Emergency declarations smooth way for vaccine makers

[Guest guest]

http://www.kansascity.com/105/story/846427.html

 

Sure, the economy is causing a crisis, but what

about anthrax? How about smallpox?

 

In a little noticed move, federal officials this

month have declared a series of public health

emergencies relating to potential weapons of biological terror.

 

On Oct. 1, Health and Human Services Secretary

Mike Leavitt declared an anthrax public health

emergency. On Oct. 10, he declared health

emergencies for smallpox, radiation sickness from

the detonation of a nuclear device and poisoning

from botulinum toxins, the active ingredient of Botox.

 

There’s no clear evidence that terrorists have

managed to weaponize anthrax or stolen large

caches of Botox from cosmetic surgeons in Beverly Hills.

 

But by declaring these public health emergencies,

HHS has granted manufacturers of anti-terrorism

drugs and vaccines and others involved with the

products protection from lawsuits if the drugs

were to cause unfortunate side effects.

 

In the past, drug companies have shied from

vaccine development because of low profit margins

and legal risks. The actions of HHS are a

necessary reassurance to persuade companies to

make the drugs, and doctors and other providers

to administer them, federal officials and some terrorism experts say.

 

But consumer advocates see it as a giveaway to

the drug industry that strips the public of legal protections.

 

“It gives the manufacturers and other people

involved a ‘get out of jail free’ card,” said

Joan Claybrook, president of Washington-based Public Citizen.

 

“These are potentially dangerous products. There

could be a bad vaccine, and suppose people relied

on that?” Claybrook asked. “There is no deterrent if there’s no liability.”

 

The emergency declarations cover a host of

antibiotics to fight anthrax infection, anthrax

and smallpox vaccines, and a drug to stimulate

white blood cell production in people harmed by radiation.

 

Concerns about the safety of vaccines against

potential bioweapons have been raised repeatedly

in recent years. Some soldiers, for example, have

balked at anthrax vaccinations. And a federal

effort to inoculate 500,000 doctors, nurses and

other health care workers against smallpox

resulted in only about 40,000 volunteering for the vaccine.

 

Health and Human Services’ authority to grant

drugmakers liability protection comes from a

controversial measure that Senate Majority Leader

Bill Frist and House Speaker Dennis Hastert added

to a Defense Department appropriations bill in the waning days of 2005.

 

The Public Readiness and Emergency Preparedness

Act targets liability protections for products

used during epidemics and pandemics, or as security countermeasures.

 

The HHS secretary can trigger the protections by

declaring that a public health emergency exists

or that there’s a “credible risk” of one in the future.

 

And legal immunity can apply to anyone involved

in the development, testing, manufacture or

distribution of the drugs. Also covered is anyone

who prescribes, dispenses or administers the

drugs, including state and local government officials.

 

Public Citizen and the Consumer Federation of

America were among the groups that protested the bill.

 

In a letter to Frist and Hastert, Sen. Ted

Kennedy and 20 other members of Congress called

the measure “a stealth provision to shield

manufacturers from responsibility for making faulty drugs and vaccines.”

 

As the law was written, it could be applied to

virtually any drug or vaccine, Kennedy and the

others said, and not just to the medications

needed to fight pandemic flu or bioterrorism.

 

 

For example, HHS could declare widespread

problems such as diabetes, obesity or

methamphetamine addiction to be epidemics and

protect a large variety of drugs from lawsuits.

 

The act does allow lawsuits for “willful

misconduct.” But that’s hard to prove, said Claybrook of Public Citizen.

 

“That can never be shown unless there’s a

whistle-blower or something turns up in

discovery,” she said. “You could be knocked out of court before that happens.”

 

The law also calls for a federal fund to pay

damages to people harmed by the drugs or

vaccines. But so far, Congress hasn’t appropriated any money for it.

 

While terrorists would like to have biological

weapons, they don’t have the sophisticated

technology yet to make them, said R. Gregory

Evans, director of the Institute for Biosecurity at St. Louis University.

 

“I’m not aware of anything that would raise our

alert level for biological (weapons),” he said.

 

But someday, terrorists may develop such weapons,

Evans said, which makes countermeasures like

vaccines and drugs “absolutely necessary.”

 

“It probably does need some liability protection

to get companies to develop vaccines that may

never be used,” he said. “The profit margins

associated with things like this are very little.”

 

Health and Human Services is not invoking the law

in response to any immediate threat, said William

Raub, science adviser to Leavitt.

 

“We don’t believe there’s anything imminent,” he

said. “We’ve tried to be careful to not instill

fear in people, (but) if we wait until the day of

an event, valuable time is lost … and people could die.”

 

HHS started working on the emergency declarations

last spring and would have issued them sooner,

Raub said, but didn’t want them to get tangled in

the controversy this summer over government bioweapons researcher Bruce Ivins.

 

In August, federal authorities said Ivins, who

committed suicide, was solely responsible for the

2001 anthrax attacks that killed five people and frightened the nation.

 

The new public health emergencies remain in

effect through 2015. And liability protections

will extend for an additional year.

 

“These are not partisan issues,” Raub said.

“These are right and need to be done.

 

“The statute would never have occurred if the

majority of Congress didn’t think so. We are a litigious society.”

 

But Claybrook of Public Citizen isn’t convinced.

 

“They’re misusing this whole concept of an

emergency, and if there were an emergency, you

still have to behave,” she said. “I don’t think it’s necessary at all.”

 

 

 

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