The New Health Dialogue

Just because a drug is new, it isn’t always necessarily better.

Nor, according to a Consumers Union article published in today’s Washington Post, does newer always mean safer.

More than half of all prescription drugs cause adverse effects. That’s a pretty startling (and scary) statistic. Many of these adverse side effects are not exposed until after the Food and Drug Administration have already approved the drug. Maybe not for years down the road.

According to the Institute for Safe Medication Practices, in 2008, more than 100,000 “serious injuries related to adverse drug events” were reported to the FDA -- an increase of about 25 percent since 2007.

Consumers Union admits that “some of the delay is inevitable” because “it’s simply not practical to detect every risk before doctors start prescribing a drug.” Clinical trials are costly, long, and have intrinsic limitations.

Consumers Union provides us with a closer look at the problem. Read the full article here for details.

Holes in the Trials Process

Too small

Too short

Too unrealistic

Too quick

Bigger Holes after Approval

Incidents aren’t always reported

Post-approval studies aren’t done

Studies aren’t published

Surveillance isn’t adequate

The FDA hasn’t been effective (click here to read the Institute of Medicine’s 2007 report on FDA drug-safety)

What You Can Do

Don’t overreact to newfound risks

Consider older drug options

Resist the direct-to-consumer advertising

Watch for Consumer Reports and FDA drug alerts

Do your part and report any serious drug reactions to your doctor