Linking the USPSTF mammogram guidelines to their virtual colonoscopy recommendations

by Mark E. Klein, MD

“I think anytime you use science to kind of fundamentally change what people are used to, I think it’s a difficult thing to grapple with.” So spoke Ned Calonge, chair of the United States Preventive Services Task Force (USPSTF) in explaining the reaction to that group’s recommendation to radically alter their previous guidelines for breast cancer screening. Regrettably the incorrect application of science, as in the current case, often leads to erroneous conclusions and profoundly bad decisions.

The USPSTF’s recent pronouncement utilizes the same warped reasoning we have already witnessed from this organization.

In November 2008 this same group recommended against the use of a terrific diagnostic procedure, Virtual Colonoscopy, also know as CT Colonography, as an alternative to traditional colonoscopy for the early detection of precancerous colon polyps. Their verdict served as the basis for Medicare’s May 2009 decision to deny payment for this procedure. The data on this technique is crystal clear. It is far safer than traditional colonoscopy, of greater or equal accuracy for the detection of significant polyps as traditional colonoscopy, and as a bonus is less expensive.

Why did the USPSTF refuse to endorse a procedure enthusiastically recommended by numerous professional physician organizations, the American Cancer Society and the national Blue Cross Blue Shield Technology Evaluation Center, a group not anxious to add to the cost of healthcare? Because although they accepted that Virtual Colonoscopy was accurate in diagnosing colon polyps, they feared that the CT-based technique could identify possible abnormalities outside of the colon that might lead to further unnecessary testing and drive up the cost of screening; a theoretical and unsubstantiated risk.

What this group chose instead to ignore was the very real risk, in fact the guarantee, that some Medicare recipients would die because they failed to get adequately screened for colon cancer because this excellent diagnostic tool was unavailable to them. The sixteen members of the USPSTF completely missed the forest for the trees.

One thousand women must undergo mammographic screening to find seven breast cancers; for 993 women the procedure is a waste of time and money. Of course we have no idea which seven of the thousand will benefit, so we screen them all. Seven out of a thousand is a pretty small number. It seems like a lot of effort for a little gain, yet women have collectively decided that they are willing to accept these numbers to achieve the 35% reduction in breast cancer deaths that mammography has delivered.

The USPSTF, having performed no new studies but merely re-analyzed existing data, is now stating that although we know that some women age 40-50 will die from breast cancer under these new guidelines, it’s a small number relative to all of the financial and other costs that would be incurred to screen all women of this age.

Let’s frame this concept a bit more simply. Just about everyone who boards an airplane is interested only in arriving at their destination safely. Unfortunately there is an infinitesimal number of individuals—we call them terrorists—who wish to blow that airliner into fragments somewhere over Ohio. It’s a very small number relative to the volume of the flying public. Is it really worth it to do any airport screening at all? While we’re at it, should we bother to inspect every food facility? Only a fraction of one percent harbors salmonella. And how about those railings on stairs, or elevator doors that only open when the elevator is really there? Are they worth all of the expense to save the few who aren’t paying attention?

All of these situations involve infinitesimal risk, but the possible outcome of ignoring that risk is monumental. Screening for any disease, unless it has an absurdly high prevalence, is all about doing a lot for a relatively small yield, but not screening results in what we have collectively decided is an unacceptable outcome.

So which is it? Do we wish to find as many early breast cancers as we can, knowing that the costs will be high and that some women will be unnecessarily frightened and even biopsied to save a small number of lives, or not? Because if we do wish to find those cancers that if caught early will save lives, then shoot for the highest possible sensitivity. Screen young women and screen annually, or don’t screen at all.

The USPSTF’s recommendations are, if not outright dangerous, at the minimum the foolish implementation of good science.

Mark E. Klein is a radiologist at Washington Radiology Associates, in Washington, DC.

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  • jsmith

    So, here we have a radiologist in favor of both more mammography and yet another radiographic procedure, virtual colonoscopy. Imagine that. He completely trashes the risk of incidentalomas, saying the risk is unsubstantiated. Huh? Sorry, Dr. Klein, but the onus is on the promoters of a new technology to prove that it is safe and effective, not the other way around. How about all the radiation from all the extra screening you would like to do?

  • Healthcare Observer

    Worrying once more to see a supposed expert who is not properly aware of the current evidence base for both examples.

  • Abalone

    “All of these situations involve infinitesimal risk, but the possible outcome of ignoring that risk is monumental. ”

    Your analysis and examples gloss over the fact that cost is a variable, too. It’s not just about risk and outcome. You treat the issue as though all costs were equally high so cost is not a player.

    The cost of making sure that an elevator door opens appropriately is trivial. There is a one-time cost to manufacture the door to higher specifications and periodic testing on the door to make sure that the workings haven’t worn out. The cost is fixed and tied to the device. You don’t have to screen each person each time he walks through the door. With mammograms and colonoscopies, OTOH, each person is tested repeatedly, which is a different construct. So elevator doors do not remotely inform the mammogram/ colonoscopy question. Not only is cost per door different from cost per person, you have very different dollar amounts. Screenings have varying costs depending on the procedure. Colonoscopies cost much more than mammograms, for example. The cost of enhanced standards on an elevator door at manufacture would be trivial compared to either.

    Your blowing off the cost factor would be fine if individuals were paying for their own screenings, in which case they could make their own decisions of whether the feedback from the screening was worth the money. But these are communal funds being spent on screenings. Cost has to be a factor there, as well as risk and outcome, unless pockets are bottomless. Surely there is some point at which the cost would be too great to justify the small return. Would you screen a million people at $50,000 each to catch one cancer? No sensible person would. So, having established that cost is, indeed, a factor, it’s a question of backing off of that extreme example to determine what a reasonable cost tolerance is for various scenarios. Maybe the cost of your mammograms and virtual colonoscopies would be determined to be justified on the basis of outcome or maybe not. What is not justified is your blowing off the cost factor and trying to make the case only on risk and outcome as though all of this were free and money were irrelevant.

  • Doc99

    Again, I’d have felt better about the Mammography guidelines had an Oncologist been on the panel. I find it more than curious that no cancer specialists were involved in evaluating guidelines for screening for cancer.

  • Mammogram-No Thanks

    1. Cost wasn’t the only consideration in the new mammography guidelines. For every life saved, 10 women become unnecessary cancer patients.

    2. If cost isn’t an issue, why don’t all the radiologists cut their salaries in half so screening is more affordable….wait a minute…it is about money.

    3. A while ago, Kevin had a blog entry about the risks of CT. Why do we throw those risks out the window? That head CT is a dangerous waste of resources but radiating the entire population is good medicine?

  • R Watkins

    “I find it more than curious that no cancer specialists were involved in evaluating guidelines for screening for cancer.”

    Because cancer specialists specialize in TREATING individuals with cancer. Epidemiologists and public health experts specialize in SCREENING large populations for cancer and other diseases.

    Oncologists don’t screen and epidemiologists don’t treat.

    It’s discouraging that this has to be explained again and again to members of the medical profession

  • http://www.MDWhistleblower.blogspot.com Michael Kirsch, M.D.

    The author is a radiologist, who may have have overt and unconscious bias. I would give him more credibility if he and his colleagues would address the enormous financial and emotional costs that his specialty is responsible for when they report incidental and trivial findings routinely. Indeed, the USPSTF was conscious of this gaping flaw. Clearly, tort reform would be a necessary element of the solution.

  • Anonymous

    I of course can understand why a posting by a radiologist would prompt some to think that promoting screening is self-serving, or all about money. One downside of social networking, and the internet in general, is that although we can freely exchange ideas we really don’t know anything about one another. Unfortunately some choose to use this anonymity to attack rather than discuss. I would prefer if instead of assuming the worst we judged each other a bit more favorably. I will simply state that none of my comments were influenced by economic issues-it’s not about the money-but about my committment as a physician to take the best care of patients as possible. I still beleive that most physicians place their patient’s welfare first.
    Virtual colonoscopy is a terrific screening procedure. It is safe, and the radiation dose is quite low, and hardly significant considering the age at which this procedure is recommended. The number of patients in whom I recommend additional testing because of other findings on the CT scan is less than 4%. As for screening mammography, it has absolutely been proven to decrease mortality from breast cancer by 30-35%, which is why I have yet to find a woman who prefers to undergo biennial screening in lieu of annual screening. One more fact to digest: a recent study demonstrated that if a woman develops breast cancer and has had regular mammography screening, her chance of dying from that cancer is 5%. If she has not had regular screening, that risk soars to 56%. Of course every woman should make her own informed decision about screening.

  • http://everythinghealth.net Toni Brayer, MD

    And isn’t is curious that the two Radiologic Societies just came out with their own “recommendations” that mammograms start at age 40. A specialty society should not be making any recommendations about screening that will benefit their own members. The conflict of interest is just too glaring. That is why USPSTF is the most unbiased in reviewing literature and recommending “screening” studies for the population at large.

  • http://www.MDWhistleblower.blogspot.com Michael Kirsch, M.D.

    To the anonymous commenter at 12:04 p.m.: With respect, you are overlooking a critical point. I take you at your word that your views are pure, and not contaminated by self-interest. You may, as the rest of us are, be subject to unconscious bias. At the very least, there is an appearance of a conflict of interest, as the author’s views coincide with his specialty’s interest. In addition, those of us in specialties tend to view the medical world through the prisms of our own niches. Surgeons, for example, may favor a surgical solution, not to make money, but this is how the ‘operate’. I am a gastroenterologist. I would not support the American College of Gastroenterology making national policy for colon cancer screening, although I think they should have a seat at the table. Haven’t we all seen how guidelines issued by various specialty societies never seem to go against the specialties’ interests?

  • Mark E. Klein, MD

    I first must apologize for inadvertently hitting the submit button before entering my name, which accounts for the anonymous post. To Dr Brayer I would say say the following. When you state that specialty societies will always promote policies that favor their specialties, you imply that they may encourage policies that are not necessarily in the patient’s self interest. Once again this is an example of assuming the worst rather than assuming the best. I know of no leader in radiology that would ever promote any procedure or method that was not supported by hard science to be in the best interest of the public. And I must strongly disagree with her statement that “A specialty society should not be making any recommendations about screening that will benefit their own members.” It is most often the specialty that has the most knowledge of a method or procedure, and they are in fact the best people to make recommendation. The USPSTF might seem unbiased, and while I trust that their intentions are excellent, its members have their own biases based on their personal experiences and frames of reference. They were dead wrong on virtual colonoscopy–as will become evident over time–and they are wrong about mammography screening. Alan Greenspan said, only months before the financial collapse, that derivatives posed no threat to our nation’s economic well-being. Even the best intentioned can miss the mark.

  • Diora

    . As for screening mammography, it has absolutely been proven to decrease mortality from breast cancer by 30-35%, which is why I have yet to find a woman who prefers to undergo biennial screening in lieu of annual screening.

    This number has not beeing proven, it is actually the number from most optimistic interpretation of the studies. This is not the number cited by Cochrane or USPSTF.

    Even if we accept this number it’s not the difference between annual and biennial screening. In fact most of the studies of mammograms done in Europe used biennial screening.

    As to what women prefer – if you keep giving them data that vastly overestimates the benefits of mammograms and forgets to mention risks, sure they’ll make the decision to screen.

    One more fact to digest: a recent study demonstrated that if a woman develops breast cancer and has had regular mammography screening, her chance of dying from that cancer is 5%. If she has not had regular screening, that risk soars to 56%.

    The particular study while interesting failed to look at the access to medical care of the women who failed to get mammograms. Since most insured women do get mammograms and most uninsured women don’t, it’s quite likely the women who didn’t get mammogram didn’t get the same treatment either. Especially considering that their mortality data from unscreened women was closed to that of the 70s. Surely there have been some progress in treatment since then?

    Of course every woman should make her own informed decision about screening.

    The key word here is informed. Your data clearly shows why it’s epidimiologists’ and not radiologists’ or oncologists’ jobs to look at the data. Your citing of studies read the same as that of the media.

  • Mattheww Weber

    Two comments:
    First the writer is in fact a Radiologist, and therefore has a financial interest in the outcome. He also leaves an important unaddressed issue. There is a link between radiation exposure and Cancer. The question becomes how much Xray exposure doesn’t occur because we don’t screen for 10 more years, and how many cancers is that reduced Xray exposure likely to prevent? Let’s face it, there is big money in Cancer detection and treatment.

    I also take issue with another statement the author makes.
    “Why did the USPSTF refuse to endorse a procedure enthusiastically recommended by numerous professional physician organizations, the American Cancer Society and the national Blue Cross Blue Shield Technology Evaluation Center, a group not anxious to add to the cost of healthcare? Because although they accepted that Virtual Colonoscopy was accurate in diagnosing colon polyps, they feared that the CT-based technique could identify possible abnormalities outside of the colon that might lead to further unnecessary testing and drive up the cost of screening; a theoretical and unsubstantiated risk.

    The risk is neither theoretical or unsubstantiated. The University of Pittsburgh recently abandoned a CT based study to look for early signs of Lung Cancer in smokers. The reason they did so was because the CT screening was finding so many previously undiagnosed anomalies, that investigating them quite literally ran the study out of money! My pulmonologist tells similar horror stories about whole body scans. They often turn up surprises, and once you know about them, cannot be safely ignored.

    So the potential costs have been shown to be very real, and have been substantiated in other studies.

  • DKBerry

    As I originally posted when USPSTF breast cancer screening guidelines were released …

    … my sister was in her early 40s when through a mamogram she found out she had some lumps. After biopsy … a double mastectomy … and chemo … she has her life back with her family.

    I really don’t care now what USPSTF guidelines are … nor any of the hired mafia of posters who think my sister could have waited to be screened and might still have survived and then she would have been ‘in the numbers’.

    Wonder if these are the same folks who manipulated the numbers to make a case for global warming?

  • http://www.jeffreydach.com jeffrey dach md

    Mammogram Guidelines, Fibrocystic Breast Disease, the Iodine Deficiency Connection

    Screening the population with mammograms based on guidelines unfortunately did not help a friend who just died from breast cancer. The incidence of breast cancer has increased to 1 in 8 women, with 4,000 new cases weekly. You might ask, could there be a preventive measure which is safe, cheap and widely available that has been overlooked? The answer is YES , and it’s the essential mineral, Iodine, which was added to table salt in 1924 as part of a national program to prevent Goiter. It turns out that this same mineral is the key to breast cancer prevention. Much has been published in the medical literature on this, for example, B.A. Eskin published 80 papers over 30 years researching iodine and breast cancer. In short, iodine deficiency causes breast and thyroid cancer in humans and animals. Iodine deficiency is also known to cause a pre-cancerous condition called fibrocystic breast disease. W.R. Ghent published a paper in 1993 which showed iodine supplementation works quite well to reverse and resolve fibrocystic changes of the breast, and this is again the subject of a current clinical study.(Can J Surg. 1993 Oct;36(5):453-60.)

    For more information see: http://jeffreydach.com/2007/05/05/jeffreydachdrdachiodine.aspx

    Jeffrey Dach MD