New evidence shows how foolhardy it is to take a newly approved drug

I’ll bet most people have a positive response to the phrase, “newly approved drug.”

There’s a promise of hope in those three words. And if a drug is new, well then it’s the cutting edge of modern medicine. Right?

Wrong.

In fact, a new drug is a mystery. And it’s probably more of a mystery than your doctor even realizes.

What you don’t know CAN hurt you

Nobody knows how effective or safe a new drug is. Only time will tell. And you know what that means. The first million users are guinea pigs.

Most pre-approval clinical trials last only a few months. So nobody has any idea how patients will react over the long term.

The perfect example is Lipitor, the best selling drug in history. Just this year — 16 YEARS after approval — the FDA admitted that the drug increases risk of cognitive dysfunction and type 2 diabetes.

Think of that. A full decade and a half after FDA approval, your doctor STILL might not have an accurate safety profile.

Recent British Medical Journal studies reveal why doctors are in the dark.

UK researchers examined the reporting of clinical trial results. They discovered “haphazard publication and incomplete data disclosure.”

In one BMJ study, researchers looked at trials funded by the NIH. Less than half of the trials received peer-reviewed publication 30 months after the trials were completed.

The UK team says that this situation “is a disservice to research participants, patients, health systems, and the whole endeavour of clinical medicine.”

The researchers also note that the problem of inadequate data disclosure is so bad that it’s “almost impossible” to accurately judge a drug’s benefits and harms.

Almost impossible! And yet, FDA officials take pride in improving their quick rate of new drug approvals.

If your doctor wants to prescribe a new drug, tell him you’ll consider it in 10 years.

Better yet, make it 20.

Sources:
“Missing clinical trial data” BMJ, Vol. 344, 1/3/12, bmj.com

“Unreported drug data a health hazard” Dawn, 1/13/12, dawn.com

“The difference in blood pressure readings between arms and survival: primary care cohort study” BMJ, Vol. 344, 3/20/12, bmj.com