Two weeks ago, Canadian Skeptics United published on their Skeptic North site a piece by an Ontario pharmacist criticizing a proposal by the province to grant limited prescribing rights to naturopaths. The essay, which was reprinted in the National Post on Tuesday, outlines the intellectual and practical conundrum presented by allowing those with education that diverges from science-based practices to prescribe drugs.

The naturopath lobby came out in force and was relatively unopposed in the 54 comments that followed, primarily because the NP closes comments 24 hours after online posting. Therefore, those with a more rational and considered viewpoint based in facts were locked out from commenting. This is quite disappointing to me personally and professionally because of the wildly emotional appeals, strawman arguments, and smears and attacks on the author himself without, of course, addressing his well-founded criticism of the prescribing proposal before the provincial government.

At the Skeptic North post, the piece even drew a naturopath who equated the criticism of his/her field with the Nazis and Mussolini. However, you can’t write critiques of these practices without attracting attacks ad hominem, especially Godwin’s Law, that are the resort of those whose arguments are logically flawed.

Naturopathy, sometimes called naturopathic medicine, is an unusual and inconsistently regulated alternative medical practice that co-opts some evidence-based medicine, often in nutrition and natural product medicines, but also subscribes to “vitalism” (vis medicatrix naturae) and makes use of homeopathic remedies that defy the rules of physics and dose-response pharmacology.

Naturopathy is, however, a warm and fuzzy term, especially when equated with “natural medicine” and the fact that people with naturopathy degrees advertise themselves with the honorific of “Dr.” The increasing popularity of naturopathy is also supported by cultural influences. I’ve written elsewhere that many, uh, natural product enthusiasts have become interested in naturopathy following the relocation of musician Dave Matthews from Charlottesville, VA, to Seattle, WA, where his wife, Ashley Harper, earned a naturopathy degree at Bastyr University.

In addition to the description of the practice in the NP op-ed, an excellent review and critical analysis of naturopathy by SBM’s Kimball C Atwood IV, MD, can be found at Medscape General Medicine. The abstract is as follows:

“Naturopathic medicine” is a recent manifestation of the field of naturopathy, a 19th-century health movement espousing “the healing power of nature.” “Naturopathic physicians” now claim to be primary care physicians proficient in the practice of both “conventional” and “natural” medicine. Their training, however, amounts to a small fraction of that of medical doctors who practice primary care. An examination of their literature, moreover, reveals that it is replete with pseudoscientific, ineffective, unethical, and potentially dangerous practices. Despite this, naturopaths have achieved legal and political recognition, including licensure in 13 states and appointments to the US Medicare Coverage Advisory Committee. This dichotomy can be explained in part by erroneous representations of naturopathy offered by academic medical centers and popular medical Web sites.

Like many alternative practices, naturopathy claims to harness the body’s own healing power as if differentiating that fact-based medicine does not also employ the body’s capacity to heal. The very same drugs that naturopaths wish to prescribe are those which can only work because they interact with targets in the body for which our endogenous compounds already act.

It seems to me that naturopathy adopts either science-based medicine or pseudoscience depending on the venue in which it serves the organization.

Because of my oft-expressed love of Canada, I had always thought that our neighbors to the north were more rational and had more finely-tuned critical thinking skills than we in the United States. However, I learned from the op-ed that British Columbia has already given prescribing rights to naturopaths.

I’m really surprised about this because of the furor that erupts whenever a proposal comes up to confer limited prescribing rights to pharmacists. Having taught in US colleges of medicine and pharmacy, I can state confidently that pharmacists have roughly four times the pharmacology and therapeutics coursework of physicians (albeit with not nearly as intensive postgraduate training). With the Doctor of Pharmacy degree firmly established as the entry-level pharmacy degree, pharmacists are now participating with physicians to gain practical clinical training in specialty areas.

But even with this extensive training in the same environment, legislated pharmacist prescribing is extremely limited worldwide. I remember it being a monumental achievement when my former PharmD student became the first pharmacist in the state of Arizona to have earned limited prescribing rights.

Therefore, I am amazed that Canadian politicians and health authorities are lending support to naturopath drug prescribing.

Another major challenge of this proposal relates to medical liability, an issue that seems to have been ignored previously but is articulated nicely in the NP op-ed:

A key role of the pharmacist is to double-check the safety and appropriateness of a prescribed drug. When required, the pharmacist resolves drug related problems with the prescriber. This is only possible because pharmacists, physicians, and nurse practitioners work from a common, science-based understanding of drugs and disease. In contrast, naturopaths may not share this science-based approach to illness, and may rely on references that are unknown to, inconsistent with, or directly contradict the medically accepted standard of care. If naturopaths prescribe a drug based on a naturopathic belief system, and a pharmacist determines that the prescription is not appropriate from a scientific and evidence-based perspective, what will the pharmacist’s responsibility be? Will pharmacists be held liable for prescriptions written by naturopaths who do not share a science-based view of illness?

Here’s a question, though: if the legislation moves forward, could pharmacists refuse to fill a prescription from a naturopath the same way that some states allow for “conscientious objection” by pharmacists for filling emergency contraceptive prescriptions?

I also wonder why pharmaceutical companies have not gotten involved in this debate. Corporate liability is also likely to be influenced as improper prescription of drugs is bound to increase the number of reported adverse reactions.

Nevertheless, the bill is moving forward:

The Bill passed second reading and was referred to the Standing Committee on Social Policy. Several naturopath organizations were on the agenda, and argued for “unambiguous authority for prescribing, compounding, dispensing or selling a drug as designated in the regulations” – essentially a clause that will allow naturopaths gain access to prescription drugs, developing a list out of the public eye. The standing committee accepted this request (the revisions may be viewed here [PDF]), and put naturopath prescribing into Bill 179. Third reading is expected sometime this fall. If it passes, the right for naturopaths to prescribe drugs will become entrenched in Ontario law.

The legislation of quackery presents a major threat to public health, pure and simple.

A rebuttal from two naturopaths has now appeared at the National Post. Therein, the typical distancing from science-based medicine is claimed while concomitantly arguing that naturopathy is based in science, followed then by excoriation of the randomized, controlled clinical trial. The typical chesnuts of distinction are invoked such as recognizing the healing power of the body, individualized patient care, and focus on disease prevention – all of which science-based medicine employs no matter how it is spun. One cannot simultaneously claim to embrace and reject science, yet this is done in the NP rebuttal. The responses are much more reasoned including an especially superb point-by-point comment by “steveisgood” (the page doesn’t provide unique URLs for each comment so you’ll have to scroll down by hand).

I am just a parent with some questions about vaccine safety and was happy to find your website.  I have noticed that the Scandinavian countries do not routinely recommend HepB vaccination unless the mother is a known carrier.  I did not see this addressed anywhere on your website and I hope you or one of your colleagues might consider discussing the reasons that some advanced countries are not routinely giving this particular vaccine. Thank you.”

Vaccination is a complicated and at times confusing topic that generates a large number of quite reasonable questions by parents like the one above.  At the same time, the ever-wandering aim of the anti-vaccinationist movement appears once again to be falling on the vaccine against Hepatitis B, and I’ve heard them pose this very question with the intent of sowing doubt in the current vaccination schedule.  Regardless of the source, this question is clearly on the mind of some parents, and I am happy to answer it.

As usual, this question has quite a bit to parse out.  I think it may be most helpful to examine why we vaccinate against Hepatitis B the way we do in the US, how most countries in the world approach the problem, and finally examine the reason why eight European countries do not universally vaccinate against HBV.  First things first though: what is Hepatitis B?

HEPATITIS B

Hepatitis B (HBV) is a double stranded DNA virus found in the bodily fluids of infected people including their blood, semen, and saliva, and can be transmitted through sexual contact, exposure of infected fluid to mucous membranes, or through injection.

As the name suggests, infection causes damage primarily to the liver, though the spectrum of disease experienced by any one person can be quite broad.  In adults, 50-70% of infections are asymptomatic or mild enough to not come to medical attention.  The remaining adults experience a range of hepatitis lasting weeks to months, with ~1% of these being a fulminant, life-threatening infection.  Adults are relatively efficient in their ability to clear the virus after the initial infection, and only ~10% become chronicly infected carriers.

Children, on the other hand, present a very different pattern of disease.  Though ~90% of infected children are initially asymptomatic, they are rarely able to clear the virus.  90% of infants and 25-50% of those 1-5 years old will become lifelong carriers.

Chronic Hepatitis B infection is a serious problem.  Beyond the ability of most chronic carriers to spread the virus throughout their lives, ~ 20% of people with chronic Hepatitis B develop cirrhosis, a condition where the liver cells are lost and the liver becomes progressively more fibrotic and dysfunctional.

Cirrhosis isn’t the only life-limiting problem to result directly from chronic Hepatitis B infection.  Hepatocellular carcinoma, a primary cancer of the liver, is in the top 10 cancers in both sexes in the US, and 60-80% of all cases are cause by Hepatitis B.  All told, around 25 % of people who become chronically infected with Hepatitis B will die from its complications.

Hepatitis B is a major cause of worldwide morbidity and mortality. More than 1/3 of the world’s population has been infected with Hepatitis B and 5% are chronic carriers.  That totals up to around 350,000,000 people chronically infected, and around 620,000 deaths from HBV yearly.

As in many health care related issues, the worldwide epidemiology of HBV infection does not necessarily reflect that of the United States.  Even so, the picture isn’t particularly pretty.  Around 5% of the US population has been infected with Hepatitis B, and 0.3 are chronic carriers.  Most HBV infections occur in those aged 25-44 (4/100,000), with the lowest rates of infection in those under 15 (0.1/100,000).   In 2007 4,519 new cases in the US were reported to the CDC, though this represents a fraction of the total number of infections.

These numbers are significant.  To put this in perspective, the mortality from HBV in the US was 5 times higher than Haemophilus influenza type B and 10 times greater than measles before vaccination was introduced.

The Hepatitis B Vaccine

HBV is a relatively stable virus posing a serious public health threat with humans as the only known reservoir, and as such is a prime target for prevention, and theoretically eradication, through vaccination. The first vaccine against HBV became available in 1981, and the current recombinant vaccine has been in use since 1986.  As a recombinant vaccine it contains proteins normally made by HBV, but does not have the virus itself, and therefore carries no risk of HBV infection.

As far as efficacy is concerned, the HBV vaccine has a very high response rate, inducing an appropriate antibody response in more than 95% of people from birth to 30 years of age, and decreasing but still significant response rates in older age groups.  Immunity from the vaccine lasts at least 20 years in healthy individuals.

The HBV vaccine has an excellent safety record.  The most common side effects are pain and swelling at the injection site in ~3% of people, and fever in ~1%.  The only serious confirmed reaction is anaphylaxis that occurs in 1/600,000 injections with no deaths reported in over 20 years of use.  Concerns regarding the HBV vaccine’s association with demyelinating diseases, the use of thimerosal in its formulation in the past or aluminum at the present have all been investigated and found to be without support; I will give such allegations no further time in this post.

Strategies of Hepatitis B Vaccine Use

There are a number of viable strategies available to countries seeking to address the spread of HBV in their populations, and variants on each.  When deciding which strategy is best for any given country, there are multiple factors to consider, including disease severity, the availability and efficacy of treatments, the risk and cost of infection, the risk, efficacy and cost of vaccination, etc.

The first option is to vaccinate people at high risk of infection.  In situations where the risk of infection is very low this makes good sense.  For instance, in the US the risk of contracting Yellow Fever is essentially zero at baseline without vaccination.  No risk or cost of vaccination, no matter how small, is small enough to offset zero risk of disease, therefore we do not routinely vaccinate against it.  However, if you were to travel to an area where Yellow Fever is endemic, your personal risk can suddenly become significant, and easily justify the minimal cost and risk of vaccinating you as a person at high risk.

Since the majority of people infected with HBV have identifiable risk factors, this approach makes some sense.  However, it has several major drawbacks.  It requires all individuals in a high-risk group to have health care, be identified, and to acquire the vaccine before they are infected.  This is labor and cost intensive, and extremely unlikely to capture the entire target population. Well executed, this approach can protect a majority of people at high risk, but in the case of HBV it will not immunize a large enough population to generate a herd immunity effect. The greatest flaw of this approach lies in the 1/3 of HBV infections that occur in people with zero known risk factors who, by definition, are unable to further reduce their risk, and are left unprotected by a vaccine. These shortcomings guarantee this strategy will fail to fully control the spread of HBV in the community.

The second approach is to vaccinate the entire population as they enter into the age of greatest incidence of infection, adolescence and early adulthood.  This addresses one of the shortcomings of the first strategy, namely the need to identify people at high risk.  It also takes advantage of the fact that children more reliably have health-maintenance office visits than do adults, and are more likely to be given vaccinations as part of a universal schedule.

Though this captures a large majority of the total number of infections, it too has a flaw; it fails to address the people infected in early childhood.  Though this is a relatively small number of people (4% of HBV infections), remember that children are far more likely to become lifelong carriers, and thus make up a disproportionate number of the infected at any one point in time (24% of chronic carriers).  While more effective at reducing the prevalence of HBV in the population than only vaccinating high-risk groups, this strategy too has little hope of eliminating HBV.

The third possible strategy is to vaccinate people at the time of birth.  This strategy addresses the problem of perinatal infection, prevents the acquisition of HBV by people during early childhood when the risk of chronic infection is highest, and since the immunity it induces lasts for decades it covers the entire population during the highest risk times of their lives.  Universal vaccination with HepB vaccine at birth, even in regions with a low prevalence of chronic carriers like the US, could reduce mortality by an additional 10-20% compared to early childhood vaccination.

Even this strategy has a drawback, however, and that is time.  Beginning an immunization program with only infants would take a few decades to generate a maximum reduction in HBV in the population.

The US Vaccination Strategy

Though the burden of disease from HBV in the US is relatively low compared to say, heart disease, it remains a significant public health threat only partially addressed through screening, education, and preventative measures, and with limited treatment options.  This makes it an ideal target for vaccination.

From 1981 through 1991 the US vaccinated only people with identified risk factors. Predictably, this campaign had an underwhelming effect on HBV infections seen during this time period.

In 1991, the strategy was reworked to better address the various methods of HBV transmission in an attempt to eliminate HBV spread in the US.  The new strategy is an amalgam of all three strategies described earlier. In addition to vaccination of high risk groups, we began universal vaccination of all infants at birth, vaccination of adolescents, and prenatal screening of pregnant women to identify children who would require not only vaccination at birth but also Hep B immunoglobulin (HBIG).

Since its launch in 1991, we have seen a steady decrease in Hepatitis B infections. Hep B incidence in the US fell from 10.7/100,000 in 1983 to 2.1 per 100,000 in 2004. (25,916 total cases down to 6212 cases).  Though it’s true other factors have been contributing to HBV’s decline, most notably the public education campaign aimed at curbing the spread of HIV, this doesn’t account for the pattern of HBV decline across age groups.  There has been a 95% drop in HBV in people under 15 years of age, 87% in ages 15-24, 71% from 25-44, and 51% decrease in people over 45 years old.  This is precisely what you would expect from a pediatric vaccination campaign.

Using a cost effective and exceptionally low-risk intervention of universal Hep B vaccination the US is well on its way to control, if not elimination, of HBV.

The Northern European Vaccination Strategy

The strategy taken by the US is typical of most developed nations, even those with a relatively low incidence of HBV.  In 1992 the WHO recommended the inclusion of HBV vaccination in nearly all national vaccination programs.  Since that time, the vast majority of countries (177/193 countries) have adopted infant HBV vaccination into their childhood schedules as can be seen here.  This graphic also illustrates the few countries that have instead opted to vaccinate only high-risk individuals, primarily those in Northern Europe, including Scandinavia.

The reason these countries have not adopted universal vaccination against HBV is the exceptionally low level of HBV in their population and the associated costs of prevention.  Sweden, for instance, has one of the lowest prevalences of HBV in the world at 0.05%.  This is 6 times lower than what we have in the US, with the majority of cases occurring in those engaged in high-risk activities or in immigrant populations that tend to have minimal contact with the indigenous population.  The public health organizations of these Northern European countries consider HBV to be a minor public health problem best addressed by targeted vaccination.  The cost of instituting universal vaccination would not offset the benefit of further reduction in HBV prevalence in their countries.

It is interesting to note that though these countries have low baseline rates of HBV infection, they have not generated the same relative decrease in rates that countries, like the US, have been able to produce with universal HBV vaccination.  This fact, in combination with high immigration rates to these countries from areas of heavy HBV, makes it likely that the cost/benefit ratios of the Northern European countries will sway even more strongly in favor of universal HBV vaccination over the next several years.

It is also worth noting that of the many factors being weighed by the medical community and public health officials of these Northern European nations, serious concerns of the Hepatitis B vaccine’s efficacy or safety are not among them.

Conclusion

We will continue to make progress in medicine by never being satisfied the care we provide is good enough; the ongoing debate about how best to apply the Hepatitis B vaccine is an excellent example of this concept.  The inconsistency between these nations’ vaccination policies is little more than physicians and health care officials seeking the most efficient and effective use of the vaccine within the unique conditions inside their borders.

I don’t know. The mainstream media is doing a wonderful job sensationalizing this case, presenting it without skepticism. Some outlets are doing a good job of discussing the relevant issues – but they don’t have the information to have a meaningful discussion of this particular case. Details are tantalizing but thin.

The case is that of Rom Houben. The story was broke, as far as I can tell, by the Mail Online – yes, that is a huge red flag. It does not make the story wrong, it just doesn’t instill in me confidence in the reporting.

Mr. Houben was in a terrible motor vehicle accident 23 years ago and has been paralyzed ever since. His diagnosis has been PVS – persistent vegetative state. However, recently, we are told, his mother insisted on a neurological re-evaluation. This is actually quite reasonable, generally speaking (again, without knowing specific details of this case).

As a result Dr. Steven Laureys did some advanced neuro-imaging on Mr. Houben. Laureys is a neurologist with not only legitimate but impressive expertise in coma and disorders of consciousness. Often the press throws around the term “top expert” without any meaning, but in this case the term seems appropriate.

I do not know what imaging was done, but Dr. Laureys’ team is doing research using functional MRI scanning and MRI spectroscopy – techniques which infer brain function from blood flow or metabolism. They are using these scanning techniques, during resting and activated states, to see how much cortical brain function there is in patients in apparent coma.

According to the press reports, Dr. Laureys found that Houben’s brain function was intact, or almost intact. This led to further evaluation of Mr. Houben’s clinical state, and it was discovered that he was able to communicate by typing out messaging on a board. Mr. Houben soon began recounting how he was awake the whole time, screaming inside his head, and eventually retreated into his dreams. He now feels like he has been reborn and looks forward to interacting with his family.

This is a wonderful story for the media. But to this neurologist, and I would think to any critically-thinking journalist, some questions come to mind. The biggest problem with this case as presented is that the finger-typing of Mr. Houben looks suspiciously like facilitated communication.

But first, a little background.

Coma, PVS, Minimally Conscious State, and Locked In Syndrome.

I have written previously about the various types of coma or disorders of consciousness. There are three states that are worth defining to understand this and similar cases. The first is persistent vegetative state (PVS) in which there is insufficient brain activity to general consious awareness. People in a PVS may display signs of wakefullness, like moving their eye and opening their mouths, but do not interact with their environment.

It is important to note that many people in PVS have documented brain damage of such an extent that there really is no question about the diagnosis, or their prognosis.

But, of course, there is also a gray zone, or transition from PVS to minimally conscious state (MCS). In an MCS a person cannot communicate but they do display signs that they can respond to their environment. Prognosis is very poor, like in PVS, but one notch above hopeless, with rare cases of meaningful recovery.

I must point out at this point also that I am talking about chronic states – not people who are days or weeks after an injury or event. People can recover after a significant injury, but they typically show potential for recovery early on. After months or years in a coma, the prognosis is grim.

In terms of diagnosis, it can be challenging to distinguish between PVS and MCS – it’s the different between no signs of consciousness and minimal signs of consciousness. Of course, there may be very subtle signs that are missed. And as our technology improves, we are sure to have greater sensitivity and pick up more cases of MCS misdiagnosed as PVS.

It remains to be seen, however, if the subtle distinction is clinically meaningful.

To add to the complexity, however, there is a condition call locked in syndrome. In this (thankfully rare) syndrome patients are conscious but paralyzed. For example, a brainstem stroke might cause a person to be paralyzed below the eyes – all they can do is blink and move their eyes. But they are fully conscious if the thinking part of the brain is intact.

Facilitated Communication

Facilitated communication, or FC, has nothing to do with coma but is relevant to this case because of some of the media reports. FC is the technique of holding a patient’s hand to “help” them communicate by pointing to letters on a board.

When FC was first proposed to the therapy community, it seemed like a powerful new technique – countless children who were thought to be too brain damaged to communicate were believed, due to FC, to actually have almost intact intellects trapped inside a non-communicating body.

Unfortunately, FC was promoted prior to proper scientific validation. When it was studied in properlyh controlled blinded trials it turned out the the facilitator, and not the client, was doing all the communicating. FC is nothing but a well-meaning delusion. But it is also a dangerous one – FC testimony has led to the false conviction of adults accused of abuse.

While we do not want to miss any cases of a person’s hidden ability to communicate, the FC experience teaches us to be cautious. We must always ask – is communication (or any sign of consciousness) real? Has it been validated in an objective and controlled way?

The Houben Case

I am always a bit uneasy analyzing these media cases, because I often do not have direct access to the patient or the medical records. So I have to add the standard disclaimer – my analysis is based upon the information that has been made public, not a thorough medical evaluation of the patient. I can often only analyze the pieces of evidence I am given, and speculate as to probabilities.

In this case there are several interesting aspects that do not all fit together. The first question is whether or not it is plausible that a patient would be diagnosed as being PVS when in fact they were locked in (that is the claim in this case). That would be unusual, but not impossible.

Typically when patients are locked in there is identifiable damage that can produce widespread paralysis, but the cortex should be relatively spared. In addition, there are typically some residual functions remaining, like eye movements. But it is possible for even that to be lacking.

More likely is the possibility that Mr. Houben was initially comatose but then over the years his brain function improved until he was able to be conscious. But by that time he was paralyzed and debilitated, and so not able to move to demonstrate his consciousness – locked in. Also by that time he would likely be in a chronic care facility and may not have had close neurological exams.

So while this would be an usual case, I can buy it. Further, this is consistent with the finding of preserved cortical activity on functional scanning.

The implications of this case, and similar cases, is that we need to use careful and standardized neurological exams to assess comatose patients, and they should be periodically reevaluated. But at the same time – not all cases have the potential to improve. Some patients are injured beyond the plausibility of making meaningful recover, and families should be given a realistic assessment of their loved-one’s condition. Also  – cases like this are the rare exception, not the rule.

Now comes the tricky part – the clinical correlation. Looking at brain anatomy and activity is important, but must be placed into a proper clinical context. At present, the clinical exam is still critical.

I don’t know what Mr. Houben’s exam is. But I do have a video of him communicating. What I can say with high confidence is that this is a video of bogus facilitated communication. The “facilitator” appears to not just be supporting Houben’s hand, but moving it around the keyboard.

Houben is looking in the general direction of the keyboard, but at times not directly at it (which is necessary for single finger typing). It is not clear if he can even see, and since his eyes are not in line it is not clear which eye he would be using.

His hand is also in a brace; his finger is not touching the board – the plastic of the brace is – so he would have little sensory feedback.

And yet his hand flies dextrously across the board typing very quickly. It seems impossible that someone with his level of paralysis, and years of inactivity, would be able to type so quickly with just a little “support”. There is little doubt, in other words, that his typing is the product of bogus FC – the facilitator is doing the communicating, not Houben.

Reporting of his typing is without skepticism, and so basic questions are not addressed. It would also be almost trivial to test whether or not the communication were legitimate – the report says he responds in Flemish – so have a non-Flemish speaking facilitator hold his hand. Apparently, he also understands English so you could have a non-English speaking facilitator answer questions posed in English. Or blind the facilitator to the keyboard or visual information that Houben has access to.

What would not be sufficient, however, is a knowledge test – asking Houben about events in the past or about his life, for example. This is too difficult to tightly control – a facilitator may have been contaminated, or may just make obvious or lucky guesses.

In an interview for NPR, Laureys reports that the family came up with the method of communication, and it was validated by having Houben identify objects that were show to him – that’s it. Laureys also reports that the medical doctors were skeptical of this communication, and it seems right that they were.

Until a tightly controlled test is done, the FC evidence is worthless.

But I do not know if this is the only clinical evidence of consciousness in Houben. Perhaps he can do what other locked in patients can do – tap once for “yes” and twice for” no,” for example. Maybe the FC is a later addition – a misguided attempt to communicate with Houben, who really is locked in. (In which case I wonder what he thinks about his facilitator – perhaps he is still screaming in his head, “get rid of this nut and let’s go back to the finger tapping.”)

The only thing I am certain about in this case is that the typing out of messages through FC is bogus. Otherwise, I do not have access to sufficiently detailed information to make any specific conclusions.

Hopefully, more information will come to light as further journalists are attracted to this case. Also, I have e-mailed Dr. Laureys hoping to get some more information directly from him. He responded with a link to his paper on this topic, but there is no identifiable information in the paper about Houben. He simply says that Houben illustrates the problem discussed in his paper – the misdiagnosis of MCS as PVS. He did not comment on the FC used in this case. If I get any further information I will write a follow up.

Meanwhile, this case stands as a cautionary tale – mostly about the dangers of the media discussing the implications of a story before the facts have been verified. It may also be a rare case of misdiagnosed locked in syndrome. My best guess is that Dr. Laureys is correct about the preserved cortical activity, but he is simply not familiar with the phenomenon of FC (he did not sound familiar on the interview) and has been deceived by it.  If this is so, then the FC is an unfortunate distraction from this case (and getting disproportionate attention from the media). I am already reading science bloggers comment on the fact that the video of Houben typing calls the whole case into question.

It is also, in my opinion, a further abuse of this patient. Mr. Houben, if he is truly conscious, has now been deprived once again of his ability to communicate – usurped by a facilitator, who will be communicating in his name (and even writing a book, we are told). Never underestimate the ability for pseudoscience to make a bad situation worse.

Addendum: Here is a new video in which Houben clearly has his eyes closed while the “facilitator” is typing furiously. This is completely impossible. (Hat tip to Orac for the link – he has also discussed the case.)

It is a potentially devastating indictment of the rising C-section rate. Most midwifery and “natural” childbirth websites claim that elective C-section triples the rate of neonatal mortality. Mainstream web sites like Feministing.com, and newspapers like The New York Times have repeated the claim. There’s just one problem. It’s not true.

The claim originated with the paper Infant and Neonatal Mortality for Primary Cesarean and Vaginal Births to Women with “No Indicated Risk,” United States, 1998–2001 Birth Cohorts, MacDorman et al, Birth Volume 33 Page 175, September 2006. According to the authors:

Neonatal mortality rates were higher among infants delivered by cesarean section (1.77 per 1,000 live births) than for those delivered vaginally (0.62). The magnitude of this difference was reduced only moderately on statistical adjustment for demographic and medical factors, and when deaths due to congenital malformations and events with Apgar scores less than 4 were excluded. The cesarean/vaginal mortality differential was widespread, and not confined to a few causes of death. Conclusions: Understanding the causes of these differentials is important, given the rapid growth in the number of primary cesareans without a reported medical indication.

The implication, of course, is C-sections done without a medical indication raises the risk of neonatal death by a factor of three. The entire study hinges on a critical detail. Are women with “no indicated risk” really women who have no risk factors? The answer is a resounding no.

Since birth certificates are such an important source for research information, they have been repeatedly studied for accuracy. Birth certificates are highly accurate for administrative data like parents’ names or numerical data like weight or Apgar scores. It is well known, however, that they are highly inaccurate when it comes to listing complications.

How Well Do Birth Certificates Describe the Pregnancies They Report? The Washington State Experience with Low-Risk Pregnancies, Dobie et al report:

Conclusions: Because birth certificates significantly underestimated the complications of pregnancies, number of interventions, number of procedures, and prenatal visits, use of these data for health policy development or resource allocation should be tempered with caution.

The reporting of pre-existing maternal medical conditions and complications of pregnancy on birth certificates and in hospital discharge data,  M. Lydon-Rochelle,  et al. found:

Results Birth certificate and hospital discharge data combined had substantially higher true-positive fractions than did birth certificate data alone for cardiac disease (54% vs 29%), acute or chronic lung disease (24% vs 10%), gestational diabetes mellitus (93% vs 64%), established diabetes mellitus (97% vs 52%), active genital herpes (77% vs 38%), chronic hypertension (70% vs 47%), pregnancy-induced hypertension (74% vs 49%), renal disease (13% vs 2%), and placenta previa (70% vs 33%)… Conclusion In Washington, most medical conditions and complications of pregnancy that affect mothers are substantially underreported on birth certificates,…

In other words, for virtually every serious pregnancy complication, that information was missing from the birth certificate in more than half the cases.

Even a cursory look at the data showed that the authors assumptions were entirely unfounded. Women in the group characterized as planned C-sections for “no medical indication” had birth certificates that indicated that they had been in labor for hours before the C-section. Although the indications had been absent, it was clear that there must have been indications for the C-section.

In response to pointed criticism in the Letters to the Editor, the authors who had originally looked at births from the 1998-2001 cohort, now looked at births from the 1999-2002 cohort, performing the same analysis but applying an intention to treat methodology. The paper entitled Neonatal Mortality for Primary Cesarean and Vaginal Births to Low-Risk Women: Application of an “Intention-to-Treat” Model was published in February 2008. As the authors explained:

… an “intention-to-treat” methodology, a methodology commonly used in medical research… [E]mergency cesarean sections performed after a woman was in labor would be combined with vaginal births to create a “planned vaginal delivery” category since the original intention of the physician and the mother in both cases was presumably to deliver the infant vaginally. The “planned cesarean delivery” group would include only those deliveries where a cesarean section was performed without labor.

This analysis led to very different results:

… In the most conservative model, the adjusted odds ratio for neonatal mortality was 1.6 (95% CI 1.35–2.11) for cesareans with no labor complications or procedures, compared with planned vaginal deliveries. Conclusions: The finding that cesarean deliveries with no labor complications or procedures remained at a 69 percent higher risk of neonatal mortality than planned vaginal deliveries is important, given the rapid increase in the number of primary cesarean deliveries without a reported medical indication.

So now instead of claiming that C-sections increase the risk by a factor of 3, they are claiming that C-sections increase the risk of neonatal death by only half that amount. But the authors still do not address the primary flaw of the study. They really have no idea which C-sections were indicated and which were not. The difference is critical. If only 0.002% of the remaining birth certificates were missing risk data, there would be no difference in mortality in the two groups at all. Based on what we know about the reliability of birth certificate data, there is reason to believe that far more than 0.002% of birth certificates lack the relevant data.

The bottom line is that MacDorman and colleagues never showed that C-section increased the risk of neonatal death by any amount.. They demonstrated an entirely different principle: garbage in, garbage out. When you apply statistical analysis to erroneous data, you reach unsubstantiated, erroneous conclusions.

Antithrombin deficiency is a hereditary disease causing low levels or defects of antithrombin, a blood protein required for controlling clot formation. Patients are at risk of blood clots, organ damage, and death. They usually have to take oral anticoagulant drugs like warfarin for life.

During high-risk procedures like surgery or childbirth, oral anticoagulants must be discontinued to minimize the chance of bleeding complications. While patients are off oral anticoagulants, they are given preventive treatment with antithrombin derived from pooled human blood. With any human blood product there is a small risk of infection with diseases like hepatitis C. And human antithrombin supplies are not plentiful.

Clever researchers found an ingenious solution. Put a human antithrombin gene in goats, milk them, isolate the human antithrombin protein from the milk, and voila! An udderly safe and plentiful source. A Brit might call it bleatin’ brilliant.

Yes, transgenic goats. No, they are not human/goat hybrids, despite a recent report that a goat had given birth to a human faun in Zimbabwe.

Sex between humans and animals does happen, but it can’t result in pregnancy because of the chromosome differences and other factors. 28% of men with bestial desires are attracted to goats. Goats come fourth after canines, equines and bovines.

You probably don’t know anyone who practices bestiality, but that doesn’t mean it doesn’t happen. I was e-mailed a video clip filmed by a Marine unit in Iraq, a light magnified night image (Improved Thermal Sight System). The marines were monitoring a known Taliban safe house. When they saw a suspect acting strangely, they thought he might be emplacing an IED. As they filmed him, they realized he was copulating with a donkey. They caught the whole thing on video. The best part is their comments as they watch the blurry images and gradually realize what they are seeing. It was apparently on YouTube briefly before it got banned. There is a similar clip with two Iraqis, one holding the donkey, that hasn’t been banned yet.  Of course, I can’t guarantee this isn’t video trickery. But in 2005 there was a well-documented case of a man who died after having sex with a horse just a few miles from where I live. Washington State is one of 17 states where sex with animals is not against the law. Instead of choosing a receptive female equine, this unfortunate man chose a stallion. The man died of a perforated colon; the horse suffered no physical damage, although I suppose we could speculate about possible psychological damage…  The whole thing was caught on videotape. Now there is even a movie. I report the facts without judgment: humani nihil a me alienum puto.

Pardon the prurient diversion. Back to the subject. Transgenic goats can’t be created by such “natural” methods: they require complicated tricky maneuvers in the lab. They are just like normal goats in every respect except that they produce one human protein, antithrombin. Still, it’s a wonder the religious fundamentalists haven’t been denouncing the evil scientists and bombing goat labs. Do they even know about this?

The recombinant human antithrombin is marketed under the brand name ATryn. It has been approved by the FDA for patients with antithrombin deficiency who are undergoing surgery or childbirth. Two clinical studies were done with 5 and 14 patients, respectively. Small studies, but it didn’t seem to call for a lot of investigation since it only amounted to replacing one of the patients’ own deficient proteins. No serious adverse events were reported.

The Medical Letter has evaluated ATryn (Volume 51, issue 1323, October 19, 2009. pages 83-63) and concluded it is a safe and effective source of replacement that may well turn out to have additional therapeutic applications.

Only one problem. It costs $2.34 per international unit, and patients in one study received anywhere from 39,200 IU to 294,000 IU. That adds up to $91,728 to $687,960 for one course of treatment for one patient. The manufacturer has a patient assistance program, but WOW! That’s a lot of money to protect one patient during childbirth! We don’t yet know how many patients will need to be treated to prevent one blood clot or save one life.

I can’t stop thinking about this. I am constantly amazed at the cost of some of the new drugs with limited applications, especially chemotherapy. And it’s not just the new, limited-use drugs. I recently got a prescription for what I thought was a cheap old antibiotic long available as a generic, and I was appalled at the price. It was more than ten times what I would have guessed.

It’s wonderful that science can accomplish such feats, and I have no ethical qualms about using goats as factories to help humans, but I wonder about the ethics of saddling society with unaffordable bills for treatments that provide only a small advantage. As we develop more of these expensive drugs, we could go bankrupt trying to provide them for every patient. It’s a dilemma that bears thinking about before it happens. One of the 4 basic principles of medical ethics is justice, or fair distribution of medical services to society.

However you look at it, our technical ability will eventually outrun our ability to pay.

Editor’s Note: Dr. Mark Crislip has been kidnapped by anti-vaccinationists. Fortunately, we have sent our black Illuminati, pharma-funded, vaccine-wielding helicopters to rescue him, but unfortunately, as a result of his trauma, his usual Friday post is likely to be delayed either until this afternoon or Saturday. In any case, fortunately for us our latest addition to the SBM crew, Dr. Tuteur, was willing to fill in on short notice; so here she is. Dr. Crislip will post by tomorrow. To whet your appetite for his patented sarcasm, let me just say that he will be having a little fun with a certain article from The Atlantic about flu vaccines. There, now doesn’t that make you want to check back tomorrow to find out what his take is on the article? I thought it would.

Buried in the midst of it new report, Monitoring emergency obstetric care; a handbook, the World Health Organization acknowledges what obstetricians have been saying for some time. The WHO’s goal of a 10-15% C-section rate lacks any empirical basis.

Earlier editions of this handbook set a minimum (5%) and a maximum (15%) acceptable level for caesarean section. Although WHO has recommended since 1985 that the rate not exceed 10–15%, there is no empirical evidence for an optimum percentage or range of percentages …

Of course, they’re not going to give up their recommendation simply because there is no science that supports it, insisting that “a growing body of research that shows a negative effect of high rates.”

Dr. Marsden Wagner, former head of the Perinatal Division of the WHO, appears to be responsible for the purported optimal C-section rate of 10-15%, the level at which both maternal and neonatal mortality rates are supposedly the lowest. Ironically, Dr. Wagner is a co-author of a recent study that actually demonstrates the opposite.

The paper is Rates of caesarean section: analysis of global, regional and national estimates (Paediatric and Perinatal Epidemiology, 2007; 21:98–113.) The article explicitly acknowledges that the 15% C-section rate recommendation was made without any data to support it:

Since publication of the WHO consensus statement in 1985, debate regarding desirable levels of CS has continued; nevertheless, this paper represents the first attempt to provide a global and regional comparative analysis of national rates of caesarean delivery and their ecological correlation with other indicators of reproductive health.

The data regarding C-section rates below 10% is stark:

…[T]he majority of countries with high mortality rates have CS rates well below the recommended range of 10–15%, and in these countries there appears to be a strong ecological association between increasing CS rates and decreasing mortality.

How about the data on C-section rates above 15%? The authors claim:

Interpretation of the relationship between CS rates and mortality in countries with low mortality rates is more ambiguous; nevertheless, the sum total of the evidence presented here supports the hypothesis that, as has been argued previously, when CS rates rise substantially above 15%, risks to reproductive health outcomes may begin to outweigh benefits.

Not exactly. Indeed, not even close. The data show that low maternal mortality and low neonatal mortality are associated almost exclusively with high and very high C-section rates.

The article contains a variety of charts that make this clear. Of note, rather than graphing C-section rates against mortality rates, the authors chose to graph the log (logarithm) of C-section rates against the log of mortality rates. A log-log graph has the advantage of exposing tiny differences when all the values are bunched close together, but all the values are not bunched together in this situation. C-section rates occur along a broad range, and mortality rates occur along a broad range. As a consequence, the log-log graph magnifies the effect of tiny differences and minimizes the effect of large differences. Therefore, you need to be very careful in interpreting the graphs.

This is an adaptation of the chart that appears in the paper comparing C-section rate to maternal mortality (the authors claim that graphing C-section rate against neonatal mortality produces a similar result). The area representing a C-section rate of 10-15% has been highlighted in yellow. The horizontal blue line represents a mortality rate of 15/100,000. Lower mortality rates are below the blue line and higher mortality rates are above the blue line.

The data themselves are quite clear. There are only 2 countries in the world that have C-section rates of less than 15% AND low rates of maternal and neonatal mortality. Those countries are Croatia (14%) and Kuwait (12%). Neither country is noted for the accuracy of its health statistics. In contrast, EVERY other country in the world with a C-section rate of less than 15% has higher than acceptable levels of maternal and neonatal mortality. There nothing ambiguous about that.

The authors claim:

Although below 15% higher CS rates are unambiguously
correlated with lower maternal mortality; above this range, higher CS rates are predominantly correlated with higher maternal mortality.

No, that’s not what it shows at all. It shows that only countries with high C-section rates have low levels of maternal and neonatal mortality. A high C-section rate does not guarantee low maternal and neonatal mortality because C-section rate is not the only factor. For example, Latin America (represented on the chart by open diamonds) has a high rate of C-sections performed for social reasons, but does not have a low level of maternal mortality.

The bottom line is this: The only countries with low rates of maternal and neonatal mortality have HIGH C-section rates (except Croatia and Kuwait). The average C-section rate for countries with low maternal and neonatal mortality is 22%, although rates as high as 36% are consistent with low rates of maternal and neonatal mortality.

The authors’ claims are not supported by their own data. There is simply no support for a C-section rate of 15%, since virtually none of the countries with low rates of maternal and neonatal mortality have a C-section rate of 15% or below, and most have rates that are far higher. There is also no support for the claim that “the sum total of the evidence presented here supports the hypothesis that … when CS rates rise substantially above 15%, risks to reproductive health outcomes may begin to outweigh benefits”. When C-sections are performed for medical indications, there is no evidence that rising C-section rates lead to rising rates of maternal or neonatal mortality.

The authors own data indicate that a C-section rate of 15% is unacceptably low, and that the average should be at least 22%, with rates as high as 36% yielding low levels of maternal and neonatal mortality.

More than 10,000 American women each year choose planned homebirth with a homebirth midwife in the mistaken belief that it is a safe choice. In fact, homebirth with a homebirth midwife is the most dangerous form of planned birth in the US.

In 2003 the US standard birth certificate form was revised to include place of birth and attendant at birth. In both the 2003 and 2004 Linked Birth Infant Death Statistics, mention was made of this data, but it was not included in the reports. Now the CDC has made the entire dataset available for review and the statistics for homebirth are quite remarkable. Homebirth increases the risk of neonatal death to double or triple the neonatal death rate at hospital birth.

As this chart shows, the neonatal mortality rate for DEM (direct entry midwife, another name for homebirth midwife) assisted homebirth is almost double the neonatal mortality rate for hospital birth with an MD. This is all the more remarkable when you consider that the hospital group contains women of all risk levels, with all possible pregnancy complications, and all pre-existing medical conditions. An even better comparison would be with the neonatal mortality rates for CNM assisted hospital birth. The risk profile of CNM hospital patients is slightly higher than that of DEM patients, but CNMs do not care for high risk patients. Compared to CNM assisted hospital birth, DEM assisted homebirth has TRIPLE the neonatal mortality rate.

The chart shows the data for 2003-2004, but the data for 2005 has recently become available. Homebirth death continues to be far higher than death in the hospital for comparable risk women. In 2005 the neonatal death rates were CNM in hospital 0.51/1000, MD in hospital 0.63/1000 and DEM attended homebirth 1.4/1000.

No wonder the Midwives Alliance of North American (MANA), the trade union for homebirth midwives, is suppressing their safety statistics. From 2001-2008, they have collected the single largest repository of data on homebirth. The data is publicly available, but only to those who can prove they will use them for the “advancement” of midwifery, and even then, a legal non-disclosure agreement must be signed as part of the process. MANA’s data may very well confirm that homebirth with a DEM has triple the neonatal mortality rate of hospital birth for comparable risk women in the same year.

What is also notable is that the results are consistent with all existing scientific studies, including the Johnson and Daviss study (Outcomes of planned home births with certified professional midwives: large prospective study in North America). Johnson and Daviss actually showed that homebirth with a CPM has a neonatal mortality rate almost triple that of hospital birth for low risk women. The latest statistics are the most recent and most reliable confirmation of that fact.

There really is no question about it. Homebirth with a homebirth midwife dramatically increases the risk of neonatal death.

I’m very pleased to announce that Dr. Amy Tuteur, otherwise known as The Skeptical O.B., has joined Science-Based Medicine. Dr. Tuteur will fill in an area where we are lacking, namely an expert in women’s health and childbirth. For those of you who don’t know Dr. Tuteur, she is an obstetrician-gynecologist. She received her undergraduate degree from Harvard College and her medical degree from Boston University School of Medicine. Dr. Tuteur is a former clinical instructor at Harvard Medical School. Her book, How Your Baby Is Born, an illustrated guide to pregnancy, labor and delivery was published by Ziff-Davis Press in 1994. She runs the website AskDrAmy.com and has her own iPhone app, the Ask Dr. Amy Am I Pregnant Quiz. Dr. Tuteur blogs at The Skeptical OB.

We expect great things from Dr. Tuteur, and hope you will join us in welcoming her to the fold. She will begin tomorrow and will post new material every Thursday. Finally, with the addition of Dr. Tuteur, it should also be noted that, due to the demands of her day job, Dr. Val Jones will decrease her posting frequency from every Thursday to every other Thursday. She will thus not be posting this week, and her next post will be on Thursday, November 12.

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.

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!

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.

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.

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:

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.

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.

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.

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.

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

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.

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.

 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.”