And now for something completely different.
I’ve been on a bit of a tear the last few days beating on Mike Adams, someone who arguably deserves the title of Woo–meister Supreme, but it’s important to remember that defending science-based medicine is more than just having a little fun every now and then slapping down quacks. It’s also about turning the same skeptical eyes that recognize the woo that people like Adams, Mercola, and the anti-vaccine movement promote onto scientific medicine when appropriate. That’s because, at its best, science-based medicine is always trying to improve treatments based on science and evidence. To do that, we practitioners of science-based medicine must have the desire and courage to look at our own practices and objectively evaluate whether they are the best we can do.
In my field of surgery, there are some unforgivable errors. Although some of us may disagree on the exact identity of some of them, most surgeons would agree on a handful of them. Certainly one of them would be to amputate the wrong limb or remove the wrong organ. This happens far more often than any of us would like to admit. Over the last couple of decades, checklists meant to prevent such occurrences have risen to the fore and become standard practice at most hopsitals. We surgeons ridicule them (myself included, at least until recently), but they work, as an increasing amount of scientific and clinical literature is showing. Another unforgivable error is to leave a sponge or surgical instrument behind during an uncomplicated elective case. I qualify that because it’s understandable that occasionally a sponge will be left behind in a trauma case or when an elective case goes bad. In both cases, things get crazy, and everyone is frantically trying to save the patient. But in the elective case, leaving a sponge or surgical instrument behind should in essence never happen. The tedious ritual of counting the sponges, needles, and instruments before and after the case is highly effective in preventing it–when surgeons listen to the nurse telling them that the counts aren’t correct. The third unforgivable error is to operate on the wrong patient, which has occasionally happened in the past. Again, checklists make such a spectacular mistake much less likely. At my own hospital, for instance, the nurses are required to ask each patient who he or she is, what operation she is having, who the surgeon is, and, if it’s appropriate for the operation, which side is being operated on. The surgeon is required to mark the body part and the side with his or her initials. Sure it sounds silly and pointless, but it’s clear that such systems reduce wrong site surgery markedly.
It’s becoming increasingly clear that most medical errors of these types are in actuality system problems. As much as surgeons like to think of themselves as incapable of making such errors, the fact is that we all are. The key to reducing such errors is to make the system such that it is more difficult to make such mistakes or, when mistakes are made, they are highly likely to be caught before a patient is injured. There are other areas of medicine where this is also true. One in particular came to national prominence in a story published in the New York Times over the weekend entitled The Radiation Boom: Radiation Offers New Cures, and Ways to Do Harm. It is a hugely disturbing story of errors in radiation therapy that caused significant harm to many patients, including deaths. Here are the two deaths.
Here’s death #1:
As Scott Jerome-Parks lay dying, he clung to this wish: that his fatal radiation overdose — which left him deaf, struggling to see, unable to swallow, burned, with his teeth falling out, with ulcers in his mouth and throat, nauseated, in severe pain and finally unable to breathe — be studied and talked about publicly so that others might not have to live his nightmare.
For his last Christmas, Scott Jerome-Parks rested his feet in buckets of sand his friends had sent from a childhood beach.
This is the first in a series of articles that will examine issues arising from the increasing use of medical radiation and the new technologies that deliver it.
Sensing death was near, Mr. Jerome-Parks summoned his family for a final Christmas. His friends sent two buckets of sand from the beach where they had played as children so he could touch it, feel it and remember better days.
Mr. Jerome-Parks died several weeks later in 2007. He was 43.
A New York City hospital treating him for tongue cancer had failed to detect a computer error that directed a linear accelerator to blast his brain stem and neck with errant beams of radiation. Not once, but on three consecutive days.
Here’s death #2:
But on the day of the warning, at the State University of New York Downstate Medical Center in Brooklyn, a 32-year-old breast cancer patient named Alexandra Jn-Charles absorbed the first of 27 days of radiation overdoses, each three times the prescribed amount. A linear accelerator with a missing filter would burn a hole in her chest, leaving a gaping wound so painful that this mother of two young children considered suicide.
Ms. Jn-Charles and Mr. Jerome-Parks died a month apart.
The article points out that Americans receive more medical radiation than ever before. Indeed, it was less than a month ago that I wrote about this very topic, and this article points out how the average lifetime dose of diagnostic radiation for Americans has increased sevenfold since 1980 and half of all cancer patients receive radiation therapy. It should also be noted that radiation therapy is also increasingly used for non-cancerous conditions, including severe thyroid eye disease, pterygium, pigmented villonodular synovitis, treatment of keloid scar growth, and prevention of heterotopic ossification. The reason is that our understanding of radiation effects and, more importantly, the equipment, technologies, and protocols to deliver the radiation have become increasingly more sophisticated.
Radiation oncology is a lot like surgery in that it treats local areas of the body as opposed to intravenous medications like chemotherapy, which treat the body systemically. Like a surgeon wielding a scalpel, the ability of radiation therapy to treat a part of the body depends on how tightly focused the beam can be, targeting the cancer or other malignant tissue but as little normal tissue as possible. With better technology, better equipment, and better software, radiation oncologists have become better than ever at doing just that. For the most part, gone are the days of routine frying of large amounts of bowel when treating pelvic tumors or hitting significant quantities of lung or heart during radiation therapy for breast cancer. It just doesn’t happen anymore, except rarely. These days, it’s possible to treat organs and tumors in much smaller, tighter anatomical spaces, even surrounded with easily injured healthy tissue. The ability to aim the beams is just that good.
Unfortunately, like many tecnological advances, the advances in radiation oncology have added layers of complexity to the procedure that weren’t there before, adding opportunity for errors. The latest thing in radiation oncology, intensity modulated radiation therapy, or IMRT, requires very sophisticated algorithms to calculate the best dosage and treatment plan. Again, the more complex the system, the easier it is for error to creep in. Indeed, the NYT investigation of 621 errors in radiation therapy between 2001 and 2008 sure looks like systemic errors:
Because New York State is a leader in monitoring radiotherapy and collecting data about errors, The Times decided to examine patterns of accidents there and spent months obtaining and analyzing records. Even though many accident details are confidential under state law, the records described 621 mistakes from 2001 to 2008. While most were minor, causing no immediate injury, they nonetheless illuminate underlying problems.
The Times found that on 133 occasions, devices used to shape or modulate radiation beams — contributing factors in the injuries to Mr. Jerome-Parks and Ms. Jn-Charles — were left out, wrongly positioned or otherwise misused.
On 284 occasions, radiation missed all or part of its intended target or treated the wrong body part entirely. In one case, radioactive seeds intended for a man’s cancerous prostate were instead implanted in the base of his penis. Another patient with stomach cancer was treated for prostate cancer. Fifty patients received radiation intended for someone else, including one brain cancer patient who received radiation intended for breast cancer.
Radiation intended for someone else? Radiation intended for a different organ? How is this any different from operating on the wrong patient or removing the wrong organ or the wrong limb? It’s not. Surgery, for all its faults and for how far it still has to go to reduce medical errors, appears to be far ahead of radiation oncology in that respect. Many of these errors listed above likely could have been prevented by changes in the system, one of which might be the implementation of checklists not unlike what we do in surgery. Nowhere in the NYT article did I see any mention of checklists, which, as I’ve pointed out before, have made a lot of news in surgery, thanks to Dr. Atul Gawande.
One thing that very well might make radiation oncology as a specialty more prone to errors is its heavy dependence on software. Indeed, there was one thing I learned in this article that completely shocked me. Specifically, how Mr. Jerome-Parks got such an overdose of radiation. It turned out that the software facilitiated it:
The software required that three essential programming instructions be saved in sequence: first, the quantity or dose of radiation in the beam; then a digital image of the treatment area; and finally, instructions that guide the multileaf collimator.
When the computer kept crashing, Ms. Kalach, the medical physicist, did not realize that her instructions for the collimator had not been saved, state records show. She proceeded as though the problem had been fixed.
“We were just stunned that a company could make technology that could administer that amount of radiation — that extreme amount of radiation — without some fail-safe mechanism,” said Ms. Weir-Bryan, Ms. Jerome-Parks’s friend from Toronto. “It’s always something we keep harkening back to: How could this happen? What accountability do these companies have to create something safe?”
This is another source of systemic error: Poorly designed software or unnecessarily complicated software. More importantly with something like a linear accelerator, there didn’t appear to be a warning that (1) the collimator that controlled the radiation beam was wide open or that (2) the dose or area of radiation programmed was too high. Yes, apparently the computer did show that the collimator was open, but for something like that there needs to be a drop-dead stop, a warning that does not allow the technician to proceed until it is addressed and a failsafe mechanism that requires the technician to jump through many “Are you sure?” hoops before delivering doses that are at a dangerous level. (Sometimes it may be medically indicated in certain short radiation protocols to administer large doses at once, but it should not be easy to do so; it should require multiple confirmations before the instrument will do it.) Eventually the manufacturer did release new software with a failsafe, but it took a spectacular error resulting in death to get it to do so.
Reducing medical errors that harm patients is about more than just physicians. It’s about the whole system. In surgery we have been discovering this (and struggling with it) over the last decade or so. It’s not enough just to target the physicians. In my specialty and in the operating room, it’s necessary that everyone be involved, from the nurse who sees the patient when he comes in, the physicians who do the surgery, the scrub techs counting instruments, the scrub nurse verifying surgical site–in essence everyone involved with the care of the patient from the moment he shows up for surgery to the moment he either goes home or is admitted to the hospital. Radiation oncology has at least as many people involved in the care of the patient, if not more: Nurses, radiation physicists, radiation oncologists, technicians operating the machinery. Moreover, because unlike surgery radiation is often given in small fractions over many visits, there are many more opportunities for error than in surgery. After all, you have surgery once; typical radiation therapy regimens for breast cancer involve 33 doses of radiation, each with the potential for errors both small and large. It only took three such errors to kill Jerome-Parks and one error at the beginning and not caught to kill Jn-Charles.
We had a hard time learning this lesson in surgery. In fact, we’re still having a lot of trouble learning it, and there is still a lot of resistance. It is human nature. However, as systems become more complicated, the potential for not just human error but errors that derive from interactions within the system itself even when each person involved makes no mistakes. While we as health care practitioners should always strive to do our best and make as few mistakes as possible, mistakes do happen. They are inevitable. We have to be more like the airline industry and build systems that are designed to catch these errors before they can harm patients and minimize the harm done. We have a long way to go, unfortunately.