Why FDA approval is no guarantee

Even though I’m generally an optimist, you may have noticed something I’m rather pessimistic about.

It’s Big Pharma.

But can you blame me? They just keep proving over and over that the drugs they peddle are worse than we fear. Not only that, but they remind us that our government isn’t protecting us the way they’re supposed to. And the study I’m going to tell you about today just adds fuel to the fire.

According to the study, almost one-third of drugs approved by the FDA end up having safety issues that weren’t known at the time of approval.

Want to know why? Because these drugs are usually tested on relatively small numbers of people. Just enough to get a “statistically significant” result.

Trust me, statisticians know how to make any number work to their advantage.

Then when these studies make it into the medical community and are sold as “evidence-based medicine,” doctors (and their patients) believe them.

Once the drugs hit the market, millions upon millions of people take them. And it’s only then that we find out about the real side effects.

The findings are not surprising to someone like me who is suspicious of drug companies to begin with. Yet I also have a degree in public health, so I know how these studies are written. More importantly, I know how to read research. There is an art to reading a study. Once you’ve mastered it, you realize there’s just as much information between the lines as in them.

There’s a big difference between a drug working in a randomized controlled trial and how it really works once it’s out there in the real world. (I’ve written before about the importance of post-market research. This study is proof positive that we need testing to continue after drugs hit the market.)

It’s why I almost never put my patients on new drugs when an older one will do the same job. Because at least with the old one, we are well aware of the side effects. There are no surprises lurking around the corner.

Not surprisingly, drugs that receive “fast-track” approval are among the most likely to have adverse safety events.

So just how bad were the drugs in this study?

Well, of the 222 new drugs studied, 71 had safety issues during the 11.7 years of follow-up. Three of the drugs had to be removed from the market because the safety issues were so bad.

And 43 had to have boxed warnings added.

Boxed warnings alert users to potentially life-threatening or preventable safety events that were reported after the drug hit the market.

Another 44 required “safety communications.” Unfortunately, those communications are sent to doctors but aren’t necessarily released to the public.

Bottom line: There are major gaps in our knowledge about the safety of drugs at the time they’re approved.

Of course, in typical spin doctor fashion, Big Pharma would tell you this isn’t necessarily a bad thing. Why?

Because, they argue, to really research drugs adequately would require a lot more time and money. Which would keep these treatments out of patients’ hands for longer…and make them much more expensive when they do hit the market.

So, in their twisted minds, they’re doing us a favor by rushing these concoctions through the approval pipeline.

Regardless of the fact that we end up paying for it in the end, one way or another.

Bottom line? The FDA needs to get its act together and force reporting of post-market events. Big Pharma may not like it — but with people’s lives at stake, it really shouldn’t be up for debate.

Unfortunately, the FDA is limited in what it can do in this regard. Any real change would have to be issued by Congress.

And I don’t have much hope for that anytime soon.

So the best thing you can do in the meantime is to keep yourself healthy naturally. Starting with what you eat, how much you move, and the nutrients you take. And I’ll be here to guide you every step of the way.