FDA: Protecting America's Health : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 3)

Science After 9/11

The events of Sept. 11, 2001, revealed the vulnerability of our nation and underscored the need for countermeasures to terrorist threats. FDA scientists are working to ensure the availability of safe and effective countermeasures. They are researching vaccines and treatments in case of biological attack, developing new methods for detecting toxins in foods, and improving blood collection and testing procedures to ensure the continuing safety of the nation's blood supply.

See what the agency is doing to detect biological and security risks, protect the nation's food supply, and communicate risks to the public at the FDA Science Forum.

For more information on the FDA 2003 Science Forum, including fees and how to register, visit www.dcscienceforum.org or call 1-757-423-8823. Early registration is recommended to assure seating. The forum will be available by webcast beginning May 16 at the same Web page.

Science in the Aftermath of 9/11

The FDA is used to dealing with emergencies. Every week, FDA personnel investigate threats to public health ranging from foodborne illness to drug tampering to malfunctioning medical gas cylinders. But never has the agency been challenged with a national emergency of the magnitude of the attacks on Sept. 11, 2001.

"Immediately after the World Trade Center and the Pentagon were hit, science at FDA played a role," says Bernard A. Schwetz, D.V.M., Ph.D., the FDA's senior advisor for science. "We immediately thought of the supply of blood."

While firefighters doused flames and rescue workers searched for victims amid the rubble, FDA scientists worked behind the scenes to enable the rapid collection of blood from thousands of people near the disaster sites. "We reviewed which parts of the information collection process and the blood testing process are nice but not essential in these circumstances," says Schwetz. After weighing the risks and benefits carefully, the FDA streamlined the processes and provided guidance to the blood community to help make blood available while still ensuring the safety of the supply. "We were better off tolerating a little more risk at that time to save lives," says Schwetz.

Another demand placed on FDA scientists was the review of drugs and burn wound dressings to determine their usefulness in treating 9/11 victims. FDA scientists, along with those from the Centers for Disease Control and Prevention, also checked mobile hospitals to ensure that they had adequate reserves of drugs and medical supplies that were current and ready for use. The FDA contacted manufacturers to see if reserve products could be transported quickly to hospitals in New York City and Washington, D.C.

"Good science and good judgment were part of responding to the emergency," says Schwetz, who adds that the FDA's administrative component is also a crucial part of emergency response. "In order to have good science be really effective, we've put an administrative process in place that allows us to respond as an agency more quickly in an emergency."

Through participation in simulated disaster exercises, FDA scientists and emergency operations personnel continue to sharpen their response skills and gain experience working in concert with other federal and state agencies to address an emergency.

Schwetz is scheduled to speak at the Science Forum on "Did Events of 9/11 and Later Make Us a Better FDA?"

A New Kind of Science: Bioinformatics

The need to make sense of the cold reality of disease and death is as old as mankind itself. Equally old are the questions: Why are some people more susceptible to disease than others? What is the risk that an individual will get a certain disease? How would a person respond to a particular treatment?

Scientists may be getting closer to the answers. In June 2000, researchers announced the first complete sequencing, or ordering, of the human genome-the total genetic content of a human. With this new knowledge, researchers are learning more about disease susceptibility and treatment responses and are working to develop new drugs and vaccines targeted to individuals based on their genetic code.

Along with the excitement generated by the human genome sequencing is an explosion of data about each of the components of the more than 30,000 genes that are expressed by this genome.

"Only a few years ago, we were evaluating a single gene at a time," says Daniel Casciano, Ph.D., director of the FDA's National Center for Toxicological Research. But scientists can now evaluate tens of thousands of genes at the same time in one experiment by using platforms, or microarrays, consisting of many thousands of genes. Unfortunately, different research laboratories use different microarrays, says Casciano. "Comparing data from these different platforms is a big problem. There's a lot of confusion because we don't have standardized tools that would be useful across any platform."

The need for tools to make sense of all the data has spawned a new kind of science: bioinformatics.

"Bioinformatics involves biology, computer science, mathematics, and statistics to analyze biological sequence data, genome content and arrangement, and to predict the function and structure of molecules," says Casciano. Applying bioinformatics, a team of FDA scientists is working to produce a standardized set of tools that will aid in evaluating biological data. Using computer algorithms, statistical models, and visualization and filtering tools, these scientists are screening out information in the genome that isn't useful ("junk DNA"), reducing the data to useful and manageable information, and portraying it in such a way that it can be interpreted by any scientist anywhere.

These tools will help FDA scientists to interpret and evaluate information from different companies, allowing the FDA to rapidly assess the safety of a new drug.

Casciano will be presenting an introduction to bioinformatics at the Science Forum.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.