November 24, 2004

Acambis suffers as US cuts drug order

by Rosie Murray
London Daily Telegraph

Acambis, the smallpox vaccine company that has been supplying the US government, saw its shares fall yesterday after it slipped into the red on its third quarter figures after a £22m profit for the same period last year.

The company lowered the floor for its full-year figures because of uncertainty over when it would see the benefit of key smallpox contracts. It posted a £4.5m loss on sales of £11.1m for the third quarter - slightly below most analyst expectations.

The third quarter of last year was far higher, with revenue of £65.8m and profit of £22.2m. Analysts had expected the company to either break even or post a small profit.

Acambis was once a biotechnology minnow but saw its revenues soar after the US, and other governments, placed orders for a smallpox vaccine because of fears over bioterrorism. The vaccine, which is live and still based on techniques pioneered over a century ago, has not been licensed by drug regulators, but bioterrorism fears are such that the company has been able to supply it on an unlicensed basis.

The company has now completed the bulk of the work on contracts to supply about 183m doses of smallpox vaccine to the US, although it has had problems along the way. Last April the company was forced to suspend the final clinical trials of the vaccine after finding three suspected cases of a heart disorder among volunteers in the tests.

Acambis has since managed to demonstrate that this is a side-effect of smallpox vaccines in general, rather than specific to the Acambis product.

In September, the US surprised the company by saying that it only wanted half of an order for 54m doses - raising fears that other countries, too, may be less keen on stockpiling the product.

The company is also now competing with Denmark's Bavarian Nordic to make a weak version of the vaccine for elderly members of the population.

Acambis shares slipped 8 to touch a 12-month low of 260p. Chris Redhead, pharmaceuticals and biotech analyst at Code Securities, said that the company was now "fundamentally overvalued".

"There has been little progress on Acambis' pipeline," he added, saying that the products the company is developing, such as a vaccine for West Nile Virus, were still a way off.

He said that Acambis will win half of the contract it is competing for with Bavarian Nordic "at best". He downgraded his share price target for the company from 250p to 230p.

November 15, 2004

Smallpox vaccine linked to heart inflammation

Associated Press

Wyeth Pharmaceuticals Inc. will add black-box warnings linking its smallpox vaccine to heart inflammation, the government announced Friday.

Healthy adults given Dryvax vaccine suffered acute myopericarditis -- inflammation of the heart and its surrounding sac -- says the warning approved by the Food and Drug Administration.

Wyeth spokesman Doug Petkus said the company no longer manufactures or markets the smallpox vaccine. The vaccine had remained in storage since the 1980s. After the Sept. 11, 2001, terrorist attacks, the government asked Wyeth to test the smallpox vaccine to ensure it was potent.

The black-box warnings apply to those vaccines repackaged by Wyeth for immediate use by firefighters, medical personnel and other first responders.

The company had provided nearly 15 million doses for government use, enough to vaccinate up to 8 million people. Government health agencies vaccinated 36,217 civilians. The military has inoculated nearly 680,000 personnel since December 2002. Roughly 13 million smallpox vaccine doses remain in the Centers for Disease Control and Prevention's stockpile.

Because of life-threatening complications associated with existing smallpox vaccines, the government has sought safer new-generation smallpox vaccines to prepare for another terror attack.

In a recent clinical trial comparing Dryvax to an investigational smallpox vaccine, eight confirmed or suspected cases of myopericarditis were detected among 1,162 patients. That means people had a 1 in 145 chance of developing the heart condition after vaccination with Dryvax.

The conclusion followed concerns raised during a 2002-03 Department of Defense vaccination program. Of 540,824 military personnel who received Dryvax, 67 developed myopericarditis -- or 1.2 per 10,000 vaccinations. The heart problems developed quickly, in three to 25 days.

Among vaccinated civilians, 21 cases of myopericarditis were reported as of May 9, 2003, according to the FDA.

Col. John Grabenstein, deputy director for military vaccine at the Army Surgeon General's Office, said the Department of Defense has warned about the heart problem since April 2003.

"This is not a new finding. This is paperwork catching up with an old finding," Grabenstein said. While the heart condition is alarming -- sending otherwise healthy people to the emergency room with chest pains mistaken for heart attacks -- he said it remains uncommon.

People stricken with the heart ailment get better, according to follow-up blood tests, heart exams and exercise stress tests. "Their recovery is very good," he said.

This summer, tens of thousands of troops stationed in the Pacific and the Middle East received mandatory anthrax and smallpox vaccines to protect against biological warfare.

In response to a federal judge's order in late October, the Pentagon halted the mandatory anthrax vaccinations for the military -- six shots spaced over 18 months.
Mandatory smallpox vaccinations, not yet challenged in the courts, continue for personnel headed to Afghanistan, Iraq and Korea. In addition, a team of smallpox-vaccinated staffers are assigned to nearly 100 military hospitals and large clinics around the world, Grabenstein said.

November 11, 2004

U.S. Defense Department Accused of ‘Disinformation’ on Anthrax Vaccine Program

By David Ruppe
Global Security Newswire

WASHINGTON — Lawyers for six plaintiffs who last month secured an injunction barring anthrax vaccinations of U.S. military personnel without informed consent yesterday accused the Defense Department of ‘disinformation’ on the ruling (see GSN, Oct. 28).

A statement released by attorneys Mark S. Zaid and John Michels said the Pentagon “has led a disinformation campaign to downplay the significance of the court’s decision, particularly regarding the length of time the injunction will remain in place.”

They charged specifically that the department has mischaracterized the injunction issued by U.S. District Judge Emmet Sullivan last month by depicting it as a temporary “pause” in mandatory vaccinations pending the resolution of a procedural question, rather than questions regarding the efficacy or safety of the vaccine.

The lawyers called the Defense Department statement “deliberately misleading” and said Sullivan’s injunction did in fact question the safety and efficacy of the vaccine.

Contacted today, Pentagon spokesman Army Lt. Col. Joe Yoswa said, “I believe we put a release out on that and I’ll let the release speak for itself.”

Meaning of the Injunction

That Oct. 27 release said, “The injunction did not question the safety and effectiveness of the anthrax vaccine or the immunization program in the DOD.”

“The injunction centered on FDA [Food and Drug Administration] procedural issues stating that additional public comment should have been sought before the FDA issued its final rule in December of 2003,” it said.

In apparent accordance with the release, Sullivan’s ruling did appear to hinge on the procedural issue of public comment.

“In this case, the court focuses not on FDA’s substantive — and highly technical — determinations regarding the safety of [the vaccine], but rather on whether or not the agency observed the relevant ‘procedure required by law,’” it said.

Sullivan found, however, that because of nonconformity with procedure, the vaccine must be considered investigational and could not be deemed safe and effective until a public comment period was conducted.

“The men and women of our armed forces deserve the assurance that the vaccines our government compels them to take into their bodies have been tested by the greatest scrutiny of all — public scrutiny,” he wrote.

“It is clear to this court that if the status of the anthrax vaccine were open for public comment today, the agency would receive a deluge of comments and analysis that might inform an open-minded agency,” he wrote, ordering the FDA to reconsider its ruling and allow public comment on approval of the anthrax vaccine.

The plaintiffs in their suit questioned the interpretation of studies the FDA used to conclude that the vaccine is effective against inhalation anthrax, and noted the vaccine was originally intended for protection against the skin form of anthrax.

“In fact, given the state of the medical and scientific evidence, it will be extremely difficult for [the] FDA to make a proper case that the vaccine has any effectiveness against inhalation anthrax,” Zaid said in yesterday’s statement.

Sullivan ruled preliminarily last December that the vaccine was investigational and not licensed to protect against inhalational exposure, but rather only for protection against the skin form of anthrax. He concluded the vaccine by law could not be given without either informed consent or a waiver by the president (see GSN, Dec. 29).

Inoculations resumed shortly afterward when the Food and Drug Administration released a final ruling without a formal public comment period that the vaccine is “safe and effective for the prevention of anthrax disease — regardless of the route of exposure.” That decision — based on an 18-year-old application — allowed vaccinations to resume without informed consent until Sullivan’s order last month.

Though Sullivan’s injunction only barred vaccinations without informed consent, Defense Secretary Donald Rumsfeld last month ordered all anthrax vaccinations to stop “until further notice.” The government has indicated it will seek to vacate the Sullivan’s injunction.

Possible Implications of DOD’s Characterization

According to Zaid and Michels, the DOD’s “disinformation campaign” regarding Sullivan’s latest ruling is significant because it suggests to troops that the safety and effectiveness off the drug is not in question.

“It does mislead, not just the public, but the soldiers who are asked to take this vaccine,” Michels told Global Security Newswire today.

The lawyers in their statement also wrote that soldiers forced to the leave the military for refusing to take the vaccine should be allowed to return and be compensated.

“Our position is that the soldiers haven’t been informed about the nature of the vaccine from day one,” he said.

The Defense Department statement last month said the vaccine was determined safe and effective for all forms of anthrax exposure by “research conducted by several prominent medical experts and a report by the National Academy of Sciences.”

“As a result of the injunction, the Department of Defense will pause giving anthrax vaccinations until the legal situation is clarified,” according to last month’s statement.

November 8, 2004

The Rutherford Institute (TRI) Sues Donald Rumsfeld & U.S. Military on Behalf of Air Force Sgt.

WILMINGTON, Del.—Attorneys for The Rutherford Institute have filed suit in federal district court on behalf of the First Amendment rights of Air Force Sergeant Jason Adkins, who was sanctioned after reporting to sick call and voicing concerns that he could be suffering the ill effects of a tainted anthrax vaccine administered to select military personnel. Sgt. Adkins is a 14-year decorated airman who served on the first C-5 aircraft flown into Baghdad in the recent Iraq War and other numerous classified special operations missions. The suit, which names Adkins’ supervisors in the Air Force, as well as James Roche, the Secretary of the Air Force, Secretary of Defense Donald Rumsfeld and others, was filed in federal district court in Wilmington, Del., by Institute affiliate attorney Thomas S. Neuberger of the Neuberger Firm. The complaint alleges that for five years the Department of Defense has subjected select military personnel to a dangerous experimental anthrax vaccine with life-threatening and debilitating side effects. Despite the DOD’s insistence that the anthrax vaccine is safe and effective, a federal judge recently ordered the Pentagon to halt the mandatory vaccination program.

“Since his first day in the Air Force, Sgt. Adkins has been trained in one basic sacred safety principle—that flight officers with unsafe medical conditions are not to fly. Even during a flight, if crew members become ill or overly tired, they are encouraged to declare ‘safety of flight,’ at which point they are relieved of their duties, no questions asked, and always without any fear of discipline or repercussions,” said John W. Whitehead, president of The Rutherford Institute. “Sgt. Adkins felt it was his moral duty as a Christian to speak out against this injustice, and he should be commended for his bravery. If left unaddressed, the military’s actions could very well give rise to a dangerous chilling free speech effect on our servicepeople.”

All U.S. troops deployed overseas are required by the military to take a series of six or more anthrax vaccinations. Sgt. Adkins, a C-5 aircraft flight engineer, received eight inoculations. However, testing by the Food and Drug Administration discovered squalene in six of the inoculations administered to Sgt. Adkins. Research indicates that even trace amounts of squalene can suppress the immune system, causing arthritis, neurological problems, memory loss and incapacitating migraine headaches. In keeping with flight safety protocol, on Oct. 21, 2004, Sgt. Adkins reported to the Dover Air Force Base flight surgeon with a “crippling” headache and was subsequently grounded from a scheduled flight mission. Shortly afterwards, Sgt. Adkins was given a career ending written reprimand and was accused of dereliction of duty and faking his medical condition, allegedly in retaliation for having voiced his concerns that he might be suffering effects of the experimental anthrax vaccine. Other military personnel have since echoed Sgt. Adkins’ concerns about the effects of the tainted vaccine. In addition to the litigation, attorneys for The Rutherford Institute are proposing that Congress adopt legislation to modify the Feres Doctrine, a Supreme Court opinion that arose out of Feres v. United States that shields the government from personal injury claims by servicemembers.

The Rutherford Institute is an international, nonprofit civil liberties organization committed to defending constitutional and human rights.