Drug trial transparency is a joke – especially with this one dirty little secret

Dancing in the dark

Yesterday, I told you about a dirty little drug industry secret. Only, it’s not so little. And these days, it’s not much of a secret.

Drug companies hide trial results. Sometimes they hide entire trials. They just wipe them out of existence. And it’s no mystery why. If the results were the least bit positive, believe me, we’d hear all about them.

Hidden research puts doctors in the dark. They literally don’t know what they’re prescribing. That puts patients in the dark too. And in danger.

But it’s not all bad news. A few forward-thinking mainstreamers are working up a plan to turn on the lights.

Vested interest in the outcome

“All trials registered. All results reported.”

That’s the mission of Dr. Ben Goldacre’s “All Trials” website (alltrials.net).

As I mentioned yesterday, Goldacre is a trial transparency crusader. So far, his All Trials partners include The British Medical Journal and GlaxoSmithKline.

That’s right… Glaxo. Smith. Kline. (They just recently signed on. And Goldacre was as shocked as I am!)

Those are serious mainstream heavy hitters. But if they’re really going to tear down and rebuild the culture of trial reporting, they’re going to have to sacrifice. Because it will all be a sham unless the drug industry hands over the ace they’ve been hiding up their sleeve.

That ace is the placebo.

Even in published trials where all the data is available, placebo contents are mostly unknown. In studies that test drugs in pill form, less than one in 10 reveal what makes up the placebo.

Placebo researcher Beatrice Golomb sizes up the problem like this: When a drug company mounts a study, the company provides the placebo pills. And, of course, the drug maker has a “vested interest” in the outcome.

Vested interest? That’s putting it about as mildly as you can put it.

A drug maker might invest millions to develop a single drug. The pressure to succeed could not be more intense. So do they let the chips fall where they may? Or do they put something extra in the placebo to help tilt the results in their favor?

You’d have to be born yesterday to believe this doesn’t happen.

The track record tells the tale. We’ve seen drug companies deliberately mislead the FDA, journal editors, and the medical community. In several cases, drug executives have put dangerous drugs on the market. That includes drugs proven and KNOWN to be unsafe.

So you have to ask. Would those executives put a little something in a placebo to give their drug an advantage?

There’s no question that this happens.

“All trials registered. All results reported.” That’s a great idea. I’m all for it.

But if Goldacre doesn’t add, “All placebos revealed,” then drug companies still have a way to keep us in the dark. And in danger.

Sources:
“Health Care’s Trick Coin” Ben Goldacre, The New York Times, 2/1/13, nytimes.com

“What’s in Placebos: Who Knows? Analysis of Randomized, Controlled Trials” Annals of Internal Medicine, Vol. 153, No. 8, 10/19/10, annals.org