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Mammography and the acute discomfort of change

As I write this, I am attending the 2014 meeting of the American Association for Cancer Research (AACR, Twitter hashtag #AACR14) in San Diego. Basically, it’s one of the largest meetings of basic and translational cancer researchers in the world. I try to go every year, and pretty much have succeeded since around 1998 or 1999. As an “old-timer” who’s attended at least a dozen AACR meetings and presented many abstracts, I can see various trends and observe the attitudes of researchers involved in basic research, contrasting them to that of clinicians. One difference is, as you might expect, that basic and translational researchers tend to embrace new findings and ideas much more rapidly than clinicians do. This is not unexpected because the reason scientists and clinical researchers actually do research is because they want to discover something new. Physicians who are not also researchers become physicians because they want to take care of patients. Because they represent the direct interface between (hopefully) science-based medicine and actual patients, they have a tendency to be more conservative about embracing new findings or rejecting current treatments found not to be effective.

While basic scientists are as human anyone else and therefore just as prone to be suspicious and dismissive of findings that do not jibe with their scientific world view, they can (usually) eventually be convinced by experimental observations and evidence. As I’ve said many times before, the process is messy and frequently combative, but eventually science wins out, although sometimes it takes far longer than in retrospect we think it should have, an observations frequently exploited by advocates of pseudoscience and quackery to claim that their pseudoscience or quackery must be taken seriously because “science was wrong before.” To this, I like to paraphrase Dara O’Briain’s famous adage that just because science doesn’t know everything doesn’t mean you can fill in the gaps with whatever fairy tale that you want. But I digress (although only a little). In accepting the validity of science that indicates either that a medical intervention that was commonly used either doesn’t help, doesn’t help as much as we thought it did, or can even be harmful, they have to contend with the normal human reluctance to admit to oneself that what one was doing before might not have been of value (or might have been of less value than previously believed) or that, worst of all, might have caused harm. Or, to put it differently, physicians understandably become acutely uncomfortable when faced with evidence that the benefit-risk profile of common treatment or test might not be as favorable as previously believed. Add to that the investment that various specialties have in such treatments, which lead to financial conflicts of interest (COI) and desires to protect turf (and therefore income), and negative evidence can have a hard go among clinicians.
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The Canadian National Breast Screening Study ignites a new round in the mammography wars

The last couple of weeks, I’ve made allusions to the “Bat Signal” (or, as I called it, the “Cancer Signal,” although that’s a horrible name and I need to think of a better one). Basically, when the Bat Cancer Signal goes up (hey, I like that one better, but do bats get cancer?), it means that a study or story has hit the press that demands my attention. It happened again just last week, when stories started hitting the press hot and heavy about a new study of mammography, stories with titles like Vast Study Casts Doubts on Value of Mammograms and Do Mammograms Save Lives? ‘Hardly,’ a New Study Finds, but I had a dilemma. The reason is that the stories about this new study hit the press largely last Tuesday and Wednesday, the study having apparently been released “in the wild” Monday night. People were e-mailing me and Tweeting at me the study and asking if I was going to blog it. Even Harriet Hall wanted to know if I was going to cover it. (And you know we all have a damned hard time denying such a request when Harriet makes it.) Even worse, the PR person at my cancer center was sending out frantic e-mails to breast cancer clinicians because the press had been calling her and wanted expert comment. Yikes!

What to do? What to do? My turn to blog here wasn’t for five more days, and, although I have in the past occasionally jumped my turn and posted on a day not my own, I hate to draw attention from one of our other fine bloggers unless it’s something really critical. Yet, in the blogosphere, stories like this have a short half-life. I could have written something up and posted it on my not-so-secret other blog (NSSOB, for you newbies), but I like to save studies like this to appear either first here or, at worst, concurrently with a crosspost at my NSSOB. (Guess what’s happening today?) So that’s what I ended up doing, and in a way I’m glad I did. The reason is that it gave me time to cogitate and wait for reactions. True, it’s at the risk of the study fading from the public consciousness, as it had already begun to do by Friday, but such is life.
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Once more into the screening breach: The New York Times did not kill your patient

One of the more depressing things about getting much more interested in the debate over how we should screen for common cancers, particularly breast and prostate cancer, is my increasing realization of just how little physicians themselves understand about the complexities involved in weighing the value of such tests. It’s become increasingly apparent to me that most physicians believe that early detection is always good and that it always saves lives, having little or no conception of lead time or length bias. Sadly, just last week, I saw another example of just this phenomenon in the form of an article written by Dr. George Lombardi entitled My Patient, Killed By The New York Times. The depth of Dr. Lombardi’s misunderstanding of screening tests permeates the entire article, which begins with his recounting a story about a patient of his, whose death he blames on The New York Times. After describing the funeral of this 73-year-old man who died of prostate cancer, Dr. Lombardi then makes an accusation:

This one filled me with a special discomfort as I knew a secret: He didn’t have to die. I knew it and he had known it. Had he told?

About 5 years ago he had just retired and had a lot more time on his hands. He was a careful man, lived alone, considered himself well informed. He got into the habit of clipping articles on medical issues and either mailing them to me or bringing them in. They came from a variety of sources and were on a variety of topics. He wasn’t trying to show me up. He was genuinely curious. I kidded him that maybe he’d like to go to medical school in his retirement. ‘No’ he laughed, ‘I just like to be in the know.’

When he came in for his physical in 2008 he told me he’d agree to the DRE but not the PSA (his medical sophistication extended to the use of acronyms: DRE stands for digital rectal exam where I feel the prostate with my gloved finger for any abnormality and PSA for prostatic [sic] specific antigen which is a blood protein unique to the prostate and often elevated in prostate cancer). He had read that the use of PSA as a screening test was controversial. This was the year that the United States Preventive Services Task Force, a government panel that issues screening guidelines, recommended against routine PSA screens for older men. It was often a false positive (the PSA was elevated but there was no cancer), led to unnecessary biopsies, and besides most prostate cancers at his age were indolent and didn’t need to be treated. I countered that prostate cancer was the second leading cause of cancer deaths in men and that it was better to know than not to know. This way it would be our decision. The patient with his doctor deciding what was best. But no, he wanted to stick to his guns and since the DRE was normal no PSA blood test was sent.

After describing a conversation with the man’s daughter, who said, “My father was killed by The New York Times,” Dr. Lombardi then goes on to anecdotal evidence and a cherry-picked publication to support his view, quoting an oncologist who says he’s “seeing more men presenting with advanced prostate cancer” and then referring to a single paper in the current Annals of Internal Medicine about PSA screening. Before I look at the article and a recently published paper on screening mammography that made the news, I can’t help but point out that I (mostly) agree with Dr. Lombardi when he says:

Public health doctors, policy experts and journalists tend to look at the population as a whole. It is a better story if it is one story. It makes a better headline. Their statistics are people I sit across from everyday trying to figure out what the future holds. We each have our job to do.

The problem is, of course, that Dr. Lombardi takes that observation and draws the wrong conclusion, namely that his patient died because of lack of screening. He attacks a straw man, sidestepping the true argument, namely that evidence shows that PSA screening probably causes more harm than good for men at average risk of prostate cancer. Unfortunately, Dr. Lombardi obviously does not understand some very basic concepts behind cancer screening, nor does he apparently recognize that doctors who deal with the population-level data that we have regarding screening tests and try to apply them to individual patients are actually looking in a very systematic way about what the benefits of screening are to the individual patient. More on that later. In the meantime, although I wouldn’t go quite as far as Dr. John Schumann did in criticizing Dr. Lombardi, I do view his lament as a jumping off point to look at some recent data on screening for the two most common cancers, breast and prostate.

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Posted in: Cancer, Politics and Regulation, Public Health, Science and the Media

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A holiday round in the mammography debate

There are times when the best-laid blogging plans of mice and men often go awry, and this isn’t always a bad thing. As the day on which so many Americans indulge in mass consumption of tryptophan-laden meat in order to give thanks approached, I had tentatively planned on doing an update on Stanislaw Burzynski, given that he appears to have slithered away from justice yet again. Then what to my wondering eyes should appear in my e-mail in box but news of a study that practically grabbed me by my collars, shook me, and demanded that I blog about it. As if to emphasize the point, suddenly e-mails started appearing by people who had seen stories about the study and, for reasons that I still can’t figure out after all these years, were interested on my take on the study. Yes, I realize that I’m a breast cancer surgeon and therefore considered an expert on the topic of the study, mammography. I also realize that I’ve written about it a few times before. Even so, it never ceases to amaze me, even after all these years, that anyone gives a rodential posterior about what I think. Then I started getting a couple of e-mails from people at work, and I knew that Burzynski had to wait or that he would be relegated to my not-so-secret other blog (I haven’t decided yet).

As is my usual habit, I’ll set the study up by citing how it’s being spun in the press. My local home town paper seems as good a place to begin as any, even though the story was reprinted from USA Today. The title of its coverage was Many women receiving unnecessary breast cancer treatment, study shows, with the article released the day before the study came out in the New England Journal of Medicine:
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The mammography wars heat up again (2012 edition)

One issue that keeps coming up time and time again for me is the issue of screening for cancer. Because I’m primarily a breast cancer surgeon in my clinical life, that means mammography, although many of the same issues come up time and time again in discussions of using prostate-specific antigen (PSA) screening for prostate cancer. Over time, my position regarding how to screen and when to screen has vacillated—er, um, evolved, yeah, that’s it—in response to new evidence, although the core, including my conclusion that women should definitely be screened beginning at age 50 and that it’s probably also a good idea to begin at age 40 but less frequently during that decade, has never changed. What does change is how strongly I feel about screening before 50.

My changes in emphasis and conclusions regarding screening mammography derive from my reading of the latest scientific and clinical evidence, but it’s more than just evidence that is in play here. Mammography, perhaps more than screening for any disease, is affected by more than just science. Policies regarding mammographic screening are also based on value judgments, politics, and awareness and advocacy campaigns going back decades. To some extent, this is true of many common diseases (i.e., that whether and how to screen for them are about more than just science), but in breast cancer arguably these issues are more intense. Add to that the seemingly eternal conflict between science and medicine communication, in which a simple message, repeated over and over, is required to get through, versus the messy science that tells us that the benefits of mammography are confounded by issues such as lead time and length bias that make it difficult indeed to tell if mammography—or any screening test for cancer, for that matter—saves lives and, if it does, how many. Part of the problem is that mammography tends to detect preferentially the very tumors that are less likely to be deadly, and it’s not surprising that periodically what I like to call the “mammography wars” heat up. This is not a new issue, but rather a controversy that flares up periodically. Usually this is a good thing.

And these wars just just heated up a little bit again late last week.
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Overdiagnosis

Dr. H. Gilbert Welch has written a new book Over-diagnosed: Making People Sick in the Pursuit of Health, with co-authors Lisa Schwartz and Steven Woloshin.  It identifies a serious problem, debunks medical misconceptions and contains words of wisdom.

We are healthier, but we are increasingly being told we are sick. We are labeled with diagnoses that may not mean anything to our health. People used to go to the doctor when they were sick, and diagnoses were based on symptoms. Today diagnoses are increasingly made on the basis of detected abnormalities in people who have no symptoms and might never have developed them. Overdiagnosis constitutes one of the biggest problems in modern medicine. Welch explains why and calls for a new paradigm to correct the problem. (more…)

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Oprah’s buddy Dr. Christiane Northrup and breast thermography: The opportunistic promotion of quackery

Fibrocystic breasts

As many readers know, October is Breast Cancer Awareness Month. What that generally means at our cancer center and in the rest of the “real world” is that, during the month of October, extra effort is made to try to raise awareness of breast cancer, to raise money for research, and promote screening for cancer. Unfortunately, what Breast Cancer Awareness Month means around the Science-Based Medicine blog is that a lot of breast cancer-related pseudoscience and outright quackery will be coming at us fast and furious. There’s no way, of course, that I can deal with it all, but there’s one area of medical pseudoscience related to breast cancer that I just realized that none of us has written about on SBM yet. Actually, it’s not really pseudoscience. At least, the specific technology isn’t. What is pseudoscience is the way it’s applied to breast cancer and in particular the way so many “alternative” medicine and “complementary and alternative medicine” (CAM) practitioners market this technology to women. The technology is breast thermography, and the claim is that it’s far better than mammography for the early detection of breast cancer, that it detects cancer far earlier.

I’ve actually been meaning to write about thermography, the dubious claims made for it with regard to breast cancer, and the even more dubious ways that it’s marketed to women. In retrospect, I can’t believe that I haven’t done so yet. The impetus that finally prodded me to get off my posterior and take this on came from what at the time was an unexpected place but in retrospect shouldn’t have been. You’ve met her before quite recently when SBM partner in crime Peter Lipson took her apart for parroting anti-vaccine views and even citing as one of her sources anti-vaccine activist Sherri Tenpenny. I’m referring, unfortunately, to one of Oprah Winfrey’s stable of dubious doctors, Dr. Christiane Northrup. Sadly, Peter’s example of her promotion of vaccine pseudoscience is not the first time we at SBM have caught Dr. Northrup espousing anti-vaccine views. We’ve also harshly criticized her for her promotion of “bioidentical hormones” and various dubious thyroid treatments. However, Dr. Northrup is perhaps most (in)famous for her advocating on Oprah’s show the use of Qi Gong to direct qi to the vagina, there apparently to cure all manner of female ills and promote fantastic orgasms in the process. This little incident ought to tell you nearly all that you need to know about her. Even Oprah looked rather embarrassed in the video in which Dr. Northrup led her audience in directing all that qi goodness “down below.”

What brought Dr. Northrup to my attention again was my having joined her e-mail list. As you might imagine, I’m on a lot of e-mail lists, ranging from that of Mike Adams, to Generation Rescue, to Joe Mercola and beyond. I do it all for you, in order to have the blogging material come to me rather than my having to seek it out. True, the price is that my e-mail in box is frequently clogged with quackery, but it’s a small price to pay. This time around, Dr. Northrup’s e-mail brought my attention to a post of hers, Best Breast Test: The Promise of Thermography. It was truly painful to read, and I consider it inexcusable that someone who claims to be an advocate of “women’s health” could write something that reveals such ignorance. But, then, I suppose I shouldn’t be surprised after her recent flirtation with anti-vaccine views. If it isn’t already complete, Dr. Northrup’s journey to the Dark Side is damned close to complete. You’ll see what I mean right from her very introduction:
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The mammography wars heat up again

PRELUDE: THE PROBLEM WITH SCREENING

If there’s one aspect of science-based medicine (SBM) that makes it hard, particularly for practitioners, it’s SBM’s continual requirement that we adjust what we do based on new information from science and clinical trials. It’s not easy for patients, either. To lay people, SBM’s greatest strength, its continual improvement and evolution as new evidence becomes available, can appear to be inconsistency, and that seeming inconsistency is all too often an opening for quackery. Even when there isn’t an opening for quackery, it can cause a lot of confusion; some physicians are often resistant to changing their practice. It’s not for nothing that there’s an old joke in medical circles that no outdated medical practice completely dies until a new generation of physicians comes up through the ranks and the older physicians who believe in the practice either retire or die. There’s some truth in that. As I’ve said before, SBM is messy. In particular, the process of applying new science as the data become available to a problem that’s already as complicated as screening asymptomatic people for a disease in order to intervene earlier and, hopefully, save lives can be fraught with confusion and difficulties.

Certainly one of the most contentious issues in medicine over the last few years has been the issue of screening for various cancers. The main cancers that we most commonly subject populations to routine mass screening for include prostate, colon, cervical, and breast cancer. Because I’m a breast cancer surgeon, I most frequently have to deal with breast cancer screening, which means, in essence, screening with mammography. The reason is that mammography is inexpensive, well-tested, and, in general, very effective.

Or so we thought. Last week, yet another piece of evidence to muddle the picture was published in the New England Journal of Medicine (NEJM) and hit the news media in outlets such as the New York Times (Mammograms’ Value in Cancer Fight at Issue).
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Another wrinkle to the USPSTF mammogram guidelines kerfuffle: What about African-American women?

A while back I wrote about rethinking how we screen for breast cancer using mammography. Basically, the USPSTF, an independent panel of physicians and health experts that makes nonbinding recommendations for the government on various health issues, reevaluated the evidence for routine screening mammography and concluded that for women at normal risk for breast cancer, mammography before age 50 should not be recommended routinely and should be ordered on an individualized basis, and that routine formalized breast self-examination (BSE) should also not be routinely recommended. In addition, for women over 50, it was recommended that they undergo mammography every other year, rather than every year. These recommendations were based on a review of the literature, including newer studies.

To say that these new recommendations caused a firestorm in the breast cancer world is an understatement. The USPSTF was accused of misogyny; opponents of health care reform leapt on them as evidence that President Obama really is preparing “death panels”; and HHS secretary Kathleen Sebelius couldn’t run away from the guidelines fast enough. Meanwhile, a society I belong to (the American Society of Breast Surgeons) issued a press release accusing the USPSTF of sending us back to the “pre-mammography” days when, presumably women only found breast cancer after it had grown to huge size (just like Europe and Canada, I guess, given that the recommendations for screening there closely mirrors those recommended by the USPSTF). Meanwhile, in the most blatant example of protecting its turf I’ve seen in a very long time, the American College of Radiology went full mental jacket with a press release that was as biased as it was insulting. Meanwhile some physicians even likened the recommendations to going back to being like Africa, Southeast Asia and China as far as breast screening goes in that he actually speculated that he’d now become very busy treating advanced, neglected breast cancers. Unfortunately, as Val pointed out, the communication of the USPSTF guidelines to the public was almost a perfect case study in how not to do it. Even though the science was in general sound and the USPSTF recommendations were in essence close to identical to what other industrialized nations do, they were communicated in just such a way as to produce maximum misunderstanding and misuse for political purposes.

Despite all the hysterical and in some cases disingenuous attacks on the new guidelines, there is one criticism that actually resonates with me because I work at a cancer center in a very urban environment with a large population of African-American women. Last week I heard on NPR this story:
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The Mammogram Post-Mortem

The Mammogram Post Mortem
Steve Novella whimsically opined on a recent phone call that irrationality must convey a survival advantage for humans. I’m afraid he has a point.
It’s much easier to scare people than to reassure them, and we have a difficult time with objectivity in the face of a good story. In fact, our brains seem to be hard wired for bias – and we’re great at drawing subtle inferences from interactions, and making our observations fit preconceived notions. A few of us try to fight that urge, and we call ourselves scientists.
Given this context of human frailty, it’s rather unsurprising that the recent USPSTF mammogram guidelines resulted in a national media meltdown of epic proportions. Just for fun, and because David Gorski nudged me towards this topic, I’m going to review some of the key reasons why the drama was both predictable and preventable.  (And for an excellent, and more detailed review of the science behind the kerfuffle, David’s recent SBM article is required reading. http://www.sciencebasedmedicine.org/?p=1926 )
Preamble
In an effort to increase early detection of breast cancer, American women have been encouraged to get annual screening mammograms starting at age 40. Even though mammograms aren’t as sensitive and specific as we’d like, they’re the best screening test we have – and so with all the caveats and vagaries associated with what I’d call a “messy test,” we somehow collectively agreed that it was worth it to do them.
Now, given the life-threatening nature of breast cancer, it’s only natural that advocacy groups and professional societies want to do everything in their power to save women from it. So of course they threw all their weight behind improving compliance with screening mammograms, and spent millions on educating women about the importance of the test. Because, after all, there is no good alternative.
However, the downside of an imprecise test is the false positive results that require (in some cases) invasive studies to refute them.  And so this leaves us with 2 value judgments:  how many women is it acceptable to harm (albeit it mildly to moderately) in order to save one life? Roughly, the answer is a maximum of 250 over 10 years (I came up with that number from the data here: http://www.sciencebasedmedicine.org/?p=565 if as many as half of women receive a “false alarm” mammogram over a period of 10 years of testing, and half of those undergo an unnecessary biopsy). And second: how many tests are we willing to do (this is more-or-less an economic question) to save 1 life? The answer is roughly 1900.
So when the USPSTF took a fresh look at the risks and benefits of mammography and recommended against screening average risk women between 40-50 (and reducing mammogram frequency to every other year for those over 50), what they were saying is that they would rather injure fewer women and do fewer costly tests for the trade off of saving fewer lives. In fact, their answer was that they were willing to perform 1300 mammograms to save 1 life, not 1900 (as has been our standard of care).
This value judgment is actually not, in and of itself, earth shattering or irresponsible. But it’s the societal context into which this judgment was released that made all the difference.
1. Timing Is Everything: Or, why not to bring a party hat to a funeral
First of all, it’s almost amusing how bad the timing of the USPSTF guidelines really were. The country was in the midst of trying to pass our country’s first serious healthcare reform bill in decades (at least, the house reform bill was being voted upon the week that the USPSTF guidelines were released) and opponents of the bill had already expressed vehement concern about arbitrary government rationing of healthcare services.
What worse time could there have been to announce that a government agency is (against the commonly held views of the rest of the medical establishment) recommending reduction in frequency  of a life-saving screening test for women? The fact that the guidelines leader said she hadn’t thought about the greater context when she scheduled the press release is quite astonishing. On the one hand, I suppose it shows how disconnected from potential political bias the workgroup really is. On the other hand, it is violates Public Relations 101 so completely as to call into question the judgment of those making… er… judgments.
2. You Can’t Replace Something With Nothing: Or How To Take Scissors From A Baby
Let’s just say for a moment that we all agree that mammograms aren’t the greatest screening test for breast cancer. They’re rather expensive, and wasteful perhaps one might even argue that in a healthcare system with limited resources, one healthy woman’s screening test is another woman’s insulin.  But – it’s all we have. And they do save lives… occasionally.
Anyone who’s seen a child pick up something harmful realizes that the only way to take it from them without tears is to replace it with something harmless. You can’t just take away mammograms from women who have come to expect it, without offering them something more sensible. If there is nothing, then I’m afraid that discontinuing them will result in considerable outrage which you may or may not wish to engage. Given the size and power of the breast lobby – I’d say it’s pretty much political suicide.
3. Know Your Opposition: Or Don’t Bring A Knife To A Gun Fight
And that brings me to point #3. The breast cancer movement is one of the most powerful and successful disease fighting machines in the history of medicine. And bravo to all the women and men who made it such a visible disease. The amount of funding, research, and PR that this cancer gets is astounding – it dwarfs many other worthy diseases (like pancreatic cancer or lymphoma), and is a force to be reckoned with.
Which is why, before you undermine a cherished tenet of such a group, you take a long hard look at what you’re going to say… Because it will be shouted from the hilltops, scrutinized from every conceivable angle, and used to rally all of Hollywood, the medical establishment, and everyone in Washington to its cause. Yeah, you better be darn sure you’re “right” (whatever that means in this context) before attempting to promote a service cut back to this group.
4. Know Who You Are: Or Unilateral Decision Making Is Not A Great Idea – Especially For Government
And finally, it’s important not only to know who you’re dealing with, but to know your mission in society so you can be maximally effective. The US government exists to honor the will of the people and serve its citizens. The best way to do that is to listen to them carefully, engage in consensus-building, and try to be a good steward of resources. When government behaves in ways counter to our expectations, it provokes some legitimate negativity.
So, for example, when a small group of civil servants hole themselves up in a room to create guidelines that will potentially take preventive health services away from women – resulting in a larger number of deaths each year… and they don’t invite input from key stakeholders, and announce their views in the midst of a firestorm about “rationing”
In summary
The new USPSTF guidelines for mammogram screenings debacle serves as a perfect public relations case study in what not to do in advancing healthcare reform. It was the perfect storm of high profile subject, bad timing, poor argument preparation, and lack of back up planning. Though we could have had a rational discussion about the cost/benefit analysis of this particular screening test, what we got instead was the appearance of a unilateral rationing decision by an out-of-touch government organization, devaluing women to the point of death. Throw that chum in the water of human frailty and you’ll get the same result every time: a media feeding frenzy that makes you regret the moment that guideline development became a twinkle in your task force eye.

Steve Novella whimsically opined on a recent phone call that irrationality must convey a survival advantage for humans. I’m afraid he has a point.

It’s much easier to scare people than to reassure them, and we have a difficult time with objectivity in the face of a good story. In fact, our brains seem to be hard wired for bias – and we’re great at drawing subtle inferences from interactions, and making our observations fit preconceived notions. A few of us try to fight that urge, and we call ourselves scientists.

Given this context of human frailty, it’s rather unsurprising that the recent USPSTF mammogram guidelines resulted in a national media meltdown of epic proportions. Just for fun, and because David Gorski nudged me towards this topic, I’m going to review some of the key reasons why the drama was both predictable and preventable.  (And for an excellent, and more detailed review of the science behind the kerfuffle, David’s recent SBM article is required reading.)

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