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Drugs Get FDA Approval Too Easily...and We Pay


Imagine if drug manufacturers tried to sell you a new prescription with the slogan "Take this medicine; it's better than nothing." It seems like a weak premise to get you to put some unfamiliar chemical into your system. Yet that is all that manufacturers have to demonstrate in order to get FDA approval for a new drug—that it outperforms a sugar pill, and sometimes not by very much, as became public last year in the case of some of the newer antidepressants. The pill doesn't have to show that it's as effective as getting more exercise, meditating, changing your diet, playing with the dog, or reducing your stress level. It's a very low standard, yet we go on popping pills, often before we try any other alternative.
We have faith in medicines because we know from experience that they can be incredibly effective. Antibiotics for infections, chemotherapy for cancer, even aspirin for a headache—all can be genuine wonder drugs. But medicine is running out of wonder drugs. At this point, eight of the top ten best-selling prescription drugs are aimed at stress-related symptoms—depression, anxiety, gastric upset, cardiac conditions—and none of them work miracles, largely because we can't escape the stress that made us sick in the first place.
Taking the pill also sounds like the easy solution. No effort required! But ten years from now, when we find out about that pill's long-term side effects, maybe it won't be so easy after all. Ten years from now, when our other systems are breaking down because of all the goop we consume as food, because we can't find our toes anymore, because the only exercise we get is finding the remote, because we still have to be working 12 hours a day to pay off the second mortgage that paid for the plasma TV that we plop ourselves in front of every night, and the SUV that we take instead of walking a block, we might realize that trusting in medication only to save us wasn't such a great idea.
An increasing number of physicians and other health-care people are recognizing just that. They follow in the footsteps of the late George Engel, who advocated what he called a biopsychosocial approach to medicine. He emphasized that a symptom involves not only the biomechanics of the patient, but his/her individual psychology and the meaning of the symptom in society. Thus, for instance, there is no such thing as depression in China, where patients never complain of it (because of shame) and doctors aren't trained to recognize it. But there is a great deal of neurasthenia in China. Neurasthenia has exactly the physical symptoms of depression—fatigue, poor appetite, disturbed sleep—the same thing that Freud was treating in Vienna as "nervous exhaustion" or what we call burnout now—but is more respectable than depression because it implies that you have simply worn yourself out dealing with a very difficult situation. So when a lonely, isolated, older patient in the U.S. visits her MD complaining of aches and pains, weakness and fatigue, the MD should of course run all the medical tests to detect a disease process at work; and when they come back negative perhaps the MD should not try to treat chronic fatigue syndrome but try to find a way to help the patient deal with her isolation and loneliness. And if the MD does consider that this might be depression rather than a "physical" illness, and prescribe an antidepressant in response, that's still not good enough.
There's research to show that regular exercise is just as good as an antidepressant for older people. That marital counseling is as good as a pill for depressed spouses. That meditation is effective treatment for some autoimmune conditions. Maybe the FDA could raise the bar a little bit when it reviews new medications—maybe it's not good enough to be better than nothing, but to be better than something else that is really good for us.

 

Last Updated: 10/06/04