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Emergency declarations smooth way for vaccine makers

By ALAN BAVLEY
The Kansas City Star
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.

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