FDA ignores its own researchers' warnings about blood pressure med's dangers

FDA to researchers: shut up about the science!

If you know anyone who still thinks that when the FDA approves a drug that it’s safe, well, this should be their “Aha” moment.

It shows, once again, how “FDA Approved” translates to really mean FDA paid off.

And of course, that also translates to not letting science get in the way.

Now, this would just be an interesting story, maybe a tale to tell around the water cooler, if it weren’t so serious.

Because if you’ve got diabetes and high blood pressure, there’s a best-selling drug that can put your life in danger.

If you were a visitor from another planet, it sure might look to you like the FDA is doing its job.

There are all those trials and studies before a drug is approved that cost millions and go on for years and years. They must prove a drug is safe before it’s allowed for sale, right?

Well, those aliens might be shocked to learn the truth. The big trials — the “real world” tests — happen after a drug is approved. After doctors are prescribing it and millions of people are already taking it.

And that’s just what happened with the high blood pressure med Benicar.

It was approved by the FDA way back in 2002. But two years after it hit the market, a big trial called ROADMAP was started. (Don’t you just love those names!)

Now ROADMAP didn’t take Daiichi Sankyo, the company that makes this blockbuster, exactly where it wanted to go. It turned out to be a map going in the opposite direction. One showing just how dangerous Benicar is.

ROADMAP didn’t finish until 2009, 7 years after Benicar hit the market. And it turned up some frightening results, especially for diabetics.

It showed that the drug could have horrible side effects for those with diabetes. A high percentage of those patients died from heart disease during the trial.

The FDA immediately limped into action. It called for a “safety review” to see if those “troubling” findings would be duplicated. And it allowed 4 years for that review to be completed.

That’s 4 more years of prescriptions flying off Rx pads while the FDA mulls over this lethal risk to diabetics!

Well, that “safety review” was just finished. And here’s where the story turns deadlier.

The FDA announced that the review showed “no clear evidence” that Benicar could increase your risk of heart disease if you’re diabetic. And the agency will not recommend that those patients avoid it.

End of story? Not really.

Because the FDA’s conclusion isn’t shared by the researchers who actually did the study. The agency’s announcement is so far off from what the study results came up with, it almost looks like no one at the FDA even bothered to read it.

Here’s what the study really concluded: Diabetics who took a high-dose of the drug for over 6 months were twice as likely to die. The drug “especially at high doses, should not be used in patients with diabetes,” it said.

And 5 of the authors of that study are FDA employees!

They were certainly good enough researchers to be put on the government payroll. But when their conclusions went against the agenda, they were not only ignored but the FDA did a complete 180.

Now imagine your doctor wants to know whether this med is safe for you to take if you’re a diabetic. If he just looked to the FDA’s announcement, he would never know how dangerous it is.

So make sure you listen to the FDA researchers and not the FDA: Don’t take Benicar.*

*The generic name of Benicar is olmesartan. And it’s also sold under the brand names of Benicar HCT, Azor and Tribenzor.

Sources:
“FDA once again reaches conclusions at odds with its own staff” Larry Husten, July 14, 2014, Forbes, forbes.com