January 11, 2005
from National Public Radio's Morning Edition

No Such Thing as a Safe Drug
by Russell Roberts

The truth is, there’s no such thing as a safe drug. Every drug has side effects. It’s only a matter of degree. And there’s usually a tradeoff between safety and effectiveness. Powerful drugs are more likely to have side effects. Everyone who undergoes chemotherapy understands that life is about tradeoffs—about the likely costs and likely benefits.

Cautiousness is always in order when you introduce a powerful drug into your body. You don’t want to die from a dangerous drug. But you also don’t want to suffer or die because the right drug is not available.

In this world of imperfect safety, why do we give the FDA the authority to make these choices for us? The FDA is the ultimate one size fits all solution. If arthritis makes my life a living hell, why can’t I decide to take on a greater risk of a heart attack? The choice between pain and risk should belong to me and my doctor.

Instead we are heading in the wrong direction, demanding that the FDA become even more cautious and careful in protecting us from harm. If FDA approval is harder to get, then drugs will be safer. But the unintended consequence will be to make it harder to get FDA approval for drugs that can save lives. The unintended consequence will be losing the drugs that we won’t discover because it’s simply too expensive to go looking for anything other than a blockbuster.

Those costs are in the future. But some of the unintended consequences have already appeared. Vioxx has shown promise fighting colon cancer. But clinical trials using powerful painkillers to fight cancer and Alzheimers are now at risk, all the findings and benefits potentially wasted.

The search for perfect safety is a mistake. After all, there’s an easy way to avoid the side effects of so-called dangerous drugs. Don’t take any drugs. We all understand that this is ludicrous. It is just as ludicrous to demand that the FDA establish an arbitrary standard of risk arbitrarily labeled as safe. The world would be a healthier place if patients and their doctors were allowed to make their own decisions on what is too much risk and what is safe enough. Let the FDA continue to provide information about the risks of drugs. Let the people decide what we put into our bodies.