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It’s All in Your Head

Posted on November 8, 2009 by Danzig

I have never used those words to a patient or about a patient. I have also never heard a colleague use any similar term to a patient. And yet on many occasions I have had patients ask me, “So you’re telling me it’s all in my head?”

The concept of what are now called psychogenic symptoms is a tricky one for various reasons. There is an unfortunate stigma attached to the notion that our brains can cause physical symptoms. Making the diagnosis is complex. Outcomes are variable and are hampered by the difficulty in communicating the diagnosis to patients. Psychogenic symptoms often mask underlying physiological disease. And the risks of both false positives and false negatives are high.

This complexity leads some to argue, in essence, that psychogenic symptoms do not exist at all – that the diagnosis is a cop out, a way to blame the patient for the failings of the physician. But this approach, ironically, is a cop out, because it seeks to white wash what is a real and complex disorder with an overly simplistic and moralistic approach.

What are psychogenic symptoms?

Various terms have been used over the years to refer to symptoms that are generated by psychological stress or other factors. Hysteria is an unfortunate term which was invented to refer to the uterus, as if such symptom were uniquely female. For obvious reasons the term “hysteria” is no longer used. Psychosomatic is still a proper term, meaning physical symptoms with a mental cause, but the term does have a bit of a stigma attached. The term psychogenic is most widely used today, simply meaning having a mental cause.

A related concept is embellishment or psychogenic overlay. In these cases there is an underlying physiological disease or disorder which then results in stress and anxiety which further generates psychogenic symptoms on top of the physiological symptoms. What this means is that the presence of even demonstrably psychogenic symptoms does not necessarily mean that there is no underlying disease, and a thorough workup is still indicated.

Psychogenic signs and symptoms are real – the patient really experiences them, and often they lack insight into the origin of their symptoms. Psychogenic is not a synonym for fake, they are usually not voluntary, and patients cannot just stop their symptoms. A psychogenic disorder is a real disorder – it is just that the problem is with the brain’s software, not hardware (if you will excuse the geek metaphor).

Sometimes people have a depressive or anxiety disorder, which may be reactive or may be primary and due to a biochemical disorder in the brain. Anxiety puts a lot of stress on the body and can absolutely manifest with physical, and sometimes very dramatic, symptoms. Stress itself can also manifest with physical symptoms.

This should be no surprise to anyone familiar with neurobiology. The brain is an organ, just like any other organ in the body. It is made of tissue, and it is connected to the rest of the body through the nerves as well as the neuroendocrine system. Thoughts alone can speed up your heart by releasing adrenaline, they can cause butterflies in your stomach or nausea through increased vagal activity, or can flood penile tissue with blood causing erection. A fright can cause your blood pressure to drop resulting in fainting. Stress can chronically increase blood pressure.

So we all have psychogenic symptoms at some point in our lives, and we take them for granted. The fact that more dramatic symptoms can also result from purely psychogenic causes should not be that surprising.

How do we known when symptoms are psychogenic?

Often knee-jerk critics of the psychogenic diagnosis claim that it is purely a diagnosis of exclusion – an expression only of lack of knowledge on the part of the diagnostician. Excluding underlying physiological causes is an important part of the diagnosis – but not the only part.

In neurology (my specialty) for example, there are many situations in which positive evidence can be brought to bear to demonstrate that a patient’s symptoms cannot be neurological. There is a well-described entity known as pseudoseizures or non-epileptic seizures in which patients have involuntary seizure-like episodes. A seizure is an abnormal electrical discharge in the brain, firing neurons in unison and causing symptoms based on where in the brain the neurons are firing. There is a limited number of patterns that seizures can have, because they are “sloppy” and just spread directly to neighboring neurons (not following complex networks of neurons). There are some patterns of convulsive movement, for example, that are simply impossible – they cannot be due to motor seizures.

Also, at times patients will have psychogenic weakness, either partial or complete paralysis of a limb. True neurological weakness has certain features which cannot be simulated (voluntarily or involuntarily) and there are techniques we use in the neurological exam to look for these features. Likewise there are features that are very suggestive of what we call effort-dependent weakness (which does not imply insight or deliberateness). Essentially, different causes of weakness have different features on neurological exam that we can distinguish, often quite easily.

Further still, without a detailed knowledge of neuroanatomy, patients with psychogenic symptoms will tend to display distributions of symptoms that do not follow anatomical pathways. Or they will display patterns of movements that do not correspond to any part of the motor system.

Another feature that is suggestive (but not proof) of a psychogenic disorder is that the hard or objective findings that normally accompany a neurological deficit are absent. These include reflexes that do not require any cooperation, voluntary effort, or subjective feedback from the patient – they come pretty close to a direct examination of a circuit in the nervous system.

To summarize, there are cases in which patients exhibit neurological symptoms which seem to defy neuroanatomy, reveal features of effort, do not correspond to known systems in the nervous system, and lack any hard or objective finding that should be present. Even in these cases, we are likely to do a full workup looking for an underlying problem (as stated above, psychogenic symptoms may simply be overlaying a physiological lesion or disease). In psychogenic cases thorough neuroanatomical scans are normal, as are physiological tests for nervous system function.

In cases where there are positive features of a psychogenic disorder, and a thorough absence of other demonstrable causes, the diagnosis of a psychogenic disorder is perfectly reasonable. It is not a negative judgment about the patient, it is simply an attempt to make an accurate diagnosis.

False positives and false negatives

Nothing in medicine is 100%, and all diagnoses have false positives and false negatives. Physicians learn to deal practically with this uncertainty. For example, even though we may have made a confident diagnosis, we will still rule out alternatives we cannot afford to miss. The diagnosis of a psychogenic disorder is no different.

The public tends to focus on the risks of the false positive – diagnosing a symptom as psychogenic when there was a missed underlying physiological disorder. While this happens, it is again no different than any form of misdiagnosis. This is, admittedly, the worst-case-scenario. But to put it in perspective, this often occurs after a thorough workup that has failed to reveal the diagnosis. So the failure to make the underlying diagnosis occurs whether or not the alternate diagnosis of psychogenic is entertained.

Putting the notion of a psychogenic cause aside, physicians often face the situation in which patients have symptoms that cannot be diagnosed. The body is complex, and we cannot always explain every symptom. Workups are designed, in fact, to look for entities which can be treated, not necessarily to explain symptoms at all costs. So when we say we don’t know what is causing a symptom what we really mean is that we have ruled out anything that we could treat. What we are left with are all the subtle biochemical or physiological causes that we either cannot rule out, or are simply not worth investigating because they will not change management.

Sometimes patients are simply uncomfortable with this situation (perhaps because it was not communicated to them well). They may seek a diagnosis until they find someone willing to make one, and then they will blame their previous doctors for “missing” the real diagnosis. Sometimes the actual diagnosis is missed, and patients were right to seek other opinions. But at other times the new diagnosis is the fake, but it is more acceptable to the patient than the stigma of stress or anxiety induced symptoms.

It should also be pointed out that sometimes there is an underlying disorder causing psychogenic symptoms – serious anxiety or depression. These are just as much “real” disorders as anything else.

In short, we see every permutation of diagnostic misadventure because the human body is complex, our knowledge and technology are limited, and the doctor-patient relationship is increasingly complex.

There are also risks to the false negative, however – missing a psychogenic disorder when that is the proper diagnosis. Patients who have disturbing symptoms due to psychological stress or anxiety will often seek multiple opinions. They will get what we call “the million dollar workup” – sometimes over and over again. There are real risks associated with so many tests. Sometimes the tests themselves are invasive and contain risks. But even safe tests, if you get enough of them, are bound to result in false positives, which could lead to a misdiagnosis, further invasive testing, and improper treatment with risks and side effects.

I have seen this scenario play out as well. I have had a few patients who, in my opinion, had entirely psychogenic symptoms, but through their tireless seeking of medical attention ended up being on numerous medications they did not need, and being subjected to many invasive procedures which then led to complications. In the end the patients had physiological and anatomical disorders and symptoms, but all ultimately resulting from the failure to properly diagnose their original symptoms as psychogenic. They would have been much better served if they were aggressively reassured that they did not have the diseases they feared, and if they were directed toward gentle quality of life interventions, as well as psychological attention for their underlying disorder. In one case the patient had what can only be called mental illness, and needed to be aggressively redirected toward psychiatric treatment.

The point is – there are risks both ways (like in all of medicine). There are risks to prematurely making the diagnosis of a psychogenic disorder or missing an additional underlying trigger, and there are risks to missing the diagnosis of a psychogenic disorder.

Conclusion

In a perfect world the unfortunate stigma attached to the psychogenic diagnosis would disappear. It is very counterproductive. We need broader understanding that the brain is also an organ and can manifest symptoms in a variety of ways. Psychogenic causes are just another item on the differential diagnosis.

Physicians, for their part, should likewise remove any stigma attached to patients with psychogenic symptoms and need to approach the diagnosis as if it were any other – with positive and negative signs, and risks to false positives and false negatives.

When Loud Wins: Will Your Tax Dollars Pay For Prayer?

Posted on November 8, 2009 by Danzig

Today the LA Times described a bizarre and troublesome healthcare reform bill provision that would require Medicare to pay for Christian Science Prayer as a medical treatment:

…a little-noticed provision in the healthcare overhaul bill would require insurers to consider covering Christian Science prayer treatments as medical expenses.

The provision was inserted by Sen. Orrin G. Hatch (R-Utah) with the support of Democratic Sens. John F. Kerry and the late Edward M. Kennedy, both of Massachusetts, home to the headquarters of the Church of Christ, Scientist.

The measure would put Christian Science prayer treatments — which substitute for or supplement medical treatments — on the same footing as clinical medicine. While not mentioning the church by name, it would prohibit discrimination against “religious and spiritual healthcare.”

Of course, I had warned about this very thing over a year ago on KevinMD’s blog – something I wish the LA Times had picked up on then.

On September 5, 2008 the ring leaders of this provision met at the National Press Club to promote their medical philosophy. I was so stunned by the sheer quackery of it all – miracle cure stories and false medical diagnoses – that I wrote a “reader take” blog post warning the medical community about the speakers. But perhaps I was warning the wrong people… or perhaps the right people don’t read medical blogs?

At the Press Club, Phil Davis (also quoted in the LA Times article) told a story about a man who sustained major multiple trauma after being in a car accident, only to be miraculously healed 2 weeks later through Christian Science prayer. Another woman, Melinna Giannini, Founder & CEO, ABC Coding Solutions, relayed a story in which she had a “mysterious” condition (in the face of a long battery of normal test results) – and found the “true diagnosis” only after seeing an alternative healthcare practitioner who looked at her tongue and prescribed treatment for “total body candidiasis.”

At the time I remember wondering how these people managed to get a hearing at the National Press Club – and was struck by their sheer determination to lobby for their misguided beliefs. Now, one year later I’m dumbfounded by their success at having a Senator (Orrin Hatch) actually add a provision to a healthcare reform bill. This tells me that determination trumps both common sense and science in the political arena. What a sad state of affairs.

If, as President Obama promised in his inaugural address, science is to be restored to its rightful place – then the first place to start is with keeping quackery out of the healthcare reform bills. It’s astonishing that this even needs to be discussed. Perhaps this is yet another wake up call regarding the war on science being waged (as recently noted by Wired Magazine and Newsweek) by a hyper-organized band of snake oil salesmen and their ill-informed Hollywood devotees? In this new Internet era – loud wins. I implore mainstream media to use their influence to make truth loud… partner with your trusted blogger sources, like the Science-Based Medicine team. We can help!

All Medicines Are Poison!

Posted on November 8, 2009 by Danzig

That’s the title of a new book by Melvin H. Kirschner, M.D. When I first saw the title, I expected a polemic against conventional medicine. The first line of the Preface reassured me: “Everything we do has a risk-benefit ratio.” Dr. Kirschner took the title from his first pharmacology lecture in medical school. The professor said “I am here to teach you how to poison people.” After a pause, he added, “without killing them, of course.”

He meant that any medicine that has effects has side effects, that the poison is in the dose, and that we must weigh the benefits of any treatment against the risks. Dr. Kirschner has no beef with scientific medicine. He does have a lot of other beefs, mainly with the health insurance industry, the pharmaceutical industry, and alternative medicine.

He explains the FDA, the standard drug approval process (phase I through III studies), fast-tracking, classification of drugs (Schedule I through V), black box warnings, drug recalls, off-label prescribing, the scientific method, package inserts, expiration dates, drug interactions, side effects, the role of sanitation in disease prevention, informed consent, developing resistance to antibiotics, placebos, immunizations, ethical issues, conflicts of interest, drug advertising, copycat drugs, why drugs cost so much, why “natural” doesn’t mean “harmless,” how dietary supplements can kill, how alternative medicine is not based on scientific evidence, chelation, DSHEA, NCCAM, the infiltration of CAM into medical schools and why we need a new Flexner report, what’s wrong with the American medical system (“What’s broken is the coverage system, not the care delivery system.”), and why “poison, cut and burn” is sometimes the only rational option. He does not like insurance companies, and he explains why. He ends by saying Lincoln’s characterization of our government as “Of the people, by the people, for the people” is now better described as

Of the people, Buy the lawmakers, For the corporations.

I liked his comments on the natural herb that has caused more human grief than any other in history: tobacco. I liked his assertion that it would be redundant to label family practitioners as “holistic.” I didn’t like his discussion of automated lab tests because he missed the opportunity to explain how ordering panels of tests to screen patients can do more harm than good by finding false positives.

I particularly liked his essay on “Doing Nothing.” Treatment is not always necessary and sometimes the decision to do nothing is actually doing something. It ties in with what I wrote about “Not Treating – A Neglected Option.”

He says,

In my opinion, CAM is often neither complementary, alternative, nor medicine.

But his criticism of alternative medicine is weak. He falsely conflates chiropractic with massage. Instead of excoriating the idiocy of therapeutic touch he merely calls it a “treatment that sometime works but is actually doing nothing.” In criticizing CAM his approach is more like that of Caspar Milquetoast than like the respectfully insolent snarkiness of our esteemed colleague Orac.

The book is derived from his previous writings over the last 60 years, everything from lectures to letters to the editor. It shows. It is fragmented, with short chapters on a variety of unconnected subjects. He has a lot of solid information and clinical wisdom to share, but his material is not well organized and suffers from an awkward, stilted style of writing. Some of the examples he uses are ill-chosen.

That said, the book might appeal to laymen and it might serve to get some very important points across to the public. The catchy title might persuade people to read it who would not otherwise be exposed to these ideas.

The cancer screening kerfuffle erupts again: “Rethinking” screening for breast and prostate cancer

Posted on November 8, 2009 by Danzig

I see that the kerfuffle over screening for cancer has erupted again to the point where it’s found its way out of the rarified air of specialty journals to general medical journals and hence into the mainstream press.

Over the last couple of weeks, articles have appeared in newspapers such as the New York Times and Chicago Tribune, radio networks like NPR, and magazines such as TIME Magazine pointing out that a “rethinking” of routine screening for breast and prostate cancer is under way. The articles bear titles such as A Rethink On Prostate and Breast Cancer Screening, Cancer Society, in Shift, Has Concerns on Screenings, Cancers Can Vanish Without Treatment, but How?, Seniors face conflicting advice on cancer tests: Benefit-risk questions lead some to call for age cutoffs, and Rethinking the benefits of breast and prostate cancer screening. These articles were inspired by an editorial published in JAMA last month by Laura Esserman, Yiwey Shieh, and Ian Thompson entitled, appropriately enough, Rethinking Screening for Breast Cancer and Prostate Cancer. The article was a review and analysis of recent studies about the benefits of screening for breast and prostate cancer in asymptomatic populations and concluded that the benefits of large scale screening programs for breast cancer and prostate cancer tend to be oversold and that they come at a higher price than is usually acknowledged.

For regular readers of SBM, none of this should come as a major surprise, as I have been writing about just such issues for quite some time. Indeed, nearly a year and a half ago, I first wrote The early detection of cancer and improved survival: More complicated than most people think. and then followed it up with Early detection of cancer, part 2: Breast cancer and MRI. In these posts, I pointed out concepts such as lead time bias, length bias, and stage migration (a.k.a. the Will Rogers effect) that confound estimates of benefit due to screening. (Indeed, before you continue reading, I strongly suggest that you go back and read at least the first of the aforementioned two posts to review the concepts of lead time bias and length bias.) Several months later, I wrote an analysis of a fascinating study, entitling my post Do over one in five breast cancers detected by mammography alone really spontaneously regress? At the time, I was somewhat skeptical that the number of breast cancers detected by mammography that spontaneously regress was as high as 20%, but of late I’m becoming less skeptical that the number may be somewhere in that range. Even so, at the time I did not doubt that there likely is a proportion of breast cancers that do spontaneously regress and that that number is likely larger than I would have guessed before the study. Of course, the problem is that we do not currently have any way of figuring out which tumors detected by mammography will fall into the minority that do ultimately regress; so we are morally obligated to treat them all. My most recent foray into this topic was in July, when I analyzed another study that concluded that one in three breast cancers detected by screening are overdiagnosed and overtreated. That last post caused me the most angst, because women commented and wrote me asking me what to do, and I had to answer what I always answer: Follow the standard of care, which is yearly mammography over age 40. This data and these concerns have not yet altered that standard of care, and I am not going to change my practice or my general recommendations to women until a new consensus develops.

Before I discuss the JAMA analysis, let me just sample a bit of how this issue is being portrayed in the popular press:

This week the conversation garnered national attention when physicians at the University of California, San Francisco, and University of Texas, San Antonio, published an analysis in the Journal of the American Medical Association expounding on their concerns about the ongoing harm inflicted on patients who undergo prostate and breast cancer screening. One problem is that screening often picks up harmless or non-life-threatening tumors that could have gone unnoticed for a lifetime, leading to unnecessary and aggressive treatment for patients. In the days before widespread mammography, for instance, physicians rarely encountered ductal carcinoma in situ (or DCIS), a type of low- to intermediate-grade breast cancer that grows slowly and may even regress, meaning that the body may rid itself of the tumor. But today DCIS accounts for nearly 30 % of all breast cancer diagnoses (more than 60,000 cases a year), leading to an untold amount of treatment and patient distress. (TIME Magazine)
The purpose of screenings is to detect cancer early, when treatments are most likely to be effective, and to save lives. That the tests do so for colon, breast and cervical cancer has been well-established for middle-age adults but is not indisputable for those who are older, as most studies have been done in people younger than 65. Research on routine PSA screening has yet to prove a definitive benefit at any age. On the other side are the potential costs, which can include unnecessary treatments for cancers that never would have become life-threatening, the anxiety and distress associated with cancer diagnosis, the complications associated with screening procedures or therapies, and medical expenses. (Chicago Tribune)
Call it the arrow of cancer. Like the arrow of time, it was supposed to point in one direction. Cancers grew and worsened. But as a paper in The Journal of the American Medical Association noted last week, data from more than two decades of screening for breast and prostate cancer call that view into question. Besides finding tumors that would be lethal if left untreated, screening appears to be finding many small tumors that would not be a problem if they were left alone, undiscovered by screening. They were destined to stop growing on their own or shrink, or even, at least in the case of some breast cancers, disappear. (New York Times)
The American Cancer Society, which has long been a staunch defender of most cancer screening, is now saying that the benefits of detecting many cancers, especially breast and prostate, have been overstated. It is quietly working on a message, to put on its Web site early next year, to emphasize that screening for breast and prostate cancer and certain other cancers can come with a real risk of overtreating many small cancers while missing cancers that are deadly. (New York Times)

The latest kerfuffle is simply the latest bubbling up of a controversy that has been going on for years. It’s also a classic example of the difficulty of applying messy science to public health issues. Science is messy, but public health initiatives, to be successful, arguably need a simple message that resonates with the public, a message like

Screening for cancer catches cancers at an earlier stage when they are more easily treated.
Screening for cancer saves lives.
You should get screened if you’re older than N years old.

Thus, when evidence that calls into question any of these messages appears, it causes consternation among the lay public. Worse, cranks leap to take advantage of such controversies and make claims, such as “mammography is useless” and publish cartoons like this. Even people who should know better say similar things. As I’ve said before, science-based medicine is hard and not always clear-cut. Moreover, I would argue that debates such as this demonstrate that the claims of cranks that physicians all march in lockstep or that there is a “conspiracy” to keep shortcomings of SBM from patients are nothing but the rankest nonsense. Finally, cranks often conflate, either through ignorance, willful ignorance, or often outright hostility to “Western medicine,” screening mammography with diagnostic mammography. Screening mammography is designed to detect disease in asymptomatic women. If a woman feels a suspicious lump, nothing–I repeat, nothing–in any of this data says that she should not have a physical exam and appropriate imaging, including mammography and ultrasound at the minimum, posthaste. That’s diagnostic mammography, and that is not what this kerfuffle is over. Suspicious lumps, especially in women over 40, need to be worked up, period. I can’t emphasize that strongly enough.

So what did Esserman et al say? They lay out the problem thusly:

A large fraction of the US population participates in screening for prostate cancer and for breast cancer. About 50% of at-risk men have a routine prostatespecific antigen (PSA) test and 75% have previously had a PSA test.^3,4 About 70% of women older than 40 years reported having a recent mammogram.⁵ Two decades of screening have resulted in a significant increase in detection of early cancers. Prostate-specific antigen testing has nearly doubled the chance that amanwill be diagnosed with prostate cancer in his lifetime: In 1980, a white man’s lifetime risk of prostate cancer was 1 in 116; today it is 1 in 6.1 A woman’s lifetime risk of breast cancer was 1 in 12 in 1980; today it is 1 in 8.1 If ductal carcinoma in situ (DCIS) is included, the risk of being diagnosed with breast cancer, like prostate cancer, has almost doubled as well.
The increase in early cancers as a fraction of total cancers detected is not necessarily beneficial. The introduction of an optimal screening test should be followed by an increase in the rate of early disease followed by a decrease in regional disease while the overall detection rate remains constant.⁷ FIGURE 1 illustrates hypothetical optimal, worst case, and intermediate-case scenarios, using 1980 breast cancer incidence rates as a starting point. In the worst case, screening leads to an increase in local disease detection without a corresponding decrease in regional disease, thereby increasing costs and morbidity due to overdetection and overtreatment of non–life-threatening cancers.

They conclude that current screening protocols for breast and prostate cancer result in a case that is intermediate between the worst case and optimal case scenarios. Because their graph illustrates this problem better than words can, I present it here:

(Click for larger image.)

Esserman et al then point out that the incidence of early stage breast and prostate cancers has increased dramatically as a fraction of total cancers detected, while regional and metastatic cancers have decreased dramatically as a fraction of those cancers detected. One example is the form of breast cancer known as ductal carcinoma in situ, abbreviated DCIS. DCIS is considered to be breast cancer, but “pre-invasive” cancer, given that the sine qua non for its diagnosis is seeing cancerous-appearing breast epithelial cells confined within the ducts with no evidence of their having invaded through the basement membrane that separates the ducts from the surrounding tissue. Thus, DCIS has been labeled “stage zero” cancer, and its 5 year survival is close to 100%, although a small proportion of patients does recur and ultimately die of breast cancer. There is even a debate over whether DCIS truly represents a precursor to cancer, as it is unclear what percentage of DCIS lesions progress to frank cancer, making the treatment of DCIS very confusing to patients. Before the mammographic screening era, which began in earnest after 1980, diagnoses of DCIS were uncommon. Now DCIS makes up nearly a third of new breast cancer diagnoses. Again, because we don’t know which of these lesions will progress and which won’t (or even which ones might regress), we treat them all, and this treatment involves nearly all the treatments used for breast cancer, with the only treatment not used on DCIS being chemotherapy.

As for more advanced regional tumors (tumors with lymph node metastases or involvement of local structures) and metastatic tumors, the absolute numbers have also decreased, but not very much. If screening were having a huge effect on breast cancer, the expectation would be that removing tumors at a smaller stage would, nearly three decades later, ultimately result in fewer advanced cancers being detected, their having been preempted by screening and appropriate treatment by surgical excision and adjuvant therapy. (This is one reason why screening for colorectal cancer has been more effective; removal of polyps is effective at preventing the subsequent development of colorectal cancer.) The conclusion, which again should be nothing surprising for anyone who saw my post from last year, is that screening by nature preferentially detects slower growing, more indolent cancers, which by their very nature tend to be less lethal and some of which may not even ever progress enough to endanger the life of the patient. The fastest-growing, most lethal cancers grow so fast that they seem to “pop up” between screenings. As a breast cancer surgeon, I see such tumors occasionally. A woman will come in with a palpable mass and an very ugly mammogram after having had a mammogram less than a year before that shows no trace of abnormality or, sometimes, an abnormality that is only appreciated in retrospect because it was so subtle. Naturally, such women are distraught because they have “done everything right” and obtained their yearly mammography just as their primary care doctors told them too. However, no practical screening program could catch tumors such as these because it would require too frequent screenings, which would also, unfortunately, increase the chances of finding abnormalities that lead to overdiagnosis. The dilemma, again, was discussed in my post, and, indeed, Figure 3 in the JAMA article is in essence the same figure that I reproduced to help me discuss length bias, only with much better design sensibilities and a dash of color:

The most distressing conclusion of Esserman’s analysis is just how many patients need to be screened to save one life. It is well-accepted that screening women over age 50 for breast cancer does decrease mortality due to breast cancer by approximately 30%, but what does this reduction really mean? This:

Essentially, mammography reduces the odds of a 60-year-old woman dying of breast cancer in the next decade by 30%. Sounds impressive, until you look at her absolute risk: by getting her annual mammogram, her chances of dying from breast cancer are whittled from 0.9% to 0.6%. Overall, for every 1,000 women in their 60s screened for breast cancer in the next 10 years, mammograms will save the lives of 3 people but 6 others will still die. (The numbers edge up or down in lockstep with a woman’s age.)

Esserman et al conclude that, to avert one death from breast cancer with mammographic screening for women between the ages of 50-70, an age range intentionally chosen because it is the age range for which mammographic screening is the least controversial, 838 women need to be screened over 6 years for a total of 5,866 screening visits, to detect 18 invasive cancers and 6 instances of DCIS. The additional price of this was estimated to be 90 biopsies and 535 recalls for additional imaging, as well as “many cancers treated as if they were life threatening when they are not.” For prostate, to prevent one death from cancer, 1,410 men need to be screened over 9 years, for a total of 2,397 screening visits and 48 cancers detected. In other words, screening takes a lot of effort for, on an absolute basis, not as many lives saved as we had hoped. The authors also point out that technology exacerbates this problem. We push for ever greater sensitivity at the cost of lower specificity, which means that we detect more and more lesions that turn out not to be cancer or to be indolent, non-lifethreatening cancer. Yet all of these cancers end up being treated the same, again because we cannot distinguish between them. The addition of hypersensitive modalities such as MRI only exacerbate this problem even further. As Esserman et al state:

After 2-1/2 decades of screening for breast and prostate cancer,conclusions are troubling: Overall cancer rates are higher, many more patients are being treated, and the absolute incidence of aggressive or later-stage disease has not been significantly decreased. Screening has had some effect, but it comes at significant cost, including overdiagnosis, overtreatment, and complications of therapy, problems likely to be exacerbated as the US population ages. Additional gains are unlikely with the current approach and may inadvertently add to the burden of treatment and diagnosis for relatively indolent disease.

So what’s the solution? Should we give up on screening?

I’ll answer the second question with an emphatic absolutely not. There is no doubt that screening can save lives; the problem is that we’re doing it “bigger” not and not necessarily better or smarter, using more or less a one-size-fits-all approach when a more tailored approach is necessary. In essence, we’re using 20th century technology, when 21st century technology can find a way out of these conundrums. Here’s where I (mostly) agree with Esserman et al. We need to change how we screen for common cancers using the latest advances in biochemistry, molecular biology, and technology to differentiate which lesions are most likely to be cancer and which are not, which cancers are likely to progress to the point of threatening a patient’s life in their remaining lifespan and which ones are not. To this end we need the following tools:

Develop biological and genetic markers of risk for various cancers. It’s long been known that screening is more effective in populations where a disease is common. The more common the disease (to a point) the more likely screening is to save lives. Thus, if we could develop better tools to identify women most at risk for breast cancer, for example, we could start screening such women at a younger age and perhaps screen them more frequently. We already do this to some extent, but our current tools (family history to identify higher risk populations, a handful of genetic markers, and ethnicity) are crude measures at best. Equally important would be to find similar markers to identify women at lower risk, who might start screening at an older age and undergo screening less frequently. Most important of all, identifying high risk patients more effectively would open up the possibility of prevention to a far greater extent than is possible now.
Identify biological markers to differentiate minimal risk cancers from cancers with significant risk. Again, we have begun to do this to some extent. For example, tests such as the Oncotype DX multigene test are now clinically used to determine which women with early stage, estrogen receptor-positive breast cancers would and would not benefit from chemotherapy. It’s relatively crude as a tool goes, but we will do better. Indeed, we are beginning to develop the tools that would allow us to go much further. It would not surprise me if, in a decade or so, we routinely do a battery of such tests on newly diagnosed tumors and then use the results to decide which ones can undergo “watchful waiting,” which ones need aggressive therapy, and which ones can undergo less aggressive therapy. Eventually, we will be using therapy targeted to the individual genetic alterations in an individuals tumor. Yes, I know I’ve expressed skepticism over such “targeted” therapy before, but that’s not because I don’t believe the concept will work; it’s because the boosters of targeted therapy often seem not to realize just how difficult and complex it is and will be to identify targets and how hard it will be to turn the targeting of proteins and genetic alterations into therapies that result in decreased mortality from cancer. In other words, I believe that genetic and biomarker analysis will ultimately allow us to tailor therapy to an individual’s tumor; I just think that getting there will take a lot longer and be a lot messier than the current generation of biotech cheerleaders either understand or will let themselves admit.
Develop better markers of response to therapy. Right now our primary assessment of whether a therapy is working or not boils down to one of two things: survival rates (the ultimate endpoint) or whether a tumor shrinks or not in response to therapy. Both are very crude. The former is the ultimate measure, but it is not helpful in the case of an individual patient, who wants to know if her treatment worked or not before she dies. The latter is notoriously inaccurate, with tumor shrinkage only showing a weak correlation to overall survival. This is one area where tests similar to the ones being developed to determine the aggressiveness of a tumor could potentially help.
Develop better imaging tools to assess risk. This is the one area that Esserman et al neglected almost completely in their review. This is an area that I have only recently become very interested in for our research program. Technology is progressing to the point where it soon may well be possible to identify a lesion as cancerous or not with greater than 90% using a “virtual biopsy” and then further to determine its risk of causing the death of the patient, when combined with biochemical and genetic analyses. Such tools would allow us to choose patients who might be appropriate for “watchful waiting” with far less anxiety over whether we’re doing the right thing than there is now and, even better, potentially to identify tumors that are likely to regress spontaneously.

None of this will be easy, and the process of getting from where we are now to this futuristic vision will be be full of fits and starts. At times it will be controversial. Advances in science-based medicine always are. Moreover, there will be significant barriers to its implementation, not the least of which is the relatively simplistic thinking that has come to predominate how we view cancer screening, not in the rarified air of the research institutions that actually study the pros and cons of screening, but “in the field” at the level of individual practitioners trying to put these screening recommendations into practice. It is not the fault of these practitioners that these fine points are not more widely known. Rather, the reason derives from the conflict between the need for simple messages to tell patients and the difficulty of applying epidemiological science to individual patients.

So what do we do in the meantime? One thing I am not going to say is to stop undergoing screening. Women should continue to undergo mammographic screening as recommended according to the standard of care, and men should continue to undergo routine prostate screening as recommended. Until a consensus develops for changing the current regimen, it is the best we have, and, for all its shortcomings, mammography remains the best and most cost-effective tool we have to detect cancer. (The case for routine mass PSA screening, in contrast, now strikes me as considerably weaker.) Even in the worst case scenario that breast cancer screening results in the appearance of a benefit all due to lead time bias (which it isn’t; I present this as a worst case scenario), treatment of cancers caught at an earlier stage is still less invasive and less morbid. True, this has to be weighed against overtreatment of lesions that would never progress, but even so the benefit of using less invasive therapy is one that is routinely discounted by the new generation of what I am sometimes tempted to call “screening nihilists,” a group that seems to think that nearly all screening is worthless.

The problem is not that screening is worthless. For example, even mammography under the most pessimistic estimates routinely touted as evidence that it’s pointless to screen clearly does save lives. A relative reduction in risk is not meaningless or of insignificant worth, either, as some nihilists will suggest. Also, don’t forget that even small absolute percentages when applied to millions upon millions of people, can result in large numbers of lives saved. That being said, I also think that these recent trials suggest that we are not doing an adequate job of informing patients of the down side of screening, such as excessive biopsies, a down side many might well be willing to accept if they were informed of it and understood it. After all, as I’ve mentioned before with regards to breast cancer, I’ve seen polls where most women say they would agree to undergo cytotoxic chemotherapy to improve their odds of surviving breast cancer by 1%. To save more lives relative to the number of women overtreated and overdiagnosed, we need to learn how to screen smarter. Our current screening regimens are not good enough. Improving them will require science-based medicine, and, unfortunately, will be controversial. Watching the jolting, jarring journey to a new scientific consensus about something as important as screening for breast and prostate cancer is much watching the proverbial sausage being made. I also can’t help but point out the contrast to “alternative” medicine, which rarely questions and almost never changes practice in the face of new data. It may well be that our hopes for screening for breast cancer and prostate cancer were too high, but in science-based medicine evidence eventually wins out. Screening practices will likely change in the face of new evidence, and that is a good thing. Certainly it’s better than the alternative, namely not changing and not improving.

When homeopaths attack medicine and physics

Posted on November 8, 2009 by Danzig

I must admit, it is possible that our fearless leader Steve has a more robust constitution than I do. I say this because he actually managed to sit through an entire video full of the most bizarre pseudoscience and mangling of physics and medicine that I’ve seen in quite some time.

And that’s saying a lot.

So, behold, Dr. Charlene Werner, an optometrist (apparently) and a homeopath. I warn you, however. If you have any understanding of physics or chemistry whatsoever or if you’ve ever read (and liked) Stephen Hawking’s book A Brief History of Time (or anything else he’s ever written), sit down now. Take a deep breath. Heck, crack open a bottle of wine and down at least half of it before you watch this video. I’m serious. You’ll need it. You might need to lie down, too. In fact, you might need to lie down with a cool washcloth across your eyes.

Don’t say I didn’t warn you:

Truly, the woo doth flow. Like a river. Like the energy from a supernova. From Bozeman, Montana, where, apparently they don’t have enough woo and have to import it from Texas. I haven’t seen such a massive pseudoscientific abuse of physics and chemistry in quite a long time.

I really like how Werner starts out by asking the audience if they’ve all had chemistry or physics classes. Truly, if anyone there said yes and didn’t immediately see her talk for the hilariously rank pseudoscience that it is, he should demand his money back from whatever school or schools he attended. Either that, or he should go back for remedial physics classes; obviously whatever he or shelearned didn’t stick.

Be that as it may, Werner then asks everyone if they know what H₂O is and who Einstein is. Now, I know why a homeopath would mention water. After all, homeopathic remedies are nothing but water. But what did poor Albert Einstein do to deserve this posthumous desecration of his monumental contribution to physics? (I know, I know, what did any physicist do to deserve such abuse of science and his good name by homeopaths?) Get a load of this:

You know that when light is energy, right? OK. And he [Einstein] gave us the theory that energy equals mass times the speed of light. E=mc². OK. If we take that formula, and we think that there’s a lot of mass, right? OK. If you collapse all the mass down into the universe, so that there is no space between the mass, do you know how much mass there is in the entire universe? You think you’re a lot of mass, right?… Well, the whole universal mass can be consolidated down into the size of a bowling ball. That’s all there is in the whole universe. So, how much mass are you? That’s right, an infinitessimal amount.

I bet you’re wondering where Werner is going with this. So was I. But I was afraid. Very afraid. Yes, I wasn’t sure whether she was right about being able to collapse the entire mass of the universe into the size of a bowling ball. My memory of my physics doesn’t tell me if it’s a bowling ball, a softball, or something the size of a house. I get the point. The vast majority of matter is the empty space between atoms and between electrons and nuclei. For purposes of this discussion it doesn’t really matter, anyway. What matters is the mind-numbing ignorance of what Werner says next:

So if you take that formula, E=mc², you can almost cross out mass. So the formula ends up being “energy = the speeed of light.”

Arrrrghhhh! Help, help, I’m being made more scientifically stupid just by looking at this video! Talk about a math FAIL. First off, if you remove the mass term, what are you left with? Zero! No mass, no energy! Even if you could legitimately just drop the mass term as an approximation, you wouldn’t be left with “energy = the speed of light.” What happened to the squared term? Moreover, Werner completely misunderstands the nature of the equation. c² is the proportionality constant for how much energy is present within a given mass. It’s a huge number, meaning that a small amount of mass contains a lot of energy, if that mass can be completely converted to energy. The point of the equation is not that mass is unimportant, rather that mass is very important indeed! That’s why I have a new equation:

I = m_air² * c⁴

where I = ignorance; m_air = the mass of the air necessary to speak a Werner sentence about science; and c = the speed of light.

That’s right. Werner’s ignorance could power the universe. (Yes, I know that the units don’t quite work out. Either that, or the units of ignorance are in fact energy squared. Just go with me on this.)

But it gets better. Look at what Werner says next:

That’s why the visual system is so important, because we have lots of photorecptors that receive light. But when Hahnemann died, the scientists didn’t fall in his camp. OK. And, um, the pieces of the puzzle didn’t fit well together.

Actually, the pieces of homeopathy never fit together when Samuel Hahnemann was alive. It was woo then, it’s woo now. The only difference is the science-y gloss that its practitioners try to put on it with quantum mechanics and mangling of physics and chemistry. But wait, there’s more:

So God in his infinite wisdom sent us another Einstein called Stephen Hawkings. Stephen Hawkings gave us the string theory. And what he discovered is that there are other “energetic particles” in the universe, and they’re shaped like little U-eys, and what they do is they work by vibration. So our body is so wonderfully designed. We have light receivers, and we have ears. Vibratory–they pick up vibration. So if we added to that theory–Einstein’s theory of relativity, E=mc², but mass is crossed out–and strings, vibration. But that still doesn’t tell us the whole picture, because what is a cell, right.

Alright, now stop right there. How much technobabble can one woman fit into a single talk? How much mangling of physics can one woman accomplish? Truly, I fear to know the answer. It was at this point that I started to wonder whether I should back out now. Just say no. Stop watching. the mind-destroying horror was too great. I could feel my neurons crying out in pain. But, no. The things I do for SBM! So I looked at what Werner said next:

The cell has a cell wall, a cell membrane, cytoplasm. Is that mass? Not very much, really. So what are they? You can break down the cells into tiny pieces of energy called electrons, protons, neutrons, right? So the whole body has an infinitessimal amount of mass, but what is the remainder? Energy. So, I am energy; you are energy.

You’ll have to excuse me if I can’t follow that logic. Maybe it’s because I understand biology and a bit of physics! Come on! She completely misunderstands Einstein’s equations. The concept that the body is a small amount of mass does not mean that it’s all energy. True, there’s a whole lot of energy in the body’s mass, but, unfortunatey, to turn that mass into all the energy described by Einstein’s classic equation would not be pleasant for the person whose energy was being–shall we say?–released. That doesn’t stop Werner’s monumental misunderstanding of physics from leading her to try to use this line of “reasoning” to argue that homeopathy is real and scientifically supported:

Now if you go to study physics, we do not know how to create energy. But we don’t know how to destroy it, either. That is not humanly possible. So what we do is we take energy and we transform it from one state to another. That’s all we do. So if that’s all we do guess what the definition of disease is. It’s not mass. We have transformed our energy state into something different. That’s what the definition of disease is.

As a physician, I can most definitely say that Werner’s definition of “disease” is related to the real definition of disease only by her own delusions. Actually, it’s not related to the real definition of disease at all. What we’re really seeing is a form of primitive vitalism, where there is some sort of “life energy” that, when its flows are disordered, blocked, or otherwise messed with magically, then you have disease, all gussied up with science-y sounding mish-mash of physics-y sounding psuedoscience. Let’s put it this way. Werner keeps using that word (energy). I do not think it means what she thinks it means. In any case, never mind those nasty microbes. After all, they’re just “mass,” and they’re far less mass than a human body or even a single mammalian cell. It’s the same with those proteins whose function becomes disordered; that DNA that has abnormalities; or those cellular functions that go awry. All mass. So, by Werner’s logic, they must not be able to cause disease, or so it would seem. Instead, she thinks she can use light, sound, and homeopathy to fix these energy “imbalances.” But what is homeopathy?

Alas, Werner is too happy to tell us:

OK, so what is homeopathy? If nothing is really mass or an infinitessimal amount of it, and everything is energy, that means everything has a vibration to it. So what if I could encase some sort of energy for later use? So if I wanted to make a bomb and I took all these chemicals and I encased it in a bomb, and tonight my neighber let his dog poop in my yard literally, and I’m mad at that dog and my neighbor. I’m going to take this bomb and I’m going to get back at him. And I threw that bomb at his house, would he be happy about it? Because what happens now when that energy is released? It destroys something. It changes it…It changes its energetic state. Well, that’s what we can do with homeopathy. We take substances. And we put ‘em in solution and we succuss it just like a bomb, we threw the bomb, to release its energy into this liquid. And then we take these little white pellets. We sprinkle them with that solution, and guess what we have just made? An energetic substance to be used when we choose to use it. So, how homeopathy works is, whatever your disease process is, it’s an energetic change. And if I can find the remedy that matches your state and give it to you when we so choose, what can we do with your energy system? Transform it to a previous better state. That’s how it works.

How simple.

Actually, Werner is right about one thing. Homeopathy is kind of like a response to a dog pooping on your lawn. Not only is it a major stinker, but one could use homeopathy to clean off the residue of dog crap from the lawn, if you use enough of it. It is, after all, water. In case anyone doesn’t know what succussion is, too, it’s what homeopaths do with their remedies between each step on the way of diluting them into nonexistence. Basically, it’s vigorous shaking. Hahnemann used to do it by smacking the vial containing his concoction against a Bible; modern day homeopaths have machines that do it. Whatever method they use, though, since Hahnemann’s time, the way homepaths prepare their remedies is that they dilute them 1:100, succuss them, dilute them 1:100 again, and so on and so forth for however many “C” the remedy is ultimately to be. If the remedy is a typical 30C remedy, that’s 30 dilutions of 1:100, or a total dilution of 10^-60, or roughly 36 to 37 orders of magnitude greater than Avagadro’s number, which guarantees that there almost certainly isn’t a single molecule left of the substance used for the homeopathy remedy. Of course, in general, it’s not a good idea to succuss bomb components. Bombmakers who do that tend to lose body parts or the physical integrity of their entire body. Now, there’s some vibration!

After I had picked up my brain off the floor, its having oozed out of my ears as I watched this, and forced it back into my skull, I wondered just who Charlene Werner is. Apparently, in addition to homeopathy, she is a practitioner of a therapy that I’ve never heard of, namely behavioral or developmental optometry. If you wnat a flavor of what developmental optometry is, I’ll refer you to Dr. Werner’s own website:

We are a holistic based optometric practice dedicated to the highest quliaty vision care for your entire family. We believe that 70% of how you physically function is through the vision system. Therefore, when the vision system is improved or enhanced it also increases overall physical wellness and performance. Don’t take our word for it … ask our patients.

70% of how we physically function is due to our vision? Where did that number come from? Why not 100%? I do understand one thing that puzzled me before. Remember how at the very beginning she mentioned how our eyes can see light and vibration? Obviously, she was combining the woo that is homeopathy with her other favored treatment modalities, which–surprise, surprise–do not appear to be evidence-based, as Steve pointed out.

In any case Werner’s website emphasizes testimonials over science and is full of claims that “behavioral optometry” can treat ADHD, dyslexia, and a wide variety of other conditions. Indeed, it can even treat problems associated with autism! Now, I know that it could be very difficult to do a vision evaluation in an autistic child and that correcting poor vision is a good thing in any child, but the results reported on Dr. Werner’s website seem rather more glowing than seems plausible. Be that as it may, why not treat autism with “visual therapy”? Dubious practitioners of all stripes have tried everything else. No doubt Werner combines homeopathy with visual therapy to produce a one-two punch of woo. All she needs is chelation therapy to complete the triad. In any case, if vision is 70% of our “physical functioning,” then what can’t it help? Of course, I do notice a disconnect between Werner’s claims that we are “all energy” and “infinitesimal mass,” then why does she even care about the physical functioning of everything in our bodies? Just make one of those homeopathic energy bombs and fix whatever’s ailing the patient! We’re all energy, anyway, and disease is energy. Isn’t that what Werner just told us?

The really sad thing about the video above is that it’s not the worst of arguments that homeopaths make. (For that, you need Dana Ullman.) Rather, Werner’s arguments for homeopathy are pretty much standard fare, although they are not nearly as entertaining as those of, say, Lionel Milgrom. What they do show is a perfect case of crank magnetism.

Just don’t let your dog poop on Werner’s lawn. You might find yourself at the receiving end of a homeopathic energetic bomb, and you know that the more she dilutes it the stronger it gets.

J.B. Handley of the anti-vaccine group Generation Rescue: Misogynistic attacks on journalists who champion science

Posted on November 8, 2009 by Danzig

There’s been something I’ve been meaning to write about all week, but only just got around to it. There were lots of other things going on at my other online locale, and this topic is such old hat for so many that I really wasn’t sure if it was worth bothering with. My reluctance may also be, sadly, because I’ve become a bit jaded at the nastiness that anti-vaccine groups such as Generation Rescue (i.e., “Jenny McCarthy and Jim Carrey’s Autism Organization”–at least these days) and its erstwile founder J.B. Handley routinely lay down when someone points out that the emperor has no clothes, that vaccines do not cause autism. I’m referring, of course, to Amy Wallace, who wrote what is the best example of an article in the mainstream media about the anti-vaccine movement that “gets it.” The article was called An Epidemic of Fear: How Panicked Parents Skipping Shots Endangers Us All and appeared in WIRED Magazine.

It was a thing of beauty. There was no false “balance” that puts cranks pushing dangerous pseudoscience on the same plane as real scientists like Paul Offit. There was even a section calling out purveyors of vaccine misinformation. Several luminaries of the the anti-vaccine movement were there, including ones discussed frequently on this blog, like Jenny McCarthy and Jim Carrey, and Robert F. Kennedy, Jr. But that wasn’t all! There was even a section on how to debunk anti-vaccine canards. What more could an advocate of science-based medicine ask for?

When I first read Wallace’s article, I knew she was going to be in for a rough time. The anti-vaccine movement doesn’t take kindly to criticism. Indeed, I even warned the publicist who had e-mailed a bunch of bloggers, including me, about the article that I hoped she was ready for a “shitstorm” (the exact word I used). After all, I’ve been the target of J.B. Handley’s wrath on more than one occasion. He’s particularly fond of trying to poison my Google reputation when I annoy him sufficiently, and one time either he or someone inspired by one of his attacks on me actually e-mailed my cancer center director a link to his screed. In fact, it wouldn’t surprise me if J.B. posts another similar smear after this post.

In any case, the publicist said she and Wallace were ready. Well, as an interview on NPR with Wallace has shown, the “shitstorm” has arrived, and it is just as disgusting and vile as the term implies, complete with misogyny and sexism. Fellow SBM blogger David Kroll pointed out how effective Wallace’s article was, and now a list of attacks on Wallace has been compiled from Wallace’s Twitter feed:

I’ve been called stupid, greedy, a whore, a prostitute, and a “fking lib.” I’ve been called the author of “heinous tripe.”
J.B. Handley, the founder of Generation Rescue, the anti-vaccine group that actress Jenny McCarthy helps promote, sent an essay title” “Paul Offit Rapes (intellectually) Amy Wallace and Wired Magazine.” In it, he implied that Offit had slipped me a date rape drug. “The roofie cocktails at Paul Offit’s house must be damn good,” he wrote. Later, he sent a revised version that omitted rape and replaced it with the image of me drinking Offit’s Kool-aid. That one was later posted at the anti-vaccine blog Age of Autism. You can read that blog here

Stay classy, J.B. Stay classy.

That’s exactly the behavior from Mr. Handley that we’ve come to know and despise. Indeed, J.B. recently smeared our very own Steve Novella. This is the sort of behavior that we expect from the anti-vaccine movement:

I’ve been told I’ll think differently “if you live to grow up.” I’ve been warned that “this article will haunt you for a long time.” Just now, I got an email so sexually explicit that I can’t paraphrase it here. Except to say it contained the c-word and a reference to dead fish.

I’ve already discussed how Paul Offit has suffered from attempted intimidation and death threats from the anti-vaccine movement. In this, the anti-vaccine is very much like the Animal Liberation Front or other animal rights groups, wielding intimidation to keep scientists from speaking out. Their level of understanding science is about at the same level, as well. But it’s not just Paul Offit. I’m currently reading Michael Specter’s new book Denialism: How Irrational Thinking Hinders Scientific Progress, Harms the Planet, and Threatens Our Lives. (Why is it that books like this always require such a long and unwieldy subtitle? Heck, even Suzanne Somers’ book is called Knockout: Interviews with Doctors Who Are Curing Cancer–And How to Prevent Getting It in the First Place. Word to publishers: Stop it! But I digress.) In Denialism, Specter includes a solid chapter about the anti-vaccine movement, Vaccines and the Great Denial, and in that chapter he describes how Marie McCormick, who led the Institute of Medicine panel that produced a seminal report in 2004 scientifically exonerating vaccines as a cause of autism suffered from similar harassment. She now has a guard posted near her office.

It’s the M.O. of the anti-vaccine movement. Unable to win on science, they try to win through intimidation and smears. As a result, scientists are reluctant to go into autism research, because they quite understandably don’t want the hassle of dealing with the attacks. Ditto vaccine science. After all, all one has to do is to look at the examples of Paul Offit and Marie McCormick to understand why public health officials shy away from getting involved and especially from speaking out in defense of science and against fear mongering. The same is also true of journalists. Indeed, the reaction of the anti-vaccine movement to Wallace’s piece makes me wonder if part of the reason for so much of the false balance and the apparent reluctance of journalists to call out Jenny McCarthy and put her on the spot in an interview has anything to do with the fear. It’s a possibility.

I do have to admit that I was quite amused by J.B.’s attack on Wallace in the anti-vaccine crank blog Age of Autism, though. It was full of whining and bits that show such a complete lack of self-awareness on J.B.’s part that it was truly hilarious to behold. Here is a sampling:

“Ms. Wallace appears to have gone exclusively to Google University to research her feeble attempt at describing a very complex topic.” I just about spit out my coffee all over my lovely MacBook Pro when I read this. Given that the “spokesperson” for Generation Rescue, Jenny McCarthy, is perhaps the best known user and abuser of the University of Google, a use and abuse that have led her to make gut-bustingly funny manglings of science like this, J.B.’s statement took my irony meter and fried that sucker into a puddle of molten metal and rubber, and even that was quivering in fear of another assault.
“I grow so weary of pointing out the same logical fallacies, misstatements, and outright factual errors that many journalists make when covering this debate, it’s going to be a struggle for my stamina to analyze her tripe in detail.” This is one of the rare areas where I’m in agreement with J.B., just not in the way he thinks. In fact, I think I’ve used that very sentence, or a variation thereof, when beginning more than one post about some nonsense published on J.B.’s anti-vaccine blog Age of Autism, because I do get tired of pointing out the same logical fallacies, misstatements, and outright factual errors that each and every blogger at AoA–nay, every anti-vaccine zealot I’ve ever encountered!–routinely parrots. J.B. is no exception; in fact, he spews more than usual, for instance his monumentally not-even-wrong project “Fourteen Studies.” But I keep doing it, because, well, it’s become my duty. In fact, I’m going to have to exercise some of that patience and stamina right here because J.B once again serves up a huge heapin’ helpin’ of logical fallacies, misstatements, and outright factual errors. As usual.
“The main targets of our movement are the CDC, AAP, and vaccine makers. Offit is an annoying sideshow, nothing more. He’s annoying because of articles like yours. He didn’t cause my son’s autism, and he has nothing to do with my son’s recovery.” For Dr. Offit’s supposedly being someone that J.B. doesn’t consider very important, who is an “annoying sideshow,” J.B.’s blog and organization sure do expend a lot of verbiage attacking him. In fact, a quick Google search for “Paul Offit” in the domain ageofautism.com pulled up over 1,000 hits. Just this week, J.B. launched a hilariously off-base attack entitled Dr. Paul Offit, The Autism Expert. Doesn’t See Patients with Autism? So hilariously self-unaware was J.B. in that post that earlier this week I seriously thought of doing a parody of it substituting Andrew Wakefield for Paul Offit. After all, Wakefield doesn’t see children with autism either. He’s been a “researcher” (and a truly incompetent, compromised, and likely fraudulent one at that) ever since he finished his training. These days, Wakefield lends his anti-vaccine cred to Thoughtful House, where he can’t see patients because of that pesky problem of having decided to flee the consequences of his large part in the promotion of the myth that the MMR vaccine causes autism, resulting in a plunge in vaccination rates and the resurgence of measles in the U.K. over the last decade, and not having a medical license. Sadly, other things got in my way. Or maybe not so sadly. I’m better at humor and sarcasm than parody.
“Offit actually has proven to be quite helpful – he’s the poster boy for the other side, which means his faults become the other side’s faults.” Project much, J.B.? Actually, it’s J.B. and his ilk who try to make Offit the poster boy for all the imagined and exaggerated faults fo the “other side.” Besides, every conspiracy movement needs a villain. For 9/11 Truther’s it’s the U.S. government (and sometimes the Mossad). For creationists, it’s Richard Dawkins. For the anti-vaccine movement, it’s Paul Offit, for much the same reason that Richard Dawkins is made into the villain by creationists and fundamentalists. They both dare to speak out against popular pseudoscience and don’t back down.

In his post, it’s also hard not to point out that J.B. does inadvertently demonstrate why any reasonable person should consider him anti-vaccine:

Why are you boring readers with misguided psychobabble? You could have used this time to read some of the science on our side of the fence which is also peer-reviewed! Clean water, toilets, and refrigerators eradicated disease, or at least 98% of it, I’ll give vaccines credit for the final 2% — and a whole lotta’ autism, allergies, and other demylenating illnesses.

Wow. Just wow. I’d really like to see what “peer-reviewed” evidence from “his side” that J.B. has that shows that it was not vaccines but rather clean water, toilets, and refrigerators that eradicated “98%” of infectious disease or that vaccines cause a “whole lotta autism allergies, and other demyelinating diseases.” Here’s hint one for J.B.: Peer-reviewed doesn’t mean it’s necessarily good research. It’s a minimum standard, and the “research” that J.B. cites has, without an exception that I’ve ever seen, been uniformly awful. (Monkey business, anyone?) As I pointed out with the most recent assault on science by the anti-vaccine movement, namely the execrable monkey study being touted as evidence that thimerosal in the hepatitis B vaccine causes “neurological damage” (an anti-vaccine code word in its “research” for “autism”), peer reviewers are routinely mislead by various studies by anti-vaccine cranks because they don’t know the subtext for these studies.

Here’s another thing that J.B.’s comment makes me wonder about. He gets very indignant when he is called anti-vaccine. He inevitably whines that he is not “anti-vaccine” but “pro-safe vaccine” or some variant thereof. I have to wonder, though. If J.B. really thinks that vaccines are only responsible for a mere 2% of the elimination of infectious disease–I mean, really, really believes it right down to the depths of his soul–why doesn’t he just come right out and admit that he’s anti-vaccine? After all, if he believes that vaccines cause an “epidemic” of autism, demyelinating diseases, and allergies, all for the benefit of a mere 2% when it comes to infectious diseases, then why not just say he is against vaccines because they don’t do any good and do a lot of harm? That’s what he just said, and I have no reason to believe he’s lying. Let’s put it this way. If I believed as J.B. apparently does, if I believed that vaccines were responsible for at most 2% of the elimination of infectious diseases and at the same time caused an “epidemic” of autism, demyelinating diseases, and other severe consequences, you can bet that I’d come out and say I was against vaccination. It would be a reasonable stance based on unreasonable beliefs about the dangers of vaccines. But I don’t believe anything of the sort. The scientific evidence simply doesn’t support J.B.’s assertions. I also suspect that, deep down J.B. doesn’t entirely believe these things either. If he truly does believe that vaccines do so little good and cause so much harm, his self-delusion would have to exceed even his obnoxiousness. Maybe it does.

After all, the evidence that vaccines played a major role in the elimination of diseases is incontrovertible. Smallpox was not eliminated by better sanitation and refrigeration. It was eliminated by a vaccine. The incidence of measles didn’t plunge dramatically primarily because of better sanitation or refrigeration; it plunged because of the introduction of an effective vaccine. (Unfortunately, this progress is being endangered by the misinformation being spread by the likes of J.B. Handley and the pseudoscience of quacks like Andrew Wakefield.) The incidence of invasive Haemophilus influenzae type B (Hib) disease didn’t plunge in the early 1990s because of better sanitation or refrigeration. Sanitation and refrigeration were just fine in the late 1980s. The incidence of severe Hib plunged because of a vaccine–indeed, to the point where younger pediatricians have never even seen a case of HiB. This is a good thing, although I’m not so sure J.B. would agree. Either that, or he’d try to claim that it wasn’t the vaccine, which is nonsense.

J.B. also can’t stand strong, principled disagreement with him. Like all people, he doesn’t like to be told he is wrong. The difference is that he reacts to criticism by attacking the person doing the criticism, not by refuting him with evidence. That’s because he can’t use evidence; his position is unsupportable by science. J.B. also has a huge amount of what appears to me to be a mixture of envy and contempt for the scientists who tell him he doesn’t know what he’s talking about. Indeed, this is what he’s written:

I’m not intellectually intimidated by any of these jokers. Their degrees mean zippo to me, because I knew plenty of knuckleheads in college who went on to be doctors, and they’re still knuckleheads (I also knew plenty of great, smart guys who went on to be doctors and they’re still great, smart guys).
I chose a different path and went into the business world. In the business world, having a degree from a great college or business school gets you your first job, and not much else. There are plenty of Harvard Business School grads who have bankrupted companies and gone to jail, and plenty of high school drop-outs who are multi-millionaires. Brains and street-smarts win, not degrees, arrogance, or entitlement.

In other words, as I said before, to J.B., it’s all about “elitism.” He honestly seems to believe that the reason the scientific community doesn’t accept his wild beliefs that vaccines cause autism is because of elitism and groupthink, not because the scientific evidence doesn’t support that belief. Unlike the case for scientists, it never occurs to him that maybe–just maybe–he might be wrong. It never occurs to him that the reason he is viewed with such disdain among scientists is because, well, he is wrong. But not just wrong, spectacularly, dangerously, and arrogantly wrong about the science. Truly, he is full of the arrogance of ignorance, and thinks that his success in the business world (or, as he puts it, his “brains and street smarts”) means that he can figure vaccines out. He can’t. Brains and street smarts count for little in science without a background understanding of science and acceptance of the scientific method, neither of which J.B. has.

One thing Amy Wallace gets completely right is described in her interview with NPR :

Wallace calls part of the discourse that has followed her article “a bullying tactic.” She points to JB Handley, founder of Generation Rescue — which contends that too many vaccines are given too soon and blames autism on vaccines — for many attacks against her in the blogosphere. She says such tactics dissuade many scientists from taking a stand in the debate. It is important to speak out against those tactics, she says, adding that she has been commenting regularly about the issue on Twitter.

Indeed it is important to stand up to bullies, and Wallace has done just that.

At this stage, I have to wonder if the anti-vaccine movement is becoming its own worst enemy. As the science keeps marching in that shows no connection between vaccines and autism and lends no support to the concept that vaccines are ineffective and dangerous promoted by the anti-vaccine movement, groups like Generation Rescue are becoming more shrill and even more quacktastic than ever. In doing so, they further marginalize themselves. Quite correctly, their behavior leads reasonable and scientific people to dismiss them more and more. Unfortunately, when that happens, all that leaves is abuse and bullying as tactics to intimidate those who speak out against them.

Those who live in glass houses…

Posted on November 8, 2009 by Danzig

The last two weeks have brought good news to those who seek to hold chiropractic to the standard of evidence and science-based medicine.

In the first bit of good news, on October 14^th Simon Singh was granted permission to appeal the High Court ruling on meaning of the term “bogus” within his original article. I’m sure most readers of this blog are familiar with Simon Singh’s legal battle with the British Chiropractic Association (BCA) regarding an article in The Guardian entitled “Beware the Spinal Trap.” We’ve covered it several times over the last year and will continue to do so as the case progresses. The nuances of the British legal system (or any legal system for that matter) are beyond my ken, and are far better explained by Jack of Kent here. The take-home point is that gaining permission to appeal the ruling on meaning was virtually essential if Simon were to have any real chance of winning this lawsuit.

Even if the BCA should win its lawsuit for libel against Singh, it seems likely to be something of a pyrrhic victory. After all, in the year since this story began, we’ve been belatedly provided with the BCA’s best evidence in support of chiropractic’s efficacy, and promptly treated to its subsequent evisceration.

We’ve also been given insight into the standards held and practices recommended by the McTimoney Chiropractic Association (MCA), which by its own reckoning is the second largest chiropractic association in Europe. In an apparent response to the attention brought by the BCA’s lawsuit, the MCA advised its members to take down their websites and remove all reference to treatment of “whiplash, colic, or other childhood problems” from their places of business to avoid a “witch hunt” targeting “any claims for treatment that cannot be substantiated with chiropractic research.” If only the Malleus Maleficarum had been written with such high standards of evidence!

In the same email we were treated to their unique perspective on ethics and the right of patients to information with this gem of a quote (punctuation intact):

we strongly suggest you do NOT discuss this with others, especially patients, Firstly it would not be ethical to burden patients with this…

I find this statement to be the most abhorrent in the entire MCA email. This is advice from a major professional organization to withhold information from patients. And not just an esoteric bit of chiropractic minutiae, but information that pertains to entire swaths of chiropractic practice. Even worse, nowhere in the email does it advise MCA chiropractors to stop treating the stated conditions, just to obfuscate the fact that they do. As I said, abhorrent.

So in their attempt to silence one critic through litigation, the BCA has drawn attention to the paucity of evidence supporting many of its practices, shown that its chosen response to criticism is litigation and not scientific discourse, and prompted some alarmingly unethical advisory statements from their chiropractic colleagues. For a group supposedly striving to gain legitimacy within modern medicine, their current course of action seems to be ill conceived at best. As the saying goes, “Those who live in glass houses shouldn’t throw stones.”

Simon has rightfully received an outstanding amount of support during this event, one example of which was a mass reposting of “Beware the Spinal Trap” coordinated by Sense about Science. Such advocacy is not without its risks, as both Simon Singh and now the Australian Skeptics can testify.

The Australian Skeptics is a coalition of volunteer advocacy groups dedicated to the advancement of science and reason. Among their many interests, they’ve chosen to be outspoken advocates for evidence and science-based medicine, using both traditional and “new media” to great effect. That they were among the many to support Singh by reposting his article in late July should have been no surprise; the trouble that simple reposting has caused them, however, was.

Evidently their re-posting of “Beware the Spinal Trap” raised the ire of an Australian chiropractor, Joseph Ierano. Shortly after sending a lengthy letter to the Australian Skeptics objecting to the content of Singh’s article, he submitted a complaint to the HCCC claiming that by posting Singh’s article, the Australian Skeptics were offering incorrect medical/health care advice and should be subject to the Australian Public Health Act of 1993. Their subsequent exchanges can be found here.

Which of course brings me to the second bit of good news. I am happy to report that on October 23^rd the Australian Skeptics received word that the HCCC of NSW dismissed the complaint filed against them by Joseph Ierano, citing that the Australian Skeptics were not health care providers and therefore did not fall under their jurisdiction. Joseph Ierano, however, certainly is a health care provider and makes some rather interesting claims on his own site that might not have the firmest of foundations. I wonder if he really intended to bring himself to the HCCC’s attention.

I heartily congratulate both Simon Singh and the Australian Skeptics that their respective cases have taken turns in their favor, and in support of good science. Though I’m sure the Australian Skeptics would have relished the opportunity to defend themselves and explore the accuracy of statements made by Singh and Ierano in open court (they’ve said as much on their site), I rather prefer that it didn’t come to that. Given that legal decisions can impact the public perception of the science but have no bearing on its validity, courtroom battles tend to be high-risk and low-gain for those of us promoting science-based medicine.

Join CFI in opposing funding mandates for quackery in health care reform

Posted on November 8, 2009 by Danzig

Not long ago, I wrote a post warning about how funding for non-science-based modalities and, indeed, modalities that are purely religion-based, have found their way into various versions of health care reform bills that are currently wending their way through both houses of Congress. In other words, purveyors of faith healing and purely religious woo are trying to do what purveyors of “alternative” medicine have already done through Senator Tom Harkin, and hijack the health care reform process to codify their preferred unscientific health care modalities as legitimate after science has rejected them.

Now, the Center for Inquiry has launched a campaign to inform and educate our legislators. You can participate by using its talking points (or paraphrasing them or voicing your own objections) to protest:

Congress is considering health care legislation that would in part mandate coverage of non-evidenced based medical treatments such as prayer and therapeutic touch. This would raise the cost of health care for all Americans and represent a violation of the principle of separation of church and state.

CFI continues:

The Center for Inquiry asks you to contact your Senators and Representative to voice your strong opposition to the proposal in the Heath Care bills that would mandate coverage of non evidence-based “alternative” medical treatments including spiritual and prayer based healing under the guise of nondiscrimination.
Talking Points
America needs a health care system that focuses on increasing the health of individuals and reducing the cost of coverage.
This type of health care system is not possible if insurers are required to pay for medical treatments with questionable at best results.
If Congress requires that insurers cover alternative treatments such as Christian Science prayer, therapeutic touch, or other non-evidence based medical procedures, the cost of health care for all Americans will go up. This runs counter to the goal that Congress has laid out: to make health care more affordable for all Americans. – If the final version of health care reform includes a public option, this mandate would also force the public insurance plan to cover these treatments. Because the public option is federally funded, the inclusion of the mandate would represent an egregious violation of the principle of separation of church and state.

I agree. It’s time to try to stop the insertion of faith-based quackery like Christian Science “prayer” treatments as reimbursable medical expenses in whatever health care reform bill(s) is/are passed by Congress. You can help by going here and writing to your Congressional representatives and Senators.

Mainstreaming Science-Based Medicine: A Novel Approach

Posted on November 8, 2009 by Danzig

I have often mused about the difference between being right and being influential – especially in light of the relative success of the anti-vaccine movement. Despite the fact that there is no evidence for a link between vaccines and autism, celebrities like Jenny McCarthy have manufactured public mistrust in one of the safest, most cost effective means of combating disease known to humankind.

So if scientists are not persuading the public with appeals to carefully designed trials and factual data, how should they make their point? I’m not sure I have the full answer, but I think I might have struck a nerve with the public lately. I decided to try a novel approach to communicating my concerns about pseudoscience on the Internet – and presented 20 slides at 20 second intervals to a conference of ePatients in Philadelphia. I did it with powerful and humorous images, tied together with a long Limerick. Sound kooky? Maybe so… but it resonated, and was received with cheers and applause. Now that’s how we like science to be recognized!

It’s hard to recreate the experience – with voice, images, and rhyme – on the blog. But please check out the slide deck here, and I’ve reproduced the Limerick in its entirety below. It’s called, “A Tale Of Two ePatients” – and the slides advanced at each “***”. I hope my fellow scientists will join me in continuing to find novel approaches to win hearts and minds. Public health really is at stake.

Megan’s Story

A woman woke up from her sleep

With a pain that felt terribly deep

It didn’t seem right

She worried all night

But resorted to counting her sheep

In the morning she saw a physician

To check on her tummy condition

But alas what he found

By poking around-

A cancer and some malnutrition

***

So she asked what her chances could be

Of finding a way to be free

Of the mutating cells

They should bid their farewells

She hoped to hear something happy

The doctor’s face turned very dour

I’m sorry but I’m almost sure

There isn’t a chance

You’re far too advanced

The prognosis is terribly poor

***

She asked if there might be some way

To research new treatments today

But the doctor moved on

To see patients anon

No time to say more now, ok?

Afraid to ask questions again

She decided to put down her pen

With her anger and hurt

And his choice to be curt

She became an ePatient right then

***

Meg soon found a doctor online

The top of his field – so kind

And his new research

From his USC perch

Showed promise for tumor decline

His knowledge promised to advanced her

For all things he had a good answer

He provided the data

And other schemata

And planned for a cure of her cancer

***

But just to be sure he was right

She checked out the NIH site

And with careful review

She knew what to do

She refused to give up on her fight

The treatment was not very easy

She often felt shaky and queasy

Yet she stayed the course

Pushing through it with force

Walking whether ‘twas sunny or breezy

***

A friend called to check on the rumor

That Meg picked a fight with a tumor

The friend offered advice

About herbals and spice

Which he presented in really good humor

Oh my friend this sounds really appealing

And I know all you want is my healing

But how do you know

To believe in this so

When all you rely on is feeling?

***

Dear Megan, he said with a wave

I know that you’re awfully brave

You don’t have to endure

The toxins I’m sure

These herbals are able to save

Well let’s look at their track record then

If they really do work I’ll give in

So they researched Medline

And Mayo Clinic online

Finding no evidence of a win

***

But there are people who say this will work

Herbs saved these three guys and a clerk

They put their minds to it

Were sure they could do it

And avoided chemo with a smirk

But my friend in this life you must see

We use science to think critically

If there is an effect

We’re sure to detect

A dose-response repeatedly

***

Meg carefully weighed all her choices

Giving weight to the most reasoned voices

She found the best science

And increased self-reliance -

Worth more than a million Rolls Royces

Her first doctor rallied to meet her

Admitting she’d saved her own keister

So she offered a toast

To the folks she loved most

And the victory couldn’t be sweeter

Julie’s Story

A woman had been in the shower

For something quite close to an hour

When she noticed a lump

The tiniest bump

Just below her tattoo of a flower

I guess I must have a bug bite

Though this bump doesn’t fe-el quite right

She wondered aloud

With her head in a cloud

Assuming that it was alright

***

Months later she noticed some pain

On the spot where she had a food stain

So she scratched off the spot

Took her walk to a trot

And proceeded to shut off her brain

Later on she woke up with a start

This lump’s really starting to smart

So she went to the net

Now breaking a sweat

Worried something was wrong with her heart

***

She netsurfed around for some time

Chatting live with the people online

They thought she might like

A short hunger strike

Or to calm down her chest pain with wine

But my skin is getting so red

Am I making this up in my head?

Why not watch for a while

Or jog for a mile

There’s nothing much more to be said

***

Julie liked her new friends on the web

Though with patience beginning to ebb

She asked yet again

To Kim, Kyle and Ken

If they had some ideas instead

An herbalist friend that I know

Diagnoses her friends on the go

Please call her right now

And she’ll show you how

To cure pain with good energy flow

***

So she called the healer in a pinch

And was told it was really a synch

She should lie on the floor

To strengthen her core

And breath without moving an inch

But my skin is beginning to crack

-Well of course it’s because you might lack

Vitamins for your dermis

Put them all in a thermos

Drink ‘em down and put on an ice pack

***

Do you think I should see an MD?

Julie asked of her community

Heck no, don’t go there

You won’t have a prayer

You’ll be poisoned immediately!

Don’t you think that there might be just one

Who could help out my skin rash a ton?

It itches and hurts

I can’t wear my shirts

I can tell you this isn’t much fun

***

Julie left her friends on the computer

To find a physician to suit her

During the exam

The doc shouted “Ma’am!”

I’ll need to call our trouble shooter

The oncologist looked on aghast

At the breast cancer’s fungating mass

Why did you wait?

You’ve sealed your fate

There’s no way to alter the past

***

You can’t fix this tumor for me?

Well now I see very clearly

My friends told me docs

Are as useless as rocks

You don’t do much good, I agree

But miss Julie, you’re breaking my heart

The oncologist, flipping his chart

We do have a cure

You’d have it for sure

If you came in with a lump at the start

***

We can treat you for pain and unease

We’ll give comfort however you please

The lesson of course:

Consider the source

As an ePatient with a disease

Oh doctor, we need to tell others

Not to mix up our health with our druthers

May my death find some meaning

My soul intervening

For breast cancer in daughters and mothers

A Science Lesson from a Homeopath and Behavioral Optometrist

Posted on November 8, 2009 by Danzig

Charlene Werner is getting a lot of attention she probably did not anticipate or desire. She is the star of a YouTube video in which she explains the scientific basis of homeopathy. Before you watch it, make sure you are sitting down, relax, and brace yourself for an onslaught of profound scientific illiteracy combined with stunning arrogance. For those with more delicate constitutions I will give you the quick summary:

Einstein taught us that energy equals matter and light, but because matter can be condensed down to a very small space if you remove all the empty space between the elementary particles (I am paraphrasing to make her statements minimally coherent), we can mostly ignore matter. Therefore energy is light, and we are all made of energy – not matter (or at least so little matter, you can ignore it). Stephen Hawking then came up with string theory, which tells us that all matter (which we can ignore) is made of vibrating strings. Therefore we are made of vibrating energy. All diseases are therefore caused by unhealthy vibrational states, and all disease can be treated by returning the body to a previous healthy vibrational state. This can be done with homeopathy, which extracts the vibrational energy out of stuff and places it in a small pill that can be used at any time.

Got it? This is now my favorite example of meaningless pseudobabble from a CAM proponent. Also, I am not picking on some unrepresentative crank – this is as good as homeopathy gets. Werner may be more clumsy and fumbling than more eloquent homeopathy proponents, but when you strip it down, magical vibrations is what you get. But Werner does a fabulous job of exposing the gaping holes is homeopathic nonsense.

Werner is also Dr. Charelene Werner which made me curious of her degree and practice, and this led me to a topic that I do not think we have every covered on SBM – behavioral optometry. Dr. Werner is an optometrist who engages is a host of pseudoscientific practices, homeopathy being just one.

Behavioral or developmental optometry is similar to chiropractic, in that it is a health care profession that is self contained, separate from mainstream medical science, with historical roots survival into modern practice. There is a kernel of legitimacy (perhaps) to some of what they do, but then a vast expanding set of clinical claims for which there is little or not evidence. The big difference is that behavioral optometrists, unlike chiropractors, have largely been flying below the radar.

There also appears to be a spectrum, like with chiropractic, and I’m sure those behavioral optometrists who try to be evidence-based may take exception to being lumped in with the likely of Dr. Werner. But – professions have an identity, and you don’t like what’s happening under the banner of your profession, clean it up from the inside.

A look at Dr. Werner’s website give us a clear picture of her philosophy:

We are a holistic based optometric practice dedicated to the highest quliaty vision care for your entire family. We believe that 70% of how you physically function is through the vision system. Therefore, when the vision system is improved or enhanced it also increases overall physical wellness and performance.

This reflects, in my opinion, the tendency for practitioners who are not science-based to slowly expand their claims and scope of practice. If anecdotes are all you require (not even minimal biological plausibility) to accept that your interventions work, then before long you will think they work for everything. Dr. Werner likely does not grasp how extraordinary a claim it is to say that 70% of physical function is through the vision system. I wonder how she came up with that figure. The vague claims to “improve or enhance…physical wellness” leaves the door nicely open to treating just about anything.

Behavioral optometry is premised on the belief that eye and visual function can be improved, at any age, through training, exercises, or glasses with special lenses or prisms. There is little support or plausibility for this claim so broadly conceived, although there may be some truth to this concept in specific cases. A thorough review of the claims and literature for the various treatments of behavior optometrists is beyond one article, but I did find some recent reviews. This review from 2008 takes a broad look at behavioral optometry practices and concludes:

There is a continued paucity of controlled trials in the literature to support behavioural optometry approaches. Although there are areas where the available evidence is consistent with claims made by behavioural optometrists (most notably in relation to the treatment of convergence insufficiency, the use of yoked prisms in neurological patients, and in vision rehabilitation after brain disease/injury), a large majority of behavioural management approaches are not evidence-based, and thus cannot be advocated.

That is what I found from a look through the literature. The studies that are being cited by proponents are small, unblinded, pilot studies. There is a distinct lack of large randomized controlled trials.

Some of the claims made run directly contrary to evidence in the neurological literature. For example, using prisms to treat dyslexia (a reading disorder) based upon the premise that dyslexia is largely a visual problem (despite normal standard visual testing). However, the evidence has shown that dyslexia is not a visual problem but a disorder of the language area of the brain – a language and learning disorder. The claims of behavior optometrists regarding dyslexia started out being without evidence, but have increasing run contrary to prevailing evidence, but optomestrists failed to adapt or update their theories and practice.

The one condition that seems the most plausible and is most accepted is called convergence insufficiency – difficulty in properly focusing both eyes on near objects. There is weak evidence to support training exercises to help with this disorder, but other methods that are used to treat it (for example and exercise called pencil push-ups) has not been shown to be effective. While this condition requires more research, it is plausible.

At the other end of the plausibility spectrum is syntonic phototherapy. This is the use of specific colors of light to treat a wide range of symptoms and conditions, and improve performance. A search in pubmed on “syntonic phototherapy” yielded zero results. There is probably some research under different terms, but just using “phototherapy” as a search terms yields too many results to wade through (legitimate phototherapy is used for a range of skin and other conditions).

According to promotional sites, syntonic phototherapy dates back to the 1920’s and one man, Dr. Harry Riley Spitler- always a red flag. They seem to follow the pattern of referencing some legitimate basic science (for example the existence of light pathways in the brain that are not involved in conscious vision) to justify specific clinical claims without referencing quality clinical evidence.

Opthalmologists (MD eye doctors) historically have flirted with some of the claims of behavioral optometry, but a recent survey of practice concluded:

Although visual training has been used for several centuries, it plays a minor and actually decreasing role in eye therapy used by the ophthalmologist. At the beginning of the twenty-first century, most visual training is carried out by non-ophthalmologists and is neither practiced nor endorsed in its broadest sense by ophthalmology.

In short, there is generally low plausibility for many of the claims of behavior optometry, a lack of evidence for most of the methods used, a lack of consistency with the overall scientific literature and practice, and an expanding list of conditions they believe they can treat. These are all symptoms of a profession that lacks an appropriate level of respect for evidence and science-based medicine.

It is therefore no surprise to find a practitioner who also uses other unscientific modalities, such as homeopathy, and can so casually display such profound scientific illiteracy. Dr. Werner therefore managed to be an embarrassment to two professions at the same time.

The effective wordsmithing of Amy Wallace

Posted on November 8, 2009 by Danzig

One of the most engaging and clearly-written pieces of science journalism over the last year or so was published in Wired magazine last week. Now in the midst of a firestorm of attention, Amy Wallace’s, “An Epidemic of Fear: How Panicked Parents Skipping Shots Endangers Us All,” is part interview with rotavirus vaccine developer, pediatric infectious disease physician and immunologist, Dr Paul Offit, and description of the anti-vaccination movement in the United States.

Wallace’s work is the centerpiece of a masterful collection of smaller articles providing science-based information about vaccination that also refuts common anti-vaccination myths including “How To Win An Argument About Vaccines” and “The Misinformants: Prominent Voices in the Anti-Vaccine Crusade”.

Wired’s follow-up discussion of the issue includes, “A Short History of Vaccine Panic,” for those of us who “have a day job” and not enough time to read Paul Offit’s 2008 book, “Autism’s False Prophets.”

On a personal note, I have to admit that it wasn’t until I began blogging four years ago that I realized just how vocal the anti-vaccination movement was in the United States. I come from a time (just on the tail end of the Baby Boom) where I still have relatives who were afflicted with polio and other now-preventable infectious diseases. From my hometown of Wallington, NJ – a stone’s throw from New York City – Bill Michalski writes in “Poland On The Passaic” how the fear of polio spread through town during the 1930s and 40s, with white flags hung out on front porches to warn away visitors. The devastation of these childhood illnesses makes the risks (yes, I agree there are some risks) of vaccination itself inconsequential.

Vaccination is a risk-benefit proposition but one where someone else’s view affects us all. Lack of vaccination compromises “herd immunity” that keeps us all safe, for example, from diseases like smallpox that have been eliminated from the face of the earth. Your vaccination is also important to others who may be immunosuppressed from cancer drugs, HIV/AIDS, or, in the case of someone close to me, immunosuppressant drugs to prevent organ transplant rejection.

Others have commented widely on Wallace’s article for its scientific and medical accuracy. However, I wanted to focus more so on the effectiveness of the writing as a scientific communication tool because much of the article gives the reader a concise view of issues and psychology that often take typical bloggers thousands of words to express (and still less effectively!).

Why is Paul Offit Perceived as Evil?
Wallace does a terrific job of showing us just how scary life is for Paul Offit and his family (with death threats reminiscent of those by animal rights and anti-abortion activists). He is a doc at the Children’s Hospital in Philadelphia and, as mentioned earlier, is one of the developers of a vaccine for rotavirus sold commercially as RotaTeq®. While not particularly deadly (although the parents of the 20-60 dead US infants and toddlers annually may beg to differ – as well as those of the half million worldwide), rotavirus causes a severe form of acute diarrhea in several hundred thousand US children annually under age 5. If you’ve had a kid with it, you wish they didn’t have to endure it if a vaccine would prevent the infection and sequelae.

Wallace also describes how Offit was in the hospital with kids suffering from polio in the mid-1950s. Hence, unlike many of today’s anti-vaccination advocates, Offit was influenced deeply and early by witnessing firsthand the devastation of now-preventable infectious diseases. That’s the world in which my parents and grandparents lived.

“It was a pretty lonely, isolating experience,” Offit says. “But what was even worse was looking at these other children who were just horribly crippled and disfigured by polio.” That memory, he says, was the first thing that drove him toward a career in pediatric infectious diseases.

Wallace goes on to describe a case in 1977 where, as an intern, Offit observed the death of a child from rotavirus, being surprised that the disease still killed kids. I’d say that many of us in science and medicine were influenced similarly by watershed events in our lives that led to pursuit of our respective career tracks.

Anti-vaccination advocates often criticize Offit for being in the pocket of Big Pharma (whatever that really means) because he made $50 million from the development of the RotaTeq vaccine. Offit admits to it being several million – a much more realistic number given what I know about deals made by institutions vs. remaining payouts to individual scientists – and he has every right to benefit from the intellectual property he has developed from his hard work. Offit has a four-bedroom house with his wife (who is also a pediatrician) and they each drive a Toyota Camry. He does not appear to have an extravagant lifestyle and, to be honest, why should we begrudge him if he did?

Offit acknowledges that he received a payout — “several million dollars, a lot of money” — when his hospital sold its stake in RotaTeq last year for $182 million. He continues to collect a royalty each year. It’s a fluke, he says — an unexpected outcome. “I’m not embarrassed about it,” he says. “It was the product of a lot of work, although it wasn’t why I did the work, nor was it, frankly, the reward for the work.”

There are plenty of us who have our kids vaccinated for rotavirus and I’m perfectly happy for Offit to collect a royalty. (I’d even encourage him to buy a more comfortable vehicle because I know how unnerving the Philadelphia commute can be.). Does this make him evil? In fact, last week the CDC published that the vaccine is already responsible for reducing cases and hospitalizations for rotavirus. If that’s the definition of evil then I aspire to be evil.

Wallace also notes indirectly that the anti-vaccination movement is doing just what they accuse Offit of doing: making money off of the situation:

At this year’s Autism One conference in Chicago, I flashed more than once on Carl Sagan’s idea of the power of an “unsatisfied medical need.” Because a massive research effort has yet to reveal the precise causes of autism, pseudo-science has stepped aggressively into the void. In the hallways of the Westin O’Hare hotel, helpful salespeople strove to catch my eye as I walked past a long line of booths pitching everything from vitamins and supplements to gluten-free cookies (some believe a gluten-free diet alleviates the symptoms of autism), hyperbaric chambers, and neuro-feedback machines.

Yes, where the science is not yet complete, pseudoscience (and the attendant hucksters and vultures) seem to fill the void. The difference between them and Offit: the product Offit developed has extensive scientific data to back up its effectiveness.

Efficiency of Words
But getting back to what impressed me most about Wallace’s article was how concisely she presented her content. Here, she sums up one of my discussion points above:

Today, because the looming risk of childhood death is out of sight, it is also largely out of mind, leading a growing number of Americans to worry about what is in fact a much lesser risk: the ill effects of vaccines.

To describe the hypocrisy of an Offit opponent:

Hence the death threats against Paul Offit. Curt Linderman Sr., the host of “Linderman Live!” on AutismOne Radio and the editor of a blog called the Autism File, recently wrote online that it would “be nice” if Offit “was dead.”
I’d met Linderman at Autism One. He’d given his card to me as we stood outside the Westin O’Hare talking about his autistic son. “We live in a very toxic world,” he’d told me, puffing on a cigarette.

To describe the logical trapping of pseudoscience believers:

. . .the astronomer Carl Sagan reached a similar conclusion: Science loses ground to pseudo-science because the latter seems to offer more comfort. “A great many of these belief systems address real human needs that are not being met by our society,” Sagan wrote of certain Americans’ embrace of reincarnation, channeling, and extraterrestrials. “There are unsatisfied medical needs, spiritual needs, and needs for communion with the rest of the human community.”
Looking back over human history, rationality has been the anomaly. Being rational takes work, education, and a sober determination to avoid making hasty inferences, even when they appear to make perfect sense. Much like infectious diseases themselves — beaten back by decades of effort to vaccinate the populace — the irrational lingers just below the surface, waiting for us to let down our guard.

To describe how people evaluate, incorrectly, perceived vs. actual risks:

Perceived risk — our changing relationship to it and our increasing intolerance of it — is at the crux of vaccine safety concerns, not to mention related fears of pesticides, genetically modified food, and cloning. Sharon Kaufman, a medical anthropologist at UC San Francisco, observes that our concept of risk has evolved from an external threat that’s out of our control (think: statistical probability of a plane crash) to something that can be managed and controlled if we just make the right decisions (eat less fat and you’ll live longer).

We scientists can do well to be students of Ms. Wallace’s efficiency with words.

Most recently, Wired demonstrates that, like the rest of us who employ the scientific method to evaluate data, it’s okay to admit (as well as the responsible thing to do) when one makes a mistake and then describe the consequences, or lack thereof, of the misstatement. For example, Wallace’s article did mistakenly state that vaccines no longer contain thimerosal (ethylmercury), an anti-microbial preservative that has proven safe in over a dozen studies:

An earlier version of this story suggested that no childhood vaccines contain thimerosal; in fact some versions of the influenza vaccine, which is not typically mandated for children’s admission to school, does contain the preservative. Go here for a further explanation.

Amy Wallace the Journalist
Finally, what I think also impresses me is Amy Wallace herself and her approach to this article. Wallace is not your typical science journalist. The majority of her portfolio is comprised of works on Hollywood and the entertainment industry. She is not a lobbyist or otherwise a representative of the pharmaceutical industry – as you might guess, she is already being accused of being such by anti-vax advocates, In fact, Wired has published a follow-up on Ms. Wallace’s background in response to a misinformation campaign about her that has already developed. (Nor this hasn’t stopped the anti-vax commenters from stating that the entire Wired feature is a paid hit job for the pharmaceutical industry.)

When the facts don’t support an opponent’s view on a pharmaceutical or therapeutic issue, the tendency is an intellectually lazy cry of “Pharma Shill.”

Wallace’s approach to Offit himself is, I think, so effective because she is supremely experienced at writing about personalities, their inner workings, and how they are viewed by the public. As an entertainment writer, she also has to delve into the truths behind the motivations of people and get past appearances and hype. She went above and beyond in giving time and publicity to anti-vaccination advocates, and their websites, and pretty much gave the reader all they need to make up their own minds about the issue.

But most importantly, all of scientists with whom I communicate on blogs and Twitter have agreed that the science reported in Wallace’s article is almost entirely valid and supported by solid, published data. Dr. Gorski has, for example, registered his support here at SBM back on October 20th.

But the combination of scientific validity, her engaging writing style, and historical/psychological commentary on pseudoscience comes together to create an example of what science journalism can and should be.

The record-setting pageviews for Wired and froth in the comments from anti-vaccination activists tells us all we need to know about how influential Ms. Wallace’s article is already – and will continue to be.

I encourage SBM readers to follow Ms. Wallace on her Twitter feed @msamywallace. Beginning last evening, she began writing about the e-mail she has received, both hateful and supportive, regarding her story. She notes that in 25 years of professional journalism (NYT, LATimes, etc.), she has never received such volume and vitriol of communications on any other topic.

Military Medicine in Iraq

Posted on November 8, 2009 by Danzig

Doctors get a lot of flak these days without ever going near a battle zone. They are bombarded with accusations of not caring about their patients, of being shills for Big Pharma, of being motivated by money, of killing patients with medical errors and drug side effects. In addition, they are bombarded with claims that non-scientific medical systems (so-called alternative medicine, from chiropractic to Ayurveda) offer greater benefits to patients.

It was a delight to read a new book about a doctor who was exposed to real flak in Iraq. His story is a wonderful reminder of how effective modern medicine is and it is an eye-opener about the selfless dedication of doctors who put themselves in harm’s way; who accept lower incomes, separation from families, and poor living conditions; who care desperately about their patients; and who magnanimously apply the same skills to treating friend and foe.

The title is Coppola: A Pediatric Surgeon in Iraq. The author, Chris Coppola, is an Air Force pediatric surgeon who was twice deployed to Balad Air Base, 50 miles north of Baghdad, as a trauma surgeon. In his first night on call, he treats the five worst gunshot injuries he has ever seen – and they are all in the same patient! Despite serious damage to liver, colon, small intestine, pancreas, duodenum, vena cava and spine, the patient, a 22 year old Iraqi policeman, recovers. As the foreword of the book explains, the survival rate for troops injured in the field was 20% in WWI, 40% in WWII, 66% in Viet Nam, and is now an astounding 97% in Iraq. Lessons learned in war are translated to civilian trauma care and we all benefit from the knowledge however much we may deplore the war.

No subluxations were adjusted, no qi manipulated, no acupuncture points stimulated, no homeopathic or herbal medicines given. Beside numbers like these, alternative medicine looks pretty puny and irrelevant. And the Air Force’s initiative to train doctors in battlefield acupuncture looks frankly delusional.

Coppola is in Iraq during the first elections. An elderly woman is the victim of an IED (Improvised Explosive Device) detonated near a line of people waiting to vote. As they prepare her for surgery to stabilize her broken bones, she proudly holds up her right index finger with the purple ink stain showing she voted. They also treat a 17 year old girl who was shot in the neck at a polling place and will likely never walk again. They treat a small child with a skull fractured by shrapnel while waiting with his father in a voting line. Children are particularly at risk from IEDs: their heads are proportionately larger and they are closer to the ground.

They treat an insurgent whose bomb detonated prematurely. He is a would-be murderer, but all Coppola sees is “a dying man who needs our treatment.”

He has to work through translators. Cultural differences intrude as he tries to explain to a father that his baby “boy” is really a girl with an intersex condition. Such a child would be raised as a girl in the US, but the Iraqi father violently objects to that option because of cultural prejudice against females.

They treat many Iraqi citizens and are worried when they release them because they are not likely to get adequate follow-up care. The Iraqi medical system has been devastated: doctors have fled, supplies are impossible to get. The Iraqis are not taxed: the government is funded only by oil sales and foreign aid. They do colostomies meant to be temporary but know it is unlikely their patients will ever be able to get the colostomies taken down. They see Iraqis with soiled towels wrapped around their colostomies because they can’t get colostomy bags. When a colleague wonders if they should send a patient to a burn facility, he is told “We are the burn facility in Iraq.”

The Iraqi children he treats are small for their age and malnourished. Nutritious food is part of the medical treatment. They discover that a Kurdish refugee boy is only taking a few bites of his meals and hoarding the rest to take home to his family. They persuade him to eat by offering him Oreos and enough other donations from their own care packages to fill two large bags to take home.

Coppola paints a vivid picture of deployed life: eating MREs (Meals Ready to Eat), jogging with 35 pounds of body armor and other protective equipment, suffering through the “hurry up and wait” military hassles, having to wear a gun in the OR during alerts, taking cover from incoming missiles, desperately missing his family. There is a signpost with the distance to various cities around the world, topped by a sign “Hell – 0 miles.” And yet he is more than willing to go back for a second deployment because he knows how badly he is needed.

He treats casualties from the battle at Abu Ghraib prison, where prisoners and insurgents mounted a coordinated attack on the guards. Iraqis tell him they were not surprised to learn that prisoners had been tortured by Americans. They assumed that torture was being used – torture had always been a part of that prison, and far worse had happened under Saddam Hussein, attested to by the adjacent mass graves. Not that that’s any excuse.

By his second tour, the patient population had changed. After the troop surge, Al Qaeda was no longer so brave about attacking Americans; now they concentrated on civilian targets, even including schools. Instead of American and Iraqi soldiers, now most of their patients are civilians and 1/3 of them are children.

One of the most affecting stories in the book is that of Leila, a little girl who was extensively burned by an incendiary bomb thrown into her home. Her father was an Iraqi officer who had been successfully subduing the insurgents in his area and this was an act of revenge. Coppola is doing a complicated skin graft procedure on Leila when an emergency intervenes to commandeer his OR; he has to improvise to save the grafts and free up the OR as soon as possible. He treats her tenderly for a couple of months and is devastated when she eventually dies of a complicating infection. Later an Iraqi adult patient is taken away by guards. Coppola learns that that patient was the one who had thrown the firebomb into Leila’s house – and the American hospital had saved his life. And he later learns that Leila’s father is killed by insurgents.

Another detainee is ungrateful even after several life-saving operations. He only speaks to repeatedly vow to shoot them all.

Coppola is in the OR during a Christmas USO show with Robin Williams, Lance Armstrong, Miss USA, Kid Rock, Lewis Black and other celebrities. He is sorry that he missed the concert but says he couldn’t have enjoyed it knowing a child was waiting to be operated on. He says, “Each new injured child I see seems to rip the scab off a wound in my heart that won’t let me rest.” One of the reasons he chose surgery over pediatrics is that he is so distressed when he has to cause pain to an awake child.

Coppola accepted an Air Force scholarship and advanced training that obligated him to 6 years of pay-back service. He points out that this meant a financial disadvantage. In 3 years in private practice he could have paid off any medical school debts and still have had a greater income than his Air Force salary for 6 years. He joined the Air Force because he wanted to serve his country. He went to Iraq because he had signed a contract and was obligated to go wherever they sent him. Some of his colleagues supported the war, some did not, but they were all there to save lives. All were volunteers.

One word kept running through my mind as I read this book. It is a word seldom used these days. The word is “honor.”

A Not-So-Split Decision

Posted on November 8, 2009 by Danzig

For those who battle tirelessly against the never ending onslaught of anti-vaccine propaganda, misinformation, and fear, there was great news the other day from Merck. The pharmaceutical company, and maker of the MMR vaccine against measles, mumps, and rubella, has decided not to resume production of the individual, or “split”, components of the vaccine. A Merck representative made the announcement during a meeting of the CDC Advisory Committee on Immunization Practices (ACIP) on Tuesday. During previous ACIP meetings, science experts on that committee presented compelling arguments against continued, large scale production of the monovalent components of the MMR vaccine, which were echoed by scientists in Merck’s vaccine division. In a moment, I’ll discuss the arguments against the split vaccine, and why this is so important a decision. First, some background on the issue of splitting the MMR.

Merck has manufactured individual measles, mumps, and rubella vaccines on a small scale for various reasons. For example, the monovalent measles vaccine has been recommended during measles epidemics to protect infants 6-12 months of age from infection, and rubella vaccine is given to women without immunity, to protect against congenital rubella syndrome in future pregnancies. But since 1967, the MMR vaccine has been the primary source of protection against measles, mumps, and congenital rubella. The original recommendation for the use of the combination vaccine at 12 months of age, and the recommendation in 1989 to add a booster dose at 4-6 years, has led to the near eradication of these diseases in the US. But in 1998, the infamous Andrew Wakefield warned the public to avoid the MMR vaccine, and instead opt for the monovalent components, spread out over time. This announcement came during a press conference to announce his also infamous, and thoroughly discredited Lancet paper linking the MMR vaccine to autism. It came as a shock to all of us who understand the importance of the MMR vaccine, and who know of no scientific rationale to split the vaccine. Wakefield claimed he had reason to believe the combined vaccine might lead to autism in some children. Of course, his reason was not based on any scientific evidence, and we now know that he had an undisclosed financial incentive to push people toward a monovalent measles vaccine. To this date, not a single shred of science supports the notion that the MMR vaccine causes autism, nor are there any scientifically plausible reasons that it would. As we know, mountains of data point to just the opposite conclusion. Despite absolutely no scientific rationale for splitting the MMR vaccine, and despite the fact that all of Wakefield’s claims about the MMR vaccine and autism have been thoroughly debunked, the myth lives on. I am still confronted by parents who are worried about the vaccine, and who request, or at least ask about, splitting the vaccine. On my local parents list-serve, the issue constantly rears its head, and each time I attempt to step in to reassure and educate, I am met with a wall of fear and opposition. Because of this irrational fear, pockets of unimmunized children have set the stage for disease outbreaks, and have already led to outbreaks around the country. Just this week I received an alert from the NYS DOH about a mumps outbreak in my own backyard, similar to an alert in July about a measles outbreak. Unbelievably, this doesn’t seem to phase the many parents who have fallen victim to the growing epidemic of vaccine fear.

There are several reasons Merck’s decision about the MMR vaccine is so important. In addition to creating the need for more doctor visits, with more shots, more pain, and at greater cost, splitting the vaccine into individual components prolongs the vaccination process (each component must be separated by at least a month to insure efficacy), increasing a child’s vulnerability to disease. Administration of separate components over prolonged intervals is also less likely to result in completion of the series, than is administration of a single vaccine. But perhaps more importantly, this decision is a vote against irrationality and an anti-scientific worldview that has begun to endanger society. Many parents will be upset and disappointed by Merck’s decision, especially those who were just recently reassured by Dr. Sears that Merck was poised to reintroduce the separate components in 2011. The fact is, this was actually a bad decision for Merck from a purely economic perspective. It costs considerably more to manufacture, produce, and test combination vaccines than monovalent vaccines. Selling three individual components would also produce more revenue than a single combination product. Nevertheless, the anti-vaccine lobby will most assuredly find a way to paint this decision as a picture of government-industry conspiracy, intent on covering up the truth and depriving parents of a safer choice. One could say “you never win”, but for now I’m just happy we did.

A science-based blog about GMO

Posted on November 8, 2009 by Danzig

Much time, money, and ink is spent in our culture obsessing over what foods are “good” or “bad” for health. Oftentimes such claims are out of proportion with available evidence, perhaps based on reasonable-sounding theories but not so much on convincing data. Here are a few examples of SBM bloggers addressing food and diet: 1, 2, 3, 4.

An interesting subset of food claims relate to the safety of genetically modified organisms (GMO) in the food chain, safety both for individuals and for ecosystems. I’d like to recommend SBM readers to a blog called Biofortified written by graduate students and scientists in plant genetics. The Biofortified bloggers explain hot topics and controversies in genetic engineering, attempting to cut through the wild propoganda in favor of calm science. The authors tend to be more pro-GMO than not—perhaps unsurprising since their careers are spent studying them—but they strike me as quite reasonable in their support. Here are a few posts I liked: on fears about GE crops, on food labels, on anecdotal health claims, on gene patents, on smoking your vaccines someday.

Today is a particularly good time for you to check out Biofortified because they are competing in the Ashoka Changemakers “GMO: Risk or Rescue?” contest. According to Karl, a grad student who writes on Biofortified, theirs is the only “pro-science” group in the running. The prize includes a nice grant and an opportunity to have a conversation with author Michael Pollan. If you like the blog enough to vote for them by this Wednesday 10/28 at 6pm EST, see details about the contest here.

Suzanne Somers’ Knockout: Dangerous misinformation about cancer (part 1)

Posted on November 8, 2009 by Danzig

If there’s one thing I’ve become utterly disgusted with in the time since I first became interested in science-based medicine as a concept, its promotion, and the refutation of quackery and medical pseudoscience, it’s empty-brained celebrities with an agenda. Be it from imbibing the atmosphere within the bubble of woo-friendly southern California or taking a crash course at the University of Google and, through the arrogance of ignorance, concluding that they know more than scientists who have devoted their lives to studying a problem, celebrities believing in and credulously promoting pseudoscience present a special problem because of the oversized soapboxes they command. Examples abound. There’s Bill Maher promoting anti-vaccine pseudoscience, germ theory denialism, and cancer quackery on his show Real Time with Bill Maher and getting the Richard Dawkins Award from the Atheist Alliance International in spite of his antiscience stances on vaccines and what he sneeringly calls “Western medicine.” Then there are, of course, the current public faces of the anti-vaccine movement, Jenny McCarthy and her boyfriend Jim Carrey, the former of whom thinks it’s just hunky dory (or at least doesn’t appear to be the least bit troubled) that her efforts are contributing to the return of vaccine-preventable infectious diseases because she apparently thinks that’s what it will take to make the pharmaceutical companies change their “shit” product (her words), and the latter of whom spreads conspiracy theories about vaccines and contempt on people suffering from restless leg syndrome. Finally, there’s the grand macher of celebrity woo promotion, Oprah Winfrey, who routinely promotes all manner of medical pseudoscience, be it “bioidentical” hormones, the myth that vaccines cause autism (even hiring Jenny McCarthy to do a blog and develop a talk show for her company Harpo Productions), or other nonsense, such as Christiane Northrup urging Oprah viewers to focus their qi to their vaginas for better sex.

Unfortunately, last week the latest celebrity know-nothing to promote health misinformation released a brand new book and has been all over the airwaves, including The Today Show, Larry King Live, and elsewhere promoting it. Yes, I’m talking about Suzanne Somers, formerly known for her testimonial of having “rejected chemotherapy and tamoxifen” for her breast cancer, as well as her promotion of “bioidentical hormones,” various exercise devices such as the Thighmaster and all manner of supplements. Her book is entitled Knockout: Interviews with Doctors Who Are Curing Cancer–And How to Prevent Getting It in the First Place. It is described on the Random House website thusly:

In Knockout, Suzanne Somers interviews doctors who are successfully using the most innovative cancer treatments–treatments that build up the body rather than tear it down. Somers herself has stared cancer in the face, and a decade later she has conquered her fear and has emerged confident with the path she’s chosen.
Now she shares her personal choices and outlines an array of options from doctors across the country:
EFFECTIVE ALTERNATIVE TREATMENTS
without chemotherapy
without radiation
sometimes, even without surgery
INTEGRATIVE PROTOCOLS
combining standard treatments with therapies that build up the immune system
METHODS FOR MANAGING CANCER
outlining ways to truly live with the diease
Since prevention is the best course, Somers’ experts provide nutrition, lifestyle, and dietary supplementation options to help protect you from getting the disease in the first place. Whichever path you choose, Knockout is a must-have resource to navigate the life-and-death world of cancer and increase your odds of survival. After reading stunning testimonials from inspirational survivors using alternative treatments, you’ll be left with a feeling of empowerment and something every person who is touched by this disease needs…HOPE.

I first found out about Somers’ book about a month and a half ago and was fortunate enough (I think) that one of my readers who had a review copy of the book sent me a chapter list. The reason I wanted a chapter list was because I was really curious just who these doctors were whom Somers had interviewed. In particular, back then I predicted (and hoped) that one of the doctors would be one whom we’ve met before. It was. Can you guess which one? Think about it. What major study did I blog about in the middle of September? What form of cancer quackery has been covered so ably by Kimball Atwood since the very beginning of this blog? No, no, you don’t have to go back to the archives and search. I’ll tell you:

Dr. Nicholas Gonzalez. He’s the second featured doctor who is “curing cancer,” right there in Somers’ book in Chapter 6!

That’s right, one of these doctors who are “curing cancer” is a quack (in my opinion, of course) whose “protocol,” which includes 150 supplement pills a day topped off by a couple of coffee enemas per day, was recently shown to be worse than useless for pancreatic cancer and, indeed, based on a recent study, far worse than conventional treatment.

From my perspective, it was incredibly bad timing and bad luck on Somers’s part to have one of the subjects she lionized in your book to have his protocol shown to be not just worthless, but likely actively harmful, a mere two months before the release of her book. In case there are any journalists who might be interviewing Somers and are interested in more than a puff piece that lets her promote her book, I list all the posts on Science-Based Medicine that have discussed the rank pseudoscience that is the Gonzalez protocol because, as many of you have figured out, I’m never satisfied with a hammer to smack down a form of woo when going nuclear is so much more fun:

Sadly, this bad timing appears to have had no effect whatsoever on the publicity blitz of an actress who every day tries to live down to the character she played on Three’s Company back in the 1970s or on the questions asked of her by interviewers. Somers has been all over the media this week, and I’ve seen nary a challenging question stronger than pointing out that some of the doctors featured in Somers’ book have gotten in trouble with their state medical boards, much less a much deserved question about Nicholas Gonzalez. Instead we’ve thus far been treated to cliched, credulous headlines like Suzanne Somers questions chemo in new book, Somers’ New Target: Conventional Cancer Treatment, or Suzanne Somers works to ‘Knockout’ cancer. The article circulating about her book on the AP wire begins:

Less than a year after the former sitcom actress frustrated mainstream doctors (and cheered some fans) by touting bioidentical hormones on “The Oprah Winfrey Show,” she’s back with a new book. This one’s on an even more emotional topic: Cancer treatment. Specifically, she argues against what she sees as the vast and often pointless use of chemotherapy.
Somers, who has rejected chemo herself, seems to relish the fight.

Let’s get one thing straight here. It is most definitely not, as implied by various articles about Somers, in any way amazing that Somers is still alive after having “rejected chemotherapy.” As I explained at the dawn of this blog, Somers had a stage I tumor with a favorable prognosis. If Somers is going to play the gambit of repeating, “I rejected chemotherapy and tamoxifen and I’m still alive” and attributing her survival to the alternative medicine woo she chose instead, perhaps now is the time to go into more detail than I’ve ever gone into before about her case. Well, not quite. I did go into quite a bit of detail in my talk at the Science-Based Medicine Conference at TAM7 in July. After all, I did the research; so I might as well get some more use out of it and spread it beyond the 150 or so people who heard my talk.

Prelude by flashback: Suzanne Somers’ breast cancer

In preparation for my talk at TAM7, I searched for all the information I could find that was publicly available about Suzanne Somers’ diagnosis of breast cancer back in 2000. For your edification, I’ve also uploaded the slides from my presentation relevant to Suzanne Somers’ breast cancer diagnosis as a PDF file. Suffice it to say, there is a great deal of misunderstanding of breast cancer in Somers’ testimonial. In this case, I don’t actually blame Somers all that much for her misunderstanding, because it is a very common misunderstanding that clearly derives from a misunderstanding of the difference between using chemotherapy for primary treatment of cancer versus adjuvant treatment of cancer. In early stage breast cancer, which can be surgically removed for cure, chemotherapy and radiation therapy are in general used as additional therapies that decrease the risk of recurrence of the cancer after surgery. That’s what adjuvant therapy is, extra therapy that improves a patient’s odds of surviving after a primary treatment. In the case of early stage breast cancer, the primary treatment is surgery.

From what I can find from publicly available information on the Internet (I’ve never read one of Suzanne Somers’ books), at age 54 Somers was diagnosed with a breast cancer that was treated by lumpectomy (excision of the “lump” or tumor) and a sentinel lymph node (SLN) biopsy, the latter of which was negative for tumor cells in the SLN, plus radiation therapy. For those not familiar with the SLN procedure, it is a procedure that developed in the 1990s to determine whether a woman’s breast cancer has spread to the axillary lymph nodes (the lymph nodes under the arm) without actually removing all of the axillary lymph nodes. Before the advent of SLN biopsy, the standard of care was to do an axillary dissection (removal of all the lymph nodes under the arm) on the side of the tumor in order to determine if and how many of the lymph nodes are positive for cancer. This is critical information, because the single most powerful prognostic indicator for potentially curable breast cancer (i.e., breast cancer that has not spread beyond the axillary lymph nodes to the rest of the body, such as bone, liver, or lung) is the presence of metastases in the axillary lymph nodes and, if they are present, how many. Unfortunately, as less invasive means of treating breast cancer were developed, such as lumpectomy, the part of the operation that carried the most morbidity was the axillary dissection. Consequently, as science-based physicians are wont to do, during the 1990s surgeons tried to find a way to get the same information (are the lymph nodes positive or negative) with a less morbid procedure and thus reserve axillary dissection only for patients who do have lymph nodes with breast cancer metastases in them.

Thus, the SLN biopsy was developed as a strategy to decrease the possibility of the most feared complication of axillary dissection, lymphedema, and still get the necessary information regarding lymph node positivity or negativity. Basically, an SLN biopsy is preformed by injecting both a radioactive dye and a blue dye (usually Lymphazurin Blue) into the breast. The dyes are then taken up in the lymphatics and head towards the axilla, where they lodge in one or more lymph nodes. This is (these are) the sentinel lymph node(s). The concept behind the procedure is that the sentinel node is the first lymph node a tumor cell that broke off from the tumor and got into the lymphatics will “see” and lodge in. In other words, the dye mimics the pathway that tumor cells take to metastasize to the axillary lymph nodes. If the sentinel node is negative, it’s an accurate indication that the rest of the lymph nodes are negative, and in general no further surgery is needed. Women are identified as node negative without removing all the axillary lymph nodes. Best of all, the risk of lymphedema from the procedure very, very small, far smaller than it is for axillary dissection (removing all the lymph nodes). Since the purpose of axillary dissection was far more diagnostic (to find out if the lymph nodes are contain tumor and, if so, how many), this is a good thing. On the other hand, if the SLN contains tumor, then axillary dissection is needed. In fact, far fewer women now undergo the procedure than in the past, and it is even coming under question whether a woman with a positive SLN truly needs a full axillary dissection.

Why do I mention this? Because I want readers to understand that Somers underwent, as far as I can tell, standard surgery for a favorable, estrogen receptor-positive stage I cancer. She also underwent radiation, although she has stated in the past and now states in Knockout that, if she had it all to do over again, she would not have opted for radiation. Be that as it may, she has been trumpeting proudly for a number of years that she rejected chemotherapy and tamoxifen and has done quite well. This claim, although true, says nothing about whether he decision to eschew those adjuvant therapies was a good one and even less about whether the woo she pursued after that had anything to do with her survival. As I described so long ago, however, surgical excision is curative for most small breast cancers. Radiation therapy reduces the risk of local recurrences (recurrences in the breast), and chemotherapy and antiestrogen therapy (like Tamoxifen) reduce the risk of systemic recurrences (recurrences elsewhere in the body). In other words, chemotherapy and radiation are “icing on the cake” after surgery. Indeed, there is a website known as AdjuvantOnline.com that allows physicians to calculate the estimated risk of recurrence and the estimated benefit of chemotherapy and, if appropriate, antiestrogen therapy. Given when Somers had her cancer diagnosed (2000) and because I know that she had a stage I tumor, i entered data for her assuming a tumor between 1-2 cm in size, mainly because most tumors under 1 cm would not warrant adjuvant chemotherapy. Here is a blowup of the key slide from my talk where I showed the results I got when I entered the known information about Suzanne Somers’ tumor into AdjuvantOnline:

(Click for a larger image.)

As you can see, based on what we know from publicly available sources, Somers had an 88.6% chance of living 10 years without any chemotherapy or Tamoxifen. Chemotherapy provides a survival advantage of 2.5%; tamoxifen, 2.5%; and combination therapy, 4.1%. In other words, eschewing chemotherapy and tamoxifen increased Suzanne Somers’ odds of dying of her cancer within 10 years by around 4%, not a huge number. As I’ve explained before, although the benefit of chemotherapy and tamoxifen for early stage breast cancer is around 30% on a relative basis, but it’s only around 4% or 5% on an absolute basis. You may think that’s not very much, but, I assure you, the vast majority of women are willing to undergo chemotherapy and hormonal therapy for that extra insurance. Indeed, I would point out that surveys I have seen have revealed that a majority of women would still opt for chemotherapy even if it provided only a 1% absolute survival benefit. Moreover, for more advanced tumors, that relative benefit generally stays around 30% or so, meaning that, as the risk of dying from cancer goes up, the absolute benefit of adjuvant chemotherapy goes up as well. Be that as it may, I’ve laid out this information to point out that testimonials like Somers’ are not particularly impressive if you know something about breast cancer. I also mention it to point out that, even though it’s a bad idea for Somers to be pumping herself full of “bioidentical hormones,” the favorable nature of her tumor means that she can get away with it. Even if it increased her risk of recurrence by 10 or 20%, the odds of survival would still be overwhelmingly in her favor, adjuvant chemotherapy and tamoxifen or not, thanks to her friendly neighborhood surgeon. So when you see a passage like this about Somers, remember what I’ve just told you:

Diagnosed with breast cancer a decade ago, she had a lumpectomy and radiation, but declined chemotherapy, as she did more recently when briefly misdiagnosed with pervasive cancer.

As I said before, Somers’ misunderstanding of the role of adjuvant therapy in breast cancer is somewhat understandable. It is a concept that can be difficult to communicate this to patients under the best of circumstances, and the absolute benefit of chemotherapy in treating a stage I ER(+) cancer is relatively small. Moreover, treatment paradigms change with new scientific evidence. Most women these days with a stage I ER(+) tumor would undergo Oncotype DX® testing, and the results of that testing would guide the decision of whether chemotherapy is recommended or not. Oncotype DX did not exist in 2000, and adjuvant chemotherapy was recommended for the vast majority of women with a stage I breast cancer with a tumor greater than 1 cm in diameter.

Somers’ second testimonial, however, is not as forgivable as the first, which is actually only somewhat forgivable, given how aggressively Somers has used her own testimonial to promote “alternative” medical treatments such as mistletoe extract (which may have some anti-tumor activity but the evidence is very weak–more on that perhaps in a future installment). It reveals such a profound ignorance of what she herself is recommending to women for their “health” that, as a breast cancer surgeon dedicated to providing only the best science-based surgical and medical care to my patients, I must call her out for it.

Knockout: Suzanne Somers’ “whole body cancer” scare

I do not yet have my promotional copy of Knockout, although, I’m assured, it’s on the way. I had debated whether to wait until I had read it to write about the book, but then last week I saw this interview with Ann Curry:

Visit msnbc.com for Breaking News, World News, and News about the Economy

It was also pointed out to me that Chapter 1 of Knockout is available online at the Random House website. It’s entitled A Cancer Story–Mine. I read it and was appalled at the degree of misinformation being discussed right there in the very first chapter of the book, so much so that I started to doubt whether it was such a good idea of me to get a copy of the whole book and do a review on it. Still, I’m made of fairly stern stuff, and Somers is out there promoting the hell out of this book; so I feel that it’s my duty to look critically at the story she begins her book with. Suffice it to say, after I read Chapter 1, I was left shaking my head that anyone would listen to Suzanne Somers about cancer or any other health issue, so deep is the ignorance and so strong the distrust of “Western medicine.” Somers starts out her book by describing a cancer scare. Specifically, she describes an incident in which she was brought to the hospital with what sounds like an anaphylactic reaction of some sort and was misdiagnosed with what she calls “full body cancer.”

Before I go on, let me say right here that I do not mean to denigrate or otherwise downplay the seriousness of what happened to Somers, nor do I mean to cast doubt on the veracity of her story. At the very least, Somers appears to believe what she is saying, and it is quite possible that she was misdiagnosed with widespread metastasis from her breast cancer. I also don’t want to under estimate how much it probably scared her. Imagine yourself having survived breast cancer and then, eight years later, being admitted to a hospital for something else and being told that you had widespread metastases. It’s a horrible thing, if it really happened the way Somers said it happened, and it’s the sort of experience that would terrify anyone.

Color me somewhat skeptical, however.

Certain elements of Somers’ story sound a bit fishy. First off, Somers declines to identify the hospital. Right at the outset, I wondered why that is and can guess at a couple of likely reasons. First, perhaps she’s worried about being sued. Of course, if you’re a celebrity and the truth is on your side you probably don’t have much worry about being sued. In such a case, it’s far more likely that the entity suing would get the worst of it, at least as far as negative publicity. More likely, Somers knows that, whatever hospital she had been admitted to and whatever doctors had cared for her, patient confidentiality and HIPAA law prevent the hospital and doctors from discussing her case–or even admitting that Somers was ever a patient. Indeed, neither the hospital nor any of the health care professionals involved with Somers care can discuss her case without her explicit permission. Their hands are completely tied, and Somers can write and say whatever she wants without fear that anyone will contradict her. That’s why it disturbs me that no one who has interviewed Somers yet has asked her a handful of very obvious–and inconvenient–questions based on the anecdote in Chapter 1, namely:

At what hospital were you hospitalized and when?
Who were your doctors?
Will you release some of your medical records and allow your doctors to speak about your hospitalization?
If not, why not?

These are questions that need be asked in addition to questions about Somers’ support for Nicholas Gonzalez, whose pancreatic cancer “protocol” was recently shown to be worse than useless, but I have yet to see anyone ask her these questions.

Now, on to Chapter 1:

I wake up. I can’t breathe. I am choking, being strangled to death; it feels like there are two hands around my neck squeezing tighter and tighter. My body is covered head to toe with welts and a horrible rash: the itching and burning is unbearable.
The rash is in my ears, in my nose, in my vagina, on the bottoms of my feet, everywhere — under my arms, my scalp, the back of my neck. Every single inch of my body is covered with welts except my face. I don’t know why. I struggle to the telephone and call one of the doctors I trust. I start to tell him what is happening, and he stops me: “You are in danger. Go to the hospital right now.” I knew it. I could feel that my breath was running out.

Right off the bat, to me Somers’ symptoms sound like an allergic reaction to something or an anaphylactic reaction. It could be something else (more later), but the first thing that comes to mind is an allergic reaction. Indeed, upon hearing this story, I couldn’t help but wonder if one of the many supplements that Somers takes on a routine basis was the cause. Did she start any new supplements recently? Certainly I’d wonder about that. (Again, more on that later; my speculation may well have been correct, just not in the way I thought at first.) Regardless of the initial cause, it certainly sounded as though the E.R. docs at whatever hospital Somers was brought to thought she was having some sort of allergic reaction. Based on that, they treated her appropriately with Benadryl, Albuterol, and steroids. Even someone as medically ignorant as Somers realized the most likely diagnosis:

I say to the doctor, “It seems to me that I’ve either been poisoned or am having some kind of serious allergic reaction to something. I mean, doesn’t that make sense? The rash, the strangling, the asphyxiation. Sounds classic, doesn’t it?”
“We don’t know. A CAT scan will tell us. I really recommend you do this,” the doctor says. “Next time you might not be so lucky — you might not get here in time. You were almost out.”

As I read this part of the story, I was puzzled, and certainly Somers didn’t initially give enough information for me to hazard a particularly educated guess about why her doctor ordered a CT scan. After all, a CT scan is not generally the test of choice for diagnosing the cause of anaphylaxis or respiratory distress, which is what it sure sounds as though Somers was being treated for. On the other hand, maybe doctors saw a mass on chest X-ray (quite likely, as we will soon see). They may also have suspected a pulmonary embolus (PE), for which chest CT has supplanted the older test previously to detect PE, namely the V-Q scan. There may have been other findings on physical examination that suggested that a CT scan might be indicated. (There almost certainly were.) Again, initially, at least, Somers doesn’t give us enough information to judge. She does, however, engage in typical pseudoscientific thinking. While acknowledging that those evil pharmaceuticals had saved her life, still she can’t help but attack them:

I am now dressed in a blue hospital gown, and so far I’ve been reinforced by three rounds of oxygen and albuterol. I’m starting to feel normal again. Drugs have been my lifesaver this time. This is what they are for. Knowing the toxicity of all chemical drugs, I’ve already started thinking about the supplement regime and detox treatments I’ll have when I get out of here, to get all the residue of pharmaceuticals out of me. I’m hopeful this will be the one and only time I have to resort to Western drugs.

Remember, whenever you hear an alt-med maven say “Western medicine” (shades of Bill Maher!), what that alt-med maven is really referring to is science-based medicine. As for supplements, if they have anything in them that does anything physiological, they contain “chemical drugs.” There is no difference between “chemical drugs” found in pharmaceuticals and “chemical drugs” found in supplements, other than that the drugs found in supplements are adulterated with all sorts of stuff. There is no magical difference between the two. They both contain chemicals, and the body responds to chemicals through its biochemistry. Nothing makes supplements magically immune to the laws of physics and chemistry. Moreover, “detox” treatments are completely unnecessary quackery. Somers apparently doesn’t realize it, but her body is more than capable of “detoxing” away those evil “Western” pharmaceuticals through its own amazing abilities. Somers appears to think that “Western” pharmaceuticals somehow leave their taint behind. Maybe she thinks the cells in her body have a “memory” in the same way that homeopaths claim that water has “memory” and that the taint has to be somehow purged, just as a Catholic believes that confession purges sins or certain Muslim sects think that self-flagellation will purge them of their sins. It really is religious thinking more than anything else for Somers to think that she was somehow “contaminated” by “Western” pharmaceuticals and needed to have that “contamination” purged.

But I digress. So what did the CT scan find? This, apparently:

We have very bad news,” he continued. My heart started pounding, like it was jumping out of my chest. “You have a mass in your lung; it looks like the cancer has metastasized to your liver. We don’t know what is wrong with your liver, but it is so enlarged that it is filling your entire abdomen. You have so many tumors in your chest we can’t count them, and they all have masses in them, and you have a blood clot, and you have pneumonia. So we are going to check you into the hospital and start treating the blood clot because that will kill you first.”

We already know that Somers did not, in fact, have cancer. (Otherwise, it would not have been a misdiagnosis.) So what she did have, I’ll get to shortly. In the meantime, let’s take a look at what Somers says about her oncologist:

The oncologist comes into my room. He has the bedside manner of a moose: no compassion, no tenderness, no cautious approach. He sits in the chair with his arms folded defensively.
“You’ve got cancer. I just looked at your CAT scan and it’s everywhere,” he says matter-of-factly.
“Everywhere?” I ask, stunned. “Everywhere?”
“Everywhere,” he states, like he’s telling me he got tickets to the Lakers game. “Your lungs, your liver, tumors around your heart … I’ve never seen so much cancer.”

So the oncologist who saw Somers first was a world-class jerk. It’s quite possible. Not every doctor has a good bedside manner, and some have a horrendous bedside manner. Sadly, some of them are oncologists, even though, if there’s a specialty that really demands a good bedside manner, it’s that of medical oncologist. On the other hand, as physicians we have to remind ourselves all the time that what we think we have said to the patient is not always how the patient has heard it and how we come across to the patient is not always how we have, in fact, come across to the patient. Maybe the oncologist was that uncaring, maybe not. We have no way of knowing because all we have is Suzanne Somers’ report. Maybe it’s also true that the other oncologist who saw her was somewhat less of a jerk but just as quick to jump to a conclusion prematurely:

Then the lung cancer doctor enters the room. Maybe he has better news. But no—he says, “I just looked at your CAT scan, and you have lung cancer that has metastasized.” He is nicer, more thoughtful. “I mean, I’m going to think about this,” he says. “Maybe it’s something else, but this sure doesn’t look good. I’ll be back tomorrow.” Leslie takes out pen and paper and is making notes. She will continue to do this the entire week, writing down everything everyone is saying. Thank God, because when you are stunned and on medication, things get foggy.
Day one is almost over. The most shocking, devastating day of my life, our life! I know the facts: when you have lung cancer and it has metastasized to your liver, heart, abdomen, and all over your body, you have at most two months—maybe only two weeks or less.

As a possible bit of perspective, I’ll point out that not too long ago I had to relearn the lesson of how my perception of what I say to a patient may not always jibe with the patient’s perception of what I said. A while back, I saw a patient with breast cancer in her hospital room, a woman I had operated on the day before. I thought I had calmly laid out the situation, reassured her that her tumor was treatable, and told her that she might not need chemotherapy. About an hour later I got a frantic page from the floor. The patient was in tears, and the family was in an uproar. I don’t know how I had done it, but I had somehow given this patient the impression that her situation was hopeless and that she was going to die. When her family arrived to take her home she was crying. Apparently she had interpreted my telling her that she might not need chemotherapy (mainly because of her age and tumor characteristics) as telling her that it was pointless to treat her more. I relearned a valuable lesson that day, one I (and, I daresay, most doctors, no matter how experienced) need to relearn periodically, namely that patients don’t always interpret what I tell them the way I think they will and that sometimes how I view a conversation with a patient may be very different than how the patient viewed the conversation. Fortunately, I was able to reassure everyone and correct the misconceptions that had been left, but I did not feel too good about my bedside manner that day. In fact, the rest of that day I felt like the most insensitive, idiotic doctor in the world.

Or maybe Suzanne Somers’ oncologist was indeed a flaming jerk. That would be the worst case for “Western medicine” in this story, and it is not nearly as uncommon as I’d like to admit for a physician to have the personality of a paper cup or the bedside manner of bully. Besides, it’s easier to assume that that is how the oncologist in question treated Somers. Even so, in that case, I’d say, “So what?” I’m sorry that Somers’ oncologist treated her badly. There’s no excuse for that. I’d also tell her simply to go and get another oncologist or go back to her regular oncologist, which she ultimately did. One nasty doctor does not invalidate “Western medicine,” nor does the occurrence of a misdiagnosis, even one apparently this spectacular. In any case, it’s quite possible that there was a bit of Somers hearing things one way when her doctors weren’t telling it the way she interpreted them as telling her. The reason I say that is because Somers goes on and on, mainly in interviews but also in the book, about how, over six days, doctors told her she needed chemotherapy. As someone who has dealt with medical oncologists every day for over 10 years, that part of her story just didn’t seem very likely to me. The reason is that, in general, oncologists are very reluctant to administer chemotherapy to a patient in the absence of a definite tissue diagnosis proving that they have cancer, be it metastatic cancer or any cancer.

This would be doubly true in a case like what Somers describes in her book, particularly given that she had one oncologist thinking that she had lung cancer, not a recurrence of her breast cancer. In any case, widespread cancer could be a recurrence of her breast cancer (especially given Somers’ proclivity to pump herself full of “bioidentical hormones” after having been treated for an estrogen receptor-positive cancer), but in a 63-year-old woman, there are lots of other possible malignancies. Chemotherapy would be used for breast cancer might not work very well against, say, colon cancer or ovarian cancer, both of which are other likely possibilities in a woman of Somers’ age. Another reason I seriously question whether doctors were pushing hard for chemotherapy in a mere six days is because, if they truly thought she had such a massively widespread recurrence of her breast cancer, particularly an estrogen receptor-positive breast cancer, all treatment would be palliative. We can’t cure most metastatic solid tumors, and the first rule in treating stage IV disease is usually the classic “First, do no harm.” Thus, oncologists usually tend to do the minimum possible that it takes to relieve symptoms and (hopefully) slow the progression of the tumor. Most likely, if this was indeed metastatic breast cancer, an oncologist would have chosen to treat Somers first with an anti-estrogen drug, probably an aromatase inhibitor (no tamoxifen if she had blood clots causing that much trouble!) and then seen how she did. In the case of a woman who has ER(+) cancer recur as stage IV disease, that is almost always the first option. In such cases, chemotherapy is usually reserved for the case when antiestrogen therapy fails. Indeed, if the cancer was truly as widespread as Somers reports, chemotherapy might not even be used at all if the likelihood of success is tiny; in such cases, hospice would be recommended.

Be that as it may, the very first thing that any competent oncologist would demand before initiating chemotherapy is a tissue diagnosis, either from a needle biopsy or other tissue, to prove that there was cancer and to identify the type of cancer, so that the correct chemotherapy could chosen. Cancer chemotherapy is not like antibiotic therapy. In the case of infectious diseases, it is not uncommon to begin an antibiotic empirically based on the most likely organisms to be causing the infection and then to tailor the therapy to whatever organism(s) can be identified by cultures. Oncologists, on the other hand, are incredibly reluctant to treat metastatic cancer empirically, particularly cancer that appears to have recurred eight years after the original diagnosis of a stage I tumor. Such cancer might very well be a different cancer from a different organ, and the chance of doing harm with chemotherapy for no benefit is too great.

That’s why I thought right away that there’s something very fishy about Somers’ story. It just doesn’t add up very well. What I suspect to have happened is that perhaps the oncologist did have a conversation about a probable need for chemotherapy, and, like my conversation with my postoperative patient, Somers saw the conversation differently from how her doctors did. She probably viewed various “what if” scenarios or “if this is recurrent breast cancer, then you will need this” conversations as “pressuring” her to take chemotherapy. If her oncologist wasn’t particularly warm and fuzzy or patient, she might have been even more likely to interpret his recommendations that way. Or perhaps her oncologists were incompetent enough to pressure her to take chemotherapy without a diagnosis of biopsy-proven cancer. Who knows? Even if the latter is true, it still doesn’t excuse Somers’ horrible ignorance that becomes manifest later in the chapter.

Ultimately, Somers did get a biopsy. She describes it in her interview above, “They cut into my neck and went in and took a piece of my lung, a piece of one of the so-called tumors around my heart turned out it was not cancer at all.”

So what was it?

I’ll admit that my first guess, sarcoidosis, was dead wrong. Given the symptoms of skin lesions, shortness of breath, and, apparently, “tumors around the heart” (which could indicate either pericardial involvement, or, more likely enlargement of the paratracheal nodes), I didn’t think it too unreasonable a first guess. (Besides, in the cases in House, MD, sarcoidosis almost always appears on the differential diagnosis list.) However, never having lived in the southwest, having forgotten my medical school learning about common fungal infections, and being what I self-deprecatingly like to call a dumb surgeon, I didn’t consider what turned out to be the real diagnosis right away, namely valley fever, or, as it’s known by its official name, coccidioidomycosis. Indeed, the description of the most severe disseminated form of coccidioidomycosis matches Somers’ presentation quite well:

The most serious form of the disease, disseminated coccidioidomycosis occurs when the infection spreads (disseminates) beyond the lungs to other parts of the body. Most often these parts include the skin, bones, liver, brain, heart, and the membranes that protect the brain and spinal cord (meninges).
The signs and symptoms of disseminated disease depend on which parts of your body are affected and may include:
Nodules, ulcers and skin lesions that are more serious than the rash that sometimes occurs with other forms of the disease
Painful lesions in the skull, spine or other bones
Painful, swollen joints, especially in the knees or ankles
Meningitis — an infection of the membranes and fluid surrounding the brain and spinal cord and the most deadly complication of valley fever

Now here’s the kicker. Take a look at these two (out of several) risk factors for the most severe form of coccidioidomycosis:

Weakened immune system. Anyone with a weakened immune system is at increased risk of serious complications, including disseminated disease. This includes people living with AIDS or those being treated with steroids, chemotherapy or anti-rejection drugs after transplant surgery. People with cancer and Hodgkin’s disease also have an increased risk.
Age. Older adults are more likely to develop valley fever than younger people are. This may be because their immune systems are less robust or because they have other medical conditions that affect their overall health.

These are risk factors for the serious disseminated coccidioidomycosis. Most people who contract coccidioidomycosis are either asymptomatic or exhibit relatively mild symptoms. Indeed, valley fever often presents as a flu-like illness from which people recover rapidly. Many people, in fact, are unaware that they’ve ever had coccidioidomycosis until there’s either an abnormality on chest X-ray done for another reason or they have a positive skin or blood test. It’s very much like histoplasmosis right here in the Midwest. So why did Somers get such a serious case? It’s a legitimate question, given how she represents her regimen of supplements, bioidentical hormones, and various other woo as a highly effective path to rejuvenation and health that she recommends to her readers. Let’s see. Somers is 63, but apparently in good health. She also takes all sorts of supplements which, or so she claims, “strengthen the immune system.” But her immune system was obviously not strong enough to prevent her from getting disseminated coccidioidomycosis. Why didn’t all those supplements ward off the fungus? For someone who takes handfuls of supplement pills every day and makes millions of dollars selling woo to “boost the immune system,” Somers sure doesn’t appear to have a particularly strong immune system, as it failed miserably to protect her from a severe infection due to an endemic fungus that usually causes only mild disease or any symptoms at all but almost killed her.

Another possibility presents itself. As we know from her previous books and appearances on The Oprah Winfrey Show, Somers takes boatloads of “bioidentical” hormones. She promotes them as a fountain of youth for women. One wonders if any of her various supplements or bioidentical hormones were somehow adulterated with corticosteroids, which suppressed her immune system, one does. Or at least I do.

One need wonder no more. Right there, in Chapter 1 of her book, is a highly plausible, highly likely explanation for why Somers became as ill as she did from coccidioidomycosis:

Day 5. Dr. Oncologist comes into my room. Now, you would think he’d say, “Well, sometimes it’s good to be wrong.” Or “Isn’t it great that you don’t have cancer?” But no. He walks in, doesn’t sit down, just looks at me and says angrily, “Well, you should have told me you were on steroids.”
I am flabbergasted. I don’t know what to say to him; I am so stunned by his lack of compassion that I just stare at him. I am not on steroids. I would never take steroids. But because he is stuck in old thinking and so out of touch with new medicine, he has no clue and doesn’t understand cortisol replacement as part of the menopausal experience.
I don’t know where to begin with him. He’s too arrogant to listen to a “stupid actress,” anyway. So much of his attitude with me has been the unsaid but definite “So you think all your ‘alternatives’ are going to help you now, missy?”
Why steroids would have anything to do with being misdiagnosed with full-body cancer, I can’t guess. But we still don’t know what has gone wrong in my body. We still have to find out what caused me to end up in the ER.

(Emphasis mine.)

It’s incredibly hard at this point not to go even beyond Mark Crislip-grade acid sarcasm at the arrogance of ignorance on display. Here we have a woman who is apparently taking cortisol as part of her “bioidentical hormone” cocktail, and this woman does not know that each and every one of those estrogens she is taking is a steroid hormone. More importantly, Somers apparently does not know that cortisol is a corticosteroid (”cortico,” get it?), the very same kind of steroid that is routinely used by us evil reductionist practitioners of “Western medicine” as an anti-inflammatory and immunsuppressant. When used that way by us evil pharma shills, cortisol is known as hydrocortisone, which is–gasp!–a pharmaceutical concoction! It’s also “bioidentical,” too, proving once more that “bioidentical” does not mean “risk-free.” Indeed, hydrocortisone is often included as one of the drugs in immunusuppressive protocols used to prevent the rejection of organ transplants. Given that Somers has said that she takes enough “bioidentical” estrogens to recreate the hormonal milieu of a woman in her 20s (in other words, far more estrogens than a 63 year old woman would ever have or need), it’s not beyond the pale to wonder whether she similarly takes a significant dose of hydrocortisone (sorry, cortisol) as part of her brew of “bioidenticals,” particularly in light of her having fallen seriously ill due to an organism that usually causes mild disease in immunocompetent hosts. Yes, valley fever can sometimes be a bad disease in immunocompetent hosts, but being immunocompromised for whatever reason is still a significant risk factor for disseminated disease or the reactivation of quiescent disease.

After reading Somers’ story in Chapter 1, I shook my head in disbelief that Random House apparently didn’t have better editors who could have told Somers that she had just written something incredibly contradictory and just plain dumb when she wrote that didn’t take steroids in the context of writing how she castigated her oncologist for “not understanding” the role of cortisol in her menopause treatments. Also, based on Somers’ (or her ghostwriters’) own words in Chapter 1 of her book, I think I have discovered the most likely explanation for Somers’ contracting disseminated coccidioidomycosis. True, it could be that she was just unlucky and getting old, given that age is indeed a risk factor for disseminated disease, but one can’t ignore all the supplements she was taking. One can’t ignore that Somers was apparently taking cortisol as part of the cocktail of “bioidentical hormones” to recapture her youth. It is thus very reasonable to wonder whether the reason that Somers became so ill last year was because she had been chronically dosing herself with cortisol and suppressing her very own immune system. Worse, Somers doesn’t even understand that cortisol is a steroid and an immunosuppressant and therefore can’t accept or admit that this is a possibility. Indeed, that misunderstanding is leading her to view her misdiagnosis as clear evidence supporting her worldview that “Western medicine” is hopelessly flawed, chemotherapy rarely works, and the “alternative” medicine doctors whom she interviews can actually cure cancers that “Western” medicine cannot. Even worse still, Somers is successful enough to be able to parlay her suspicion into a highly lucrative career, and her promotion of dubious, unproven, and even ineffective medical treatments for cancer may well result in cancer patients who might be saved eschewing science-based medicine and endangering their lives. At least, that is what I fear.

A panoply of unproven treatments and what’s to come

As I said before, I plan on looking at Knockout and writing a more formal review once I get my copy to read. That’s why this post is labeled “Part 1.” However, so incensed was I at the rank pseudoscience and dangerous misinformation being promoted relentlessly over the past week by a woman who is apparently utterly ignorant of what a steroid hormone is or that steroids are immunusuppressive that I decided to do this post now, while Somers’ media blitz is still at its height. I concluded that an antidote to Somers’ promotion of nonsense such as the Gonzalez protocol needed to be provided in clear, concrete, unequivocal terms was needed now, that someone needed to express his opinion now that pseudoscience such as the Gonzalez protocol is quackery, particularly given the limp, woo-friendly response of Dr. Otis Brawley, chief medical officer for the American Cancer Society. His article, Somers’ cancer advice is risky, appeared on CNN.com. In it Dr. Brawley practically bent over backwards to be conciliatory, calling Somers a “wonderful actress” (she’s not and never has been), writing that he is “not critical of the concept of alternative and complementary medicine” (I am) and that “open-mindedness to other ideas is how we advance conventional medicine” (apparently his mind is so open that his brains threaten to fall out), even going so far as to invoke the hoary old alt-med examples of aspirin being derived from tree bark or vincristine being derived from a plant as though pharmacognosy were the same thing as herbalism. It’s not. Moreover, I wanted to provide a handy-dandy resource for journalists who may be interviewing Somers or people who may be seeing her at book signings or promotional events, hoping against hope that skeptics will ask her why she doesn’t think a steroid like cortisol wouldn’t predisopose her to disseminated coccidioidomycosis or why she thinks that Dr. Gonzalez is “curing cancer” when a clinical trial was published a mere two months before her book was released that showing clearly that his protocol is worse than useless and that pancreatic cancer patients undergoing conventional therapy live three times longer than those undergoing the Gonzalez protocol.

A guy can hope, can’t he?

In the meantime, here’s a chapter list, which will give you an idea of what you have to look forward to when I get around to reading the book:

The Doctors Who Are Curing Cancer
Chapter 5: Stanislaw Burzynski, M.D.
Chapter 6: Nicholas Gonzalez, M.D.
Chapter 7: Burton Goldberg
Chapter 8: Julie Taguchi, M.D.
Chapter 9: James Forsythe, M.D.
Preventing Cancer Before it Starts
Chapter 10: Russell Blaylock, MD
Chapter 11: Steve Haltiwanger, MD
Chapter 12: David Schmidt
Chapter 13: Jonathan Wright, M.D.
Chapter 14: Steven Sinatra, M.D., F.A.C.C., F.A.C.N.
Chapter 15: Michael Galitzer
Chapter 16: Cristiana Paul, M.S.

Most names I actually don’t know, but some names stand out, such as Dr. Burzynski, whom we haven’t yet discussed much on this blog but should (reviewing this book will give me just that opportunity), and Dr. Blaylock, who is best known for videos like this about H1N1:

I’ll spare you parts 2 and 3 of Dr Blaylock’s video. You get the idea, and if you are masochistic enough top want to view them, you can easily find them on YouTube. Suffice it to say, showing up on Alex Jones’ Prison Planet TV is not exactly a way to burnish one’s scientific credentials. Jones’ websites, Infowars and Prison Planet, are repositories of conspiracy craziness on par with David Icke’s lizard people, including 9/11 Truthers, “New World Order” conspiracy theorists (including, of course, the Illuminati and the Rothschilds), and a heaping helping of anti-vaccine and alt-med conspiracy mongering. In fact, Dr. Blaylock isn’t too far from David Icke’s rant about how the swine flu vaccine is a plot by the Illuminati.

Such are Suzanne Somers’ “doctors who are curing cancer.”

The bottom line is that, whatever her intentions, whether they be to help people or make money or both, Somers is unwittingly promoting dangerous cancer “cures” that are anything but cures. They are treatments that are anything but science-based, as well. Just as Jenny McCarthy, Jim Carrey, and Bill Maher are promoting anti-vaccine pseudoscience to the nation and Oprah Winfrey is providing an unmatchable soapbox for all manner of promoters of woo, Somers is taking advantage of her position to bash conventional medicine and promote non-science-based medicine, most likely raking in the cash hand over fist.

People may well die as a result.

“Methodolatry”: My new favorite term for one of the shortcomings of evidence-based medicine

Posted on November 8, 2009 by Danzig

I’d like to thank revere right now publicly. He’s taught me a new word:

Methodolatry: The profane worship of the randomized clinical trial as the only valid method of investigation.

Many of you have e-mailed me and other SBM bloggers about a recent article in The Atlantic by Shannon Brownlee and Jeanne Lenzer, two reporters whose particular bias is that we as a nation are “over treated.” That may be true, although not to the extent that Brownlee, at least, seems to think, and her article on swine flu was truly biased and painful to read. Moreover, “methodalatry” perfectly describes one of the complaints we at SBM have about the “evidence-based medicine” paradigm. So I’m really glad that revere took it on and demolished it.

The hero of The Atlantic article, Tom Jefferson clearly has an agenda about flu vaccines. Indeed, he has such an agenda that he was invited to the National Vaccine Information Center’s vaccine conference in early October. The NVIC is the oldest and biggest antivaccine organization there is. Either he didn’t know that, in which case he’s clueless, or he didn’t care. In any case, it was clear that he was invited there because of his stance on flu vaccination, and he was even going to be awarded the NVIC “Courage in Science” Award. To his credit, Jefferson backed out when he found out that he would be sharing the stage with Andrew Wakefield, who was to be given the NVIC “Humanitarian Award.” He was appropriately horrified. Still, he should never have accepted in the first place, given that the NVIC clearly wanted to coopt him and use his gadfly status to make its anti-vaccine stance seem reasonable and science-based.

That’s just one reason why I don’t take Tom Jefferson particularly seriously anymore. I tend to agree with revere that Jefferson is drifting perilously close to crank territory with respect to flu vaccines. Indeed, “methodolatry” is an awesome term to describe his approach. Actually, it’s a great term to describe some of the Cochrane scientists responsible for analyzing the efficacy of mammography screening, as well; their conclusions and methods rather remind me of Jefferson’s.

Finally, you might also want to reread (or read for the first time if you haven’t read it already) Mark Crislip’s article on flu vaccine efficacy, which, although not directly written in response to Brownlee’s article, does address many of the shortcomings in its analysis of H1N1 vaccine efficacy.

Maine’s Dirigo Health Savings One-Third of Original Estimate

Posted on November 8, 2009 by Danzig

Maine's Acting Insurance Superintendent, Eric Cioppa, ruled last Monday (17 September) that the Dirigo Health Program saved the health care system $32.8 million in its third year of operation; roughly only one-third of the original $92.7 million savings estimate released on 8 July 2007.

Despite Karynlee Harrington, executive director of the Dirigo Health Agency, previously stating in the Portland Press Herald that the agency had refined the methodology used to determine the savings amount based on past decisions of the superintendent, it appears the agency needs a new mathmagician in accounting.

On 27 July, the Dirigo Health Board of Director had reduced the estimated $92.7 million to $78.1 million. The September 17 ruling of $32.8 million is the lowest savings figure, to date, in the agency's short, but beleaguered history; a possible indication that the agency has lost its steam. Last year's savings were $34.2 million and the first year savings were ruled to be $43.7 million.

Of the $32.8 million, Cioppa found that the program provided $25 million in hospital savings, $6.3 million in uninsured and under-insured initiatives, and $1.5 million in provider fee savings. The savings form the basis of the Savings Offset Payment (SOP), the sole funding mechanism for the program.

At a Dirigo Board meeting held after Cioppa's ruling, members discussed the possibility that the decrease in funding may result in the elimination of the subsidies currently paid to a majority of DirigoChoice program participants.

The Maine Dirigo Health program was established in 2003. Dirigo stopped accepting new enrollees July 1, 2007.?

August a Flurry of Activity

Posted on November 8, 2009 by Danzig

I have to apologize for the abrupt shortage of articles in August, but the month was an absolute flurry of activity, behind the scenes.

In addition to maintaining BLOG Medicine, we operate a parent company (Maynard & Company) that provides healthcare consulting and management services. Thanks to the steady increase in clients throughout New England, the services provided through Maynard & Company have transitioned to a new entity called Origin Health Group, recently taking on clients in the additional regions of the Mid-Atlantic and Deep South. The stretch goal for 2008 is for Origin Health Group to have a presence coast-to-coast.

Also, after 11 months of brainstorming and hard work, we've created MedBay, the on-line auction community for healthcare equipment and services. MedBay is wrapping up testing and is targeted for general release October 1. Given the heightened awareness about health insurance and reform, MedBay will provide the ideal community mix for patient, provider, and purchaser. I think MedBay will offer an exciting and attractive alternative to the current more restrictive and cost-prohibitive approach to paying for healthcare. We'll be providing more information over the next few weeks as we approach our "go-live" date.

Finally, BLOG Medicine is evolving. Over the next few months, BLOG Medicine will integrate into a larger blog platform that will include a mix of topics written by contributors from throughout the blogosphere. Although my dedication hasn't changed, due to the other time commitments, my BLOG Medicine entries will now be biweekly on Mondays and Thursdays. Bloggers interested in contributing to BLOG Medicine and/or the larger platform (including suggesting a name for it) are welcome to comment/contact me here.

Exciting times, indeed. Expect BLOG Medicine to be back on schedule (and topic) with today's submission and watch for appropriate updates regarding MedBay over the coming weeks and [Insert New Blog Platform Name Here] over the coming months. As always, I'd like to thank the readers of BLOG Medicine and especially those who have taken the time to comment -- we're nothing without you.?

New Orleans: Health Challenges

Posted on November 8, 2009 by Danzig

The Saturday, 4 August 2007 New Orleans Advocate reported that while the city is still facing the same significant healthcare needs and large racial disparities in health that existed prior to 2005's Hurricane Katrina, the storms also had a leveling affect across many health access and utilization measures, creating new access to care barriers for many still living in the region.

The basis for the article is the recently released report by the Kaiser Family Foundation, "Health Challenges for the People of New Orleans," that acknowledged that Katrina has made life more difficult for everyone in the area.

The Kaiser report is the result of a door-to-door survey of 1,500 residents in Orleans, Jefferson, St. Bernard, and Plaquemines parishes in Fall 2006.?

Dirigo Health: Con Artists, Liars, and Thieves?

Posted on November 8, 2009 by Danzig

With no new enrollment as of July 1 and stated savings estimates and membership numbers gyrating up and down faster than a turkey trot, one has to wonder if Maine's Dirigo Health is made up of con artists, liars, and thieves or if they actually believe their mathmagical accounting.

On 8 July 2007, Dirigo Health released a 2006 estimated savings amount of $92.7 million. By Friday, 27 July Maine's Dirigo Health Board of Directors had reduced the amount they claim the Dirigo Health program has saved the state's healthcare system in 2006 to $78 million, still more than twice the amount determined in 2005 that required a ruling by the State Supreme Court to be settled. The recently reduced $78 million figure will now be submitted to the state superintendent of insurance, who has historically reached a lower number than the board, for final determination.

Karynlee Harrington, executive director of the Dirigo Health Agency, was quoted in the Portland Press Herald stating that the agency has refined the methodology used to determine the savings amount based on past decisions of the superintendent seemingly oblivious as to why it should be objectionable that Dirigo's accounting methodologies are changeable, year-to-year and seem to conveniently eliminate Dirigo's earlier cost concerns. However, not only do Dirigo's accounting methodologies change based on the needs of the day, but the membership numbers experience dramatic unexplained leaps, as well.

On 1 July 2007, when Dirigo stopped accepting new enrollees stating cost concerns, they quoted membership of 14,400, many of whom already had insurance and less than half of the 31,000 Dirigo said they would cover in 2003 and nowhere near the 130,000 Dirigo forecast for coverage by 2009. By 28 July 2007, only 27-days after halting enrollment, Dirigo mathmagically claims 26,000 Maine residents have been helped.

For their part, as expected, Maine insurance carriers plan to dispute the board's figures, adding that it's a conflict of interest for the Dirigo board to make a determination on savings that will translate into income for its program.

Dirigo's annual attempt to be more than just another failed attempt at healthcare reform with lingering delusions of grandeur is similar, in its own way, to the frivolousness, fantasy, and mathmagical fiction that might be found in a Harry Potter book -- too bad, unlike JK Rowling, Dirigo doesn't know when to end the fairy tale.?

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