Severe radiation burns and possible cancers arising from the increasing use of sophisticated X-rays have become new examples in the continuing saga of medical neglect and ignorance.
More and more, doctors are using special X-rays for diagnosis or to guide their medical procedures. But they are often insufficiently trained to monitor the amounts of radiation they give their patients.
While experts say the benefits of X-ray procedures still outweigh their risk, one example of what can happen after excessive radiation exposure is a rash and then a hole in the flesh. These radiation injuries can be quite disfiguring and painful.
Only recently has there been some heightened attention at medical conferences and in the medical literature about this health threat, which has been building for at least a decade.
Only Recently Getting Attention
The Food and Drug Administration is about to propose new guidelines for a type of machine implicated in causing these radiation burns.
"It has taken a long time, but more health professionals are beginning to wake up to this issue because it is getting harder to ignore the type of data that is becoming available," said radiation expert Louis Wagner of the Houston Medical School of the University of Texas. "But there is still a lot of catching up to do."
In July, a paper co-authored by Wagner will be published in a major medical journal. It will provide details of 73 cases of severe skin injuries, such as large, deep holes and burns caused by medical radiation.
In all these cases, the X-ray-emitting procedure used was fluoroscopy and often involved cardiologists who cleared out plaque from clogged arteries, a technique known as angioplasty.
Rather than cut open a patient to do angioplasty, doctors insert their miniaturized medical instruments through fine tubes, or catheters, threaded up to the heart through a patient's blood vessels. Doctors monitor where the blockage is using the X-ray pictures produced by fluoroscopy, which are converted into visible light images that can be revealed by a television camera and then exhibited on a TV monitor. Depending upon the complexity of the blockage, these procedures can take several hours, potentially exposing a patient to a lot of radiation.
It is the doctor's job to control the X-ray beam by stepping on a pedal.
Besides cardiologists, gastroenterologists, surgeons and other medical specialists are increasing their use of fluoroscopy methods in their practice.
Physicians Aware of the Issue
Cardiologists and radiologists acknowledge that radiation burns can be a problem.
Some cardiologists performing angioplasties today may not have had training in radiation exposure, but the next generation will, says Dr. John W. Hirsfeld Jr., chairman of the cardiac catheterization and interventional committee of the American College of Cardiology.
Radiologists have worked with the FDA to develop the new guidelines for fluoroscopy machines, says Dr. Anne Roberts, past president of the Society of Cardiovascular and Interventional Radiology.
Wagner says that as more doctors use fluoroscopy, he is learning of more injuries. He now knows of an additional 25 cases of fluoroscopy-related skin injury.
Those are not large numbers, considering that about 700,000 fluoroscopy-guided angioplasties are done every year in this country and that they often save lives.
Government Getting Involved
But Thomas Shope, a radiation expert at the FDA, says the reported injury cases are likely a drop in the bucket. "There is probably a great bit of under-reporting of these types of cases," he said.
Wagner knows of patients who had undiagnosed injuries for many months before it was finally determined they had suffered radiation burns from fluoroscopy. "Patients can see several doctors before somebody makes the connection between the injury and medical radiation," he said.
Radiation burns can even take time — even months — to surface on the skin and become apparent, making them even more difficult to diagnose correctly.
Concerned about this issue, the FDA told ABCNEWS.com that it will soon propose new standards for fluoroscopy, recommending that all new machines come with a meter to show doctors how much radiation exposure their patients receive.
But any change in the standards for fluoroscopy equipment could take several years because the agency must comply with an extensive schedule of public review and comment.
So, obviously this problem of exposing patients to excess amounts of radiation is not about to be resolved any time soon by FDA action.
CT Scans in Children Possibly Problematic
Meanwhile, the FDA will also begin focusing more attention on the ways that computed tomography, or CT — another X-ray technique — could expose patients, including children, to excessive dosages of radiation.
An FDA advisory committee will take up the issue next month, a move that could eventually lead to new standards for CT scans.
This CT evaluation comes on the heels of two studies published in February estimating that about 1,500 of the 1.6 million children below age 15 who get CT scans annually will eventually die from cancer.
"When you think in terms of any one individual, it's a small risk but these numbers add up to a fairly significant public health issue," said David Brenner, a professor of radiation oncology and public health at Columbia University and author of one of the studies.
The main problem is that many children who get CT scans are receiving an excessive amount of radiation. "Children, who are more sensitive to radiation than adults, are receiving adult doses and there are studies suggesting that the dose can be reduced at least by half and the procedure can be just as effective," Brenner said. "And most radiologists are not reducing the dose."
Brenner says that one stumbling block to change is that some doctors still do not believe that medical radiation doses can be harmful.
Upon publication of his study, for example, the Society for Pediatric Radiology commented "radiation used in CT scans has not been proved to cause cancer during a child's lifetime."
"We know that low doses can be harmful," Brenner counters. "For instance, we know from studies of A-bomb survivors who were far away from the explosion that low-dose exposure can lead to cancer. What they were exposed to is similar to the doses children receive from their CT scans."
Brenner also points to a recent study conducted by researchers at McGill University in Montreal that showed a significantly increased risk of leukemia in children who had two or more CT scans.
There is also some research showing that some people may be more genetically susceptible to harm from X-rays. "This is another reason why we should be conservative in the doses we use," Brenner said.
Here again, medical neglect and ignorance continue to loom large. It's been at least a decade since the potential danger of using too much radiation on children was first raised in medical research.
Benefits Outweight Risks
Like other radiation experts interviewed for this column, Brenner emphasizes that, thus far, the benefits of medical procedures involving X-rays significantly outweigh the known risks. But he adds lowering X-ray doses in some cases and better monitoring of doses can go a long way to reduce some of the risks.
"In the case of CT scans, it's essentially pushing a button to reduce the dose, and that's about it," he said.
"Doctors need much better educational training in issues surrounding medical radiation and most are simply not getting it," said Wagner, who spends part of his time giving lectures on the subject to medical groups. "You need to understand that you can deliver very large doses to patients. You need to understand what levels of doses you are using in your procedures and you need to make some measurements."
Wagner said some hospitals are encouraging doctors to get serious on this issue, but many are not. "It continues to be an uphill struggle," he said.
And the FDA's Shope agrees that simply putting dose meters on new X-ray equipment will not likely solve the problem. "Continuing medical education will become very important," he said.
But that's easier said than done. Back in the mid-1990s, the FDA sent out two detailed advisories to hospitals, recommending proper methods to avoid use of excessive radiation during fluoroscopy. But as Shope points out, "these were only suggestions."
The FDA's mandate is to regulate products such as fluoroscopes and not medical behavior.
Physicians Need Push
But try and try again. To help boost the training of doctors in medical radiation, the FDA is holding discussions with the Joint Commission on Hospital Accreditation, an agency that monitors practice standards at hospitals.
The implication here is that nothing short of legally forcing the medical profession to adhere to strict procedural standards in the use of X-rays will have the required impact.
So far, trying to encourage the medical profession to voluntarily provide adequate training about the proper uses of radiation has pretty much fallen on deaf ears.
It's time to take this issue far more seriously — now.