What you don’t know

If your doctor wants you to try a newly approved drug, tell him you’ll consider it in five years.

Better yet, make it 10.

The reason is simple. A new drug is a mystery. It’s probably more of a mystery than your doctor even realizes.

What your doctor doesn’t know CAN hurt you.

Haphazard culture

Nobody — not even your doctor — knows how effective or safe a new drug is. Only time will tell. You know what that means. The first million users are guinea pigs.

Let’s start with safety.

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.

That means your doctor might not have an accurate safety profile even 10 years after approval!

Recent British Medical Journal studies reveal one of the key reasons your doctor is in the dark.

UK researchers examined the reporting of clinical trials. They discovered what they called a “culture of haphazard publication and incomplete data disclosure.” It seems a lot of evidence goes unreported. In addition, much of what drug companies report is inadequate.

In one study, they 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 wrote that this situation “is a disservice to research participants, patients, health systems, and the whole endeavour of clinical medicine.”

And that’s because vital information that affects your health is not getting to your doctor.

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

That’s devastating news to anyone who relies on a new drug to address a chronic condition.

It’s also devastating news for those mainstreamers who crow about the high standards of drug regulation. It’s closer to high comedy than high standards.

You and your doctor may decide that you still need to a new drug to treat a challenging health issue. If so, you both need to diligently monitor your vital signs and be extra alert to any changes.

What seems like a symptom might actually be a side effect.

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


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Allan Spreen, M.D.
Dr. Allan Spreen, Chief Medical Advisor

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