Since 9/11, the U.S. has faced with growing awareness and alarm the threat of biochemical attacks against its citizens at home and abroad. The scenarios are sometimes described as so frightening as to be almost unimaginable. But imagination, some say, is exactly what is needed to see and fill the gaping holes that remain in the nation's defense against biological weapons.

The global pharmaceutical industry -- "Big Pharma" -- has a vital role in this war: developing drugs to protect civilians and the military. Soon after the anthrax-by-mail attacks of 2001, the industry responded with a program coordinated by the Pharmaceutical Research and Manufacturers of America (PhRMA), the industry trade group based in Washington, D.C.

Industry Action

Here are the highlights of that early response:

* Bayer Corporation donated two million tablets of Cipro (ciprofloxacin) to the U.S. Department of Health and Human Services for first-responders and promised to supply up to 300 million tablets to the federal government at greatly reduced cost.

* Johnson & Johnson sought FDA approval of an existing antibiotic, Levaquin, to treat anthrax.

* Bristol-Myers Squibb Company made its antibiotic Tequin (gatifloxacin) available free of charge to people infected by or exposed to anthrax, provided that the FDA approved its use for anthrax. The company also said it would consider sharing the Tequin license with the government or with other companies in "the unlikely event that the need exceed the supply."

* Merck-Medco Managed Care, L.L.C. agreed to use its technology and expertise to transform stockpiles of medicines into individual prescriptions.

In addition to these actions, according to a PhRMA statement at the time, "Pharmaceutical company scientists are researching existing and potential infectious disease threats, including testing existing medicine to see which ones work best to treat anthrax and other diseases, and developing next-generation vaccines and treatments."

To help make this happen:

* GlaxoSmithKline plc pledged a team of scientists and a facility to research solutions to potential bioterrorism threats.
* Bristol-Myers Squibb dedicated an antibioterrorism team of 20-25 scientists who specialize in antibacterial research that would, "Under government direction...initiate a multipronged attack on the microbial weapons of bioterrorism."
* Aventis offered technical and scientific support to the U.S. government to manufacture new vaccines and antibiotics.

Government Initiatives

The President and Congress took steps to acquire a national supply of smallpox vaccine and ensure that, by the end of fiscal year 2002, the National Pharmaceutical Stockpile would contain sufficient antibiotics to treat 20 million people against diseases such as anthrax, plague, and tularemia.

The administration's budget for 2003 provided $650 million to enhance the National Pharmaceutical Stockpile even further by storing drugs in cities and states where they are most likely to be needed.

The fiscal year 2003 budget also devoted $2.4 billion to jump-start the research and development process needed to provide the U.S. with the medical tools needed to support an effective response to bioterrorism.

Drag Factors

What progress has the pharmaceutical industry made since 2001?
According to The Washington Post, economic factors have been a brake. Reporters John Mintz and Joby Warrick wrote in the November 8, 2004 edition: "...a top priority [of the U.S. government] is persuading large drug firms to make big investments in biological warfare research -- in essence, creating a biodefense industry from scratch.... 'Big Pharma' is now not interested for several reasons, industry and government officials say. Big firms are accustomed to huge profits on their drugs for arthritis, ulcers, impotence and the like, and foresee returns a fraction of that size for biodefense work."

Individual pharmaceutical manufacturers were hesitant to discuss their research in this area, but PhRMA spokesman Jeff Trewhitt told us,

"Companies are now screening existing drugs to see if they have use against bioterrorism agents," and "they are taking old compounds off the shelf to see if they have potential new uses. Furthermore, companies are researching new antibiotics all the time and also are seeking to determine if they also have use against bioterrorism agents."

Trewhitt said the pharmaceutical industry needs legislative relief before it can move more quickly, especially in the areas of federal product liability and  antitrust laws. Under current law, companies can't work together to expedite treatments. In addition, they must follow very specific FDA guidelines in testing new drugs, including rules that require six to eight years of human clinical trials of new drugs after completion of successful animal testing.

"It is very important to understand that when you are developing new treatments for bioterrorism agents, quite often you cannot test the potential new treatment in humans," Trewhitt said. "Quite often the only testing that can be done is in laboratory animals. It is difficult for companies to get involved in the development of new medicines without securing relief from these provisions."

Until Congress provides this relief, Trewhitt said, "the job remains unfinished," and the pharmaceutical industry will be handicapped in its ability to produce what's needed to defend against bioterrorism.