Drug Studies Don't Lie, But They Do Fool People - Part 3

dr_cleaves_bennett_136By  Cleaves M. Bennett, M.D.

Statistical significance is not the same as clinical significance

Let's say you are the vice-president for development at a major pharmaceutical company. Your scientists have a new, hot drug prospect. It could be a "biggy". It's looked real good in lab animals. It doesn't kill people (so far).

Your statisticians tell you how many patients and how many years for the big clinical trial. Usually it's several years, maybe even 5. But not 20 or 30 years! The company  just needs to go long enough until they get a statistically significant difference between their drug and the placebo. And then if they're smart (and believe me, they are smart), they quit while they're ahead!

None of the drugs in use today, that don't cure anything but only reduce the number and severity of risk factors for say cardio-vascular disease, have been tested out beyond about 3 to 5 years. And many of them, although they do reduce risk factors, have not been shown yet to let you avoid hospitalization, or severe disability or even death.

Let's all agree on this one: reducing risk factors (i.e. high blood pressure or cholesterol numbers) with drugs is not at all the same as preventing heart attacks and saving lives.

Reducing risk is not the same as true prevention
Pfizer did this with their blockbuster drug Lipitor®, the best selling drug of all time. They set out to do a study of 10,000 patients for 5 years, Lipitor® vs placebo. The patients were all at high risk for getting cardiovascular disease. (Remember that, it's important.) At the end of 3.3 years the survival curves had separated significantly. They could state with statistical certainty that Lipitor® treatment reduced the heart attack rate by 45% by the end of 3.3 years. So they quit while they were ahead. We don't know what would have happened over the next 1.5 to 2 years, (let alone 5, 10 or 20 years) if that same benefit would have persisted or not. It's not been studied out that far and it never will be.

The actual benefit of Lipitor was not all that great anyway. The impressive 45% fall in risk was a "relative risk reduction". The actual reduction in heart attacks was very much smaller, from about 2% of patients having heart attacks on placebo down to about 1% having heart attacks on the Lipitor®. Think about what that means. For every 100 high risk patients your doctor prescribes Lipitor, only 1 is actually benefited over the next few years.

If you are low risk (the only problem is your cholesterol is high) there are no studies showing lowering it with drugs actually prevents anything.

Too many seniors take too many pills
Here's one last thing to think about when you are standing in line at the druggist to fill all your different prescriptions. Let's see, you've got 2 for your blood pressure, one for your cholesterol, one for your leaky bladder, one for your heartburn, one for sleep, one to prevent weak bones, one for your low thyroid and one for depression.

Let's see, did we forget any? Oh yes, the newest one, for that pesky bladder infection you've had over the last few months. Doc said he was going to try a new antibiotic that's pretty strong this time, so the infection doesn't keep coming back.

I guess that's ten in all. It's a lot, but then Mary next door, she takes even more than that. Most of your lady friends take lots of pills ‘cause you all have so many different health problems. Well, of course. You're all in your eighties, so what can we expect?

Well, for starters I expect you to engage your brain before you get in line at the drug store. You should ask your pharmacist about how those drugs interact with each other when they're all circulating around inside you at the same time.

Your pharmacist may have trouble answering your questions. Don't panic. It's time to go back to your doctor and ask her. If she has to do some research here, and she's a little bit inconvenienced by this, maybe she'll encourage you to take better care of yourself--so you won't have to take so many pills!

The problem is, none of these combinations of pills have ever been tested all together like that, so we don't really know how much they interfere with each other or increase the chances for toxicity.

Some drugs are detoxified and eliminated by the same system and so if two or more are "waiting for the bathroom" at the same time, well, you get my gist. Such problems all get a lot worse when you're over 70, because by then it's likely that your liver and kidneys aren't as good at detoxifying and eliminating medicines as when you were younger. Of course it's the over 70 folks that end up with lots of medications. And the most serious side effects.

If your doctor is prescribing many different pills for all your many problems he or she is doing an uncontrolled drug study on you. You can only hope he's gotten permission from the FDA, and also some authoritative local committee empowered to set up and monitor human drug studies. Because that's what this is, a human drug study of 10 drugs, with only one participant. That unwitting experimental subject, whether you realized it before or not, is you. Good luck!

Drug Studies Don't Lie, But They Do Fool People part 1
Cleaves M. Bennett MD obtained his MD from the University of Rochester (New York) with honors in 1960. He was Clinical Professor of Medicine in the Division of Nephrology at Harbor/UCLA Medical Center, from 1969 until retiring in 2006.
He is the author of several books including 
In 12 weeks You Can Control Your High Blood Pressure Without Drugs.

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