Archived Issue - PRAKTIKOS Summer Solstice, 2005

None love the messenger who brings bad news.
    - Sophocles

Finding Relief for Pain

No one wants to feel pain; it’s the reason that pain relief is a huge business. Witness the incredible explosion and then the even more dazzling implosion of the newest class of pain killers known as COX-2 inhibitors.

Back in 1999 these COX-2 inhibitors arrived on the scene to great fanfare. Vioxx, Celebrex, and Bextra were approved for the United States market by the F.D.A. as a safe alternative to older pain killers for such chronic ailments as arthritis.

This group of older drugs known as NSAIDS (non-steroidal anti-inflammatory drugs) has been around for some time. They are effective but have serious drawbacks when used for long periods of time.

Chronic use of these NSAIDS is known to damage both the liver and the kidneys, but the most damning problem is stomach irritation and bleeding.

One study of people using ibuprofen (Advil) to relieve their osteoarthritis pain concluded that more than 16,000 people died every year from acute gastric bleedouts due to this stomach irritation.

So when the new COX-2 drugs hit the market, there was a strong demand for something that would relieve pain without causing stomach bleeding.

Adding to the demand were the newly relaxed rules for drug advertising. We all witnessed an amazing number of ads for these new wonder drugs. One manufacturer actually spent more money promoting its product each year than Pepsi did promoting its line of soft drinks.

Soon everyone was using, or knew someone who was using, one of these COX-2 drugs. It was like a miracle: pain relief without stomach bleeding.

Never mind that the new drugs cost almost as much per pill as the old ones cost per bottle of pills. Everyone was happy. Everyone was a winner.

The drug companies were especially happy. Because chronic pain is such a common problem, there was a huge market. One company alone was reporting profits of more than one billion dollars each year from the sales of its COX-2 drug.

Then came the fall. In October of 2004 the F.D.A. asked the Merck Co. to remove Vioxx from the market due to safety concerns. Well, “safety concerns” might be a slight understatement.

New studies showed that use of Vioxx actually doubled a user’s chances of suffering a heart attack or a stroke. That is correct, doubled.

The ensuing investigation revealed that Merck had been aware of the problem since 2000 but had continued to advertise and sell the drug to an unsuspecting populace anyway.

The firestorm continued to grow, and it soon spread to the other manufacturers of COX-2 drugs and to the F.D.A., which had approved the drug.

The F.D.A.’s role in this fiasco was most interesting and is already leading to a review of how this government watchdog agency does business.

One problem is that new drug safety studies are usually done on young, healthy volunteers who are taking no other drugs, while the eventual end users are usually older people who have multiple health problems and who are taking several drugs.

Another problem is that the scientists who conduct the safety studies are often employees of the drug company. This gives them a strong desire for the drug to be approved.

The final problem is that drug safety studies examine only short-term use, while many drugs are designed for long-term use and may exhibit problems only after months or years of use.

A combination of all these problems is what finally dragged the
COX-2 inhibitors down. A scientist who was not beholden to the manufacturer was doing a long-term study of the drugs. He was investigating the possible protective effects of the COX-2 drugs against colon polyps in an older and less healthy population.

To his dismay, the numbers showed a clear danger when the drugs were taken regularly longer than six months. Then to the dismay of Merck and Co., he reported his findings and all hell broke loose.

To understand the enormity of this issue, it is necessary only to know what I used to teach grade school kids when I volunteered for the American Heart Association. Fully half of all deaths in the United States each year are due to stroke and heart attack.

A drug that doubles the rate of our most potent killer is indeed a major problem.

Now, at this point it might be easy to think: well, at least those drugs are off the market now. We’ll be safe. Except…

Recently, another disturbing piece of news appeared. Researchers were looking into the possible protective action of NSAIDS against mouth cancer in smokers. After a 20-year study they announced two findings, one good and the other definitely bad.

First, they did demonstrate a reduction of mouth cancer in smokers who used NSAIDS. Second, they noticed that smoking NSAIDS users died twice as often from heart attacks and strokes when compared to smokers who did not use the drugs. Wow!

The only drugs that did not demonstrate this doubling effect were aspirin and acetaminophen (Tylenol), both of which have their own side effects.

So what can we learn from all this? One thing is that all drugs have side effects. Just because the F.D.A. clears a drug does not mean the drug is totally safe.

Another thing is that some side effects are not so bad and others are horrible. Stomach bleeding actually seems like a minor irritation compared to a doubling of your chances of suffering a stroke or heart attack.

Finally, if the cause of your pain is a fixable thing, have it fixed. Treating pain as the enemy is just plain wrong. Pain is a messenger that there is a problem.

Think of a fire in your house as the problem, and the fire alarm as the messenger. If you take the battery out of the alarm, your house will burn to the ground. If you throw buckets of water on the fire, you may not be sleeping under the stars tonight.

If you have pain, don’t turn off the alarm. Don’t kill the messenger. Instead, call us: together we can get to the root of your problem and fix it. Your heart and your stomach will thank you.