Drug Studies Don't Lie, But They Do Fool People - Part 2

dr_cleaves_bennett_136By  Cleaves M. Bennett, M.D.

Reducing risk is not the same as true prevention

Generally, only a small percentage of patients are personally benefited in drug trials that are placebo controlled. One must assume then that once released to the general public, the same small percentage are benefited by taking the drug.

It might very well be even less, since in drug studies, every patient takes every pill, attends every appointment and is followed very carefully and frequently the entire duration of the study. Plus, everyone in the study is encouraged if not actually ordered to eat better, stop smoking and exercise. Is that what's going on in your doctor's office?

There may be an important benefit of a new drug, such as reducing the risk of a heart attack or a stroke, and that's what you hear about on the nightly news. But actual prevention is only for a lucky few. I believe this is potentially a big problem in the area of "informed consent."

Have you ever heard of a doctor telling their patients, "Now I want you to take these pills every day, and refill the prescription every month, because we have to control your high blood pressure. If we don't you could be at increased risk for a heart attack or stroke." (This is what doctors say, because they're all reading from exactly the same script.)

"But I have an admission to make. I reviewed the research done on this drug over the last few years, and I learned something that surprised me. To be perfectly honest, there‘s less than a 10% chance that this drug will actually benefit you personally in any way!" Side effects? Yes. Costs? Yes. Benefits? Only a small chance for benefits."

"Worse still, I'm afraid that you'll have to take these pills every day for the rest of your life. I don't think I've told you this before. I'm sorry, I should have. If you ever stop them, since you are not cured of anything, the conditions ( high blood pressure and cholesterol ) eventually will come back, probably in a few months or so. And pretty soon you'll be no better off than if you had never taken the pills at all."

Of course that has to be true. You're still doing all those dumb, self-destructive things that caused the problems in the first place. Of course the high blood pressure is going to come back. And the high cholesterol problem too. Worse yet, pretty soon you're liable to be coming down with diabetes, because your belly is still hanging over your belt. Remember what your doctor told you?

The only way you're going to get those high numbers to go down and that big belly to go away permanently is eating sensibly and exercising more. What, you think God is going give you a pass just because you took a few pills for a while?

Now here is another startling revelation. No one really knows what most of these drugs do during the second 5 years, or the third or the fourth 5 year cycle.

Hey, that's an important omission! If you start taking blood pressure or cholesterol pills when you're 45 say, you'd hope you're still kicking 20 years later. Or else, why would you bother taking the pills?

But the drug companies can't tell you whether you are going to continue to enjoy the same benefits ( i.e. slightly reduced risk of stroke or heart attack ) beyond the first 5 years. They have strong positive opinions of course, but no scientifically validated evidence. No double blinded studies. No large group of patients kept on placebo for 10 or 20 years. In fact, if you continue to live unhealthfully while taking the medication, you very well may not enjoy much if any benefits beyond the first few years.

Remember, during the studies, even some of the people on active medication got into trouble, that's always the case. All these drugs reduce the risk of problems, but not to zero. Because they are not a cure!

Maybe instead of reducing the risk of heart attacks the pills only delay them. Maybe unhealthful lifestyle trumps pills if you go out far enough, 10 or 20 years. Nobody knows. Here's why.

The drug companies can't run a double blind study for ten or twenty years. That would involve keeping half the patients on placebo, therefore not treated for hypertension or high cholesterol or whatever else is wrong, for ten or twenty years. Not treating a patient for that long of course would be unethical. Even 5 years is pushing it.

So everyone who takes some medication for ten or fifteen or twenty years, or everyday for the rest of their life is doing an uncontrolled experiment on himself. The drug companies don't know if it's still working that far out. They've got no data. And they're not going to get any either. After 4 or 5 years you are on your own.

Now I've been in science for a long time. The "gold standard" for testing if a new drug has enough beneficial effects that it's worth the cost and risk of side effects, and the ‘not taking another drug that might actually work better' dilemma, the gold standard is a double blind, placebo controlled, several years study. The longer the better.

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