Thanks to great work by the King County, Wash., Health Department, we had lab evidence indicating the bacteria came from a single source. Interviews with some of the victims suggested the source was a particular brand of apple juice. We knew the juice had been shipped to six different Western states. We also knew that four children who had consumed the juice were already stricken with hemolytic uremic syndrome, an acute condition in which the kidneys begin to shut down. But we didn’t have hard scientific confirmation that E. coli 0157H7 was in the apple juice–and we needed to act quickly.
The tough part was whether we should ask the company to undertake a nationwide recall. That was the safest course of action if the apple juice were contaminated–but what if the E. coli came from another source? We estimated there was an 80 percent chance we were right and got on the phone with the company. It wanted to do what was in the public interest and agreed to announce a recall. By the next morning the word was getting out on the morning talk shows, and the emergency was under control.
Decisions like this help underscore the need for a strong and credible FDA. Because we live in a global economy, FDA protects Americans from health risks all around the world: modern air travel means potentially dangerous diseases are just one flight away. The FDA is one of the most important public-health agencies anywhere. We have high standards, and our jurisdiction covers a vast array of products. These include everything in our food supply except for meat and poultry, all prescription and nonprescription drugs, cosmetics, breast implants, the nation’s blood supply and prescription drugs used to treat animals. These products affect all of us in our daily lives.
My six years at the agency–I’ve now decided to step down–have been a challenge. I have had to deal with the issues that the FDA faces as a public-health agency and learn to cope with the relentless pressures that are always part of the job. Both the agency and I have been vilified. I feel very strongly, however, that if you believe in what you’re doing, all the name-calling in the world won’t stop you.
The FDA must respond vigorously to the nation’s changing health needs. In 1990 there was only one AIDS drug, and that was AZT. The FDA, after talking with the AIDS communities, mapped out a policy to help drug manufacturers bring new drugs to market sooner for the people who need them. We said that if a company could show that a drug acted on certain early indicators–if it had some effect on the number of immune cells, for instance–then that drug could get accelerated approval. Once it was on the market and people had access to the drug, the firm would be required to go ahead with the follow-up studies to make sure the drug worked. Now we have nine drugs for treating AIDS, all approved in record time, and we have cut the approval time on drugs for other diseases as well.
For a public-health agency to make a difference, there is no better strategy than prevention. The two chief causes of preventable death in the United States are poor diet and smoking. The new food labels that FDA developed are helping millions of Americans make healthier choices. It used to be that a cheesecake manufacturer could advertise its product as ““light’’ cheesecake merely because it cut the standard serving size in half–although the content of the product was exactly the same. That’s no longer allowed. If you want to see people affecting their own health for the better, go to the store and watch them read the Nutrition Facts label.
Then there’s smoking. In August, President Clinton took a historic and unprecedented action when he announced that FDA was asserting its jurisdiction over cigarettes and smokeless tobacco. We issued a regulation that will make it more difficult for children and adolescents to obtain tobacco products and tougher for the industry to aim its advertising at young people. Based on what we now know, I believe the tobacco companies can no longer credibly claim their products aren’t addictive. Our goal over the next seven years is to cut in half the number of children who start to smoke. Because of FDA’s regulation, tobacco companies will no longer be able to advertise their products with cartoons and other methods that appeal to young people.
Maybe the world in which our children live will be a little bit safer. No longer will kids be able to reach for a pack of cigarettes while they stand at the candy counter. No longer will they be bombarded by whimsical images of Joe Camel as they walk to school. No longer will we, as a society, tolerate advertising practices that have proven so tragically effective. The things we have done at FDA can and will affect the public’s health–and that means we’ve fought the good fight.
