Carl B. Feldbaum, BIO President
Since its inception in the 1970's, the biotechnology industry's mission has been to improve and save human lives. The industry has followed through on that commitment with more than 120 new drugs and vaccines, plus another 350 in late-stage clinical development. Biotechnology has also been used to benefit the environment, with new crops that reduce pesticide use and industrial enzymes that cut chemical waste and energy consumption in manufacturing.
Biotechnology has been enlisted in federal efforts to develop defenses against biological warfare as well, but before September 11 these efforts had all the urgency of any that involve a purely hypothetical threat. The Department of Health and Human Services spent $50 million on bioterrorism preparedness in fiscal 2001; now, the agency is proposing a $1.5 billion package. Resources are always scarce, and in medicine they tend to flow toward the most urgent needs - usually, cancer, HIV/AIDS, heart attack, stroke, atherosclerosis, kidney failure, diabetes. Government and private investment in biotechnology have paid off with a wave of new medicines for all of these diseases, but now, sadly, we must add bioterrorism to that list. One of the lingering tragedies of September 11 and its aftermath may be the diversion of precious scientific and financial resources to the development of products we hope never to use.
The techniques of the biotechnology revolution - such as genetic engineering, monoclonal antibodies, and genomic and proteomic analysis - can be developed for national defense and public health just as they have been to create a new generation of medicines for use in conventional healthcare. And indeed, many biotechnology companies have already worked with federal agencies through existing programs to develop new techniques for defending against biological, chemical or nuclear attack.
Companies working on defense projects are discovering genetic Achilles' heels in viruses and bacteria that can be targeted with a new generation of antibiotics, antivirals and synthetic antibodies. The list of biotech products and technologies with potential defense applications is too long for this space, but here is a sampling: new oral or patch versions of existing drugs that are currently injected, for more convenient distribution and administration on the battlefield or during a civilian crisis; specialized enzymes for decontamination of exposed environments; technologies to allow faster design and production of vaccines or antibodies against new strains of viruses or bacteria; and products that create molecular barriers to infection at vulnerable sites in the body, such as mucous membranes. Most of these projects are in early-stage development, but some products, such as portable devices for rapid diagnosis of infection and atmospheric detection of infectious agents, are being tested and refined now.
Some biological defense products that emerge from the new research imperative will likely be useful for meeting conventional healthcare needs - broad-spectrum antibiotics can be used to treat a gamut of infections, for example - but many, such as the smallpox vaccine on which the administration is proposing to spend $509 million (for a disease eradicated years ago in natural environments), have no viable spin-off applications and will essentially be stored under glass for use only in an emergency.
Serving as an unofficial liaison between the biotech industry and federal officials in recent weeks, BIO staff members have witnessed the commitment on both sides to harnessing the potential of biotechnology for national security and public health. The response to this crisis will require mobilizing every component of the national health care and research system - from individual family doctors, hospitals and public health centers that man the front lines against such assaults, to epidemiologists who must contend with a whole new paradigm of disease propagation, to federal health officials who have been suddenly thrust into the discomfiting realm of defense strategy. Biotechnology, of course, has a mission as well: to create and develop the molecular shields to face a challenge we frankly did not want, but cannot decline to meet.