The radiation delivered by CT scanners has gone largely unregulated

Although the medical profession has been harming unlucky patients for centuries, the patient safety movement didn’t take flight until 1999, when the Institute of Medicine published its seminal report, To Err is Human. And that report would have ended up as just another doorstop if not for its estimate that 44,000-98,000 Americans each year die from medical mistakes, the equivalent of a jumbo jet crashing each day.

Come to think of it, the quality movement also gelled after the publication of Beth McGlynn’s 2003 NEJM study, which produced its own statistical blockbuster: American medical care comports with evidence-based practice 54% of the time, a number close enough to a coin flip to be unforgettably disturbing.

These two examples demonstrate the unique power of a memorable statistic to catalyze a movement.

Recently, my colleague Rebecca Smith-Bindman, professor of radiology, epidemiology, and ob/gyn at UCSF and one of the nation’s experts in the risks of radiographs, gave Medical Grand Rounds at UCSF. Her talk was brimming with amazing statistics, but this is the one that took my breath away:

A 20-year old woman who gets an abdominal-pelvic CT scan (i.e., just about any young woman coming to the ED with belly pain) has a 1 in 250 chance of getting cancer from that single scan.

Did that fully register? One CAT scan, which until recently most of us ordered with no more restraint than we exhibit when asking the Starbucks barista for a tall latte, will cause cancer in one out of every 250 patients. Two-hundred fifty: that’s the number of students in my college Bio 101 class. Wow.

This is particularly scary given the remarkable increase in the use of this technology. Get this:

  • Three million CT scans were performed in the U.S. in 1980. In 2011, there will be 72 million, an average of 19,500 every day.
  • One in five Americans will receive a CT scan in any given year; some experts suggest that at least one-third of those scans are unnecessary.
  • Between 2000 and 2005, Medicare spending for imaging studies more than doubled, from $6.6 billion to $13.7 billion, twice the rate of growth of physician fees.

And, although none of these examples has quite the impact of the 1-in-250 statistic, there are lots of other scary risk data, such as:

  • The best estimates are that radiation from CT scans causes 29,000 excess cancers each year in the U.S., mostly in women.
  • Researchers estimate that 15,000 people will die from the direct effects of the 72 million CT scans performed in 2007 alone.
  • A 2004 study found that less than 50 percent of radiologists, and 9 percent of ER docs, were aware that CT scans could increase the subsequent risk of cancer.
  • A multiphase abdominal/pelvic CT scan has the same radiation wallop as 500 transcontinental flights, 450 chest radiographs, and 74 mammograms.
  • And those airport body scanners you’ve been so worried about? You’d need to be scanned 200,000 times in order to accumulate the radiation that you get from a single CT scan. I’m a 1K United flyer, but I won’t close in on 200,000 scans for the next couple of centuries.

In her grand rounds, Rebecca walked us through the multiple lines of evidence on the risks of radiation from CT scans, particularly those drawn from studies of Japanese A-bomb survivors and individuals who received radiation for both malignant (i.e., lymphoma) and non-malignant (i.e., acne) disease. All pointed to the conclusion that doses in the range of those delivered by CT scans are fully capable of causing cancer.

Remarkably, with all the attention given to regulating food and drugs, the radiation delivered by CT scanners has gone largely unregulated. (If you ask me, I’d rather receive a precise and predictable dose of radiation than of Vitamin D or Azithromycin.) Rebecca found that CT scanners at four Bay area hospitals delivered radiation doses 66% higher than the usually-quoted doses, and that there were staggering variations (up to 13-fold) among different scanners performing precisely the same test. In her talk, she blamed the lax regulations on radiation physicists, fastidious types who have been reluctant to take a stand on maximum radiation doses since they can’t define those doses precisely.

While I’m sure that’s true, I have to believe that some of the reluctance to blow the whistle can be traced to the usual Medical-Industrial Complex: scanning equipment manufacturers, radiologists, and hospitals who have no particular interest in killing this particular egg-laying goose. If you doubt that these forces are at play, witness the billboards for $1000 total body scans that line Florida’s highways (scans that, when performed in healthy people searching for asymptomatic tumors, undoubtedly cause more cancers than they cure). Even now, despite powerful evidence of the risks, there are some in the radiology community who don’t find the science compelling enough to alter their practice. The parallels to the Global Warming debate are eerie, and troubling.

Even if the risks turn out to be less than we fear, most skeptics now agree that we’re causing a lot of cancers, and that many could be prevented if we took a few sensible steps. Manufacturers, hospitals, and radiology facilities should test the radiation exposure of their scanners, with the goal of decreasing the variation and delivering the minimum dose that creates an acceptable image. Ultrasounds should be substituted for CTs when possible, such as in follow-up of patients with documented kidney stones. There is evidence from Mass General that the use of computerized appropriateness protocols can markedly cut down on the number of CT scans, and thus the cancer risk. And, if we need to obtain the patient’s informed consent before transfusing a unit of blood, we should also do so before ordering a CT scan, since the latter is a far riskier procedure.

But changing culture will be more important, and harder, than changing protocols. We physicians have become so accustomed to saying “Get the scan” that we have turned our brains off. Several months ago, I cared for a woman with a painful lumbar compression fracture of unknown duration. We asked the orthopedic surgery service to see her in consultation, and the resident’s recommendation – made without a hint of self-awareness or irony – was that we obtain both a CT and an MRI. I was dumbfounded. Yes, each test can provide slightly different information, but I don’t believe that both were absolutely necessary; nor did a couple of experts I later spoke with. (We ended up getting the MRI only, which produced all the information we needed.) Somehow, we must find a way to break our reflexive radiographic profligacy.

As we struggle as a nation to “bend the cost curve” and we grapple with the nexus of low yield and expensive medicine (the dreaded “R word”), let us all agree that when we have an issue like this – an overused technology that harms or kills thousands of patients each year – we come together to do the right thing. CT scans can be immensely helpful, even miraculous, at times, but there is no question that the right thing is to Just Say No far more often than we ever have before.

Bob Wachter is chair, American Board of Internal Medicine and professor of medicine, University of California, San Francisco. He coined the term “hospitalist” and is one of the nation’s leading experts in health care quality and patient safety. He is author of Understanding Patient Safety, Second Edition, and blogs at Wachter’s World, where this post originally appeared.

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  • http://seaspray-itsawonderfullife.blogspot.com SeaSpray

    What can the patients already exposed to multiple CTs do to build themselves up so they are at less risk in the future. Say no to more CTs *if* it is possible. But …after the fact?

    All I can think is to stay as physically fit as possible, getting quality nutrition, sleep, and some other things.

    And give it all to God.

    • Dave

      How radiation effects people is still being determined. While there are those, like the author of this article, that feel that radiation is a linear function, there are others that feel it is more of a threshold in that, provided you don’t exceed the bodies ability to repair DNA damage/remove “bad” cells you’ll be okay (go over this and you start getting risk of cancer).

      Note, I feel this lies somewhere in-between in that, any radiation carries some risk, but the function is likely such that, over a certain amount, this risk increases much faster than at lower dosages.

      FYI, I’ve never actually had a CT, though I have spent lots of time in and around MRI scanners. Hopefully we can drastically reduce the costs of an MRI so that they become the “no-brainer” option and CT’s are only ordered when they offer a clear advantage over the MRI. MRI’s are quite reasonable in other countries (the oft quoted cost of 100 bucks in japan vs several thousand in the US) so this might be doable. Doubly so if we actually start using smaller bore magnets that, rather than doing the entire body, just fit the head, leg, etc (and are thus much cheaper/need less space than a full-sized MRI).

  • http://drpauldorio.com Paul Dorio

    Once again I am appalled at the sensationalistic way the “evidence” regarding radiation exposure due to radiologic imaging is presented. There has never been a cancer reported that is proven to be due to medical imaging exposure. The “estimates” of cancer have been based on Hiroshima and Nagasaki data, in addition to what is known as “linear dose threshold.” Both of these components of risk estimation are woefully flawed for our purposes of understanding our risks from radiation exposure due to imaging.

    In my opinion, instead of reporting, parroting and amplifying possible truths and half-truths, doctors of all kinds should be bent on sleuthing out just exactly what the risks really are. It is important to be realistic, not sensationalistic. We want people to understand that imaging, when needed, is essential for their health care. Understanding radiation risks, but not fearing them, is also essential.

    In addition, decrease scanning by eliminating self-referral. For anyone who doesn’t realize it, self-referral is where your doctor orders a scan on you and has it performed in his office on the scanner he/she owns. The propensity is for the doctor to order more scans than needed because that ownership component is more on his/her mind than it would be otherwise. Self-referral has contributed to the fastest rise in CT scans in this country. Eliminate that issue and you rapidly return to “scan what’s needed.”

    In support of my comments, here is a link to another doctor’s similar viewpoint, with several embedded links to statistics (hard to include here): http://bit.ly/cNepaS

    • http://www.myheartsisters.org Carolyn Thomas

      Dr. Dorio, you might want to include a standard disclosure statement in the future about your Naples Diagnostic Imaging Centers (in which you offer CT scanning procedures) so it won’t be surprising for readers to see blanket statements here like “…never been a cancer reported that is proven to be due to medical imaging exposure”. Really? Since Cahan et al first published “Sarcoma Arising in Irradiated Bone” in 1948, it actually appears there have been many such cancers.

      And as radiation oncologist Dr. Chris Loiselle wrote for the non-profit Global Resource for Advancing Cancer Education (GRACE):

      “A completely safe minimum dose threshold, below which there is zero risk for radiation carcinogenesis, does not appear to exist.”

      • http://drpauldorio.com Paul Dorio

        Ms Thomas,
        Thanks for your comments, but you have a significant misunderstanding about radiation exposure that needs correction:

        Anytime a portion of someone’s body is “irradiated” for the purpose of treating a cancer, that area is given a SIGNIFICANTLY larger dose of ionizing radiation than when one undergoes ANY imaging study, i.e. CT scan. There is no possible realistic or useful comparison between the two. It is however, as you bring up, essential for the public (and doctors) to understand the vast difference between the two.

        And as far as any disclosure is concerned, thank you for noticing. I always add my website and use my full name so there is never any hint of a chance that someone might think I am “hiding” my association with imaging centers. To further clarify, I am an interventional radiologist. We contract with two hospitals in Naples, FL, and staff/own four imaging centers in town that have been operational, helping people, for over 25 years. We do not self-refer, but gladly accept all patients who either make their own appointments through word-of-mouth, or are referred by their doctors. There is no conflict there and my statement was one of fact: “To date there has never been a cancer reported that is proven to be due to medical imaging exposure.”

    • http://www.myheartsisters.org Carolyn Thomas

      Hi Dr. D – intrigued by the clear disconnect between the “facts” expressed by experts like Dr. Rebecca Smith-Bindman and yourself, I came across the following, from Scotland’s Dr. David Sutton, Radiation Protection Adviser to the University of Dundee and editorial board member of the British Journal of Radiology. His independent report – http://www.c2i2.org/vol_vi_issue_2/Population_and_patient_risk_from_CT_scans.asp – was also published on the website of GE Healthcare, manufacturers of CT imaging equipment. And his conclusions – which don’t appear to be “woefully flawed” – indeed seem “realistic, not sensationalistic” as you wisely recommend:

      * The number of CT scans being performed is increasing at about 10% per annum

      * CT accounts for 15% of all procedures in radiology but contributes 50% of the population dose resulting from the diagnostic use of ionising radiation

      * The doses from CT are high enough to allow reasonable estimates to be made of the number of cancers induced in the population as a result of its use

      * There is convincing evidence that a CT scan can be associated with the risk of cancer in an individual patient

      * The challenge presented by the issue of radiation dose in CT is not being met

  • http://www.myheartsisters.org Carolyn Thomas

    Very interesting post, Dr. Bob – thanks for this.

    My very thorough family doctor has decided to refer me for a CT colonography procedure in hospital. I have no symptoms, no family history, no reason other than for preventive screening. I also have annual fecal occult testing done (and that’s ANNUALLY, not every two years as current protocols recommend). Everything’s fine. I had a sigmoidoscopy ordered about five years ago – simply for baseline purposes, no symptoms, test was perfectly fine. No reason that I can deduce for ordering this new upcoming CT.

    However when I read things like your post, or this study’s conclusion: “CT colonography is an effective screening test for colorectal neoplasia. However, it is more expensive and generally less effective than optical colonoscopy.” (Am J Gastroenterol. 2007 February; 102(2): 380–390) it gives me cause for concern.

    I’m calling my doc this morning to cancel this CT procedure.

    • http://drpauldorio.com Paul Dorio

      To support my comments from my other reply to you, I would support your discussing CT colonography and its benefits and risks with your physician. It is certainly important that we all understand both risks and benefits to any study, lab test, etc that we are asked to undergo.

      • http://www.myheartsisters.org Carolyn Thomas

        I agree, Dr. D. – Particularly when this “new” diagnostic procedure is described as “more expensive and generally less effective” than the “old” one!

  • http://www.MRImetaldetector.com/blog Tobias Gilk

    The whole Walt Bogdanich series (that began in late 2009) on medical exposure to ionizing radiation has been a real eye-opener… principally to the regulatory ‘doughnut hole’ with respect to radiology safety (concerning far more than CT).

    FDA regulates the device, but (with the notable exception of mammography under MQSA) does not regulate quality or safety at the point of care. Radiology accreditation bodies often emphasize image quality above safety measures, hospital accreditors have historically steered clear of radiology due to a lack of expertise, and States rarely have the resources or expertise.

    So, despite the fact that medical exposure to ionizing radiation *is* regulated, it’s regulated by a group of organization I visualize as standing in a circle, staring at the tops of their shoes, each trying to avoid (or legally prohibited from) assuming any responsibility for the situation.

    Though, approaching as we are MRI Safety Week, it’s worth pointing out that at least ionizing radiology safety does have safety regulations (and some, like the State of California, are really stepping up to the plate). MRI doesn’t offer any regulations that would require best practices that could readily prevent the vast, VAST majority of accidents that injure patients and staff in the MRI environment.

  • http://www.medicalimaging.org David Fisher

    Over the course of the last 20 years medical imaging has become a central part of medicine…and for good reason. It is a safe and effective means to diagnose patients and improve health outcomes. Medical devices are heavily regulated by the Food and Drug Administration (FDA) and cannot be sold without Agency clearance.

    CT manufacturers have a long history of reducing medical radiation through innovative new technologies. In some procedures, dose has been reduced by up to 75 percent while dramatically improving image quality. The Medical Imaging and Technology Alliance (MITA) continues to work with our member companies and the FDA to further enhance the safety of CT machines. One key element of this has been the manufacturer-led CT Dose Check Initiative, an industry-wide commitment to include additional safeguards on all new CT machines, designed to help better manage radiation dose, prevent medical errors and track dose levels to help providers understand how their facility compares to local and national standards. MITA is also a strong supporter of operator certification, facility accreditation, and physician appropriateness criteria, all of which have been shown to help facilitate safe and medically appropriate scans, while still preserving patient access to the right scan at the right time.

    It is also essential to consider the enormous health benefits that CT offers. CT is a proven, lifesaving technology that is integral to modern standards of care and holds the potential to do even more. As just one recent example, a watershed study published last week in the New England Journal of Medicine found that lung cancer screening using low dose CT reduced mortality by 20 percent amongst smokers.

    We need to remember that the benefits of medical imaging far outweigh the risks. CTs turn patients into survivors. They are the answer, not the problem.

    - David Fisher, Executive Director, Medical Imaging and Technology Alliance

  • http://www.mdwrites.com MD

    Easy solution to reduce CT scans in this country. Reform malpractice. Make it so that doctors who abide by evidence based guidelines can not be sued by patients. This will fix things overnight.

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