The Drug of a Lifetime

After yesterday’s post about the overuse of statin drugs in the elderly, this morning I came across the results of a recent study investigating medications for high blood pressure.

Stop, I Say!

Actually, the study looked at patients who stop taking meds for high blood pressure. Several recent studies have noted that higher blood pressure in the elderly is associated with better brain function, so the investigators wondered whether taking patients off their medication would help those who had some degree of cognitive impairment.

After 16 weeks, those patients who had stopped their medication didn’t do any better on cognitive tests than those who continued on the drugs. There was also no difference in other aspects of mental function, such as mood, memory, and quality of life. The researchers were somewhat surprised, and guessed that they hadn’t tracked the two groups for long enough to notice a difference.

The premise is that brain function depends on adequate blood flow, so maintaining a higher volume and pressure of blood through the brain might improve things, or at least keep function from deteriorating. But other trials had shown that lowering blood pressure in the elderly didn’t change brain function either, so it’s possible that BP doesn’t affect the brain in either direction. The flip side of this is that stopping medication for high blood pressure won’t cause harm to the brain, either.

We’re All Lab Rats Now

As it happens, I’m especially interested in meds for blood pressure, because I have a family history of the condition—in both parents and my younger sister—and it’s the only medical condition I have. My doctor prescribed a relatively benign medication for me, a beta blocker. Still, I’m not happy about the idea of a lifetime of morning pills. For one thing, it’s a pain. And for another, our generation is part of a giant on-going experiment—and we’re the lab rats.

Drug trials are considered long-term if they go beyond 6 months or so, and new drug approvals are based on the risk/benefit ratio that appears in that short time. (See my recent post about Addyi/flibanserin, for example.) That’s simply not enough time to get the full assessment of truly long-term risks and benefits.

Since 1995, 26 drugs have been withdrawn* from the US market after having been approved by the FDA. Some of these had been around for more than 20 years; it took that long for reports and observational studies to pick up the pattern of adverse effect from these drugs. And granted that this is an outlier, but one drug, DES, is currently under review for adverse effects in the grandchildren of women who took it in the ‘50s and ’60s to prevent complications in pregnancy.

One review of the study above said that it represented a “paradigm shift” in the way we conduct trials on lifetime medications. Hooray for that.

* “Market withdrawal” means that the FDA pushed the maker to stop manufacturing and distributing the drug in the US permanently, mostly for reasons of safety. A “recall” occurs when the FDA requires a maker to pull something from the market. This is usually over a temporary issue, such as a manufacturing glitch or labeling problems. Recalls most often apply to specific lots or batches of a drug, and seldom affect its long-term future.

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