Are black box warnings inevitable?

A sociologist and health policy researcher has some stern language for drugmakers and their regulators. "Drug disasters are literally built into the current system of drug testing and approvals in the United States," Donald Light said in presenting his figures on new drugs to the American Sociological Association.

According to Light's data review, one in seven new drugs is superior to existing ones, but two in every seven end up emblazoned with a black box, an adverse reaction warning--or they're withdrawn.

And all those post-marketing adverse event reports and black box warnings? They're almost inevitable, given the fact that drugmakers test their products on patients that are typically healthier than the entire population actually targeted by the drugs. And trials are long enough only to pick up short-term side effects, Light said.

Some would argue that the uptick in drug warnings is actually a reflection of the FDA's newly cautionary stance rather than an indication that drug safety is slipping overall. Check out Light's data and see what you think.

- read the post at Pharmalot

Suggested Articles

Former Retrophin CEO was hoping for a SCOTUS hail mary to escape his seven-year fraud sentences Turns out the court was interest in hearing his plea.

A new investigation shines light on how Purdue pushed back on negative coverage of opioids, placed opioid-friendly experts in think tanks and more.

After Merck and Bayer's vericiguat scored in a heart failure trial, you'd expect potential rivals to brace themselves. Not so for Novartis'…