Emergency declarations smooth way for vaccine makers

The Kansas City Star | October 20, 2008
By Alan Bavley

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.”