Observe and report

And you thought a drug was safe just because the FDA says so?

Unfortunately, all too often, the most dangerous side effects emerge AFTER the FDA gives its stamp of approval to a drug and it’s in use by millions of people.

Now the prestigious Institute of Medicine (IOM) has caught on to that chilling reality.

In a new report, the IOM urged the U.S. Food and Drug Administration to improve its post-marketing surveillance of medications.

The IOM now acknowledges that it’s just not feasible to know every risk associated with a new drug before it’s approved. Initially, a drug is approved based on limited data from a very select group of patients included in clinical trials. So these pre-approval clinical trials can exclude vulnerable subsets of patients, like children or the elderly, and people already taking other drugs. This explains one reason why some safety concerns don’t emerge until after a drug is on the open market.

Some of this is an inevitable part of this process. But that’s precisely why the FDA needs to do a better job of monitoring the safety of drugs they’ve already approved.  

The IOM believes that the FDA needs to take a greater role in choosing appropriate studies for post-marketing surveillance.

And the best type of study to monitor the risks and side effects of drugs isn’t the oft-touted “gold standard” randomized, controlled clinical trial.

“Observational studies need to be thought of as an important tool in the arsenal,” the IOM said. 

Finally, some sanity in the midst of the statistical gibberish the science bureaucrats typically rely on.

In fact, many times, only observational studies have the power to detect a problem.

Biphosphonate drugs for osteoporosis (such as Fosamax and Boniva) are a perfect example. The risk of serious bone fractures associated with these medications would never have been pinpointed without clinical observations.

In other cases, it may be unethical or impractical to do a randomized controlled trial. 

I’m glad the IOM is catching on to what I’ve been saying for years. That what physicians observe with their own eyes, in their own patients, still counts for something—if not ultimately everything! And that the public needs to be aware that just because a drug is “approved” by the FDA doesn’t mean it’s safe.

In fact, a drug’s safety is the least established at the time of approval as it will ever be. Which is another reason to opt for generic drugs. They’ve been around long enough to pass “post-marketing surveillance.” So you can be sure they’ll work effectively and safely.

“IOM Urges FDA to Be More Aggressive in Monitoring Safety of Approved Drugs,” JAMA. 2012; 307(23): 2,475-2,476