Bioterrorism Response Hampered by Problem of Profit

In 2000, the Pentagon's Defense Science Board concluded that to successfully respond to a bioterrorist attack, the United States would need 57 specific drugs, diagnostic tools and vaccines. At the time, only one was available.

Five years later, officials say that number has increased to two.

Despite the promises of the drug industry after the 2001 anthrax attacks, and last year's passage of the $5.6 billion Project BioShield bill designed to speed development of new products, officials say the nation is scarcely any better protected than it was in 2000.

Now, in a renewed effort to encourage the drug industry to develop and produce the needed countermeasures, senators are aggressively promoting legislation that would grant companies unprecedented enticements to work on meeting the bioterrorism defense needs on the classified list.

One of the key incentives -- extending patent protection on the most profitable drugs of companies that develop new defenses against biological weapons -- has set off sharp protests.

This "wild-card patent extension" could be worth billions by shielding a drug company's products from generic competition for up to 18 additional months.

The bill's sponsors, including Sens. Orrin G. Hatch (R-Utah), Joseph I. Lieberman (D-Conn.) and Sam Brownback (R-Kan.), say that without an incentive of this magnitude, big drug companies will not invest in financially risky bioterrorism research. Although vaccines and antibiotics for smallpox, anthrax, plague and other potential biological weapons may be lifesavers some day, they are unlikely ever to be profitable.

Opponents say the patent extension is a giveaway to the drug industry that would keep the costs of widely used drugs unnecessarily high. Last month, Sen. Charles E. Schumer (D-N.Y.) called the patent extension provision "outrageous" and a boondoggle that would help the pharmaceutical industry more than Americans.

Hatch said critics of the BioShield II bill were misguided. Although the bill may be criticized as going too far, he said, "the day after the next bioterrorist attack or natural disease outbreak, I bet there will be 535 members of Congress who will be thinking that it did not go fast or far enough."

He added that drugmakers have "largely voted with their feet, or at least their pocketbooks" and not engaged "in the search for medical countermeasures to bioterror agents and emerging infectious disease."

Drugmakers and their supporters say companies could face ruinous lawsuits if their admittedly risky products unintentionally harm people. Under new Food and Drug Administration regulations announced after the 2001 anthrax attacks, bioterrorism defense products can be approved without the clinical testing on people that is required for new drugs and vaccines, and so might be riskier than most medications.

The BioShield II bill would give companies broad liability protection. In a recent Senate hearing, only George W. Conk, a product liability specialist and professor at Fordham University School of Law, aggressively criticized the provision, saying it went too far and would protect companies that acted negligently and irresponsibly.