The medical profession has a long record of disasters caused by treating people with untested drugs, devices and surgeries. And it continues today to offer treatments before they're proven safe and effective.
Although many untested remedies ultimately have proved to be lifesaving medical breakthroughs, patients should -- at a minimum -- know if untested drugs, surgeries or devices are being used on them.
The first question to ask, according to Dr. Richard Greene of the Agency for Health Care Policy and Research: What is the evidence that shows I would benefit from taking the drug you are prescribing or undergoing the surgery you are recommending?
Greene and Dr. Robert Temple of the Food and Drug Administration have several other questions to ask your doctor:
Is the evidence based on the randomized clinical trial, which is the most scientific way of proving safety and effectiveness?
If a drug or medical device is not approved, why hasn't it been approved?
If the drug or device is being used off-label -- that is, used in a way that it hasn't been approved for -- is this a recommended off-label use based on a wide range of scientific evidence?
If the surgical procedure is new, how many people has it been used on and what are the success rates and complications? If it is an older procedure, what is the evidence that shows this procedure is necessary?
What are the known risks vs. the benefits?
If the off-label drug is used in combination with another drug, what is known about interactions between the two?
"The public needs to learn that one person's spectacular anecdote may not be true," Temple says.
"Somehow, people simply have to understand that those kinds of observations are often wrong and if you don't look scientifically, you don't find the truth." -- Tim Friend
Copyright 1996, USA TODAY. Reprinted with permission.
