New ACS Screening Guidelines – Are we falling into line…or for a line?

For many years, we have been relying on the American Cancer Society (ACS) to uphold the familiar screening mammography guidelines – that is, “annual mammograms starting at age 40, and continue as long as you are healthy,” updated in 2003, but no real change since 1997. From 1983 to 1997, the 40-49 recommendation had been “every 1-2 years.”

 

The original recommendation from the ACS, by the way, was in 1976, when data were really slim – back then, it was “annual mammograms for women after 50, but for women in their 40s, there should be a family history of breast cancer in a first-degree relative.” The “baseline mammogram at 35-39” was adopted in 1980, but dropped in 1992.

 

In 2009, the U.S. Preventive Services Task Force recommended major cutbacks in screening – start at 50, and every 2 years thereafter. This launched a new battle between pro-screeners vs. screening minimalists. Comparable to the Mammography Civil War in the 1990s, neither side was willing to budge.

 

On October 20, 2015, the American Cancer Society caved, ostensibly at least, to the anti-screening tsunami, announcing its new guidelines in JAMA – in brief, “begin at age 45, screen annually to 54, then switch to every 2 years (biennial).”

 

At least that’s the “all meat no potatoes” version of the new guidelines. Cleverly embedded in the new guidelines are the old guidelines, but you probably won’t hear about that. In fact, the ACS stated that women should still have the option to begin at 40, and that they should have the option to continue annually. These options are not buried in fine print – no, in fact, they are in the Abstract along with the same level of “Qualified Recommendation” as all but one of the other guidelines. The only recommendation listed as “Strong” was the 45 starting age. Switching to biennial screening was “Qualified”… the recommendation to screen as long as overall health is good and life expectancy of 10 or more years was “Qualified”… and no need for clinical exam in women without risk factors was “Qualified.” The old recommendations are listed right there as “Qualified” with all the others, but the old “option” was suppressed within minutes of the ACS announcement. And since most rely on the media for their medical updates, well, precious few will be able to quote the true ACS guidelines.

 

Why will the old guidelines, now “optional” be suppressed? Because the War on Cancer is coming to an end. Today, there is a powerful contingency that has declared War on the Harms Associated with Cancer Detection and Treatment, no matter how many lives may be lost in the process. The politically correct focus is on doing no harm, an impossibility in medicine, by the way. More accurately, it’s about harm:benefit ratios, a completely subjective judgment call, balancing apples against oranges. But the screening minimalists do everything they can to attach numbers and justifications for their position. In an accompanying Editorial to the new guidelines, Drs. Keating and Pace, who are deeply engaged in informing patients of the harms of screening, don’t even acknowledge the fact that the old guidelines are left as an “option” for women who want to continue what they have done for many years. Instead, they dwell on the harms, their favorite topic, as evidenced by their “informed consent” which results in a statistically significant “improvement” in women opting to do less screening.

 

The American Cancer Society, for the first time ever, broke the data down into 5-year increments, rather than the usual 10-year approach. Highly sophisticated analyses, transparency and independent review, all the wonderful things that go into formulating guidelines are there, like never before. All of this was in line with the 2011 Institute of Medicine guidelines on how to create guidelines. And to help themselves, the ACS drew from several other guideline resources including the “GRADE” terminology to distinguish between “strong” and “qualified” recommendations. Guidelines on how to create Guidelines, then Guidelines on how to communicate these Guidelines to the People intended to benefit – this is “evidence-based medicine” in all its glory. But when it comes to the end – harms vs. benefits – it’s a total judgment call whether to screen or not, at what ages, and at what intervals.

 

On the bright side, the ACS included observational studies, something that makes purists like the Task Force sick to their stomachs. Benefits are greater in these studies because (pick one): 1) women actually get mammograms here, rather than be “invited to screen,” plus those mammograms are performed using modern technology, or 2) the extra benefit is due to lead time bias, length time bias, overdiagnosis, and selection bias.

 

In contrast to the Task Force that didn’t utilize expert opinion, the ACS asked 22 experts and 26 relevant organizations to review the guidelines in advance. When it was all said and done, with the world literature review performed by the Duke University Evidence Synthesis Group (a separate article in JAMA), the ACS recommendations appear to be bullet-proof.

 

In reviewing how the ACS arrived at age 45, they addressed the issue from multiple angles, pointing out that incidence and mortality from breast cancer during ages 45-49 are actually closer to the 50-54 group than to the 40-44 group (barely). Frankly, the whole thing smacks of a predetermined compromise, thus the early decision to use 5-year blocks of time. “Let’s shoot for peace and harmony here. We must stop the madness that prevails today in conflicting recommendations. We’ll address the problem in 5-year intervals, allowing us to justify the compromise age of 45. The rest doesn’t matter so much, since the greatest controversy is the starting age.” Or, so I imagine.

 

The lead author for the ACS, Dr. Kevin Oeffinger, claims that this is a great victory for personalized screening – “The evidence simply no longer supports one-size-fits-all,” he is quoted as saying in TIME magazine. A terribly proud moment, considering only about 1,000 women will die each year if these guidelines are followed. And what a great month to make the announcement – Breast Cancer Awareness Month. When your 44-year-old friend is diagnosed with Stage IIB breast cancer, by self-exam (since the ACS no longer endorses clinical exam), you have now been made aware that you can tell her: “Oh, but think of all the heartache of unnecessary biopsies you’ve spared other women!”

 

We already disenfranchise 5% of eventual breast cancer victims by offering nothing to women under 40 to help with early detection, unless they are at very high risk (and most who develop breast cancer are not at high risk). By moving to 45, another 7% will be disenfranchised, bringing our total to 12%. And if the Task Force were to get their way, starting at 50, the total number of eventual breast cancer victims left out in the cold without screening will be an astounding 23%.

 

Dr. Stephen Feig, pioneering breast radiologist, has warned that “personalized screening” is a euphemism for “restricted screening.” Where “personalized screening” can be beneficial is when risk factors and breast density become the foundation to do “something more.” To use it to “do less” is deceptive. Call it what it is – limited and restrictive screening – there’s nothing beneficial in it for the average risk patient, which by the way, is the population where most breast cancers occur.

 

Admittedly, the ACS took a leadership role in 2007 when they introduced high-risk screening guidelines using breast MRI, starting at age 30. This is “personalized screening” in the good sense. They will be releasing new guidelines for these women in the near future. My hope is that they don’t “personalize” high-risk screening to the point that it’s pointless.

 

As a final point, we don’t need “more screening” as much as we need “better screening,” and this is happening already. 3-D tomosynthesis mammography is in the first stage of implementation, and the numbers coming in are remarkably good, with improvements in both Sensitivity and Specificity (fewer false-negatives and fewer false-positives). So, the recommended “informed consent” as proposed by screening minimalists are already “misinformed consents.” And, with the addition of whole breast ultrasound and breast MRI applied to a broader population, mortality reductions will be far superior compared to what is accomplished today. Too bad that the anti-screeners gained so much momentum at precisely the point in time when screening is getting an upgrade, or perhaps being revolutionized.

 

One thing for sure, not a single additional life will be saved by switching to the new American Cancer Society policy of “personalized screening,” which is designed to spare women anxiety from false-positives and theoretical “overdiagnoses.” Oh yes, and to save money. We’ve finally “fallen into line” with other countries around the world that have committed to screening mammography. And what a line it is!

 

 

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