Observations

Spinach contaminated with Escherichia coli (E. coli) O157:H7 sickened more than 200 people in 26 states in the fall of 2006. More recently, tomatoes served at a restaurant were named as the culprit after more than 180 people in 21 states got salmonella. And another 160 people in New York, New Jersey, and other states became ill with E. coli after eating at a fast-food taco restaurant chain.

In February 2007, the FDA issued a warning after the Centers for Disease Control and Prevention (CDC) completed an epidemiological study that linked 288 cases of foodborne illness in 39 states to consumption of several types of Peter Pan peanut butter. The contamination of fresh spinach with the bacteriaduring the fall of 2006 led to one of the largest and deadliest outbreaks of foodborne illness in recent years.

Foodborne illness is nothing new. According to the CDC, 5,000 Americans die each year because of something they ate, another 76 million get sick, and 325,000 are hospitalized.

From the first indications that fresh spinach was the culprit in the fall 2006 outbreak, investigators from the FDA, the CDC, and the states worked together to trace the implicated spinach back from consumption to the fields. Our cover story is titled "How the FDA Works to Keep Produce Safe."

Also called research studies, clinical studies, or clinical investigations, clinical trials are conducted to evaluate the safety and effectiveness of new products, medical procedures, or other means of treating, diagnosing, or preventing diseases.

Many clinical trials are done to see whether a new drug or device is safe and effective for people to use. Clinical trials also are done for other reasons. Some compare existing treatments to determine which is better. The current, approved treatments are called the standard treatments. Sometimes, clinical trials are done to learn how to best use the treatment in a different population, such as children, in whom the treatment was not previously tested. For more on how controlled critical trials have been used by the FDA to ensure the safety of drugs, read our article titled "The Advancement of Controlled Clinical Trials."

Pharmacists have long been allowed to combine, mix, or alter drug ingredients to tailor a medication to specialized needs of a patient in a process called traditional compounding.

Although almost all compounded drugs lack FDA approval, the agency has long recognized the important public health function served by traditional pharmacy compounding. In traditional compounding, pharmacists extemporaneously combine, mix, or alter drug ingredients to create a medication tailored to the specialized needs of a patient. For example, a compounding pharmacy might prepare a unique medicine for someone who is allergic to an ingredient in an FDA-approved drug.

This kind of compounding, which is done in accord with a valid prescription from a licensed health care practitioner, follows a physician's decision that his or her patient has a special medical need that cannot be met by FDA-approved drugs. The FDA, however, is concerned about the improper use of compounded topical anesthetic products designed to dull the pain of hair removal after the deaths of two college students. For more on the FDA's concerns about pharmacy compounding, see our article titled "Warnings for Makers of Compounded Pain Products."

Raymond Formanek Jr.
Editor

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