Articles Posted in Radiation Therapy

The medical community is waking up to an enormous problem with radiation – mainly X-rays and CT scans – used to diagnose disease and injury. Patients are getting too much radiation, and the excess itself causes injuries, many years down the road, in a big uptick in the risk of cancer.

Even a “routine” CT scan of the abdomen, ordered thousands of times every day in the United States for patients with belly pain, carries a large risk of downstream cancer, just from that single scan.

Dr. Rebecca Smith-Bindman, MD, of the University of California San Francisco, estimates a 20-year-old woman who undergoes a CT scan of the abdomen and pelvis has a one in 250 chance over her lifetime of getting cancer just from that single dose of radiation. This number was in a talk she gave recently at UCSF, as reported by her colleague Bob Wachter, MD, a patient safety expert at UCSF.

A physician who gave nearly 100 veterans with prostate cancer incorrect doses of radiation has been sanctioned by the Nuclear Regulatory Commission (NRC). The errors involved the incorrect placement of iodine-125 seeds in patients to treat prostate cancer.

Out of 116 such brachytherapy procedures performed at the facility between 2002 and 2008, the VA reported that 97 were carried out incorrectly. The NRC investigation found that Dr. Gary Kao, a radiation oncologist at the VA Medical Center in Philadelphia, took part in 91 of the 97 incorrect procedures. In several cases, the incorrect doses were caused by Kao having implanted the seeds in nearby organs or surrounding tissue.

As a result, the NRC ruled that Kao cannot take part in agency-related activities without undergoing more training. The NRC also issued a separate order requiring Gregory Desobry, a medical physicist who worked at the same facility, to notify the agency if he accepts employment in that capacity involving NRC-regulated activities within 20 days of beginning such work. Last year, the NRC fined the Philadelphia VA hospital $227,500 over the incidents.

Many women with early breast cancer do not need to have their armpit lymph nodes removed, according to a new study. Currently, this painful procedure has long been routine, as physicians believed it would prolong women’s lives by keeping the cancer from spreading or coming back. However, the study shows that removing the cancerous lymph nodes is unnecessary when women receive chemotherapy and radiation, which wipes out most of the disease in the nodes.

The study indicates that for about 20% of women (40,000 women a year in the U.S.), the removal of the cancerous lymph nodes doesn’t (a) alter the treatment plan for the patient; (b) improve survival rates; or (c) make the cancer less likely to recur. And it has a downside, since it can cause complications like infection and lymphedema, a chronic swelling in the arm.

Experts say that the new findings, combined with similar ones from earlier studies, should change medical practice for many patients. However, they warn that change may come slowly because the notion that the nodes must be removed is very deeply ingrained.

Why do patients who need focused, precise doses of radiation get walloped with huge overdoses that cause serious and even fatal injuries? A deadly combination of non-user-friendly radiation equipment, incompatible software when machines from different manufacturers are cobbled together, user error by the technicians administering the radiation, and lax regulation by federal authorities: All these are major issues in the ongoing expose by the New York Times of malpractice issues in radiation therapy.

In the latest installment, the team led by reporter Walt Bogdanich focuses on linear accelerators, machines that originally were intended to give broad-beam radiation doses to large swaths of the body, but now are increasingly modified to deliver what are supposed to be precise, focused radiation beams. The therapy is called stereotactic radiosurgery, and it allows hospitals who lack the more expensive competitor device, gamma knife surgery, to compete for radiation therapy business when the patient needs a very focused, intense dose to sensitive tissue — such as a nerve deep in the brain.

But without proper setup, and without an easy way to see when the machine’s beam has not been focused properly, tragedies can happen, as the reporters document.

The Food and Drug Administration has canceled its policy of giving rubber-stamp approval to marketing of powerful new radiation therapy equipment like linear accelerators. From now on, the manufacturer of the machine is going to have to prove the equipment has proper safety checks to prevent dangerous overdoses of radiation to patients.

The New York Times ran a series in January 2010 that exposed some horrific tragedies that occurred, particularly when hospitals rushed into operation new and complicated equipment without thorough safety checks and training of technicians. The series also showed that the equipment often lacked simple fail-safe devices such as a way of preventing the machine from delivering a walloping overdose of radiation even if one had been inadvertently programmed by a technician.

But since the FDA only has power over manufacturers and not over hospitals themselves, it still will be possible for poorly trained technicians to cause errors that hurt patients by either delivering overdoses or underdoses of radiation.

The scandal about injuries to cancer patients from malpractice in radiation therapy has had one beneficial side effect: the Food and Drug Administration is gaining urgency and attention for its new initiative to reduce unnecessary radiation in diagnostic imaging of patients.

Here is a link to the FDA’s White Paper on its steps to make sure patients get only the dosage of radiation needed, at the right time and in the right way.

One part of the project is to make it easy for patients to keep track of how much radiation they’ve had, because accumulated dosing is what causes long-term injuries. The FDA says it is working

Time and again in U.S. health care, new technologies are hurried into wide use with little testing, scant training of their human operators, and lack of solid evidence that newer really is better. After the flush of optimism has faded, billions of dollars later, we learn how to judiciously use the new equipment, but only after patients have been hurt or killed by the rush to the new.

The latest example is the deployment of new radiation therapy machines on cancer patients with operators who are not properly trained or credentialed and equipment that has not been tested or calibrated. The New York Times’ recent investigative series on the subject prompted one knowledgeable reader, Dr. Joseph Imperato, medical director of the Center for Advanced Radiation Medicine at Lake Forest (Ill.) Hospital. to write this:

To the Editor:

What can cancer patients do to protect themselves from malpractice in radiation therapy? This urgent question arises from a lengthy series of investigative reports in the New York Times. The articles exposed serious patient injuries that stem from therapists who are overwhelmed and inexperienced, lax regulation and indifference by hospital administrators.

A key part of the problem is that technological sophistication has outrun the ability of the humans running the radiation machines to monitor the safety of the radiation beams they train on patients’ bodies.

Another issue is that no central agency is responsible for inspecting the machines and credentialing the people who run them. Depending on the type of radiation involved, the Food and Drug Administration, the Nuclear Regulatory Commission and various state health agencies could have jurisdiction. Or worse, each could claim that someone else has the jurisdiction, and the patient can slip through the cracks.

More evidence of the urgent need for “checklists” to protect patient safety in complex medical treatments comes with a long article in the New York Times about terrible injuries from malpractice episodes during radiation therapy. Yet readers have to dive deep into the article to find this key point.

Scott Jerome-Parks suffered terrible radiation burns to his neck, and lingered for two years in agony before dying, because he received a seven-fold overdose in the radiation that was supposed to treat his tongue cancer, on three separate occasions. Why did it happen? The hospital, St. Vincent’s in New York, blamed a confluence of tragic coincidences. But I reached a different conclusion, as I wrote in a blog post to the Times’ “Well” blog:

Deep in this tragic article is the following paragraph that exposes the reforms that are needed before medical care can become safe for all patients:

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