What do current CT scanners have in common with shoe-fitting fluoroscopes invented in the 1920s? Both are great examples of how the U.S. Food and Drug Administration does little to protect consumers against dangerous levels of radiation.In the 1920s, a number of inventors started looking for new ways to use the latest technology: the fluoroscope. This device is made up of an X-ray-generating tub and a fluorescent screen. The patient stands between the two, the machine is then activated and an X-ray of the body part being examined appears on the screen.By 1927, the Adrian Co. of Milwaukee received a patent for a “shoe fitting machine.” It encased the fluoroscope in a nifty wooden or metal cabinet and made it possible for shoe buyers to get the perfect fit. Customers would try on a pair of shoes, walk over to the cabinet and stick their feet inside an opening in the bottom. The only thing between the customer’s feet and the X-ray tub was a .039-inch-thick piece of aluminum. With a press of a button, a green glow of radiation produced a clear picture of the customer’s foot bones. At the same time, a semi-circle of X-ray beams escaped from the opening into the store.The fitter was equipped with three viewers: one for the customer, another for the sales person and a third for a parent. Everyone got to see how the shoes fit. The machine hit the market at just the right time. With the advent of the Great Depression, saving money on shoes became extremely important. A parent could tell in an instant if their child’s toes were too close to the end of the shoes! Customers quickly gravitated to shoe stores with “fitting machines,” and the contraption started spreading like hot cakes (pun intended) throughout the country.OK, so that was in the 1930s, when little was known about the dangers of radiation. But by 1950, the FDA realized the units were unsafe. A study published that year in the Berkeley Medical Journal concluded that “sufficient information has now been accumulated to prove that the fluoroscopic shoe-fitting machine represents a potential, if not obvious, hazard.” Besides lacking an effective radiation shield, the strength and duration of the X-rays produced by individual machines varied greatly. However, instead of banning what was essentially a dangerous novelty item, the FDA decided to quietly dissuade its use.I became fascinated with the machine in 1956 during a shopping trip for my first-grade school shoes. I watched other people stick their feet into the fitter lots of times, but my father wouldn’t allow us to use it. “Don’t go near that thing kids,” he’d bark as we entered the store. However, on that particular trip he went to get a haircut while my mother took us to buy shoes. Well, it didn’t take long for my brothers and I to nag her into letting us use the machine. I got my first glimpse of my bony feet, and I was hooked!I had an hour to kill after school every day before catching the bus; and, for the next few years, the shoe store became one of my regular stops. If the owner was busy with a customer, I could easily slip inside and X-ray my feet before he knew I was there. I looked with fascination as the bones appeared. No self-respecting kid could pass this thing by. I can’t say whether it was the appeal of the forbidden or the warmth given off by the fitter on a cold day, but I thought the machine was the next best thing to television. A few years later, the owner of the store died of thyroid cancer. “Probably that damn machine,” my father said. I hoped he was wrong, but even then I doubted it.Now, to the CT scanners invented in 1972. “CT” is an abbreviation for computed tomography. It takes multiple X-rays from various angles and turns them into a three-dimensional image of the body’s organs, tissues and bones. There’s no doubt CT scans save lives. Clear images of the brain or abdomen literally let a physician diagnose a patient’s condition in seconds. But since the dangers of excessive radiation were well known in 1972, all logic says the FDA should have demanded safety controls to prevent hazardous radiation levels from occurring before the first machine came on the market. But it didn’t.According to the FDA, one abdominal CT scan delivers the same amount of radiation as “400 chest X-rays.” Even when the machine is operated correctly, a patient increases his or her risk of getting cancer with every scan. A December 2009 article in the “Wall Street Journal” stated that “29,000 future cancers could be related to CT scans received in 2007.”I don’t know about you, but in a life or death situation, I’m getting the scan anyway. However, with more than 70 million scans performed each year in this country, patients should know the risks before popping into the unit. Furthermore, I think that number would drop dramatically if patients understood there are no safety controls to shut the machine down before it delivers killing doses of radiation, should the machine malfunction or the operator be asleep at the switch.There is good news. On March 30 and 31 the FDA will hold a public meeting “to collect suggestions about new safety features and training that should be required for CT and fluoroscopic devices.” After which the agency “will likely require” CT units to “record and report settings and radiation doses for each procedure and issue alerts when the doses exceed optimal doses.”It’s about time. Unfortunately, it’s too late for 260 Los Angeles Cedars-Sinai Medical Center patients. In February 2008, a hospital scanner was recalibrated incorrectly. Over the next 18 months, patients receiving brain scans were exposed to radiation levels eight times higher than the normal dose. The hospital became aware of the problem when a patient’s hair fell out after a scan. Two other hospitals in Los Angeles revealed possible “overdoses by imaging equipment to at least 104 people.” What damage these “overdoses” caused will not be fully known for years. But it’s time for the FDA to do more than “likely requiring” safety controls that should have been installed in 1972.Like the shoe fluoroscope, the amount of radiation a patient receives for the same type of CT scan varies greatly from unit to unit. That’s not because CT devices are faulty; it’s because of human error and the lack of radiation standards in the medical industry.The FDA is charged with protecting consumers against dangerous food, medicine or consumer goods. Yet, history shows the FDA moves at a snail’s pace. A shoe fluoroscope was still being used in a store in Madison, W. Va., in 1981. It seems the FDA’s “quiet dissuasion” program was too quiet. And 38 years after the CT was invented, patients are forced to throw the dice and hope for the best because the FDA still isn’t doing its job.This column does not necessarily represent the views of The New Falcon Herald.
