Respectful Insolence

“Alternative” cancer tests

The new UPSTF recommended guidelines for screening mammography of healthy women have opened up a can of worms whose consequences have not played out yet, indeed, likely will not play out for a long time. Coming in rapid succession after the announcement of the UPSTF guidelines was a study that suggested that low dose radiation from mammography may put young women with breast cancer-predisposing BRCA mutations at a higher risk for breast cancer. A consequence of the USPSTF recommendations is that politicians have pounced on it as “proof” that President Obama really is preparing death panels for your mother and grandmother.

Like politicians, both well-meaning and unscrupulous, have taken full advantage of any hint of recommendations that we are screening for breast cancer too much to claim that the government is going to take away all screening, quacks and cranks have taken advantage of these developments to promote their agenda and go in the opposite direction. Specifically, quacks and cranks have wasted no time taking advantage of the USPSTF recommendations and the aforementioned study to seize upon them as vindication that “mammography is worthless” and, in a flurry of invocation of the “vindication of all kooks” corollary to the principle of crank magnetism, that all “Western” (a.k.a. science-based) medicine is worthless. Meanwhile, the woo-friendly have similarly pointed to them as yet one more reason why they distrust medicine. One manifestation of this is that I’ve been getting gloating e-mails pointing to the “failure” of mammography and touting “alternative” breast cancer screening methods. One of these, although it doesn’t explicitly mention the latest USPSTF guidelines (apparently the website hasn’t been updated yet), does encapsulate this sort of nonsense; so I thought I’d take a look at it. It’s an article on the International Wellness Directory entitled nofollow">Mammography: Myths and Alternatives, which references an article at the Weston Price Foundation entitled Mammography Madness, which spews out downright dangerous advice along the same lines, although I note with amusement that this latter article actually contradicts the article that references it. Both are typical examples of the “alt-med” take on screening for and treatment of breast cancer, and both contain numerous myths presented as fact, while promoting unvalidated and ineffective breast cancer screening tests and, in the case of the latter article, treatments.

For example, the “mammography myths” article starts out with this:

1. Mammograms Save Lives

Yes, yes, yes. I hear it all the time too: “My mammogram saved my life!” However, statistically, breast cancer mortality is the same for those who have had mammograms as those who have not had them.

No, no, no, no. I hear this claim all the time, and it is not true. In fact, as I pointed out when discussing the new USPSTF guidelines. The question is not whether mammography decreases mortality from breast cancer; it’s by how much and in what age groups. The very reason for the controversy is that the decrease in breast cancer mortality for women under 40 who undergo routine screening is less and the potential for false positives and overtreatment is higher. Even controling for lead time bias and overdiagnosis, there is still a survival benefit from detecting breast cancer by mammogram. Who ever wrote this article is simply ignorant or lying.

2. Mammograms Catch Cancer In It’s Early Stages

They do not, and the number of false positives and false negatives seem to really mess up women’s lives. Mammography can find only advanced tumors.

Wrong again. The very reason that overdiagnosis is a major consideration with mammography is because it does find cancers far earlier than physical examination can. With the increase in mammographic screening, there has been a shift in diagnosis towards less advanced tumors, in particular ductal carcinoma in situ (DCIS), in which there are cancerous cells in the breast ducts that have not broken out into the surrounding tissue. The problem with DCIS is that it’s not clearly known what percentage of DCIS will actually advance into full cancer, but we treat it all because we can’t take the risk. In fact, the problem with mammography is that it can find tumors at such an early stage. As for false positives, well, yes, they are a major concern because they do lead to biopsies and worry, and, yes, false negatives can potentially mess up a women’s life even more by delaying diagnosis and treatment. The problem is that critics like this fail to note that, on balance, overdiagnosis and false positives are more of a problem than false negatives. Either way, it is the balance between these that matters.

3. Mammograms Are Safe

They can cause cancer. They can help existing tumors to spread. William Campbell Douglass, M.D., has said: “I find it maddeningly contradictory that medical students are taught to examine breasts gently to keep any possible cancer from spreading, yet radiologists are allowed to manhandle them for a mammogram.”

The first thing I noted about this claim was that there was not a single reference to any study or peer-reviewed literature to back up this claim. Since there was no literature or evidence presented other than presenting Dr. Campbell as an authority in a classic appeal to authority, I Googled Dr. Douglass and found his website The Douglass Report. Suffice it to say that I sort of doubted the legitimacy of him as a medical authority when I found this gem on his website entitled Are you Smoking Enough to Stay Healthy? In it he claims that tobacco smoke alleviates heart attacks and stroke and that it can prevent cancer, among other things. Somehow, given that, I have a hard time taking him seriously when it comes to mammography. But, hey, he’s a brave maverick doctor; so you should listen to him, right? Wrong.

There’s no evidence that the manipulation due to mammography “spreads” breast cancer. Certainly there’s no such evidence presented on Dr. Campbell’s website, which is a repository of pure woo. For example, in this article, he simply asserts that the “squeeze” due to mammography spreads cancer. The same was true of virtually every article on his site that I could find that even mentioned mammography. Meanwhile, we have plenty of evidence that, for women over 50 at least, mammography does significantly decrease mortality from breast cancer, as I discussed when I wrote about the USPSTF guidelines.

The next claim is this:

4. Mammograms Are the Most Dependable Breast Cancer Screening Method

Far from it. There are safer methods and more dependable methods. The NCI estimates that the risk of a false positive is about 40% which leads to unnecessary biopsies, mastectomies, lumpectomies, and radiation (which can damage your cardiovascular health).

The article continues:

According to Irwin Bross in his book Fifty Years of Folly and Fraud “In The Name of Science,” the one of the biggest myth today is that low level radiation is harmless, adding that myths are invulnerable to truth.

Irwin Bross, while working at the National Cancer Institute as a biostatistician, discovered how radiation shrunk tumors, while allowing the spread of the malignancy. He found that when you attack a cancer with radiation therapy or even a mammogram, statistically, it has a better chance of spreading than if radiation had not been used. He even discovered, through his statistics, that most tumors, even though under a microscope might look malignant, would not become malignant until attacked by radiation or chemotherapy. Bross was one of the first to theorize that one natural path for breast cancers is to spontaneously regress.

Bross’ findings have just been corroborated in a report published in the Journal of the American Medical Association’s Archives of Internal Medicine (Arch Intern Med. 2008;168[21]:2302-2303) after it was discovered that breast cancer rates increased significantly in four Norwegian counties after women began getting mammograms every two years. The study also pointed out that start of screening mammography programs throughout Europe has been associated with increased incidence of breast cancers.

I don’t know what planet Irwin Bross lives on, but medicine hasn’t claimed that low level radiation is “harmless” anytime in my medical career, which, if you count medical school, now spans a quarter of a century. Be that as it may, I had never heard of Irwin D. Bross; so I did a bit of Googling. Truly, Dr. Bross is a favorite among the quack set. The above claim that he said that radiation “spreads” cancer pops up on many, many websites. He also apparently came to the conclusion that animal research in cancer is “worse than useless.” Oddly enough, I found an article by Dr. Bross from 1976 arguing that mammographic screening for breast cancer should start at age 50. Moreover, I couldn’t find a single peer-reviewed paper authored by Dr. Bross that claimed that radiation therapy facilitates the spread of cancer. I did find multiple books by Dr. Bross claiming “crimes of science,” as well as this description of his activities in the late 1980s. The impression I came away with is of a formerly respected scientist who devolved into crankery in his later years, much as Peter Duesberg and Linus Pauling did, particularly his attacks against the NSABP studies that showed the value of adjuvant chemotherapy in breast cancer and the fact that he is prominently mentioned on many animal rights, anti-chemotherapy, and anti-mammography websites.

However difficult it was to figure out anything about Dr. Irwin Bross, I was very happy to see that the anti-mammogram article cited an article I had blogged about. Suffice it to say that it completely misrepresents what the finding of that paper was, and I will refer you to my comprehensive discussion of that study one year ago for why.

So what does this article recommend? First, it recommends breast self-examination (BSE), the very modality that was shown not to decrease breast cancer mortality and is therefore no longer routinely recommended, at least not as the regimented, formalized, monthly examination that had previously been routinely recommended. (Oddly enough, the woo-friendly article recommended by the authors of this article referred to BSE as “worthless.”) Second, it recommends an array of unproven and ineffective “alternative” tests, including thermography, the anti-malignan antibody in serum test, and NMP66. I’ll start with the last first by quoting the article:

It seems that NMPs (Nuclear Matrix Proteins) help form the nuclei (the cell’s control center) of healthy cells. It is theorized that abnormal amounts of NMPs in the blood is a sign that cancer is present in the body. Furthermore, there is a breast-specific NMP called NMP66. The test was simple: 78 women were sent in for testing, all of them had been tested and screened for cancer already. The test found the cancer in all of the ones already diagnosed (except for just one) and found nothing in the cancer free women. Yes, it is a small study, but it is still very promising.

So let’s say this is completely true. Here the author of this article is recommending what is by his very own characterization a potential screening test that has only been subjected to a clinical trial with 78 women. Even if it were so promising, that wouldn’t be nearly enough evidence to recommend it routinely–or even for the FDA to approve it. Moreover, the most recent peer-reviewed articles I could find on ths particular marker date back to 2003, while articles describing Matritech’s attempts to market this particular NMP marker as a diagnostic test for breast cancer petered out, as far as I can tell, nearly four years ago. A fact sheet dated 2005 from the company developing this test states that the NMP66 test is in the “test method optimization” stage of development, while the company’s website itself lists the assay still “developing test methods for NMP66 proteins in a Proprietary Laboratory.”Procedure.”

As far as the anti-malignan antibody, that’s another unvalidated medical test. In fact, I perused PubMed and was able only to find 14 articles about malignan in cancer, and nearly all of them were principally authored by the same two people or have them as co-authors. Samuel Bogoch and Elenore Bogoch, who are apparently a husband-wife team of researchers in Italy. This alone should raise red flags, because validation by other researchers is critical to any new scientific discovery and if malignan truly had as much value as is claimed for it diagnostic test companies would be knocking down the door. An article from 13 years ago touts it as a new antibody test that will do all sorts of wonderful things, while the most recent study I could find was from 2005, which found the test to be insufficiently sensitive to spare patients biopsy and had a false positive rate “far too high for population screening.” Moreover, no one anywhere, as far as I can tell, is recommending this test as anything other than an adjunct to other tests–except quacks, that is. Pathguy has a good rundown on the test; there’s clearly a lot of bad science behind this test, which is very likely why it never went anywhere. In any case, given how much ant-med aficianados rant and rail against mammography for breast cancer and PSA screening for prostate cancer, it never ceases to amaze me how willing they are to leap to unproven “alternatives” that don’t have anywhere near as much evidence behind them and, even more oddly, are marketed by biotech companies–part of the same evil medical-industrial complex that they so hate.

Finally, there’s thermography. This is the granddaddy of breast cancer screening woo. No, the concept of thermography is most definitely not woo, but the claims made for it are. For example, the claim that thermography can detect between 256 and 4,896 cancer cell whereas lesions detectable by mammography generally have at least a billion cells in them is presented with absolutely no evidence to back it up. The overblown claims aside, thermography sounds plausible as a modality, as it relies on the observation that malignant tumors tend to have more bloodflow and more blood vessels than the surrounding tissue, leading it to be warmer. Consequently, it is theoretically feasible to use infrared imaging to detect these tumors, although it’s highly unlikely that it is feasible to use it to detect 256 cancer cells. Even better, breasts could be scanned without breast compression and without ionizing radiation.

There was actually a great deal of enthusiasm for thermography back in the 1970s, but unfortunately when subjected to testing thermography was never able to justify that enthusiasm. It was not able to outperform (or even match) the modalities of mammography and ultrasound when it came to detecting breast cancer accurately. The problem, as you might imagine, is that it’s hard to do thermal imaging sufficiently accurately to be useful. One might have expected that improvements in technology might result in sufficient improvements in image resolution to make breast thermography useful enough to serve either as an adjunct to mammography or even a potential replacement, but it was not to be. Over the last 5-10 years, breast MRI has largely taken the role that thermography could have possibly taken in that MRI is very good at identifying regions of increased bloodflow, exactly the same information that thermography was used to find. In addition, MRI provides detailed 3D anatomic information, to boot!

None of this is to say that thermography might not someday be a useful imaging modality to use as an adjunct to mammography and other breast imaging modalities, but that is not what the cranks claim about it. They tout it as a replacement for, not a complement to, mammography. There is no good evidence to justify such a claim. Indeed, such a claim is irresponsible at best and quackery at worst. Even the largest breast thermography site I know of doesn’t make such claims, although it does tout thermography as being proven to be an effective adjunct to other imaging modaliteis without strong evidence, touting testimonials, endorsements from woo-friendly doctors like Christiane Northrup, and case studies with pretty pictures rather than evidence, dismissing the evidence that failed to find thermography to be useful for breast imaging, and making claims that thermography today is much, much better than it was 30 years ago. This may be true, but that doesn’t mean it has improved to the point where it can replace mammography, as I pointed out before and as the breast thermography site concedes.

Indeed, claims that thermography is “97% accurate” in the detection of breast cancer and that it can detect breast cancer 8-10 years before mammography can are highly overblown at best. Even if these claims weren’t overblown, let’s consider the situation where the claim that thermography can identify breast cancer when it’s at the stage where there are less than 4,000 cells in the primary lesion is really true. In that case, as I’ve discussed before, the problem of overdiagnosis and overtreatment would be vastly exacerbated, not helped. More women would undergo more biopsies and more imaging. Alternatively, as many “alt-med” practitioners “treat” thermography abnormalities with various woo and then declare them to have disappeared.

In the end, though, it never ceases to amaze me how alt-med woo-meisters worship tests for cancer that are in reality based on that evil reductionist science they so detest. Thermography, for example, requires considerable technology to be feasible. The NMP66 test is based on proteonomics. Indeed, the protein itself was originally detected using mass spectrometry, and the assay to detect its RNA and protein requires PCR and immunoassay. More than anything else, the reason why woo-meisters embrace these tests is not so much because they weren’t developed using science-based medicine but because science-based medicine has either as yet failed to show them to be useful or has found them to be worthless. To them, that’s all that matters. If science-based medicine has rejected it or failed to embrace it, it must be good.

Comments

  1. #1 Marilyn Mann
    December 7, 2009

    Interesting, thanks.

  2. #2 lurker
    December 7, 2009

    Did you mean to write something extra on the end of the second last paragraph?

  3. #3 James Sweet
    December 7, 2009

    The “Don’t Squeeze It!” theory of cancer prevention? Nice.

  4. #4 T. Bruce McNeely
    December 7, 2009

    Well, how many times have you seen a malignant tumor in a roll of Charmin?

  5. #5 Scott
    December 7, 2009

    If squeezing breasts were a cause of cancer, somehow I doubt that mammograms would be the major thing to worry about…

  6. #6 David D.G.
    December 7, 2009

    Excellent as always, Orac! These articles you bring up are exactly the sort of things that need to be exposed as publicly as possible, because they can masquerade convincingly (to most laypeople) as being supported by sound science, while in fact being very much the reverse. Keep up the good work!

    ~David D.G.

  7. #7 jake
    December 8, 2009

    Thanks Orac. My mother’s breast cancer has come back, and she’s the type that doesn’t trust this administration (vast understatement). So your recent posts on these issues have been particularly interesting and useful to me.

  8. #8 kittykitty7555
    December 8, 2009

    Orac, you’re a smart guy, but in my opinion, you are an apologist for a medical procedure that has produced bona fide harm and scant benefit.

    A number of knowledgeable individuals (not crazies or quacks) believe that biopsies and surgery on breast tumors can spread cancer. Please see:

    http://www.theijs.com/article/article_full.php?aid=165

    There’s only an abstract of the research, but below is a Wall St. Journal article that provides info that non-medical professionals can understand. If you google Judah Folkman you can find out more about the stimulation of angiogenesis – ensuring that tumors have enough blood supply to grow – due to ill-advised medical procedures.

    I think the point is that screening mammo leads too many women into procedures that produce net harm. And it’s not all idiots and cranks that believe this.

    Also, the proper metric for whether any screening procedure is worthwhile is all-cause mortality, not just whether the person dies of his or her cancer. Why? Because the unnecessary cancer treatment that is an inevitable side effect of cancer screening of healthy people shortens life. Please see:

    http://www.bmj.com/cgi/eletters/339/jul09_1/b2587

    Read the response that begins, “Breast Cancer Overdiagnosis May Increase All-Cause Mortality”, a posting by scientists from the National Cancer Institute – these people are NOT cranks.

    Giving your readers the impression that only crazies and cranks believe that screening mammography of healthy women is a terrible idea is doing them a disservice. The harms are clear as day, and the “benefits” are sketchy – and the evidence for this has been around for years. It’s time to stop all the lies. It’s not the cranks that are hurting us, it’s the radiologists, GPs that bully women into doing something that produces a net harm (because they are judged by how many women they get to agree to yearly irradiation of their brests), “Women’s Health Advocates” like the ACS, mammography techs,…and on…and on…and on..what a wonderous propaganda machine is at work here!

  9. #9 Orac
    December 8, 2009

    Don’t lecture me about Judah Folkman. He is one of my scientific heroes and one of the reasons I went into the area of research that I did. I met Judah Folkman on three occasions when he was alive, one time in a lab meeting for our lab when I was still at the University of Chicago. He actually liked my research and cited one of my papers in a talk–one of my proudest moments. Most of my peer-reviewed papers have been about angiogenesis. Suffice it to say, I’m aware of the evidence, and in humans it’s weak at best that removing the primary tumor can rsult in the blossoming of metastases. In fact, I can tell you that Judah Folkman himself said as much in talks that I saw him give about angiostatin and the mouse model that he used to study it.

    As for the BMJ article you cite, I blogged about it:

    http://scienceblogs.com/insolence/2009/07/overdiagnosis_of_breast_cancer_due_to_ma.php

    I’ve also blogged a lot about overdiagnosis and the problems with mammography. Use the search box up above if you don’t believe me; I don’t feel like spoonfeeding you what I’ve written before. However, even though it’s not a perfect test, the scientific consensus is that mammography does indeed save lives, for sure for women between 50-70 and to a lesser extent between the ages of 40 and 50. Read and learn.

    But let’s for the sake of argument say that mammography is as bad as you say. None of that would validate thermography or any of the other “alternative” tests for breast cancer or other cancers. Note that those tests don’t have any evidence to show that their use prolongs life, and many of them don’t have enough evidence to show that they are even all that promising.

    In other words, your argument is a massive straw man based on ignorance of some very recent stuff that I’ve written.

  10. #10 kittykitty7555
    December 9, 2009

    Orac, I realize that you know more than I do about this. I’m not a medical professional. However, I believe that American women have been ill-served by the cancer industry as regards screening healthy women via mammography. We literally never hear about the possibility of harms. And breast cancer diagnosis soared after the introduction of screening mammo – something like 40%. What on earth could cause a 40% increase in breast cancer? It was literally (in a functional sense) like these unsuspecting women were subject to some new environmental factor that caused incidence to skyrocket. What was that factor? Screening mammography.

    How Ironic!

    Personal experience is irrelevant in public health policy, But I can’t resist – visiting with my 75 year old mom over the weekend, we discussed screening mammo (she is a faithful screener) – I found myself thinking thank God my Mom was not one of those overtreated. She is rather frail in any case, and I know that it would have been the end. Chemo was the end of my 80 year old Dad.

    Where does the hold that the medical-industrial complex have on our lives end? My guess is when you are bled white. Sorry this sounds bitter and personal, but Orac, you lack perspective as well. Screening mammo has never been proven to save lives. Look at all-cause mortality. Can you say women who are screened live longer? I already know the answer.

  11. #11 Poogles
    December 9, 2009

    “And breast cancer diagnosis soared after the introduction of screening mammo – something like 40%. What on earth could cause a 40% increase in breast cancer? It was literally (in a functional sense) like these unsuspecting women were subject to some new environmental factor that caused incidence to skyrocket. What was that factor? Screening mammography.”

    Wouldn’t the most likely explanation be that more cancers were being DIAGNOSED, not that the actual incidence rose? I mean, it’s only logical that if screening is increased that more cancer will be found that wouldn’t have been found before. In fact, I think that exact point has been made a couple of times in the recent posts Orac has written on these new guidelines…

  12. #12 Orac
    December 9, 2009

    Actually, it’s true of any screening test. Indeed, increased intensive screening for autism since the mid-1990s is one reason why autism diagnoses have appeared to skyrocket. Any time you screen for something, you will find more of it, and incidence will appear to increase.

  13. #13 Ryan Crafts
    April 8, 2010

    If screening mammography were a newly developed pill that you took once a year to prevent dying of breast cancer, you would need 2000 women age 40-49 to participate for 10 years to save one life. Of those remaining 1999 women 10 would be given a completely 100% curable form of breast cancer they would never have had without taking the pill over those same 10 years. We would reject that pill(I hope). Proper informed consent requires women age 40-49 understand the magnitude of the small benefit and small risk. For 30 years we have never bothered to tease out the magnitude of the benefits and the magnitude of the risks. Instead we used catch phrases like “early detection” and “screening saves lives”.

    First do no harm is a good catch phrase also. It is unethical to release an unproven screening test on the healthy population without knowing the benefits and risks? It is unethical to subject healthy human subjects to what amounts to an experiment without informing them of the best guess risks and benefits? Overdiagnosis and unnecessary diagnosis and pseudodisease are not terms used when counseling women on screening mammography. And now as the evidence becomes overwhelming, we say well it’s not a perfect test.
    http://www2.cochrane.org/reviews/en/ab001877.html
    “This means that for every 2000 women invited for screening throughout 10 years, one will have her life prolonged and 10 healthy women, who would not have been diagnosed if there had not been screening, will be treated unnecessarily”

    But the stats can be argued back and forth for another 30 years and we’ll have replaced or supplemented screening mammography with something to predict which tumors are aggressive and which ones are not. Then women will just have to live with the knowledge that they have a “benign” cancer. Sort of like what we do with elevated PSA tests and a low gleason score on prostate biopsy, so called watchful waiting.

    At some point we have to accept that a majority of the women we’ve come to refer to as survivors because of early detection are in fact women who were harmed by unnecessary diagnosis and unnecessary treatment. We’ll have to change our mental tally of wins and losses all at once. We’ll have to accept that legions of surgeons, oncologists and radiologists hired to deal with the sequela of this experiment were unnecessary and on average harmful.

    It’s going to suck.

    The visceral response that some of you feel right now is unavoidable; our emotions and pieces of our identity are tied up in the institutions we have been indoctrinated into.

    But it doesn’t really matter what you feel deep down in your gut about whether those women with early breast cancer were harmed or saved by our interventions, your opinion and experience don’t matter. What matters is whether these individuals consenting to be tested are given the opportunity to explore what we currently understand about the risks and benefits of these tests.

    I can’t think of a more intelligent more motivated demographic for shared decision making.

    40 yo women…….

    Let’s hope they’re not terribly vindictive.

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