Without Criminal Intent

Without criminal intent, several organizations have decided that screening women below age 50 does more harm than good. Most importantly, the U.S. Preventive Services Task Force led this crusade with their 2009 recommendations that flip-flopped from their 2002 recommendations. “New data” was the alleged reason, but if you read my book, Mammography and Early Breast Cancer Detection, you will learn what really happened.


The so-called “new data” on the beneficial side of screening was the results from a single trial that, while supporting mammography for young women, did not alter the 2002 calculations one fraction. In 2002, the Task Force calculated a 15% relative reduction in mortality through screening women in their 40s. After the new data was added, then the 2009 Task Force calculated an identical 15% mortality reduction. No difference in benefit, so why the dramatic change in policy? Answer: the harms of screening.


The “harms” are things like “false-positives,” which are mostly the routine call-backs that come with screening. We call back roughly 10% of those screened, then after diagnostic views, only 5% are left with either short-interval follow-up or a biopsy that proves to be benign. However, the full 10% are “harmed,” according to the Task Force. Others weighed in with publications demonstrating permanent psychological damage from a benign biopsy (Why didn’t they measure the permanent psychological harm from a delayed diagnosis of breast cancer?) By inflating the harms, then magically balancing how many call-backs equal a saved life, the 2009 Task Force issued their reversal in policy – no routine screening under age 50.


The position of many of us who practice breast cancer screening is that the “15% relative mortality reduction” for women in their 40s is understated, perhaps greatly understated. Why? Too many reasons to list here (again, refer to my book), but let me offer the two most important. The first is that these calculations are based on obsolete technology used in the 1970s and 1980s primarily, with screening studies ending by the 1990s. With the later introduction of digital mammography, and more importantly, 3-D tomosynthesis mammography, our detection rates are much improved. One of the reasons it was hard to demonstrate breast cancer mortality reduction in younger women was that too many breast cancers were missed on mammography. But if we were missing half of detectable cancers in this group in the early days of screening (and we were!), yet still could demonstrate a mortality reduction, think what we could accomplish by finding the other half. Or even half of the other half!


The second reason is the “Intent to Treat” rule, or in this case, the “Intent to Screen” rule that haunts all prospective, randomized trials for screening, the gold standard in research. Outcomes are based on the group to which people are assigned in these “high quality” studies, not to what patient volunteers actually did. In the case of screening mammography trials, this is a huge issue. Many women assigned to mammography were not compliant, and many assigned to no mammography opted to have mammograms anyway. Toss them out of the study? No. That would be scientific malfeasance. No, instead, they are counted to the group to which they were originally assigned. That’s right. Women who did not get mammograms stay in the mammography group, and those who had mammograms were counted in the no-mammography group. One has to read the small print in these studies to learn the outcomes for those patients who were compliant, and guess what – the mortality reduction is always improved beyond the official study outcomes when measuring the benefit in the compliant patients only. But these are unofficial results. Meanwhile, the official “15% mortality reduction” is a deceptive tool used to mislead the masses as to the minimal benefit, and yet from the standpoint of scientific purity, it’s right on the mark.


Now, I’m finally to my point. I have always carried a burden of concern for women under age 40 diagnosed with breast cancer. To me, it has been callous disregard for a large number of women that our guidelines for screening begin at 40, when 5% of eventual victims of breast cancer are under age 40. My favorite word here (for decades now) has been disenfranchised. These young women are disenfranchised by a screening establishment that left them high and dry.


In 2007, this was partially corrected by the introduction of high-risk guidelines for screening breast MRI (added to mammography) where there is now a starting age of 30, and for some, age 25. Finally! But one problem – this only addresses the young women with risk factors, that is, very high risk. Unfortunately, this is only about one-fifth of the eventual patients who will be diagnosed with breast cancer prior to the age of 40 (or, 1% of the 5%).


I once made my “disenfranchised” statement at a national meeting where an ad hoc committee had been formed to discuss screening guidelines. It went over like a lead balloon. A participant turned to me and said, “These women are not disenfranchised, they have clinical exam and self-exam.” Really?! That may be a good way to diagnose Stage II and Stage III breast cancer, but it’s not the way to save lives. Even more remarkable here is the fact that there has never been a single study that remotely indicates that self-exam or clinical exam saves lives.


So, how big is this problem that has been shoved under the rug for years, based on the misconception that we’re only talking about a tiny minority? 5% of eventual victims sounds rather small, doesn’t it? Well, in 2015, the American Cancer Society estimated that 231,840 new cases of INVASIVE breast cancer (I’m not even going to count DCIS) were diagnosed in the U.S. That means that 11,592 of these women were under the age of 40. How does that compare to other cancer numbers?


Let’s take cervical cancer where one hears about Pap smears and vaccines and so forth all the time, as an entire industry surrounds the 11,955 diagnosed in 2013. Think of it. We offer NOTHING to the 11,592 women in their 20s and 30s who are bound for breast cancer (unless at very high risk), while an entire industry is focused on the same number of women who are headed toward cervical cancer, all ages included.


(As an aside, this is the reason that I have pursued blood testing and alternative imaging options for younger women in my research.)


But now we face a problem that absolutely dwarfs the 11,592 disenfranchised young women headed toward breast cancer. Now, we have the Task Force leading the way – without criminal intent, mind you – to disenfranchise an additional 20% of eventual breast cancer victims from the benefits of screening. Instead of ignoring a mere 12,000, we’re now going to let nature take its course into worse stages of breast cancer with 57,960 women every year. And I hate to tell you what’s next – “no screening beyond 70 or 75,” whereupon 116,000 women to be diagnosed with breast cancer every year will be relying on the unreliable self-exam.


How does this 57,960 eventual breast cancer patients under the age of 50 stack up to other cancers? According to American Cancer Society stats for estimated cases in 2016, here’s the list of some cancer types all ages included, most of which have no proven screening options: Uterine cancer (60,000), kidney cancer (62,000), all types of leukemia (60,140), pancreatic cancer (53,070), thyroid (64,300). The point is that we are going to deny a staggering number of eventual breast cancer victims (57,960) the benefit of early detection with screening, based on flawed and archaic data, all in the name of “evidence-based medicine” and scientific purity that is, in fact, covert cost containment.


And notice one other tidbit: I’ve limited my discussion here to the number of women diagnosed with invasive breast cancer, to avoid the controversial aspects of ductal carcinoma in situ (DCIS). But if we include DCIS, as can be justified by its greater significance in younger women, then we’re talking about an additional 60,000 diagnoses each year (all ages), bringing our total number of breast cancers to nearly 300,000 per year. In this all-inclusive projection, the exclusion of screening women under 50 disenfranchises 75,000 eventual breast cancer victims every year. It only takes 13 years to deny early detection through screening to 1 million women headed for breast cancer. This is the recommendation of the U.S. Preventive Services Task Force, a rotating group of government-funded non-experts (this assures neutrality) who crank out recommendations for over 100 preventive health care measures.


To admit to a 15% mortality reduction (while the reality is probably closer to a 30% mortality reduction), with breast cancer screening under the age of 50, but then turn around and deny screening to these 57,960 headed toward invasive disease each year, well, let’s hope the Task Force appreciates the fact that there is no criminal prosecution in the establishment of guidelines.