Medical science never advances perfectly. Whenever a large number of patients benefit from some new drug, device or procedure, it is a certainty that a small number will also be harmed. New stuff also takes some time to be assimilated into normal practice and some doctors will adopt new things quickly whereas others are more cautious and take a wait-and-see attitude. An irreducible number of people will be injured or lose an opportunity for a good result and we can only sigh and realize that life isn’t always a bowl of cherries. But, some of the inevitable mistakes are avoidable, and no better indication of avoidability exists than when all of those responsible start pointing fingers at each other.
Thrombolytic drugs—clot busting drugs—have been in use for the treatment of heart attacks since the mid 80’s and for treatment of strokes since the early 90’s. Thrombolytic therapy is highly time sensitive, meaning that treatment must be given within a brief time frame after a patient experiences symptoms in order for the thrombolytic agent to be effective. Rapid diagnostic testing has assumed critical importance in distinguishing who will benefit from thrombolytic therapy from those who will not.
The cerebral perfusion CT has become very popular for screening potential stroke patients for thrombolytic therapy. This technique usually only requires a software upgrade to a hospital’s existing CT scanner and every stroke patient needs to have a CT brain scan anyway. The whole test takes less than a minute and tells the doctor not only that the patient is eligible for thrombolytics, but also the extent and location of the stroke. Everything seemed fine until recently.
This past Sunday, the New York Times laid out the scandal. For the last 10 months the FDA has been looking into reports of radiation burns resulting from cerebral perfusion CT scans. And guess what? The CT scanner manufacturers are blaming the hospitals, the hospitals are blaming the CT scanner manufacturers, the New York Times is blaming capitalism, Republicans admit mistakes were made and the Democrats are calling for more regulation. I’m just kidding about the Republicans and Democrats.
Not surprisingly, it takes a mighty blast of radiation to get all the radiologically desirable information in less than a minute. Radiologists have traditionally traded off some image quality to keep the radiation dose at an acceptable level. Typically the radiologist made the adjustment by the seat of his pants to keep the same safe dose for every patient, but had to accept a less than ideal image. The CT manufacturers saw an entrepreneurial opportunity. The manufacturers began to offer a feature that could make automatic adjustments based upon the patient’s size, thinking that image quality would not have to be sacrificed while the patient still would not receive too much radiation. Unfortunately, things didn’t work as advertised and a lot of patients were burned. Most suffered hair loss in a bizarre pattern and some had confusion, seizures and weight loss. Because radiation injuries tend to evolve over time, there is no telling how much brain injury these patients will ultimately suffer. And, it didn’t just happen at a single hospital. Cases are being reported in Alabama, Florida and in many California hospitals.
At least the problem has been recognized and it should not happen again. The manufacturers are reprogramming and adding safety features and the radiologists are training their technicians better. The patients who have been injured need to be made whole and our courtrooms should do that. I don’t think we need to get rid of capitalism.
Glenn L. Goodhart, M.D., J.D. 
6065 Roswell Rd. Northside Tower
Suite 410
Sandy Springs, GA 30328
Phone: (404) 255-3282
Toll Free: 866-959-2148
6065 Roswell Rd. Northside Tower
Suite 410
Sandy Springs, GA 30328
Phone: (404) 255-3282
Toll Free: 866-959-2148
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