As I discussed in detail when I analyzed them, the new USPSTF recommendations for screening mammography for breast cancer have sparked a debate that has degenerated from a scientific and public policy debate into pure emotional rhetoric. When last I visited this topic, yesterday, I had intended it to be my last post for a while, perhaps ever. However, the amount of idiocy that I was dealing with became so overwhelming and the post grew to even huger than Orac-ian proportions. So I decided to split the post into two parts, because the particular argument I’m about to discuss deserves its very own takedown. It also cleverly allowed me to post a big “TO BE CONTINUED…” and thereby nefariously manipulate my audience to be curious over whom the target of today’s Insolence would be and thus more likely to pay me a return visit. Or not. Who knows? Either way, it let me make two long posts out of one gargantuan post. How cool is that?
For those just joining the debate, I concluded yesterday’s post by describing the claim that the USPSTF’s recommendations were the equivalent of “death panels” and an example of the horrors that will come if the health insurance plan being debated in the Senate right now were to become law as the undead beast continuing to lumber on, using one of my favorite analogies, the brain-eating zombie, to describe how the whole “death panels” thing destroys any intelligent argument and renders its adherents stupid and/or ignorant, much the way certain varieties of brain-eating zombies do when they feast upon grey matter. In fact, as I said yesterday, the brain-eating death panel zombie even shows up in places where you wouldn’t necessarily expect it. In this case, it appears to have eaten can eat the brains of bloggers that I used to consider fairly reasonable, creating new zombies. However, unlike the drooling “Hot Air“-type death panel zombie, though, the new “death panel” zombies are more like the speedy, running zombies in 28 Days Later, not the shambling, dripping, drooling zombies of Night of the Living Dead. They’re the new, improved, cleverer zombie, like the ones in The Return of the Living Dead who, after feasting on the brains of paramedics, picked up the radio from their ambulance and asked the dispatcher to send more paramedics. But at the heart, the zombie lie continues on, eating brains and reducing the level of debate from the merits of the recommendations as a matter of science and public to raw emotions manipulated by fear of government.
Most disturbing to me all was that a blogger who really should know better than to use such brain-chomped terms to describe a complex issue, Dr. Rich, has fallen victim to the zombie, likening the USPSTF’s recommendations to “soft death panels“:
It is this image of a death panel that allowed Ms. Palin’s many critics to ridicule her backward ways, and dismiss both her and her unruly supporters (mindless rabble, angry mobs, and teabaggers one and all) as complete buffoons, unworthy of any response save disdain. For, this sort of death panel truly is patently absurd.
It would be far too inefficient (and far too personal) to set up your death panels in this way.
To get a glimpse of what death panels will really look like, let us consider the new “Recommendation Statement on Screening for Breast Cancer,” released just yesterday by the United States Preventive Service Task Force (USPSTF).
These new recommendations will seem stunning to many, because they constitute a significant about-face for the USPSTF. The new document, for the first time, emphasizes the risks of cancer screening, and greatly reduces the type, frequency, and duration of recommended breast cancer screening, compared with the same agency’s recommendations of just a few years ago.
These changes, DrRich humbly submits, reflect just what one would expect to see from an actual death panel – if there were such a thing as death panels. It is not the “hard” death panel that Ms. Palin’s critics accuse her of raving about; rather, it is a “soft” death panel (and more likely what she actually meant).
Noooo! Not you, too, Dr. Rich! This is not a “death panel”! And I can’t believe you gave the ever-ignorant Sarah Palin the benefit of the doubt on this issue, because she clearly didn’t mean this when she first pushed the “death panel” nonsense! (Yes, I know she did have someone write something for her on Facebook later that backpedaled a bit and sounded more in line with Dr. Rich’s speculations. Probably someone affiliated with her told her how utterly idiotic her first spew was.) Remember, that was all a ploy to demonize quite reasonable provisions in the health insurance reform bill to reimburse for end-of-life counseling.
Be that as it may, only someone nearly completely ignorant of the issues and difficulties with cancer screening and its pitfalls would be the least bit surprised that an advisory panel would recommend scaling back screening for cancer. The “surprise” only comes from people who haven’t been paying attention to the literature on screening over the last decade. Sadly, that includes even some oncologists and breast cancer specialists. Suffice it to say that screening women under 50 by mammography has been controversial for a long time, and the USPSTF’s latest revision of its screening mammography recommendations is only the latest zig-zag on this issue. Moreover, Dr. Rich is easily demonstrably wrong when he claims that this is the first time the USPSTF has emphasized the risks of cancer screening. Again, only someone ignorant of the issues involved in screening a healthy population for cancer could say something so monumentally ignorant of the literature. Heck, it’s not even the first time that the USPSTF recommended against screening, as Dr. Rich would know if he had just bothered, oh, to peruse at the USPSTF website. Let’s see, there’s its recommendations from 2008 for prostate cancer screening:
Summary of Recommendations
- The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of prostate cancer screening in men younger than age 75 years. Grade: I Statement.
- The USPSTF recommends against screening for prostate cancer in men age 75 years or older. Grade: D Recommendation.
D’oh! And that was under the Bush Administration, too! In fact, several advisory bodies, such as the American Cancer Society) concluded over the last few years that routine screening for prostate cancer for men under 75 probably causes more harm than good, and, except for high risk populations, routine prostate cancer screening with PSA testing is no longer recommended in general. None of this is anything new. A major rethinking of the benefits versus risks of cancer screening has been going on for at least five years now. It happened first for prostate cancer, where it was far more obvious that screening was finding a lot of cancers that would never threaten the life of the men in which they were diagnosed but subjected these men to overtreatment, including major surgery and radiation. It’s happening now for breast cancer, where the problem of overdiagnosis is not nearly as great as it is for prostate cancer, but nonetheless significant. Moreover, the USPSTF did discuss potential harms of breast screening in its 2002 recommendations. Here are selected examples:
- The precise age at which the benefits from screening mammography justify the potential harms is a subjective judgment and should take into account patient preferences. Clinicians should inform women about the potential benefits (reduced chance of dying from breast cancer), potential harms (e.g., false-positive results, unnecessary biopsies), and limitations of the test that apply to women their age. Clinicians should tell women that the balance of benefits and potential harms of mammography improves with increasing age for women between the ages of 40 and 70.
- Women who are at increased risk for breast cancer (e.g., those with a family history of breast cancer in a mother or sister, a previous breast biopsy revealing atypical hyperplasia, or first childbirth after age 30) are more likely to benefit from regular mammography than women at lower risk. The recommendation for women to begin routine screening in their 40s is strengthened by a family history of breast cancer having been diagnosed before menopause.
- In the trials that demonstrated the effectiveness of mammography in lowering breast cancer mortality, screening was performed every 12-33 months. For women aged 50 and older, there is little evidence to suggest that annual mammography is more effective than mammography done every other year. For women aged 40-49, available trials also have not reported a clear advantage of annual mammography over biennial mammography. Nevertheless, some experts recommend annual mammography based on the lower sensitivity of the test and on evidence that tumors grow more rapidly in this age group.
- The precise age at which to discontinue screening mammography is uncertain. Only 2 randomized controlled trials enrolled women older than 69 and no trials enrolled women older than 74. Older women face a higher probability of developing and dying from breast cancer but also have a greater chance of dying from other causes. Women with comorbid conditions that limit their life expectancy are unlikely to benefit from screening.
Read, Dr. Rich. Read. Or ask an oncologist or breast surgeon familiar with the issues involved. Similarly, as is described by the New York Times, the American College of Obstetricians and Gynecologists is revising its recommendations for Pap smears to decrease the frequency and increase the age at first screening. Again, none of this is anything new, and you really should learn about the issues involved–or at least the history of this whole issue–before you stick your foot in your mouth, blogophorically speaking. Indeed, medical history is littered with examples of overzealous screening that we had to back off from after scientific studies showed that they either didn’t do much good or did as much or more harm than good. Screening asymptomatic patients for cancer (or other disease) is one of the hardest issues there are in medicine because it’s so difficult to define how many benefit and at what cost. Not all that long ago there was a lot of enthusiasm for screening for lung cancer with either chest X-ray or spiral CT scans. It turns out that screening almost certainly doesn’t decrease mortality from lung cancer and comes at a high cost and potential harm, which is why the USPSTF doesn’t recommend screening for lung cancer, either.
Dr. Rich then characterizes independent panels such as the USPSTF as in essence stealth death panels:
DrRich must therefore remind his readers that bias is inevitable in clinical research, and those who control the process get to control the bias – and therefore control what turns out to be medically right and wrong. Further, clinical research of any kind only tells you about the average response within a large group of patients, and cannot tell you how specific individuals will respond, or which specific individuals are likely to respond differently from the average, or which individuals would – if given the opportunity – weigh the risks and benefits differently than a panel of experts thinks they should. In other words, what we are getting with such a system is group medicine, and not individualized medicine.
So, the hallmark of soft death panels will be to take clinical evidence collected in groups of patients – interpreted with an overwhelming bias toward reducing costs – and to institutionalize and enforce the application of that evidence to individual patients. Soft death panels will be in the business of interpreting clinical evidence in the service of covert rationing, and the results will be packaged and sold as science – pure, sweet, clear, and unassailable science.
Is Dr. Rich for real here? Because there might be bias in clinical research, these panels will control the bias and research and therefore control what medically is “right” and “wrong”? Dr. Rich takes a tiny germ of a reasonable concern and drives right off the cliff with it. Worse, his observations about clinical research are trivial and obvious to anyone who knows anything about clinical research. They’ve always been true. Clinical research of almost any kind always involves deriving conclusions from studying populations because statistically valid conclusions can’t really be drawn for individuals. Much of the challenge of science-based medicine is the application of data taken from groups to individual patients. That’s been true for decades now. In fact, if anything, with the advent of genomic medicine, for the first time we have the possibility of truly personalized medicine. Dr. Rich is in essence making a “well, duh!” observation and yoking it to his special “covert rationing” agenda. Thus, his observation not in the least bit insightful, nor is it particularly useful. Like so much of what I’ve described before, it’s heat but no light. In fact, more than anything, it reminds me of the same sorts of criticisms CAM advocates use to justify ignoring the standard of care in favor of woo: EBM doesn’t apply to my patient; I provide individualized care; EBM is hopelessly biased; only randomized clinical trials count. How many times have I addressed such “concerns” on this blog when they came from woo-meisters or political cranks. The Association of American Physicians and Surgeons couldn’t have said it better.
Dr. Rich then goes on to make statements that exhibit, frankly, an amazing collection of ignorance about breast cancer and misrepresentation of the USPSTF’s recommendations. Some examples:
The bottom line is that breast cancer screening is just as effective for women aged 40 – 49 as it is for women aged 50 – 59; the reduction in mortality is the same. But because there are more false-positives among the younger women, and so it is more expensive to save those lives, the USPSTF has stopped recommending breast cancer screening for the younger women.
If this is something other than a pure cost play, DrRich does not see it.
Dr. Rich only sees what he wants to see, actually. More precisely, he doesn’t see what he doesn’t want to see, which is why he can’t see that this is not a “pure cost play.” It’s also why I refer Dr. Rich to the following, that he may begin his education on the issues involved in cancer screening, be it for breast or other cancers:
- Early detection of cancer, part 1: More complex than you think
- The spontaneous regression of breast cancer?
- Overdiagnosis of breast cancer due to mammography
- Rethinking cancer screening?
- Really rethinking breast cancer screening
No need to thank me. It’s my pleasure.
Suffice it to say that there were far more elements than just cost involved in the decision. Indeed, not only was cost not mentioned in the modeling studies used to formalize the recommendations, but the panel explicitly denies that costs were a consideration:
But Ned Calonge, who chairs the 16-member panel, defended the recommendations and denied that cost or the debate over health-care reform played any role in the decision. “Cost just isn’t a consideration when the task force deliberates,” said Calonge, who is also the chief medical officer for the Colorado Department of Public Health and Environment. Twelve of the task force members were seated during the Bush administration, and the remaining four were chosen before President George W. Bush left office, he said.
Worse, Dr. Rich’s suspicion of evidence- and science-based medicine reminds me, more than anything else, of alternative medicine practitioners. I’ve seen exactly the same sort of rhetoric on various woo-friendly forums. Not company one wants to emulate.
Next, Dr. Rich’s discussion of breast self-exam is, quite frankly, embarrassing. He points out that the populations of the two largest trials that drive the consensus that breast self-examination does not save lives, making speculation after speculation that the results would have been different in the U.S. Here’s the problem: There’s no counterevidence compelling enough to cast sufficient doubt on the results of these studies to reject them out of hand. Because Dr. Rich doesn’t like the results of the trials and (more importantly, I suspect) the body using them to make recommendations, he decides that he’d rather recommend an intervention that has no better evidence in the context he likes to support it. (One wonders if he’d do the same thing about a cardiology intervention, where he understands the issues involved.) Indeed, even advocate groups, such as the Susan J. Komen Foundation, have backed off on recommending routine breast self-exam, except as a tool to become aware of what is and is not normal for the individual woman and admitting that the evidence that it saves lives is lacking. Even the Young Survival Coalition, a patient advocacy group that I much admire dedicated to younger women who have or have had breast cancer, wrote this position statement back in 2002:
Currently, women under 40 have no other existing methodology for detecting breast cancer other than monthly breast self-examination and annual clinical examination. These methods have not been proven to save lives, however a woman should be educated about how to be her own best health advocate and make a very personal choice about whether or not to perform BSE.
In essence, the YSC recommended BSE with caveats and the understanding that it probably doesn’t decrease mortality from breast cancer. Its justification is that for young women there is no other tool, which seems like a fairly reasonable position, based on the lack of evidence and other options. It’s also not that all far out line with what the USPSTF recommended on Monday. And the YSC wrote it seven years ago.
Dr. Rich’s speculation that women in America would get a mammogram if they felt a lump, while seemingly reasonable, neglects that many, if not most, such women ultimately end up with a biopsy unless the mammography and ultrasound show a cyst or is stone cold normal. In the latter case they’d have a high probably of either getting an MRI or having to come back for multiple followup visits and exams. In other words, it’s impossible to tell whether there would be a huge difference in the U.S. A case could equally be made that American women would suffer more harm and more biopsies. No one can tell, and, true to science- and evidence-based medicine we can only use the best evidence available. That evidence does not support the contention that teaching routine monthly breast self-examination saves lives. As I said before, I really, really wish it did, but the evidence just isn’t there to show that it does. Indeed, most breast surgeons, primary care doctors, and oncologists no longer promote BSE routinely, although most do consider it reasonable to teach women to be aware of how their breasts normally look and feel and to bring to a physician’s attention any changes that concern them. We still do that at our clinic. That is not the same thing as teaching BSE.
In any case, Dr. Rich’s claim that the USPSTF was abusing EBM, who’s abusing EBM, the person who takes imperfect data and makes the best recommendation he can with it or the person who simply urges wholesale discounting of existing evidence from randomized trials based on speculative objections without other evidence to suggest that evidence is in error or not applicable, all to promote a political agenda?
Finally, Dr. Rich demonstrates further his ignorance of breast cancer:
The USPTSF, in defending this unusual recommendation, says “the benefits of screening occur only several years after the actual screening test, whereas the percentage of women who survive long enough to benefit decreases with age.” In case that didn’t sink in, they go on to say that, “women of this age are at much greater risk for dying of other conditions that would not be affected by breast cancer screening.”
In other words, it is not particularly valuable to identify early, treatable breast cancer in these old coots, since they are fixing to die anyway. In fact (one can almost hear them say), you’ve had a nice long life already – what the hell do you expect from us?
This is as close as the “soft” death panel gets, within this remarkable set of recommendations, to behaving like the “hard” death panels Sarah Palin and her unsophisticated followers like to complain about.
The ignorance, it burns us, preccciooousss! Dr. Rich, that’s just despicable. Pure nastiness mixed with ignorance. I’m so disappointed.
Once again, Dr. Rich, consider the case of prostate cancer, where 75% of men over 80 have foci of cancer in their prostate glands, yet relatively few of them as a fraction of total men ever exhibit clinical cancer or die from the disease. Most die from something else, and their cancer never bothers them. However, we have in the past probably done harm to a great many men who did not require treatment, through screening too aggressively, detecting a lot of disease that didn’t need treatment, and then removing or radiating a lot of prostates. We’re now starting to recognize that for men with low volume, low Gleason score disease, watchful waiting is very likely a better approach. Under Dr. Rich’s logic, such a decision would be exercising a “death panel.”
We are also increasingly learning that the same biological behavior is true of breast cancer, albeit to a lesser extent. There appear to be a proportion of breast cancers that never advance. There are breast cancers that even regress. There are cancers that grow so slowly that it would take 20 years or more for them to become a problem. But we treat virtually all breast cancers because we can’t identify the ones that are safe to watch; i.e., the ones that will not progress or may even regress over the course of the woman’s remaining lifetime. Moroever, it tends to be older women who have more indolent disease, which is why we’re less likely to recommend chemotherapy for women over a certain age, particularly if they have comorbidities. There are even trials asking if radiation is always necessary for small breast cancers in older women. (OMG! Death panels!) In any case, calculations of remaining life expectancy can’t be separated from calculating the benefits of any intervention, be it screening, radiation, or chemotherapy, because it takes several years for the survival curves to separate. If that separation is not likely to occur until after a reasonable estimation of life expectancy, it just doesn’t make a lot of sense to do it. It’s not a plot; it’s not “death panels”; it’s just a reasonable weighing of the risks and benefits. True, it would have been better if the USPSTF had pointed out that whether screening should continue probably depends upon how much additional life expectancy a woman over 75 has, based on her medical history, but it is true that there really is a paucity of data for women over 75. Could the recommendations be turned into “rationing”? Possibly, but these recommendations, whatever their shortcomings from a scientific standpoint are not it.
For example, Dr. Rich scoffs at “nonmalignant” risks from screening, but such a complaint clearly shows that he has no concept of what overdiagnosis and overtreatment are with respect to cancer. For example, ductal carcinoma in situ (DCIS) is often viewed as a precursor lesion to breast cancer, but we don’t know what percentage of DCIS lesions will advance into breast cancer that will threaten a woman’s life. So we treat them all with surgical excision, be it lumpectomy or mastectomy, with radiation for women who undergo lumpectomy, often all followed by five years of tamoxifen therapy. There are complications from this, and even occasional deaths (for instance, from a pulmonary embolus due to tamoxifen’s tendency to increase blood clotting). And guess what kind of cancer mammography is particularly good at detecting? DCIS. As Dr. H. Gilbert Welch put it:
“This represents a broader understanding that the efforts to detect cancer early can be a two-edged sword,” said Dr. H. Gilbert Welch, a professor of medicine at Dartmouth who is among the pioneers of research into the negative effects of early detection. “Yes, it helps some people, but it harms others.”
Dr. Welch said this week’s recommendations could mark a turning point in public acceptance of that notion. “Now we’re trying to negotiate that balance,” he said. “There’s no right answer, but I can tell you that the right answer is not always to start earlier, look harder and look more frequently.”
Exactly. If you screen more, you will find more disease. But you will also cause some harm in the process and find subclinical disease that may never have required treatment, the treatment of which will not save lives. As I pointed out before, the balancing of these risks and benefits is less a matter of science than a matter of making a value judgment, and different patients and doctors may come down on different sides of the issue. As I said before, I was surprised that these recommendations came out now and just how far they went, but I was not at all surprised that recommendations had been made to scale back screening for breast cancer somewhat. The evidence has been trending that way for quite some time. I do understand, however, why some are so suspicious of these recommendations:
“It’s going to take time, there’s no doubt about it,” said Louise B. Russell, a research professor at the Rutgers University Institute of Health who has studied whether prevention necessarily saves money (and found it does not always do so). “It’s going to take time in part because too many people in this country have had a health insurer say no, and it’s not for a good reason. So they’re not used to having a group come out and say we ought to do less, and it’s because it’s best for you.”
As hard as it is to believe, sometimes less is more. I’m not sure I’m entirely convinced that this is the case for the USPSTF recommendations, but I am sure that they are not an attempt to set up “soft death panels” and deny your grandma life-saving screening for breast cancer. In fact, this debate has been going on for decades, with most evidence leading to recommendations that routine screening of women under 40 with mammography should not be recommended. Here’s just one example in the long-running war:
Seeking to clear up uncertainty about the benefits of breast cancer screening in younger women, NCI held a consensus conference in early 1997. Many of the key players in the controversy from 1969 to the present participated in the conference, either as a panelist or speaker. Presentations and discussions focused only on the 40-to-49 age group.
Initially, the 13-member consensus panel reached a unanimous agreement about the conclusions and wording. After reading the draft consensus statement, two panelists disagreed with the document’s language. When the panel could not reach a unanimous consensus, the final document included majority and minority opinions (NIH Consensus Statement 1997 Jan. 21-23; 15(1): 1-35).
The majority opinion stated that “the data currently available do not warrant a universal recommendation for mammography for all women in their forties. Each woman should decide for herself whether to undergo mammography.”
Then Congress got involved:
For example, when a National Institutes of Health panel declared in 1997 that routine mammograms for women in their 40s may not be worth the risks, the Senate convened hearings and voted 98 to 0 to urge the National Cancer Advisory Board to endorse routine screenings for that age group, a recommendation that was eventually adopted.
Here’s what Dr. Robert Aronowitz, author of Unnatural History: Breast Cancer and American Society, has to say:
Nor is the controversy that has flared since the announcement something new. It’s the same debate that’s gone on in medicine since 1971, when the very first large-scale, randomized trial of screening mammography found that it saved the lives only of women aged 50 or older. Despite the evidence, doctors continued to screen women in their 40s.
Again in 1977, after an official of the National Cancer Institute voiced concern that women in their 40s were getting too much radiation from unnecessary screening, the National Institutes of Health held a consensus conference on mammography, which concluded that most women should wait until they’re 50 to have regular screenings.
I don’t agree with Dr. Aronowitz’s apparent nihilism about therapy for breast cancer that he expresses elsewhere in his article, but I do like how he laid out the decades-long history of this debate. As I said. Dr. Rich should learn a little history, or at least demonstrate that he knows the history. His characterization of the USPSTF and its recommendations as being akin to a “soft death panel” is ignorant and offensive, regardless of whether one agrees with the USPSTF’s recommendations. You may think I was too harsh on Dr. Rich. Maybe I was. On the other hand, hijacking recommendations like this and demonstrating such monumental ignorance of the history of mammographic screening and the science and clinical trials behind it makes me angry. Real angry. Over the last couple of days I’ve become very disappointed at the tenor this debate has taken and in particular disappointed at the level of understanding I’ve seen in fellow physicians and their willingness to engage in cheap rhetorical gambits designed to exaggerate and demonize rather than illuminate. Indeed, sometimes I wonder if the panel released its findings now in order to sabotage the health insurance reform bill now being debated by the Senate. Probably not. The best time to have released these results to accomplish that would probably have been back when Sarah Palin was mindlessly suggesting that end of life counseling recommendations were the equivalent of setting up “death panels.”
There are real issues in these recommendations that need debate and a couple of the recommendations are not as strongly grounded in evidence and science as I would like. I even tend to think that the panel struck too dogmatic a pose when it comes to discouraging BSE. (I would have probably recommended not promoting it but suggesting it as a tool for a woman to know what is and is not normal for her, which is what I do now.) My disagreements aside, the USPSTF recommendations are probably, although not certainly, more strongly grounded in science than earlier recommendations. They are also a first word, not a last word, in deciding how the standard of care will change when it comes to breast cancer screening.
I realize that emotions run high when it comes to breast cancer, particularly among survivors and relatives of survivors. Unfortunately, the “misogyny” gambit, the “Third World” gambit, and the “Obama death panel” gambits do not contribute to this debate or provide an effective refutation of these guidelines. They’re all heat, no light.
ADDENDUM: Here’s a reasonable take on the issue at Our Bodies Our Blog.