Have you ever wondered about the safety of your medications? Who decides if drugs are safe for use and, in fact, whether they provide benefit for treatment of disease?
Each year, with millions of Americans taking billions of dollars worth of prescription drugs, how do we know if the chemicals we take are more helpful than harmful?
Prescription and nonprescription drugs are approved and regulated by the U.S. Food and Drug Administration.
The life of a new drug often begins in the laboratories of the pharmaceutical industry with a creative idea about how to design a chemical to treat a particular symptom or disease. After initial production of the drug, the company completes an application to the FDA for testing and approval. This leads to a multistep process to manufacture and test the new chemical. The process often takes many years.
Initial research on new medications occurs in the laboratory and with testing on animals. These steps are designed to see how the drug works and whether it is safe. Only then can testing proceed to human subjects, first among small groups of volunteers. If the drug appears safe and beneficial, larger-scale studies are conducted, usually involving as many as 10,000 patients in so-called phase III clinical trials.
Only after these stages of research are completed and the drug has been deemed both safe and effective does the drug receive FDA approval for marketing by the manufacturer.
Only a small fraction of drugs make it from the drawing board to widespread use. Many drugs fail because of either toxicity or failure to produce a benefit. Meanwhile, tens to hundreds of millions of dollars are spent by manufacturers on each potential drug during this so-called research and development stage. Therefore, once a drug is approved for use, there is considerable incentive for the company to market the drug and begin to recoup its investment and hopefully make a profit.
During marketing, physicians and consumers alike are told about all the potential benefits. No doubt, you've seen the direct-to-consumer marketing of medications in magazines and on TV. The promises often seem too good to be true.
Often, the drug initially enjoys widespread use, as many patients demand it and more physicians prescribe it. Unlike the thousands of patients on whom it was tested, the drug now is used by millions of patients. Soon, less common or less easily recognizable side effects or toxicities may be discovered. This is the so-called "postmarketing" surveillance phase.
Depending on the severity of postmarketing side effects, the FDA may issue alerts to patients and physicians or may pull the drug from the market. In some instances, such as the now well-publicized case of Vioxx, this may occur as many as eight to 10 years after the drug has been approved.
More commonly, as more is learned over five to 10 years about the use of the medication, it continues to be used in a subset of patients for whom it is safest and most effective.
Dr. Matthew A. Clark is a board-certified physician in internal medicine and pediatrics practicing at the Southern Ute Health Center in Ignacio.