The U.S. Food and Drug Administration approves every medical drug, device and treatment that is available to us by prescription or over-the-counter. They all undergo a rigorous testing process that takes years, sometimes decades, before they can be marketed and sold to us for our care.
At the center of the drug approval process are studies called clinical trials. These are studies in humans that take place following basic studies in animals and after a review board makes sure the studies are acceptable and reasonably protect participants from harm. These trials produce the data the FDA uses to approve or reject a drug.
The process is so strict that most drugs studied never complete the process because of concerns about quality, safety or efficacy. Despite these safeguards, no approved drug or treatment is 100 percent safe and effective. Every treatment has risks and benefits. And the best treatment for one person may not be the best for someone else.
“Clinical trials get at the broad picture, but we are all unique individuals,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in the Center for Drug Evaluation and Research at the FDA. “While we can say generally what we expect for most patients based on clinical trials that have been well conducted…it’s an imperfect science. So we have to expect that there will be unique needs.”
Kweder spoke last October at a meeting hosted by the Society for Women’s Health Research, a Washington, D.C., based advocacy organization.
If researchers tried to eliminate all uncertainties about drugs before approval, it would cause considerable delays in new treatments reaching patients. To protect patients, the FDA continues to study and monitor drugs for adverse events after they’re available. Even with this monitoring program in place, it is important for you to work with your health care providers to carefully choose the best treatment for your individual situation. As a team, you must weigh the potential risks and benefits of available treatments.
If you are experiencing a life threatening illness or your symptoms greatly affect your quality of life, you and your doctor may decide that a potentially risky treatment is worth the opportunity to find relief. If your symptoms are minor and not a serious threat to your physical or emotional well being, a high risk treatment is probably not worth it.
“Family history, preexisting conditions and the use of other medications can also impact the safety and effectiveness of the drug you take,” said Jo Parrish, vice president of communications for the Society for Women’s Health Research. “You have to take these things into consideration when selecting a treatment. And once you start taking a treatment, it is important to monitor your progress and report any adverse effects to your doctor. This is especially true for women in whom many drugs have not been thoroughly tested.”
Adverse events are common and often the result of confusing medical information or the failure of patients to follow instructions. The FDA reports that each year approximately 300,000 preventable adverse events occur in hospitals alone.
“You have a responsibility to carefully follow the instructions that come with your drug and to discuss any problems or concerns with your doctor or pharmacist,” Parrish said. “It may seem like a burden, but taking an active role in your care has benefits. Studies show that engaged patients recover faster.”
The label or prescribing information for every drug contains instructions on when and how to use the medication. It also describes potential side effects, some of which can be dangerous or deadly. Make yourself familiar with this information and monitor your progress the entire time you are taking the medication. You should immediately report to your health care providers any negative side effects or abnormal changes to your condition.
What should you do when the media reports new health risks associated with a drug you are taking? Or what if the FDA issues a warning about the drug, changes its label or pulls it off the market?
“If the FDA pulls a drug off the market, stop taking it immediately and call your doctor,” Parrish said. “In all other cases, call your doctor immediately to determine if the risks apply to you and whether the way you use the drug increases risk.”
By taking these steps and playing an active role in your care, you improve your chances of having a quick and successful recovery.
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Written by: Richard Schmitz
Society for Women’s Health Research
© February 22, 2007 Society for Women's Health Research
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