2001, McCarthy Building Cos. was about to break ground on one of its most challenging projects ever -- a high-security laboratory for the U.S. government in Atlanta -- when it suddenly got the order to stop.

The terrorist attacks on Sept. 11 had raised the specter that more attacks could come, possibly using biological agents. McCarthy's client, the federal Centers for Disease Control and Prevention suddenly wanted an even bigger, more secure facility. "CDC had a massive change order," says Walter Guest, senior vice president of St. Louis-based McCarthy, the project's general contractor. Costs increased about $30 million to $214 million, and the facility wasn't completed until this past October.

That jump in cost was a fraction of what the federal government plans to spend on new facilities to fight bioterrorism -- at least $1.0 billion over the next decade on seven large new buildings housing laboratories for research designated "biosafety level-4," reserved for life-threatening diseases with no known cure. The amount of space reserved for BSL-4 research could top 100,000 square feet in the seven buildings, experts say.

Labs that work on infectious micro-organisms range in levels of biosafety from one to four. BSL-1 labs, which resemble high-school science classrooms, are for agents that don't normally cause disease in healthy adults. In BSL-2 and BSL-3 labs, scientists wear protective gear to work on pathogens that are more easily transmissible to humans, such as measles (BSL-2) and tuberculosis (BSL-3). The BSL-4 labs are highly secure facilities that research the most infectious diseases, such as the Ebola virus and other viral hemorrhagic fevers.

For the past few decades, research on BSL-4 agents has been limited primarily to the CDC and the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick in Frederick, Md. But with the threat of bioterrorism and emerging infectious diseases, these facilities aren't adequate for the growing demand for research into BSL-4 agents, scientists say. Prior to the new facility, the CDC's most recent lab for highly infectious diseases was built in 1988. A U.S. Army lab facility planned for Fort Detrick will be 700,000-square-feet -- the size of seven Wal-Marts -- and will cost at least $400 million, although plans could change by the time it is completed in 2013.

Some critics have questioned the many construction projects and the need for so much lab space devoted to BSL-4 research. "It's a mystery what they are going to fill these labs up with, because there are, frankly, not that many BSL-4 agents, and not that many researchers to keep these places busy," said Edward Hammond, director of Austin, Texas-based Sunshine Project, which monitors the U.S. biodefense program.

CDC director Julie Gerberding says the new CDC labs will relieve a research backlog. Among many projects the CDC has planned is testing of antiviral drugs to treat smallpox. In the past, "we would have to make really hard choices about what to work on," she says.

A few academics contend that the construction spree will overcompensate for past deficiencies. "Any one of these facilities would probably bring us into the position of meeting the national need, but we will be getting at least seven," said Richard Ebright, a chemistry and molecular biology professor at Rutgers, the State University of New Jersey.

Some communities have protested the research of deadly viruses in their neighborhoods. In July, the University of Washington abandoned its attempt to build a BSL-3 lab, ostensibly because of funding concerns, but the project also drew hundreds of opponents. The lab at Boston University Medical Center is expected to go forward but is facing legal challenges.

The BSL-4 labs were funded by congressional appropriations to individual agencies, namely the National Institute of Allergy and Infectious Diseases, but also Homeland Security and Defense departments, after President Bush announced an aggressive program to fight biological threats after the anthrax scare of 2001.

The building boom presents an opportunity for McCarthy and a handful of other construction companies. Many of these companies don't specialize in high-security labs, but they aren't newcomers to this type of construction. McCarthy, for one, has built hospitals with containment areas for illnesses like tuberculosis.

"There's nothing else that we've ever seen that even comes close," says Mike Simpson, project executive for Houston-based Vaughn Construction, which built the BSL-4 lab at the University of Texas Medical Branch at Galveston and is currently constructing the university's second one.

Some of the other BSL-4 labs are already under way: Skanska AB's Skanska USA Building Inc. is constructing a lab in Hamilton, Mont., for the National Institute of Allergy and Infectious Diseases. Gilbane Building Co., is building BSL-4 labs for the Department of Homeland Security and the NIAID at Fort Detrick. Turner Construction Co. and McCarthy are building a $178 million biocontainment lab at Boston University Medical Center.

The BSL-4 labs have numerous safety features. Only certain scientists may access the labs. Doors lock between chambers. Air flow is monitored on multicolored screens to make sure the labs are properly pressurized. Scientists working in the labs wear pressurized moon suits, hook up to their own air supply, and conduct all their work on infectious agents in biological safety cabinets, which also have their own air supplies.

In addition, all holes for electrical outlets, plumbing, cameras and piping must be designed in advance and embedded in the concrete walls. "If you screwed up and a conduit is in the wrong place, you cannot go and just chip that out of the concrete wall. You would have to demolish that whole wall and start over," said Mr. Guest of McCarthy Building.

The public concern and the demanding requirements of these facilities put pressure on project managers to educate their crews and subcontractors, says Jeffrey Schramm, vice president for the Providence, R.I.-based Gilbane. Vaughn Construction, which won the contract to build a $167 million lab at UTMB-Galveston, practiced building walls offsite to make sure it had the right concrete mix.

Administrators at the University of Georgia know too well what happens when a lab isn't done right. In 1996, the university started construction on an Animal Health Research Center to study livestock diseases only to find cracks in the structure. It is expected to open with a BSL-3 agriculture designation in early 2006.

"I've been involved in this project for about 15 years now -- this one building," says Michael Mispagel, facility program manager at the University of Georgia center. "I am ready to get this facility operational."

Posted by MBVIC at 7:35 PM |

December 22, 2005

Mandatory anthrax inoculations should resume, court told


By Gordon Trowbridge
Times staff writer

A government agency’s ruling that the controversial anthrax vaccine is safe should clear the way for resumption of mandatory shots for military personnel, government attorneys argue in a new court filing.

A Dec. 19 ruling by the Food and Drug Administration that the vaccine is “safe and effective” against all forms of anthrax should lead to either reversing a federal judge’s ruling halting the vaccinations, or tossing the case out as moot, Justice Department lawyers argue in a request to the U.S. Court of Appeals for the District of Columbia Circuit.

That court is considering the government’s appeal of a lower-court ruling that halted the Pentagon’s mandatory anthrax vaccinations. The case involves six anonymous plaintiffs who argued the government was violating the law by requiring military personnel to take the shots or face legal punishment.

But the FDA ruling, the government argues, destroys the reasoning for the lower court’s decision. And though the court could simply vacate that ruling and end the case, the government says it should instead reverse the lower court and rule that the government was within its rights all along to order the vaccine.

That is a crucial issue for military members, said Steve Robinson of the National Gulf War Resource Center, which opposes mandatory vaccinations.

Even if the new FDA ruling allows vaccinations to go forward, “we still have the question of all these people who have been court-martialed in the interim,” Robinson said.

Those service members, he said, were justified in refusing the vaccine before the FDA’s formal approval of its use.

Robinson views as suspicious the timing of the FDA ruling, which came less than three weeks after the appeals court heard oral arguments in the case.

“They’ve had plenty of opportunity to show any scientific evidence,” he said. “They did this strictly on the basis of the lawsuit.”

The government’s latest filing in the case specifically denies that FDA has been “holding back” its new order. “FDA has simply worked diligently to complete its longstanding regulatory responsibilities,” the motion contends.

The new filings are just the latest twist in a complicated legal process that dates back to 1998, when the Pentagon began requiring vaccinations to protect troops against anthrax used as a biological weapon.

The case, which involves arguments about scientific research methods, disputes over complex statistics and debates over federal laws and agency rules governing drug safety, is at heart a debate over one question: Is the anthrax vaccine safe?

Government officials contend that reams of scientific data show the shots are safe, and that they protect against all forms of anthrax, including airborne spores likely to be the form used as a weapon.

But opponents say the vaccine, manufactured by a Michigan company that has had numerous financial and technical problems, risks making service members ill.

Hundreds of troops have complained of health problems they believe are linked to the vaccine. And despite congressional requirements that the Pentagon track the potential health risks of anthrax shots, the Daily Press of Newport News, Va., reported this month that defense officials had kept from public view reports of more than 20,000 hospitalizations of service members following vaccinations.

The government contends there is no evidence that any of those hospitalizations are connected to the vaccine.

Posted by MBVIC at 4:34 PM |

38 Senators With Up to $13.4 Million in Pharmaceutical Stock Approve Drug Industry's Sweetheart Deal


To: National Desk

Contact: Carmen Balber, 310-392-0522 ext. 324 or Jamie Court, 310-392-0522 ext. 327, both of the Foundation for Taxpayer and Consumer Rights

SANTA MONICA, Calif., Dec. 22 /U.S. Newswire/ -- 38 U.S. Senators with up to $13.4 million in pharmaceutical holdings increased the value of their stock portfolios last night when they approved an amendment to the defense appropriations bill that immunizes drug makers from accountability to the public when they sell dangerous drugs and other products, according to the Foundation for Taxpayer and Consumer Rights (FTCR).

"When Senators can vote to harm the health and safety of the American public and line their own pockets while they're at it, the motive behind every vote is in question. No Senator should be able to vote in his own financial interests at the expense of the public," said Carmen Balber, consumer advocate with the nonprofit, nonpartisan Foundation for Taxpayer and Consumer Rights.

FTCR released an analysis of Senate personal financial disclosures last week, revealing that 42 senators -- 27 Republicans and 15 Democrats -- held pharmaceutical stock worth between $8.1 and $16 million in 2004. Senators earned an additional $2.5 to $7.2 million in capital gains and dividends, and two senators' spouses also earned salaries from pharmaceuticals. View the analysis: http://www.consumerwatchdog.org/resources/SenPharma.pdf.

"The fact that Senators had the guts to block oil drilling in the Arctic National Wildlife Refuge, but failed to eliminate this giveaway to the pharmaceutical industry, shows this body is beholden to drug companies and their personal stake in the industry's profits," said Balber.

The 38 Senators with pharmaceutical stock that voted for the provision are: Allen (R-Va.), Bayh (D-Ind.), Bingaman (D-N.M.), Bond (R-Mo.), Boxer (D-Calif.), Brownback (R-Kan.), Burns (R-Mont.), Carper (D-Del.), Coburn (R-Okla.), Cochran (R-Miss.), Conrad (D-N.D.), Crapo (R-Idaho), Dayton (D-Minn.), DeWine (R-Ohio), Dole (R-N.C.), Ensign (R-Nev.), Feinstein (D-Calif.), Frist (R-Tenn.), Hatch (R-Utah), Hutchison (R-Texas), Inhofe (R-Okla.), Isakson (R-Ga.), Kerry (D-Mass.), Kyl (R-Ariz.), Landrieu (D-La.), Lautenberg (D-N.J.), Levin (D-Mich.), Lieberman (D-Conn.), Lott (R-Miss.), Reed (D-R.I.), Reid (D-Nev.), Roberts (R-Kan.), Stevens (R-Alaska), Sununu (R-N.H.), Talent (R-Mo.), Vitter (R-La.), Voinovich (R-Ohio) and Warner (R-Va.). Four Senators with pharmaceutical holdings did not vote.

The provision grants immunity to drug companies for any vaccine or product, classified by the Bush Administration as necessary to respond to a public health threat, when patients are harmed by dangerous drugs. Its broad language will protect any product considered a "countermeasure," not just vaccines or drugs needed to respond to health emergencies.

Sen. Bill Frist added the provision to the defense conference report, approved by the House of Representatives on Sunday, after conferees had signed what they were told was the final product. Nine members of the Senate conference committee hold pharmaceutical stock.

Sen. Frist's blind trust included stock in drug companies Abbott Laboratories and Johnson & Johnson through 2004, each worth $15,000 to $50,000 when the trust was created. Frist also reported holdings in Orthodontic Supply Inc. worth between $1,001 and $15,000.

Congressional leaders tried to provide similar protection to the makers of the vaccine additive Thimerosal in 2002 with an amendment to a Homeland Security bill based on legislation Frist carried. Public backlash forced the Senate to remove the immunity provision.

Posted by MBVIC at 6:22 AM |

December 20, 2005

Frist, Hastert Aid Vaccine Companies


Roll Call
By John Stanton, Roll Call Staff

In a late-night move that could be worth billions of dollars to a small group of major drug manufacturers, Senate Majority Leader Bill Frist (R-Tenn.) and Speaker Dennis Hastert (R-Ill.) inserted language into the fiscal year 2006 Defense Department spending conference report.

Shortly before midnight on Sunday, the leaders agreed — after House and Senate negotiators had already signed the report and announced its details to the public — to insert controversial language that protects vaccine manufacturers from product liability claims in the event of a viral pandemic, such as one caused by avian flu.

Observers familiar with the procedural history of conference reports said that they were unaware of any precedent for inserting language after conferees had signed off on the report. A review of several Congressional Research Service guides to conference proceedings make no reference to any prior example.

If the law is applied as Frist and other supporters intend, it will represent enormous financial relief for a small group of largely foreign-owned pharmaceutical companies that have worked to promote vaccine liability protection. The companies include the Dutch vaccine manufacturer, Sanofi Pasteur, and the Swiss-based pharmaceutical giant, Novartis.

These companies have wielded substantial influence in Washington, D.C. Campaign finance disclosures show that the companies at the center of Congressional bird flu efforts have significant Washington-based operations, including well-funded corporate political action committees and a host of top lobbyists on retainer.

During an early-morning meeting of the House Rules Committee on the bill, Rep. Dan Burton (R-Ind.), a vocal critic of the vaccine industry, complained bitterly that he had been assured the language would not be included in the bill. “This kind of thing should not be done at 11 at night,” he said.

House Appropriations Committee ranking member David Obey (D-Wisc.) accused the GOP of tricking conferees, saying on the House floor that he had been assured the liability provision would not make it into the defense bill.

Republicans strongly denied that they misled negotiators and insist that the unusual arrangement to include the language was struck only because the provisions had been inadvertently left out.

“There appears to have been some administrative snafu ... that led to much confusion,” a Senate Republican aide familiar with the situation said, adding that it took “several hours’ work to clear up that the avian package ... were indeed physically included along the lines understood by the Leader and the Speaker.”

Posted by MBVIC at 7:48 PM |

Effects of Anthrax vaccine downplayed


NEWPORT NEWS, VA — The Pentagon never told Congress about more than 20,000 hospitalizations involving troops who took the anthrax vaccine from 1998 through 2000, despite repeated promises that such cases would be publicly disclosed. Instead, generals and Defense Department officials claimed that fewer than 100 people were hospitalized or became seriously ill after receiving the shot, according to an investigation by the Daily Press of Newport News.

Written policies required that public reports be filed for hospitalizations, serious illnesses and cases where someone missed 24 hours or more of duty. But only a few of the cases were actually reported; the rest were withheld from Congress and the public, according to records obtained by the Daily Press. Critics of the vaccine, veterans' advocates and congressional staffers say the Pentagon's deliberate low-balling of hospitalizations helped persuade Congress and the public that the vaccine was safe.

Withholding the full record contributed to a shorter list of government-recognized side effects for the drug, which gave patients and physicians a false idea of what might constitute a vaccine-related illness or problem. Repeated evidence of the same adverse side effect after a vaccination is one of the most telling signs of a systematic problem, vaccine safety experts say.

The newspaper found three cases of amyotrophic lateral sclerosis (ALS), known as Lou Gehrig's disease, that the military hadn't reported. The disease destroys muscles and nerves, is always fatal, and rarely hits people younger than 45. One of the three cases involves Navy Capt. Denis Army of Virginia Beach, who died in 2000 after developing symptoms less than a week after his first anthrax vaccination.

His widow filed the first public acknowledgement of his death and its connection to the vaccine after talking to a Daily Press reporter and learning that she could file a report with the federal Vaccine Adverse Event Reporting System (VAERS).

Col. John Grabenstein, director of the military's vaccine agency, said no one from the military intentionally misled Congress or the public. The 20,765 hospitalizations merely followed vaccinations in time, without documented proof of a cause-and-effect relationship, he claimed. However, the data that the Daily Press used to document the underreporting came from an unpublished report that Grabenstein supplied in response to its request.

Quarterly analysis of the vaccine's effects ended just as the nation's only manufacturer, BioPort, Inc. regained its license in 2002, after a 1998 shutdown by federal inspectors who found safety and other problems. The decision to discontinue the quarterly monitoring end systematic long-term studies of the health of those who have taken the drug, the newspaper notes. Most studies that the Pentagon cites as support for the vaccine's safety involve monitoring that lasted no longer than a few months.

After the quarterly reviews stopped, more than a million troops were forced to take the vaccine — until a federal judge ruled last year that the drug had never been adequately licensed for protection against anthrax use in warfare. He ordered the military to make vaccination voluntary. The Pentagon is appealing that ruling. A decision is expected by February.

Tyson’s prayers conflict with deeds
FAYETTEVILLE, AK — Tyson Foods, the meat- and chicken-industry giant, is trying to sell God along with its chickens, beef, and pre-prepared frozen meals, Ad Age reports. The latest step is "mealtime prayer booklets" being distributed for a variety of faiths all over the world.

According to Ad Age, "What started out as the internal manifestation of Tyson's mission statement — a set of core values that includes ‘striving to be a faith-friendly company’… and ‘to honor God’ … has over the last few years morphed into placing 128 part-time chaplains in 78 plants across the country and, now, the external marketing initiative to play a part in mealtime prayer."

The prayerful image conflicts with a January 2005 report by Human Rights Watch, “Blood, Sweat and Fear,” which condemned Tyson for some less than godly behavior, including unsafe working conditions at many of its production facilities, and using illegal means to stop union organizing. Tyson workers "contend with conditions, vulnerabilities, and abuses which violate human rights," concluded the report.

In April, the U.S. Securities and Exchange Commission successfully sued Tyson Foods and former chairman Don Tyson for filing misleading disclosures, investigative journalist Doug Ireland reports. The SEC found that while Don Tyson was chairman, the company provided an estimated $3 million in personal benefits to Tyson, his wife, their daughters, and three close personal friends.

In August, the U.S. Equal Employment Opportunity Commission filed a suit against Tyson alleging that its Alabama-based facility maintained a "whites-only" bathroom and that managers sternly disciplined black workers who complained about it, Ireland writes. The U.S. Labor Department has accused the company of cheating its workers out of $340 million in "lost" wage hours.

To underline the irony, Ad Age points to that Tyson's chairman, the born-again John Tyson, is a sometime drug addict and alcoholic.

Global Notebook is compiled and edited by Greg Guma, co-editor of Vermont Guardian.

Posted by MBVIC at 4:32 PM |

December 19, 2005

FDA reaffirms worth of DoD anthrax vaccine


Cidrap

In a new chapter in a 2-year legal battle over the US military's anthrax vaccination program, the Food and Drug Administration (FDA) has reaffirmed its earlier finding that the anthrax vaccine used by the military is safe and effective for preventing all forms of anthrax.

It was not immediately clear whether the FDA decision announced last week would help the Department of Defense (DoD) revive its mandatory anthrax vaccination program, which was stopped by a federal judge in October 2004.

DoD has been giving the vaccine, called Anthrax Vaccine Adsorbed (Biothrax), to military personnel on a voluntary basis since April of this year.

"In light of the [FDA's] Final Order, the Department will review program options," Dr. William Winkenwerder, assistant secretary of defense for health affairs, said in a Dec 16 statement. "The military services will continue anthrax vaccinations as they have since April 2005 on a voluntary basis for eligible service members with the option to refuse."

More than 1.3 million service members serving in the Middle East and other areas have received anthrax shots since 1998. But some have objected to the shots out of concern about side effects.

In a lawsuit filed by military and civilian contractor personnel, a federal judge ordered DoD to stop requiring the shots because the FDA, in his view, had never specifically approved the vaccine for inhalataional anthrax.

The FDA quickly responded with a statement that the vaccine was for safe and effective for all forms of anthrax disease. District Judge Emmet G. Sullivan in Washington, DC, then lifted his injunction. But in October 2004 he stopped the vaccinations again, ruling that the FDA had not followed proper procedures in issuing the new approval.

In January 2005, the FDA granted DoD's request for emergency authority to resume the vaccination program, but said the shots had to be voluntary.

Also in January, the FDA, to satisfy Sullivan's objections about procedures, proposed a new approval of safety and effectiveness for the vaccine and asked for public comments. In its 73-page final order issued last week, the agency lists and responds to the public comments.

Winkenwerder said experts have consistently found the vaccine to be safe and effective. "The threat of anthrax as a weapon remains real," he said. "For people at increased risk of exposure, the benefits of the vaccine far outweigh the risks when all factors are considered. Vaccination against anthrax is the best round-the-clock protection available to protect our forces at risk."

Posted by MBVIC at 7:50 PM |

Service members must OK anthrax inoculation, court told


By Gordon Trowbridge
Times staff writer

Attorneys for six military members fighting the Pentagon’s anthrax vaccination program argued Monday that a law designed to protect service members from experimental drugs should apply to the controversial vaccine.

The arguments, in a legal brief filed Monday with the U.S. Court of Appeals for the District of Columbia Circuit, are the latest step in a long battle over the vaccine. The court earlier this month asked both the government and the anonymous plaintiffs in the case to file briefs on whether a 1998 law, passed in response to concerns over Gulf War illness, requires the Pentagon to seek permission before injecting those in uniform with the vaccine. The law applies to any drug being used in any application not approved by the Food and Drug Administration.

Earlier, government attorneys had argued that law doesn’t apply to the anthrax shots because the vaccine was licensed by the National Institutes of Health in the 1970s under an earlier system. Several years ago, the FDA took over vaccine licensing from the NIH.

But in passing the experimental drug rule, “Congress saw fit to impose strict limits for vaccines,” tougher rules than the original NIH license, the brief filed Monday argues.

The government is seeking to overturn a lower-court ruling blocking the mandatory vaccinations. But it received new ammunition on Friday, when the FDA repeated an earlier finding that the vaccine is safe and effective for use against inhaled anthrax spores — the kind most likely to be used in a weapon. The plaintiffs have argued that FDA misused other research findings in reaching that decision.

That decision could open the way for the government to resume mandatory vaccinations, but Defense Department officials said the shots will remain voluntary for now.

Posted by MBVIC at 4:30 PM |

December 17, 2005

Military may not change anthrax shot rules


The FDA's OK of the vaccine opens the door for mandatory shots, but it's unlikely to happen soon.
BY BOB EVANS

The U.S. Food and Drug Administration has once again decided that the anthrax vaccine used by the military meets safety and effectiveness standards, paving the way for the return of the controversial mandatory shot program.

But that doesn't mean the "take the shot or take a court-martial approach" will resume soon - or for very long.

The FDA ruling, announced late Thursday, means the military could bypass a court injunction and resume putting needles into troops' arms without their consent, says Mark Zaid. He's one of the lawyers who has helped six unnamed members of the military and Department of Defense employees win a series of rulings in federal court that stopped the mandatory vaccination program in October 2004.

For the time being, the Department of Defense will continue the voluntary program put in place in May while it mulls its options, defense spokeswoman Cynthia Smith said Friday. She declined comment on the legal issues involved.

Since the voluntary program began, about half the troops eligible to receive the vaccine have accepted it, the Pentagon has said. At Fort Eustis, only 27 percent have been willing to get the shots, medical officials said last month.

Zaid said he and his colleagues anticipated the FDA decision and have prepared a lawsuit that would attempt to block any mandatory vaccination program on other grounds.

The anthrax vaccine has been controversial since the early 1990s, when some doctors and veterans of the 1991 Gulf War began questioning whether widespread health problems among veterans of that war were attributable to the vaccine.

Even though the vaccine has been licensed by the government since 1970, it hadn't been given to more than a few hundred people a year until the 1991 war, when military officials fearful of Saddam Hussein's use of chemical and biological weapons began inoculating troops.

When many troops came home from that war and began complaining about joint pain, memory loss, intestinal problems and other maladies that doctors couldn't explain, some researchers began to link those who were sick with those who'd taken the shots. That research was inconclusive and the military decided in 1998 to make the shots mandatory for everyone in uniform and for civilians who might enter areas where anthrax could be used as a weapon.

They said Iraq and other countries might figure out how to turn anthrax into a weapon and that the consequences of not vaccinating troops could be catastrophic.

Anthrax is a biological weapon that produces toxins once inside the body, whether it is ingested, inhaled or comes in contact with open sores in the skin.

Anthrax as a weapon would take the form of an aerosol - something that would be dispersed in the air and inhaled.

When the vaccine was first licensed for use by the government, there was no distinction made about whether it was considered effective against anthrax that came in contact with the skin or anthrax that was inhaled. The scientific trials with humans that led to licensing primarily involved situations where anthrax came in contact with the skin.

In the mid-1970s, a panel of scientists asked to review licensing of anthrax vaccine and other drugs said there was insufficient evidence that it was effective against inhaled anthrax but recommended it be allowed for protection against anthrax in contact with skin. The license didn't distinguish between the two exposures, however.

As troops began complaining about the effects of the vaccine in recent years, they began examining the licensing process and found that the FDA had never properly held an effective, meaningful public comment period before approving the drug.

They went to court and argued that because of this failure, the Department of Defense couldn't force troops to take the vaccine without their consent - that the drug was, in effect, experimental.

A federal judged ruled repeatedly that the troops were right. He stopped the vaccination program last year, then in May allowed it to continue as long as troops signed statements that they'd taken the vaccine voluntarily after being given information about its potentially harmful effects.

Posted by MBVIC at 4:28 PM |

December 16, 2005

FDA: Anthrax vaccine is safe


From staff and wire reports

The Food and Drug Administration on Thursday confirmed its previous finding that the anthrax vaccine being given to members of the U.S. military is safe and effective for all forms of the disease, including the inhalation variety that is most likely to be encountered on the battlefield.

That is a key step in the government’s efforts to overturn a federal court ruling in late 2004 that shut down the military’s mandatory anthrax vaccine program and allowed the shots to continue only on a voluntary basis only.

The court ruling came in a multiyear lawsuit that began when six members of the military challenged the Pentagon’s use of a mandatory vaccination against anthrax in some military troops.

Published in the Federal Register, the FDA review on the Anthrax Vaccine Absorbed, or AVA, “determines AVA to be safe and effective and not misbranded.”

FDA spokeswoman Julie Zawisza said the agency found no evidence to alter its previous finding that the vaccine is safe.

“We believe the vaccine is safe and effective for intended use, which would include [prevention of] inhalation anthrax,” she said.

The agency also received public comments about the vaccine, but Zawisza was unable to characterize them Thursday.

However, after the public comment period closed in May, a random review by Army Times of about 20 percent of the roughly 300 comments received — many of them from current a former service members and their families — showed strong opposition to the vaccine.

Since 1998, 1.2 million troops have been vaccinated against anthrax in six-shot regimens. But there have been numerous reports of service members who believe the vaccine made them ill.

Hundreds of others had been punished or discharged for refusing the shots until U.S. District Judge Emmet Sullivan in suspended the military’s mandatory program in December 2004 after finding fault with the FDA’s process for approving the drug as safe and effective against inhalation anthrax.

In large part, Sullivan based his ruling on the fact that the FDA did not follow its own regulatory procedures, which included a failure to solicit public comment on the vaccine.

Several months after ordering the shutdown of the military’s mandatory vaccine program, Sullivan said the Pentagon could resume giving vaccinations, but only to troops who volunteer for them. Several months into the voluntary program, only about half the service members offered the vaccine were accepting it.

Following Sullivan’s ruling, the government quickly appealed to reinstate mandatory inoculations. That lawsuit is ongoing in federal court.

Dr. William Winkenwerder, assistant secretary of defense for health affairs, said in a statement that the military will continue to provide anthrax vaccines on a voluntary basis, and service members will still be able to refuse the vaccine.

However, he added, “The threat of anthrax as a weapon remains real. It is very important to provide our service members with maximum protection against this threat, particularly when operating in certain areas of the world.

He said that for “people at increased risk of exposure, the benefits of the vaccine far outweigh the risks when all factors are considered.”

“Vaccination against anthrax is the best round-the-clock protection available to protect our forces at risk.”

Read the FDA’s final rule on the anthrax vaccine published in the Federal Register.

Posted by MBVIC at 4:26 PM |

Will Congress Give Vaccine Makers a Shot in the Arm?


Marcia Coyle
The National Law Journal


Fear of lawsuits, hostility toward trial lawyers, short-sightedness and pandering to special interests are behind a Republican-led effort to enact quickly unprecedented vaccine liability protection for drug manufacturers and sellers with little or no compensation for injured victims in the event of a pandemic flu outbreak, say a host of health, consumer, union and other groups.

Many of those groups have joined together in an effort to force into the open what have been closed-door negotiations by Senate and House Republicans over a plan to attach the liability waiver to a pending Department of Defense appropriations bill expected to pass both chambers before the year's end.

"They are putting this provision on the Defense appropriation because they know it's insufficient standing alone and that's how you get it through the Congress," said Barbara Coufal, legislative affairs specialist for the American Federation of State, County and Municipal Employees. "I think that speaks to the inadequacy of this one-sided approach."

Democrats appear to be locked out of the negotiations in the Senate. Their staffers and the groups' legislative directors have been unable to get details of what's being proposed, other than the broad liability protection for vaccine manufacturers. The groups themselves are divided on the need for liability protection to encourage vaccine production, but they are united in the belief that any liability protection must be coupled with a compensation program if a vaccination effort is to succeed.

"[Senate Majority Leader Bill] Frist says the industry needs this protection in order to motivate it," said Jillian Aldebron, civil justice counsel for Public Citizen's Congress Watch. "It's not even true. They're all falling all over each other to get into the bird flu business. The prospect of global disease and big government purchases has them all salivating."

"We're concerned about making sure that, like first responders, consumers will have somewhere to turn if there is gross negligence and the like [in vaccine production and use]," said Helen Gonzales, policy director for USAction.

"For Republican leadership to be moving forward with a very broad liability waiver while doing nothing for first responders and consumers seems not the proper way to do this," she said. "You can do it quickly, but not in the middle of night in a secret way."

The nation's experience with vaccination programs, particularly the recent and spectacular failure of the federal smallpox vaccination program, proves the truth of what Gonzales says, according to Michael Greenberger of the University of Maryland School of Law, director of the university's Center for Health and Homeland Security.

"It's a very, very complicated issue," he said. "There is no doubt vaccine manufacturers need sufficient liability protection, but it has to be accompanied by a sophisticated and adequate compensation policy for those injured by the vaccine. What's driving policymakers now is they fear and dread the onset of attorneys bringing frivolous lawsuits. Certainly that can be worked out in the compensation process."

The federal government has implemented three major vaccine liability and compensation programs in the last 30 years: the National Swine Flu Immunization Program of 1976, the National Childhood Vaccine Injury Compensation Act of 1986 and the so-called Phase I smallpox vaccination program launched in 2003.

Fear of a swine flu pandemic surfaced in January 1976 when four cases of swine flu were reported in New Jersey. Congress authorized the purchase of about 200 million doses of the swine flu vaccine in April of that year.

But concerns about vaccine manufacturers' liability, according to Greenberger, did not arise until insurers -- pointing to a federal court decision holding polio vaccine manufacturers strictly liable for failing to provide product warnings directly to consumers -- announced they would end coverage in June of that year.

Congress responded with the Swine Flu Act, under which the United States assumed the liability of manufacturers, distributors and vaccinators. Injured parties filed their court claims against the government under the Federal Tort Claims Act after first filing an administrative claim. The act allowed the government to seek indemnification from negligent parties covered by the liability protections. The act also did not limit the amount of awards to injured claimants.

By 1985, the government had paid $90 million in awards to injured claimants and thus began, said Greenberger, the government's increasing reluctance to assume the financial risks in vaccination programs.

Congress got back into the vaccine business in the mid-1980s in response to a decline in the number of manufacturers making childhood vaccines. However, the lawmakers drafted a more limited liability and compensation policy under the National Childhood Vaccine Injury Compensation Act than provided by the Swine Flu Act.

NCVICA set up a two-stage compensation system for specific childhood vaccines. In the first and mandatory stage, a federal court special master administered no-fault compensation for specific injuries. Awards are capped and the government is the defendant.

If dissatisfied with the administrative result, claimants could sue the vaccine manufacturer in the tort system -- the second stage under NCVICA. But Congress enacted certain liability protections for the manufacturers here, such as immunity from punitive damages if they had complied with the Federal Food, Drug and Cosmetic Act and the Public Health Service Act. NCVICA also made compensation secondary to federal, state and private sources of compensation.

In January 2003, the Bush administration launched the Phase I smallpox vaccination program, designed to vaccinate 500,000 civilian first responders with an existing smallpox vaccine.

The program initially relied on Section 304 of the Homeland Security Act of 2002 for liability protection and compensation. But it soon became clear, as health care workers and unions balked at being vaccinated, that those provisions were neither clear nor adequate to overcome first responders' concerns that if injured by the vaccine, they would be compensated.

Congress worked on additional liability and compensation provisions over the next few months. Ultimately, however, the program failed to achieve its goal. Roughly 40,000 first responders out of the targeted 500,000 have been vaccinated.

"The program sort of disappeared off the face of the earth," said Greenberger, who wrote about all three programs in a recent law review article. "The overwhelming problem pre-event -- and vaccination for a flu pandemic will need to be done pre-event -- is that health care unions don't want to participate if they are not assured their workers will receive adequate compensation if injured," he said.

There are reports that the pandemic flu vaccine being developed appears to be very effective, he said. The United States has ordered about 2 million doses and the message is going out that hospital and health care workers will have to be vaccinated.

"We are going to go through the exact thing again, as with smallpox, if there's not an adequate compensation program," said Greenberger. "The cost of an adequate program is quite small compared to the public health benefits to be derived."

NO LIABILITY, NO MONEY

The focus of the behind-closed-door negotiations on pandemic flu vaccine liability appears to be Section 6 of S. 1873, the Biodefense and Pandemic Vaccine and Drug Development Act of 2005, sponsored by Senator Richard Burr, R-N.C.

Under that section, vaccine manufacturers are immune from any liability except in the case of willful misconduct. And a willful misconduct claim is determined by the secretary of the Department of Health and Human Services. The bill would provide compensation for injured persons in accordance with the compensation provisions of the small pox vaccination program.

But various Hill sources contend that Republican leaders are only preparing the immunity side of the equation for amendment to the Defense appropriations bill. And that section has been expanded to allow the secretary to waive liability under certain emergency conditions.

"The immunity there is fairly broad," said Joanne Doroshow of the Center for Justice & Democracy. "It doesn't allow any lawsuit for gross negligence or recklessness. In order for even a claim of intentional misconduct, the secretary of HHS would have to designate it as such before a suit could go forward and there's no compensation at all."

The Burr bill itself is "problematic," said AFSCME's Coufal, because it uses the smallpox program as a compensation model. "We don't think that's appropriate because it only covers first responders and health care workers," she said. "We think any compensation program has to cover the entire public."

Burr spokesman Doug Heye said his boss is still working with Democrats on a bipartisan compromise on the bill that Burr hopes will be the Senate vehicle because it represents a more comprehensive approach to a bioterror threat.

Republican leaders negotiating the liability provision may believe they can deal with compensation later, said Julie M. Mair of Johns Hopkins Bloomberg School of Public Health. "With pandemic flu, the compensation issues might be different. For smallpox, we wanted people to volunteer to be vaccinated. You needed compensation. People probably will be rushing down the door to get pandemic flu vaccine. It needs to be investigated, but I would not say it's a definite component."

But some question whether liability protection is necessary. "Is this what is affecting vaccine production?" asked Doroshow. "Experts pretty universally say this is not the reason. A study in the Journal of the American Medical Association a month ago said liability has nothing to do with this. The reasoning behind liability protection is a lot of hype, anti-trial lawyer hype."

Public Citizen's Aldebron agreed, adding that the industry already has indemnification under Bush Executive Order 10789, which has been made part of HHS' pandemic flu plan. "They're holding us hostage. Let's call their bluff."

The drug companies have been quiet on the negotiations. When Bush announced a pandemic flu plan last month, drug manufacturers said liability protection was essential. "The liability provision is not finished yet, so we're not ready to say something," said a spokesperson for the Biotechnology Industry Organization.

Greenberger said that manufacturers are interested, but the country is not going to get the amount of vaccine it needs quickly without liability protection.

"With such hostility towards plaintiff litigation, that's a very hard thing to sell, but I feel strongly the government needs to step in here," he said.

"It can fight off frivolous lawsuits or have lawsuits dealt with in an administrative process, but to say there is no compensation is asking for trouble."

Posted by MBVIC at 6:29 AM |

December 14, 2005

Local Police Request Quarantine Guidelines


Global Security Newswire

The International Association of Chiefs of Police has voiced concern that
its members lack guidelines for enforcing quarantines, USA Today reported
today (see GSN, Nov. 23).

While federal agencies and the military would lead quarantine efforts
following a bioterrorist event or naturally occurring disease outbreak,
according to USA Today, the association has complained that local law
enforcement officials lack basic information about their role in such a
crisis.

"We're the ones who are going to be the first to respond. ... I would have
thought we would be further along than we are now," said association
President and Gaithersburg, Md., Police Chief Mary Ann Viverette. "We need
some guidance."

The Centers for Disease Control and Prevention developed a model state law
on quarantines following the terrorist attack of Sept. 11, 2001. The model
has been used as the basis for 80 pieces of legislation in 32 states; 30 of
those bills have become law, according to the Center for Law and the Public's
Health at Georgetown and Johns Hopkins universities.

These laws, however, have created a "patchwork-quilt of legislation" with
few specific guidelines for local police, according to the chiefs' group.

Ram Koppaka, associate director for policy and preparedness in the CDC
Global Migration and Quarantine Division, said the agency would review the
association's concerns (Kevin Johnson, USA Today, Dec. 14)

Posted by MBVIC at 7:55 PM |

Court asked to allow mandatory inoculations


A law banning the Pentagon’s use of experimental drugs without troops’ consent does not preclude mandatory anthrax vaccinations, government lawyers contend in their latest court filing in the long-running legal battle over the vaccine.
The government brief, filed this week with the U.S. Court of Appeals for the District of Columbia Circuit, argues that the controversial vaccine’s licensing under a law governing biological products trumps a 1998 law in which Congress required troops to consent before the military administered investigational drugs.

Applying the 1998 law — passed in response to widespread concerns about the use of experimental drugs and the emergence of Gulf War Syndrome — would “preclude the military from requiring the administration of any vaccine,” the government contends. “No basis for such a reading exists in law or logic.”

The Pentagon is seeking to overturn a federal court ruling last year that halted mandatory anthrax vaccinations. That ruling was a victory for the six anonymous military and Defense Department civilian plaintiffs who contend the Pentagon was requiring vaccinations using a drug unapproved for use against airborne anthrax spores — the kind of anthrax most likely to be used by an enemy in battle.

The appeals court heard oral arguments in the case Dec. 1 and four days later ordered the parties to file briefs on whether the 1998 law, which bars mandatory use of drugs for uses unapproved by the Food and Drug Administration, should apply to the anthrax vaccine. That law had played little role in the legal battle before the three-judge panel that is hearing the case raised it during oral arguments.

The government’s brief, filed Dec. 12, argues that because vaccines and other “biological products” are licensed not by the FDA, but by the National Institutes of Health under a separate law, the congressional ban should not apply to the vaccine.

Lawyers for the six anonymous military members who filed the suit are scheduled to respond to the government’s brief by Dec. 19. A decision by the appeals court is not expected for several weeks.

Posted by MBVIC at 4:23 PM |

December 10, 2005

Sailor links rare cancer diagnosis to anthrax shot


By Bob Evans
Daily Press

NEWPORT NEWS, Va. - Patrick Kelly was a rising star in the Navy, a junior-grade lieutenant who rose from entry-level seaman the hard way - working his way up without benefit of college or special programs. Kelly's 19-year career was studded with commendations for his ability to understand, enact and explain to others the ever-expanding use of computers on modern warships - a skill highly prized by admirals. But his last three years in uniform, after inoculation with anthrax vaccine, were also marked with a series of ailments: chronic joint pain, impotence, rapidly deteriorating eyesight, sudden onset of asthma, chronic fatigue and then broken bones in his back - just from rolling over in bed.

Doctors finally figured out that Kelly had multiple myeloma, a rare form of cancer. It's an autoimmune disease in which the body produces too many plasma cells, destroying the person's healthy cells and bones in the process. Military doctors told Kelly his illness wasn't related to his anthrax shots. But several medical experts say there's good evidence that the naysayers are wrong.

That evidence includes blood from retirees at the nation's key chemical and biological warfare lab, where nearly all workers are vaccinated for anthrax. Those samples show signs of a condition that precedes multiple myeloma.

It includes vials of vaccine contaminated with a controversial additive that causes severe autoimmune illnesses in lab animals. Several prominent vaccine researchers died from multiple myeloma after injecting themselves with similar additives.

Multiple myeloma is a rare form of cancer, typically afflicting people ages 50 and older. Kelly was 47 when diagnosed - young, but not shockingly so.

Within three years, half die.

Kelly says his arm was tender for days after each of his first three anthrax vaccinations. After the fourth, his bicep swelled to twice normal size.

In the following months, Kelly bounced from one medical problem to another.

When he was finally diagnosed with multiple myeloma at Naval Medical Center Portsmouth (Va.) in April 2003, Kelly says, he asked his doctor when it started. Dr. William Jawien, a Navy Reserve officer and cancer specialist estimated two to three years.

Kelly counted back and realized that was when he'd received his anthrax shots.

Jawien says he doubts a connection because there's no good scientific research proving a link. The connection isn't far-fetched biologically, though, he says. The anthrax shot, like many vaccines, activates B cells - white blood cells that make antibodies - to do its work. B cells gone berserk are a hallmark of multiple myeloma.

Pentagon officials in charge of the anthrax program say they don't know how many troops who received the vaccine have contracted multiple myeloma

Before Kelly had multiple myeloma, he had a rare but undiagnosed blood condition known as MGUS - "monoclonal gammopathy of undetermined significance." It always precedes multiple myeloma.

Robert Kyle is a hematologist at the Mayo Clinic in Minnesota and one of the world's leading experts on multiple myeloma. He was the first to identify and study MGUS. He says he doubts Kelly's illness is related to the vaccine, but no one can be sure.

Kyle says people with MGUS don't always progress to multiple myeloma - only about 1 percent a year. "There has to be an additional factor to trigger the multiple myeloma." So far, those triggers have eluded scientists. "When it comes to the individual patient, there's absolutely no way of saying."

A number of researchers have theorized that vaccinations in general trigger the disease in people genetically predisposed. Kyle and others are skeptical.

One possible link between vaccines and MGUS surfaced last year. It was in a medical journal article by military researchers looking at possible side effects of the frequent vaccines given to troops.

They found that retirees from the Fort Detrick, Md., biological warfare laboratory had a "surprising" level of blood protein indicative of MGUS, after years of taking multiple vaccines to protect them at work. It was "the most important finding of this study," worthy of further investigation, they wrote.

Of the 155 people from Fort Detrick, 91.6 percent had received anthrax vaccinations.

A similar study of Fort Detrick workers in 1974 noted that one died of multiple myeloma. There was no mention of whether she had taken the anthrax vaccine. Oddities in blood were found then, too, but that was before MGUS had been identified.

H. Hugh Fudenberg is a former member of the National Institutes of Health's Task Force on Multiple Myeloma and Chronic Leukemia. He says health records of Fort Detrick workers that he examined about 20 years ago showed widespread evidence of MGUS.

Fudenberg is one of several experts on vaccines and autoimmune diseases who say Kelly's cancer very well might have been triggered by his anthrax shots - especially given the contamination involved. Kelly's medical records and findings by the Food and Drug Administration show that all five doses of anthrax that he received came from vaccine batches containing squalene.

Squalene is an oil that occurs naturally in the body. It's an essential ingredient for making cells and hormones, and it's also a controversial additive to vaccines. No vaccine containing squalene is licensed for use in the United States, though it's licensed overseas. The Defense Department has patented at least one squalene-based vaccine additive. The work was done at Fort Detrick.

Experiments with laboratory animals show that some, though not all, contract painful and debilitating autoimmune diseases after squalene injections.

Fudenberg and Pam Asa, a researcher at Tulane University in New Orleans, point out that a group of immunologists who pioneered vaccine additives such as squalene and other oils in the mid-20th century often injected themselves as part of their experiments. Several died of multiple myeloma, including the leader of the movement, researcher Jules Freund.

FDA officials told Congress that the level of squalene found in samples of anthrax vaccine were too small to matter. But they admitted that they couldn't be sure. Samples from six batches of vaccine - totaling 1.2 million doses - tested positive.

Asa and other Tulane researchers say they've found a high correlation between veterans with autoimmune problems and doses from those batches. "There were a number of people on myeloma watches" in the mid-1990s, when she first began looking into the possible relationship of the drug and illnesses suffered by veterans of the 1991 Persian Gulf War, Asa says.

She and others have been fighting for money and data to look deeper - at bigger groups of patients, she says. But, she says, the government hasn't given those resources to researchers critical of the vaccine program.

The military and vaccine manufacturer deny that squalene was given to troops without their knowledge. They deny knowing how it got into the vaccine given to Kelly and others.

The Government Accountability Office, Congress' investigative arm, says the military experimented with squalene in anthrax vaccine before the Gulf War and considered giving it to troops then. The agency also says the head of the military program wouldn't cooperate with its investigation.

Kelly and other ill veterans say they think that the squalene in their vaccine was an experiment - just another example of the Pentagon using troops as guinea pigs.

"My concern is that this is going to be like Agent Orange," a plant-killing chemical used in Vietnam to destroy jungles and deny the enemy a hiding place, Kelly says. "They said for 30 years that Agent Orange wasn't anything."

Now the government has a list of 18 diseases and illnesses linked to Agent Orange. It estimates that 178,000 veterans will be disabled from it by 2008.

"This could be bigger," Kelly says. But given the military's refusal to admit mistakes, "we'll have to wait 30 years to find out."

Kelly probably doesn't have that kind of time. He's pushed the limits of living with multiple myeloma, though his cancer has stabilized in recent months, surprising a succession of doctors who say he has one of the tougher and stronger versions of the disease.

On a good day, he can muster just enough energy to take his kids to a doctor and make them dinner. They recently moved to New Jersey, so relatives could help.

Kelly is one of two people left from a 10-patient test of a new drug, and he just hopes to hang on.

"I'll just stay on it as long as I can, as long as I'm stable," he says. "That makes for more time for them to develop another drug."

Posted by MBVIC at 7:56 PM |

20,000 who got anthrax shot were hospitalized

By Bob Evans
The Daily Press

NEWPORT NEWS, Va. - The Pentagon never told Congress about more than 20,000 hospitalizations involving troops who'd taken the anthrax vaccine, despite repeated promises that such cases would be publicly disclosed.


Instead, a parade of generals and Defense Department officials told Congress and the public that fewer than 100 people were hospi-talized or became seriously ill after receiving the shot from 1998 through 2000.

They also showed Congress written policies that required public reports to be filed for hospitalizations, serious illnesses and cases where someone missed 24 hours or more of duty.

But only a sliver of those cases were reported, while the rest were withheld from Congress and the public, records obtained by the Daily Press show.

Critics of the vaccine, veterans' advocates and congressional staffers say the Pentagon's deliberate low-balling of hospitalizations helped persuade Congress and the public that the vaccine was safe.

Keeping the actual number of illnesses secret contributed to a shorter list of government-recognized side effects for the drug, giving patients and physicians a false idea of what might constitute a vaccine-related illness or problem. Doctors are expected to know the full list of side effects and alert federal drug safety officials whenever they see a repeat of those symptoms.

Repeated evidence of the same adverse side effect after a vaccination is one of the most telling signs of a systematic problem with a drug or vaccine, as opposed to a coincidental relationship, vaccine safety experts say.

Lou Gehrig's disease

During the Daily Press' investigation of the vaccine and its effects, the newspaper found three cases of amyotrophic lateral sclerosis - ALS, or Lou Gehrig's disease - that the military hadn't reported. The disease destroys muscles and nerves, is always fatal and rarely hits people younger than 45.

One of the three cases involves Navy Capt. Denis Army of Virginia Beach, Va. Army died in 2000, after developing symptoms less than a week after his first anthrax vaccination - and a few days before his 45th birthday. His widow filed the first public acknowl-edgement of his death and its temporal connection to the vaccine this year. That occurred after she talked to a Daily Press reporter and learned that she could file a report with the federal Vaccine Adverse Event Reporting System, or VAERS.

Navy Petty Officer 2nd Class Kristin Shemeley died of ALS in 2001, at 29. Her symptoms began about two months after her third shot, a sworn legal document detailing her illness says.

Before Shemeley died, she spent 14 months in Walter Reed Army Medical Center in Washington, D.C., where she was regularly vis-ited by high-ranking military officers, said her mother, Ginger Shemeley of Quakertown, Pa. She says her daughter repeatedly told those generals and admirals that she was suffering because of the vaccine and even pleaded with one of them to stop giving it to troops. Several of those generals and admirals had promised Congress that such cases would be publicly
reported to VAERS.

The military never filed a VAERS report on Kristin Shemeley. Ginger Shemeley filed one after her daughter died.

Col. John Grabenstein, director of the military's vaccine agency, said no one from the military intentionally misled Congress or the public. He said the 20,765 hospitalizations merely followed vaccinations in time, without documented proof of a cause-and-effect relationship.

He said a statistical analysis showed that those who'd been vaccinated weren't more likely to be hospitalized or likely to seek medi-cal treatment than those in the military who hadn't been vaccinated from 1998 through 2000.

Some medical experts say this approach doesn't adequately address the problems of many people who report illnesses after anthrax vaccination. That's because the approach is limited to comparing rates of illness involving one symptom or disease - instead of the complex combination of symptoms and illnesses that many veterans report after getting their shots.

The data that the Daily Press used to document the underreporting of hospitalizations came from a report that Grabenstein supplied in response to the newspaper's request. It had never been made public.

It covers 1998 through 2000, when the Pentagon did detailed evaluations every three months to compare hospitalizations, clinic vis-its and medical treatment data for those who'd been vaccinated, compared with troops who hadn't. This quarterly analysis stopped and hasn't been done since, Grabenstein said.

The practice of not reporting all hospitalizations continues.

Quarterly analysis of the vaccine's effects ended just as the nation's only manufacturing site for the drug regained its license. That was in 2002, after federal inspections found many safety and other problems that prompted a shutdown and renovation that began in early 1998.

The company's current manufacturing techniques provide greater potency compared with earlier versions of the drug, said the Government Accountability Office, Congress' investigative arm. The manufacturer, BioPort Inc., says there's no difference in the drug made since 2002 that might cause health problems.

No long-term study

The decision to discontinue the quarterly health monitoring program means that the biggest gap in research about the vaccine re-mains: There are no systematic long-term studies of the health of those who've taken the drug. Most studies that the Pentagon cites as support for the vaccine's safety involve monitoring that lasted days to a few months.

None lasted as long as five years, the minimum length of time recommended by a nationally recognized panel of scientists assem-bled by the Institute of Medicine in 2002. The institute is a nonprofit organization that provides expert advice to Congress and other government agencies.

After the quarterly reviews of the vaccine's effects stopped, more than a million troops were forced to take the vaccine - until a federal judge ruled last year that the drug had never been adequately licensed for protection against anthrax use in warfare.

He ordered the military to make vaccination voluntary. The Pentagon is appealing that ruling. A decision is expected by February.

Grabenstein said he decided to halt the quarterly studies after consulting the chairman of the Institute of Medicine panel and its staff, and with doctors affiliated with the military. He acknowledged that he didn't consult the general who ultimately was responsible for the anthrax program.

The chairman of the institute panel, Brian Strom, said he didn't recall what was discussed at the time about the quarterly reports. But he said, "I think they should continue to be using it," in case there's a problem.

Another panel member, Linda Cowan, said she's sure the committee expected quarterly reviews to continue and pointed to a num-ber of the panel's recommendations and findings that she said clearly contradicted Grabenstein's interpretation of its report.

Strom and Cowan emphasized that they thought the vaccine was still safe.

Beth Clay isn't so sure. She directed the staff of Congress' House Government Reform Committee investigation into the anthrax vaccine from 1998 to 2001. She continued working on the subject as a congressional staff member through 2003, after her Republican boss was no longer chairman of the committee.

Clay said the military's decision not to report all the hospitalizations gave the public and Congress a rosier picture of the vaccine than it deserved.

"We were never given this data," she said. "Had we seen this, the committee would have had significant questions" and would have demanded more information about the program.

After reviewing the report obtained by the Daily Press, Clay said it raised several questions about the vaccine's safety. She said Congress was never told about the detailed level of data in the report but was assured regular monitoring of the vaccine and its health ef-fects would continue.

Terminating the quarterly reviews would seem to break those promises, she said. "It's just appalling that they didn't keep up with this," she said.

Posted by MBVIC at 7:37 PM |

December 9, 2005

The anthrax vaccine: New questions, weak data


BY BOB EVANS
Daily Press

(Newport News, Va.)NEWPORT NEWS, Va. - The Pentagon never told Congress about more than 20,000 hospitalizations involving troops who'd taken the anthrax vaccine, despite repeated promises that such cases would be publicly disclosed.

Instead, a parade of generals and Defense Department officials told Congress and the public that fewer than 100 people were hospitalized or became seriously ill after receiving the shot from 1998 through 2000.
They also showed Congress written policies that required public reports to be filed for hospitalizations, serious illnesses and cases where someone missed 24 hours or more of duty.
But only a sliver of those cases were reported, while the rest were withheld from Congress and the public, records obtained by the Daily Press show.
Critics of the vaccine, veterans' advocates and congressional staffers say the Pentagon's deliberate low-balling of hospitalizations helped persuade Congress and the public that the vaccine was safe.
Keeping the actual number of illnesses secret contributed to a shorter list of government-recognized side effects for the drug, giving patients and physicians a false idea of what might constitute a vaccine-related illness or problem. Doctors are expected to know the full list of side effects and alert federal drug safety officials whenever they see a repeat of those symptoms.
Repeated evidence of the same adverse side effect after a vaccination is one of the most telling signs of a systematic problem with a drug or vaccine, as opposed to a coincidental relationship, vaccine safety experts say.
During the Daily Press' investigation of the vaccine and its effects, the newspaper found three cases of amyotrophic lateral sclerosis - ALS, or Lou Gehrig's disease - that the military hadn't reported. The disease destroys muscles and nerves, is always fatal and rarely hits people younger than 45.
One of the three cases involves Navy Capt. Denis Army of Virginia Beach, Va. Army died in 2000, after developing symptoms less than a week after his first anthrax vaccination - and a few days before his 45th birthday. His widow filed the first public acknowledgement of his death and its temporal connection to the vaccine this year. That occurred after she talked to a Daily Press reporter and learned that she could file a report with the federal Vaccine Adverse Event Reporting System, or VAERS.
Navy Petty Officer 2nd Class Kristin Shemeley died of ALS in 2001, at 29. Her symptoms began about two months after her third shot, a sworn legal document detailing her illness says.
Before Shemeley died, she spent 14 months in Walter Reed Army Medical Center in Washington, where she was regularly visited by high-ranking military officers, said her mother, Ginger Shemeley of Quakertown, Pa. She says her daughter repeatedly told those generals and admirals that she was suffering because of the vaccine and even pleaded with one of them to stop giving it to troops. Several of those generals and admirals had promised Congress that such cases would be publicly reported to VAERS.
The military never filed a VAERS report on Kristin Shemeley. Ginger Shemeley filed one after her daughter died.
Col. John Grabenstein, director of the military's vaccine agency, said no one from the military intentionally misled Congress or the public. He said the 20,765 hospitalizations merely followed vaccinations in time, without documented proof of a cause-and-effect relationship.
He said a statistical analysis showed that those who'd been vaccinated weren't more likely to be hospitalized or likely to seek medical treatment than those in the military who hadn't been vaccinated from 1998 through 2000.
Some medical experts say this approach doesn't adequately address the problems of many people who report illnesses after anthrax vaccination. That's because the approach is limited to comparing rates of illness involving one symptom or disease - instead of the complex combination of symptoms and illnesses that many veterans report after getting their shots.
The data that the Daily Press used to document the underreporting of hospitalizations came from a report that Grabenstein supplied in response to the newspaper's request. It had never been made public.
It covers 1998 through 2000, when the Pentagon did detailed evaluations every three months to compare hospitalizations, clinic visits and medical treatment data for those who'd been vaccinated, compared with troops who hadn't. This quarterly analysis stopped and hasn't been done since, Grabenstein said.
The practice of not reporting all hospitalizations continues.
Quarterly analysis of the vaccine's effects ended just as the nation's only manufacturing site for the drug regained its license. That was in 2002, after federal inspections found many safety and other problems that prompted a shutdown and renovation that began in early 1998.
The company's current manufacturing techniques provide greater potency compared with earlier versions of the drug, said the Government Accountability Office, Congress' investigative arm. The manufacturer, BioPort Inc., says there's no difference in the drug made since 2002 that might cause health problems.
The decision to discontinue the quarterly health monitoring program means that the biggest gap in research about the vaccine remains: There are no systematic long-term studies of the health of those who've taken the drug. Most studies that the Pentagon cites as support for the vaccine's safety involve monitoring that lasted days to a few months.
None lasted as long as five years, the minimum length of time recommended by a nationally recognized panel of scientists assembled by the Institute of Medicine in 2002. The institute is a nonprofit organization that provides expert advice to Congress and other government agencies.
After the quarterly reviews of the vaccine's effects stopped, more than a million troops were forced to take the vaccine - until a federal judge ruled last year that the drug had never been adequately licensed for protection against anthrax use in warfare.
He ordered the military to make vaccination voluntary. The Pentagon is appealing that ruling. A decision is expected by February.
Grabenstein said he decided to halt the quarterly studies after consulting the chairman of the Institute of Medicine panel and its staff, and with doctors affiliated with the military. He acknowledged that he didn't consult the general who ultimately was responsible for the anthrax program.
The chairman of the institute panel, Brian Strom, said he didn't recall what was discussed at the time about the quarterly reports. But he said, "I think they should continue to be using it," in case there's a problem.
Another panel member, Linda Cowan, said she's sure the committee expected quarterly reviews to continue and pointed to a number of the panel's recommendations and findings that she said clearly contradicted Grabenstein's interpretation of its report.
Strom and Cowan emphasized that they thought the vaccine was still safe.
Beth Clay isn't so sure. She directed the staff of Congress' House Government Reform Committee investigation into the anthrax vaccine from 1998 to 2001. She continued working on the subject as a congressional staff member through 2003, after her Republican boss was no longer chairman of the committee.
Clay said the military's decision not to report all the hospitalizations gave the public and Congress a rosier picture of the vaccine than it deserved.
"We were never given this data," she said. "Had we seen this, the committee would have had significant questions" and would have demanded more information about the program.
After reviewing the report obtained by the Daily Press, Clay said it raised several questions about the vaccine's safety. She said Congress was never told about the detailed level of data in the report but was assured regular monitoring of the vaccine and its health effects would continue.
Terminating the quarterly reviews would seem to break those promises, she said. "It's just appalling that they didn't keep up with this," she said.
Steve Robinson is executive director of the National Gulf War Resource Center, a lobbying and advocacy group for veterans. He said he was stunned when he learned that the reviews had stopped: "They track the flu vaccine and not the anthrax vaccine, which is totally crazy to me."
He said discovery of the hospitalization data showed that the Pentagon couldn't be trusted to monitor the vaccine's safety.
"You can't let Enron investigate Enron, and you can't let DOD (the Department of Defense) investigate DOD," he said. "We work with the people who have been hurt by this vaccine every day."
No one knows how many, or how few, of the 20,765 hospitalizations are directly attributable to the vaccine. Ruling out certain illnesses, such as broken bones or injuries from falls or other accidents, might appear a safe bet. But military doctors have documented cases where broken bones and other injuries from falling were the result of vaccine-induced loss of consciousness affecting the nervous system - sometimes beginning months after vaccination.
The difficulty of figuring out what's related and what isn't is why safety officials encourage people to file reports even if they're not sure.
Still, medical experts consulted by the Daily Press said it's unlikely that the vast majority of the 20,765 hospitalizations resulted from the vaccine. They said that if all hospitalizations had been filed with VAERS, it would have overloaded the system and caused problems for experts trying to analyze the data.
Grabenstein said those were among the reasons that the full number of hospitalizations was not reported. Another reason, he said, was that examinations of the data showed that if there were adverse effects from the vaccine, they were so infrequent, they weren't detectable by statistical analysis. Doing this type of analysis - instead of simply reporting the incidents to VAERS - provided a more definitive look at the health effects of the vaccine, he said. As a result, "we decided not to file" public reports about all hospitalizations, he said.
Those considerations weren't relayed to Congress or the public.
During the years covered by the hospitalization report obtained by the Daily Press, dozens of sick veterans who'd received the shot went to Capitol Hill, complaining of various health problems. Some got the shot for the 1991 Persian Gulf War, in which the vaccine had its first widespread use. Others were members of the military forced to take the shots under a mandatory program that began in 1998.
Their complaints had common themes: Fatigue. Chronic pain in joints and other symptoms of arthritis. Tingling in their feet, arms and hands. Mental lapses. Often, more than one of the symptoms were present, making diagnoses difficult.
Sympathetic doctors testified that these complaints were indicative of autoimmune problems, in which the body's natural protective mechanisms go haywire and start attacking healthy cells and tissue. The doctors said that could result if the vaccine overstimulated the vets' immune systems. The vaccine primes the system to develop protection against anthrax.
Bewildered and sometimes-angry members of Congress asked how many vets were affected. Pentagon doctors and generals used the cases reported to VAERS - fewer than 100 hospitalizations or other "serious events" from 1998 to 2000 - or said the number was so small, it couldn't be detected.
The two sets of numbers for how many hospitalizations followed the shot come from a comparison of two sets of data kept by three federal agencies.
The Food and Drug Administration and the Centers for Disease Control and Prevention maintain the only database open to public inspection, VAERS. VAERS is the nation's first line of defense in identifying possible problems with vaccines after they've been licensed, said Susan Ellenberg, who led the FDA's efforts to monitor vaccine safety from 1993 to 2004.
During congressional testimony before the House Government Reform Committee's Subcommittee on National Security, Veterans Affairs and International Relations in July 1999, Ellenberg explained how and why the system worked.
VAERS was established to help identify and head off problems once a vaccine is licensed and more people are taking it, she said. The few hundred people typically involved in vaccine or drug testing and licensing trials can't mimic the diversity of age, race, gender and other biologic variables encountered once the vaccine gets widespread public use, she explained.
Reports to VAERS by civilian doctors and hospitals are mostly voluntary, based on suspicion of a connection between an illness or injury and a vaccination, Ellenberg told Congress.
Doctors and others are encouraged to file a report, known as a VAERS-1, even when they aren't sure there's a cause and effect, she said. That's because VAERS requires as many reports of problems as possible, so experts can identify possible patterns and investigate further, she said.
During the same congressional hearing, Lt. Gen. G. Robert Claypool - then the deputy assistant secretary of defense for health operations policy - assured Congress that military doctors, hospitals and medical officials were filing VAERS-1 forms, too.
And, he said, they were expected to report even more cases than civilians - including all hospitalizations.
"The duty to report adverse medication events has been codified for many years," Claypool testified. "The joint regulation requires submission of a form VAERS-1 for all adverse events resulting in more than 24 hours of lost duty time or any period of hospitalization. These requirements represent a higher standard than in comparable civilian community health care settings."
There was no mention that the word "all" didn't mean all hospitalizations.
Two months later, Lt. Gen. Ronald R. Blanck, then the Army's surgeon general and the top Pentagon official responsible for the anthrax vaccine program from 1998 to 2000, gave similar assurances to Congress.
He said, "We have a reporting system that when either of those two criteria are met, that is, either a patient is hospitalized following an anthrax immunization or misses duty because of it for greater than 24 hours, we have an active reporting system. That must be reported to us. We, in turn, report it to the Food and Drug Administration, and they have a group that reviews those reactions."
Clay and other congressional aides say these assurances came in private, too. "We had lengthy conversations that they were supposed to report," she said.
But the numbers reported were very low. And the Pentagon stuck with them for years to persuade the public that the shot was safe.
In December 2003, Pentagon officials conducted a news conference to rebut a judge's ruling that the shots had been given illegally and that troops had been used as "guinea pigs." Grabenstein was asked whether he had "any data on the numbers of people who have had bad adverse reactions to the vaccine and would have required hospitalization."
He said that only 69 hospitalizations had been reported to VAERS for the anthrax vaccine from 1998 through 2000. A panel of civilian experts had analyzed each, he said, and decided that 11 were results of the shot. The 69 cases were "a complete, exhaustive list of what was reported," Grabenstein said.
Grabenstein told the Daily Press that his statement wasn't misleading. He said no one should expect all hospitalizations after vaccination to be reported to VAERS - despite the Pentagon's written policies - because the number included cases unrelated to the vaccine, sometimes years after vaccination.
He said, "The simple answer is it's so obvious, it's never appeared in the memo."
The memo, "Policy for Reporting Adverse Events Associated With the Anthrax Vaccine," serves as the standing order for all military personnel. It reads: "For the purposes of reporting anthrax vaccine adverse events, a Form VAERS-1 must be completed and submitted using service reporting procedures for those events resulting in a hospital admission or time lost from duty for greater than 24 hours or for those events suspected to have resulted from contamination of a vaccine lot."
The memo lists additional circumstances requiring a report, but nothing that would permit excluding hospitalizations after vaccination. It refers to the Pentagon's formal regulations, which don't include the exclusions that Grabenstein cited.
The data on all hospitalizations after anthrax vaccination comes from the Pentagon's Defense Medical Surveillance System, or DMSS. This computerized tracking system pulls medical records for every shot, clinic visit, hospitalization or other instance of medical treatment for active-duty military personnel.
Experts in health care and statistics say it's one of the most important medical databases in the world. That's because of its precision, its millions of patients, and the diversity of drugs and vaccines used by the armed forces. By design, it's more complete and accurate than VAERS. Unlike VAERS, its data isn't open to the public.
The Institute of Medicine report that Grabenstein cited as supporting the vaccine's safety and his decision to end the quarterly monitoring program also says the DMSS database should be open to researchers outside the government, with precautions to protect the privacy of individuals' health records.
This hasn't been done. Grabenstein said the military had not been able to figure out how to protect individuals' health records and make it work.
Strom of the institute panel and other experts say it should not be that difficult. "There's no excuse," he said. "We use these kinds of data sets in Medicaid and Medicare data all the time. There are technological solutions."
Cowan, another member of the panel, said the institute's recommendation was based, in part, on the military saying it couldn't afford all the analysis that the data was good for: "That way, you get the most of what the American people have invested in."
Strom said keeping the data from the public only bolstered the perception that the military was hiding the truth about the vaccine.
Walter Schumm is a professor of family studies and an expert on statistical methods at Kansas State University. He said he and other researchers would love to get the DMSS data. He's a retired Army colonel who's spent more than a decade using statistical analysis to examine the vaccine's safety - after friends and others in uniform began complaining about health problems after the shots.
Schumm has used other data made public on the anthrax vaccine to publish several scientific papers that poke holes in the safety assertions made by Pentagon doctors and researchers.
Good science involves people with different approaches to the same problem having a chance to test their theories, Schumm and others say. Their findings might cement the safety assertions, he said, but no one knows for sure until the military loosens its hold on the facts and data.
He said, "If you let independent people have the data, you risk losing control. In combat, letting things get out of control gets people killed, so loss of control is a very sensitive issue. I'm just sure they're trying to protect their program."

Posted by MBVIC at 4:20 PM |

December 8, 2005

Appeals Court Pursues Unexpected Inquiry In DOD Anthrax Shots Case


Inside the Pentagon
By Elaine M. Grossman

A federal appeals court considering a Bush administration request to restart mandatory anthrax inoculations for selected military personnel this week ordered both sides in the case to submit written arguments on a point of law neither party has emphasized to date.

The government appeal seeks to reverse a 2004 decision by U.S. District Court Judge Emmet Sullivan, who declared the Pentagon anthrax inoculation program "illegal" because the Food and Drug Administration had not properly approved the vaccine for protection against inhaled spores.

On Monday (Dec. 5), the DC Circuit Court directed the government to submit a brief by Dec. 12 on the question of whether the anthrax vaccine is a "drug unapproved for its applied use" under the law governing the armed services, because the vaccine was originally licensed in a manner unrecognized by Title 10 of the U.S. Code.

The drug's license was approved by the National Institutes of Health for individuals such as veterinarians, laboratory workers and others exposed to potentially infected animals.

During Dec. 1 oral arguments before the appeals court, Judge David Tatel asked if the government was relying on a Title 10 provision that requires drug labeling approved by the FDA under the terms of the Federal Food, Drug and Cosmetic Act.

Justice Department attorney Michael Raab replied that the Public Health Service Act extended the coverage of the Federal Food, Drug and Cosmetic Act to NIH-approved biological products like the anthrax vaccine.

What is unusual is that this is not an argument that those who brought the case against the Defense Department have emphasized to date.

Another member of the three-judge appeals panel, A. Raymond Randolph, asked a plaintiffs' attorney to address the issue.

John Michels -- who filed the suit with co-counsel Mark Zaid in 2003 on behalf of five anonymous military personnel and one civilian who refused the shots -- said he did not question the validity of the NIH anthrax vaccine license itself. Rather, he asserted the Defense Department wants to use the anthrax vaccine in a manner "not described in the approved labeling" to protect against inhaled spores, as opposed to less risky skin contact with anthrax.

If so, the anthrax vaccine would be considered an "investigational new drug" and inoculations would require either a service member's consent or a presidential waiver based on national security considerations, Michels said. This is the argument upon which Sullivan's decision -- and his ban on DOD's mandatory shots program -- was based.

Appeals Judge Thomas Griffith also questioned whether there is a legal basis to ban anthrax inoculations across the Defense Department, rather than apply such a remedy solely to the six plaintiffs. But since the status of the vaccine applies to any military personnel, it is a "logical outgrowth" to decide the case Pentagon-wide, Michels argued.

On the question of the anthrax vaccine license validity, the appeals court directed Michels and Zaid to respond to the government brief by Dec. 19. The administration will have an opportunity to reply with another short written brief of its own by Dec. 22.

Posted by MBVIC at 7:59 PM |

December 7, 2005

Post-9/11 vaccines linked to heart risk


Miami Herald

A study showed that people who received smallpox vaccinations after the Sept. 11 attacks suffered a higher rate of heart inflammation than ever documented.

ATLANTA - (AP) -- Smallpox shots may have triggered a painful heart inflammation in a very small number of emergency workers vaccinated after the Sept.11 attacks, researchers say.

A study in today's Journal of the American Medical Association showed a higher rate of heart inflammation cases than ever documented in people who got smallpox vaccinations.

''I think that was completely not anticipated,'' Dr. Inger Damon, an author of the study, said.

Overall, however, the vaccine appears to carry an extremely small risk of serious side effects, researchers reported after looking at nearly 700,000 civilians and soldiers who received vaccinations after Sept. 11.

The United States ended routine childhood vaccination against smallpox in 1971, and the World Health Organization reported the disease was eradicated in 1980.
But about 15 months after the Sept. 11 attacks, the U.S. government ordered certain military personnel vaccinated and recommended shots for front-line healthcare workers.

The smallpox vaccine, Dryvax, made by Wyeth Laboratories, has long been suspected of triggering neurological complications, including encephalitis, in rare cases.

But Dryvax was not associated with heart problems until 2003, when three adults died suddenly of heart attacks.

As a precaution, health officials advised people with heart disease to skip the vaccination.

EMERGENCY WORKERS


One of the studies published Wednesday looked at emergency responders, a group made up largely of female healthcare workers ages 40 to 64.

Researchers counted 100 possible cases of serious side effects in 37,901 people who got the shots from January to October 2003.

Among the 100 were 21 cases of nonfatal heart inflammation and six heart attacks, two of which were fatal.

Posted by MBVIC at 8:13 PM |

Screening, Education Could Limit Health Problems Related to Smallpox Vaccine, Study Finds


By Chris Schneidmiller
Global Security Newswire

WASHINGTON - Extensive screening and education appear to have reduced the potential for serious side effects among people who were vaccinated against smallpox in recent years, according to an article published this week in the Journal of the American Medical Association (see GSN, Nov.14).

Still, the vaccine was not without risks - at least three people died shortly after receiving the shot during a U.S. Health and Human Services vaccination program and two suffered permanent disabilities. Nevertheless, researchers said the safety system set up for vaccine recipients could point the way to safeguarding patients who are exposed to the pathogen in an act of bioterrorism.

Health and Human Services between Jan. 24 and Oct. 31, 2003, administered the Dryvax smallpox vaccine to 37,901 civilian medical professionals and first responders in 55 jurisdictions, according to the article by Centers for Disease Control researcher Christine Casey and 18 colleagues. That count was far less than the millions of volunteers the Bush administration hoped to inoculate so that they could safely provide medical and emergency care following an intentional release of smallpox.

All potential volunteers received educational material that included a questionnaire that would help them determine if they had risk factors such as eczema or immune system deficiencies that could lead to health problems following vaccination.

Recipients also received instructions on proper care for the vaccine injection site and details on reporting any "adverse events" following vaccination. An adverse event is a health problem that arises following vaccination that cannot be directly connected to the treatment, the article states. An "adverse reaction" is one that is found to be caused by the shot.

There were no reports of potentially fatal adverse reactions or reactions that required treatment with the vaccinia immune globulin, the article states. "The absence . provides indirect evidence of effective vaccination screening and education, as well as attentive vaccination site care and monitoring," the article states.

"The goal of the education and the screening was to make this as safe a vaccine administration program as possible for the adverse events we know about and were able to prevent. And I would say that we succeeded in that with this program," Gina Mootrey, associate science director for the epidemiology and surveillance division of the CDC National Immunization Program, said in an interview.

Volunteers were also monitored following vaccination. State and local jurisdictions contacted the recipients within 28 days to ensure that any serious health effects had been identified, the article states.

All adverse events were to be reported to the Centers for Disease Control and to the nationwide Vaccine Adverse Event Reporting System, Mootrey said.

There were 822 reports of adverse events - 100 of which were determined to be serious. Eighty-five people required hospital care, with 10 suffering life-threatening conditions.

Two women, ages 55 and 57, suffered fatal heart attacks within four days of vaccination, while a 45-year-old man died following a heart attack 69 days after his treatment.

"This was the safest possible vaccination program that could be undertaken with the smallpox vaccine, but at its best it remains a very hazardous vaccine," Vanderbilt University vaccine expert William Schaffner told the Washington Post. "Eighty-five hospitalizations, two permanent disabilities, 10 life-threatening reactions and three deaths. That is not a safe vaccine."

There were a total of 203 potential cardiac events that were possibly linked to the smallpox inoculations, according to the researchers. That included 21 cases of heart inflammation and 10 "ischemic cardiac events" - heart attacks or angina. Such responses "were not anticipated based on historical data," the article states. They quickly led to increased screening in Health and Human Services and Defense Department vaccination programs of vaccinees for potential heart problems that could be exacerbated by inoculation.

No heart attacks and angina were reported after the heightened screening was instituted, the article states.

The researchers note in the article that the rate of heart events "identified in civilian vaccinees, including the incidence of sudden death, does not appear to be greater than that expected in a comparable nonvaccinated population." It remains unknown whether the vaccine actually caused the incidents.

The researchers encouraged additional study of heart and skin risk factors and development of a vaccine less likely to produce reactions as steps toward further reducing potential health effects from the treatment.

Mootrey said the safety system used in the Health and Human Services program could be used in a mass, rapid vaccination effort in preparation for or in the wake of a bioterror incident. The educational material is available and the reporting system operating, she said.

"Our understanding of the adverse events that was gained in this small program would be readily available," she said. "We wouldn't have to learn it again."

Neurologic Events

A separate study published this week in the Journal reported limited neurologic adverse events connected to the smallpox vaccine.

The Defense and Health and Human Services departments vaccinated 665,000 people from 2002 to 2004. Subsequently, there were 214 reports of neurologic problems potentially linked to the shot. The most common complaint was headaches, with 95 cases, the article states.

There were eight seizures, which resulted in one death. Also reported were 13 cases of suspected meningitis, three incidents of suspected encephalitis and 11 cases of Bell palsy. Twenty-seven of the 39 serious events occurred in first-time vaccines, and 37 of the cases were reported within 12 days of vaccination. The events "occurred in accordance with expected ranges," according to the article.

Posted by MBVIC at 8:12 PM |

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