January 30, 2003

Marine who refused the vaccination could face prison time

By Jeanette Steele

CAMP PENDLETON – Cpl. Anthony Fusco has become the first San Diego County-based Marine to face court-martial for refusing the anthrax vaccination since the military resumed the controversial program last fall.

Fusco, a switchboard operator, said he believes the vaccine isn't safe, based on his Internet research.

"They haven't really done any studies on long-term side effects," Fusco, 22, said in an interview. "I believe it's your own body. It's your own right to put something in your body."

Fusco, a Santa Clarita native, was charged this month with disobeying a lawful order and probably will go to a special court-martial in February, he said. If convicted, his maximum sentence would be a year in military prison and a bad-conduct discharge.

Fusco is the only member of the 45,000-person 1st Marine Expeditionary Force charged with refusing since the vaccinations resumed, said 1st Lt. Dan Rawson, a Camp Pendleton spokesman.

For the military community, it is an old debate coming to the forefront again.

Fusco is accused of the same offense that at least 37 service members were convicted of when they refused inoculations in the late 1990s. The Pentagon largely suspended its anthrax vaccination program in 2001 because of low supply from troubled manufacturer BioPort Corp. of Michigan.

With a potential war against Iraq, the Marines in September began inoculating troops bound for the Middle East and Southwest Asia.

All members of the 1st Marine Expeditionary Force at Camp Pendleton and Miramar Marine Corps Air Station are expected to get the shot if they might deploy.

The anthrax bacterium can be deadly, especially when inhaled. Spores enter the lungs and migrate to lymph nodes, where they produce lethal toxins that destroy vital organs. Five Americans died in late 2001 when anthrax-laced letters circulated through the postal system.

Rawson said the Marine Corps has tried to educate troops about the safety of the vaccine – the same version given to service members in the late 1990s.

"Whenever a Marine thinks about refusing the anthrax vaccine, that refusal is thought to be a misunderstanding of the purpose and efficacy of the vaccination," he said.

"The Marine is given multiple opportunities to sit down one on one with a number of individuals in the chain of command and learn and have his questions answered. If that fails, charges can be brought."

Fusco said he fears the vaccine might cause autoimmune diseases and birth defects when he and his wife decide to have children.

He studied a Web site called www.majorbates.com, which is a collection of articles and documents about the vaccine. The site is run by retired Air Force reservist Lt. Col. John Richardson, who launched it in 2000 after fruitless attempts to get the military to change its mandatory vaccine policy.

Richardson disputes the military's claims of the vaccine's safety.

"Objective information makes me believe it's not safe," he said yesterday. "I've talked to victims."

Fusco, who joined the Marine Corps in 1999 during the height of the earlier courts-martial, said he had never heard of the controversy until he was offered the shot, if he wanted it, while stationed in Japan later that year. He declined.

In December, he was ordered to be inoculated when his 13th Marine Expeditionary Unit was scheduled for a six-month deployment to the Persian Gulf in June. He refused.

Fusco said he was removed from his unit and initially was offered nonjudicial punishment, which he intended to accept to avoid a negative discharge. With hopes of becoming a police officer, he worries that a bad-conduct discharge could hurt his chances.

Then his superiors told him the deal was off, Fusco said. Now he has been told he faces a special court-martial, the second-highest kind of military trial.

Fusco said he still hopes for a less-severe general discharge. But if he doesn't get it, he won't be sorry.

"Even if it's hard for me, I'll do my own business or something," Fusco said. "I'll make it.

"I still don't hate the Marine Corps. I just think what they are doing is very wrong."

January 28, 2003

Bureau of National Affairs Army Researchers' Plan Seeks Exemption From FDA Experimental Product Safety Rules

By M. Alexander Otto

Under a plan proposed by U.S. Army human research regulators, the Department of Defense could ignore key Food and Drug Administration safety standards when administering experimental products to soldiers, according to an October memorandum recently obtained by BNA from the U.S. Army Medical Research Institute of Infectious Diseases Office of Human Use and Ethics. Under current FDA rules, experimental drugs and devices can only be used in well-controlled clinical trials that test safety and efficacy.

That means the principal investigator must supervise the administration of the product and serious side effects must be reported to FDA within seven days, neither of which are practical in combat situations, according to the memorandum, dated Oct. 11, 2002. Investigational products also must carry labels that state "Caution: New Drug-Limited by Federal (or United States) Law to Investigational Use."

"This label can lead the war fighter to question the safety and/or effectiveness of the product and may threaten operational objectives," according to the memo.

New FDA Category. The plan would exempt the military from the clinical trial requirement. Instead, a joint military and FDA panel would review the safety and efficacy of the agent, determine whether a clinical trial is feasible, identify ethical obligations, and approve the product under a new FDA category: "licensed for contingency."

The category would be reserved for "products unlikely to receive FDA approval under current rules but that have sufficient human safety and animal efficacy experience to permit military . use." The memo noted, however, that the military often fields products that have not been tested in humans "because of the great danger to individuals of conducting human clinical efficacy trials." "DoD should continue to conduct trials when ethically appropriate and when time and resources permit compliance with the [Federal] Food, Drug and Cosmetic Act," the five-page memo stated.

Some of the content for this position paper was added to the DOD Medical Department legislative agenda, Dr. Arthur O. Anderson told BNA. Anderson is chief of the USARMIID Office of Human Use and Ethics and Department of Clinical Pathology. He co-authored the memo with Chris Beardmore, an administrator in the Office of Human Use and Ethics.

Advocate Skeptical. The move would resolve ongoing conflict with FDA about the use of experimental products. Following the Gulf War and action in Bosnia, DOD was criticized for failing: to report adverse events, to properly label and track investigational products, and to ask soldiers' permission before administering experimental agents.

Dr. Meryl Nass, an advocate for soldiers injured by anthrax vaccine, botulinum toxin, nerve gas antidote, and other experimental products, takes a dim view of the initiative. "It is part of an ongoing DOD campaign to free the military from basic human subject protections," she said. Soldiers are subject to military discipline if they refuse an experimental product. Those injured have no recourse; soldiers cannot sue DOD for injuries received while in the service, Nass noted.

January 27, 2003

3 Allege Reprisals Over Smallpox Shots

The Associated Press

Three civilians in the U.S. Merchant Marine say they refused to be vaccinated against smallpox and anthrax and were fired from the crew of a ship loaded with Army vehicles.

The ship's captain, Joseph Hood, said no one had been fired and declined to comment about the shots.

The three were assigned to the Cape Taylor, one of three "ready reserve" ships docked at Corpus Christi. The ship is believed to be heading to the Middle East with Army tanks and trucks.

The three civilians are part of the ship's crew of 27 and are among 20 who belong to the Seafarers International Union.

"If they do not replace us they cannot sail, and that is Coast Guard rules," Erik Ortwein of Tacoma, Wash., told the Corpus Christi Caller-Times on Sunday. "A lot of people are worried about this."

Ortwein, Lino Remorin of McAllen, Texas, and Jose Camales of Puerto Rico said Hood fired them Sunday after they refused to sign papers committing them to be immunized.

They said Sunday was the first time they were told the shots would be required.

"They gave us no information," said Ortwein. "No doctors, no physicals. I have no idea how this stuff was manufactured."

January 11, 2003

Forced To Withdraw Drug Company Immunity From 2002 Homeland Security Bill After Outcry...

Knight Ridder
James Kuhnhenn

Under pressure to undo what they had done in secret, congressional Republicans agreed Friday to eliminate special-interest provisions in last year's homeland security bill, including language that would have protected pharmaceutical companies from lawsuits stemming from certain vaccines.

Under the agreement, drug manufacturers such as Eli Lilly no longer will enjoy limited liability for mercury-based vaccines that are the target of lawsuits by parents of autistic children.

Discovery of these special provisions caused an uproar that almost sank the homeland security bill in November. Democrats and moderate Republicans threatened to vote against the bill if they weren't removed.

Republican leaders salvaged the bill as the final vote was under way, promising Republican Sens. Lincoln Chafee of Rhode Island and Olympia Snowe and Susan Collins of Maine that the offending language would be removed by this session of Congress.

"The 11th hour addition of these special-interest provisions in the homeland security bill was both egregious and unacceptable," Snowe said Friday. Collins called the agreement "a victory for fairness."

The vaccine provision caused the biggest furor, because it was designed to protect vaccine makers from lawsuits targeting thimerosal, a preservative containing mercury that until two years ago was used to store children's vaccines. Parents of autistic children have sued vaccine makers, saying the thimerosal may have contributed to the condition. Scientists have not established a clear link between the two.

Republicans added the provision to encourage pharmaceutical companies to produce vaccines that could thwart biological attacks. The idea was that fear of lawsuits could create a chilling effect that would reduce the number of vaccines available. But by making the provision retroactive, the law threatened to knock thousands of parents' lawsuits out of court.

The most obvious beneficiary of the provision is Eli Lilly, an Indianapolis-based company that manufactured thimerosal more than two decades ago. Eli Lilly lobbied for the lawsuit protection, but has said it played no part in putting it into the homeland security bill.

Within a week of President Bush's signature on the homeland security bill, an Oregon judge dismissed three lawsuits against Eli Lilly, citing the new liability provision.

Michael Williams, a lawyer representing the families of autistic children, said eliminating the provision might permit him to refile the cases. But he said he didn't know whether the statute of limitations on filing the suit might have run its course.

Republicans agreed to consider broader vaccine legislation within six months that would include liability protections as well as incentives to produce new vaccines.

In a statement Friday, Eli Lilly said it was disappointed by the agreement, but that it would seek to incorporate the eliminated provision in new vaccine legislation.