Baby aspirin and the Vytorin scandal

You can't just do one study and learn all there is. It's sort of like a software beta test. You don't really learn its bugs and true capabilities until it's out in the world. Which leads us to the Vytorin scandal.

Bayer Leverkusen team shieldYou can't learn everything about a compound while it's patented. (Bayer Leverkusen is the only soccer team I know with a pill in its team shield.)

Take aspirin. When I was a little kid my mom gave me baby aspirin for headaches. Little, orange, chewable. Delicious. On a night that went into family lore my older sister invited me, around midnight, to a "baby aspirin party."

I don't remember our stomachs getting pumped out. We washed them down with Ex-Lax tablets.

So now, in middle age, I take baby aspirin. For my heart. I wish it were chewable, but it's not. Maybe if I washed it down with a Bloody Mary.

Even when I was a child, aspirin was off-patent. After I grew up it was found that aspirin should not be given to little children. Then it was found its blood-thinning effect might stave off heart attack or stroke.

And today we learn that many people are aspirin-resistant, that this aspirin therapy may be hurting them, causing the heart attacks they are trying to prevent.

So you never know, do you? Or at least it takes a long time to know. You can't just do one study and learn all there is. It's sort of like a software beta test. You don't really learn its bugs and true capabilities until it's out in the world.

Which leads us to the Vytorin scandal. And the general topic of statins.

Vytorin adStatins were developed in the 1980s to lower cholesterol. So the first such drug, Zocor, was going off-patent, and its maker decided to combine it with another cholesterol-lowering formula, the patented Zetia, to create Vytorin.

The idea was that Vytorin would extend the profits Zocor was making under patent, by getting a new patent.

Trouble is, the Vytorin people learned, their new drug was no better than Zocor alone. Somehow the results of this study, called ENHANCE, took an awful long time to compile. Vytorin brought in $1.9 billion in 2006.

Congress says this sounds like a scandal, and maybe it is. But the truth is we really don't know much about statins, even now, and the truth (as it comes out) is far more complex than we first thought.

The media is now ginning up a scandal over a study showing that statin use may have no statistical relationship to heart attacks in women or people over 65. Cholesterol levels past that age may be irrelevant.

On the other hand...

Regular readers here recall how, last month, I wrote about a study by Dr. Helen Hobbs, which concluded that cholesterol causes plaque levels to rise from infancy, and it might thus make sense to give low-dose statins to young people.

We recently learned that statins may prevent the onset of Alzheimer's Disease, again by lowering cholesterol levels and preventing the build-up of plaque, this time in brain tissue. A host of other potential benefits are being studied, including a possible link to diabetes.

Not all the news is good. A mini-industry has developed around dissing statins. Calcium build-up may have as much to do with heart attacks as cholesterol. Links are claimed to depression and cancer.

The truth, as with aspirin, is we just don't know the whole truth. A science experiment tries to isolate a single variable, and if a compound acts against that variable it is deemed to work.

But our bodies defy experimentation. Everyone knows this. That doesn't mean science is bad or wrong or flawed in any way. It just takes a lot more science to make definite progress than most people think.

We're complicated. Deal with it.

Recommendations are just that, the best suggestion we can offer based on what we think we know now. But we keep learning more, and so recommendations change. You only learn when you change your mind, and you can only learn when you're open to that change.

Dwight D. EisenhowerRemember how doctors recommended that President Eisenhower eat margarine instead of butter? Then we found out about trans-fats. Those doctors weren't committing malpractice. They were offering the best advice they had at the time.  

Woody Allen lampooned this  in his early film Sleeper. His character was into health food, but awoke into a future where doctors were plying him with cigarettes and martinis, claiming they were what was good for you.

We're not going that far. But we are going to continue to learn, and we're going to find that many old compounds have impacts, both good and bad, we never knew about when they were under patent.

The next wonder drug, in other words, may have already been invented.